laporan tahunan...laporan tahunan 2019 program farmasi pharmacy programme annual report 2019 issn...

PROGRAM PERKHIDMATAN FARMASIPHARMACEUTICAL SERVICES PROGRAMME

Kementerian Kesihatan MalaysiaMinistry of Health Malaysia

PROGRAM FARMASI

LAPORAN TAHUNAN

PHARMACY PROGRAMME ANNUAL REPORT 2019

MOH/S/FAR/04.20(AR)

PROGRAM FARMASI

LAPORAN TAHUNAN

PHARMACY PROGRAMME ANNUAL REPORT 2019

LAPORAN TAHUNAN 2019 PROGRAM FARMASI PHARMACY PROGRAMME ANNUAL REPORT 2019

ISSN 2232-1462 eISSN 2735-1254 MOH/S/FAR/04.20(AR)

Diterbitkan oleh:Program Perkhidmatan FarmasiKementerian Kesihatan MalaysiaLot 36, Jalan Universiti,46200 Petaling Jaya, Selangor.T 603 7841 3200 F 603 7968 2222

©Kementerian Kesihatan Malaysia

Hak Cipta Terpelihara. Tidak dibenarkan mengeluar ulang mana-mana bahagian artikel, ilustrasi, isi kandungan buku ini dalam apa-apa juga bentuk dan dengan cara apa jua sama ada secara elektronik, fotokopi, mekanik, rakaman atau cara lain sebelum mendapat izin bertulis daripada penulis dan penerbit.

MENGENAI LAPORAN INIABOUT THIS REPORT 02

PROGRAM FARMASI SEKILAS PANDANGPHARMACY PROGRAMME AT A GLANCE 03

PIAGAM PELANGGANCLIENT CHARTER 04

VISI & MISIVISION & MISSION 05

OBJEKTIF BAHAGIANDIVISION OBJECTIVE 06

PERUTUSAN PENGARAH KANAN PERKHIDMATAN FARMASIMESSAGE FROM THE SENIOR DIRECTOR OF PHARMACEUTICAL SERVICES 07

CARTA ORGANISASIORGANISATIONAL CHART 08

KEPIMPINAN KAMIOUR LEADERS 09

JAWATANKUASA EDITORIALEDITORIAL COMMITTEE 12

BAHAGIAN DASAR DAN PERANCANGAN STRATEGIK FARMASIPHARMACY POLICY AND STRATEGIC PLANNING DIVISION 13

1.0 PengenalanIntroduction 15

2.0 StatistikStatistic 19

3.0 Aktiviti dan SorotanActivities and Highlights 31

4.0 Pencapaian dan PengiktirafanAchievement and Recognition 42

5.0 Penerbitan dan KajianPublication and Research 48

BAHAGIAN AMALAN DAN PERKEMBANGAN FARMASIPHARMACY PRACTICE AND DEVELOPMENT DIVISION 49






BAHAGIAN PENGUATKUASAAN FARMASIPHARMACY ENFORCEMENT DIVISION 92




4.0 Kolaborasi dan Penglibatan AntarabangsaCollaboration and International Participation 113


BAHAGIAN REGULATORI FARMASI NEGARANATIONAL PHARMACEUTICAL REGULATORY AGENCY 116





5.0 Kolaborasi dan Penglibatan AntarabangsaCollaboration and International Participation 135


BAHAGIAN LEMBAGA FARMASI MALAYSIAPHARMACY BOARD MALAYSIA DIVISION 141





INSIDE THIS REPORTISI KANDUNGAN

Laporan Tahunan 2019 Program FarmasiPharmacy Programme Annual Report 2019

ABOUT THIS REPORTMENGENAI LAPORAN INI

Laporan Tahunan Program Farmasi 2019 menerangkan operasi, perkhidmatan yang ditawarkan dan pencapaian Bahagian-bahagian di dalam Program Perkhidmatan Farmasi sepanjang tahun 2019. Laporan tahunan ini memberikan gambaran yang menyeluruh untuk segala inisiatif dan aktiviti yang dilaksanakan bagi mencapai matlamat jangka pendek dan panjang yang dirancang demi meningkatkan perkhidmatan kesihatan kepada rakyat.

Pharmacy Programme Annual Report 2019 describes operations, services provided and performance of the Pharmaceutical Services Programme throughout 2019. This report provides a holistic view of initiatives and activities implemented to achieve our immediate and long-term goals towards improvement of healthcare services to the nation.

Laporan Tahunan 2019 Program Farmasi 2

PHARMACY PROGRAMME AT A GLANCEPROGRAM FARMASI SEKILAS PANDANG

Program Perkhidmatan Farmasi bertanggungjawab untuk memastikan keluaran farmaseutikal yang digunakan di dalam negara adalah mematuhi piawaian, berkualiti, selamat dan berkesan, melindungi kepentingan rakyat dengan menguatkuasakan undang-undang dan peraturan berkaitan farmaseutikal dan memastikan ubat-ubatan digunakan secara rasional oleh profesional kesihatan dan juga pengguna.

Sejak ditubuhkan pada tahun 1951, Program Perkhidmatan Farmasi telah melalui beberapa siri transformasi untuk memastikan perkhidmatan yang diberikan sejajar dengan hasrat kerajaan, setanding dengan perkembangan perkhidmatan farmasi sejagat serta kemajuan industri farmaseutikal.

Program Perkhidmatan Farmasi terdiri daripada lima (5) Bahagian utama yang diketuai oleh Pengarah Kanan Perkhidmatan Farmasi. Kelima-lima Bahagian ini mempunyai peranan yang penting dalam aspek yang berbeza dengan satu matlamat yang sama iaitu untuk menyediakan perkhidmatan farmasi yang terbaik kepada rakyat.

Pharmaceutical Services Programme ensures pharmaceutical products marketed in the country comply with the standards, are safe, efficacious and of good quality. This programme plays a role to protect the nation through enforcement of relevant pharmaceutical law and legislation and ensuring rational use of medicines by both healthcare providers and consumers.

Since its establishment in 1951, Pharmaceutical Services Programme has gone through a series of transformation in order to ensure the services provided are in line with national transformation plans, on par with international standards and advancement of pharmaceutical industry.

Pharmaceutical Services Programme consists of five (5) main divisions headed by a Senior Director of Pharmaceutical Services. These five (5) main divisions play important roles in different aspects and approaches towards the same objective that is providing the best professional pharmacy services to the nation.

BAHAGIAN DASAR DAN PERANCANGAN STRATEGIK FARMASIPHARMACY POLICY

AND STRATEGIC PLANNING DIVISION

BAHAGIAN AMALAN DAN PERKEMBANGAN

FARMASIPHARMACY PRACTICE

AND DEVELOPMENT DIVISION

BAHAGIAN PENGUATKUASAAN

FARMASIPHARMACY

ENFORCEMENT DIVISION

BAHAGIAN REGULATORI FARMASI

NEGARANATIONAL

PHARMACEUTICAL REGULATORY AGENCY

BAHAGIAN LEMBAGA FARMASI MALAYSIAPHARMACY BOARD MALAYSIA DIVISION

Pharmacy Programme Annual Report 2019 3

BIL PIAGAM PELANGGAN | CLIENT CHARTER SASARANTARGET

PENCAPAIANACHIEVEMENT

1

Keputusan penyenaraian ubat ke dalam FUKKM dimaklumkan kepada pemohon dalam masa 15 hari bekerja dari tarikh Mesyuarat Kaji Semula Senarai Ubat-ubatan KKM dijalankan.Results on MOH Formulary listing application notified to the applicant within 15 working days from the date of the MOH Drug List Review Meeting.

100% 100%

2

Pengeluaran kebenaran Import/Eksport Dadah Berbahaya dalam tempoh 7 hari bekerja dari tarikh permohonan lengkap diterimaIssuance of dangerous drugs import / export authorization within 7 working days from the date the complete application is received

100% 100%

3

Pengeluaran kebenaran Lesen Import/Eksport Bahan Psikotropik dalam tempoh 7 hari bekerja dari tarikh permohonan lengkap diterimaIssuance of psychotropics import / export authorization within 7 working days from the date the complete application is received

100% 100%

4Kelulusan e-Permit (Eksport) dalam tempoh 7 hari bekerja dari tarikh permohonan lengkap diterimaE-Permit (Export) approval within 7 working days of complete application is received

100% 100%

5Kelulusan e-Permit (Import) dalam tempoh 3 hari bekerja dari tarikh permohonan lengkap diterimaE-Permit (Import) approval within 3 working days of complete application is received

100% 100%

6

Keputusan bagi permohonan sijil iklan ubat dan iklan perkhidmatan kesihatan diproses dalam tempoh 5 hari bekerja dari tarikh permohonan lengkap diterima The result on the application for the drug advertisement certificate and health service advertisement is processed within 5 working days from the date the complete application is received

90% 93.81%

7

Pengeluaran Sijil Pendaftaran Ahli Farmasi dalam tempoh 7 hari bekerja dari tarikh terima permohonan lengkap dan menurut perundanganIssuance of Pharmacist Registration Certificate within 7 working days from receiving complete application

100% 100%

8

Pengeluaran Sijil Pendaftaran Pertubuhan Perbadanan dalam tempoh 7 hari bekerja dari tarikh terima permohonan lengkap dan menurut perundanganIssuance of Body Corporate Registration Certificate within 7 working days from receiving complete application

100% 100%

9Pengeluaran Sijil Tahunan Ahli Farmasi dalam tempoh 7 hari bekerja dari tarikh terima permohonan lengkap dan menurut perundanganIssuance of Annual Certificate within 7 working days from receiving complete application

100% 100%

10

Pengeluaran Sijil Pendaftaran Ahli Farmasi Provisional dalam tempoh 7 hari bekerja dari tarikh terima permohonan lengkap dan menurut perundanganIssuance of Certificate of Provisional Registration within 7 working days from receiving complete application

100% 100%

11

Pengeluaran Sijil Tahunan Pertubuhan Perbadanan dalam tempoh 7 hari bekerja dari tarikh terima permohonan lengkap dan menurut perundanganIssuance of Body Corporate Annual Certificate within 7 working days from receiving complete application

100% 100%

BIL PIAGAM PELANGGAN | CLIENT CHARTER SASARANTARGET

PENCAPAIANACHIEVEMENT

1Preskripsi didispen dalam tempoh 30 minit Prescription dispensed in 30 minutes

95% 96.19%

2Sijil Pendaftaran Ahli Farmasi diproses dalam tempoh 7 hari bekerjaPharmacist Registration Certificate processed in 7 working days

100% 100%

PIAGAM PELANGGAN PROGRAM PERKHIDMATAN FARMASI, IBU PEJABAT KEMENTERIAN KESIHATAN MALAYSIA

PIAGAM PELANGGAN TERAS KEMENTERIAN KESIHATAN MALAYSIA

CLIENTS’ CHARTER OF THE PHARMACEUTICAL SERVICES PROGRAMME, MINISTRY OF HEALTH HEADQUARTER

MINISTRY OF HEALTH CLIENT CHARTER


VISI VISION

MISI MISSION

Meningkatkan kesihatan rakyat menerusi kecemerlangan dalam amalan farmasi.Enchancing our nation’s health through excellence in the practice of pharmacy.

Menguatkuasakan undang-undang dan memperbaharui polisi sedia ada yang diperlukan untuk memastikan

produk farmaseutikal dan perkhidmatan memenuhi standard.

Uphold legislations and improve policies to ensure quality

pharmaceutical products and services.

Membina warga kerja yang berkeupayaan dan berkebolehan serta professional menerusi pembangunan tenaga kerja yang berkepakaran dan

berdaya saing. Build capabilities and professionalism

through talent development and workforce empowerment.

Memastikan sistem organisasi yang responsif dan efektif demi mencapai perkhidmatan yang kekal berkualiti.

Ensure effective and responsive organisational systems towards

sustainable quality services.

Memperhebatkan kolaborasi dalam memastikan amalan baik dalam

perkhidmatan sentiasa dilaksanakan dan memenuhi standard.

Intensify collaboration towards best practices and standard.


OBJEKTIF BAHAGIAN | DIVISION’S OBJECTIVES

BAHAGIAN AMALAN DAN PERKEMBANGAN FARMASIPHARMACY PRACTICE AND DEVELOPMENT DIVISION

• Memastikan akses berterusan kepada ubat-ubatan yang berkualiti, selamat dan kos efektif.

• Mengukuhkan penggunaan ubat secara selamat dan rasional ke arah kesihatan yang lebih baik.

• Meningkatkan perkhidmatan penjagaan farmaseutikal sejajar dengan standard dan amalan baik.

• Ensuring continuous access to the quality, safe and cost-effective medicines.

• Strengthening the quality and rational use of medicines towards the better health.

• Enhancing pharmaceutical care services in line with the good standards and practices.

BAHAGIAN REGULATORI FARMASI NEGARANATIONAL PHARMACEUTICAL REGULATORY AGENCY

• Memastikan produk yang diluluskan untuk dipasarkan adalah selamat, efektif dan berkualiti dan memastikan produk natural dan kosmetik yang bernotifikasi selamat dan berkualiti.

• To ensure that products approved for the local market are safe and of quality and also to ensure that natural products and cosmetics are safe and of quality.

BAHAGIAN PENGUATKUASAAN FARMASIPHARMACY ENFORCEMENT DIVISION

• Memastikan semua penjualan, pembekalan, pemilikan dan pengiklanan bahan-bahan, produk dan kosmetik mematuhi peruntukan undang-undang.

• Ensuring all sales, supply, possession and advertising of substances, products and cosmetics are in compliance with the legal provision.

BAHAGIAN LEMBAGA FARMASI MALAYSIAPHARMACY BOARD MALAYSIA DIVISION

• Memastikan pendaftaran ahli farmasi dan pertubuhan perbadanan memenuhi keperluan Akta Pendaftaran Ahli Farmasi 1951 dan peraturannya.

• Menetapkan standard bagi kelakuan, etika, kemahiran, pendidikan dan latihan, serta Pembangunan Profesional Berterusan.

• Ensuring the registration of pharmacists and body corporate complies with Registration of Pharmacists Act 1951 and its regulations.

• Setting standard for conduct, ethics, proficiency, education and training, and Continuous Professional Development (CPD).

BAHAGIAN DASAR DAN PERANCANGAN STRATEGIK FARMASIPHARMACY POLICY AND STRATEGIC PLANNING DIVISION

• Membangunkan dasar-dasar bagi sektor farmaseutikal selaras dengan keperluan penjagaan kesihatan negara.

• Memastikan pengurusan sumber yang cekap dan efisien.

• Developing policies for the pharmaceutical sector in line with the needs of national healthcare.

• Ensuring excellent and efficient resources management.


Pengarah Kanan Perkhidmatan FarmasiPERUTUSAN

Assalamualaikum Warahmatullahi Wabarakatuh dan Salam Sejahtera,

Alhamdulillah, syukur ke hadrat Allah S.W.T kerana dengan izinNya, Program Perkhidmatan Farmasi masih teguh melaksanakan amanah dan sentiasa komited menangani pelbagai perubahan dalam menangani isu-isu kesihatan yang sentiasa berkembang dari masa ke semasa. Sejajar dengan aspirasi Kementerian dan gelombang transformasi pucuk pimpinan atasan, Program Perkhidmatan Farmasi telah mengharungi cabaran-cabaran tersebut dengan cemerlang sepanjang tahun 2019.

Syabas dan tahniah kepada seluruh warga Program Perkhidmatan Farmasi kerana telah berjaya melaksanakan inisiatif dan aktiviti yang telah dirancangkan untuk tahun 2019. Dedikasi dan tekad usaha mereka telah menyumbang kepada kejayaan dan prestasi cemerlang Program ini dalam menyampaikan perkhidmatan farmasi yang terbaik kepada rakyat. Pelbagai aktiviti kolaborasi bersama agensi dalam negara dan peringkat antarabangsa telah dirakamkan serta pelbagai usaha dilaksanakan sepanjang tahun 2019 bagi meningkatkan jaringan kerjasama untuk memperkukuhkan bidang farmaseutikal negara kita. Tahniah sekali lagi diucapkan dan diharapkan usaha ini akan diteruskan di masa hadapan. Syabas juga ditujukan kepada sidang editorial atas usaha merakamkan setiap perjalanan dan pencapaian setiap Bahagian sepanjang tahun 2019.

Akhir kata, sekalung penghargaan kepada seluruh warga Program Farmasi dan semua pihak berkepentingan yang sentiasa memberi sokongan padu demi merealisasikan visi dan misi Program ini. Saya ingin menyeru kepada semua warga Perkhidmatan Farmasi agar terus berusaha untuk mencapai kecemerlangan dan semoga kita terus mengekalkan semangat kerjasama ini demi meningkatkan tahap kesihatan rakyat.

Sekian, terima kasih.

DR. RAMLI BIN ZAINAL

Pelbagai aktiviti kolaborasi bersama agensi dalam negara dan peringkat antarabangsa telah dirakamkan serta pelbagai usaha dilaksanakan sepanjang tahun 2019 bagi meningkatkan jaringan kerjasama untuk memperkukuhkan bidang farmaseutikal negara kita.


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KEPIMPINAN KAMI | OUR LEADERS

PIMPINAN PENGURUSAN ATASAN | TOP MANAGEMENT

Dr. Ramli bin Zainal

Pengarah Kanan Perkhidmatan Farmasi

Senior Director of Pharmaceutical Services

Dr. Hasenah binti Ali

Pengarah Dasar dan Perancangan

Strategik FarmasiDirector of

Pharmacy Policy & Strategic Planning

Datin Dr. Faridah Aryani binti Md. Yusof

Pengarah Regulatori Farmasi Negara

Director of National Pharmaceutical

Regulatory

Dr. Roshayati binti Mohamad Sani

Pengarah Amalan dan

Perkembangan FarmasiDirector of

Pharmacy Practice and Development

Tan Ann Ling

Pengarah Penguatkuasaan Farmasi

Director of Pharmacy Enforcement

A’tia binti Hashim

Pengarah Lembaga

Farmasi MalaysiaDirector of

Pharmacy Board Malaysia


Nur ‘Ain Shuhaila binti ShohaimiTimbalan PengarahCawangan Dasar FarmasiDeputy Director of Pharmacy Policy Subdivision

BAHAGIAN DASAR DAN PERANCANGAN STRATEGIK FARMASIPHARMACY POLICY AND STRATEGIC PLANNING DIVISION

BAHAGIAN AMALAN DAN PERKEMBANGAN FARMASIPHARMACY PRACTICE AND DEVELOPMENT DIVISION

BAHAGIAN PENGUATKUASAAN FARMASIPHARMACY ENFORCEMENT DIVISION

Mazlan bin IsmailTimbalan Pengarah Cawangan Forensik FarmasiDeputy Director of Pharmacy Forensic Subdivision

Saleha binti Abdul Rahman @ NgahTimbalan PengarahCawangan Kawalan IklanDeputy Director of Advertisement Control Subdivision

Hj Ghazali bin MansorTimbalan PengarahCawangan PerundanganDeputy Director of Legislation Subdivision

Adnan bin SaliminTimbalan PengarahCawangan Perisikan dan OperasiDeputy Director of Intelligence and Operation Subdivision

Salbiah binti Mohd SallehTimbalan Pengarah Cawangan Pengurusan Harga UbatDeputy Director of Medicines Pricing Subdivision

Rozita binti MohamadTimbalan PengarahCawangan Penjagaan FarmaseutikalDeputy Director of Pharmaceutical Care Subdivision

Fatimah binti Abdul RahimTimbalan PengarahCawangan Pengurusan Farmasi LogistikDeputy Director of Logistic Pharmacy Management Subdivision

Munira binti MuhammadTimbalan PengarahCawangan Penggunaan Ubat BerkualitiDeputy Director of Quality Use of Medicines Subdivision

Rohana binti HassanTimbalan PengarahCawangan Pengurusan FormulariDeputy Director of Formulary Management Subdivision

Latifah binti Hj. IdrisTimbalan PengarahCawangan PelesenanDeputy Director of Licensing Subdivision

Nurhairani binti Abdul LatifTimbalan PengarahCawangan Pembangunan Infrastruktur dan Kualiti FarmasiDeputy Director of Pharmacy Infrastructure Development & Quality Subdivision

Timbalan Pengarah Cawangan Pembangunan Profesion FarmasiDeputy Director of Pharmacy Professional Development Subdivision

Ezatul Rahayu binti AnuarTimbalan PengarahCawangan Teknologi Maklumat dan Informatik FarmasiDeputy Director of Pharmacy Information Technology & Informatics Subdivision

Faridah binti SaidiKetua Profesion Cawangan Pembangunan Profesion Penolong Pegawai FarmasiHead of Profession for the Pharmacy Assistants Professional Development Subdivision

Dr. Azuana binti RamliTimbalan Pengarah Cawangan Penyelidikan dan Pembangunan FarmasiDeputy Director of Pharmacy Research & Development Subdivision


BAHAGIAN REGULATORI FARMASI NEGARANATIONAL PHARMACEUTICAL REGULATORY AGENCY

Siti Aida binti AbdullahTimbalan PengarahPusat Pembangunan dan Perancangan StrategikDeputy Director for the Centre of Development and Strategic Planning

Wan Mohaina binti Wan MohammadTimbalan PengarahPusat Pasca Pendaftaran Produk dan Kawalan KosmetikDeputy Director for the Centre of Post Product Registration and Cosmetic Control

Mohammad Lukmani bin IbrahimTimbalan PengarahPusat Komplians dan PelesenanDeputy Director for the Centre of Compliance and Licensing

Rosilawati binti AhmadTimbalan PengarahPusat Pendaftaran ProdukDeputy Director for the Centre of Product Registration

Noorul Akmar binti Mohd NurTimbalan PengarahPusat Kawalan KualitiDeputy Director for the Centre of Quality Control

Dr. Zaril Harza bin ZakariaTimbalan PengarahPusat Kajian Ubat BaruDeputy Director for the Centre of Investigational New Product

PENTADBIRAN SOKONGANMANAGEMENT SUPPORT

Azlin binti AhmadKetua Unit Pusat Pentadbiran Bahagian Regulatori Farmasi NegaraHead of Administrative Unit, National Pharmaceutical Regulatory Agency

Saidatul Fariana binti Che MoriKetua Unit PentadbiranBahagian Dasar dan Perancangan Strategik FarmasiHead of Administrative Unit, Pharmacy Policy and Strategic Planning Division

Halipah binti HamdanKetua Unit KewanganBahagian Dasar dan Perancangan Strategik FarmasiHead of Finance Unit, Pharmacy Policy and Strategic Planning Division

BAHAGIAN LEMBAGA FARMASI MALAYSIAPHARMACY BOARD MALAYSIA

Salwati binti Abd. KadirTimbalan PengarahCawangan PendaftaranDeputy Director of Registration Subdivision

Siti Aisah binti BahariTimbalan PengarahCawangan Pengiktirafan dan EtikaDeputy Director of Accreditation and Ethics Subdivision


JAWATANKUASA EDITORIAL | EDITORIAL COMMITTEE

Dr. Hasenah binti AliPengarah

Bahagian Dasar dan Perancangan Strategik Farmasi

PENASIHAT | ADVISOR

EDITOR | EDITORS

Nur’Ain Shuhaila binti ShohaimiTimbalan Pengarah


Bibi Faridha binti Mohd SallehKetua Penolong Pengarah Kanan


Lau Ling WeiKetua Penolong Pengarah Kanan


Leona Tan Sze PingKetua Penolong Pengarah Kanan


Mohd Azuwan bin Mohd ZubirKetua Penolong Pengarah Kanan


Umikalsom binti IbrahimKetua Penolong Pengarah Kanan

Bahagian Lembaga Farmasi Malaysia

Syazana Akmal binti Ahmad KamalKetua Penolong Pengarah

Bahagian Penguatkuasaan Farmasi

Zulkurnain bin EmbranPenolong Pengarah Kanan

Bahagian Amalan dan Perkembangan Farmasi

Syuhadah binti Mohamed HassanKetua Penolong Pengarah Kanan

Bahagian Regulatori Farmasi Negara

Hanum Maisarah binti Abdul RahmanKetua Penolong Pengarah

Bahagian Regulatori Farmasi Negara


PHARMACY POLICY ANDSTRATEGIC PLANNING DIVISION

BAHAGIAN DASAR DAN PERANCANGAN STRATEGIK FARMASI

8,375PEGAWAI FARMASI

PHARMACIST

100%

Jumlah Perjawatan Pegawai Farmasi di Kementerian Kesihatan Malaysia

Total Pharmacist Post in the Ministry of Health Malaysia

Peratus Pegawai Farmasi yang Mencapai 40 Mata

Minimum CPDPercentage of Pharmacist Achieved Minimum 40 CPD

Points

99.72%Peratus Penolong Pegawai Farmasi yang Mencapai 40

Mata Minimum CPDPercentage of Pharmacy

Assistant Achieved Minimum 40 CPD Points

1,204PEGAWAI FARMASI KONTRAK

CONTRACT PHARMACIST

Jumlah Graduan Farmasi Dilantik Sebagai Pegawai Farmasi secara Kontrak Total Pharmacy Graduates Appointed as Contract Pharmacist

1,247FASILITI FARMASI KKM

MOH PHARMACY FACILITIES

Jumlah Fasiliti Farmasi KKM di Seluruh Negara Melaksanakan PhIS dan CPS

(Go-Live)Total MOH Pharmacy Facilities Nationwide

Using PhIS and CPS (Go-Live)

867PENYELIDIKAN FARMASIPHARMACY RESEARCH

Jumlah penyelidikan farmasi dijalankanTotal pharmacy research conducted


PHARMACY POLICY AND STRATEGIC PLANNING DIVISIONBAHAGIAN DASAR DAN PERANCANGAN STRATEGIK FARMASI

1.0 PENGENALAN | INTRODUCTION

Bahagian Dasar dan Perancangan Strategik Farmasi terdiri daripada enam cawangan utama: Cawangan Dasar Farmasi, Cawangan Pembangunan Profesion Farmasi, Cawangan Perkembangan Infrastruktur dan Kualiti Farmasi, Cawangan Penyelidikan dan Pembangunan Farmasi, Cawangan Teknologi Maklumat dan Informatik Farmasi, dan Cawangan Pembangunan Profesion Penolong Pegawai Farmasi. Fungsi keseluruhan Bahagian ini adalah:

1. Merancang, menggubal, memantau dan menilai dasar berkaitan penyampaian perkhidmatan dan profesion farmasi

2. Merancang keperluan sumber manusia untuk Perkhidmatan Farmasi di seluruh negara

3. Merancang, menyelaras, membangun dan mengembangkan sistem maklumat bagi Perkhidmatan Farmasi

4. Menyelaras dan memantau sistem kualiti Perkhidmatan Farmasi

5. Merancang dan membelanjakan peruntukan kewangan secara berhemah

Pharmacy Policy and Strategic Planning Division consists of six main branches: Pharmacy Policy Branch, Pharmacy Professional Development Branch, Pharmacy Infrastructure Development and Quality Branch, Pharmacy Research and Development Branch, Pharmacy Information Technology and Informatics Branch, and Assistant Pharmacist Professional Development Branch. The overall functions of the Division are:

1. Planning, drafting, monitoring and evaluating policy related to service delivery and pharmacy profession

2. Planning of human resource needs for the pharmacy services throughout the country

3. Planning, coordinating, developing and expanding the information system for pharmacy services

4. Coordinating and monitoring the pharmacy service quality system

5. Planning and prudent spending of the financial budget


• Merancang, menyelaras dan menjalankan semua aktiviti / pelan tindakan Dasar Ubat Nasional (DUNas) yang dikenalpasti di peringkat Jawatankuasa Teknikal / Jawatankuasa Kerja / Jawatankuasa Pemandu.

• Merancang, menyelaras dan menjalankan aktiviti pemantauan pencapaian semua komponen, Jawatankuasa Kecil dan keseluruhan pelaksanaan DUNas serta mengenalpasti masalah-masalah pelaksanaan jika ada.

• Membuat analisa ke atas data-data pemantauan setiap komponen, laporan pencapaian semua Jawatankuasa Kecil DUNas kajian-kajian spesifik yang dijalankan dan menyediakan laporan hasil penilaian.

• Merancang dan menyelaras pembangunan Pelan Strategik Program Perkhidmatan Farmasi.

• Menyelaras dan memastikan pemantauan berterusan indikator–indikator Pelan Strategik Program Perkhidmatan Farmasi mengikut tempoh pelaksanaan yang ditetapkan.

• Menyelaras keperluan maklum balas yang diperlukan bagi dasar-dasar di bawah seliaan Kementerian Kesihatan Malaysia dan dasar-dasar awam berkaitan farmaseutikal.

• Menyelaras maklum balas dan koordinasi tindak balas inter dan intra agensi bagi Program Perkhidmatan Farmasi dengan Ibu Pejabat KKM (IPKKM) dan pihak luar.

• Mengendalikan pengurusan aduan awam dan aduan produk yang diterima oleh Program Perkhidmatan Farmasi.

• Merancang dan mengkaji keperluan Pegawai Farmasi di semua fasiliti KKM bagi memastikan penyampaian perkhidmatan farmasi yang berterusan dapat diberikan di seluruh negara.

• Merancang dan menyelaras urusan pengambilan, penempatan, pertukaran dan pelan penggantian berdasarkan keperluan perkhidmatan serta memastikan pengagihan Pegawai Farmasi KKM secara optimum di seluruh negara.

• Mengkaji dan menambah baik pembangunan profesion farmasi dan skim perkhidmatan pegawai farmasi di KKM.

• Merancang, menyelaras dan memantau latihan (jangka pendek dan jangka panjang) bagi Pegawai Farmasi di peringkat Ibu Pejabat KKM.

• Plan, coordinate and implement all activities/ action plans of the National Medicines Policy (DUNas) identified at the level of the Technical Committee/ Working Committee/ Steering Committee

• Plan, coordinate and conduct monitoring activities for all components, sub-committees and overall implementation of DUNas, and identify issues related to implementation, if any

• Analyze data monitored for each component, achievement report of all sub-committees on specific studies conducted and prepare assessment reports

• Plan and coordinate the development of the Pharmaceutical Services Programme Strategic Plan

• Coordinate and ensure continuous monitoring of the Pharmaceutical Services Programme Strategic Plan according to implementation timeline

• Coordinate feedback for policies under the Ministry of Health and pharmaceutical-related policies

• Coordinate inter- and intra-agency feedback and response for Pharmaceutical Services Programme with MOH Headquarters (MOH HQ) and outside parties

• Handle management of public and product complaints received by the Pharmaceutical Services Programme

• Planning and projecting the needs of Pharmacists in MOH facilities to ensure continuous pharmacy services delivered to the nation.

• Planning and coordinating the pharmacists’ employment process and succession strategies based on service demand and ensure the distribution of MOH’s Pharmacists is optimal across the country.

• Assessing the development of the pharmaceutical profession and improving pharmaceutical service management schemes at MOH.

• Planning, coordinate and monitoring training (short term and long term) for MOH pharmacists at the states and headquarters’ office.

CAWANGAN DASAR FARMASIPHARMACY POLICY BRANCH

CAWANGAN PEMBANGUNAN PROFESION FARMASIPHARMACY PROFESSIONAL DEVELOPMENT BRANCH

FUNGSI CAWANGAN | FUNCTION OF BRANCH


• Menetapkan polisi/ piawaian pembangunan infrastruktur farmasi

• Menyelaras data pembangunan fasiliti farmasi KKM

• Merancang, menyelaras dan memantau pencapaian indikator kualiti Program Perkhidmatan Farmasi

• Menguruskan inisiatif kualiti di peringkat program

• Mengurus dan mengumpul data perolehan ubat dari fasiliti untuk tujuan penghasilan laporan Malaysian Statistics On Medicines (MSOM)

• Menganalisis data bagi projek MSOM dan projek-projek lain

• Menguruskan penyediaan draf, pengeditan dan penerbitan buku laporan MSOM secara berkala mengikut tahun

• Memantau dan mengumpul statistik status penyelidikan-penyelidikan farmasi yang dijalankan di fasiliti-fasiliti KKM

• Menguruskan dan melaksanakan projek penetapan Pharmacy Health Research Priority Areas

• Mengurus, memantau dan menjalankan aktiviti pelaksanaan projek-projek kajian nasional mengikut keperluan Program Perkhidmatan Farmasi

• Memproses dan menguruskan permohonan memperoleh data-data penyelidikan dari institusi luar untuk kegunaan penyelidikan

• Memproses dan menguruskan permohonan pelaksanaan penyelidikan secara kolaborasi dengan penyelidik dari institusi luar

• Establish policies/ standard for pharmacy infrastructure development

• Coordinate MOH pharmacy facilities developmental data

• Plan, coordinate and monitor achievement of quality indicators of the Pharmaceutical Services Programme

• Manage quality initiatives at the programme level

• Manage and collect medicines procurement data from facilities for the Malaysian Statistics on Medicines (MSOM) report

• Analyse data for MSOM Project and other projects

• Manage drafting, editing and publishing of MSOM report books periodically

• Monitor and collect statistical status of pharmacy research conducted at MOH facilities

• Manage and implement projects of the Pharmacy Health Research Priority Areas

• Manage, monitor and implement national research projects based on requirements of the Pharmaceutical Services Programme

• Process and manage applications for obtaining research data from outside institutions for research purpose

• Process and manage research applications in collaboration with researchers from outside institutions

CAWANGAN PERKEMBANGAN INFRASTRUKTUR DAN KUALITI FARMASIPHARMACY INFRASTRUCTURE DEVELOPMENT AND QUALITY BRANCH

CAWANGAN PENYELIDIKAN DAN PEMBANGUNAN FARMASIPHARMACY RESEARCH AND DEVELOPMENT BRANCH

• Merancang dan menyelaras pelaksanaan kemajuan kerjaya laluan Pakar Bidang Khusus (Subject Matter Expert – SME) dan Credentialing bagi Pegawai Farmasi KKM.

• Mengenalpasti, merancang dan memantau aktiviti Continuing Professional Development (CPD) bagi Pegawai Farmasi di Program Perkhidmatan Farmasi IPKKM serta menyelaras dan memantau aktiviti CPD Pegawai Farmasi KKM di peringkat negeri/ institusi bagi meningkatkan kompetensi.

• Menyelaras dan memantau Pegawai Farmasi KKM yang mengikuti kursus dalam pelbagai bidang farmasi di peringkat sarjana dan doktor falsafah (PhD).

• Menyelaras dan menyediakan input teknikal farmasi berkaitan urusan pembangunan sumber manusia dan modal insan melibatkan skim perkhidmatan Pegawai Farmasi di KKM.

• Planning and coordinating the implementation of the career pathway for Subject Matter Expert (SME) and Credentialing Programme for the MOH pharmacists.

• Identify, plan and monitor Continuing Professional Development (CPD) activities at the headquarters level as well as coordinating and monitoring CPD activities at the state/ institution level to enhance competency among MOH pharmacists.

• Coordinating and monitoring MOH pharmacists who are pursuing postgraduate studies.

• Coordinate and provide technical input related to human resource development and human capital for MOH pharmacists.


Teknologi Maklumat dan Komunikasi (ICT)

• Bertanggungjawab dalam mengenal pasti persekitaran bisnes dan teknologi semasa, mengenalpasti hala tuju ICT serta menyediakan pelan tindakan organisasi.

Pengurusan Projek ICT

• Menyelaras sebarang perancangan ICT serta melaksana, mengawal dan menilai projek-projek ICT termasuk projek yang lebih kompleks, besar dan berbilang.

Pengurusan Infrastruktur ICT

• Merancang, menyedia dan mengurus infrastruktur, keselamatan dan aktiviti sokongan teknikal ICT organisasi.

Pengurusan Sistem Maklumat

• Bertanggungjawab dalam pelaksanaan dan pengurusan sistem maklumat program termasuk penyediaan khidmat sokongan dan latihan, serta pelaksanaan kajian yang berkaitan.

Pengurusan Data & Standard

• Bertanggungjawab dalam perancangan dan pengurusan seni bina data dan standard serta pelaksanaan analisis, penyediaan data dan laporan bagi sistem maklumat organisasi.

Information and Communication Technology (ICT)

• Responsible for identifying current technology and business environments, identifying ICT directions and preparing organizational action plans.

ICT Project Management

• Coordinate ICT planning as well as implementing, controlling and evaluating ICT projects including complex, large and multiple projects.

ICT Infrastructure Management

• Planning, provide and managing ICT infrastructure, security and technical support activities of the organization.

Information System Management

• Responsible for the implementation and management of information systems programme including the provision of support and training services, as well as conducting relevant studies.

Data & Standard Management

• Responsible for the planning and management of data architecture and standard as well as the implementation of analysis, data and report preparation for the information system in the organization

CAWANGAN TEKNOLOGI MAKLUMAT DAN INFORMATIK FARMASIPHARMACY INFORMATION TECHNOLOGY AND INFORMATICS BRANCH

• Merancang keperluan sumber manusia untuk perkhidmatan Penolong Pegawai Farmasi di KKM

• Merancang, menyelaras dan memantau latihan Penolong Pegawai Farmasi KKM di peringkat ibu Pejabat dan negeri

• Merancang penempatan dan pengisian Penolong Pegawai Farmasi KKM secara optimum di seluruh negara

• Menambahbaik skim Perkhidmatan Penolong Pegawai Farmasi di KKM

• Mengenalpasti, merancang dan memantau aktiviti Continuous Professional Development (CPD) bagi meningkatkan kompetensi Penolong Pegawai Farmasi di KKM

• Memantau aktiviti-aktiviti pembangunan kualiti dan penyelidikan Penolong Pegawai Farmasi KKM.

• Menyelaras dan mengurus keperluan fasiliti latihan bagi pelajar Diploma Farmasi Institut Pengajian Tinggi Awam / Institut Pengajian Tinggi Swasta (IPTA / IPTS).

• Menyedia dan mengurus dokumen-dokumen MoA bersama IPTA / IPTS bagi pelajar Diploma Farmasi.

• Mengurus dan memantau penyenaraian Penolong Pegawai Farmasi awam dan swasta.

• Planning for human resource for MOH assistant pharmacist services

• Planning, coordinating and monitoring in–service training for MOH assistant pharmacist at states and headquarters level.

• Planning and optimising the placement and distribution of MOH assistant pharmacist across the country.

• Planning and coordinating the development and career pathways for MOH assistant pharmacist

• Identifying, planning and monitoring activities on Continuing Professional Development (CPD) to improve the competency of MOH assistant pharmacist.

• Monitoring the quality and research development activities of assistant pharmacist of MOH.

• Coordinate and manage the training facilities requirements for students of Diploma in Public Higher Education Institute / Private Higher Education Institute (IPTA / IPTS) Pharmacy.

• Prepare and manage MoA documents with IPTA / IPTS for Pharmacy Diploma students.

• Manage and monitor the listing of assistant pharmacist in Public and Private Sector.

CAWANGAN PEMBANGUNAN PROFESION PENOLONG PEGAWAI FARMASIASSISTANT PHARMACIST PROFESSIONAL DEVELOPMENT BRANCH


2.0 STATISTIK | STATISTICS

563 (7%)

7,812 (93%)

Jumlah Pengisian Jawatan | Total Filled PostsJumlah Kekosongan Jawatan | Total Vacancies

Rajah 1: Perjawatan Pegawai Farmasi di Kementerian Kesihatan Malaysia (KKM)Figure 1: Pharmacist Posts in Ministry of Health Malaysia (MOH)

ProgramProgramme

Aktiviti/Fasiliti Activities/Facilities

Jumlah Jawatan

Total Posts

PengisianFilled

KekosonganVacancies

Peratus Pengisian

Percentage Filled (%)

Perkhidmatan FarmasiPharmaceutical Services

Pengurusan Farmasi (IPKKM & Negeri)Pharmacy Management (MOH HQ & States)

66 63 3 95

Amalan dan Perkembangan Farmasi (IPKKM & Negeri) Pharmacy Practice and Development (MOH HQ & States)

213 207 6 97

Penguatkuasaan Farmasi (IPKKM & Negeri) Pharmacy Enforcement (MOH HQ & States)

655 630 25 96

Bahagian Dasar dan Perancangan Strategik Farmasi, IPKKM Pharmacy Policy and Strategic Planning Division, MOH HQ

43 42 1 98

Bahagian Lembaga Farmasi Malaysia, IPKKM Pharmacy Board Malaysia Division, MOH HQ

9 9 0 100

Bahagian Regulatori Farmasi NegaraNational Pharmaceutical Regulatory Division

334 325 9 97

Pengurusan Management

Bahagian Perolehan & Penswastaan, IPKKMProcurement & Privatization Division, MOH HQ

2 2 0 100

Kolej Sains Kesihatan Bersekutu College of Allied Health Sciences 5 3 2 60


ProgramProgramme

Aktiviti/Fasiliti Activities/Facilities

Jumlah Jawatan

Total Posts

PengisianFilled

KekosonganVacancies

Peratus Pengisian

Percentage Filled (%)

Kesihatan AwamPublic Health

Bahagian Perkembangan Kesihatan Awam, IPKKM Public Health Development Division, MOH HQ

6 6 0 100

Pejabat Kesihatan Daerah & Klinik Kesihatan District Health Offices & Health Clinics

2,280 2195 85 96

Perubatan Medical

Bahagian Perkembangan Perubatan, IPKKM Medical Development Division, MOH HQ

9 9 0 100

Bahagian Perubatan Tradisional & Komplementari, IPKKMTraditional & Complementary Medicine Division, MOH HQ

15 15 0 100

Hospital & Institusi Khas Hospital & Special Institutions 4,686 4255 431 91

Penyelidikan & Sokongan Teknikal Research & Technical Support

Institut Penyelidikan Klinikal Institute Clinical Research 39 38 1 97

Pusat Penyelidikan Penyakit BerjangkitInfectious Disease Research Centre 1 1 0 100

Pusat Penyelidikan Perubatan Herba Herbal Medicine Research Centre 4 4 0 100

Pusat Penyelidikan KanserCancer Research Centre 1 1 0 100

Bahagian Perancangan, IPKKM Planning Division, MOH HQ 2 2 0 100

Institut Penyelidikan Sistem KesihatanInstitute for Health System Research 4 4 0 100

Bahagian Dasar & Perancangan PenyelidikanResearch Policy and Planning Division

1 1 0 100

Jumlah Keseluruhan Grand Total 8,375 7,812 563 93

Jadual 1: Perjawatan Pegawai Farmasi mengikut Program di KKM 2019Table 1: Pharmacist Posts based on Programme in MOH 2019


0 0 0 0 0 0

12

64

1

13 13

4

8

39

Bilangan Pegawai Farmasi Yang Meletak Jawatan | Number of Resigned PharmacistsBilangan Pegawai Farmasi Yang Bersara | Number of Retired Pharmacists

0

10

20

30

40

50

60

70

Bila

ngan

Peg

awai

Far

mas

iNu

mbe

r of P

harm

acis

t

Gred | Grade

Rajah 2: Peletakan Jawatan dan Persaraan Pegawai FarmasiFigure 2: Resignation and Retirement of Pharmacists

Seramai 64 orang Pegawai Farmasi telah meletak jawatan dari 1 Januari sehingga 31 Disember 2019 dan 13 orang Pegawai Farmasi telah bersara pada tahun yang sama.

PELANTIKAN SECARA KONTRAK PEGAWAI FARMASI BAGI MENJALANI LATIHAN SISWAZAH DAN/ KHIDMAT WAJIB DI KEMENTERIAN KESIHATAN MALAYSIA (KKM) Seramai 1,204 graduan Farmasi telah dilantik sebagai Pegawai Farmasi secara kontrak pada tahun 2019.

PENEMPATAN DAN PERTUKARAN PEGAWAI FARMASI Bagi memastikan perkhidmatan yang berterusan dapat diberikan di peringkat fasiliti, penempatan dan pertukaran pegawai telah dilaksanakan untuk memastikan bilangan Pegawai Farmasi yang optimum dapat dikekalkan. Pada tahun 2019, sebanyak 1,718 permohonan pertukaran telah diproses oleh cawangan ini. Manakala, sebanyak 70 Arahan Pertukaran bagi jawatan strategik Pegawai Farmasi di KKM telah diproses.

KENAIKAN PANGKAT PEGAWAI FARMASI Seramai 1,627 Pegawai Farmasi di KKM telah menerima kenaikan pangkat pada tahun 2019.

A total number of 64 pharmacists resigned since 1st January until 31st December 2019 and 13 pharmacists retired in the same year.

APPOINTMENT OF CONTRACT PHARMACISTS FOR PROVISIONAL TRAINING AND/ COMPULSORY SERVICE AT MINISTRY OF HEALTH MALAYSIA (MOH)A total of 1,204 pharmacy graduates have been appointed as contract pharmacists in 2019.

TRANSFER AND POSTINGS OF PHARMACISTSIn ensuring continuous service delivery at the facility level, transfer and postings of pharmacists are carried out to ensure the optimum number of staff can be maintained. In 2019, a total of 1,718 applications for transfer were received. Besides, a total of 70 ‘Arahan Pertukaran’ for MOH pharmacists’ strategic post was processed.

PROMOTION OF PHARMACISTSIn 2019, a total of 1,627 MOH pharmacists being promoted to higher grades.


Gred Grade

Bilangan Pegawai Farmasi Number of Pharmacist

Utama A 0

Utama B 0

Utama C 0

Utama C (KUP) 0

UF54 274

UF52 345

UF48 637

UF44 371

Jumlah Total 1,627

Jadual 2: Bilangan Pegawai Farmasi dinaikkan pangkatTable 2: Number of pharmacists being promoted

NAIK TARAF GRED JAWATAN PEGAWAI FARMASI UPGRADING OF GRADES FOR PHARMACIST’S POSTSPada tahun 2019, sebanyak 86 jawatan telah diproses secara pindah butiran.

In 2019, a total of 86 posts have been processed for redeployment.

Negeri State

Bilangan Jawatan Pindah ButiranNumber of Redeployed Posts

Sarawak 52

Johor 12

Pulau Pinang 7

Perlis 6

WP Kuala Lumpur & Putrajaya

6

Pahang 2

Perak 1

Jumlah Total 86

Jadual 3: Bilangan Jawatan Pindah ButiranTable 3: Number of Redeployed Posts

LATIHAN DALAM PERKHIDMATAN (LDP)IN-SERVICE TRAININGS Sejumlah RM 2,489,791.43 peruntukan Latihan Dalam Perkhidmatan (LDP) telah dibelanjakan bagi memastikan kompetensi anggota farmasi di KKM.

A total RM 2,489,791.43 budget for in-service training has been spent to ensure the competency of pharmacy staff in MOH.

PENCAPAIAN MATA CONTINUOUS PROFESSIONAL DEVELOPMENT (CPD)CONTINUOUS PROFESSIONAL DEVELOPMENT (CPD) ACHIEVEMENTSPada tahun 2019, sejumlah 7,776 Pegawai Farmasi telah dibuat pemantauan bagi pencapaian mata CPD. Peratus pencapaian 40 mata CPD bagi Pegawai Farmasi adalah 100% manakala bagi Penolong Pegawai Farmasi pula adalah sebanyak 99.72%.

For the year 2019, a total of 7,776 pharmacists have been monitored their Continuing Professional Development (CPD) achievements. 100% of MOH pharmacists and 99.72% of pharmacist assistants have achieved minimum of 40 CPD points.

CUTI BELAJARSTUDY LEAVESebanyak 166 permohonan cuti belajar telah diterima pada tahun 2019. Sebanyak 34 slot bagi sarjana dan 2 slot bagi PhD telah diluluskan bagi Program Perkhidmatan Farmasi. Manakala terdapat 20 permohonan cuti belajar tanpa tajaan yang telah diluluskan sepanjang tahun 2019.

A total of 166 applications for further studies received in 2019. Out of those applications 34 slots were for Masters and 2 slots for PhD were approved for Pharmaceutical Services Programme. 20 applications for study leave without scholarship were approved in 2019.

AKTIVITI CREDENTIALING PROGRAM FARMASIPHARMACY CREDENTIALING PROGRAMMESebanyak 54 permohonan telah diterima pada tahun 2019 dan 127 permohonan Credentialing telah diluluskan meliputi pelbagai bidang dalam Farmasi.

A total of 54 applications received in 2019 and 127 applications approved for credentialing in various fields of interest in pharmacy.

PENEMPATAN DAN PERTUKARAN PENOLONG PEGAWAI FARMASITRANSFER AND REDEPLOYMENT OF ASSISTANT PHARMACISTSebanyak 7 kali urusan penempatan dan pertukaran telah berjaya dilaksanakan sepanjang tahun 2019.


GREDGRADE U40 U38 U36 U32 U32KUP/U29 JUMLAH

TOTAL

Urusan PertukaranTransfer 0 1 9 13 115 138

Urusan PenempatanRedeployment 8 21 50 25 80 184

JUMLAHTOTAL 8 22 59 38 195 322

Jadual 4: Urusan Pertukaran dan Penempatan Penolong Pegawai FarmasiTable 4: Transfer and Redeployment of Pharmacy Assistant

URUSAN CUTI BELAJAR SEPARUH GAJI (CBSG) BAGI PENOLONG PEGAWAI FARMASI KKM‘CUTI BELAJAR SEPARUH GAJI’ FOR MOH PHARMACY ASSISTANTS

Kursus dipohonCourse applied

Bilangan Pemohon (Penolong Pegawai

Farmasi KKM)Number of applicants

(MOH Pharmacy Assistant)

Nama IPTA/ IPTSName of IPTA/ IPTS

Ijazah Sarjana Muda FarmasiBachelor of Pharmacy 4

MAHSA UniversityAIMST University

Cyberjaya University College Medical SciencesUniversiti Pendjajaran, Bandung, Indonesia

Ijazah Sarjana Muda BiokimiaBachelor of Biochemistry 1 Universiti Malaya Kuala Lumpur

Ijazah Sarjana Muda Perubatan Veterinar Bachelor of Veterinary Medicine 1 Universiti Malaysia Kelantan

JUMLAHTOTAL 6

Jadual 5: Urusan Cuti Belajar Separuh Gaji Penolong Pegawai FarmasiTable 5: ‘Cuti Belajar Separuh Gaji’ for Pharmacy Assistant

PERMOHONAN PROJEK FASILITI BARU UNTUK PELBAGAI JABATAN FARMASI DI BAWAH RANCANGAN MALAYSIA KE-11 (RMKe-11) ROLLING PLAN 4 (RP4) TAHUN 2020Untuk permohonan Projek Fasiliti KKM Rancangan Malaysia Ke-11 (RMKe-11) Rolling Plan 4 (RP4) Tahun 2020 bersama Bahagian Pembangunan KKM, Cawangan ini telah terlibat secara langsung di dalam sesi ini yang telah dilaksanakan mengikut jadual sepanjang tempoh 11 Februari hingga 1 Mac 2019. Sebanyak 11 projek berkaitan perkhidmatan farmasi dari pelbagai Jabatan Farmasi telah dibentangkan permohonan dengan pecahan skop seperti berikut:

APPLICATION OF NEW FACILITY PROJECT FOR VARIOUS PHARMACY DEPARTMENTS UNDER THE 11TH MALAYSIAN PLAN (RMKe-11) ROLLING PLAN 4 (RP4) 2020For application of the 11th Malaysia Plan (RMKe-11) Rolling Plan 4 (RP4) 2020 MOH Facility Project in collaboration with the MOH Development Division, the Branch was directly involved in this session which was carried out on schedule throughout 11 February till 1 March 2019. A total of 11 pharmacy services-related projects from various pharmacy departments were presented with the following breakdowns:

Jenis Fasiliti (Perkhidmatan)Type of facility (Services)

Bilangan FasilitiNumber of facilities

Logistik Farmasi Logistic Pharmacy 4

Bilik Bersih Farmasi (Perkhidmatan Steril) Pharmacy Clean Room (Sterile Service) 4

Gabungan: Logistik Farmasi dan Bilik Bersih Farmasi Combination: Logistic Pharmacy and Clean Room 3

Jadual 6: Jenis dan Bilangan Fasiliti yang terlibat dalam Projek berkaitan Perkhidmatan FarmasiTable 6: Type and Number of Facilities involved in Pharmacy Services related Projects


Daripada 11 projek ini, hanya 7 projek yang diterima untuk dibawa ke peringkat penyenaraian Keutamaan Program Perkhidmatan Farmasi. Secara umumnya, projek-projek ini disusun dan diterima atas faktor hala tuju perkhidmatan program, jumlah kos, beban kerja sedia ada, kesediaan tapak projek, impak kepada pesakit dan proses decanting.

Daripada 7 projek keutamaan Program Perkhidmatan Farmasi, hanya 4 projek berkaitan farmasi diterima KKM untuk dibawa kepada penilaian Kementerian Hal Ehwal Ekonomi (MEA). Setelah melalui beberapa tapisan seterusnya, kelulusan projek Fasiliti KKM RMKe-11 RP4 Tahun 2020 untuk perkhidmatan farmasi telah diumumkan pada 18 November 2019 seperti berikut:

a) Projek Lulus RMKe-11 RP4 (Tahun 2020):

1. Pembinaan Baru Kompleks Farmasi Steril, Hospital Tengku Ampuan Rahimah, (HTAR), Klang, Selangor

2. Mengubahsuai Dobi kepada Kompleks Farmasi Steril, Hospital Labuan, WP Labuan

b) Projek di bawah Kerja-kerja Awalan RMKe-11 RP4 (Tahun 2020):

1. Pembinaan Baru Kompleks Logistik Farmasi dan Perkhidmatan Steril Farmasi, Hospital Tuanku Jaafar, Seremban, Negeri Sembilan

2. Pembinaan Baru Blok Wanita & Kanak-kanak dengan skop Logistik Farmasi, Unit Rekod dan Parking Bertingkat, Hospital Melaka

Out of the 11 projects, only 7 were accepted to be taken to the priority listing of the Pharmaceutical Services Programme. In general, these projects are organized and accepted on the basis of programme’s direction, total cost, existing workload, project site readiness, impact on patients and decanting process.

Out of the 7 Pharmaceutical Services Programme priority projects, only 4 pharmacy-related projects were approved by the MOH to be taken for evaluation by the Ministry of Economic Affairs (MEA). After a few rounds of screening, the approval of the RMKe-11 RP4 2020 MOH Facility Project for pharmacy services was announced on 18 November 2019 as followed:

a) RMKe-11 RP4 (Year 2020) approved projects:

1. New construction of Sterile Pharmacy Complex, Hospital Tengku Ampuan Rahimah, (HTAR), Klang, Selangor

2. Renovation of laundry of Sterile Pharmacy Complex, Hospital Labuan, WP Labuan

b) RMKe-11 RP4 (Year 2020) early work projects:

1. New construction of Logistic Pharmacy Complex and Pharmacy Sterile Services, Hospital Tuanku Jaafar, Seremban, Negeri Sembilan

2. New construction of Women and Children Block with Logistic Pharmacy scope, Record Unit and multi-storey carpark, Hospital Melaka

PERUNTUKAN BP01100 (PERALATAN PERUBATAN) TAHUN 2019 UNTUK PELBAGAI JABATAN FARMASIHasil perbincangan bermula bulan Disember 2018, Bahagian Pembangunan KKM telah meluluskan siling sebanyak RM 5,000,000.00 untuk pembelian peralatan perubatan di bawah pelbagai Jabatan Farmasi menerusi peruntukan BP01100 (Peralatan Perubatan) pada 28 Februari 2019. Selain itu, Cawangan ini turut membuat permohonan tambahan BP01100 untuk pelbagai Jabatan Farmasi kepada Bahagian Pembangunan KKM dan telah diluluskan sebanyak RM 1,774,195.00 pada 30 Oktober 2019.

Rumusan agihan peruntukan BP01100 berdasarkan keutamaan jenis peralatan di peringkat Program Perkhidmatan Farmasi adalah seperti di Jadual di bawah.

BP01100 ALLOCATION (MEDICAL EQUIPMENT) 2019 FOR VARIOUS PHARMACY DEPARTMENTSAs an output of the discussions beginning in December 2018, MOH Development Division has approved a ceiling of RM 5,000,000.00 to purchase medical equipment under various pharmacy departments through BP01100 Allocation (Medical Equipment) on 28 February 2019. Our Branch also applied for additional allocation and was approved with RM 1,774,195.00 on 30 October 2019.

The summary of the BP01100 allocation based on priority of type of equipment for the Pharmaceutical Services Programme is as shown in the table below. The listing of equipment is based on service needs, replacement for the damaged, obsolete, old and rusty equipment that are deemed harmful to the patients.

Penyenaraian peralatan ini adalah berdasarkan keperluan perkhidmatan farmasi, penggantian peralatan yang telah rosak, usang, uzur dan berkarat yang boleh memudaratkan kepada pesakit.

Bil. No.

Jenis PeralatanType of equipment

Agihan Peruntukan Asal (RM)Original allocation (RM)

Agihan Peruntukan Tambahan (RM)Additional allocation (RM)

1. Peti Sejuk Farmaseutikal Pharmaceutical fridge

1,963,500.00 742,700.00

2. Peralatan Pengeluaran (Steril & Bukan Steril)Production equipment (sterile & non-sterile)

1,485,300.00 273,705.00

3. Temperature Alarm System 97,100.00 336,000.00

4. Troli Ubat (Unit of Dose)Medicine trolley (Unit of Dose)

170,600.00 92,650.00


5. Top Loading Refrigerator 100,000.00 21,500.00

6. Peralatan MakmalLaboratory equipment

1,132,500.00 51,500.00

7. Queue Management System 51,000.00 256,140.00

JUMLAH | TOTAL 5,000,000.00 1,774,700.00

PENGURUSAN PROJEK TEKNOLOGI MAKLUMAT DAN KOMUNIKASI (ICT)Pengurusan projek ICT di bawah Program Perkhidmatan Farmasi dikawal selia oleh dua buah jawatankuasa iaitu JK Teknikal ICT dan JK Induk ICT yang berfungsi untuk memantau isu dan aspek teknikal projek ICT bagi memastikan garis panduan dipatuhi sebelum membawa projek berkaitan ke peringkat kementerian melalui Jawatankuasa Pemandu ICT, KKM. Pada tahun 2019, 3 Mesyuarat Jawatankuasa Teknikal dan 3 Mesyuarat Jawatankuasa Induk ICT Program Perkhidmatan Farmasi telah dijalankan di mana 14 permohonan projek ICT diterima dan dinilai secara teknikal.

INFORMATION AND COMMUNICATION TECHNOLOGY (ICT) PROJECT MANAGEMENTThe ICT project management under the Pharmacy Services Programme is regulated under two committees, which is ICT Technical Committee and ICT Steering Committee which serves to monitor the issues and technical aspects of ICT projects to ensure that guidelines are followed before bringing relevant projects to the ministry level through the MOH ICT Steering Committee. In 2019, 3 Technical Committee Meeting and 3 ICT Steering Committee Meeting of Pharmacy Services Programme were conducted where 14 ICT project applications were received and technically assessed.

Pembangunan SistemSystem Development

Perkakasan/Perisian (termasuk lesen)

Hardware/ Software (including licence)

RangkaianNetwork

PerkhidmatanService

JUMLAHTOTAL

DiterimaApproved 12 1 0 1 14

Diterima bersyaratConditional Approval 0 0 0 0 0

Ditolak Rejected 0 0 0 0 0

Jadual 7: Permohonan Projek ICT 2019 Table 7: ICT Project Application 2019

PENGUKUHAN SISTEM MAKLUMAT DAN APLIKASIBagi memastikan jabatan memanfaatkan ICT dalam menyokong penyampaian perkhidmatan, Cawangan Teknologi Maklumat dan Informatik Farmasi (CTMIF) secara proaktif perlu memantau dan melaksanakan pembangunan dan naik taraf sistem serta melaksanakan penyelenggaraan sesuai dengan keperluan semasa. Bagi tahun 2019, CTMIF telah melaksanakan aktiviti berikut:

i) Pembangunan Portal Research@Pharmacy Bertujuan membantu aktiviti mengumpul, menyemak dan menilai artikel dalam menerbitkan laporan teknikal penyelidikan farmasi tahunan

ii) Menyempurnakan pelaksanaan projek Pharmacy Information System & Clinic Pharmacy System (PhIS & CPS)Selaras dengan tamatnya Perjanjian Konsesi Makmal Ubat dan Stor (2011 hingga November 2019), aktiviti pelaksanaan telah diselesaikan di semua fasiliti Farmasi KKM yang bersedia dengan infrastruktur elektrik dan rangkaian MyGovNet bagi menyokong keperluan sistem

REINFORCEMENT OF INFORMATION SYSTEM AND APPLICATIONTo ensure Pharmaceutical Services Programme leverages ICT in delivering its services, Pharmacy Information Technology and Informatic Subdivision (CTMIF) proactively monitoring the development and upgrading of system as well as providing maintenance according to current requirements. In 2019, CTMIF has carried out the following activities:

i) Development of Portal Research@PharmacyTo collect, review and evaluate the articles in the publication of annual pharmaceutical research technical reports

ii) Completion of PhIS & CPS project implementationIn line with the completion of Concession Agreement of Privatisation of ‘Makmal Ubat dan Stor’ (2011 to November 2019), implementation activities were completed at all pharmacy at MOH facilities equipped with electrical infrastructure and MyGovNet network


Jenis FasilitiFacility Type

Bilangan fasiliti Go-LiveNo. of facility Go-Live Full Based Pharmacy

BasedInventory

BasedIndent Based IWP

Hospital/ InstitutHospital/ Institute 145 5 121 19 - -

MUS/ PBFN 8 - - 8 - -

PK/ PKD 108 - - 57 - 51

KK 986 17 726 18 225 -

Jumlah fasilitiTotal Facilities 1,247 22 847 102 225 51

MUS/ PBFN = Makmal Ubat dan Stor/ Pusat Bekalan Farmasi NegeriPK/ PKD = Pejabat Kesihatan/ Pejabat Kesihatan Daerah | Health Office/ District Health OfficeKK = Klinik Kesihatan | Health ClinicIWP = Integrated Web Portal

Jadual 8: Status Pelaksanaan PhIS & CPSTable 8: PhIS & CPS Status Implementation

Bil.No.

Pelaksanaan naik tarafUpgrade Implementation

HospitalHospital

InstitutInstitute PK/PKD KK Jumlah

Total

1 Pharmacy Based to Full Based (with TPC-OCHIS) - - - 6 6

2 Inventory-D to Full Based with (with HIS@KKM) 1 - - - 1

3 Inventory-B to Inventory-A - - 5 - 5

4 Inventory-E to Pharmacy Based - - - 11 11

5 Inventory-D to Pharmacy Based 6 1 - 116 123

Jadual 9: Aktiviti Naik Taraf Jenis PelaksanaanTable 9: Upgrade of Implementation Type Activity

SistemSystem

NaiktarafUpgrade

PhIS & CPS Versi 2.0 ke Versi 2.2Version 2.0 to Version 2.2

My. Pharma-C Modul PelesananLicensing Module

PRiSMA Permohonan automatik Sijil Pengekalan Ahli Farmasi Automatic application for Pharmacist Retention Certificate

Jadual 10: Naiktaraf sistemTable 10: System Upgrade

iii) Melaksanakan aktiviti tambah baik sistemAktiviti tambah baik sistem dilaksanakan mengikut keperluan dan mematuhi tatacara Pengurusan Projek dan Perolehan yang berkuat kuasa

iii) Implement system improvement activitiesSystem enhancement activities ware performed as required and are consistent with Project Management and Procurement guidelines


PENGURUSAN INFRASTRUKTUR DAN KESELAMATAN ICT Objektif utama yang perlu dicapai adalah bagi memastikan keupayaan ICT selari dengan hala tuju strategik organisasi:

• mengoptimumkan penggunaan sumber ICT bagi mengurangkan kos;

• memastikan ketersediaan infrastruktur ICT berdasarkan teknologi terkini;

• meningkatkan keselamatan dan perkhidmatan sokongan teknikal ICT bagi meminimumkan segala risiko yang boleh menjejaskan penyampaian perkhidmatan.

Aktiviti berikut telah dilaksanakan bagi memastikan kecekapan perkhidmatan:

• Perolehan melibatkan 104 unit komputer (PC), 7 unit pencetak dam 1 unit firewall selain perisian automasi pejabat serta lain-lain perisian dan lesen berkaitan.

• Naik taraf sejumlah 40 unit PC

• Naik taraf kabel rangkaian di bilik server

• Penempatan semula lokasi pusat data bagi sistem PhIS & CPS dari Shah Alam dan Cyberjaya ke Pusat Data Sektor Awam bertempat di Putrajaya dan Kulim. Aktiviti yang bermula pada Ogos 2019 berjaya disempurnakan pada 25 November 2019.

ICT INFRASTRUCTURE, SECURITY AND TECHNICAL SUPPORTThe main objective to be achieved is to ensure ICT capabilities are aligned with strategic direction of the organization:

• Optimize the use of ICT resources to reduce costs;

• Ensuring the availability of ICT infrastructure based on the latest technology;

• Improve security and ICT technical support services to minimizing risk affecting service delivery.

The following activities have been implemented for ensuring service efficiency:

• Acquisition of 104 units computer (PC), 7 units printers and 1 unit firewall besides office automation and other software and related license.

• Upgraded 40 units PC

• Upgrade the network cable in the server room

• PhIS & CPS System Data center relocation from Shah Alam and Cyberjaya to Pusat Data Sektor Awam located in Putrajaya and Kulim. This activity started in August 2019 and completed successfully on November 25, 2019.

RM8,557.00 RM44,566.53

RM466,598.00

Perkhidmatan | Service Perisian | Software Perkakasan | Hardware

Rajah 3: Perbelanjaan Perolehan ICT Sepanjang Tahun 2019Figure 3: Total ICT Expenditure Year 2019

PENINGKATAN KUALITI PERKHIDMATAN SOKONGAN PENGGUNABagi meningkatkan kecekapan pengurusan dan pemantauan aduan ICT Program Perkhidmatan Farmasi, Sistem Pengurusan Aduan Secara Atas Talian telah dibangunkan. Skop sokongan teknikal diperluaskan meliputi sokongan terhadap sistem maklumat dan aplikasi secara berpusat. Melalui sistem ini sejumlah 261 aduan telah diterima dan diambil tindakan sewajarnya.

IMPROVEMENT OF USER SUPPORT SERVICESTo improve the efficiency and monitoring of ICT related complaint in Pharmacy Services Program, the Online Complaints Management System was developed. The scope of technical support has expanded to include support for information systems and applications. A total of 261 complaints have been received via this system and action has been taken accordingly.


Portal Sokongan Berpusat ICT PPFICT Centralised Support Portal

TAHUNYEAR

JUMLAH ADUANTOTAL COMPLAINTS

2013 316

2014 577

2015 569

2016 380

2017 355

2018 270

2019 261

Jadual 11: Jumlah Aduan berkaitan ICT yang diterimaTable 11: Total Number of ICT Related Complaint Received

TAHUNYEAR

JUMLAH PENGEMASKINIAN

KANDUNGAN PORTALNUMBER OF PORTAL CONTENT UPDATES

JUMLAH KUNJUNGAN/ HIT KEPADA PORTAL

TOTAL VISIT/ HIT TO PORTAL

BILANGAN PELAWAT PORTALNUMBER OF PORTAL VISITOR

PELAWAT BARUNEW VISITOR

PELAWAT BERULANG

RETURNED VISITOR

2015 734 1,588,452 536,570 265,431

2016 640 1,743,653 505,363 351,708

2017 621 2,106,010 541,120 124,621

2018 1,191 2,212,158 621,081 377,617

2019 887 2,371,269 735,736 1,126,192

Jadual 12: Kunjungan ke Portal dan Pengemaskinian KandunganTable 12: Portal Visits and Content Updating

PENGUKUHAN TADBIR URUS DATAData merupakan aset penting bagi sesebuah organisasi. Tadbir urus data yang berkesan perlu dititikberatkan bagi memperoleh nilai maksimum, sambil melindunginya sebagai aset utama organisasi. Pada tahun 2019, CTMIF telah berjaya membangunkan Integrated Repository of Pharmacy Information System (IRIS) sebagai platform repositori data bagi sistem maklumat di bawah Program Perkhidmatan Farmasi. Pembangunan platform ini merupakan inisiatif di bawah Pelan Strategik Program Farmasi 2017-2020 yang akan berfungsi sebagai pusat bagi perkongsian dan analisis data. Sehingga Disember 2019 IRIS telah berjaya menghubungkan sistem di bawah program termasuk QUEST3+, PhIS, My.Pharma-C, ‘Pharmacist Registration Management System’ (PRiSMA), ‘Medication Error Reporting System’ (MERS) dan Sistem Data Penguatkuasaan Farmasi (eDPF).

Sehingga akhir 2019, PPF telah menyumbang 34 set data secara terbuka melalui portal Data Terbuka Sektor Awam yang antara lain bertujuan membolehkan akses terhadap data secara lebih meluas dan telus kepada rakyat. PPF dengan kerjasama Unit Pemodenan Tadbiran dan Perancangan Pengurusan Malaysia (MAMPU) juga telah berjaya menyalurkan data dari sistem QUEST3+, Sistem Pengurusan Iklan dan My.Pharma-C ke gerbang ‘Business

STRENGTHENING OF DATA GOVERNANCEData is an important asset to an organization. Effective data governance needs to be taken into account to achieve maximum value while protecting it as the primary asset of the organization. In 2019, CTMIF successfully developed Integrated Repository of Pharmacy Information System (IRIS) as a data repository platform for information systems under the Pharmaceutical Services Programme. The development of this platform is an initiative under the Pharmacy Programme Strategic Plan 2017-2020 that will serve as a center for data sharing and analysis. As of December 2019, IRIS has successfully integrated information systems under this programme including QUEST3+, PhIS, My.Pharma-C, Pharmacist Registration Management System (PRiSMA), Medication Error Reporting System (MERS) and ‘Sistem Data Penguatkuasaan Farmasi’ (eDPF).

As of the end of 2019, PSP has contributed 34 sets of open data published through the Public Sector Open Data portal, among others, aimed at enabling broader and more transparent access to data. PPF in collaboration with the Malaysian Administrative Modernisation and Management Planning Unit (MAMPU) has also successfully integrated data from QUEST3+ system, Advertisement Management System and My.Pharma-C to ‘Business Licensing Electronic Support System’ (BLESS) gateway to enable users to check


the status of licence and permit applications by Pharmacy Enforcement Division and ‘Bahagian Regulatori Farmasi Negara’ through the gateway.

Data management is an important activity to ensure that the quality and integrity of the data is maintained so that services can run smoothly. During 2019, CTMIF has processed 5,691 PhIS data update applications from MOH facilities nationwide. Among these, 276 were applications involving drug data, 4,530 for non-drug items while 885 for other data.

Licensing Electronic Support System’ (BLESS) bagi membolehkan pengguna menyemak status permohonan lesen dan permit oleh Bahagian Penguatkuasaan Farmasi dan Bahagian Regulatori Farmasi Negara melalui gerbang berkenaan.

Pengurusan data merupakan aktiviti penting bagi memastikan kualiti dan integriti data terpelihara agar perkhidmatan dapat berjalan lancar Sepanjang tahun 2019, CTMIF telah memproses 5,691 permohonan pengemaskinian data PhIS dari fasiliti KKM seluruh negara. Daripada jumlah ini, 276 merupakan permohonan melibatkan data ubat, 4,530 untuk item bukan ubat manakala 885 melibatkan lain-lain data.

BahagianDivision

Bilangan Data Terbuka yang Dikongsikan

Number of Open Data Shared

Amalan dan Perkembangan FarmasiPharmacy Practice and Development 7

Dasar dan Perancangan Strategik FarmasiPharmacy Policy and Strategic Planning 5

Penguatkuasaan FarmasiPharmacy Enforcement 6

Lembaga Farmasi MalaysiaPharmacy Board Malaysia 3

Bahagian Regulatori Farmasi NegaraNational Pharmaceutical Regulatory Agency 11

Jadual 13: Data Terbuka yang dikongsikan dengan Portal Data Terbuka Sektor Awam (DTSA)Table 13: Open Data Shared with Malaysia’s Open Data (DTSA) Portal

PEMBUDAYAAN DAN PENINGKATAN KEMAHIRAN ICTCULTIVATING AND UPGRADING OF ICT SKILL

TajukTitle

TarikhDate

PesertaParticipant

Technology Update: Self-Service Data Analytics using Tableau & Alteryx 10 Januari 2019 22

Bengkel Analisis & Pengvisualan Data 13-14 Februari 2019 36

Bengkel Pembangunan Sistem Menggunakan Kerangka Aplikasi Drupal 10-12 April 2019 25

Bengkel Pemantapan Champion PhIS & CPS 2019 (3 siri) 3-10 Oktober 2019 97

Jadual 14: Aktiviti Peningkatan Kemahiran ICT untuk Anggota FarmasiTable 14: Upgrading of ICT Skill for Pharmacy Staff


Bil.No.

NegeriState

Bil. Champion/ Trainer

No. of juara/ pelatih

2018 - 2019

Bil. Sesi latihan PhIS & CPS di FasilitiNo. of PhIS & CPS training session at facilities

Handholding/ On Job Training

Sesi Latihan Formal (Kelas Terancang)

Formal training session (Planned classes)

1 Johor 102 214 25

2 Kelantan 10 1 44

3 Selangor 149 388 25

4 Perak 108 213 16

5 Pahang 41 26 13

6 Negeri Sembilan 86 153 35

7 Melaka 26 23 4

8 Perlis 26 74 3

9 Pulau Pinang 102 374 3

10 Terengganu 66 36 13

11 Sarawak 173 283 13

12 Sabah 128 260 26

13 JKWP Kuala Lumpur & Putrajaya 35 40 6

14 JKWP Labuan 7 19 0

15 Hospital Kuala Lumpur 6 18 3

16 Kedah 43 96 0

JKWPKL = Jabatan Kesihatan Wilayah Persekutuan | Federal Territory Health Department

Jadual 15: Aktiviti Latihan Penggunaan Sistem PhIS & CPSTable 15: PhIS & CPS Usage Training Activity


HARI FARMASI SEDUNIA 2019Hari Farmasi Sedunia disambut pada 25 September setiap tahun bagi meningkatkan kesedaran awam tentang profesion ahli farmasi dan mengiktiraf kepentingan bidang farmasi di dalam perkhidmatan kesihatan. Pada tahun ini, Program Perkhidmatan Farmasi, Kementerian Kesihatan Malaysia telah berjaya menganjurkan Hari Farmasi Sedunia 2019 di Dewan Dato’ Penggawa Permatang, Kuala Selangor pada 5 Oktober 2019. Tema sambutan adalah ‘Safe and Effective Medicines for All’ yang menekankan fungsi ahli farmasi dalam memastikan keselamatan pesakit dengan meningkatkan penggunaan ubat-ubatan dengan cara yang betul dan mengurangkan kadar kesalahan pengubatan.

Bersempenaan dengan sambutan Hari Farmasi Sedunia 2019, Program Santuni Rakyat: Kenali Ubat Anda telah dilancarkan dengan majlis perasmian disempurnakan oleh YBhg. Datuk Dr. Noor Hisham bin Abdullah, Ketua Pengarah Kesihatan Malaysia. Antara aktiviti yang diadakan adalah ‘FunWalk’ dan ‘Jom Jelajah Komuniti: Kenali Ubat Anda’ yang dirasmikan oleh YB Datuk Seri Dr. Dzulkefly bin Ahmad, Menteri Kesihatan Malaysia. Beliau telah turut bersama-sama dengan ahli-ahli farmasi melawat ke rumah pesakit di sekitar Kuala Selangor untuk menilai pengurusan ubat pesakit dan mengenal pasti masalah-masalah lain berkaitan ubat-ubatan. Selain itu, aktiviti seperti pemeriksaan kesihatan, kaunseling ubat-ubatan, pameran kesihatan, ceramah kesihatan, Pharmazania dan Forum Fakta & Mitos berkaitan ubat-ubatan juga telah diadakan.

3.0 AKTIVITI DAN SOROTAN | ACTIVITIES AND HIGHLIGHTS

WORLD PHARMACIST DAY 2019World Pharmacist Day is celebrated on 25 September every year to raise public awareness of pharmacy profession and to recognize the importance of pharmacy in the health services. The Pharmaceutical Services Programme, Ministry of Health Malaysia has successfully organised the World Pharmacist Day 2019 at the Dewan Dato’ Penggawa Permatang, Kuala Selangor on 5 October 2019. The theme of the celebration was ‘Safe and Effective Medicines for All’ which emphasized the role of pharmacists in ensuring patient safety by improving right medication use and reducing medication errors.

In conjunction with the World Pharmacist Day 2019, ‘Program Santuni Rakyat: Kenali Ubat Anda’ was launched with an opening ceremony by YBhg. Datuk Dr. Noor Hisham bin Abdullah, Director General of Health Malaysia. Among the activities organised were ‘FunWalk’ and ‘Jom Jelajah Komuniti: Kenali Ubat Anda’ launched by YB Datuk Seri Dr. Dzulkefly bin Ahmad, the Minister of Health Malaysia. Accompanied by pharmacists, he visited patients around Kuala Selangor to evaluate their medication management and identify other mediation-related issues. Activities such as health check-up, medication counseling, health fairs, health talks, Pharmazania and Facts & Myths of Medicines Forum were held.

Aktiviti-Aktiviti yang Dilaksanakan Semasa Hari Farmasi Sedunia 2019

Activities organised during the World Pharmacist Day 2019

Majlis PerasmianOpening Ceremony

Pelancaran ‘Funwalk’ Funwalk Launching

Lawatan ke Rumah Pesakit

Visit to Patient’s Houses


AKTIVITI CREDENTIALING PROGRAM PERKHIDMATAN FARMASICredentialing merupakan satu aktiviti di bawah komponen sumber manusia DuNAS yang dibangunkan oleh Program Perkhidmatan Farmasi, KKM untuk memberi pengiktirafan kemahiran kepada anggota yang terlatih, mahir dan cekap dalam sesuatu bidang yang dikenalpasti.

Pada tahun 2019, Jawatankuasa Credentialing Farmasi meluluskan 127 permohonan Credentialing yang meliputi bidang – bidang berikut:

PHARMACY CREDENTIALING PROGRAMME Credentialing is one of the activities which has been introduced under the Human Resource component, National Medicine Policy and developed by Pharmaceutical Services Programme, MOH for the purpose to certify the skills of pharmacy staff in the specified areas of interest.

In 2019, the Pharmacy Credentialing Committee has approved 127 applications for credentialing in the specified areas of interest as below:

BidangCredentialing Area

ModulModule

Farmasi KlinikalClinical Pharmacy

1. Perkhidmatan Farmasi Wad Ward Pharmacy Services

• Penjagaan Rapi (ICU) Intensive Care Unit

• Pediatrik (Wad) Paediatric (Ward)

• Perubatan Medical

2. Farmasi Nefrologi Nephrology Pharmacy

3. Farmasi Respiratori Respiratory Pharmacy

4. Farmasi Retroviral Disease Retroviral Disease Pharmacy

5. Farmasi Nuklear Nuclear Pharmacy

6. Farmasi Nutrisi Parenteral Parenteral Nutrition Pharmacy

7. Farmasi Psikiatrik Pyschiatric Pharmacy

8. Farmasi Geriatrik Geriatric Pharmacy

9. Farmasi Kardiologi Cardiology Pharmacy

10. Farmasi Onkologi Oncology Pharmacy

11. MTAC Diabetes Diabetes MTAC

12. MTAC Warfarin Warfarin MTAC

13. MTAC Hemofilia Haemophilia MTAC

14. Farmakokinetik Klinikal Clinical Pharmacokinetic

KURSUS “EKSLUSIFKAN DIRIMU” BAGI PEGAWAI FARMASI KKM TAHUN 2019Kursus berstruktur ini diadakan khusus untuk Pegawai-pegawai Farmasi Gred UF54 yang bertujuan untuk mengukuhkan lagi kemahiran dan kualiti kepimpinan Pegawai Farmasi dalam meningkatkan kecemerlangan perkhidmatan dalam organisasi. Kursus tersebut telah berlangsung di Avillion Admiral Cove Hotel, Port Dickson dari 26 hingga 28 Ogos 2019.

“EKSLUSIFKAN DIRIMU” COURSE FOR MOH PHARMACISTS 2019 The structured course was organized specifically for the UF54 pharmacists. The objectives of the course were to enhance their talents and leadership skills in managing the organization towards excellence. The workshop was held at Avillion Admiral Cove Hotel, Port Dickson on 26 to 28 August 2019.

Kursus “Ekslusifkan Dirimu” Bagi Pegawai Farmasi KKM Tahun 2019

“Ekslusifkan Dirimu” Course For MOH Pharmacists 2019


BENGKEL TRAINING ROAD MAP BAGI PEGAWAI FARMASI KKM TAHUN 2019Bengkel berstruktur ini diadakan bertujuan untuk membangunkan rangka kompetensi bagi Pegawai Farmasi di Kementerian Kesihatan Malaysia. Bengkel ini diadakan secara berfasa melibatkan kumpulan sasar yang berbeza bagi membangunkan modul kompetensi fungsional untuk Pegawai Farmasi di KKM. Bengkel tersebut telah berlangsung di Hotel Best Western, i-City Shah Alam dan Dewan Serai Wangi, Petaling Jaya pada 23 hingga 25 April 2019, 24 hingga 26 Julai 2019 dan 11 hingga 13 September 2019.

TRAINING ROAD MAP WORKSHOP FOR MOH PHARMACISTS 2019 The structured workshop was organized to develop the competency framework for MOH pharmacists. The workshop was organized in phases which involved different target group as to develop functional competency module for MOH pharmacists. The workshop was held at Best Western Hotel, i-City Shah Alam and Dewan Serai Wangi, Petaling Jaya on 23 to 25 April 2019, 24 to 26 July 2019 and 11 to 13 September 2019.

Bengkel Training Road Map Bagi Pegawai Farmasi KKM Tahun 2019

Training Road Map Workshop For MOH Pharmacists 2019

BENGKEL `WORKLOAD INDICATORS OF STAFFING NEED’ (WISN)Program Perkhidmatan Farmasi KKM telah menggunakan kaedah ‘Workload Indicators of Staffing Need’ (WISN) dalam menentukan keperluan sumber manusia yang optimum berdasarkan beban tugas.

Bengkel ‘Workload Indicators of Staffing Need’ (WISN) bagi Cawangan Amalan dan Perkembangan Farmasi dan Cawangan Pengurusan Farmasi negeri telah dilaksanakan dalam menentukan keperluan sumber manusia yang optimum berdasarkan beban tugas pada kedua-dua cawangan tersebut di Bahagian Perkhidmatan Farmasi negeri.

Bengkel ini telah diadakan pada 3 hingga 5 Julai 2019 bertempat di Dewan Serai Wangi, Bahagian Regulatori Farmasi Negara. Seramai 31 orang peserta daripada Cawangan Amalan dan Perkembangan Farmasi dan Cawangan Pengurusan Farmasi negeri telah menghadiri bengkel ini.

WORKLOAD INDICATORS OF STAFFING NEED (WISN) WORKSHOPThe Pharmaceutical Services Programme, MOH has come out with the Workload Indicators of Staffing Need (WISN) method in determining the optimal number of human resources based on workload.

A Workload Indicators of Staffing Need (WISN) workshop for States Pharmacy Practice and Development Branch and State Pharmacy Management Branch has been organized to determining the optimal number of human resources based on workload for each branch in State Pharmacy Service Division.

The workshop was held on 3 to 5 July 2019 at the Dewan Serai Wangi, Bahagian Regulatori Farmasi Negara. A total of 31 participants from the State Pharmacy Practice and Development Branch and State Pharmacy Management Branch attended the workshop.

Bengkel `Workload Indicators Of Staffing Need’ (WISN)Workload Indicators Of Staffing Need (WISN) Workshop


BENGKEL MENGINTERPRETASI DATA DAN PENULISAN MANUSKRIP PENYELIDIKAN & PEMBANGUNAN (R&D) PENOLONG PEGAWAI FARMASIBengkel tersebut telah diadakan di Institut Latihan KKM, Sultan Azlan Shah, Ulu Kinta, Perak 18 hingga 20 Februari 2019. Objektif penganjuran bengkel adalah untuk meningkatkan tahap kefahaman, pengetahuan dan kemahiran para peserta dalam menghasilkan penyelidikan yang bernilai dan berimpak tinggi kepada Program Perkhidmatan Farmasi.

Seramai 40 orang peserta dari kalangan Penolong pegawai Farmasi Gred U29/U32 dan U36 telah menghadiri bengkel selama tiga (3) hari tersebut. Seramai tiga (3) orang penceramah jemputan dari Hospital Serdang dan ILKKM Sultan Azlan Shah, Ulu Kinta, Perak telah menyampaikan ceramah masing-masing dalam bengkel tersebut.

WORKSHOP FOR DATA INTERPRETATION AND RESEARCH & DEVELOPMENT (R&D) MANUSCRIPT WRITING FOR PHARMACY ASSISTANTSThe workshop was held at the MOH Training Institute, Sultan Azlan Shah, Ulu Kinta, Perak from 18 to 20 February 2019. The objective of the workshop was to increase the participants’ level of understanding, knowledge and skills in producing valuable and impactful research to Pharmaceutical Services Programme.

About 40 participants from Pharmacy Assistant of grade U29/U32 and U36 attended the three-day workshop. Three (3) invited speakers from Serdang Hospital and Sultan Azlan Shah ILKKM in Ulu Kinta, Perak delivered their talks at the workshop.

Peserta kursus bersama penceramah yang terlibat dalam bengkel tersebut

Participants and speakers involved in the workshop

KURSUS PEMANTAPAN PEMBEKALAN UBAT-UBATAN BERKUALITI Kursus tersebut telah diadakan di Dewan Serai Wangi, Bahagian Regulatori Farmasi Negara, KKM pada 18 hingga 19 Mac 2019. Objektif penganjuran kursus tersebut adalah untuk memberi kefahaman lebih jelas dan terperinci kepada para peserta tentang kepentingan membekalkan ubat-ubatan berkualiti kepada para pesakit secara profesional berdasarkan garis panduan terkini Program Perkhidmatan Farmasi, KKM. Dalam kursus tersebut seramai 60 orang peserta dari kalangan Penolong Pegawai Farmasi Gred U29 dan U32 dari seluruh negara telah menghadiri bengkel selama dua (2) hari tersebut. Sebanyak 7 ceramah telah disampaikan oleh para penceramah dari Program Perkhidmatan Farmasi KKM dan Hospital Kuala Lumpur dalam kursus tersebut.

KURSUS PEMANTAPAN PEMBEKALAN UBAT-UBATAN BERKUALITI The course was held at the Dewan Serai Wangi, Bahagian Regulatori Farmasi Negara, MOH from 18 to 19 March 2019. The objective of the course was to provide participants with a clearer and more detailed understanding of the importance of providing quality medicines to patients professionally based on the latest guidelines of the Pharmaceutical Services Programme, MOH. During the course, 60 participants of Pharmacy Assistant U29 and U32 from all around the country attended the workshop for two (2) days. A total of 7 lectures were delivered by speakers from Pharmaceutical Services Programme, MOH and Hospital Kuala Lumpur during the course.

Peserta kursus yang hadirCourse participants


KURSUS KEMAHIRAN EKSEKUTIF (MIDDLE MANAGEMENT) PENOLONG PEGAWAI FARMASI Kursus yang bertemakan “Kerja Berpasukan Pencetus Keunggulan Organisasi” tersebut telah diadakan di Institut Latihan Kementerian Kesihatan Malaysia Sultan Azlan Shah, Ulu Kinta, Perak pada 22 hingga 23 April 2019. Objektif penganjuran kursus tersebut adalah untuk melahirkan Eksekutif Penolong Pegawai Farmasi KKM sebagai personel kesihatan yang berupaya membina semangat kerja berpasukan yang mantap dalam organisasi selaras dengan hasrat kerajaan dan negara.

Seramai 60 orang peserta dari kalangan Penolong Pegawai Farmasi gred U32 hingga gred U40 dari seluruh negara telah menghadiri bengkel tersebut. Selain daripada Program Perkhidmatan Farmasi KKM, penceramah juga dijemput dari Fakulti Farmasi Dan Sains Kesihatan Universiti Kuala Lumpur (UniKL) Perak.

EXECUTIVE SKILLS COURSE (MIDDLE MANAGEMENT) FOR PHARMACY ASSISTANTS

The course with a theme of “Kerja Berpasukan Pencetus Keunggulan Organisasi” was held at the MOH Training Institute of Sultan Azlan Shah, Ulu Kinta, Perak from 22 to 23 April 2019. The objective of the course was to produce MOH Executive Pharmacy Assistant as health personnel who are capable of building a strong teamworking spirit within the organization in line with the goals of the government and nation.

60 participants of Pharmacy Assistant U32 and U40 from all around the country attended the workshop. In addition to speakers from the Pharmaceutical Services Programme, speakers were also being invited from the Faculty of Pharmacy and Health Sciences of the University of Kuala Lumpur (UniKL) Perak.

Peserta-peserta yang terlibat dalam kursus tersebut Course participants

KURSUS STRATEGI MENANGANI CABARAN PERUBAHAN DALAM PERKHIDMATAN FARMASI DI ERA MODEN BAGI PENOLONG PEGAWAI FARMASI Kursus kolaborasi bersama Universiti Kolej Antarabangsa PICOMS (PIUC) tersebut telah berjaya diadakan di Kampus Taman Batu Muda, Kuala Lumpur berkenaan pada 25 hingga 26 Jun 2019. Objektif penganjuran kursus tersebut adalah untuk mendedahkan kepada para peserta tentang cabaran-cabaran utama yang sering dihadapi di era moden dari segi kesalahan pengubatan dan penggunaan ubat-ubatan berkualiti serta halal.

Seramai 150 orang peserta dari kalangan Penolong Pegawai Farmasi gred U32 hingga gred U40 dari seluruh negara termasuk pelajar-pelajar tahun akhir Diploma Farmasi di Universiti Kolej Antarabangsa PICOMS telah menghadiri kursus tersebut. Selain daripada Program Perkhidmatan Farmasi KKM, penceramah juga dijemput dari Universiti Taibah, Madinah, Arab Saudi serta dari kolej universiti itu sendiri juga.

STRATEGIC COURSE FOR ADDRESSING CHALLENGE OF CHANGES IN MODERN ERA’S PHARMACY SERVICES FOR PHARMACY ASSISTANT The collaborative course with the PICOMS International University College (PIUC) was successfully held at the Taman Batu Muda Campus, Kuala Lumpur from 25 to 26 June 2019. The objective of the course was to expose the participants to the major challenges often encountered in modern era from the medical error, quality use of medicines and halal medicines perspective.

A total of 150 participants of Pharmacy Assistant U32 to U40 from all over the country including final year students of the Diploma in Pharmacy of PIUC attended the course. In addition to speakers from the Pharmaceutical Services Programme, speakers were also being invited from the Taibah University, Medina, Saudi Arabia as well as from the university’s own college.

Barisan urusetia terdiri dari Program Perkhidmatan Farmasi dan Universiti Kolej Antarabangsa PICOMS

Secretariat from Pharmaceutical Services Programme and PICOMS International University College


PELAKSANAAN SISTEM PENGURUSAN KUALITI MS ISO 9001:2015 Program Perkhidmatan Farmasi di Ibu Pejabat Kementerian Kesihatan Malaysia (IPKKM) telah mendapat pensijilan Sistem Pengurusan Kualiti MS ISO 9001:2015 sejak tahun 2018. Pelbagai aktiviti telah dilaksanakan dan diselaraskan oleh Jawatankuasa Kerja ISO Program Perkhidmatan Farmasi IPKKM sepanjang tahun 2019. Berikut adalah antara aktiviti yang telah dilaksanakan :

IMPLEMENTATION OF MS ISO 9001: 2015 QUALITY MANAGEMENT SYSTEMPharmaceutical Services Programme at the Ministry of Health Malaysia’s Headquarters (IPKKM) has received certification for MS ISO 9001: 2015 Quality Management System since 2018. Various activities have been implemented and coordinated by the ISO Working Committee of the IPKKM Pharmacy Services Programme throughout the year 2019. The following are some of the activities that have been carried out:

a) Bengkel Semakan Dokumen MS ISO 9001:2015 (Objektif Kualiti): 18 Februari 2019 di Bilik Mesyuarat Delima

b) Bengkel Penilaian dan Pengurusan Risiko MS ISO 9001:2015: 20-21 Februari 2019 di Dewan Anggerik

c) Bengkel Pembudayaan MS ISO 9001:2015 (Pemahaman + Pelaksanaan): 4 dan 5 Mac 2019 di Dewan Serai Wangi

d) Audit Pemantauan Sistem Pengurusan Kualiti MS ISO 9001:2015: 18-19 Mac 2019 (Penemuan: 4 Opportunity for Improvement)

e) Kursus Analisa Punca dan Tindakan Pembetulan bagi Penemuan Audit SPK MS ISO 9001:2015: 15 April 2019 di Dewan Serai Wangi

f) Bengkel Pemantapan Juruaudit Dalaman MS ISO 9001:2015: 8-9 Julai 2019 di Dewan Serai Wangi

g) Bengkel Penyediaan Senarai Semak Audit MS ISO 9001:2015: 18 September 2019 di Bilik Mesyuarat Delima

h) Audit Dalaman Bil. 1/2019 pada 1-10 Oktober 2019 (Penemuan: 8 Opportunity for Improvement)

KURSUS PEMBANGUNAN PANEL PENILAI KUMPULAN INOVATIF DAN KREATIF (KIK) HORIZON BAHARU: 12-13 FEBRUARI 2019 ANJURAN INSTITUT TADBIRAN AWAM NEGARA (INTAN) Bagi tahun 2019, Bahagian ini mengubah keutamaan latihan dengan menghantar lima orang anggota farmasi menghadiri Kursus Pembangunan Panel Penilai KIK Horizon Baharu anjuran INTAN Jalan Elmu, Kuala Lumpur pada 12-13 Februari 2019. Tujuan latihan ini adalah bagi membangunkan sekumpulan pengadil yang diiktiraf oleh pihak INTAN dari kalangan anggota farmasi yang mampu memahami kriteria pemarkahan, peringkat dan proses penilaian sesuatu projek KIK itu. Berikut adalah nama anggota-anggota farmasi yang telah berjaya mengikuti kursus tersebut:

REVIEW PANEL DEVELOPMENT FOR NEW HORIZON INNOVATIVE AND CREATIVE GROUP (KIK) COURSE: 12-13 FEBRUARY 2019 ORGANIZED BY THE NATIONAL INSTITUTE OF PUBLIC ADMINISTRATION (INTAN)In 2019, this Division changed its training priority by sending five pharmacists and pharmacists assistant to the Kursus Pembangunan Panel Penilai KIK Horizon Baharu organized by INTAN Jalan Elmu, Kuala Lumpur on February 12-13, 2019. The purpose of the training is to develop a team of judges endorsed by the National Institute of Public Administration (INTAN) among the pharmacy staffs that able to understand the scoring criteria, the evaluation stage and process of a KIK project. The following are the names of pharmacy personnel who have successfully completed the course:

Bengkel Semakan Dokumen MS ISO 9001:2015 (Objektif Kualiti)

MS ISO 9001:2015 Document Review Workshop (Quality Objective)


i. Puan Yeap Hui Bing (Ketua Penolong Pengarah UF48, Bahagian Dasar & Perancangan Strategik Farmasi)

ii. Puan Nurul Adilah Bt. Abd Mutalib (Pegawai Farmasi UF52, Hospital Selayang)

iii. Puan Asdayati Binti Buang (Pegawai Farmasi UF48, Hospital Banting)

iv. Tuan Hj. Mohd. Rozali Jaffar (Penolong Pegawai Farmasi U36, Hospital Raja Perempuan Zainab II, Kelantan)

v. Encik Mohd. Fadhli Anang (Penolong Pegawai Farmasi U32, Hospital Serdang)

BENGKEL TEORI PENYELESAIAN MASALAH INVENTIF: TRIZ (TEORIYA RESHENIYA IZABREATATELSKIKH ZADATCH) :12-13 MAC 2019 DI HOTEL CRYSTAL CROWN, PETALING JAYABengkel ini yang diadakan ulung kalinya oleh Bahagian Dasar & Perancangan Strategik Farmasi telah dihadiri sebanyak 45 orang pegawai farmasi daripada seluruh Malaysia. Peserta didedahkan dengan konsep Teoriya Resheniya Izabreatatelskikh Zadatch (TRIZ) oleh Dr Zulhasni bin Abdul Rahim, pensyarah daripada Malaysia-Japan International Institute of Technology (MJIIT), Universiti Teknologi Malaysia (UTM). TRIZ adalah kaedah penyelesaian masalah sistematik berdasarkan logik dan data, bukan intuisi atau kreativiti spontan oleh individu atau kumpulan. Pengasasnya Genrich Altshuller, merupakan seorang pengkaji hak paten berbangsa Rusia. Beliau mulai mengkaji trend dalam hak paten sejak tahun 1940 dan menghasilkan satu kaedah penyelesaian masalah yang dikenali sebagai TRIZ. Bengkel TRIZ yang merupakan latihan tahap 1 ini mendedahkan peserta tentang 39 parameter, 40 Prinsip Inventif dan 76 penyelesaian yang piawai (standard) yang dapat membantu mencipta inovasi dan seterusnya memberikan tambah nilai kepada produk, sistem, kaedah dan sebagainya.

WORKSHOP ON INVENTIVE PROBLEM-SOLVING: TRIZ (THEORY OF RESHENIYA IZABREATATELSKIKH ZADATCH) WORKSHOP: 12-13 MARCH 2019 AT CRYSTAL CROWN HOTEL, PETALING JAYAThis first-ever workshop organized by Policy & Strategic Planning Division of Pharmacy was attended by 45 pharmacists from all over Malaysia. Participants were exposed to the concept of Resheniya Izabreatatelskikh Zadatch Theory (TRIZ) by Dr Zulhasni bin Abdul Rahim, an academician from the Malaysia-Japan International Institute of Technology (MJIIT), University of Technology Malaysia (UTM). TRIZ is a systematic problem-solving method based on logic and data, not the intuition or spontaneous creativity of individuals or groups. Its founder, Genrich Altshuller, is a Russian patent rights researcher. He began studying the trends in patent rights since 1940 and came up with a method for solving problems known as TRIZ. Within this workshop which is a Level 1 training exposes participants to 39 parameters, 40 Inventive Principles and 76 standard solutions that can help innovate and add value to products, systems, methods and so on.

Sesi ceramah TRIZ

TRIZ lecture sessions

Gambar semua peserta bersama fasilitator kursus, Encik Hazrizal Zainul

Programme participants with course facilitator, Mr. Hasrizal Zainul

Sesi kerja berkumpulan

Group work session

Pembentangan hasil kerja berkumpulanPresentation of group work

Gambar semua peserta bersama pelatih TRIZ, Dr Zulhasni bin Abdul Rahim

Programme participants with TRIZ trainer, Dr Zulhasni bin Abdul Rahim


BENGKEL PENULISAN LAPORAN A3 LEAN MANAGEMENT PROGRAM PERKHIDMATAN FARMASI 2019: 17-18 JULAI, DEWAN SERAI WANGIBengkel ini adalah bertujuan meneruskan kesinambungan aktiviti Lean ke fasa terakhir iaitu analisis, penyediaan laporan dan pembentangan, serta merupakan aktiviti berterusan hasil daripada latihan dan sesi konsultasi bersama Bahagian Penyelidikan Kualiti Kesihatan (Lean Healthcare), Institut Pengurusan Kesihatan (IPK). Lima (5) proses Lean terlibat dalam bengkel ini iaitu:

WORKSHOP ON REPORT WRITING OF A3 LEAN MANAGEMENT FOR THE PHARMACEUTICAL SERVICES PROGRAMME 2019: 17-18 JULAI, DEWAN SERAI WANGIThis workshop aims to drive the continuity of Lean’s activities into the final phase of analysis, preparation of reports and presentations, as well as ongoing activities as a result of training and consultation sessions with the Division of Health Quality Research (Lean Healthcare), Health Management Institute. Five (5) Lean processes are involved in this workshop:

i. Regulatori Farmasi Negara (Pusat Pendaftaran Produk): Minor variation for New Chemical Entity (NCE) product – Prior Approval (MiV-PA) Application

ii. Penguatkuasaan Farmasi (Cawangan Kawalan Iklan): Pengeluaran kelulusan oleh Lembaga Iklan Ubat

iii. Amalan & Perkembangan Farmasi (Pengurusan Formulari): Permohonan Kelulusan Memperolehi Ubat Berdaftar di luar FUKKM

iv. Dasar & Perancangan Strategik Farmasi (Teknologi Maklumat & Informatik Farmasi): Pengurusan Aduan Peralatan ICT

v. Lembaga Farmasi Malaysia (Cawangan Pendaftaran): Proses Permohonan Sijil Pengekalan Tahunan Ahli Farmasi

Bengkel Penulisan Laporan A3 Lean ManagementWorkshop on Report Writing of A3 Lean Management

AUDIT KPI PENGARAH KESIHATAN NEGERIAudit ke atas KPI Pengarah Kesihatan Negeri telah dijalankan bersama-sama dengan Sekretariat Induk KPI KKM dari 27 Ogos 2019 hingga 7 Oktober 2019. Audit melibatkan 15 negeri dan 5 indikator PKN oleh wakil-wakil daripada bahagian yang berkaitan daripada Program Perkhidmatan Farmasi. Sebanyak 12 negeri berjaya mencapai “fully comply” manakala 3 negeri mencapai “partially comply”. Kriteria yang perlu ditambah baik di negeri tersebut ialah kefahaman auditee dan kesahihan data.

STATE HEALTH DIRECTORS’ KPI AUDITAn audit on State Health Directors’ KPI was conducted with MOH KPI Secretariat form 27th August 2019 to 7th October 2019. 5 KPIs involving 15 states was audited by representatives from related divisions under the Pharmaceutical Services Programme. 12 states successfully achieve “full comply” status while 3 states were rated “partially comply”. The criteria that could be improved in the “partially comply” states were auditee understanding and data validity.

Audit KPI Pengarah Kesihatan NegeriState Health Directors’ KPI Audit


BENGKEL GOOD CLINICAL PRACTICE (GCP) Bahagian Dasar dan Perancangan Strategik Farmasi, Kementerian Kesihatan Malaysia (KKM) dengan kerjasama Pusat Penyelidikan Klinikal (CRC) Hospital Putrajaya telah menganjurkan Bengkel Good Clinical Practice (GCP) pada 16 hingga 18 April 2019 di Dewan Serai Wangi, Bahagian Regulatori Farmasi Negara. Tujuan bengkel ini diadakan adalah untuk memberi latihan GCP kepada Pegawai-pegawai Farmasi KKM dan memastikan bahawa pegawai-pegawai berkenaan memenuhi keperluan pensijilan GCP di dalam menjalankan penyelidikan klinikal. Seramai 37 orang Pegawai Farmasi KKM dari seluruh negara telah menghadiri bengkel tersebut di mana 33 orang peserta telah lulus dalam Peperiksaan GCP dan menerima Sijil GCP.

GOOD CLINICAL PRACTICE (GCP) WORKSHOPThe Good Clinical Practice (GCP) Workshop was organised by the Pharmacy Policy and Strategic Planning Division, Ministry of Health Malaysia (MOH), in collaboration with the Clinical Research Centre (CRC) of Putrajaya Hospital, from 16 to 18 April 2019 at Dewan Serai Wangi, Bahagian Regulatori Farmasi Negara. The objective of the workshop was to provide GCP training for MOH pharmacists in fulfilment of GCP certification for clinical research. A total of 37 MOH pharmacists attended the workshop in which 33 of them have passed the GCP Examination and received the GCP Certificates.

Penyampaian cendera hati oleh Dr. Azuana Ramli kepada penceramah dan penganjur bengkel, Dr. Nurain Mohd Noor, Pakar Perunding Perubatan (Endokrinologi) dan Ketua Pusat Penyelidikan Klinikal (CRC), Hospital

PutrajayaDr. Azuana Ramli presented a token of appreciation to the

workshop speaker and joint organiser, Dr. Nurain Mohd Noor, Consultant Endocrinologist and Head of Clinical

Research Centre (CRC), Putrajaya Hospital

Peserta-peserta sedang membuat persediaan untuk Peperiksaan GCP

The participants were preparing for the GCP Examination

BENGKEL PENULISAN MANUSKRIP PEGAWAI FARMASIBahagian Dasar dan Perancangan Strategik Farmasi, KKM telah menganjurkan Bengkel Penulisan Manuskrip Pegawai Farmasi pada 22 hingga 24 April 2019 di Hotel Eastin, Kuala Lumpur. Objektif utama bengkel ini diadakan adalah untuk meningkatkan pengetahuan dan kemahiran Pegawai Farmasi dalam penyediaan dan penulisan manuskrip yang bermutu. Ceramah bengkel tersebut telah disampaikan oleh Dr. Ernieda Md Hatah dari Universiti Kebangsaan Malaysia dan dibantu oleh Dr. Abdul Haniff Mohamad Yahaya dari Hospital Teluk Intan sebagai fasilitator. Peserta bengkel juga berpeluang untuk mendapat khidmat nasihat serta berbincang tentang manuskrip mereka dengan penceramah dan fasilitator di dalam bengkel tersebut. Seramai 27 orang Pegawai Farmasi dan seorang Penolong Pegawai Farmasi dari seluruh negara telah menyertai bengkel tersebut.

MANUSCRIPT WRITING FOR PHARMACISTS WORKSHOP Pharmacy Policy and Strategic Planning Division, MOH had organised Manuscript Writing for Pharmacists Workshop on 22 to 24 April 2019 at Eastin Hotel Kuala Lumpur. The main objective of the workshop was to improve the knowledge and skills of writing good quality manuscripts among pharmacists. The workshop was delivered by Dr. Ernieda Md Hatah from Universiti Kebangsaan Malaysia and facilitated by Dr. Abdul Haniff Mohamad Yahaya from Hospital Teluk Intan, Perak. Participants had the opportunity to consult and discuss about their manuscripts with the speaker and facilitator during the workshop. A total of 27 pharmacists and one pharmacist’s assistant had participated in that workshop.

Perserta bersama penceramah dan fasilitator bengkelParticipants together with workshop speaker and facilitator


BENGKEL MALAYSIAN ALLIANCE FOR EMBEDDING RAPID REVIEWS IN HEALTH SYSTEMS DECISION MAKING (MAERA) Bengkel penulisan MAera telah di anjurkan oleh Bahagian Dasar dan Perancangan Strategik Farmasi (BDPSF) bersama Institut Penyelidikan Sistem Kesihatan (IHSR) pada September 2019 bertempat di bilik Mesyuarat D, Institut Kesihatan Negara (NIH). Bengkel ini bertujuan melatih pegawai farmasi menggunakan kaedah ‘rapid review’ bagi mengumpul maklumat dan dokumen berkaitan untuk digunakan oleh pihak pengurusan di dalam membuat keputusan. Seramai 22 orang pegawai farmasi daripada Bahagian Amalan dan Perkembangan Farmasi, Bahangian Regulatori Farmasi, Bahagaian Penguatkuasaan Farmasi dan BDPSF itelah menghadiri bengkel ini. Para peserta telah dibahagikan kepada lima kumpulan berlainan dan lima topik berkaitan bahagian masing-masing telah dipilih untuk dibincangkan bagi menghasilkan maklumat yang diperlukan menggunakan kaedah ‘rapid review’.

MALAYSIAN ALLIANCE FOR EMBEDDING RAPID REVIEWS IN HEALTH SYSTEMS DECISION MAKING (MAERA) WORKSHOPThe MAera workshop was organized by the Pharmacy Policy and Strategic Planning Division (PPSPD), Ministry of Health Malaysia (MOH) in collaboration with the Institute of Health Research System (IHSR) on September 2019 and was held at the Meeting Room D, National Institute of Health (NIH). The main objective of this workshop was to provide training for pharmacists in using rapid review methods to synthesize evidence from literature and other documents to support decision-making. A total of 22 pharmacists from Pharmacy Practice and Development Division, Bahagian Regulatori Farmasi Negara, Enforcement Division and PPSPD attended the workshop. The participants were divided into five groups and five different topics were critically discussed for the application of rapid review methods.

Para peserta bersama penceramah dan fasilitator bengkelParticipants together with workshop speaker and facilitator

TECHNICAL MEETING ON REGIONAL COLLABORATIVE STRATEGY FOR THE ASEAN DRUG SECURITY AND SELF-RELLIANCEDi bawah ASEAN Health Cluster 3 (Strengthening Health System and Access to Care Work Plan for 2016-2020) – Theme 2 (Availability and Quality of Care), Malaysia telah diamanahkan untuk mengetuai projek Development of Regional Collaborative Strategy for the ASEAN Drug Security and Self-Reliance (ADSSR). Bahagian Dasar dan Perancangan Strategik Farmasi (BDPSF), Kementerian Kesihatan Malaysia (KKM) selaku sekretariat projek tersebut telah menjalankan kajian Situational Analysis and Feasibility Study on Pooled Procurement of Essential Medicines, Life-Saving and Orphan Medicines di peringkat ASEAN pada tahun 2019 menggunakan kaedah kaji selidik dan kajian literatur. Kesinambungan daripada kajian situational analysis tersebut satu mesyuarat teknikal peringkat ASEAN yang bertajuk Technical Meeting on Regional Collaborative Strategy for the ASEAN Drug Security and Self-Reliance (ADSSR) telah dianjurkan oleh BDPSF pada 6-8 November 2019 di Hotel Everly, Putrajaya

Tujuan mesyuarat teknikal ini diadakan adalah untuk membincangkan rangka kerja kolaborasi antara negara-

TECHNICAL MEETING ON REGIONAL COLLABORATIVE STRATEGY FOR THE ASEAN DRUG SECURITY AND SELF-RELLIANCEUnder the ASEAN Health Cluster 3 (Strengthening Health System and Access to Care Work Plan for 2016-2020) – Theme 2 (Availability and Quality of Care), Malaysia has been appointed to lead the ‘Development of Regional Collaborative Strategy for the ASEAN Drug Security and Self-Reliance (ADSSR)’ project. Pharmacy Policy and Strategic Planning Division (PPSPD), Ministry of Health Malaysia (MOH) as the secretariat of the project has initiated a research on ‘Situational Analysis and Feasibility Study on Pooled Procurement of Essential Medicines, Life-Saving and Orphan Medicines in ASEAN’ in 2019 employing survey and document review methods. Following this situational analysis, the PPSPD has organized a Technical Meeting on Regional Collaborative Strategy for the ASEAN Drug Security and Self-Reliance (ADSSR) in ASEAN on 6th to 8th November, 2019 in the Everly Hotel, Putrajaya.

The objective of the meeting was to discuss and develop a framework for regional collaborative strategies and action plans to improve drug security and self-reliance among ASEAN Countries and to discuss the feasibility of pool


negara ASEAN bagi meningkatkan sekuriti dan kemandirian ubat-ubatan serta membincangkan kesesuaian pelaksanaan perolehan ubat-ubatan secara bersama (pool procurement) di rantau ini. Seramai 31 orang delegasi daripada enam negara ASEAN telah menghadiri mesyuarat teknikal ini. Setiap wakil daripada negara ASEAN yang hadir telah membuat pembentangan dan berkongsi maklumat penting situasi farmaseutikal di negara masing-masing. Para peserta juga telah diberikan pendedahan tentang isu-isu berkaitan melalui sesi pembentangan daripada pakar-pakar yang dijemput seperti di dalam jadual di bawah. Pada hari terakhir mesyuarat ini, satu sesi lawatan ke kilang farmaseutikal di Puchong (Pharmaniaga LifeSciences Sdn. Bhd.) telah diadakan.

procurement in the region. A total of 31 delegates from six countries attended the meeting.

During the meeting, the representative from each member state presented the current pharmaceutical situation with regards to ADSSR in their respective countries. A number of invited speakers also shared valuable information on the issues through several presentations as listed in table above. On the last day of the technical meething, a study visit to a manufacturing plant of Pharmaniaga LifeSciences Sdn. Bhd. in Puchong was organized for interested delegates.

PenceramahPresenter

Bahagian DiwakiliRepresented Department

Tajuk CeramahTitle of the Talk

Ahmad Shamsury Sulaiman

The Malaysian Organisation of Pharmaceutical Industries (MOPI)

Production of Non-Commercially Viable Products: Manufacturers’ Perspective

Fatimah Abd Rahim

Bahagian Amalan dan Perkembangan Farmasi, Kementerian Kesihatan Malaysia

The Experience of Pooled Procurement – Malaysia’s Perspective

Rosilawati Ahmad Bahagian Regulatori Farmasi Negara, Kementerian Kesihatan Malaysia (NPRA)

ASEAN Harmonisation-Efforts for Pharmaceuticals

Dr. Nakorn Premsi Director of National Vaccine Institute (NVI), Thailand

ASEAN Vaccine Security and Self-Reliance (AVSSR)

Dr. Soccoro Escalante

Coordinator for Essential Medicines and Health Technologies World Health Organization (WHO) Western Pacific Region (WPRO)

Improving Regional Drug Security and Self Reliance to Accelerate Access to Safe, Effective, Quality and Affordable Essential Medicines

Jadual 16: Senarai PenceramahTable 16: List of speakers

Wakil dari ASEAN Secretariat dan negara-negara ASEAN bersama Pengarah Bahagian Dasar dan Perancangan Strategik, Dr. Hasenah Ali dan urusetia

Representative from ASEAN Secretariat and ASEAN Member States with the Director of Pharmacy Policy and Strategic Planning Divison, Dr. Hasenah Ali and her secretariat team


KONVENSYEN INOVASI DAN KREATIVITI FARMASI TAHUN 2019 (KIKF 2019)Konvensyen Inovasi dan Kreativiti Farmasi (KIKF) 2019 telah berlangsung dengan jayanya pada 5-7 Ogos 2019 di Berjaya Waterfront Hotel, Johor Bahru. Konvensyen ini merupakan yang ke-6 seumpamanya dianjurkan oleh Program Perkhidmatan Farmasi sejak tahun 2009. Tema konvensyen yang dipilih pada kali ini ialah “Memacu Kelestarian Inovasi”. Konvensyen yang diadakan setiap dua tahun ini bertujuan untuk memberi pengiktirafan kepada hasil inisiatif kualiti yang diperkenalkan oleh warga farmasi Kementerian Kesihatan Malaysia. Ia juga merupakan satu platform perkongsian idea hasil ciptaan masing-masing yang dapat menyumbang kepada peningkatan kualiti penyampaian perkhidmatan farmasi di negara ini. Majlis perasmian penutup telah disempurnakan oleh Pengarah Kanan Perkhidmatan Farmasi, Dr. Ramli bin Zainal pada 7 Ogos 2019.

4.0 PENCAPAIAN DAN PENGIKTIRAFAN | ACHIEVEMENT AND RECOGNITION

PHARMACEUTICAL INNOVATION AND CREATIVITY CONVENTION 2019 (KIKF 2019)The Pharmacy Innovation and Creativity Convention (KIKF) 2019 was successfully held on 5-7 August 2019 at the Berjaya Waterfront Hotel, Johor Bahru. This convention is the 6th of its kind organized by the Pharmaceutical Services Program since 2009. The theme chosen for this convention was “Driving Sustainability of Innovation”. The two-yearly event is aimed at recognizing the quality initiatives carried out by the pharmacy workforce in the Ministry of Health Malaysia. It also serves as a platform for sharing innovation ideas that are able to contribute in improving the quality of pharmaceutical service delivery of this country. The closing ceremony was officiated by the Senior Director of Pharmacy Services, Dr. Ramli bin Zainal on August 7, 2019.

Ucapan pembukaan penutup oleh Dr. Ramli Zainal

Senior Director of Pharmaceutical Services, Dr. Ramli Zainal delivering officiating speech

Perasmian penutup oleh Dr. Ramli ZainalOfficiation of KIKF 2019 by Dr Ramli Zainal

Barisan AJK penganjur KIKF 2019Organizing committee of KIKF 2019

Seramai 449 orang anggota farmasi dari seluruh Malaysia telah terlibat dalam pengajuran kali ini. Sebanyak 80 projek dari 8 kategori telah dipertandingkan iaitu 12 projek dari kategori QA Oral, 16 projek di bawah QA Poster, 10 projek masing-masing dari kategori Inovasi Teknologi, Inovasi Perkhidmatan, Inovasi Proses dan Inovasi Produk, serta 12 projek dari kategori KIK Penciptaan dan Penambahbaikan. Konvensyen kali ini turut mengetengahkan acara baharu iaitu Showcase untuk tujuan sharing and bridging. 5 projek farmasi yang telah mendapat pengiktirafan di peringkat kebangsaan dijemput untuk menyertai acara ini sebagai salah satu platform untuk peluasan dan replikasi projek.

A total of 449 pharmacists and pharmacy technicians from all over Malaysia were involved in the program. As many as 80 projects from 8 categories were contested throughout the convention. This includes 12 projects from the QA Oral category, 16 projects under the QA Poster, 10 projects each in the Technology Innovation, Service Innovation, Process Innovation and Product Innovation, as well as 12 projects from the KIK Invention and Improvement categories. This convention also features a new event namely showcase for sharing and bridging. 5 nationally and internationally recognized pharmacy projects are invited to participate in this event as one of the platforms for project expansion and replication.


NAMA PROJEK PROJECT’S NAME

FASILITIFACILTY

PENCAPAIAN TERTINGGIHIGHEST ACHIEVEMENT

Ezy Weigh Hospital Serdang, Selangor Peringkat Antarabangsa: Anugerah Emas International on Quality Control Circles 2018, Singapore

Dx Home Hospital Raja Perempuan Zainab II, Kelantan

Peringkat Antarabangasa:Anugerah medal Platinum Temu Karya Mutu & Produktivitas Nasional (TKMPN) XXII dan International Quality & Productivity Convention (IQPC) 2018, Batam, Indonesia

E-Mix Hospital Tanjong Karang, Selangor

Peringkat Antarabangsa:Naib Johan APHM International Healthcare Conference and Exhibition 2017

I-Tres (Intelligent Tracking & Recording Exhibit System)

Cawangan Penguatkuasaan Farmasi, JKN Pulau Pinang

Peringkat Kebangsaan:Tempat Kedua Kategori Teknologi Anugerah Inovasi KKM 2018

Skuad Cakna Ubat PKD Kuala Nerus, Terengganu Peringkat Kebangsaan:Tempat Kedua Kategori Perkhidmatan Anugerah Inovasi KKM 2018

Jadual 17: Senarai showcase KIKF 2019Table 17: List of KIKF 2019 showcase

Pemenang-pemenang setiap kategori yang dipertandingkan telah diumumkan sewaktu upacara penutup. Senarai penuh pemenang KIKF2019 adalah seperti berikut:

The winners of each contested categories were announced during the closing ceremony. The full list of KIKF2019 winners is as followed:

KATEGORICATEGORY

KEDUDUKANPOSITION

NAMA PROJEKPROJECT’S NAME

FASILITIFACILITY

QA ORAL

JOHANCHAMPION

Reducing Medication Omission Error (MOE) In Yellow Zone (YZ) Emergency Department (ED)

Hospital Serdang, Selangor

NAIB JOHANFIRST RUNNER UP

Improving Appropriateness of Injectable Antibiotics Dilution and Administration in Multidisciplinary Wards

Hospital Tanjong Karang, Selangor

TEMPAT KETIGASECOND RUNNER UP

Improving the Prescribers’ Ordering of Chemotherapy in Surgical Department

Hospital Raja Permaisuri Bainun, Perak

QA POSTER

JOHANCHAMPION

Meningkatkan Peratus Pesakit Bebas Dadah Rekreasi Di Kalangan Pesakit Methadone

Klinik Kesihatan Larkin, Johor


Meningkatkan peratus kepatuhan pesakit antenatal dalam pengambilan zat besi di Klinik Kesihatan Daerah Kota Bharu

Pejabat Kesihatan Daerah Kota Bharu, Kelantan

TEMPAT KETIGASECOND RUNNER UP

Reducing Percentage of Polypharmacy Error (PE) Among Patients with Multiple Follow Ups in Outpatient Pharmacy Department (OPD)

Hospital Banting, Selangor

KIK PENCIPTAAN

JOHANCHAMPION C-Crush Hospital Kuala

Krai, Kelantan


Perlaksanaan Pengurusan Pembekalan Ubat Yang Efektif Kepada Pesakit Discaj Di Wad

Hospital Serdang, Selangor

TEMPAT KETIGASECOND RUNNER UP I-Box Hospital Melaka,

Melaka

KIK PENAMBAHBAIKAN

JOHANCHAMPION Pharmacy Integrated Community Care (PICC)

Pejabat Kesihatan Daerah Kuala Nerus, Terengganu

NAIB JOHANFIRST RUNNER UP Meningkatkan Penjimatan Ubat Pesakit Kronik

Pejabat Kesihatan Daerah Kemaman, Terengganu

TEMPAT KETIGASECOND RUNNER UP Transit Med-Kit

Hospital Tuanku Ampuan Najihah, Negeri Sembilan


KATEGORICATEGORY

KEDUDUKANPOSITION


FASILITIFACILITY

INOVASI PERKHIDMATAN

JOHANCHAMPION Meds2home Hospital Changkat

Melintang, Perak

NAIB JOHANFIRST RUNNER UP Farmasi Secara Temujanji (FaST2u)

Cawangan Amalan & Perkembangan Farmasi, Bahagian Perkhidmatan Farmasi Melaka

TEMPAT KETIGASECOND RUNNER UP PharmFair

Pejabat Kesihatan Daerah Kuala Nerus, Terengganu

INOVASI PRODUK

JOHANCHAMPION Medi-Kit Hospital Segamat,

Johor

NAIB JOHANFIRST RUNNER UP Label ABC

Pejabat Kesihatan Daerah Perak Tengah, Perak

TEMPAT KETIGASECOND RUNNER UP Smadic (Smart Display Cart)

Pejabat Kesihatan Daerah Mersing, Johor

INOVASI PROSES

JOHANCHAMPION Rail Ur Medicine

Pejabat Kesihatan Daerah Kinta, Perak

NAIB JOHANFIRST RUNNER UP Malaright Label Hospital Tawau,

Sabah

TEMPAT KETIGASECOND RUNNER UP Pembekalan Gas Perubatan Berkualiti

Pejabat Farmasi Bahagian Sarikei, Sarawak

INOVASI TEKNOLOGI

JOHANCHAMPION

Sistem Pengurusan Pendaftaran Ahli Farmasi (PRiSMA)

Bahagian Dasar & Perancangan Strategik Farmasi/ Lembaga Farmasi Malaysia, Ipkkm

NAIB JOHANFIRST RUNNER UP Haemophilia Pal App Hospital Ampang,

Selangor

TEMPAT KETIGASECOND RUNNER UP Antimicrobial Stewardship Database (AMD) Hospital Seberang

Jaya, Pulau Pinang

SENARAI PEMENANG ANUGERAH INOVASI, KONVENSYEN KIK DAN KONVENSYEN QA PEIRNGKAT KEBANGSAAN, KKM TAHUN 2019Tahniah diucapkan kepada semua projek farmasi yang telah memenangi pertandingan di peringkat KKM atau Kebangsaan dalam tahun 2019. Diharapkan kemenangan ini menjadi inspirasi kepada semua anggota farmasi dalam memberikan perkhidmatan yang terbaik kepada pesakit atau pelanggan.

LIST OF WINNERS OF INNOVATION AWARDS, KIK CONVENTION AND NATIONAL QA CONVENTION, MOH 2019Congratulations to all pharmacy projects that have won the MOH or national competition in 2019. It is hoped that the success will inspire all pharmacists in providing the best service to patients or customers.

Senarai Pemenang Anugerah Inovasi KKM 2019List of Winners of MOH Innovation Awards 2019

KATEGORI PERKHIDMATAN | SERVICE CATEGORY

PEMENANGWINNER

TAJUK PROJEKPROJECT’S TITLE

FASILITI / NEGERIFACILITY / STATE

KUMPULANGROUP

KEDUAFIRST RUNNER UP PHARMFAIR BAHAGIAN PERKHIDMATAN

FARMASI, JKN TERENGGANU MOHD SYAFIQ BIN YUSOF


KATEGORI TEKNOLOGI | TECHNOLOGY CATEGORY

PEMENANGWINNER


FASILITI/ NEGERIFACILITY/ STATE

WAKIL KUMPULANGROUP REPRESENTATIVE

PERTAMACHAMPION

SISTEM PENGURUSAN PENDAFTARAN AHLI FARMASI (PRiSMA)

PROGRAM PERKHIDMATAN FARMASI, IPKKM

MOHD HADAFI MOHD YASIM

Kategori Perkhidmatan | Service Category Kategori Teknologi | Technology Category

Senarai Pemenang Konvensyen KIK KKM 2019List of Winners of KIK Convention MOH 2019

KATEGORI PRIMER: PENCIPTAAN | PRIMARY CATEGORY: CREATION

PEMENANGWINNER



KUMPULANGROUP

PERTAMACHAMPION C-RUSH HOSPITAL SULTAN ISMAIL PETRA,

KELANTAN S-MASH

KATEGORI KIK HYBRID: PENCIPTAAN & PENAMBAIKAN | KIK HYBRID CATEGORY: CREATION & RENOVATION

PEMENANGWINNER



KUMPULANGROUP

KEDUAFIRST RUNNER UP

METHA SAFE BOX(MSB)

KLINIK KESIHATAN PONTIAN, JOHOR PONTIANVENGERS

Kategori Primer: Penciptaan Primary Category: Creation

Kategori KIK Hybrid: Penciptaan & Penambaikan

KIK Hybrid Category: Creation & Renovation


KONVENSYEN QUALITY ASSURANCE PERINGKAT KEBANGSAAN TAHUN 2019NATIONAL QUALITY ASSURANCE CONVENTION 2019

KATEGORI POSTER | POSTER CATEGORY

Kategori Poster: Naib JohanPoster Category: First Runner Up

PEMENANGWINNER

TAJUK PROJEK

PROJECT’S TITLE

FASILITI / NEGERI

FACILITY / STATE

PEMBENTANGPRESENTER

Naib JohanFirst runner up

PP-25 Meningkatkan pemahaman Teknik suntikan insulin pesakit diabetes di Unit Farmasi Pesakit Luar Hospital Teluk Intan

Hospital Teluk Intan, Perak

Noor Fatin Amalina Binti Kamaruddin

Kategori Poster: Tempat KetigaPoster Category: Second Runner Up

PEMENANGWINNER

TAJUK PROJEK

PROJECT’S TITLE

FASILITI/ NEGERI

FACILITY/ STATE

PEMBENTANGPRESENTER

Tempat ketigaSecond runner up

PP-09 Towards reducing antimicrobial injection preparation errors in a pediatric ward, Hospital Pulau Pinang

Hospital Pulau Pinang, Pulau Pinang

Leong Wei Luen

ANUGERAH KHAS JURI (KATEGORI POSTER)PANEL SPECIAL AWARD (POSTER CATEGORY)

PEMENANGWINNER



PEMBENTANGPRESENTER

Tempat ketigaSecond runner up

PP-24 Increasing percentage of elderly patients taking hypertension and diabetes mellitus medications correctly in Klinik Kesihatan Malim Nawar dan Klinik Bergerak PKD Kampar

Pejabat Kesihatan Daerah Kampar, Perak Ong Su Yin

ANUGERAH MENCIPTA VIDEO PENDEKSHORT VIDEO-MAKING AWARD

PEMENANGWINNER



Tan Chek Nam VP-24 Improving the prescribers’ ordering of chemotherapy in Surgical Department, Hospital Raja Permaisuri Bainun

Hospital Raja Permaisuri Bainun, Perak


Anugerah Khas Juri (Kategori Poster)Panel Special Award (Poster Category)

Anugerah Mencipta Video PendekShort Video-Making Award

PENGUKUHAN SISTEM MAKLUMAT DAN APLIKASISistem Pendaftaran Ahli Farmasi (PRiSMA) telah memperoleh Johan dalam kategori Inovasi Teknologi dalam dua pertandingan iaitu Konvensyen Inovasi & Kreativiti Farmasi 2019 dan Anugerah Inovasi Kementerian Kesihatan Malaysia 2019.

REINFORCEMENT OF INFORMATION SYSTEM AND APPLICATION Pharmaceutical Registry Management System (PRiSMA) has won the Technology Innovation category in two competitions, ie. Konvensyen Inovasi & Kreativiti Farmasi 2019 and Anugerah Inovasi Kementerian Kesihatan Malaysia 2019.

Penerimaan anugerah johan Konvensyen Inovasi & Kreativiti Farmasi 2019 (Kategori Inovasi Teknologi)

Winner award of Konvensyen Inovasi & Kreativiti Farmasi 2019 (Technology Innovation Category)

Penerimaan anugerah johan Anugerah Inovasi Kementerian Kesihatan Malaysia 2019

(Kategori Inovasi Teknologi)Winner award of Anugerah Inivasi Kementerian Kesihatan

Malaysia 2019 (Technology Innovation Category)


LAPORAN PENYELIDIKAN FARMASI JILID 2 2019Laporan Penyelidikan Farmasi diterbitkan sejak tahun 2018 sebagai salah satu usaha Program Perkhidmatan Farmasi di dalam mempertingkatkan perkongsian hasil penyelidikan dan pengetahuan selaras dengan Pelan Strategik Program Farmasi 2017-2020. Laporan ini mengandungi artikel-artikel penyelidikan farmasi yang telah dijalankan di fasiliti-fasiliti Kementerian Kesihatan Malaysia (KKM) oleh pegawai-pegawai farmasi dengan kerjasama pegawai-pegawai kesihatan yang lain. Penyebaran hasil-hasil penyelidikan adalah penting supaya ianya dapat dimanfaatkan di dalam membuat keputusan serta menambah baik amalan harian dan perkhidmatan farmasi. Perkongsian ini juga diharap dapat menggalakkan lebih ramai pegawai farmasi untuk melibatkan diri di dalam bidang penyelidikan. Laporan Penyelidikan Farmasi Jilid 2 2019 telah diterbitkan pada bulan Disember 2019. Ia mengandungi tujuh artikel penyelidikan farmasi yang dipilih daripada 98 manuskrip yang diterima oleh Sidang Editorial dari tahun 2018 hingga 2019 dan telah dinilai secara ‘peer-review’. Laporan ini boleh dimuat turun di https://www.pharmacy.gov.my/v2/ms/dokumen/laporan-penyelidikan-farmasi.html-0.

5.0 PENERBITAN DAN KAJIAN | PUBLICATION AND RESEARCH

PHARMACY RESEARCH REPORTS VOLUME 2 2019The Pharmacy Research Reports was published since year 2018 as part of the Pharmaceutical Services Programme’s efforts to enhance research and knowledge sharing, as stipulated in the Pharmacy Programme Strategic Plan 2017-2020. The reports contain research articles of pharmacy related researches conducted in the Ministry of Health Malaysia (MOH) facilities by MOH pharmacists and other healthcare professionals throughout the country. The communication of research findings is aimed at encouraging pharmacists in the country to utilise scientific evidence for decision making in improving their practices and services. It is also hoped that this publication could spark new interests and encourage pharmacists to be involved in pharmacy research. The Pharmacy Research Reports Volume 2 2019 was published in December 2019. It contains seven peer-reviewed research articles carefully selected from a total of 98 manuscripts received by the Editorial Board from year 2018 to 2019. The report is available at https://www.pharmacy.gov.my/v2/en/documents/pharmacy-research-reports.html.


PHARMACY PRACTICE AND DEVELOPMENT DIVISION

BAHAGIAN AMALAN DAN PERKEMBANGAN FARMASI

Bilangan Pusat Pungutan Ubat Susulan Setempat Baru Yang Diwujudkan

Numbers Of New ‘Pusat Pungutan Ubat Susulan Setempat’ Established

3,978,941Bilangan Preskripsi Susulan Yang Didispens Melalui Perkhidmatan Tambah Nilai Numbers Of Follow-Up Prescription Dispensed Through Value-Added Services

699,870BILANGAN INTERVENSI

PRESKRIPSI PESAKIT LUARBILANGAN INTERVENSI

PRESKRIPSI PESAKIT DALAM

808,107

Fasiliti KKM MOH FacilitiesRM 130.7 juta RM 130.7 million

Fasiliti Bukan KKM / Institusi SwastaNon-MOH Facilities / Private Institution

RM 129.9 juta RM 129.9 million

67PPUSS

815FASILITI DENGAN PERKHIDMATAN KLINIKKEPATUHAN TERHADAP UBAT-UBATANFACILITIES WITH MEDICATION THERAPYADHEARANCE CLINIC (MTAC) SERVICES

6284AKTIVITI PENGGUNAAN UBAT SECARA BERKUALITIQUALITY USE OF MEDICINES ACTIVITIES

332,747BILANGAN

PERTANYAAN UBATNUMBERS OF DRUG

INFORMATION ENQUIRIES

1447BILANGAN DUTA KENALI UBAT ANDANUMBER OF ‘KNOW YOUR MEDICINES’ AMBASSADOR

NUMBERS OF INTERVENTIONS OFOUT-PATIENT PRESCRIPTIONS

NUMBERS OF INTERVENTIONS OFIN-PATIENT PRESCRIPTIONS

HOME MEDICATION REVIEW VISITS

9

RM 2,801.28 JUTAPEROLEHAN UBAT-UBATAN KKM (RM)

RM 1,145.76 JUTAPEROLEHAN BUKAN UBAT (RM)

12,144LAWATAN HMR

YANG DIJALANKAN

INTERVENTION

NEW MEDICINES LISTEDIN THE MOH MEDICINE

FORMULARY

PENYENARAIAN UBAT BARU KE DALAM FORMULARI UBAT KKM

MOH MEDICINES PROCURED (RM) MOH NON-MEDICINES PROCURED (RM)

KOS UBAT-UBATAN KELULUSAN KETUA PENGARAH KESIHATANCOST OF SPECIAL APPROVALDRUGS BY DG OF HEALTH


PHARMACY PRACTICE AND DEVELOPMENT DIVISIONBAHAGIAN AMALAN DAN PERKEMBANGAN FARMASI


Bahagian Amalan dan Perkembangan Farmasi (A&P) bertanggungjawab memastikan keperolehan dan kepenggunaan ubat-ubatan yang berkualiti melalui amalan farmasi yang berkesan bagi mempertingkatkan Perkhidmatan Farmasi di Malaysia supaya setanding dengan kemajuan perkembangan perkhidmatan farmasi di negara-negara maju. Lima cawangan telah ditubuhkan di bawah pengawasan A&P, iaitu Penjagaan Farmaseutikal, Pengurusan Harga Ubat, Pengurusan Farmasi Logistik, Pengurusan Ubat Berkualiti dan Pengurusan Formulari.

The Pharmacy Practice and Development Division is responsible for ensuring the quality of drug procurement and usage through effective pharmacy practice in order to improve pharmacy services in Malaysia to be on par with other developed countries. Five branches under the management of Pharmacy Practice and Development Division are Pharmaceutical Care, Medicine Pricing Management, Logistic Pharmacy Management, Quality Use of Medicines, and Formulary Management.


• Memantau peruntukan, perbelanjaan dan kedudukan semasa inventori iaitu ubat, vaksin, bukan ubat dan reagen.

• Menyelaras dan memantau aktiviti pengurusan stor di fasiliti KKM.

• Menyelaras aktiviti kesiapsiagaan bagi memastikan perkhidmatan farmasi dapat berjalan lancar dan sempurna di semua peringkat operasi.

• Menyelaras bekalan ubat untuk rawatan kusta yang diperolehi daripada WHO.

• Merancang dan menyelaras keperluan proses tender ubat-ubatan KKM.

• Melaksanakan penilaian teknikal dalam pengurusan tender ubat-ubatan KKM.

• Memantau pembekalan kontrak ubat yang sedang berkuatkuasa serta isu-isu yang berkaitan dengan kontrak semasa.

• Merancang dan menyelaras keperluan ubat-ubatan di bawah senarai konsesi.

• Melaksanakan penilaian teknikal dalam pengurusan ubat-ubatan di dalam senarai konsesi.

• Memantau pembekalan ubat di bawah senarai konsesi serta isu-isu yang berkaitan.

• Merancang polisi dan pelan tindakan berkaitan akses kepada ubat sama ada bagi Formulari Ubat-ubatan Kementerian Kesihatan Malaysia (FUKKM) atau ubat dengan kelulusan khas.

• Menyediakan dan menambah baik garispanduan, polisi dan peraturan berkaitan akses kepada ubat dari semasa ke semasa mengikut keperluan semasa.

• Menyelaras aktiviti perbincangan dan mesyuarat yang melibatkan polisi berkaitan FUKKM.

• Merancang dan menjalankan aktiviti penilaian bagi ubat-ubat yang merangkumi keberkesanan, keselamatan dan elemen ekonomi bagi menyediakan input teknikal kepada pembuat keputusan bagi membantu dalam proses pemilihan ubat untuk disenaraikan ke dalam FUKKM.

• Menyelaras dan mengawal akses kepada ubat-ubatan yang tidak tersenarai dalam FUKKM dan ubat-ubatan yang tidak berdaftar dengan Pihak Berkuasa Kawalan Dadah sebagai satu strategi untuk meningkatkan akses pesakit terhadap ubat-ubatan baru yang terbukti berkesan, berkualiti dan juga selamat.

• To monitor budget allocation, expenditure and current inventory level of drugs, vaccines, consumables and reagents.

• To coordinate and monitor store management activities in MOH facilities.

• To coordinate preparedness activities to ensure that pharmaceutical services going smoothly at all levels of operations.

• To coordinate supply of drugs for leprosy treatment obtained from WHO.

• To plan and coordinate the requirements of the MOH drugs tender process.

• To conduct technical evaluation process in the management of MOH drugs tender.

• To monitor the supply of tender drugs and issues related to the current contract.

• To plan and coordinate the requirements of the drugs under concession list.

• Conducting technical assessment process in the management of the drugs under concession list.

• To monitor the supply of the drugs under concession list and related issues.

• Plan policies and action plans related to access of medicines, either for the Ministry of Health Formulary Medicines (MOHMF) or special approved medicines.

• Review and improve guidelines, policies and rules on access to medicines from time to time based on current needs.

• Conduct discussions or meetings relating to policy on MOHMF.

• Plan and conduct evaluation activities for medicines on the elements of efficacy, safety and economic in preparation of technical input, as a guide for decision maker to choose medicines for listing into the MOHMF.

• Coordinate and regulate the access to medicines not listed in MOHMF and unregistered medicines, as a strategy to improve access to new treatment which is proven to be effective, quality and safe.

CAWANGAN PENGURUSAN FARMASI LOGISTIKLOGISTIC PHARMACY MANAGEMENT BRANCH

CAWANGAN PENGURUSAN FORMULARIFORMULARY MANAGEMENT BRANCH



• Merancang dan menjalankan usahasama sektor awam-swasta dalam usaha meningkatkan akses terhadap ubat-ubatan bagi majoriti rakyat Malaysia.

• Memperkukuh aktiviti maklumat ubat dan pendidikan pengguna berkaitan ubat-ubatan.

• Memberi pendidikan kepada orang awam berkaitan penggunaan ubat secara berkualiti.

• Menyedia maklumat ubat-ubatan yang tepat, relevan dan tidak berat sebelah.

• Meningkatkan akses maklumat ubat-ubatan kepada orang awam.

• Mempromosi penggunaan ubat secara berkualiti melalui pelbagai media.

• Menjalinkan usaha kolaborasi dengan pelbagai agensi untuk meningkatkan penyebaran maklumat berkaitan penggunaan ubat secara berkualiti.

• Menguruskan sistem pelaporan kesilapan pengubatan (Medication Error Reporting System- MERS) di Malaysia

• Memperkukuhkan aktiviti keselamatan pengubatan di fasiliti-fasiliti kesihatan.

• Menetapkan polisi dan garis panduan/prosedur berkaitan amalan keselamatan pengubatan

• Merancang polisi dan pelan tindakan berkaitan dengan amalan penjagaan farmaseutikal bersesuaian dengan dasar yang telah ditetapkan oleh Program.

• Merancang dan menyelaras perkhidmatan penjagaan farmaseutikal di fasiliti kesihatan awam dan swasta bagi memastikan farmakoterapi pesakit selamat, berkesan serta mencapai kesan terapeutik optimum di samping meningkatkan kepatuhan pesakit terhadap pengambilan ubat.

• Merancang pelaksanaan aktiviti pembekalan ubat pesakit dalam dan ambulatori di peringkat fasiliti kesihatan awam dan swasta bagi memastikan penyediaan, pembekalan dan pendispensan ubat yang tepat dan selamat kepada pesakit.

• Memantau aktiviti dan pencapaian dalam amalan penjagaan farmaseutikal di peringkat fasiliti kesihatan awam dan swasta bagi memastikan praktis farmasi adalah mematuhi dasar dan peraturan yang telah ditetapkan.

• Menyelaras Jawatankuasa-jawatankuasa Farmasi Klinikal, Farmasi Pesakit Dalam dan Farmasi Ambulatori bagi memperkembangkan dan menambahbaik perkhidmatan farmasi di fasiliti kesihatan awam dan swasta.

• Plan and conduct public-private partnership in the effort to improve access to medicine for majority of Malaysians.

• Strengthen drug information and consumer education activities.

• Educate the public on quality use of medicines.

• Provide accurate, relevant and unbiased information on medicines.

• Improve access to drug information towards the public.

• Promote quality use of medicines through various media.

• Create collaborative efforts with various agencies to improve the dissemination of information on quality use of medicines.

• Manage the Medication Error Reporting System (MERS) in Malaysia.

• Strengthen medical safety activities at health facilities.

• Develop policies and guidelines/ procedures related to medical safety practices.

• Develop policies and strategies on pharmaceutical care practice in line with the policy of Pharmaceutical Services Programme, MOH.

• Plan and coordinate pharmaceutical care services in government and private healthcare facilities as to ensure safe and effective delivery of pharmacotherapy which achieves optimal therapeutic effect while improving patients’ adherence to their medications.

• Plan activities related to medication supply to ensure preparation, supply and dispensing of medicines at public and private healthcare facilities are conducted accurately and in a safe manner.

• Ensure that the provision of pharmaceutical care services abides to the current policy and regulations through continuous monitoring of the implementation and achievement of pharmaceutical care activities and practices in public as well as private healthcare facilities.

• Enhance and improve on pharmacy services in government and private health facilities by setting up and coordinating respective committees for clinical pharmacy, inpatient pharmacy and ambulatory pharmacy.

CAWANGAN PENGURUSAN UBAT BERKUALITIQUALITY USE MEDICINE BRANCH

CAWANGAN PENJAGAAN FARMASEUTIKALPHARMACEUTICAL CARE BRANCH


• Merancang dan menyelaras latihan berkaitan amalan penjagaan farmaseutikal bagi memantap dan meningkatkan kemahiran anggota Farmasi agar penyampaian perkhidmatan penjagaan farmaseutikal setanding dengan kemajuan terkini bagi memenuhi keperluan rawatan semasa.

• Menerbitkan dan mengemaskini garis panduan dan protokol berkaitan aktiviti amalan dan penjagaan farmaseutikal di fasiliti kesihatan bagi menjamin kualiti dan keseragaman dalam penyampaian perkhidmatan.

• Menyelaras dan memperkasa aktiviti-aktiviti berkaitan Perkhidmatan Tambah Nilai Farmasi untuk meningkatkan kualiti penyampaian perkhidmatan farmasi kepada pelanggan.

• Menyelaras, merancang keperluan dan pelaksanaan aktiviti pengeluaran sediaan steril dan non-steril mengikut amalan pengilangan baik di fasiliti awam dan swasta.

• Menyelaras dan merancang pemantauan terhadap penggunaan dan perbelanjaan antimikrobial (termasuk antibiotik, ubat-ubatan highly active antiretroviral therapy (HAART), antimalaria, antituberkulosis dan ubat-ubatan kusta) serta bekerjasama dengan Bahagian dan agensi lain dalam mengawal kerintangan antimikrobial.

• Merancang dan menyelaraskan pelaksananaan aktiviti farmasi dalam Program Rawatan Gantian Methadon di fasiliti dalam dan luar KKM.

• Plan and coordinate training programmes to strengthen and improve skills of pharmacists to ensure that pharmaceutical care delivery meets the current advancements.

• Publish and update guidelines and protocols as well as standard training modules on the practice of pharmaceutical care.

• Coordinate and strengthen Pharmacy Value-Added Services at facilities as to improve on the quality of pharmaceutical service delivery.

• Coordinate and plan activities related to the production of sterile and non-sterile preparations in government and private health facilities in accordance with Good Manufacturing Practice.

• Collaborate with other Divisions and agencies in the management of antimicrobials and combating drug resistance through monitoring of antimicrobial utilisation and expenditure (including antibacterials, antiretrovirals, antimalaria, antituberculosis and antileprosy).

• Plan and coordinate pharmaceutical care activities in Methadone Maintenance Treatment Programme at facilities under the Ministry of Health and other agencies.

• Merancang, memantau dan melaksanakan dasar, polisi dan pelan tindakan berkaitan dengan pengurusan dan penetapan harga ubat-ubatan di Malaysia.

• Merancang dan mengurus pangkalan data harga ubat-ubatan daripada setiap peringkat rantaian pengedaran di sektor awam dan swasta di Malaysia serta dari sumber-sumber negara lain sebagai maklumat asas /rujukan harga ubat-ubatan.

• Merancang dan menyelaras aktiviti pemantauan harga ubat-ubatan di sektor awam dan swasta.

• Melaksanakan kajian dan analisa harga ubat-ubatan bagi menentukan harga ubat yang menguntungkan kerajaan dalam proses perolehan KKM dan penyenaraian FUKKM melalui aktiviti penilaian kewangan kepada bahagian lain di KKM, badan berkanun dan institusi kerajaan yang lain.

• Merancang, memantau dan menyelaras pelan komunikasi strategik berkaitan dasar dan polisi harga ubat-ubatan melibatkan stakeholder, aduan, maklum balas parlimen, media massa dan lain-lain.

• Mengurus akses dan penyebaran informasi harga ubat-ubatan kepada pengguna melalui aplikasi dan portal rasmi Program Perkhidmatan Farmasi bagi memberi pilihan bermaklumat ubat-ubatan yang mampu milik kepada rakyat.

• Plan, coordinate and conduct the policy, strategies and action plans related to the management and setting of medicines prices in Malaysia.

• Plan and manage the medicines price database from each level of distribution chain in public and private sectors as well as sources from other countries for the purpose of price comparison and referencing.

• Plan and coordinate medicines price monitoring activities in public and private sectors.

• Conduct research and medicine prices analysis to determine the best prices in procurement and listing of new medicines in the Ministry of Health Medicines Formulary by providing financial evaluation to other divisions in Ministry of Health, statutory bodies and government institutions.

• Outline and coordinate strategic communication plans on medicines pricing policies such as handling stakeholder’s and consumer’s complaints, parliamentary questions and feedback, print and electronic media and others.

• Manage access and dissemination of medicine price information through applications and the official public portal of Pharmacy Services Programme in providing informed choices for affordable medicines to the people.

CAWANGAN PENGURUSAN HARGA UBATDRUG PRICING MANAGEMENT BRANCH


• Menyelaras aktiviti dan kolaborasi dengan badan antarabangsa seperti WHO berkenaan dengan dasar harga ubat mampu milik dan lain-lain agar selari dengan keperluan antarabangsa.

• Establish co-operative and collaborative network with international bodies such as the World Health Organisations (WHO) in effort to keep abreast with international standards for affordable medicine pricing policies.

• Menguruskan dan memantau peruntukan dan perbelanjaan Bahagian Amalan & Perkembangan Farmasi (A&P) untuk mengoptimakan sumber kewangan.

• Menyelaras dan memantau peruntukan dan pelaksanaan Pelan Operasi Latihan Bahagian A&P agar semua berjalan seperti yang telah dirancang.

• Menyelaras dan memantau pencapaian aktiviti kualiti Bahagian A&P seperti key performance indicator,piagam pelanggan dan ISO agar perkhidmatan farmasi yang berkualiti dapat diberikan.

• Menyelaras dan memantau pelaksanaan Audit Dalam Amalan farmasi (ADAF) bagi memastikan semua fasiliti farmasi mematuhi standard amalan farmasi yang ditetapkan.

• Menyelaras dan memantau pengurusan sumber manusia yang melibatkan Bahagian A&P untuk memastikan perkhidmatan farmasi berjalan lancar dengan sumber manusia yang mencukupi.

• Menyelaras dan memantau pencapaian Pelan Strategik Farmasi dan Pelan Tindakan DUNas yang melibatkan aktiviti Bahagian A&P agar selari dengan hala tuju Pelan Tindakan Kementerian Kesihatan Malaysia.

• Mengurus dan menyelaraskan Pelan Tindakan Bahagian A&P agar selari dengan perancangan Pelan Strategik Farmasi dan Pelan Tindakan DUNas.

• Menyelaras dan memantau pengurusan pembangunan dan perolehan aset yang melibatkan Bahagian A&P bagi memastikan keperluan fasiliti farmasi disediakan.

• Menyelaras dan memantau penyediaan maklumbalas dari Bahagian A&P bagi sebarang aktiviti di peringkat Program Perkhidmatan Farmasi, kementerian dan agensi luar bagi memastikan maklumbalas yang dikemukakan adalah tepat dan dalam tempoh masa yang dikehendaki.

• Manage and monitor the allocation and expenditure of the Pharmacy Practice & Development Division (A&P) to optimize financial resources.

• Coordinate and monitor the allocation and implementation of A&P Division’s Training Operational Plan to ensure it is according to the plan.

• Coordinate and monitor the achievements of A&P Division quality activities such as key performance indicator, client charter and ISO to provide quality pharmaceutical services.

• Coordinate and monitor the implementation of Audit on Pharmacy Practices (ADAF) to ensure that all pharmaceutical facilities comply with the prescribed standard of pharmaceutical practice.

• Coordinate and monitor human resource management that involves A&P Division to ensure that pharmaceutical services run smoothly with adequate human resources.

• Coordinate and monitor the achievement of Pharmaceutical Strategic Plan and DUNas Action Plans involving A&P Division activities to ensure the direction in line with the Ministry of Health Malaysia Action Plan.

• Manage and coordinate the A&P Division Action Plan to be in line with the planning of the Pharmaceutical Strategic Plan and DUNAS Action Plan.

• Coordinate and monitor development management and asset acquisition involving A&P Division to ensure that pharmaceutical facility requirements are provided.

• Coordinate and monitor the preparation of feedback from A&P Division for any activity at the Pharmaceutical Services Programme level, ministries and external agencies to ensure that the feedback is accurate and within the required timeframe.

SEKSYEN KOORDINASICOORDINATION SECTION


PERBELANJAAN UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (KKM)Pada tahun 2019, nilai perolehan ubat-ubatan di semua hospital, institusi dan klinik kesihatan KKM ialah sebanyak RM 2,801.28 juta. Nilai perbelanjaan bagi ubat-ubatan tersebut meningkat sebanyak 20.52 peratus berbanding tahun 2018.

MINISTRY OF HEALTH MALAYSIA (MOH) MEDICINES EXPENDITUREThe total cost of medicines procured in 2019 for all MOH hospitals, institutions and health clinics was RM 2,801.28 million. This shows increasing by 20.52 percent in medicines expenditure compared to 2018.


TahunYear

Jumlah Perbelanjaan (RM, Juta)Total Expenditure (RM Million)

Peratus peningkatan berbanding tahun lepas (%)Percentage increment over the previous year (%)

2015 2,323.12 -2.58

2016 2,107.61 -9.28

2017 2,382.55 13.05

2018 2,324.25 -2.45

2019 2,801.28 20.52

Jadual 18: Perbelanjaan Ubat-ubatan KKM, 2015-2019Table 18: MOH Medicines Expenditure, 2015-2019

Jumlah Perbelanjaan (RM, Juta)% Peningkatan Berbanding Tahun Sebelumnya

-2.58

-9.28

13.05

-2.45

20.52

0.00

500.00

1,000.00

1,500.00

2,000.00

2,500.00

3,000.00

-15

-10

-5

0

5

10

15

20

25

(RM

, jut

a)

2015 2016 2017 2018 2019

Rajah 4: Perbelanjaan Ubat-ubatan KKM, 2015-2019Figure 4: MOH Medicines Expenditure, 2015-2019

Ubat-ubatan ini diperolehi melalui syarikat konsesi, kontrak pusat dan pembelian terus & sebut harga seperti pecahan berikut:

Medicines were puchased through the concessionaire company, MOH central contract and direct purchase & quotations as followed:

TahunYear

APPL (RM)APPL (RM)

Kontrak KKM (RM)MOH Contract (RM)

Pembelian Terus & Sebutharga (RM)Local Purchase & Quotation (RM)

2019 1,007,662,610 1,302,917,621 490,700,125

Jadual 19: Jenis Perolehan Ubat-ubatan pada Tahun 2019Table 19: Types of Medicines Procurement in 2019


RM1,302,917,62146.51%

RM490,700,12517.52%

RM1,007,662,61035.97%

Kontrak Pusat APPL Pembelian Terus dan Sebutharga

Rajah 5: Perolehan Ubat-ubatan KKM Berdasarkan Kaedah Perolehan, Tahun 2019Figure 5: Types of Medicines Procurement in 2019

PENDISPENSAN UBAT DI HOSPITAL DAN KLINIK KESIHATAN KKMPada tahun 2019, terdapat peningkatan sebanyak 1.2 peratus bagi jumlah preskripsi pesakit luar yang diterima di hospital dan klinik kesihatan berbanding tahun sebelumnya. Jumlah preskripsi yang diterima di fasiliti-fasiliti kesihatan awam ialah 60.9 juta di mana 39.1 juta preskripsi diterima di klinik kesihatan (KK) dan 21.8 juta preskripsi diterima di hospital. Terdapat penurunan sebanyak 7.4 peratus bagi jumlah preskripsi pesakit dalam yang diterima di hospital di mana jumlah keseluruhannya ialah 16.4 juta preskripsi.

DISPENSING OF MEDICINES IN MOH HOSPITALS AND HEALTH CLINICSIn 2019, there was an increase of 1.2 per cent for the number of outpatient prescriptions received in hospital and health clinics compared to the previous year. The number of prescriptions received at public health facilities was 60.9 million, of which 39.1 million prescriptions were received in health clinics (KK), and 28.1 million prescriptions were in hospitals. There was a drop of 7.4 per cent for the number of inpatient prescriptions received at the hospital where the total was 16.4 million prescriptions.

KK Hospital Jumlah

2015 2016

Num

ber o

f pre

scrip

tions

(mill

ion)

0

10

20

30

40

50

60

70

2017 2018 2019

19.3

31.4

19.5

32.6

20.8

38

21.8

38.4

21.8

39.1

50.752.2

58.8 60.2 60.9

Rajah 6: Bilangan preskripsi pesakit luar yang diterima, 2015 hingga 2019

Figure 6: Number of outpatient prescriptions received, 2015 to 2019

Bila

ngan

pre

skrip

siNu

mbe

r of p

resc

riptio

ns

0

5,000,000

10,000,000

15,000,000

20,000,000

25,000,000

2015 2016 2017 2018 2019

23,381,05122,610,733

19,036,67317,722,454

16,410,045

Rajah 7: Bilangan preskripsi pesakit dalam yang diterima, 2015 hingga 2019

Figure 7: Number of inpatient prescriptions received, 2015 to 2019


PENYENARAIAN ATAU PINDAAN KEPADA FORMULARI UBAT KKMFormulari Ubat Kementerian Kesihatan Malaysia (FUKKM) merupakan senarai ubat-ubatan yang telah diluluskan untuk digunakan di semua fasiliti KKM. Ia berfungsi sebagai panduan kepada anggota kesihatan KKM dalam menentukan ubat-ubatan yang diperlukan untuk rawatan pesakit. Permohonan penyenaraian/ pindaan kepada FUKKM diputuskan dalam Mesyuarat Panel Kaji Semula Senarai Ubat-ubatan KKM yang bersidang sebanyak tiga kali setahun. Cawangan Pengurusan Formulari selaku Sekretariat bagi mesyuarat tersebut bertanggungjawab untuk memproses dan menilai permohonan penyenaraian/pindaan terhadap FUKKM.

Sehingga Disember 2019, terdapat sebanyak 1,684 persediaan yang merangkumi 858 entiti kimia telah disenaraikan dalam FUKKM. Bilangan ubat-ubatan yang tersenarai dalam FUKKM dari tahun 2016 hingga 2019 diringkaskan seperti bawah.

LISTING OR AMENDMENT TO MOH MEDICINES FORMULARY Ministry of Health Medicines Formulary (MOHMF) is a list of drugs that have been approved for use in all MOH facilities. It serves as a guide to MOH healthcare professionals in determining medicines for the treatment of patients. Applications to list/ amend the MOHMF will be tabled in the MOHMF Review Panel meeting which meets three times a year. The Formulary Management Branch as the Secretariat for the meeting is responsible for processing and evaluating the application for listing/ amendment to MOHMF.

As of December 2019, 1,684 preparations comprising of 858 chemical entities are listed in the MOHMF. Number of drugs listed in MOHMF from 2016 to 2019 is summarised as below.

Jumlah (Total) Entiti Kimia (Chemical Entity)Kekuatan / Formulasi / Bentuk Dosej Ubat Baru (New Medicine) Pemansuhan (Delisting)

0

5

10

15

20

25

30

35

40

0

200

400

600

800

1000

1200

1400

1600

1800

848 849 854 858

1694 1676 1678 1684

Bila

ngan

/Nu

mbe

r

Jum

lah

/ Tot

al

2016 2017 2018 2019

1514

11 119

38

6

9

13

6

9 9

Rajah 8: Ubat-ubatan yang Tersenarai dalam FUKKM (2016-2019)Figure 8: Drugs Listed in the MOHMF (2016-2019)

Bermula tahun 2016, permohonan penyenaraian ubat-ubatan ke dalam FUKKM bagi kategori ubat baru, tambahan indikasi (ubat sedia ada), formulasi, kekuatan dan bentuk dosej yang sebelum ini dipohon oleh fasiliti KKM, dikemukakan oleh syarikat farmaseutikal. Sepanjang tahun 2019, sebanyak 43 dossier telah berjaya dibentangkan dalam Mesyuarat Panel Kaji Semula Senarai Ubat-ubatan KKM. Bilangan dossier dan keputusan Mesyuarat Panel Kaji Semula Senarai Ubat-ubatan KKM dari tahun 2016 hingga 2019 dirumuskan seperti rajah di bawah.

Beginning 2016, applications to list new medicine, new indication (for existing medicine), formulation, strength or dosage form into the MOHMF are submitted by pharmaceutical companies instead of MOH facilities which was practiced previously. In 2019, a total of 43 dossiers were successfully presented in the MOHMF Review Panel Meeting. The number of dossiers and outcome of the MOHMF Review Panel Meeting from 2016 until 2019 are summarised in the figures below.


D3 (pindaan kategori preskriber / D3 (change category of prescriber D5 (pemansuhan / D5 (delist)

D1 (tambahan indikasi) /D1 (add indication)D1 (ubat baru) /D1 (new medicine)D2 (formulasi, bentuk dosej / kekuatan) /D2 (formulation / dosage form / strength)

0

5

10

15

20

25

2016 2017 2018 2019

Bila

ngan

dos

sier

/Nu

mbe

r of d

ossi

ers

19

2 0

4

6

22

1110

7 7

20

7

5

16

9

20

4 4

10

5

Rajah 9: Bilangan Dossier Dibentangkan Dalam Mesyuarat Panel Kaji Semula Senarai Ubat-ubatan KKM (2016-2019)Figure 9: Number of Dossiers Presented in the MOHMF Review Panel Meeting (2016-2019)

0

2

4

6

8

10

12

14

16

18

20

22

2017 2018 20192016

Bila

ngan

/Nu

mbe

r

D1 (ubat baru) /D1 (tambahan indikasi) /D2 (formulasi, bentuk dosej / kekuatan) /

D3 (pindaan kategori preskriber) /

D5 (pemansuhan) /

(new medicine)(add indication)

(formulation / dosage form / strength)

(change category of prescriber)

(delist)

D1 (ubat baru) /D1 (tambahan indikasi) /D2 (formulasi, bentuk dosej / kekuatan) /

D3 (pindaan kategori preskriber) /

D5 (pemansuhan) /

(new medicine)(add indication)

(formulation / dosage form / strength)

(change category of prescriber)

(delist)

Jumlah dossier / Total dossier Bilangan dossier ditolak / Number of dossier rejected

12

1 0 0

3

13

11

7

3 34

5 5

0 0 12

1

3

9

2

4

6

19

22

20

11

7

5

16

10

7 7

9

4 45

10

20

Rajah 10: Keputusan Dossier Dibentangkan dalam Mesyuarat Panel Kaji Semula Senarai Ubat-ubatan KKM (2016-2019)Figure 10: Outcome of Dossier Tabled in the MOHMF Review Panel Meeting (2016-2019)


PERMOHONAN UNTUK PELAKSANAAN PATIENT ACCESS SCHEME (PASc) Cadangan pelaksanaan Patient Access Scheme (PASc) di fasiliti KKM telah diluluskan oleh Kementerian Kewangan Malaysia pada tahun 2017 dan Guideline on Proposal Submission for Patient Access Scheme Implementation in Ministry of Health telah berjaya dihasilkan pada tahun 2018. Sebanyak 12 kertas cadangan PASc daripada syarikat farmaseutikal telah diterima dan diproses oleh Sekretariat PASc bagi tahun 2018 dan 2019.

Sebelas (11) kertas cadangan yang diterima adalah dikelaskan sebagai skim kompleks (complex scheme) manakala satu (1) kertas cadangan sebagai skim ringkas (simple scheme). Sehingga kini masih tiada kertas cadangan yang telah diluluskan oleh Pegawai Pengawal KKM berdasarkan kriteria dan pertimbangan yang diambil kira.

PROPOSALS FOR PATIENT ACCESS SCHEME (PASc) IMPLEMENTATION The proposal for implementation of Patient Access Scheme (PASc) in MOH was approved by the Ministry of Finance in 2017 and Guideline on Proposal Submission for Patient Access Scheme Implementation in Ministry of Health was successfully produced in 2018. The PASc Secretariat has received and processed a total of 12 PASc proposals from pharmaceutical companies in 2018 and 2019.

Eleven (11) proposals were classified as complex schemes while one (1) proposal was classified as simple scheme. To date, no PASc proposal has been approved by the MOH Controlling Officer based on criteria and consideration required.

Bila

ngan

/Nu

mbe

r

2018 2019

6 6

0

2

4

6

8

Rajah 11: Permohonan pelaksanaan Patient Access Scheme (PASc) bagi Tahun 2018 dan 2019

Figure 11: Patient Access Scheme (PASc) Proposal Papers for 2018 and 2019

PENILAIAN DOSSIER Pada tahun 2019, sebanyak 43 penilaian ubat meliputi aspek efikasi, keselamatan dan ekonomi bagi permohonan dossier yang lengkap telah dijalankan bagi permohonan penyenaraian ubat-ubatan/ indikasi baru ke dalam FUKKM (merangkumi dossier D1, D2 & D3) serta pemansuhan ubat-ubatan daripada senarai FUKKM (dossier D5). Proses penilaian ubat-ubatan tersebut melibatkan perbandingan dengan 89 ubat yang lain. Jumlah penilaian ubat yang telah dijalankan serta bilangan ubat yang digunakan sebagai perbandingan bagi penilaian dossier dari tahun 2016 hingga 2019 diringkaskan dalam rajah di bawah.

DOSSIER EVALUATIONIn 2019, a total of 43 drug evaluations on efficacy, safety, and economics of complete dossier applications were carried out for new medicine/ indication listing into the MOH Drug Formulary (including D1, D2 & D3 dossiers) and medicine delisting from the MOH Medicines Formulary (dossier D5). The evaluation process involved comparison with another 89 drugs. The number of drug evaluations carried out and the number of comparator drugs used for comparison for dossier evaluation from 2016 to 2019 are summarised in figure below.

Bil dossiers Comparators

2016 2017 2018 20190

50

100

150

200

250

Bila

ngan

/Nu

mbe

r

61

39

83

49

120

43

89

231

Rajah 12: Statistik Penilaian Dossier (2016-2019)Figure 12: Dossier Evaluation Statistic (2016-2019)


PENGEMASKINIAN FUKKM Bagi memastikan maklumat yang terkandung dalam FUKKM sentiasa dikemaskini dan relevan untuk kegunaan semasa, pihak fasiliti KKM/ syarikat farmaseutikal digalakkan untuk menghantar cadangan pengemaskinian sekiranya terdapat sebarang pindaan yang ingin dibuat pada maklumat dalam FUKKM. Cadangan pengemaskinian FUKKM boleh dikemukakan kepada Sekretariat FUKKM dengan menggunakan Borang Cadangan Pengemaskinian Maklumat dalam FUKKM yang boleh didapati di laman sesawang Program Perkhidmatan Farmasi, KKM. Terdapat sebanyak 72 cadangan pindaan terhadap FUKKM telah dilaksanakan daripada tahun 2015 sehingga 2019 berdasarkan cadangan yang diterima di mana majoriti cadangan diterima daripada fasiliti KKM. Cadangan pengemaskinian yang diterima diringkaskan dalam rajah di bawah.

0

1

2

3

4

5

6

7

8

9

2015 2016 2017 2018 2019

Bila

ngan

/Nu

mbe

r

Dos/Indikasi/Nama/Name Indication Dose Safety Interaction Others

Keselamatan/ Interaksi/ Lain-lain/

3

1

2

0 0 0 0 0 0 0 0 0 01

3

1 1

4

8

6

7

5

7 7

55

1

2

1

2

Rajah 13: Cadangan Pengemaskinian Maklumat dalam FUKKM (2015-2019)Figure 13: Suggestions for Changes to the MOHMF Information (2015-2019)

*Data keselamatan termasuklah kontraindikasi, langkah berjaga-jaga dan kesan mudarat *Safety data includes contraindications, precautions and adverse effects

UBAT KELULUSAN KHAS KETUA PENGARAH KESIHATAN (KPK) ATAU PENGARAH KANAN PERKHIDMATAN FARMASI (PKPF)

Fasiliti Kementerian Kesihatan MalaysiaKelulusan khas daripada KPK/ PKPF diperlukan untuk memperoleh dan menggunakan ubat yang tidak tersenarai dalam FUKKM termasuk ubat berdaftar atau ubat tidak berdaftar. Permohonan bagi kelulusan khas ini dipertimbangkan untuk rawatan alternatif dengan memberi keutamaan kepada penggunaan ubat-ubatan yang terdapat dalam FUKKM. Sepanjang tahun 2019, terdapat 8,141 permohonan telah diterima daripada fasiliti-fasiliti KKM dengan peningkatan sebanyak 25.1 peratus berbanding tahun 2018 (6,506 permohonan). Secara keseluruhan,

MOHMF REVISIONTo ensure up-to-date and relevant information in the MOHMF, the MOH facility/ pharmaceutical company is encouraged to submit their suggestions for changes to the information in the MOHMF. Suggestions for MOHMF amendments can be submitted to the MOHMF Secretariat using the “Borang Cadangan Pengemaskinian Maklumat dalam FUKKM” which is accessible from Pharmaceutical Services Program website. A total of 72 proposed amendments to the FUKKM were implemented from 2015 to 2019 based on suggestions received, of which a majority are from the MOH facilities. The amendments are summarised in figure below.

DIRECTOR GENERAL OF HEALTH (KPK) OR SENIOR DIRECTOR OF PHARMACEUTICAL SERVICES SPECIAL APPROVAL DRUGS (PKPF)

Ministry of Health Malaysia FacilitiesSpecial approval from the KPK/ PKPF is required to obtain and use drugs not listed in MOHMF including registered drugs or unregistered drugs. Applications for special approval are considered as alternative treatments with the priority to use options available in the MOHMF. Throughout 2019, a total of 8,141 applications were received from MOH facilities which was an increment of 25.1 percent compared to 2018 (6,506 applications). Of that amount, 93.6 percent (7,625 applications) were approved with an estimated cost of RM 130.7 million. The number and costs of special drug


93.6 peratus (7,625 permohonan) telah diluluskan dengan anggaran kos sebanyak RM 130.7 juta. Bilangan dan kos kelulusan permohonan ubat khas fasiliti KKM dari tahun 2016 hingga 2019 diringkaskan seperti dalam rajah di bawah.

approvals for MOH facilities from year 2016 to 2019 are summarised in the figure below.

Kos Kelulusan Juta (RM) /Cost Million (MYR) Number of ApprovalBilangan Kelulusan /

3,734

4,887

6,095 7,625

Kos

/ Cos

t (RM

)

2016 2017 2018 20190.00

20.00

40.00

60.00

80.00

100.00

120.00

140.00

160.00

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

9,000

62.60 93.60 137.50 130.70

Bila

ngan

/Nu

mbe

r

Rajah 14: Bilangan dan Kos Kelulusan Permohonan Ubat Khas Fasiliti KKM (2016-2019) Figure 14: Number and Cost of Special Drug Approvals from MOH Facilities (2016-2019)

Fasiliti bukan KKM atau Institusi SwastaCawangan Pengurusan Formulari juga memproses permohonan untuk memperoleh dan menggunakan ubat tidak berdaftar dengan Pihak Berkuasa Kawalan Dadah daripada fasiliti bukan KKM atau institusi swasta untuk tujuan rawatan alternatif pesakit dengan memberi keutamaan terlebih dahulu kepada penggunaan ubat berdaftar yang bersesuaian.

Pada tahun 2019, sebanyak 4,040 permohonan diterima daripada fasiliti-fasiliti bukan KKM termasuk fasiliti kesihatan Kementerian Pengajian Tinggi, Kementerian Pertahanan serta Institut Jantung Negara dengan peningkatan sebanyak 14.6 peratus berbanding tahun 2018 (3,526 permohonan). Secara keseluruhan, sebanyak 90.4 peratus (3,653 permohonan) telah diluluskan dengan anggaran kos sebanyak RM 129.9 juta. Bilangan dan kos kelulusan permohonan ubat khas bagi fasiliti bukan KKM dari tahun 2016 hingga 2019 diringkaskan seperti rajah di bawah.

Non-MOH Facilities or Private InstitutionsFormulary Management Branch also receives and processes applications for procuring and using unregistered drugs with the Drug Control Authority from non-MOH facilities or private institutions.

In 2019, a total of 4,040 applications were received from non-MOH facilities including health facilities under Ministry of Higher Education, Ministry of Defense and National Heart Institute, with an increase of 14.6 percent compared to 2018 (3,526 applications). Overall, 90.4 percent (3,653 applications) was approved with an estimated cost of RM 129.9 million. Number and cost of special drug approval for non-MOH facilities from 2016 to 2019 is summarised in figure below.


Kos Kelulusan Juta (RM) /Cost Million (MYR) Number of ApprovalBilangan Kelulusan /

Kos

/ Cos

t (RM

)

2016 2017 2018 2019

Bila

ngan

/Nu

mbe

r

0

20

40

60

80

100

120

140

0

500

1000

1500

2000

2500

3000

3500

4000

63.80

1,804

75.60

2,568

119.80

3,271

129.90

3,653

Rajah 15: Bilangan dan Kos Kelulusan Permohonan Ubat Khas Fasiliti Bukan KKM (2016-2019) Figure 15: Number and Cost of Special Drug Approval Non-MOH facilities (2016-2019)

SISTEM PELAPORAN KESILAPAN PENGUBATAN (MERS)“To ensure medication safety” ialah objektif ke-7 daripada 13 objektif yang ditetapkan di bawah Malaysian Patient Safety Goals. Medication Error Reporting System (MERS) merupakan kaedah yang digunakan untuk memantau indikator kesilapan pengubatan yang berlaku di fasiliti kesihatan sama ada kesilapan actual ataupun near misses. Pada tahun 2019, sebanyak 47,251 laporan kesilapan pengubatan yang diterima melalui MERS (rujuk Rajah 16). Rajah 16 menunjukkan menunjukkan jumlah pelaporan kesilapan pengubatan meningkat sebanyak 6.88 peratus (3,040) pada tahun 2019 berbanding 44,211 laporan pada tahun 2018. Peningkatan bilangan laporan yang diterima pada tahun 2019 adalah disebabkan oleh aktiviti-aktiviti promosi yang dijalankan telah berjaya meningkatkan kesedaran dalam kalangan anggota penjagaan kesihatan untuk melaporkan kejadian kesilapan pengubatan yang dikenal pasti melalui MERS. Kebanyakan laporan kesilapan pengubatan yang diterima ialah near misses iaitu 95.32 peratus (45,039) manakala hanya 4.68 peratus (2,212) merupakan actual error (Jadual 20). Rajah 17 menunjukkan proses yang terlibat bagi kesilapan pengubatan yang dilaporkan iaitu mempreskripsi (73.74 peratus), pendispensan (25.19 peratus), administrasi (1.03 peratus) dan lain-lain (0.04 peratus). Pegawai Farmasi merupakan pelapor MERS yang tertinggi dan ini menyumbang kepada penemuan kesilapan mempreskripsi yang tinggi.

Near misses merupakan kesilapan pengubatan yang telah berlaku dan berpotensi menyebabkan mudarat kepada pesakit tetapi ianya tidak sampai kepada pesakit kerana kesilapan tersebut berjaya dikesan apabila intervensi dijalankan oleh anggota penjagaan kesihatan, pesakit atau penjaga. Pelbagai inisiatif telah dilaksanakan oleh Program Perkhidmatan Farmasi, KKM untuk mengurangkan kesilapan pengubatan melalui penganjuran latihan kepada

MEDICATION ERROR REPORTING SYSTEMS (MERS)“To ensure medication safety” is the 7th goal out of 13 goals determined under the Malaysian Patient Safety Goals. Medication Error Reporting System (MERS) is used to monitor indicators relating to medication errors occurring in health facilities, either “actual” or “near misses”. A total of 47,251 medication error reports were received through MERS in the year 2019 (Figure 16). Figure 16 showed an increment of 6.88 percent (3,040) of medication error reports in 2019 compared to 44,211 reports in year 2018. The number of medication error reports received increase in year 2019 due to the promotional activities carried out to raise awareness among healthcare providers to report identified medication error through MERS. Most of the reported cases are near misses which was 95.32 percent (45,039) and only 4.68 percent (2,212) were actual errors (Table 20). Figure 17 demonstrated the processes involved with regard to the medication errors reported, which include prescribing (73.74 percent), dispensing (25.19 percent), administration (1.03 percent) and others (0.04 percent). Reporting by pharmacists was the highest and thus contributes to the highest number of prescribing errors detected.

A near miss is defined as an error that occurred that might have resulted in harm but the error did not reach the patient because of timely intervention by healthcare providers or the patient or family. Various initiatives have been implemented by the Pharmaceutical Services Program, MOH to limit and mitigate these errors through organizing training for healthcare personnel such as talks, briefings, courses /workshops and exhibitions. In 2019, the Pharmaceutical Services Program, MOH has published “Medication Safety Alert” intended to increase awareness and educate all healthcare professionals on strategies to improve medication safety. The World Health Organization (WHO) also has declared September 17, 2019 as the first World Patient Safety Day with the theme of “Patient Safety:


anggota penjagaan kesihatan dalam bentuk ceramah, taklimat , kursus/ bengkel dan pameran. Pada tahun 2019, Program Perkhidmatan Farmasi,KKM telah menerbitkan “Medication Safety Alert” untuk memberi kesedaran dan pendidikan kepada anggota penjagaan kesihatan ke arah meningkatkan keselamatan pengubatan. Pertubuhan Kesihatan Sedunia (WHO) juga telah mengumumkan 17 September 2019 sebagai “Hari Keselamatan Pesakit Sedunia ” yang pertama dengan tema “Patient Safety: A Global Health Priority” dan slogan “ Speak up for Patient Safety” . Ianya akan disambut pada 17 September setiap tahun sebagai menunjukkan komitmen terhadap keutamaan keselamatan pesakit di seluruh negara.

Berikut adalah antara topik yang telah dimuatkan dalam “Medication Safety Alert”.

• Accidental Injection of Potassium Chloride Instead of Dextrose 50%

• Medication Administration Errors (MAEs): A Risk to Patient Safety

• Safety Reminder on The Use of Chloral Hydrate

• Lignocaine HCL (Lidocaine HCL) Injection: Be Aware of Different Indications, Drug Formulations, Preparation & Route of Administration

A Global Health Priority” and the slogan is “Speak up for patient safety”. It will be celebrated on September ,17 each year to show the commitment of patient safety as the health priority.

Below are the highlighted topics included in the “Medication Safety Alert”.

• Accidental Injection of Potassium Chloride Instead of Dextrose 50%

• Medication Administration Errors (MAEs): A Risk to Patient Safety

• Safety Reminder on The Use of Chloral Hydrate

• Lignocaine HCL (Lidocaine HCL) Injection: Be Aware of Different Indications, Drug Formulations, Preparation & Route 0f Administration

2017 2018 2019

Bila

ngan

lapo

ran

kesi

lapa

n pe

ngub

atan

/No

. of m

edic

atio

n er

ros

repo

rt

26,056

44,21147,251

5000

10000

15000

20000

25000

30000

35000

40000

45000

50000

Rajah 16: Jumlah Kesilapan Pengubatan Yang Diterima Mengikut Tahun (2016 - 2019)Figure 16: Total Number of Medication Errors by Year (2016-2019)

TahunYear

2017 2018 2019

n % n % n %

Near Miss 24,569 94.3 42,101 95.2 45,039 95.4

Actual Error 1,487 5.7 2,110 4.8 2,212 4.6

Jumlah Total 26,056 100.0 44,211 100 47,251 100

Jadual 20: Jumlah Kesilapan Pengubatan Mengikut Kategori (2016 - 2019) Table 20: Total Medication Errors by Category (2016-2019)


Prescribing Dispensing (includes filling) Administration Others

34843 (73.74%)

20(0.04%)

485(1.03%)

11903(25.19%)

Rajah 17: Jumlah Kesilapan Pengubatan Yang Diterima Mengikut Proses Pada Tahun 2019Figure 17: Number of Medication Errors by Process in Year 2019

AUDIT DALAM AMALAN FARMASI (ADAF)

Aktiviti ADAF Pusat Tahun 2019Pasukan ADAF Pusat telah melaksanakan audit di 13 fasiliti seperti berikut:

AUDIT ON PHARMACY PRACTICES (ADAF)

Activities of ADAF Pusat in the Year 2019The ADAF Pusat team has conducted audits in 13 facilities as followed:

BIL.NO.

FASILITIFACILITY

TARIKH AUDITAUDIT DATE

MARKAHSCORE

TAHAP PEMATUHANCOMPLIANCE LEVEL

1. KK BATU 2 ½, KEMAMAN 21-22 OGOS 2019 93.7 BAIK | GOOD

2. HOSPITAL KEMAMAN 19-21 OGOS 2019 93.3 BAIK | GOOD

3. HOSPITAL SULTANAH AMINAH, JOHOR BAHRU

08-10 JULAI 2019 91.7 BAIK | GOOD

4. INSTITUT KANSER NEGARA 29-30 OGOS 2019 90.9 BAIK | GOOD

5. KK KEMPAS 10-11 JULAI 2019 90.4 BAIK | GOOD

6. HOSPITAL KULIM 19-21 OGOS 2019 89.4 BAIK | GOOD

7. HOSPITAL PAPAR 15-16 JULAI 2019 88.3 BAIK | GOOD

8. HOSPITAL TUANKU FAUZIAH, KANGAR 26-28 OGOS 2019 87.9 BAIK | GOOD

9. HOSPITAL TENGKU AMPUAN RAHIMAH, KLANG

20-22 MAC 2019 86.9 BAIK | GOOD

10. CAWANGAN FARMASI LOGISTIK NEGERI SABAH

17-18 JULAI 2019 86.5 BAIK | GOOD

11. KK KULIM 21-22 OGOS 2019 86.4 BAIK | GOOD

12. KK ARAU 28-29 OGOS 2019 85.5 BAIK | GOOD

13. HOSPITAL SELAYANG 26-28 OGOS 2019 81.4 BAIK | GOOD

Jadual 21: Senarai Fasiliti Diaudit oleh Pasukan ADAF Pusat pada Tahun 2019Table 21: List of Pharmacy Facilities Audited by ADAF Pusat Teams in the Year 2019


Aktiviti ADAF Pusat dan ADAF Negeri Tahun 2019Hasil audit ke atas 461 fasiliti sepanjang tahun 2019 mendapati 391 fasiliti mendapat status Baik manakala 67 fasiliti mendapat status Sederhana. Walau bagaimanapun, masih terdapat tiga (3) fasiliti yang mendapat status Lemah dan memerlukan lebih banyak langkah penambahbaikan ke atas amalan farmasi di fasiliti tersebut.

Activities of ADAF Pusat and ADAF Negeri in Year 2019Audit on 461 facilities throughout the year 2019 found that 391 facilities had good compliance status while 67 facilities had moderate compliance status. However, there were three (3) facilities with poor compliance status and required a lot of improvement in their pharmacy practice.

Bil.No

NegeriState

Bilangan Fasiliti Di NegeriNumber of Facility In State

BaikGood

SederhanaModerate

LemahPoor

PencapaianAchievement

1 Hospital Kuala Lumpur 1 1 0 0 100.00%2 Institut Kanser Negara 1 1 0 0 100.00%3 Institut Perubatan Respiratori 1 1 0 0 100.00%4 Johor 58 57 1 0 98.28%5 Kedah 32 31 1 0 96.88%6 Kelantan 42 34 8 0 80.95%7 Melaka 18 18 0 0 100.00%8 Negeri Sembilan 26 23 3 0 88.46%9 Pahang 43 33 10 0 76.74%

10 Perak 43 41 2 0 95.35%11 Perlis 5 5 0 0 100.00%13 Pulau Pinang 15 15 0 0 100.00%14 Sabah 52 28 21 3 53.85%15 Sarawak 42 32 10 0 76.19%16 Selangor 43 33 10 0 76.74%17 Terengganu 26 26 0 0 100.00%18 WP Kuala Lumpur & Putrajaya 11 10 1 0 90.91%19 WP Labuan 2 2 0 0 100.00%

NASIONALNATIONAL 461 391 67 3 84.82%

Jadual 22: Tahap Pematuhan Fasiliti Berdasarkan ADAF 2019 berdasarkan NegeriTable 22: Facility Compliance Level Based on ADAF 2019 by States

Baik / Good Moderate PoorSederhana / Lemah /

84.82%

14.53%

0.65%

Rajah 18: Tahap Pematuhan Fasiliti Secara Keseluruhan Berdasarkan ADAF 2019Figure 18: Overall Facility Compliance Level Based on ADAF 2019


KURSUS PEMANTAPAN PENGURUSAN STOR DAN INVENTORI UNTUK PEGAWAI FARMASI LOGISTIKKursus ini telah diadakan sebanyak dua (2) sesi iaitu pada 12 sehingga 14 Mac 2019 dan 08 sehingga 10 April 2019 di Hotel Premiere, Klang dan Vivatel Hotel, Kuala Lumpur. Objektif utama kursus ini adalah:

i. Mengemas kini pengetahuan asas dalam aktiviti pengurusan perolehan dan stor kerajaan

ii. Berkongsi pendekatan yang boleh digunakan untuk meningkatkan keberkesanan dalam pengurusan stor dan inventori

iii. Meningkatkan kemahiran peserta untuk mengenal pasti permasalahan berkaitan pengurusan stor dan inventori serta penyelesaian kepada permasalahan.

Kursus Pemantapan Pengurusan Stor Dan Inventori Untuk Pegawai Farmasi Logistik Bil 1/2019

Store and Inventory Management Enhancement Course for Pharmacists Session 1/2019


STORE AND INVENTORY MANAGEMENT ENHANCEMENT COURSE FOR PHARMACISTSThe course has been held in two (2) sessions from 12 to 14 March 2019 and 8 to 10 April 2019 at Premiere Hotel, Klang and Vivatel Hotel, Kuala Lumpur. The main objectives of the course are:

i. To update basic knowledge of government procurement and store management activites

ii. To share approaches that can be used to enhance the effectiveness of store and inventory management

iii. To improve participants’ skills to identify problems related to store management and inventory and to solve problems.

Kursus Pemantapan Pengurusan Stor Dan Inventori untuk Pegawai Farmasi Logistik Bil 2/2019

Store and Inventory Management Enhancement Course for Pharmacists Session 2/2019

BENGKEL PEMANTAPAN FORMULARI UBAT-UBATAN KKM (FUKKM) 2019Bengkel Pemantapan Formulari Ubat-Ubatan KKM 2019 telah diadakan pada 8 hingga 10 Julai 2019 di Hotel Premiere, Klang dan dihadiri oleh seramai 41 orang pegawai farmasi daripada hospital seluruh negara. Bengkel ini bertujuan untuk memantapkan formulari ubat-ubatan KKM sedia ada dengan mengemaskini maklumat berkaitan ubat-ubatan yang tersenarai berdasarkan informasi terkini dan garis panduan semasa.

MOH MEDICINE FORMULARY REINFORCEMENT WORKSHOP 2019The MOH Medicines Formulary Workshop for 2019 was held from July 8 to 10, 2019 at the Premiere Hotel, Klang and attended by a total of 41 hospital pharmacists. The objective of the workshop was to enhance the existing MOH Medicine Formulary (MOHMF) by updating details pertaining to the listed drugs based on recent information and current practice guidelines.

Bengkel Pemantapan Formulari Ubat-ubatan KKM (FUKKM) 2019MOH Medicine Formulary Reinforcement Workshop 2019


BENGKEL EVIDENCE BASED MEDICINE (EBM) & BUDGET IMPACT ANALYSIS (BIA) Bengkel Evidence Based Medicine (EBM) & Budget Impact Analysis (BIA) telah diadakan pada 27 hingga 29 Ogos 2019 di Hotel Premiere, Klang. Seramai 60 orang pegawai farmasi daripada hospital dan klinik kesihatan telah menyertai bengkel tersebut. Objektif penganjuran bengkel ini adalah untuk meningkatkan kemahiran pegawai farmasi di fasiliti KKM dalam menilai keperluan ubat-ubatan berdasarkan bukti keberkesanan dan keselamatan yang bermutu tinggi. Bengkel ini juga bertujuan untuk melatih pegawai dalam merancang peruntukan kewangan, perolehan ubat-ubatan dan pengurusan formulari ubat fasiliti menggunakan BIA sebagai salah satu panduan dalam membuat keputusan pemilihan ubat-ubatan. Para peserta juga terlibat secara aktif dalam bengkel ini melalui pembentangan projek dan juga perkongsian pengalaman daripada fasiliti masing-masing.

EVIDENCE BASED MEDICINE (EBM) & BUDGET IMPACT ANALYSIS (BIA) WORKSHOPAn Evidence Based Medicine (EBM) & Budget Impact Analysis (BIA) workshop was held on 27 to 29 August 2019 at Hotel Premiere, Klang. The workshop was attended by 60 participants from MOH hospitals and health clinics. The objective of the workshop was to enhance the skills of pharmacists at MOH facilities in assessing medication needs based on high quality evidence of efficacy and safety. It was also conducted to train participants in budget planning, medicines procurement and the management of drug formulary at facility level by using BIA as one of the guides/tools in decision-making process for medicines selection. Participants were also actively involved in discussion through experience sharing on current decision-making practice at their facility and presentation of group projects.

Bengkel Evidence Based Medicine (EBM) & Budget Impact Analysis (BIA)

Evidence Based Medicine (EBM) & Budget Impact Analysis (BIA) Workshop

TAKLIMAT DAN LATIHAN PERMOHONAN UBAT KELULUSAN KHASSebanyak tiga (3) sesi taklimat berkenaan Permohonan Kelulusan Ubat Khas telah dilaksanakan pada 21 Oktober dan 4 hingga 5 November 2019 yang melibatkan seramai 95 pegawai-pegawai farmasi KKM khususnya yang terlibat secara langsung dengan proses kerja tersebut. Taklimat ini diadakan bagi memberi penerangan yang lebih jelas berkenaan dengan tatacara serta keperluan dalam mengemukakan permohonan tersebut dan juga cadangan untuk menurunkan kuasa melulus bagi permohonan ulangan ubat berdaftar kepada Pengarah Hospital/Institusi.

BRIEFING AND TRAINING SESSIONS ON SPECIAL APPROVAL DRUG APPLICATIONSA total of three (3) briefing sessions and training on Special Approval Drug Applications were conducted on 21 October and 4 to 5 November 2019 involving 95 MOH pharmacists who are mainly involved in the work process. The briefing was held to provide a better understanding of the application procedure and requirements as well as the proposal to delegate the approval to the Hospital / Institution Director for repeat applications for registered products.

Taklimat & Latihan Permohonan Ubat Kelulusan KhasBriefing & Training Sessions on Special Approval Drug

Applications


BENGKEL “ADVANCED LEVEL CERTIFICATION SMOKING CESSATION SERVICE PROVIDER (CSCSP) 2019”Bengkel “Advanced Level Certification Smoking Cessation Service Provider (CSCSP) 2019” telah diadakan pada 8 April 2019 di Dewan Serai Wangi, Program Perkhidmatan Farmasi Kementerian Kesihatan Malaysia. Objektif bengkel ini adalah seperti berikut:

a) Melaksana dan membuat penilaian bagi intervensi secara pendidikan dalam bidang Farmakoterapi Berhenti Merokok di kalangan pegawai farmasi.

b) Mengemaskini pengetahuan dan meningkatkan kompetensi pegawai farmasi dalam menjalankan perkhidmatan Farmakoterapi Berhenti Merokok.

c) Melatih pegawai farmasi sebagai persediaan untuk dilantik sebagai preseptor dalam perancangan penubuhan lebih banyak pusat latihan dalam bidang Farmakoterapi Berhenti Merokok di fasiliti KKM.

Seramai 18 Pegawai Farmasi dari pelbagai gred telah menyertai bengkel tersebut. Bengkel ini telah dirancang dan diatur dengan spesifik agar para peserta mendapat pendedahan kepada semua cabaran yang mungkin dihadapi semasa menjalankan perkhidmatan Farmakoterapi Berhenti Merokok di fasiliti kesihatan, ini termasuk jenis penggunaan bahan tembakau yang terkini (contohnya, vape) di pasaran, maklumat terkini dalam rawatan ketagihan nikotin, kemahiran komunikasi dan kaunseling dengan pesakit dalam rawatan ketagihan dan sebagainya. Penceramah yang dijemput adalah Associate Professor Dr Mohamad Haniki Nik Mohamed, Pengerusi Malaysia Academic of Pharmacy (MAP) dan juga Dean of Kulliyyah of Pharmacy, International Islamic University Malaysia, yang mana beliau mempunyai pengetahuan yang sangat mendalam dalam bidang ini.

CERTIFICATION SMOKING CESSATION SERVICE PROVIDER (CSCSP): ADVANCED LEVEL WORKSHOP 2019Certification Smoking Cessation Service Provider (CSCSP): Advanced Level Workshop 2019 was held on the 8th of April 2019 at Dewan Serai Wangi, Pharmaceutical Services Programme, Ministry Of Health Malaysia. The main objectives of the workshop were:

a) To develop, implement and evaluate a targeted educational intervention focusing on smoking cessation with pharmacists.

b) To update the knowledge and increase competency among the pharmacists in smoking cessation service.

c) To train the pharmacists in preparation of becoming preceptors in order to set up smoking cessation training centre in MOH facilities.

18 pharmacists attended this workshop. The workshop are formulated in a manner that allow our fellow pharmacy personnel to be exposed to a wide array of challenges face in conducting Smoking Cessation Pharmacotherapy Service their healthcare setting, including the most current trend of nicotine devices in the market, updates of the latest nicotine addiction treatment, communication and counselling skill in addiction treatment and many more. A distinguished speaker with expertise in tobacco control and treatment was invited to share his knowledge and experience, which is Associate Professor Dr Mohamad Haniki Nik Mohamed, Presiden Malaysia Academic of Pharmacy (MAP) and also the Dean of Kulliyyah of Pharmacy, International Islamic University Malaysia.

Bengkel “Advanced Level Certification Smoking Cessation Service Provider (CSCSP) 2019”Certification Smoking Cessation Service Provider (CSCSP): Advanced Level Workshop 2019


BENGKEL TRAINING OF TRAINERS (TOT) PEGAWAI FARMASI : PROGRAM RAWATAN METHADONEBengkel Training of Trainers (TOT) bagi Pegawai Farmasi telah diadakan pada 23 hingga 25 Julai 2019 di Hotel Premiere, Klang, Selangor. Objektif bengkel ini adalah :

a) Mengaplikasikan pengetahuan dengan evidence-based di dalam praktis terapi methadone

b) Mengukuhkan peranan Pegawai Farmasi dalam memberikan perkhidmatan kaunseling dan pengurusan kes

c) Menyediakan peluang untuk mempertingkatkan pengetahuan dan kemahiran dalam menguruskan pesakit yang menerima rawatan methadone

d) Sebagai platform bagi perkongsian pengalaman dalam praktis melalui sesi interaktif & perbincangan kes

Seramai 50 Pegawai Farmasi yang terlibat di dalam perkhidmatan pendispensan methadone telah menyertai bengkel tersebut. Penceramah yang dijemput adalah terdiri daripada pelbagai disiplin yang terlibat di dalam memberikan rawatan di dalam Program Rawatan Pesakit iaitu Pakar Psikiatri, Pegawai Perubatan, wakil daripada Agensi Anti Dadah Kebangsaan (AADK) dan Pegawai-pegawai Farmasi yang terdiri daripada Jawatankuasa kerja Farmasi Methadone. Pengisian bengkel ini meliputi ceramah, pembentangan kajian dan aktiviti kerja berkumpulan bagi membincangkan case studies telah diadakan.

PHARMACIST TRAINING OF TRAINERS (TOT) WORKSHOP: METHADONE TREATMENT PROGRAMMEPharmacist Training Of Trainers (TOT) Workshop was held on the 23 to 25 of Julai 2019 at Hotel Premiere, Klang, Selangor.

The main objectives of the workshop were:

a) Apply evidence-based knowledge on methadone therapy to day-to-day practise

b) Indicate the role of pharmacist in counselling and case management play in methadone maintenance treatment

c) Provide an opportunity for pharmacists to update knowledge and expertise in managing patient receiving methadone treatment

d) Share real life experiences through interactive sessions and case discussion

A total of 50 pharmacists that involved in dispensing methadone in MOH facilities has attended this workshop. Speakers invited were multidisciplinary and expert in methadone treatment programme, which are psychiatrist, medical officers, representative from National Anti-Drug Agency (NADA) and pharmacists (member of methadone pharmacy working group committee). Participants were fortunate to listen to the talks, research presentation and involved in group work where case studies were discussed.

Bengkel Training of Trainers (TOT) Pegawai Farmasi: Program Rawatan MethadonePharmacist Training of Trainers (TOT) Workshop: Methadone Treatment Programme


TAKLIMAT PRESEPTOR LATIHAN SANGKUTAN JANGKA PENDEK PEGAWAI FARMASI (PENGKHUSUSAN NUTRISI PARENTERAL)Taklimat ini diadakan selama dua hari dari 1 hingga 2 April 2019 di Ibu Pejabat Program Perkhidmatan Farmasi, KKM atas usaha Jawatankuasa Kerja Farmasi Klinikal (Pengkhususan Nutrisi Parenteral) dan dihadiri oleh 20 orang peserta. Ia merupakan satu refresh course untuk preseptor yang telah dan akan dilantik bagi Latihan Sangkutan Jangka Pendek Pegawai Farmasi dalam bidang Pengkhususan Nutrisi Parenteral. Tujuan taklimat ini adalah menilai dan mempertingkatkan kompetensi preseptor serta menyemak semula bahan pengajaran sedia ada yang digunakan dalam latihan sangkutan tersebut.

MYPAP NETWORK MEETING II: HIGHLIGHTS AND UPDATESMyPAP Network Meeting II dianjurkan oleh Jawatankuasa Kerja Farmasi Kinikal (Pengkhususan Onkologi) dengan kerjasama The Max Foundation pada 16 April 2019 di Nexus Bangsar South, Kuala Lumpur dan Flipchart CML & GIST telah dilancarkan dalam mesyuarat ini. Mesyuarat ini bertujuan untuk mendedahkan pegawai farmasi kepada maklumat dan penemuan klinikal terkini dalam rawatan pesakit CML & GIST. Seramai 60 pegawai farmasi daripada seluruh negara telah menghadiri mesyuarat ini. Objektif mesyuarat ini adalah bagi:

i. Mempertingkatkan pengetahuan pegawai farmasi berkenaan penyakit CML & GIST

ii. Mengkongsi pengetahuan dan pengalaman klinikal dalam menjalankan kaunseling ubat-ubatan kepada pesakit CML & GIST

MyPAP Network Meeting II merupakan usaha dalam mempertingkatkan kualiti hidup pesakit CML & GIST dengan mendidik pesakit untuk mengenalpasti dan mengatasi masalah kesan sampingan ubat.

Fasilitator sedang memberi penerangan

semasa aktiviti berkumpulanFacilitator gave explanation during group activity

PHARMACIST SHORT TERM TRAINING (PARENTERAL NUTRITION SPECIALIZATION) Clinical Pharmacy Working Committee (Parenteral Nutrition Specialization) had organized two days briefing session from 1 to 2 April 2019 at Pharmaceutical Services Programme Headquarters, MOH with total of 20 participants had attended this briefing. This is a refresh course for pharmacist who have been and will be appointed as preceptors for the Pharmacist Short Term Training in the field of Parenteral Nutrition Specialization. The purpose of this briefing was to evaluate and enhance the competency level of these preceptors and to review the existing teaching materials which used for the training.

MYPAP NETWORK MEETING II: HIGHLIGHTS AND UPDATESMyPAP Network Meeting II was organized by Clinical Pharmacy Working Committee (Oncology Specialization) in collaboration with The Max Foundation on 16 April 2019 at Nexus Bangsar South, Kuala Lumpur and CML & GIST Flipchart was launched during this meeting. The aim of the meeting was to expose pharmacist towards latest information and clinical evidence in treating CML & GIST patient. About 60 pharmacists from all over Malaysia had join the meeting. The objectives of this meeting were to:

i. increase pharmacist’s knowldege in CML & GIST disease

ii. sharing clinical knowledge and experience in conducting medication counseling to CML & GIST patient

MyPAP Network Meeting II is great effort in improving the quality life of CML & GIST patients by educating patients to identify and address the side effets of medication.

Peserta berbincang dalam kumpulan bagi aktiviti role playParticipations discussed in group during role play activity


Flipchart GISTGIST Flipchart

Flipchart CMLCML Flipchart

SEMINAR NATIONAL PHARMACY PAIN Jawatankuasa Kerja Farmasi Klinikal (Pengkhususan Pain Management) telah menganjurkan National Pharmacy Pain Seminar selama 3 hari dari 24 hingga 26 Jun 2019 di Hotel Crystal Crown, Petaling Jaya. Seminar ini merupakan seminar berkaitan Pain Management yang julung kali dianjurkan dan seramai 52 pegawai farmasi yang terlibat dengan perkhidmatan Pain MTM daripada seluruh Malaysia telah menyertai seminar ini. Penceramah-penceramah daripada pelbagai bidang telah dijemput untuk memberi ceramah iaitu daripada pensyarah, pakar perubatan (pain), pakar perubatan (paliatif), ahli psikologi klinikal, pegawai fisioterapi dan pegawai farmasi. Objektif seminar adalah untuk:

• Membantu peserta dalam memahami patofisiologi, definisi dan jenis-jenis kesakitan

• Mempertingkatkan pemahaman pegawai farmasi terhadap perlaksanaan dan aktiviti-aktiviti berkaitan Pain Medication Therapy Management (MTM), Pain Free Programme (PFP), Pain as 5th Vital Sign (P5VS) serta dasar baru yang berkaitan dengan pengurusan kesakitan

• Bertindak sebagai platform untuk berkongsi pengetahuan mengenai pengurusan kesakitan dari perspektif selain farmakoterapi

• Meningkatkan kemahiran pegawai farmasi dalam memberi kaunseling yang berkesan kepada pesakit

NATIONAL PHARMACY PAIN SEMINARThe Clinical Pharmacy Working Committee (Pain Management Specialization) hosted a 3-day National Pharmacy Pain Seminar from 24 to 26 June 2019 at Crystal Crown Hotel, Petaling Jaya. This is the first seminar related to pain management organized and 52 pharmacists who involve with Pain MTM from all over Malaysia had attended this seminar. Speakers from various fields were invited to give lectures ranging from lecturer, pain specialist, palliative specialist, clinical psychologist, physiotherapist and pharmacists. The objectives of the seminar were to:

• assist participant to understand pathophysiology, definition and type of pain

• increase pharmacist’s understanding in implementation and activities related to Pain Medication Therapy Management (MTM), Pain Free Programme (PFP), Pain as 5th Vital Sign (P5VS) and new policy related to pain management

• serve as a platform to share knowledge on pain management from non-pharmacology perspective.

• Improve pharmacist’s skills in providing effective medication counselling

•


Jawatankuasa Kerja Farmasi Klinikal (Pengkhususan Pain Management) dan Urusetia National Pharmacy Pain Seminar bersama Timbalan Pengarah Bahagian Amalan dan Perkembangan Farmasi, KKM

Clinical Pharmacy Working Committee (Pain Management Specialization) and National Pharmacy Pain Seminar Committee with Deputy Director of Pharmacy Practice and Development Division, MOH

Acara perasmian seminar dan pelancaran Flipchart Pengurusan Terapi Kesakitan oleh Timbalan Pengarah

Bahagian Amalan & Perkembangan Farmasi, KKMDeputy Director of Pharmacy Practice & Development

Division, MOH officiated the seminar and launch Flipchart Pengurusan Terapi Kesakitan

Penceramah jemputan, Dr Kavitha M. Bhojwani menunjukkan demonstrasi akupuntur kepada pesertaInvited speaker, Dr. Kavitha M. Bhojwani demonstrating

acupuncture to participant

SEMINAR NUCLEAR PHARMACY SCIENTIFIC Seminar Nuclear Pharmacy Scientific telah diadakan pada 12 hingga 13 April 2019 di Institut Kanser Negara, Putrajaya dengan temanya ‘Applications of Emerging Targeted Therapeutic Radiopharmaceuticals for Radionuclide Therapy’. Seminar ini juga adalah merupakan seminar yang julung kalinya dianjurkan oleh Jawatankuasa Kerja Farmasi Klinikal (Pengkhususan Farmasi Nuklear). Objektif seminar ini adalah:

• Untuk memberikan pengetahuan terkini kepada peserta melalui perkongsian pengetahuan dan pengalaman oleh pegawai perubatan nuklear dan pegawai farmasi nuklear.

• Untuk berkongsi pengetahuan berkaitan produk dan teknologi terkini radiofarmaseutikal yang berada di pasaran melalui sesi ceramah dan praktikal

NUCLEAR PHARMACY SCIENTIFIC SEMINAR For the first time ever, Clinical Pharmacy Working Committee (Nuclear Pharmacy Specialization) was organizing the Nuclear Pharmacy Scientific Seminar from 12 to 13 April 2018 at National Cancer Institute, Putrajaya with the theme of ‘Applications of Emerging Targeted Therapeutic Radiopharmaceuticals for Radionuclide Therapy’. The objectives of the seminar are:

• To update knowledge via plenary talks, which delivered by nuclear medicine physician and fellow nuclear pharmacists

• To share knowledge and update of the latest products and technologies in the market to the stakeholders through the talk session as well as practical session


• Untuk mempromosikan pembangunan kerjaya kepada peserta serta memberikan peluang kepada semua pegawai farmasi nuklear daripada 6 buah fasilti perubatan nuklear di KKM untuk bertemu dan berkongsi ilmu dan pengalaman.

Seminar ini telah dihadiri oleh 31 orang pegawai farmasi nuklear daripada 6 buah fasilti perubatan nuklear, Kementerian Kesihatan Malaysia. Pakar daripada pelbagai bidang berkaitan farmasi nuklear telah dijemput untuk berkongsi ilmu dan pengetahuan dan juga berkongsi pengalaman ketika menghadiri latihan sangkutan di bawah program tajaan Agensi Tenaga Atom Antarabangsa (International Atomic Energy Agency)

Timbalan Pengarah Bahagian Amalan dan Perkembangan Farmasi, KKM, peserta, penceramah dan Jawatankuasa Kerja Farmasi Klinikal (Pengkhususan Farmasi Nuklear)Deputy Director of Pharmacy Practice and Development

Division, MOH, participants, speaker and Clinical Pharmacy Working Committee (Nuclear Pharmacy Specialization)

members

• To promote career development to the staff and provides valuable opportunities to meet and create network, as this seminar will bring together nuclear pharmacists from 6 institutions under the Ministry of Health Malaysia.

This conference was attended by 31 pharmacists from 6 institutions under the Ministry of Health Malaysia. Experts from various fields were invited to update the crowd regarding latest updates and sharing experience during their attachment under International Atomic Energy Agency Program.

Urusetia Nuclear pharmacy Scientific SeminarNuclear Pharmacy Scientific Seminar secretariat

NATIONAL CLINICAL PHARMACOKINETIC UPDATES 2019National Clinical Pharmacokinetic Updates 2019 adalah usaha Jawatankuasa Kerja Farmasi Klinikal (Pengkhususan Farmakokinetik Klinikal) yang telah diadakan dari 15 hingga 16 Julai 2019 di Institut Kanser Negara, Putrajaya dengan tema “Pharmacometric: A New Frontier For Pharmacokinetics”. Objektif seminar ini adalah untuk:

• memperkukuhkan pengetahuan peserta berkaitan konsep asas farmakokinetik

• memberikan informasi terkini berkaitan farmakokinetik dan farmakometrik

• mempelajari hubungkait diantara konsep farmakokinetik dan farmakometrik

Seminar ini telah dihadiri oleh 133 pegawai farmasi pelbagai gred jawatan daripada hospital dan klinik kesihatan Kementerian Kesihatan Malaysia. Pakar berkaitan farmakometrik dan farmakokinetik telah dijemput untuk berkongsi ilmu dan pengetahuan. Selain itu, peserta juga telah mempersembahkan poster mereka berkaitan kajian farmakokinetik yang dilaksanakan di peringkat hospital atau negeri.

NATIONAL CLINICAL PHARMACOKINETIC UPDATES 2019The National Clinical Pharmacokinetic Updates 2019 from 15 to 16 July 2019 at National Cancer Instutite, Putrajaya was an effort of Clinical Pharmacy Working Committee (Clinical Pharmacokinetic Specialization) with the theme of “Pharmacometric: A New Frontier For Pharmacokinetics”. Objectives of the conference were to:

• strengthen the knowledge on basic concept of pharmacokinetic

• provide the latest updates on development of pharmacokinetic and pharmacometric

• learn the concept of pharmacokinetic and pharmacometric and how it was related to each other

This event was attended by 133 pharmacists with various grade from hospital and health clinic of Ministry of Health Malaysia. Experts from various fields including academician were invited to update the crowd regarding latest updates and their experience in the pharmacokinetic and pharmacometric. Besides that, the program involves free oral and posters presentation to encourage the participants to engage in evidence-based practice.


Timbalan Pengarah Bahagian Amalan dan Perkembangan Farmasi, KKM, peserta, penceramah dan Jawatankuasa Kerja Farmasi Klinikal (Pengkhususan Farmakokinetik Klinikal)

Deputy Director of Pharmacy Practice and Development Division, participants, speaker and Clinical Pharmacy Working Committee (Clinical Pharmacokinetic Specialization) members

Urusetia National Clinical Pharmacokinetic Updates 2019National Clinical Pharmacokinetic Updates 2019 secretariat

BENGKEL HEALTHCARE FAILURE MODE EFFECT & ANALYSIS (HFMEA)Bengkel Healthcare Failure Mode Effect & Analysis (HFMEA) adalah anjuran Bahagian Amalan & Perkembangan Farmasi, KKM dari 20 hingga 22 Ogos 2019 di Best Western I-City, Selangor yang dilaksanakan kerjasama di antara Jawatankuasa Kerja Farmasi Pesakit Dalam dan Seksyen Keselamatan Pengubatan. Bengkel ini telah dihadiri oleh 40 orang peserta yang terdiri daripada pegawai farmasi terlibat dalam aktiviti keselamatan pengubatan dan farmasi pesakit dalam. Penceramah yang dijemput adalah Dr. Zaharimah Bt Abdul Kadir (Pengarah Hospital Tuanku Ampuan Najihah), beliau seorang berpengetahuan dan berpengalaman dalam HFMEA dan Root Cause Analysis. Penceramah telah mengendalikan bengkel HFMEA dengan cara memberi ceramah, kerja kumpulan, pembentangan dan perbincangan.

HEALTHCARE FAILURE MODE EFFECT & ANALYSIS (HFMEA) WORKSHOPThe Healthcare Failure Mode & Analysis (HFMEA) Workshop was organized by Pharmacy Practice & Development Division of MOH from 20 to 22 August 2019 at Best Western I-City, Selangor, which a collaboration between In-patient Pharmacy working committee and Medication Safety Section. The workshop was attended by 40 participants comprising pharmacist involved in In-patient pharmacy and medication safety activities. The speaker, Dr. Zaharimah Bt Abdul Kadir (Director of Hospital Tuanku Ampuan Najihah) is have vast knowledge and experience in conducting HFMEA and Root Cause Analysis. Speakers have conducted HFMEA workshops by giving lectures, group work, presentations and discussions.


Sesi pemberian cenderahati

Souvenir presentation

BENGKEL SKILLS TO DEVELOP SUSTAINABLE GOALS IN CLINICAL PHARMACY SERVICESBengkel ini telah diadakan dari 2 hingga 4 Julai 2019 di Hotel Vistana, Pulau Pinang dan dihadiri oleh 44 orang peserta, empat (4) orang fasilitator dan seorang urusetia. Para peserta yang terlibat adalah pegawai yang berpengalaman dalam farmasi klinikal mengikut bidang pengkhususan, ketua pegawai farmasi atau ketua unit daripada fasiliti yang berkaitan. Bengkel ini telah dibimbing oleh dua (2) orang fasilitator terlatih iaitu Dr. Abdul Hakim Abdul Rashid dan Dr. Muhammad Aadiyat Abdul Hamid daripada Bahagian Perkembangan Perubatan, KKM. Mereka turut dibantu oleh Dr. Zaitulhusna Md Safee dan Puan Alia Hani Rosly dari Hospital Kuala Lumpur. Beberapa sesi taklimat, perbincangan kumpulan dan pembentangan telah diadakan untuk:

i. Mengenalpasti isu dan cabaran dalam perkhidmatan farmasi klinikal

ii. Menganalisa faktor-faktor penyebab dan halangan yang dihadapi

iii. Membangunkan sustainable goals dan merancang tindakan penambahbaikan yang perlu diambil

WORKSHOP ON SKILLS TO DEVELOP SUSTAINABLE GOALS IN CLINICAL PHARMACY SERVICESThe workshop was conducted from 2 to 4 July 2019 at Vistana Hotel, Penang. Pharmacists from different field of expertise, chief pharmacists and heads of units of identified hospitals have attended this workshop. Dr. Abdul Hakim Abdul Rashid and Dr. Muhammad Aadiyat Abdul Hamid from Medical Development Division, Ministry of Health were invited as facilitator for the workshop. They were also assisted by Dr. Zaitulhusna Md Safee and Madam Alia Hani Rosly from HKL. Sessions of lecture and group discussion were held to:

i. Identify issues and challeges in pharmacy clinical services

ii. Analise the causal factors to the obstacles in service development

iii. Develop sustainable goals and action plans for any neccesary remedial actions

Peserta memberi tumpuan kepada ceramah yang disampaikan

Participants attentively listened to the lecture

Bengkel Skills to Develop Sustainable Goals in Clinical Pharmacy ServicesWorkshop on Skills to Develop Sustainable Goals in Clinical Pharmacy Services


KURSUS PENGUKUHAN FARMAKOTERAPI RENAL 2019Kursus ini telah diadakan pada 6 September 2019 di Kompleks Pakar dan Rawatan Harian (SCACC), Hospital Kuala Lumpur dan dihadiri oleh 36 orang peserta. Objektif kursus ini adalah untuk berkongsi pengetahuan terkini dalam konteks pemilihan farmakoterapi renal dan membincangkan pendekatan bagi meningkatkan kepatuhan pesakit terhadap rawatan. Pelbagai topik ceramah yang berkaitan dalam penjagaan pesakit nefrologi telah diberikan oleh pegawai farmasi, pakar perunding nefrologi dan juga pegawai dietetik. Kursus ini memberikan satu kelainan di mana diadakan satu sesi perbahasan yang melibatkan pegawai farmasi daripada pelbagai bidang pengkhususan iaitu nefrologi, geriatrik dan nutrisi parenteral untuk membahaskan pendekatan farmakoterapi terhadap pesakit nefrologi yang mempunyai pelbagai komorbiditi.

RENAL PHARMACOTHERAPY COURSE 2019The course was conducted on 6 September 2019 at Specialist Complex and Ambulatory Care Centre (SCACC), Hospital Kuala Lumpur. A total of 36 pharmacists have attended this course. The main objectives of this course is to strengthen renal pharmacotherapy knowledge and to discuss various approaches to improve patient’s adherence in medication. Experts from respective fields were invited to share experience and thoughts on handling patients with kidney diseases. The highlight of workshop was a debate session held to discuss the pros and cons of different approaches in caring for kidney patients with co-morbidities.

Kursus Pengukuhan Farmakoterapi Renal 2019

Renal Pharmacotherapy Course 2019

PERSIDANGAN PEDIATRIK FARMASI KEBANGSAAN KALI KETIGA 2019Persidangan ini telah dianjurkan oleh Jawatankuasa Kerja Farmasi Klinikal (Pengkhususan Pediatrik) dari 23 hingga 25 Julai 2019 di Hotel Le-Meridian, Putrajaya, yang bertemakan Child Health: We Share, We Care & We Prevent. Persidangan ini telah dihadiri oleh 91 orang peserta yang terdiri daripada pegawai farmasi Kementerian Kesihatan Malaysia dan juga ahli farmasi swasta. Objektif persidangan ini adalah untuk menyampaikan maklumat terkini berkaitan vaksin dan imunisasi serta isu berkaitan penyakit kulit yang biasa dialami oleh kanak-kanak. Persidangan ini juga merupakan satu platform untuk perkongsian maklumat yang berkaitan dengan farmasi pediatrik di kalangan para peserta.

Satu pra-persidangan bertajuk Thalassemia Adherence Management Workshop juga telah diadakan pada 23 Julai 2019 iaitu sehari sebelum persidangan berlangsung. Pra-persidangan ini bertujuan untuk memberi fokus tentang isu dan cabaran semasa penjagaan pesakit Thalassemia dan cara pengurusan pesakit Thalassemia terutamanya dari segi meningkatkan tahap kepatuhan pesakit terhadap pengambilan ubat-ubatan Thalassemia.

THIRD NATIONAL PEDIATRICS PHARMACY MEETING 2019This conference was conducted from 23 to 25 July 2019 at Le-Meridian Hotel, Putrajaya, participated by 91 pharmacists from both government and private sector. This year’s theme is Child Health: We Share, We Care & We Prevent. The objective of this event as to update participants on the latest information regarding vaccination and immunisation, and also any skin related issues among children. This conference is also a platform where all participants could exchange ideas and thoughts on how to improve paediatric care services.

Alongside with the conference, a pre-conference Thalassemia Adherence Management Workshop was held on the 23 July 2019. This workshop was to focus on challenges faced by healthcare provides while handling Thalassemia patients and also allow participants to get exposure on the latest Thalassemia treatment and ways to improve patients adherence to medication.


Persidangan Pediatrik Farmasi Kebangsaan Kali Ketiga 2019

Third National Pediatrics Pharmacy Meeting 2019

Sesi Lawatan Poster Oleh Pengarah Amalan dan Perkembangan Farmasi

Poster Booth Visit by Director of Pharmacy Practice and Development

BENGKEL EFFECTIVE MEDICATION REVIEW FOR OLDER PERSONS 2019Bengkel Effective Medication Review for Older Persons 2019 anjuran JKK Farmasi Klinikal (Pengkhususan Geriatrik) telah berlangsung pada 16 hingga 17 April 2019 di Hospital Rehabilitasi Cheras . Objektif bengkel ini adalah seperti berikut :

a) Untuk mewujudkan kesedaran mengenai kepentingan pengurusan ubat dalam penjagaan geriatrik.

b) Untuk mendidik pegawai farmasi mengenai peranan mereka dalam semakan ubat untuk orang tua

c) Mengukuhkan kemahiran pegawai farmasi untuk meningkatkan kualiti pengurusan ubat geriatrik.

Bengkel ini telah dihadiri oleh 40 pegawai farmasi dari fasiliti KKM seluruh Malaysia. Pakar-pakar bidang geriatrik telah dijemput sebagai penceramah untuk berkongsi ilmu dan pengalaman dalam pengendalian pesakit geriatrik. Selain itu, terdapat juga sesi kumpulan di mana peserta membincangkan dan membentangkan isu bertajuk ‘Cabaran Dan Senario: Semakan Ubat Yang Berkesan Dalam Penjagaan Warga Tua Di Malaysia’.

Bengkel Effective Medication Review for Older Persons 2019Effective Medication Review for Older Persons 2019 Workshop

EFFECTIVE MEDICATION REVIEW FOR OLDER PERSONS 2019 WORKSHOPThe Effective Medication Review for Older Persons 2019 Workshop was held on 16 to 17 April at Cheras Rehabilitation Hospital. The objective of this workshop is as follows:

a) To create awareness about the importance of drug management in geriatric care

b) To educate pharmacists on their role in reconciliation of drug among elderly patients

c) Strengthen skills to improve quality of drug management among geriatric patients

40 pharmacists attended this workshop. Experienced geriatricians were invited to deliver lectures and share their experience in geriatric care. Interesting group discussion session was also organised to talk about ‘’Challenges and Scenarios: Efficient Medication Check Among Geriatric Care in Malaysia’’.


BENGKEL PSYCHIATRY PHARMACY UPDATES 2019Bengkel Psychiatry Pharmacy Updates Workshop 2019 telah diadakan pada 26 hingga 28 Mac 2019 di Institut Latihan Kementerian Kesihatan Malaysia (ILKKM) Sultan Azlan Shah, Perak anjuran bersama Jawatankuasa Kerja Farmasi Klinikal (Pengkhususan Psikiatri) dan Jawatankuasa Kerja Klinikal Farmasi Wad, Bahagian Amalan & Perkembangan Farmasi KKM. Tema bengkel ini adalah Less Work Stress, Healthier Mental Health dengan objektif bengkel seperti berikut:

a) Untuk menambah ilmu pengetahuan tentang perkembangan terkini di dalam bidang psikiatri yang berasaskan praktis evidence-based medicine.

b) Untuk mengenalpasti punca dan mempelajari cara untuk mengelakkan tekanan di tempat kerja dan mewujudkan persekitaran kerja yang kondusif dalam mempertingkatkan mutu perkhidmatan yang diberikan.

Bengkel ini telah dihadiri oleh 84 pegawai farmasi dari fasiliti KKM seluruh Malaysia. Pakar-pakar bidang dari Hospital Bahagia Ulu Kinta yang berhampiran telah dijemput sebagai penceramah untuk berkongsi ilmu dan pengalaman dalam pengendalian pesakit psikiatri. Selain itu, terdapat juga sesi bersama pegawai psikologi mengenai topik Coping Stress At Work dan sesi forum membincangkan topik: Family Vs. Work? How To Choose And Not Feel Guilty.

PSYCHIATRY PHARMACY UPDATES WORKSHOP 2019Psychiatry Pharmacy Updates Workshop 2019 was held in Institut Latihan Kementerian Kesihatan Malaysia (ILKKM) Sultan Azlan Shah, Perak on 26 to 28 March 2019 and was attended by 84 pharmacists. The theme of this workshop is Less Work Stress, Healthier Mental Health; and its objectives are:

a) To provide knowledge on the latest development in psychiatry with evidence based medicine concept

b) To determine cause and ways to handle work stress and create conductive working environment to increase work quality

Psychiatrist from Hospital Bahagian Ulu Kinta were invited to share experiences in handling psychiatric patients. There was also a forum session to discuss the topic Family vs Work? How To Choose and Not Feel Guilty.

Bengkel Psychiatry Pharmacy Updates 2019Psychiatry Pharmacy Updates Workshop 2019

LAWATAN SAMBIL BELAJAR KE HOSPITAL BAHAGIA ULU KINTAPada 26 Mac 2019, seramai 14 orang ahli Jawatankuasa Kerja Farmasi Klinikal (Pengkhususan Psikiatri) telah menyertai lawatan sambil belajar ke Hospital Bahagia Ulu Kinta (HBUK) yang merupakan Institusi Kesihatan Mental tertua dan terbesar di Malaysia.

Tujuan lawatan ini adalah untuk mendapatkan pendedahan tentang kemudahan fasiliti dan perkhidmatan psikiatri yang dijalankan di HBUK. Peserta lawatan telah dibawa melawat ke Unit Farmasi, Muzium HBUK dan Wad Kebun Perempuan. Dengan lawatan ini, ahli JKK dapat mempelajari tentang sejarah institusi ini dan saling bertukar-tukar pandangan mengenai penjagaan pesakit psikiatri dengan lebih mendalam.

HOSPITAL BAHAGIA ULU KINTA VISIT14 committee members from Clinical Pharmacy Working Committee (Subspecialty Pharmacy Psychiatry) had organised a visit to the largest and oldest mental health facility in Malaysia -- Hospital Bahagia Ulu Kinta (HBUK).

The focus of this visit is to expose committee members to the facilities and psychiatric services available in HBUK. This tour includes a visit to the Pharmacy Unit, HBUK Museum and Female Wad Garden. The members have gained precious understanding about the history of this institution and had the opportunity to gain more ideas about psychiatric patient care.

Lawatan Sambil Belajar ke Hospital Bahagia Ulu KintaHospital Bahagia Ulu Kinta Visit


QUALITY IMPROVEMENT THROUGH INTERRUPTED TIME SERIES ANALYSIS OF ANTIBIOTIC UTILISATION DATA WORKSHOPThis workshop was held on 22 to 23 April 2019 at Institute of Broadcasting and Information Tun Abdul Razak, Kuala Lumpur and was attended by 51 pharmacists from MOH facilities nationwide. The objective of the workshop was to expose participants to interrupted time series (ITS) analysis and its application in the analysis of antibiotic utilisation data. Throughout the workshop, participants were trained to conduct ITS analysis on antibiotic utilisation data using the Statistical Package for the Social Sciences (SPSS) software. From ITS analysis, changes in antibiotic utilisation trend before and after the implementation of antimicrobial stewardship programme can be measured and it can be determined whether there is significant change in trend. Lecture topics and practical sessions were delivered by Dr. Wan Rozita binti Wan Mahiyuddin who is a Senior Research Officer at the Institute for Medical Research.

BENGKEL QUALITY IMPROVEMENT THROUGH INTERRUPTED TIME SERIES ANALYSIS OF ANTIBIOTIC UTILISATION DATA Bengkel ini telah diadakan pada 22 hingga 23 April 2019 di Institut Penyiaran dan Penerangan Tun Abdul Razak, Kuala Lumpur dan telah dihadiri oleh seramai 51 orang Pegawai Farmasi KKM dari seluruh negara. Objektif bengkel ialah bagi memberi pendedahan kepada peserta tentang interrupted time series (ITS) analysis dan aplikasinya dalam menganalisis data penggunaan antibiotik. Sepanjang bengkel, peserta telah dilatih untuk menjalankan analisis ITS terhadap data penggunaan antibiotik menggunakan perisian Statistical Package for the Social Sciences (SPSS). Melalui analisis ITS, perubahan dalam corak penggunaan antibiotik sebelum dan selepas pelaksanaan program antimicrobial stewardship dapat diukur dan ditentukan sama ada ianya signifikan. Sesi ceramah dan praktikal telah dikendalikan oleh Dr. Wan Rozita binti Wan Mahiyuddin yang merupakan Pegawai Penyelidik Kanan dari Institut Penyelidikan Perubatan.

Bengkel Quality Improvement Through Interrupted Time Series Analysis Of Antibiotic Utilisation Data Quality Improvement Through Interrupted Time Series Analysis Of Antibiotic Utilisation Data Workshop

KURSUS BEHAVIOUR CHANGE TECHNIQUE FOR ANTIMICROBIAL STEWARDSHIP Kursus ini telah diadakan pada 27 hingga 28 Ogos 2019 di Bahagian Regulatori Farmasi Negara. Ia telah dihadiri oleh 47 orang Pegawai Farmasi yang terlibat dalam aktiviti antimicrobial stewardship (AMS) di hospital dan klinik kesihatan KKM di seluruh negara. Kursus ini bertujuan untuk memberi pengetahuan dan kemahiran dalam teknik pengubahan tingkah laku yang boleh diaplikasikan di tempat bertugas bagi meningkatkan keberkesanan program AMS. Sesi ceramah dan kerja berkumpulan telah dikendalikan oleh pakar psikologi yang berpengalaman luas, Dr. Hariyati Shahrima binti Abdul Majid.

BEHAVIOUR CHANGE TECHNIQUE FOR ANTIMICROBIAL STEWARDSHIP COURSE

This course was organised on 27 to 28 Ogos 2019 at the Bahagian Regulatori Farmasi Negara. 47 pharmacists who were involved in antimicrobial stewardship (AMS) activities at MOH hospitals and health clinics throughout the country had participated in this course. This course aimed to provide knowledge and skill in behaviour change technique which can be applied in daily work to enhance the effectiveness of AMS programme. Lecture and group work sessions were handled by Dr. Hariyati Shahrima binti Abdul Majid, who is an experienced psychologist.

Peserta berbincang semasa kerja berkumpulanDiscussion during group work

Penyampaian sijil penghargaan kepada penceramahHanding of certificate of appreciation to the speaker


MESYUARAT TEKNIKAL PEMURNIAN GARIS PANDUAN HARGA UBATMesyuarat Teknikal Pemurnian Garis Panduan Harga Ubat telah diadakan pada 2 sehingga 4 Julai 2019 bertempat di Hotel Avillion Admiral Cove, Port Dickson, Negeri Sembilan. Objektif utama mesyuarat ini adalah untuk menambah baik deraf Garis Panduan Harga Ubat. Mesyuarat ini telah dihadiri oleh wakil daripada pelbagai pihak seperti berikut:

i. Kementerian Perdagangan Dalam Negeri dan Hal Ehwal Pengguna

ii. Kementerian Pertahanan Malaysia

iii. Kementerian Pendidikan Malaysia yang diwakili oleh:

• Pusat Perubatan Universiti Kebangsaan Malaysia

• Pusat Perubatan Universiti Malaya

iv. Bahagian Dasar dan Hubungan Antarabangsa KKM

v. Bahagian Regulatori Farmasi Negara

vi. Bahagian Dasar dan Perancangan Strategik Farmasi, KKM

vii. Bahagian Amalan & Perkembangan Farmasi, KKM

viii. Bahagian Penguatkuasaan Farmasi

ix. Hospital Kuala Lumpur

MEDICINES PRICES GUIDELINES REVISION TECHNICAL MEETINGMedicines Prices Guidelines Revision Technical Meeting has been conducted from 2 till 4 of July 2019 at Avillion Admiral Cove Hotel, Port Dickson, Negeri Sembilan. The objective of this meeting is to improve and revised draft of the Medicines Price Guidelines. This meeting has been attended by representatives from the following parties:

i. Ministry of Domestic Trade and Consumer Affairs

ii. Ministry of Defense

iii. Representatives from Ministry of Education:

• Universiti Kebangsaan Malaysia Medical Centre

• Universiti Malaya Medical Centre

iv. Policy and International Relations Division, Ministry of Health

v. National Pharmaceutical Regulatory Division

vi. Pharmacy Policy & Strategic Planning Division, Ministry of Health

vii. Pharmacy Practice and Development Division, Ministry of Health

viii. Pharmacy Enforcement Division, Ministry of Health

ix. Hospital Kuala Lumpur

Gambar semasa Mesyuarat Teknikal Pemurnian Garis Panduan Harga Ubat Photo taken during Medicines Prices Guidelines Revision Technical Meeting

SESI PERBINCANGAN MEJA BULAT MEKANISME HARGA UBATTarikh: 30 Oktober 2019

Tempat: Bilik Delima, Program Perkhidmatan Farmasi, Kementerian Kesihatan Malaysia

ROUND TABLE DISCUSSION ON MEDICINES PRICE MECHANISMDate: 30 of October 2019

Venue: Bilik Delima, Pharmaceutical Services Programme, Ministry of Health

Gambar diambil sekitar sesi perbincangan meja bulat

Photo taken during round table discussion


SESI LIBAT URUS DAN PERBINCANGAN DENGAN PELBAGAI PIHAK PEMEGANG TARUH BAGI MEKANISME HARGA UBATTempat: Program Perkhidmatan Farmasi, Kementerian Kesihatan Malaysia

LAWATAN SAMBIL BELAJAR KE UNIVERSITI MAHIDOL, BANGKOK, THAILANDSatu lawatan sambil belajar telah dijalankan oleh 5 wakil JKK Farmasi Kardiologi ke Universiti Mahidol di Bangkok, Thailand dari 26 hingga 30 November 2018. Institusi ini adalah salah satu centre of excellence dalam bidang kardiologi di Thailand. Objektif lawatan ini adalah untuk mendapatkan pandangan dan idea dari negara lain untuk memajukan perkhidmatan farmasi kardiologi di Malaysia.

Tumpuan khas juga diberikan kepada program latihan yang ditawarkan di Universiti Mahidol. Institusi ini banyak bekerjasama dengan universiti lain yang turut menawarkan latihan sangkutan kardiologi. Pasukan ini juga dapat berjumpa dengan Profesor Madya Surakit Nathisuwan yang merupakan salah seorang pakar farmasi yang mempunyai kelulusan Board Certified Pharmacotherapy Specialist (BCPS) dan juga preseptor bagi latihan sangkutan Klinik Anticoagulation, perkhidmatan Acute Coronory Symptoms (ACS) dan perkhidmatan Heart Failure di Thailand.

Lawatan Sambil Belajar ke Universiti Mahidol, Bangkok,

ThailandUniversiti Mahidol, Bangkok, Thailand Field Trip

ENGAGEMENT AND DISCUSSION WITH VARIOUS STAKEHOLDERS ON MEDICINES PRICING MECHANISM Venue: Pharmaceutical Services Programme, Ministry of Health

Foto sekitar berlangsung sesi libat urus dan perbincangan dengan pihak pemegang taruhPhoto captured during engagement and discussion sessions held with various stakeholders

UNIVERSITI MAHIDOL, BANGKOK, THAILAND FIELD TRIPFive (5) representatives from Clinical Pharmacy Working Committee (Speciality Pharmacy Cardiology) have visited one of the centres of excellence in cardiology in Bangkok, Thailand - Mahidol University from 26 to 30 November 2018. The objective of this tour was to meet up with the experts in cardiology clinical pharmacy to gain insights and idea in order to improve Malaysia’s cardiology pharmaceutical care in the future.

Special interest was on the training program in the university. This university had a good collaboration with other hospitals which provide training for pharmacists especially in cardiology activities. The team also managed to meet up with Associate Professor Surakit Nathisuwan who is a certified pharmacist of the Board Certified Pharmacotherapy Specialist (BCPS) and also a preceptor for the Anticoagulation Clinic, Acute Coronory Symptoms (ACS) and Heart Failure service in Thailand.


Gambar Berkumpulan dengan Profesor Madya Surakit Nathisuwan

Group photo with Associate Professor Surakit Nathisuwan

KURSUS FUNDAMENTALS OF MEDICAL DECISION MAKING DAN VALUE BASED HEALTHCARE (VBHC), FROM THEORY TO IMPLEMENTATIONSeorang pegawai daripada Seksyen Penilaian Ubat dan Farmakoekonomik, Cawangan Pengurusan Formulari iaitu Puan Nazatul Syima Idrus telah berpeluang mengikuti kursus luar negara di bawah Pelan Operasi Latihan 2019. Beliau telah menghadiri kursus bertajuk Fundamentals of Medical Decision Making dan Value Based Healthcare (VBHC), From Theory to Implementation yang berlangsung pada 12 hingga 23 Ogos 2019 bertempat di Erasmus Medical Centre, Rotterdam, Netherlands. Kursus tersebut ditawarkan di bawah Erasmus Summer Programme yang dianjurkan oleh Erasmus University.

BENGKEL MEDICINES PRICE NEGOTIATION IN THE WESTERN PACIFIC REGIONTarikh : 12 hingga 14 Mac 2019Tempat : Manila,FilipinaPeserta : Cik Nordiana binti Shariff Puan Saliza binti Ibrahim

FUNDAMENTALS OF MEDICAL DECISION MAKING DAN VALUE BASED HEALTHCARE (VBHC), FROM THEORY TO IMPLEMENTATION COURSEAn officer from the Drug Evaluation and Pharmacoeconomic Section, Formulary Management Branch, Madam Nazatul Syima Idrus, had have an opportunity to attend an overseas course under the Training Operations Plan 2019. She attended courses entitled Fundamentals of Medical Decision Making and Value Based Healthcare (VBHC), From Theory to Implementation that took place from 12 to 23 August 2019 at Erasmus Medical Centre, Rotterdam, Netherlands. Those courses were offered under the Erasmus Summer Programme organized by the Erasmus University.

WORKSHOP ON MEDICINES PRICE NEGOTIATION IN THE WESTERN PACIFIC REGIONDate : 12 to 14 March 2019Venue : Manila, the PhilippinesParticipants : Miss Nordiana binti Shariff Madam Saliza binti Ibrahim

Bengkel Medicines Price Negotiation in The Western Pacific RegionWorkshop on Medicines Price Negotiation in The Western Pacific Region


FORUM FAIR PRICING KALI KEDUATarikh : 11 hingga 13 April 2019 Tempat : Johannesburg, Afrika SelatanPeserta : Dr. Roshayati Binti Mohamad Sani Puan Salbiah Mohd Salleh

SECOND FAIR PRICING FORUMDate : 11 to 13 April 2019Venue : Johannesburg, South Afrika Participants : Dr. Roshayati Binti Mohamad Sani Madam Salbiah Binti Mohd Salleh

PERSIDANGAN ACCESS TO MEDICINES UNDER UNIVERSAL HEALTH COVERAGE IN THE ASIA PACIFIC REGION KALI KEENAM.Tarikh : 24 hingga 25 September 2019Tempat : Manila, FilipinaPeserta : Cik Noraini Saari

SIXTH MEETING ON ACCESS TO MEDICINES UNDER UNIVERSAL HEALTH COVERAGE IN THE ASIA PACIFIC REGIONDate : 24 to 25 September 2019Venue : Manila, the PhilippinesParticipant : Miss Noraini Saari

Persidangan Access to Medicines under Universal Health Coverage in the Asia Pacific Region Kali KeenamSixth Meeting on Access to Medicines under Universal Health Coverage in the Asia Pacific Region

PERSIDANGAN TEKNIKAL REGIONAL COLLABORATIVE STRATEGY FOR ASEAN DRUG SECURITY AND SELF RELIANCE Tarikh : 6 hingga 8 November 2019Tempat : The Everly Hotel, PutrajayaPeserta : Cik Noraini Saari

TECHNICAL MEETING ON REGIONAL COLLABORATIVE STRATEGY FOR ASEAN DRUG SECURITY AND SELF RELIANCE Date : 6 to 8 November 2019Venue : The Everly Hotel, PutrajayaParticipant : Miss Noraini Saari

Persidangan Teknikal Regional Collaborative Strategy for Asean Drug Security and Self RelianceTechnical Meeting on Regional Collaborative Strategy for Asean Drug Security and Self Reliance


AKTIVITI PEMURNIAN UBAT RESPIRATORI INHALER Aktiviti pemurnian ubat respiratori inhaler telah dibentangkan di Konferens HTAsiaLink 2019 pada 24 hingga 27 April 2019 di Seoul, Korea. Pembentangan oral kajian bertajuk ‘A practical application of Multiple Criteria Decision Analysis in the context of Health Technology Assessment: A pilot study on Ministry of Health Medicines Formulary listing of respiratory inhalers’ telah dibentangkan oleh Cik Yong Yee Vern. Beliau telah dianugerahkan tempat kedua bagi ‘Excellence in Oral Presentation on Health System Research & Others’ di konferens tersebut.


REASSESSMENT ACTIVITY OF RESPIRATORY INHALERSThe reassessment activity of respiratory inhalers was presented in HTAsiaLink 2019 Conference on 24 to 27 April 2019 in Seoul, Korea. The oral presentation entitled ‘A practical application of Multiple Criteria Decision Analysis in the context of Health Technology Assessment: A pilot study on Ministry of Health Medicines Formulary listing of respiratory inhalers’ was presented by Miss Yong Yee Vern. She was awarded the second place winner for ‘Excellence in Oral Presentation on Health System Research & Others’ in that conference.

Tempat kedua bagi ‘Excellence in Oral Presentation on Health System Research & Others’

Second place winner for ‘Excellence in Oral Presentation on Health System Research & Others’


PROGRAM KENALI UBAT ANDA Program Kenali Ubat Anda telah terpilih sebagai salah satu program yang akan dinilai di bawah Penilaian Outcome Kementerian Kesihatan Malaysia. Kertas Kajian Penilaian Outcome ini merupakan KPI bagi Ketua Setiausaha (KSU) Kementerian Kesihatan Malaysia. Penilaian outcome dan impak akan dibentangkan kepada Audit Negara dan Unit Penyelarasan Pelaksanaan (ICU) Jabatan Perdana Menteri. Program Kenali Ubat Anda juga telah terpilih untuk membentangkan hasil Kajian Penilaian Outcome di Konvensyen dan Pembentangan Laporan Penilaian Outcome Kepada Mesyuarat Jawatankuasa Penilaian Outcome (JKPO) ICU, JPM peringkat Kementerian bagi tahun 2019 pada 30 September 2019. Sebanyak 14 outcome yang telah dicapai melalui Program Kenali Ubat Anda telah dibentangkan.

Artikel Know Your Medicine Ambassadors Program Implementation in Malaysia telah diterbitkan dalam Malaysia Journal of Health Promotion.


KNOW YOUR MEDICINE PROGRAM‘Know Your Medicine’ Programme has been selected as one of the programs to be evaluated under the Ministry of Health Malaysia Kajian Penilaian Outcome. This Outcome Evaluation Study paper is a KPI for the Chief Secretary (KSU) of the Ministry of Health Malaysia. Outcome and impact assessments were presented to the Prime Minister’s Department (Jabatan Perdana Menteri) and Implementation Coordination Unit (ICU). The Know Your Medicine Program has also been selected to present the results of the Outcome Evaluation to the ICU, Outcome Evaluation Committee (JKPO) during Outcome Evaluation Convention which was held on September 30th 2019. A total of 14 outcomes have been achieved throughout the program implementation.

Know Your Medicine Ambassadors Program Implementation in Malaysia article has been published in the Malaysia Journal of Health Promotion (MJHP).

GARISPANDUAN FARMAKOTERAPI BERHENTI MEROKOK (FBM) EDISI KEDUA 2019Garispanduan ini merupakan satu sumber rujukan bagi pegawai farmasi yang menjalankan perkhidmatan berhenti merokok di fasiliti KKM. Garispanduan ini fokus kepada aspek farmakoterapi ubat yang digunapakai dalam menangani masalah ketagihan nikotin daripada tabiat merokok. Ia mengandungi borang-borang pengurusan yang berkaitan dengan perkhidmatan ini, panduan kaunseling berhenti merokok dan maklumat berkenaan ubat-ubatan bagi berhenti merokok.

‘FARMAKOTERAPI BERHENTI MEROKOK’ (FBM) GUIDELINE, SECOND EDITION 2019This guideline acts as a reference for pharmacists who are conducting smoking cessation service at the MOH facilities. It focuses on the pharmacotherapy aspect used in combating the nicotine addiction among the smokers. Included in this guideline are the relevant administrative forms, counselling guide on smoking cessation and information on drugs for quit smoking.

Garispanduan Farmakoterapi Berhenti Merokok (FBM) Edisi Kedua 2019‘Farmakoterapi Berhenti Merokok’ (FBM) Guideline, Second Edition 2019


FLIPCHART PENGURUSAN TERAPI KESAKITANFlipchart Pengurusan Terapi Kesakitan ini adalah sebagai panduan dan alat bantuan kepada pegawai farmasi untuk menjalankan kaunseling ubat-ubatan tahan sakit kepada pesakit.

‘PENGURUSAN TERAPI KESAKITAN’ FLIPCHARTThis ‘Pengurusan Terapi Kesakitan’ flipchart used as a guide and tool for pharmacist to provide counselling on pain medication.

Pengurusan Terapi Kesakitan Flipchart‘Pengurusan Terapi Kesakitan’ Flipchart

BUKU PANDUAN CLINICAL PHARMACOKINETIC PHARMACY, EDISI KEDUABuku Panduan Clinical Pharmacokinetics Pharmacy Edisi ke-2 ini disediakan sebagai panduan kepada pegawai farmasi dalam memastikan keseragaman dalam memberikan perkhidmatan farmakokinetik klinikal di semua fasilti Kementerian Kesihatan Malaysia. Semua rekomendasi yang diberikan di dalam buku ini telah mengambilkira polisi sedia ada yang digunapakai oleh fasiliti dalam menyampaikan perkhidmatan farmakokinetik klinikal.

CLINICAL PHARMACOKINETIC PHARMACY HANDBOOK, SECOND EDITION Clinical Pharmacokinetic Pharmacy Handbook 2nd Edition is guide for pharmacist to ensure standardize Clinical Pharmacokinetic Service provided across all Ministry of Health Malaysia facilities. All recommendations given in this handbook had considered existing policies practiced in providing Clinical Pharmacokinetic Service.

Buku Panduan Clinical Pharmacokinetic Pharmacy, Edisi Kedua

Clinical Pharmacokinetic Pharmacy Handbook, 2nd Edition


GARIS PANDUAN PEMBEKALAN UBAT FARMASI PESAKIT DALAM, EDISI KETIGA 2019Garis Panduan Pembekalan Ubat Farmasi Pesakit Dalam Edisi Ke-3 ini lebih komprehensif dengan mempertimbangkan semua elemen yang berkaitan dengan perkhidmatan Farmasi Pesakit Dalam. Ianya menerangkan mengenai prosedur - prosedur kerja yang melibatkan pembekalan ubat kepada pesakit di wad/unit dengan lebih jelas dan komprehensif. Garis panduan ini satu panduan kepada anggota farmasi di fasiliti KKM untuk menerapkan amalan pembekalan ubat-ubatan yang baik dan meningkatkan mutu penyampaian perkhidmatan, sejajar dengan usaha kerajaan untuk menyediakan perkhidmatan yang terbaik.

‘PEMBEKALAN UBAT FARMASI PESAKIT DALAM’ GUIDELINE, THIRD EDITION 2019‘Garis Panduan Pembekalan Ubat Farmasi Pesakit Dalam’ Third Edition is formatted more comprehensive with latest elements of In-patient Pharmacy Services. The guideline explained more clearly and comprehensively on standard operational procedures involved in supplying medication to patient in ward/ unit. With this guideline, pharmacy staff at MOH facilities able to adopt good medication supply practices and improve the quality of service delivery, in line with the government’s efforts to provide the best services.

Garis Panduan Pembekalan Ubat Farmasi Pesakit Dalam, Edisi Ketiga 2019

‘Pembekalan Ubat Farmasi Pesakit Dalam Guideline’, Third Edition 2019

PROTOKOL MTAC NEFROLOGI, EDISI KEDUA 2019Protokol ini mengandungi modul-modul untuk MTAC Chronic Kidney Disease, MTAC Dialisis dan MTAC Renal Transplant. Perkhidmatan MTAC telah menyumbang kepada peningkatan penjagaan pesakit yang lebih efektif, selamat dan kos-efektif. Sehingga kini terdapat 40 hospital major yang menawarkan sekurang-kurangnya satu jenis perkhidmatan MTAC Nefrologi.

Protokol ini menggariskan prosedur dan dokumen-dokumen yang digunakan semasa sesi MTAC Nefrologi. Ia akan menjadi rujukan utama pegawai farmasi semasa mengendalikan pengurusan pesakit buah pinggang ambulatori. Kewujudan protokol ini akan mengekalkan standard perkhidmatan MTAC Nefrologi di semua fasiliti KKM.

NEPHROLOGY MTAC PROTOCOL, SECOND EDITION 2019This protocol encompasses the modules for Chronic Kidney Disease MTAC (CKD-MTAC), Dialysis MTAC and Renal Transplant MTAC (RTX-MTAC). The benefits of MTAC services have shown to improve the quality, safety and cost effectiveness of patient care. Today, a total of 40 major hospitals are providing at least one Nephrology MTAC services.

This protocol outlines the procedure and documentations during all Nephrology MTAC sessions. It is intended as the key reference for pharmacists in the course of managing renal patients at the ambulatory care settings. The availability of this protocol would sustain the standardization of practice across MOH facilities.

Protokol MTAC Nefrologi, Edisi Kedua 2019Nephrology MTAC Protocol, Second Edition 2019


PROTOCOL MTAC NEUROLOGI, EDISI PERTAMA 2019Protokol ini menerangkan MTAC Neurologi, yang pada masa ini ditawarkan untuk pesakit strok, epilepsi dan penyakit Parkinson di fasiliti KKM. Ia menggariskan prosedur dan dokumentasi semasa sesi MTAC dan berfungsi sebagai panduan untuk membolehkan piawaian amalan dan penubuhan perkhidmatan MTAC Neurologi di seluruh fasiliti KKM.

MTAC NEUROLOGY PROTOCOL, FIRST EDITION 2019This protocol will describe MTAC Neurology, which is currently offered for patients with stroke, epilepsy and Parkinson’s disease at an ambulatory setting. It outlines the procedures and documentations during MTAC sessions and serve as a guide to enable standardisation of practice and establishment of MTAC Neurology service throughout MOH facilities.

Protocol MTAC Neurologi, Edisi Pertama 2019MTAC Neurology Protocol, First Edition 2019

PROTOKOL HOME CARE PHARMACY SERVICES, EDISI KEDUA 2019Perkhidmatan Farmasi Home Care Pharmacy Services (PFHC) yang dahulunya dikenali sebagai Home Medication Review (HMR) bertujuan untuk menggalakkan penggunaan ubat-ubatan secara optimum dan berkualiti. Aktiviti-aktiviti yang terlibat adalah drug reconciliation dan pemantauan ubat-ubatan preskripsi & bukan preskipsi secara komprehensif dan sistematik.

Objektif utama perkhidmatan ini adalah untuk meningkatkan hasil kesihatan dan kualiti hidup pesakit dengan menekankan penggunaan ubat-ubatan yang berkualiti, melalui penggunaan ubat-ubatan yang sesuai, selamat, bijaksana dan tepat.

HOME CARE PHARMACY SERVICES PROTOCOL, SECOND EDITION 2019Home Care Pharmacy Services (HCPS) formerly known as Home Medication Review (HMR) is aiming to advocate optimal and quality use of medications as the whole process involves comprehensive and systematic activities that include drug reconciliation and medication review for all prescription and non-prescription medications.

The main objectives of this service are to provide seamless care to improve health outcomes and quality of life of patients by emphasising the quality use of medicines, through appropriate, safe, judicious and proper use of medication in the home or residential setting. Pharmacists work with the patients, caregivers, doctors and other health care providers in evaluating medication-related information, identifying and preventing side effects and adverse drug reactions as well as optimising health outcomes.

Protokol Home Care Pharmacy Services, Edisi Kedua 2019Home Care Pharmacy Services Protocol, Second Edition

2019


GARIS PANDUAN KAUNSELING UBAT-UBATAN, EDISI KETIGA 2019Garis panduan ini berfungsi sebagai sumber rujukan untuk pegawai farmasi dalam memberikan kaunseling yang berkesan kepada pesakit. Ini adalah untuk memastikan pesakit akan menerima faedah terbaik daripada rawatan yang diterima, dan meningkatkan pematuhan terhadap ubat-ubatan.

‘KAUNSELING UBAT-UBATAN’ GUIDELINE, THIRD EDITION 2019This guideline serve as a source of reference for pharmacists in providing effective counsellings to patients. It also has laid down common issues or concerns regarding medications faced by patients, together with pharmaceutical interventions that could have been done in order to resolve them. This is to ensure patients will receive the best possible benefit from their treatment provided, improve compliance and adherence.

Garis Panduan Kaunseling Ubat-ubatan, Edisi Ketiga 2019‘Kaunseling Ubat-ubatan’ Guideline, Third Edition 2019

NATIONAL ANTIMICROBIAL GUIDELINE 2019 (EDISI KETIGA)National Antimicrobial Guideline 2019 (Edisi Ketiga) telah dilancarkan oleh Yang Berhormat Menteri Kesihatan, Datuk Seri Dr. Dzulkefly bin Ahmad, pada 26 September 2019 di Institut Kanser Negara. Garis panduan ini dihasilkan melalui beberapa siri perbincangan yang melibatkan Pakar-pakar Perunding/Pakar-pakar Perubatan dari pelbagai disiplin dan Pegawai Farmasi. Ia melibatkan proses perbincangan yang intensif bagi memastikan kandungan yang selaras dengan perkembangan terkini dalam amalan klinikal dan polisi semasa berkaitan penggunaan ubat-ubatan antimikrob. Garis panduan ini boleh didapati di laman sesawang Program Perkhidmatan Farmasi.

NATIONAL ANTIMICROBIAL GUIDELINE 2019 (THIRD EDITION)The National Antimicrobial Guideline 2019 (Third Edition) was launched by the Honourable Minister of Health, Datuk Seri Dr. Dzulkefly bin Ahmad, on 26 September 2019 at National Cancer Institute. This guideline has been developed through series of discussions which involve Consultants/Specialists from related disciplines, as well as pharmacists. The intensive discussion process was to ensure that contents of the guideline are in line with the current clinical practice and policies regarding antimicrobial use. This guideline is available at the website of the Pharmaceutical Services Programme.

National Antimicrobial Guideline 2019 (Edisi Ketiga)National Antimicrobial Guideline 2019 (Third Edition)

National Antimicrobial Guideline 2019 (Edisi Ketiga) dilancarkan oleh Yang Berhormat Menteri Kesihatan

National Antimicrobial Guideline 2019 (Third Edition) was launched by the Honourable Minister of Health


GARIS PANDUAN PENGENDALIAN PATIENT ACCESS SCHEME (PASC)Penerbitan garis panduan ini bertujuan untuk memberikan panduan kepada fasiliti KKM berhubung pengendalian ubat-ubatan ditawarkan secara PASc yang telah diluluskan di samping memastikan pelaksanaannya mematuhi pekeliling, peraturan dan tatacara sedang berkuatkuasa. Draf garis panduan telah diedarkan kepada pihak berkepentingan berkaitan sebelum ianya diluluskan oleh Timbalan Ketua Setiausaha (Kewangan) untuk dimuktamadkan dan diedarkan pada bulan Oktober 2019.

SENARAI UBAT PENTING KEBANGSAAN (NEML), EDISI KELIMASenarai Ubat-Ubatan Penting Kebangsaan (NEML) adalah senarai ubat-ubatan asas bagi keperluan penjagaan kesihatan majoriti penduduk yang diadaptasi daripada World Health Organization (WHO) Model List of Essential Medicines (EML). Matlamat utama NEML adalah untuk memastikan accessibility dan affordability ubat-ubatan penting kepada rakyat Malaysia di samping membantu memastikan perolehan dan penggunaan ubat-ubatan dibuat secara rasional berdasarkan keperluan fasiliti masing-masing.

Edisi kelima NEML ini boleh dimuat turun di laman sesawang rasmi Program Perkhidmatan Farmasi, www.pharmacy.gov.my.

GARIS PANDUAN FARMAKOEKONOMI 2019Edisi kedua Garis Panduan Farmakoekonomi 2019 telah disiapkan pada Disember 2019 bertujuan untuk mengemaskini informasi berkaitan dengan kajian farmakoekonomi di Malaysia. Garis panduan ini disasarkan kepada penyelidik, syarikat farmaseutikal, ahli dalam bidang kesihatan ekonomi, ahli profesional dalam bidang kesihatan dan lain-lain yang terlibat dalam menjalankan atau menggunakan kajian ekonomi dan analisa impak bajet di Malaysia.

PATIENT ACCESS SCHEME (PASC) HANDLING GUIDELINEPublication of this guideline is intended to provide guidance to MOH facilities regarding the handling of approved PASc drugs as well as to ensure that their implementation is in compliance with the current circulars, regulations and procedures. The draft guideline was circulated to the relevant stakeholders before it was approved by the Deputy Secretary-General (Finance) for finalization and distributed in October 2019.

NATIONAL ESSENTIAL MEDICINES LIST (NEML), FIFTH EDITIONThe National Essential Medicines List (NEML) is a list of basic medicines that satisfy the health care needs of the majority of the population adapted from the World Health Organization (WHO) Model List of Essential Medicines (EML). The main goal of NEML was to safeguard the accessibility and affordability of essential medicines to the Malaysian population. NEML also aims to facilitate rationalisation of the procurement of medicines and formulating essential lists according to facility needs to encourage rational use of medicines.

This fifth edition of NEML can be downloaded from the Pharmacy Services Program official website, www.pharmacy.gov.my.

PHARMACOECONOMIC GUIDELINES 2019The Pharmacoeconomic Guidelines 2019, Second Edition was completed in December 2019 aiming to update on information related to the pharmacoeconomic field in Malaysia. These guidelines are intended for use by researchers, pharmaceutical companies, health economists, health professionals and all those who are involved in the conduct or use of economic evaluations and budget impact analysis in Malaysia.


PHARMACY ENFORCEMENT DIVISION

BAHAGIAN PENGUATKUASAAN

FARMASI

100%SERBUAN | RAIDS

99.48%KES | CASES

95.39%IKLAN | ADVERTISEMENT

Serbuan yang berjaya diambil tindakan penguatkuasaan daripada jumlah serbuan yang dijalankan. (1422 daripada 1422 serbuan)Successful raids which enforcement action can be taken out of total numbers of raids done. (1422 out of 1422 raids)

Lesen/permit baharu yang dikeluarkan di bawah Akta Racun 1952 dalam tempoh 7 hari bekerja.

(3100 daripada 3198 lesen/permit)New licenses/permits issued under the Poisons Act 1952

within 7 working days. (3100 out of 3198 licenses/permits)

96.94%LESEN/PERMIT

LICENSES/PERMITS

96.94%LAPORAN PEMPROFAILAN

PROFILING REPORTS

95.55%KERTAS SIASATAN

INVESTIGATION PAPERS

Kertas siasatan yang berjaya mendapat saksi/kebenaran untuk mendakwa daripada jumlah kertas siasatan yang dikemukakan kepada Timbalan Pendakwa Raya (967 daripada 1012 kertas siasatan)Investigation papers given sanction/permission to sue from total number of investigation papers submitted to Deputy Public Prosecutor (967 out of 1012 investigation papers)

Kes yang berjaya dalam perbicaraan mahkamah daripada jumlah kes yang didakwa di mahkamah.

(953 daripada 958 kes)Successful case in court proceedings out of total number

of cases charged in the court. (953 out of 958 cases)

Iklan ubat-ubatan di dalam media cetak yang mematuhi undang-undang yang dikuatkuasakan.(9527 daripada 9987 iklan)Medicine advertisements in print media that comply to the Law. (9527 out of 9987 advertisements)

Laporan pemprofilan yang diambil tindakan dalam

tempoh 14 hari bekerja (603 daripada 618 laporan

pemprofilan)Profiling reports taken action within 14 working days (603 out of 618 profiling reports)

95.24%KERTAS SIASATAN

INVESTIGATION PAPERS

Kertas siasatan yang disiapkan dalam tempoh 4 bulan (961 daripada 1009

kertas siasatan)Investigation papers

completed within 4 months (961 out of 1009

investigations paper)

98.48%RISIKAN TAKTIKALTACTICAL INTELLIGENCE

Risikan taktikal yang diselesaikan dengan arahan serbuan dalam tempoh 2 bulan (130 daripada 132 risikan taktikal)Tactical intelligence completed with operation order within 2 months (130 out of 132 tactical intelligence)

99.22%TINDAKAN SUSULAN

FOLLOW-UP ACTIONS

Tindakan susulan yang diambil dalam tempoh 3 bulan selepas

pemeriksaan premis (1658 daripada 1671 tindakan)

Follow-up actions taken within 3 months after inspection of

premises (1658 out of 1671 actions)

100%Aduan berkaitan pelanggaran

akta-akta farmasi disahkan dan diberi maklum balas dalam tempoh

2 minggu (1539 daripada 1539 aduan)

Complaints related to infringement of pharmacy laws verified and

responded within 2 weeks (1539 out of 1539 complaints)

ADUAN | COMPLAINTS


PHARMACY ENFORCEMENT DIVISIONBAHAGIAN PENGUATKUASAAN FARMASI


Bahagian Penguatkuasaan Farmasi berperanan untuk memastikan semua produk farmaseutikal, tradisional dan kosmetik dalam pasaran adalah sah daripada segi pendaftaran dan notifikasi. Ia juga berfungsi untuk memastikan bahawa pengendalian rangkaian bekalan dan pemasaran, pengiklanan produk-produk kesihatan dan perkhidmatan perubatan dikendalikan dengan mematuhi peruntukan undang-undang yang dikuatkuasakan iaitu di bawah Akta Racun 1952, Akta Jualan Dadah 1952 dan Akta Ubat Iklan dan Penjualan 1956. Usaha ini dilakukan melalui aktiviti risikan dan operasi terancang, kawalan melalui sistem pelesenan berintegrasi, pemantauan beterusan dan bersepadu dan juga aktiviti seranta bersama agensi-agensi berkepentingan bagi menurunkan permintaan terhadap produk yang tidak selamat atau membahayakan.

The Pharmacy Enforcement Division plays a pivotal role to ensure that all pharmaceutical products, traditional medicines and cosmetics available in the market are genuine in terms of registration and notification. It also acts to ensure that the link between supply and marketing, advertising of healthcare products and medical services is conducted in compliance with the provisions of the existing legislations in Poisons Act 1952, Sale of Drugs Act 1952 and Medicines Advertisement and Sale Act 1956. These activities are carried out through intelligence and operations, control of licensing and integrated monitoring and collaborative activities with stakeholders to reduce the demands for unsafe or hazardous products.


• Menjalankan risikan berdasarkan maklumat yang diterima/ diperolehi

• Menjalankan serbuan ke atas premis yang menjual/ membekal/ menyimpan/ mengilang produk-produk tidak berdaftar, kosmetik tidak bernotifikasi

• Menjalankan serbuan ke atas premis yang menjual/ membekal/ menyimpan/ mengilang racun, bahan psikotropik, bahan kimia dan ubat-ubat terkawal yang beroperasi tanpa lesen yang sah

• Menjalankan aktiviti audit ubat-ubat terkawal

• Memproses lesen/ permit/ kebenaran merangkumi aktiviti penjualan, penggunaan, pengimportan dan pengeksportan bagi racun, dadah berbahaya, bahan psikotropik, bahan terkawal dan bahan kimia prekursor

• Menjalankan pemeriksaan ke atas premis yang dilesenkan di bawah Akta yang dikuatkuasakan

• Menyelaras dan memantau aktiviti saringan dan pemeriksaan pengimportan produk dan bahan-bahan yang dikawal di pintu-pintu masuk Kastam

• Menyelaras dan memantau aktiviti pelesenan dan pemeriksaan di Cawangan Penguatkuasa Farmasi Negeri

• Menjalankan dan mengawalselia aktiviti penggubalan undang-undang melibatkan pewartaan, pindaan, kemaskini senarai racun dan pelantikan pegawai di bawah Akta-akta yang dikuatkuasakan

• Memproses pengecualian khas bagi pengimportan keluaran tidak berdaftar bagi institusi kerajaan, swasta, pusat-pusat pengajian tinggi dan makmal-makmal penyelidikan

• Memantau perjalanan aktiviti siasatan bagi kes-kes berkaitan keluaran farmaseutikal, racun dan bahan kimia yang dikawal di bawah Akta-akta yang dikuatkuasakan

• Mengendalikan pendakwaan dan perbicaraan kes-kes di mahkamah berdasarkan Akta-akta yang dikuatkuasakan

• Conduct intelligence based on the information received/ gathered

• Conduct raids on the premises selling/ supply/ store/ manufacture of unregistered products and un-notified cosmetics

• Conduct raids on the premises selling/ supply/ store/ manufacture of poisons, psychotropic substances, chemicals and controlled medicines operating without a valid licence

• Conduct audits on controlled medicines

• Processing licences/ permits/ authorizations which cover the activity of sale, use, import and export of poisons, dangerous drugs, psychotropic substances, controlled substances and chemical precursors

• Conduct inspection on the premises licenced under the acts in force

• Co-ordinate and monitor screening and inspection activities on imported products and controlled substances at the entry points

• Co-ordinate and monitor licensing and inspection activities at the state level

• Conduct and regulate the activities of legislations involves gazette, amendments, updates the list of poisons and appointment of officers under the acts in force

• Process the application for special exemptions to import unregistered products received from government institutions, private sector, institute of higher learning and research laboratories

• Monitor the progress of inspection activities which involve pharmaceutical products, poisons and chemicals controlled under the acts in force

• Conduct prosecution in the court in line with the acts in force

CAWANGAN PERISIKAN DAN OPERASIINTELLIGENCE AND OPERATION BRANCH

CAWANGAN PELESENAN LICENSING BRANCH

CAWANGAN PERUNDANGANLEGISLATION BRANCH


95Pharmacy Programme Annual Report 2019

• Memproses permohonan kelulusan iklan ubat-ubatan dan perkhidmatan kesihatan

• Memantau iklan yang disiarkan melalui media cetak dan elektronik bagi memastikan peruntukan undang-undang sedia ada dipatuhi

• Menjalankan siasatan bagi kes-kes berkaitan pengiklanan ubat-ubatan dan perkhidmatan perubatan

• Mengumpul dan menyelaras statistik penguatkuasaan farmasi dan memantau aktiviti berkaitan kualiti dan inovasi penguatkuasaan farmasi

• Menyelaras perancangan aktiviti dan latihan penguatkuasaan farmasi

• Menganalisa sampel-sampel produk yang terdapat di pasaran, yang disyaki melanggar peruntukan undang-undang yang dikuatkuasakan

• Mewujudkan pangkalan data bagi sampel yang diuji dan maklumat-maklumat yang berkaitan penguatkuasaan untuk dijadikan bahan rujukan dan kajian penyelidikan bagi aktiviti penguatkuasaan farmasi

• Mengkoordinasi dan memberi input teknikal dan forensik farmasi dalam proses siasatan kes yang melibatkan pelanggaran undang-undang yang dikuatkuasakan oleh Bahagian Penguatkuasaan Farmasi berkaitan digital

• Menjalankan forensik digital dan pemulihan data bagi membolehkan maklumat dibawa ke mahkamah

• Menjalankan pengumpulan maklumat-maklumat digital untuk tujuan tindakan penguatkuasaan

• Mewujudkan rangkaian kerjasama agensi penguatkuasaan undang-undang berkaitan siber dari segi kemahiran siasatan serta perkongsian maklumat

• Mengadakan latihan di dalam bidang forensik digital kepada anggota KKM dan Pegawai Penguatkuasa Farmasi khususnya

• Menyelaras dan memantau aktiviti kajian dan pembangunan (R&D) berkaitan penguatkuasaan farmasi

• Process the applications of products and medical services advertisements

• Monitor advertisements advertised in the printed and electronic media to ensure compliance to the existing rules and legislations.

• Conduct investigation on cases involving advertisements of products and medical services

• Compile and co-ordinate enforcement statistics as well as monitor the activities involving quality and innovation of Enforcement Pharmacy

• Planning and co-ordinate the activities and training of Enforcement Pharmacy

• Conduct analysis on the sample of products available in the market, which is suspected of infringing the legal provisions in force

• Creating a database of tested samples and information pertaining to enforcement to be used as a reference and research study for pharmacy enforcement activities

• Coordinate and Provide technical inputs and pharmaceutical forensics in case investigation process involving a violation of law enforced by digital-related Pharmacy Enforcement Division

• Conduct digital forensics and data recovery to enable information to be brought to court

• Collect digital information for the purpose of enforcement

• Establish networks collaboration among law enforcement agencies in terms of cyber related investigative skills as well as information sharing

• Conduct training in the field of digital forensics to MOH officers and pharmacy enforcement officers in particular

• Coordinate and monitor research and development (R&D) activities related to pharmacy enforcement

• Coordinate and monitor all activities regarding innovation and quality assurance (QA) studies conducted by the State’s Pharmacy Enforcement Branch

CAWANGAN PENGIKLANAN DAN INOVASIADVERTISEMENT AND INNOVATION BRANCH

CAWANGAN FARMASI FORENSIKFORENSIC PHARMACY BRANCH


LEMBAGA IKLAN UBATStatistik permohonan kelulusan iklan daripada Lembaga Iklan Ubat (LIU) pada tahun 2019 adalah seperti di Jadual 23 manakala perbandingan untuk tahun 2017 hingga 2019 adalah seperti dalam Jadual 24.

MEDICINE ADVERTISEMENT BOARDStatistics on the applications for advertisement approval from Medicine Advertisements Board (MAB) in 2019 are as shown in Table 23 whereas comparisons across years 2017 to 2019 are as in Table 24.


IklanAdvertisement

Permohonan Diterima

Application Received

LulusApproved

Tidak LulusNot

Approved

Tidak Perlu

KelulusanApproval

Not required

Permohonan Terbatal (selepas pemohon

gagal memberi maklumbalas)

Application closed (after applicant failed to follow

up on inquiry)

TertangguhDeffered

Yuran Dikutip (RM)Fees

Collected (RM)

ProdukProduct 2063 1991 3 3 16 50 618900

Perkhidmatan PerubatanMedical Services

1056 1008 1 9 16 22 316800

JumlahTotal 3119 2999 4 12 32 72 935700

Jadual 23: Permohonan kelulusan iklan pada tahun 2019Table 23: Advertisements Applications for Year 2019

Keterangan/ Tahun Description/ Year 2017 2018 2019

Bilangan Permohonan yang Diterima Total number of applications 3228 3138 3119

Jumlah permohonan yang diproses dalam tempoh piagam pelanggan Total number of applications processed within client charter period 3098 2867 2305

Jumlah permohonan yang diproses di luar tempoh piagam pelanggan Total number of applications processed outside of client charter period 130 104 152

Peratusan permohonan yang diluluskan dalam tempoh piagam pelanggan (Sasaran > 90%) Percentage of applications approvals within client charter period (Target > 90%)

95.97% 91.36% 93.81%

Jadual 24: Kelulusan Permohonan Iklan untuk Tahun 2017-2019Table 24: Advertisement Approvals for Years 2017-2019

Mulai 1 Januari 2019, semua permohonan bagi kelulusan Lembaga Iklan Ubat perlu disertakan dengan kadar fi baharu iaitu RM300 seperti yang ditetapkan dalam pindaan peraturan berikut:

Peraturan-Peraturan Lembaga Iklan Ubat 1976 (Pindaan) 2018 iaitu:

• 8(3) Setiap permohonan untuk mendapatkan kelulusan iklan hendaklah disertakan dengan fi sebanyak tiga ratus ringgit

• (4) Fi yang telah dibayar di bawah subperaturan (3) tidak boleh dibayar balik.

Starting January 1, 2019 all applications for Medicines Board Approval will need to be included with the new fee of RM300 as set out in the following regulatory amendments:

The Medicines Advertisements Board Regulations 1976 (Amendment) 2018 are:

• 8 (3) Each application for advertisements approval must be accompanied by a fee of three hundred ringgit.

• (4) Fees paid under subregulation (3) are non-refundable


PENYARINGAN IKLAN UBAT DAN SESI DIALOGAktiviti utama yang dijalankan ialah penyaringan iklan ubat yang dijalankan secara proaktif dan berkala ke atas semua media yang meliputi tiga (3) medium utama yang dikategorikan sebagai media cetak, media elektronik dan media baru. Ia melibatkan media nasional yang telah dikenalpasti oleh Cawangan Kawalan Iklan serta penyaringan di peringkat negeri oleh Unit Iklan di Cawangan Penguatkuasa Farmasi Negeri (CPF) yang memberi fokus kepada iklan-iklan ubat di peringkat tempatan. Media yang terlibat ialah seperti akhbar, majalah, televisyen, radio, internet dan lain-lain. Selain itu, saringan juga dijalankan secara reaktif melalui maklumat atau aduan yang diterima daripada orang awam.

Tujuan penyaringan iklan dijalankan ialah bagi memastikan semua iklan berkaitan perubatan yang dikawalselia di bawah Akta Ubat (Iklan dan Penjualan) 1956 adalah mematuhi undang-undang dan peraturan yang dibuat di bawah Akta ini. Di samping itu, ia juga dapat memastikan maklumat dan informasi yang tepat sahaja yang disiarkan dalam iklan–iklan tersebut seterusnya memberi manfaat kepada pengguna untuk membuat pilihan.

MEDICINES ADVERTISEMENT SCREENING ACTIVITY AND ENGAGEMENTAt the headquarter level, the screening and monitoring of medicine advertisements in the mass media are conducted regularly and proactively. The activity covers printed, electronic and online media such as newspapers, magazines, television, radio, and internet. The national stream medias are monitored by the headquarter office while the local media are monitored by the state office. Apart from that, reactive screening is carried out based on complaint or information received from the public.

The main objective of this activity is to ensure that advertisement related to medicines and health services are in compliance with the act, namely the Medicines (Advertisement & Sale) Act 1956 and its regulations. Besides, it is important to ensure that consumers receive accurate and reliable information on the medicines and healthcare services advertisement.

Media cetak yang disaring

Screened ads in print media

Media baru (internet)Screened ads in

Internet

Media elektronik(segmen tajaan/siaran

langsung)Screened sponsored

segments in electronic media

Media elektronik (jingle)

Screened ads in electronic media

(Isentia)

Jumlah Saringan Number of ads screened

3,317 18,820 758 310

Jadual 25: Jumlah saringan iklan yang telah dilakukan sepanjang tahun 2019Table 25: Total number of advertisements screened in 2019

Peringatan/ AmaranReminder/ Warning

Tindakan Undang-Undang (CPF Negeri)Legal Action (refer to State Pharmacy Enforcement Branch)

Rujuk agensi lainRefer to other agency

241 53 161

Jadual 26: Tindakan iklan keseluruhan sepanjang tahun 2019Table 26: Actions Taken Towards Inappropriate Advertisements in 2019

Bagi meningkatkan keberkesanan dalam mengawalselia iklan-iklan perubatan, pelbagai sesi dialog dan kerjasama serta lawatan kerja bersama-sama agensi berkepentingan lain seperti pengendali e-marketplace, media cetak dan elektronik dan pihak konsesi lebuh raya telah diadakan. Secara keseluruhan, sebanyak 22 sesi dialog dan engagement telah dihadiri oleh para pegawai di Cawangan Kawalan Iklan sepanjang tahun 2019 yang turut melibatkan agensi kerajaan, bukan kerajaan dan pihak swasta.

In view of the purpose to increase effectiveness of monitoring medicines, and medical services advertisements, various activities were held including dialogue sessions, study visit and engagements with relevant stakeholders namely advertisement agencies, e-marketplace platform providers and online medical services providers. A total of 22 dialogue sessions and engagements have been attended by officers of Advertisements Monitoring Branch throughout the year 2019.


LEMBAGA RACUNLembaga Racun adalah merupakan lembaga penasihat yang telah diberi kuasa untuk menjalankan penilaian terhadap pengelasan ubat / bahan kimia dan seterusnya menasihati Menteri mengikut peruntukan-peruntukan yang terkandung di bawah Akta Racun 1952. Ahli lembaga yang telah bermesyuarat bagi kali ke-88 pada 18 Jun 2019 dan kali ke-89 pada 26 November 2019 telah memutuskan perkara-perkara berikut:

POISONS BOARD The Poisons Board is an advisory board, authorized to evaluate the classification of medicines/chemical substances and thereby to advice the Minister in accordance with the provisions stipulated under the Poisons Act 1952. The Board met for its 88th meeting on 18 June 2019 and 89th meeting on 26 November 2019 to decide on the followings:

i) Classification of new poisonsThe Board has agreed with the classification of new chemicals as shown in the table below:

i) Pengkelasan bahan kimia baru Ahli lembaga telah bersetuju dengan pengkelasan bahan-bahan kimia baru seperti yang dinyatakan dalam jadual di bawah:

Bil.No.

Nama ubat/ bahan kimiaMedicines/ chemical name

KumpulanGroup

1 Erdosteine C

2 Ixazomib B

3 Glecaprevir B

4 Pibrentasvir B

5 Letermovir B

6 Apalutamide B

7 Triptorelin B

8 Baloxavir marboxil B

9 Desloratadine C

10 Etelcalcetide B

11 Lubiprostone B

12 Bedaquiline B

13 Sarilumab B

14 Erenumab B

15 Emicizumab B

16 Mepolizumab B

17 Ixekizumab B

18 Guselkumab B

19 Benralizumab B

20 Lisdexamfetamine B & bahan psikotropik | psychotropic substance

ii) Pengelasan semula racunSelain itu, ahli lembaga juga telah bersetuju dengan cadangan pengelasan semula seperti berikut:

a) Cadangan mengecualikan kosmetik bernotifikasi mengandungi terbitan hydantoin daripada kawalan di bawah Akta Racun 1952

b) Cadangan mengecualikan kawalan kesemua peranti perubatan yang mengandungi racun daripada Akta Racun 1952 dan cadangan pindaan racun local anaesthetic

c) Cadangan pindaan kawalan terhadap persediaan allergen di bawah Akta Racun 1952

ii) Poisons reclassificationBesides, the board has agreed to the following reclassification proposals:

a) Proposal to exempt the control of notified cosmetics containing hydantoin derivatives from the Poisons Act 1952

b) Proposal to exempt the control of all medical devices containing poison from the Poisons Act 1952 and to amend the local anaesthetic’s details

c) Proposal to amend the control of allergen preparation under the Poisons Act 1952

Bil.No.

Nama ubat/ bahan kimiaMedicines/ chemical name

KumpulanGroup

21 Fluralaner B

22 Brigatinib B

23 Lorlatinib B

24 Isavuconazole B

25 Risankizumab B

26 Iopamidol B

27 Lonoctocog alfa B

28 Cladribine B

29 Brodalumab B

30 Cariprazine B

31 Simoctocog alfa B

32 Ripasudil B

33 Semaglutide B

34 Abemaciclib B

35 Ertugliflozin B

36 Neratinib B

37 Gluthathione

C (Semua persediaan untuk administrasi

parenteral | All preparations for parenteral

administration)


d) Cadangan untuk mengelaskan semula racun nitric oxide di bawah Akta Racun 1952

e) Cadangan untuk membatalkan nama racun zacyclonol dalam Senarai Racun

d) Proposal to reclassify nitric oxide under the Poisons Act 1952

e) Proposal to cancel the name of zacyclonol in the Poisons List

ANALISA SAMPELANALYSIS OF SAMPLES

Jan Feb Mac Apr Mei Jun Jul Ogo Sep Okt Nov Dis0

20

40

60

80

100

24

69

45

56

74

39

81

26

65

54 54

36

Bila

ngan

sam

pel d

iana

lisa

Num

ber o

f sam

ple

anal

ysed

Rajah 19: Jumlah sampel yang dianalisa bagi tahun 2019Figure 19: The total number of samples analysed in 2019

PENCAPAIAN OBJEKTIF KUALITI SEKSYEN FORENSIK KIMIA TAHUN 2019Objektif Kualiti: Sampel aduan selesai dianalisa oleh Makmal Forensik BPF dalam tempoh 30 hari bekerja dari tarikh penerimaan sampel. Sasaran ditetapkan ialah 85 percent.

ACHIEVEMENT OF QUALITY OBJECTIVES IN FORENSIC CHEMISTRY IN 2019Quality Objective: Complaint sample analysis completed within 30 working days. Target set is 85 percent.

Jumlah Sampel Aduan diterima dan selesai dianalisaNumber of complaint sample received and completed 109

Bilangan Sampel Aduan dianalisa < 30 hari bekerjaNumber of complaint sample completed < 30 working days 99 (90.83%)

Bilangan Sampel Aduan dianalisa > 30 hari bekerjaNumber of complaint sample completed > 30 working days 10 (9.17%)


KURSUS PEMANTAPAN AKTIVITI PELESENANSatu Kursus Pemantapan Aktiviti Pelesenan telah dianjurkan pada 2 hingga 4 Julai 2019 oleh Bahagian Penguatkuasaan Farmasi, KKM. Objektif kursus ini adalah untuk meningkatkan pengetahuan dan kefahaman Pegawai Penguatkuasa Farmasi dalam kawalan domestik dan antarabangsa yang melibatkan bahan terkawal serta menekankan aspek pemantauan kepada pegawai yang menyelaras aktiviti pelesenan dan pemeriksaan. Kursus ini telah disertai oleh 48 orang Pegawai Penguatkuasa Farmasi dari Cawangan Penguatkuasaan Farmasi Negeri di seluruh negara. Ceramah-ceramah yang disampaikan bukan sahaja berkaitan dengan skop pelesenan dan pemeriksaan di penguatkuasaan farmasi tetapi juga melibatkan pendedahan maklumat dan pengetahuan daripada penceramah yang dijemput dari agensi-agensi lain seperti Cawangan Kawalan Amalan Perubatan Swasta (CKAPS), KKM, Jabatan Perlindungan Data Peribadi dan Suruhanjaya Komunikasi dan Multimedia Malaysia.

COURSE ON STRENGTHENING OF LICENSING ACTIVITIESThe Course on Strengthening of Licensing Activities was organized by Pharmacy Enforcement Division, MOH on 2 to 4 July 2019. The objective of this course is to enhance the knowledge and understanding of Pharmacy Enforcement Officers on domestic and international controls involving controlled substances and to highlight the monitoring aspects for officers who coordinating the activities of licensing and inspection. The course was attended by 48 Pharmacy Enforcement Officers from State Pharmacy Enforcement Branches nationwide. Talks presented not only cover the scope of licensing and inspection in pharmacy enforcement but there are also information and knowledge sharing by invited speakers from other agencies namely the Private Medical Practice Control Section (CKAPS), MOH, Department of Personal Data Protection and the Malaysian Communications and Multimedia Commission.

Kursus Pemantapan Aktiviti PelesenanCourse On Strengthening Of Licensing Activities


KURSUS KAWALAN PENGIMPORTAN PINTU MASUK Kursus Kawalan Pengimportan Pintu Masuk telah dianjurkan oleh Bahagian Penguatkuasaan Farmasi, KKM pada 3 hingga 5 September 2019. Kursus ini melibatkan seramai 45 orang wakil daripada semua Cawangan Penguatkuasaan Farmasi Negeri dan Bahagian Penguatkuasaan Farmasi. Kursus ini diadakan bertujuan untuk meningkatkan pengetahuan dan kefahaman Pegawai Penguatkuasa Farmasi dalam kawalan pintu masuk negara di samping memberi fokus kepada aspek pemantauan kepada pegawai yang menyelaras aktiviti kawalan pintu masuk.

COURSE ON IMPORT CONTROL AT THE ENTRY POINT

Course on Import Control at the Entry Point was organised by Pharmacy Enforcement Division on 3 to 5 September 2019. There were 45 representatives attended this training from all the State Pharmacy Enforcement Branches and Pharmacy Enforcement Division. The objective of this training was to enhance the knowledge and understanding of Pharmacy Enforcement Officers in the import control, besides focusing on the monitoring aspect of entry point activities.

Kursus Kawalan Pengimportan Pintu MasukCourse On Import Control At The Entry Point


BENGKEL “INSIDE-OUT WEBERTISING”Bengkel ini telah diadakan pada 24 hingga 26 Jun 2019 di Hotel Corus Paradise, Port Dickson, Negeri Sembilan. Kursus ini telah melibatkan 45 orang pegawai daripada semua Cawangan Penguatkuasa Farmasi Negeri dan Bahagian Penguatkuasaan Farmasi. Kursus ini diadakan bertujuan untuk meningkatkan pengetahuan dan kefahaman terhadap metod pengiklanan ubat terkini dalam internet serta berkongsi idea untuk menangani isu penjualan dan pengiklanan ubat tidak berdaftar dalam talian.

WORKSHOP ON “INSIDE-OUT WEBERTISING”This workshop was held on 24 to 26 June 2019 at Corus Paradise Hotel, Port Dickson, Negeri Sembilan. 45 participants from the State Pharmacy Enforcement Branches and Pharmacy Enforcement Division attended this course. The main objectives of this course were to enhance the Pharmacy Enforcement Officers’ knowledge and understanding in latest method of advertising on the Internet and also serve as a platform to share idea in tackling the issue on selling and advertising of unregistered product on the Internet.

Bengkel “Inside-Out Webertising”Workshop On “Inside-Out Webertising”

PERBINCANGAN KUMPULAN BERFOKUS DENGAN KERJASAMA WORLD HEALTH ORGANIZATION (WHO)Perbincangan kumpulan berfokus yang dianjurkan ini adalah dengan kerjasama World Health Organization (WHO) telah berlangsung pada 19 hingga 21 November 2019 bertempat di Bangi Resort Hotel, Bangi. Dr. Lucky S Slamet dari Indonesia selaku konsultan yang dilantik telah bersama-sama membantu dalam mencapai objektif yang telah digariskan. Objektif utama penganjuran program berkenaan adalah:

1. Untuk mengkaji perundangan berkaitan pengiklanan ubat di negara-negara lain

2. Untuk mengawal pengiklanan ubat termsuklah di Internet di Malaysia

3. Untuk memperkukuhkan perundangan sedia ada berkaitan dengan pengiklanan ubat termasuklah di Internet

FOCUS GROUP DISCUSSION IN COLLABORATION WITH WORLD HEALTH ORGANIZATION (WHO)This Focus Group Discussion has been organized in collaboration with World Health Organization (WHO). It was held on 19 to 21 November 2019 at Bangi Resort Hotel, Bangi. Dr. Lucky S Slamet from Indonesia as the appointed consultant has been together in the 3-day program in assisting the Pharmacy Enforcement Division to meet the objective of the program. The objectives of this program as followed:

1. To study other countries’ legal practice in regulating medicinal product advertisement including via Internet

2. To regulate advertising of medicinal product including via Internet in Malaysia

3. To strengthen the current national legislation on the advertising of medicines including on the Internet

Perbincangan Kumpulan Berfokus Dengan Kerjasama World Health Organization (WHO)

Focus Group Discussion In Collaboration With World Health Organization (WHO)


SESI DIALOG BERSAMA-SAMA PENYEDIA E-MARKETPLACE Sesi dialog bersama-sama penyedia e-marketplace telah diadakan pada 15 Mei 2019. Tujuan dialog ialah bagi membincangkan berkenaan isu-isu berhubung pengiklanan dan penjualan produk kesihatan secara dalam talian di platform e-dagang. Dialog yang dipengerusikan oleh Pengarah Bahagian Penguatkuasaan Farmasi ini telah dihadiri oleh wakil-wakil daripada penyedia e-dagang utama di Malaysia dan para pegawai daripada Bahagian Penguatkuasaan Farmasi.

DIALOGUE SESSION WITH E-MARKETPLACE PLATFORM PROVIDERThe Pharmacy Enforcement Division has organized a dialogue session with e-marketplace platform provider on 15 May 2019 at the Delima Meeting Room. The main objective of this bilateral discussion is to inform online platform providers on the requirement to comply with the Medicines (Advertisement and Sales) Act 1956 and its regulation in publishing any medicines and service advertisements on their platforms. This dialogue was chaired by Director Pharmacy Enforcement Division has been attended by main online platform providers which are based in Malaysia.

Sesi Dialog Bersama-Sama Penyedia E-MarketplaceDialogue Session With E-Marketplace Platform Provider

LATIHAN SANGKUTAN PEGAWAI PENGUATKUASA FARMASI DI CAWANGAN KAWALAN IKLAN DAN SEKSYEN FORENSIK SIBER Sebanyak lapan (4) sesi latihan sangkutan pegawai farmasi di Cawangan Kawalan Iklan dan Seksyen Forensik Siber telah dijalankan pada tahun 2019. Latihan sangkutan ini bertujuan untuk memantapkan pengetahuan pegawai penguatkuasa farmasi negeri dalam mendalami proses kerja berkaitan kelulusan iklan perubatanyang dilaksanakan oleh Lembaga Iklan Ubat. Selain itu, penekanan terhadap aktiviti saringan dan tindakan iklan meliputi media cetak, media elektronik dan media baru juga diberikan selain dapat meningkatkan kemahiran dalam penyiasatan kes iklan melibatkan media baharu.

HANDS ON TRAINING OF PHARMACY ENFORCEMENT OFFICER IN ADVERTISEMENT CONTROL BRANCH AND CYBER FORENSIC SECTION Four (4) hands on training sessions of pharmacy enforcement officers were conducted at Advertising Control Branch and Cyber Forensic Section. This attachment training aims to strengthen the knowledge of state pharmacy enforcement officers in the advertisement approval working processes carried out by the Medicine Advertisement Board. In addition, these attachments also emphasis on advertisements screening activities particularly in print media, electronic media and new media as well as enhancing skills in investigating advertising cases involving new media.

Latihan Sangkutan Pegawai Penguatkuasa Farmasi Di Cawangan Kawalan Iklan Dan Seksyen Forensik SiberHands On Training Of Pharmacy Enforcement Officer In

Advertisement Control Branch And Cyber Forensic Section


BUAL BICARA DI STESEN TV DAN RADIO SEMPENA KEMPEN WASPADA PEMBELIAN UBAT DALAM TALIAN #BIARBETULIKLANNI! Beberapa siri bual bicara berkenaan kempen kesedaran waspada pembelian ubat dalam talian telah dijalankan di sepanjang tahun 2019. Bual bicara tersebut memfokuskan pendidikan kepada pengguna agar sentiasa menyemak maklumat ubat yang terdapat pada iklan ubat di Internet.

ON AIR IN TELEVISION AND RADIO CHANNEL IN CONJUNCTION WITH BE CAUTIOUS WHEN BUYING MEDICINE ONLINE CAMPAIGN #BIARBETULIKLANNI!There were a few series of talk show that have been held throughout 2019 in disseminating the information to the public on the risk of buying medicine online. Besides that, this year campaign was also been stressed on the public to verify first when they see the information in the medicine advertisement online.

STESEN RTM1 SEWAKTU PESONA XY PADA 13 FEBRUARI 2019

Pegawai daripada Cawangan Kawalan Iklan iaitu Puan Siti Ainul Fadhilah Jamaludin telah hadir ke sesi bual bicara tersebut.

RTM1 TV CHANNEL DURING PESONA XY ON 13 FEBRUARY 2019

An officer from Advertisement Control Branch, Puan Siti Ainul Fadhilah Jamaludin has attended the session.

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STESEN RADIO SELANGOR.FM PADA 30 SEPTEMBER 2019

Pegawai daripada Bahagian Penguatkuasaan Farmasi iaitu Puan Siti Fatimah Binti Idris telah hadir ke sesi bual bicara tersebut.

SELANGOR.FM RADIO STATION ON 30 SEPTEMBER 2019

An officer from Pharmacy Enforcement Division, Madam Siti Fatimah Binti Idris has attended the session.

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STESEN RADIO NASIONAL.FM PADA 17 OKTOBER 2019

Pegawai daripada Cawangan Penguatkuasa Farmasi Wilayah Persekutuan Kuala Lumpur dan Putrajaya iaitu Puan Shafiqah Adam dan Encik Ahmad Zuhri Bin Md Ali telah hadir ke sesi bual bicara tersebut.

NASIONAL.FM RADIO STATION ON 17 OCTOBER 2019

Officers from Kuala Lumpur Federal Territory Pharmacy Enforcement Branch, Madam Shafiqah Adam and Mr. Ahmad Zuhri bin Md Ali have attended the session.

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STESEN RTM1 SEWAKTU SELAMAT PAGI MALAYSIA PADA 25 OKTOBER 2019

Pegawai daripada Cawangan Kawalan Iklan iaitu Puan Normawati Binti Mohamed Noor telah hadir ke sesi bual bicara tersebut.

RTM1 TV CHANNEL DURING SELAMAT PAGI MALAYSIA ON 25 OCTOBER 2019

An officer from Advertisement Control Branch, Madam Normawati Binti Mohamed Noor has attended the session.

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STESEN RADIO BERNAMA.FM PADA 5 NOVEMBER 2019

Pegawai daripada Cawangan Kawalan Iklan iaitu Puan Normawati Binti Mohamed Noor telah hadir ke sesi bual bicara tersebut.

BERNAMA.FM RADIO CHANNEL ON 5 NOVEMBER 2019

An officer from Advertisement Control Branch, Madam Normawati Binti Mohamed Noor has attended the session.

KERJASAMA DENGAN PIHAK BERKUASA TEMPATANPelan Tindakan kerjasama dengan Pihak Berkuasa Tempatan (PBT) adalah merupakan satu inisiatif di bawah Pelan Strategik Program Perkhidmatan Farmasi 2017-2020 yang bertujuan untuk membanteras pengiklanan produk perubatan yang melanggar undang-undang yang dikuatkuasakan yang perlu dicapai 100 peratus pada tahun 2020. Pada tahun 2019, sebanyak 21 aktiviti melalui penganjuran sesi dialog serta operasi banteras iklan haram 3B #Bunting, Billboard, Banner telah dijalankan oleh Cawangan Penguatkuasa Farmasi Negeri iaitu mencapai 93 peratus (141 PBT) daripada jumlah keseluruhan 151 PBT iaitu melepasi sasaran 2019 iaitu sepatutnya 70 peratus.

ENGAGEMENT WITH LOCAL AUTHORITY (LA)Engagement with Local Authority is an initiative under the Strategic Plan of the Pharmaceutical Services Program 2017-2020 which aims to reduce unapproved medicine advertisement. The target is 100 percent must be covered all Local Authorities by 2020. In 2019, a total of 21 activities including dialogue sessions and 3B Operation #Bunting, Billboard, Banner were carried out by the State Pharmacy Enforcement Branch. This a great achievement done by State Pharmacy Branch which reached 93 percent (141 LAs) LA covered out of the total 151 LA, which surpassed the 2019 target of 70 percent.

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OPS 3B CPF Kelantan dengan Kerjasama Majlis Daerah Machang

OPS 3B by CPF Kelantan with Machang District Council

OPS 3B CPF Kelantan dengan Majlis Perbandaran Kota Bharu

OPS 3B by CPF Kelantan with Kota Bharu Municipal Council

Sesi Dialog CPF Kedah dengan Majlis Daerah SikDialogue Session with Sik District Council

Sesi Dialog CPF Selangor dengan Majlis Perbandaran Selayang

Dialogue Session with Selayang Municipal Council


KEMPEN WASPADA PEMBELIAN UBAT DALAM TALIAN #BIARBETULIKLANNI!Kempen ini adalah kesinambungan daripada kempen yang telah dimulakan pada tahun 2015. Kempen ini bertujuan untuk meningkatkan kesedaran orang ramai terhadap pembelian dan pengiklanan ubat dalam talian. Beberapa siri hebahan informasi telah dibuat menggunakan tagline baru iaitu #biarbetuliklanni! melalui posting di akaun Facebook rasmi Kementerian Kesihatan Malaysia, Program Perkhidmatan Farmasi dan Duta Kenali Ubat Anda, Pengumuman Khidmat Awam melalui televisyen dan radio, mesej WhatsApp, sambutan sempena Hari Farmasi Sedunia, dan portal www.pharmacy.gov.my yang diadakan sepanjang bulan Oktober 2019.

BE AWARE WHEN BUYING MEDICINES ONLINE CAMPAIGN #BIARBETULIKLANNI!This campaign is a continuation of a campaign that was initiated in 2015. This campaign with new tagline #biarbetuliklanni! aims to raise public awareness on purchasing and advertising of medicines via online. A series of infographic posters were posted on the official Facebook account of the Ministry of Health Malaysia, www.pharmacy.gov.my portal, WhatsApp messages, Public Service Announcement via television and radio and World Pharmacist Day Celebration throughout October 2019.

Maklumat kesedaran di dalam akaun Facebook rasmi Program Perkhidmatan Farmasi, KKM dan Duta Kenali Ubat Anda

Awareness information via Pharmaceutical Services Programme’s official Facebook account and ‘Duta Kenali Ubat Anda’s’ account

Webpage Waspada Pembelian Ubat Dalam Talian’’

Awareness information in www.pharmacy.gov.my

Contoh crawler Pesanan Khidmat Awam oleh media elektronik

Crawler on Awareness Be Cautious when Buying Medicine Online in one of the TV channels


World Pharmacist Day Peringkat Kebangsaan pada 5 Oktober 2019National Level World Pharmacist Day on 5 October 2019

World Pharmacist Day WP KL & Putrajaya World Pharmacist Day Pahang

World Pharmacist Day Melaka World Pharmacist Day WP Labuan

AKTIVITI PENGESANAN PEMESONGAN BAHAN TERKAWAL MELALUI OPERASI KHAS BAHAN TERKAWAL 2019Pemesongan bahan terkawal menjadi satu ancaman kepada keselamatan dan kesihatan orang ramai apabila bahan terkawal yang dipesongkan digunakan untuk tujuan penyalahgunaan bersama dadah berbahaya dan diedarkan kepada pasaran haram. Bahan terkawal yang sering dikaitkan dengan salahguna ialah bahan psikotropik dari kumpulan Benzodiazepine (seperti Midazolam, Alprazolam dan Diazepam) dan terbitan narkotik (seperti dihydrocodeine, pethidine). Selain itu terdapat juga bahan terkawal farmaseutikal yang sering digunakan untuk tujuan penyalahgunaan seperti ubat batuk Diphenhydramine dan ubat tahan sakit Tramadol. Kegagalan mengendalikan bahan terkawal mengikut keperluan undang-undang meningkatkan risiko berlakunya pemesongan bahan psikotropik untuk tujuan penyalahgunaan dan pengedaran ke pasaran haram.

SPECIAL OPERATIONS CARRIED OUT IN 2019 TO DETECT ACTIVITIES OF DIVERSION FOR CONTROLLED SUBSTANCEDiversion of controlled substances poses a serious threat to public safety and health when the diverted controlled substances are used for the purpose of abusing with dangerous drug and distributing them to illegal markets. The controlled substances that are often associated with the abuse are psychotropic substances from Benzodiazepine psychotropic groups (e.g. Midazolam, Alprazolam and Diazepam) and narcotic derivatives (e.g. Dihydrocodeine and Pethidine). In addition, the pharmaceuticals substances which are frequently abused are Diphenhydramine cough medicine and Tramadol (pain killer). Handling of controlled substances without accordance with the legal requirements increases the risk of psychotropic substances diversion.


Bahan terkawalControlled susbstances

PsikotropikPsychotropic Diphenydramine Tramadol

Bil. Pemeriksaan premis yang dijalankanNumber of inspection of premises carried out 162 21 61

Jumlah premisTotal premises 241

Bahan Psikotropik yang kerap dilaporkan dalam kesalahan undang-undang ialah Phentermine [30 kesalahan (23 peratus)], diikuti oleh Dihydrocodeine [29 kesalahan (18 peratus)], Alprazolam [25 kesalahan (16 peratus)], Diazepam [11 kesalahan (7 peratus)] dan Pethidine [10 kesalahan (6 peratus)]. Bagi Tramadol dan ubat batuk Diphenyhydramine, didapati masing-masing 33 peratus dan 43 peratus premis yang diperiksa tidak merekodkan sebahagian besar penjualan Tramadol dan ubat batuk Diphenyhydramine dan disyaki dibekalkan bukan untuk tujuan rawatan.

The most commonly reported psychotropic substances in legal offenses were Phentermine [30 offenses (23 percent)], followed by Dihydrocodeine [29 offenses (18 percent)], Alprazolam [25 offenses (16 percent)], Diazepam [11 offenses (7 percent)] and Pethidine [10 offenses (6 percent)].For Tramadol pain killer and Diphenyhydramine cough medicine, it was found that 33 percent and 43 percent of the premises inspected did not record the majority sales transactions of the Tramadol and Diphenyhydramine cough medicine and the transactions were suspected to be not supplied for the purpose of treatment.

TINDAKAN PENGUATKUASAAN TERHADAP CECAIR ROKOK ELEKTRONIK MENGANDUNGI NIKOTIN BAGI TAHUN 2019Aktiviti pengilangan, pembekalan dan penjualan cecair rokok elektronik yang mengandungi Nikotin adalah dikawal di bawah Akta Racun 1952. Nikotin yang merupakan racun kumpulan C di bawah Akta tersebut hanya boleh dibekalkan untuk tujuan rawatan perubatan oleh Ahli Farmasi Yang Berlesen dan Pengamal Perubatan yang berdaftar. Pembekalan nikotin oleh pihak-pihak yang lain adalah salah di sisi undang-undang. Namun Nikotin dalam produk tembakau dikecualikan dari kawalan Akta ini.

Berikutan pertambahan aduan berkenaan penjualan nikotin yang diterima oleh BPF, KKM, pemeriksaan dan serbuan bersepadu telah dijalankan terhadap penjual cecair rokok elektronik di seluruh negara. Sebanyak 128 premis penjual telah diperiksa sebanyak 104,974 botol/ bekas cecair rokok elektronik yang disyaki mengandungi Nikotin telah dirampas dengan nilai rampasan sebanyak RM 8,003,194. Kesemua kes akan disiasat di bawah Seksyen 13 Akta Racun 1952 dan jika didapati bersalah boleh dihukum di bawah Seksyen 32(2) Akta yang sama iaitu denda tidak melebihi RM 3,000 atau penjara tidak melebihi 1 tahun atau kedua-duanya.

ENFORCEMENT ACTION ON ELECTRONIC CIGARETTES CONTAINING NICOTINESS FOR THE YEAR 2019The activity of manufacturing, supplying and selling electronic cigarettes containing Nicotine is regulated under the Poisons Act 1952. Nicotine which is a group C poison under the Act can only be supplied for medical treatment by a Licensed Pharmacist and Medical Practitioner. The supply of nicotine by other parties is illegal. However, nicotine in tobacco products is exempt from the control of this Act.

Following the increasing complaints regarding the sale of nicotine received by BPF, MOH, integrated inspections and raids have been conducted against electronic cigarette sellers nationwide. A total of 128 premises were inspected and 104,974 bottles/ containers of electronic cigarettes suspected to contain Nicotine were confiscated with a seizure value of RM 8,003,194. All cases will be investigated under Section 13 of the Poisons Act 1952 and if found guilty can be punished under Section 32 (2) of the same Act, a fine not exceeding RM 3,000 or imprisonment not exceeding 1 year or both.

Tindakan Penguatkuasaan Terhadap Cecair Rokok Elektronik Mengandungi Nikotin Bagi Tahun 2019Enforcement Action On Electronic Cigarettes Containing Nicotiness For The Year 2019


ADUAN YANG DITERIMA BERKAITAN PENJUALAN PRODUK TIDAK BERDAFTAR DAN KOSMETIK TIDAK BERNOTIFIKASI SELURUH MALAYSIASejumlah 2120 aduan dari seluruh Malaysia telah diterima sepanjang tahun 2019. Daripada jumlah tersebut, sebanyak 1,966 aduan telah diambil tindakan penguatkuasaan seperti pemeriksaan premis, serbuan, atau dimajukan ke agensi-agensi yang berkaitan untuk tindakan lanjut. Sebanyak 154 aduan lagi masih di peringkat pengumpulan maklumat lanjut untuk tindakan Penguatkuasaan.

COMPLAINTS RECEIVED REGARDING THE SALES OF THE UNREGISTERED PRODUCTS AND UNNOTIFIED COSMETICS IN MALAYSIAA total of 2120 complaints from all over Malaysia were received during the year 2019. Of these, a total of 1,966 complaints have been taken action such as premises inspections, raids, or forwarded to relevant agencies for further action. A further of 154 complaints are still in the process of gathering more information for enforcement action.

INCB TRAINING ON PROJECT ION INCIDENT COMMUNICATION SYSTEM (IONICS) AND THE PRECURSOR INCIDENT COMMUNICATION SYSTEM (PICS) FOR PRACTITIONERS FROM SOUTH-EAST AND SOUTH ASIA, BANGKOK, THAILANDA training on the Project ION Incident Communication System (IONICS) as well as the Precursor Incident Communication System (PICS) organized by the International Narcotics Control Board (INCB) was held in Bangkok, Thailand from 17 to 18 January 2019. The training was attended by 25 participants from seven (7) countries including Malaysia. Malaysian participants were attended by representatives from the Pharmacy Enforcement Division, the Royal Malaysian Police and the Royal Malaysian Customs. Among the objectives of the workshop were to train selected officials from relevant authorities in Southeast Asia and South Asia on how to operate the IONICS and PICS systems as well as to strengthen cooperation among international agencies on incidents involving NPS (New Psychoactive Substance), synthetic opioids and precursors.

This training exposes the participants to the use of the IONICS system developed by INCB, which is a special platform for real-time communication of incidents involving suspicious delivery, sale (trafficking), production and distribution of NPS. Hands-on training was also conducted during the training. In addition, the workshop also exposes the participants to the PICS system, dedicated to precursor seizure reporting and also hands-on training conducted.

INCB TRAINING ON PROJECT ION INCIDENT COMMUNICATION SYSTEM (IONICS) AND THE PRECURSOR INCIDENT COMMUNICATION SYSTEM (PICS) FOR PRACTITIONERS DARIPADA ASIA TENGGARA DAN ASIA SELATAN, BANGKOK, THAILANDSatu bengkel mengenai penggunaan sistem Project ION Incident Communication System (IONICS) dan juga sistem Precursor Incident Communication System (PICS) yang dianjurkan oleh International Narcotics Control Board (INCB) telah diadakan di Bangkok, Thailand pada 17 hingga 18 Januari 2019. Bengkel ini telah dihadiri oleh 25 orang peserta dari tujuh (7) buah negara termasuk Malaysia. Peserta Malaysia dihadiri oleh seorang wakil daripada Bahagian Penguatkuasaan Farmasi, Polis DiRaja Malaysia dan Kastam DiRaja Malaysia. Antara objektif bengkel tersebut adalah untuk melatih pegawai terpilih dari pihak berkuasa yang berkenaan di Asia Tenggara dan Asia Selatan tentang cara mengendalikan sistem IONICS dan PICS dan juga untuk mengukuhkan kerjasama antara agensi antarabangsa berkaitan dengan insiden yang melibatkan NPS (New Psychoactive Substance), opioid sintetik dan prekursor.

Bengkel ini mendedahkan peserta kepada penggunaan sistem IONICS yang telah dibangunkan oleh INCB yang merupakan platform khas bagi komunikasi masa sebenar (real-time) insiden-insiden yang melibatkan penghantaran yang mencurigakan, penjualan (trafficking), penghasilan atau pengeluaran NPS. Latihan secara hands-on juga dilaksanakan semasa bengkel berlangsung. Di samping itu, bengkel ini juga mendedahkan peserta kepada sistem PICS yang khusus bagi pelaporan rampasan prekursor serta latihan secara hands-on dijalankan.

INCB Training on Project IONICS and PICS


LATIHAN SANGKUTAN BERKENAAN KAWALAN PENANAMAN HEMP UNTUK TUJUAN PERINDUSTRIAN DAN PENANAMAN KANABIS UNTUK TUJUAN PERUBATAN – KEPERLUAN PELESENAN, KEPERLUAN IMPORT/ EKSPORT DAN KAWALAN KESELAMATAN KE ATAS AKTIVITI, DI VICTORIA, AUSTRALIAPada 22 hingga 26 Julai 2019, dua (2) Pegawai Penguatkuasa Farmasi dari Cawangan Pelesenan, Bahagian Penguatkuasaan Farmasi telah mengikuti latihan sangkutan berkenaan kawalan ke atas penanaman Cannabis (marijuana dan hemp) di Victoria, Australia. Pegawai telah diberi pendedahan mengenai peruntukan undang-undang di Australia dan kawalan ke atas Cannabis untuk tujuan perubatan dan industri.

Objektif latihan tersebut adalah untuk:

i. Mempelajari mekanisme kawalan penanaman Cannabis (marijuana untuk tujuan perubatan dan hemp untuk tujuan industri) di Australia

ii. Mempelajari proses yang terlibat dalam pengeluaran lesen bagi membenarkan penanaman Cannabis (marijuana dan hemp) di Australia

iii. Mengenalpasti keperluan yang perlu dipenuhi dalam permohonan untuk menanam Cannabis (marijuana dan hemp) di Australia

iv. Mengenalpasti pertimbangan yang diberikan dalam membenarkan penanaman Cannabis (marijuana dan hemp) di Australia.

v. Mengenalpasti penggunaan Cannabis (marijuana dan hemp) yang sah dan dibenarkan di Australia

ATTACHMENT IN CONTROL OF HEMP CULTIVATION FOR INDUSTRIAL PURPOSES AND CONTROL OF CANNABIS CULTIVATION FOR MEDICAL PURPOSES – LICENSING, IMPORT/ EXPORT AUTHORIZATION AND OTHER REQUIREMENTS AND SAFETY CONTROL ON THE ACTIVITIES, STATE OF VICTORIA, AUSTRALIAFrom 22 to 26 July 2019, two (2) Pharmacy Enforcement Officers from the Licensing Branch, Pharmacy Enforcement Division attended an attachment program on the control of Cannabis (marijuana and hemp) cultivation in Victoria, Australia. Officers were given exposure to the legal provisions and the control mechanism of Cannabis for medical and industrial purposes in Australia.

The objectives of the training are:

i. To learn about the mechanism of control for Cannabis cultivation (medical marijuana and industrial hemp) in Australia

ii. To learn about the process involved in issuing a license to legalize the cultivation of Cannabis (marijuana and hemp) in Australia

iii. To identify the requirements that need to be met in the application to grow Cannabis (marijuana and hemp) in Australia

iv. To identify the consideration given to legalizing the cultivation of Cannabis (marijuana and hemp) in Australia.

v. To identify legal uses of cannabis (marijuana and hemp) in Australia

Latihan Sangkutan di Victoria, AustraliaAttachment at Victoria, Australia

Pegawai telah berpeluang mengadakan perbincangan, bertukar pandangan dan sesi perkongsian dengan beberapa agensi yang bertanggungjawab dalam mengawal selia cannabis di Australia seperti Office of Drug Control, Therapeutic Goods Administration, Department of Health and Human Services, Agriculture Victoria dan AgriBio. Selain itu juga, pegawai berkesempatan untuk melawat fasiliti yang telah dilesenkan untuk menjalankan penanaman cannabis bagi tujuan perubatan dan fasiliti memproses makanan berasaskan hemp.

Officers have had the opportunity to hold discussions, exchange views and sharing sessions with several agencies responsible for regulating cannabis in Australia such as the Office of Drug Control, Therapeutic Goods Administration, Department of Health and Human Services, Agriculture Victoria and AgriBio. In addition, officers were given the opportunity to visit a facility licensed to carry out cannabis cultivation for medical purposes and hemp-based food processing facilities.


KURSUS JENAYAH SIBER DAN FORENSIK SIBER 2019Pada 1 hingga 5 Julai 2019, seorang pegawai penguatkuasa dari Cawangan Farmasi Forensik, Bahagian Penguatkuasaan Farmasi telah menghadiri kursus jenayah siber dan forensic siber selama 5 hari di Taipei, Taiwan. Objektif kursus adalah untuk menambah pengetahuan berkaitan siasatan dan analisa kes yang melibatkan peranti digital. Antara aktiviti yang dilakukan termasuk berkongsi pengalaman daripada MJIB, Taiwan dalam siasatan kes yang melibatkan penggunaan “cryptocurrency’’. Peserta kursus juga turut melawat makmal forensik digital MJIB, Taiwan bagi mempelajari pengurusan makmal dan akreditasi ISO yang telah diterima. Isi kandungan kursus adalah seperti berikut:

1. Crime Scene First Responder Digital Evidence

2. Cyber Forensic on Mobile Phone

3. Case Study First Commercial Bank case

4. Case Study Trading Secret case

5. Virtual Currency

6. Sharing Experience by case office from New Taipei City Division

7. Bilateral meeting and Introduce Forensic Lab

CYBERCRIME AND CYBER FORENSIC COURSE 2019From 1 to 5 July 2019, an enforcement officer from the Forensic Branch, Pharmaceutical Enforcement Division attended a course cybercrime and cyber forensic in Taipe, Taiwan which was organized by the Ministry of Justice, Bureau Investigation, Taiwan. The objective of this course was to increase knowledge of investigations and case studies involving digital devices. Participants shared experiences from MJIB, Taiwan in a case study involving cryptocurrency use. They also visited the MJIB, Taiwan digital forensic laboratory to learn the accepted laboratory management and ISO accreditation. The course content includes:

1. Crime Scene First Responder Digital Evidence

2. Cyber Forensic on Mobile Phone

3. Case Study First Commercial Bank case

4. Case Study Trading Secret case

5. Virtual Currency

6. Sharing Experience by case office from New Taipei City Division

7. Bilateral meeting and Introduce Forensic Lab

Kursus Jenayah Siber Dan Forensik Siber 2019Cybercrime And Cyber Forensic Course 2019


KERJASAMA AWAM-SWASTA UNTUK PENCEGAHAN BAGI BAHAN PSIKOAKTIF BARU, OPIODS SINTETIK DAN PREKURSOR MELALUI SURFACE WEB BERASASKAN E-DAGANG Pada 14 hingga 16 Januari 2019, seorang pegawai penguatkuasa dari Cawangan Farmasi Forensik, Bahagian Penguatkuasaan Farmasi telah menghadiri bengkel bertajuk kerjasama awam-swasta untuk pencegahan bagi bahan psikoaktif baru, opiods sintetik dan prekursor melalui Surface web berasaskan E-dagang anjuran Lembaga Kawalan Narkotik Antarabangsa yang diadakan di Bangkok Thailand. Objektif kursus adalah untuk membincangkan penemuan terbaru yang berkaitan dengan pemerdagangan bahan psikoaktif baru (NPS), opioid sintetik dan prekursor melalui Internet oleh INCB. Para peserta bengkel berkongsi pengalaman dan trend terkini dalam usaha mencegah dan membasmi NPS, opioid sintetik, terutamanya fentanyl yang tidak berdaftar, dan prekursor yang relevan, melalui platform e-dagang berasaskan web permukaan, platform perniagaan (B2B). Selain itu, di bengkel tersebut peserta juga dapat:

1. Stocktaking, sharing of information a n d experiences

2. Substantive d iscussions: Legislation/ rules, Monitoring approaches/ tools i n respective countries/ organizations

3. Exchange of operational i n formation, common approaches/ t o o ls and specific case examples.

4. Review and adopt recommendations for actions

PRACTITIONERS’ WORKSHOP ON PUBLIC-PRIVATE PARTNERSHIP FOR PREVENTION OF TRAFFIC IN NPS, SYNTHETIC OPIODS AND PRECURSORS THROUGH THE SURFACE WEB BASED E-COMMERCE PLATFORMSFrom 14 to 16 January 2019, an enforcement officer from the Forensic Branch, Pharmaceutical Enforcement Division attended an a ’Workshop on Public-Private Partnership for Prevention of Traffic in NPS, Synthetic Opiods and Precursors through the surface web based E-commerce platforms which was organized by the International Narcotics Control Board in Bangkok, Thailand.The objective of such course was to Discuss latest findings related to trafficking in NPS, synthetic opioids and precursors through the Internet by INCB. Participants of the workshop got to share recent experiences and trends in preventing and eradicating NPS, synthetic opioids, especially unregistered fentanyl, and relevant precursors, through a web-based e-commerce platform, B2B. Other than that, the contents of course include:

1. Stocktaking, sharing of information a n d experiences

2. Substantive d iscussions: Legislation/ rules, Monitoring approaches/ tools i n respective countries/ organizations

3. Exchange of operational i n formation, common approaches/ t o o ls and specific case examples.

4. Review and adopt recommendations for actions

LATIHAN SANGKUTAN OLEH NATIONAL DRUG AUTHORITY (NDA) UGANDALatihan sangkutan oleh National Drug Authority (NDA) Uganda ini telah diadakan di Bahagian Penguatkuasaan Farmasi pada 23 hingga 24 April 2019. Ia dihadiri oleh tiga (3) wakil dari National Drug Authority (NDA), Uganda. Latihan ini memberi pendedahan kepada mekanisma kawalan pengimportan dan aktiviti penguatkuasaan di pintu masuk untuk wakil NDA Uganda yang hadir. Lawatan ke pintu masuk Kargo KLIA turut diadakan dalam latihan ini bagi melihat aktiviti di pintu masuk.

TRAINING ATTACHMENT NATIONAL DRUG AUTHORITY (NDA) UGANDAThe training attachment National Drug Authority (NDA) Uganda was held on 23 to 24 April 2019 at Pharmacy Enforcement Division. Three (3) representatives from the National Drug Authority (NDA) of Uganda attended the attachment training. Participants from NDA were exposed to information pertaining the control of import and pharmacy enforcement activities at the entry point. The participants also had the opportunity of visiting the Kuala Lumpur International Airport (KLIA) Cargo to view the entry point activities.

Latihan Sangkutan Oleh National Drug Authority (NDA) UgandaTraining Attachment National Drug Authority (NDA) Uganda


40TH MEETING OF ASEAN SENIOR OFFICIALS ON DRUG MATTERS (40TH ASOD) DI SIEM REAP, CAMBODIA40th Meeting of ASEAN Senior Officials on Drug Matters (40th ASOD) telah diadakan pada 27 hingga 30 Ogos 2019 di Siem Reap, Cambodia. Bahagian Penguatkuasaan Farmasi, Kementerian Kesihatan Malaysia yang merupakan pihak berkuasa berwibawa di Malaysia bagi ketiga-tiga Konvensyen Dadah Antarabangsa telah hadir sebagai salah seorang daripada delegasi ke mesyuarat tersebut.

Mesyuarat ini melibatkan wakil dari sepuluh (10) Negara ASEAN yang diadakan setiap tahun bagi membincangkan kawalan dadah dan kerjasama Negara ASEAN yang melibatkan kumpulan kerja teknikal bagi penguatkuasaan, rawatan dan pemulihan, pendidikan preventif, penyelidikan serta pembangunan alternatif berkaitan dadah.

4.0 KOLABORASI DAN PENGLIBATAN ANTARABANGSA COLLABORATION AND INTERNATIONAL PARTICIPATION

40TH MEETING OF ASEAN SENIOR OFFICIALS ON DRUG MATTERS (40TH ASOD) IN SIEM REAP, CAMBODIA40th Meeting of ASEAN Senior Officials on Drug Matters (40th ASOD) was held at Siem Reap, Cambodia on 27 to 30 August 2019. The Pharmacy Enforcement Division, Ministry of Health, as a competent authority in Malaysia for the three International Drug Conventions, was present as one of the delegates to the meeting.

40th ASOD Meeting involved ten (10) ASEAN countries and the main objective of this meeting is to discuss pertaining drugs controls and ASEAN cooperation in five technical working group namely law enforcement, treatment and rehabilitation, preventive drug education, research and alternative development regarding drugs control.

43RD HEADS OF NATIONAL DRUG LAW ENFORCEMENT AGENCIES (HONLEA) ASIA AND THE PACIFIC MEETING DI BANGKOK, THAILAND43rd Heads of National Drug Law Enforcement Agencies (HONLEA) Asia and the Pacific Meeting telah diadakan pada 22 hingga 25 Oktober 2019 di Bangkok, Thailand. Mesyuarat ini melibatkan wakil daripada 25 Negara Asia dan Pasifik yang diadakan setiap tahun. Bahagian Penguatkuasaan Farmasi, Kementerian Kesihatan Malaysia yang merupakan pihak berkuasa berwibawa di Malaysia bagi ketiga-tiga Konvensyen Dadah Antarabangsa telah hadir sebagai salah seorang daripada delegasi ke mesyuarat tersebut.

43RD HEADS OF NATIONAL DRUG LAW ENFORCEMENT AGENCIES (HONLEA) ASIA AND THE PACIFIC MEETING IN BANGKOK, THAILANDThe 43rd Heads of National Drug Law Enforcement Agencies (HONLEA) Asia and the Pacific Meeting were held on 22 to 25 October 2019 in Bangkok, Thailand. The meeting involves representatives from 25 Asian and Pacific Countries held annually. The Pharmacy Enforcement Division, Ministry of Health, as a competent authority in Malaysia for the three International Drug Conventions, was present as one of the delegates to the meeting.

40th Meeting Of Asean Senior Officials On Drug Matters (40th ASOD) In Siem Reap, Cambodia


Fokus utama mesyuarat itu adalah untuk membincangkan penyelesaian dalam menangani pengeluaran dadah haram, pemerdagangan dan cabaran yang berkaitan di rantau ini. Topik-topik yang dibincangkan termasuk kerjasama serantau dan antarabangsa untuk mengurangkan penanaman haram dan penghasilan ubat-ubatan haram termasuk pembangunan alternatif, modus operandi baru dalam perdagangan dan trend penyembunyian dan pengangkutan serta teknik penyiasatan yang berkesan, mengatasi pengubahan wang haram, aliran kewangan haram dan penggunaan daripada darknet dan cryptocurrencies berhubung dengan perdagangan dadah, dan alternatif ke atas hukuman untuk kesalahan yang berkaitan dengan dadah dan kerjasama antara sektor kesihatan, sosial dan jenayah. Sehubungan dengan itu, UNODC Regional Office for Southeast Asia and the Pacific (ROSEAP) juga telah menganjurkan satu mesyuarat sampingan yang berasingan untuk membincangkan kawalan bahan kimia prekursor.

The main focus of the meeting was to discuss solutions in addressing illicit drug production, trafficking and associated challenges in the region. Topics discussed include regional and international cooperation to reduce illicit cultivation and production of drugs including alternative development, new modus operandi in trafficking and trends in concealment method and transport and effective investigative techniques in response thereto, countering money-laundering, illicit financial flows and the use of the darknet and cryptocurrencies in relation to the drug trade, and alternatives to conviction or punishment for drug-related offences and enhanced cooperation between health, social and criminal justice sectors. In this regard, the UNODC Regional Office for Southeast Asia and the Pacific (ROSEAP) also has organized a standalone side meeting to discuss precursor chemicals control.

DEBRIEF OPERASI PANGEA XIMesyuarat debrief bagi Operasi Pangea XI anjuran Interpol telah diadakan pada 12 hingga 14 Mac 2019 di Dublin, Ireland. Objektif mesyuarat ini adalah bagi membanteras penjualan ubat-ubaatan yang menyalahi peruntukan undang-undang dalam talian. Para peserta telah mengadakan perbincangan gambaran keseluruhan Operasi Pangea dan komunikasi risiko global serta membuat perancangan aktiviti kesedaran.

43rd Heads Of National Drug Law Enforcement Agencies (Honlea) Asia And The Pacific Meeting In Bangkok, Thailand

Debrief Operasi Pangea XIPangea Operation XI Debrief

PANGEA OPERATION XI DEBRIEFOperation Pangea XI Debrief which was organized by Interpol was held on 12 to 14 March 2019 in Dublin, Ireland. The objective of the debrief session was to combat the sale and illicit medicine online. Participants also was given an overview of Operation Pangea and discussed about the global risk communication and made plans for awareness activities.


PENERBITAN BOOKLET ‘PANDUAN KEPADA INDUSTRI DALAM PENGIKLANAN PRODUK KESIHATAN’ Cawangan Kawalan Iklan telah mengambil langkah inisiatif menerbitkan e-booklet bertajuk “Panduan Kepada Industri dalam Pengiklanan Produk Kesihatan” bagi membantu pihak industri yang terlibat dalam mempromosikan produk kesihatan terutamanya di media sosial pada Jun yang lalu. Panduan yang menekankan aspek Do’s and Don’ts dalam pengiklanan produk kesihatan ini telah diedarkan kepada pihak-pihak berkepentingan, persatuan dan media penyiaran. Panduan ini boleh didapati di www.pharmacy.gov.my.


PUBLICATION- BOOKLET ON ‘GUIDANCE FOR INDUSTRY IN HEALTH PRODUCTS ADVERTISING’The Advertisement Control Branch has taken the initiative to publish an Industry Guide booklet in Health Product Advertising to help industries who involve in promoting health products especially on social media. A guide that emphasizes the Do’s and Don’t’s aspects of advertising health products has been distributed to the relevant stakeholders, organization and media. This publication is available at www.pharmacy.gov.my.


NATIONAL PHARMACEUTICAL REGULATORY AGENCY

BAHAGIAN REGULATORI FARMASI NEGARA

77VETERINARVETERINARY

315SUPPLEMEN KESIHATAN

HEALTH SUPPLEMENT

679SEMULAJADI

NATURAL

66BUKAN PRESKRIPSINON-PRESCRIPTION

187PRESKRIPSI

PRESCRIPTION

BILANGAN PRODUK YANG DIDAFTARKAN:NUMBER OF PRODUCTS REGISTERED:

JUMLAH ADUAN DAN PERTANYAAN YANG DISELESAIKAN OLEH HELPDESKNUMBER OF QUERIES AND COMPLAINTS SOLVED BY HELPDESK12,551

9NUMBER OF CLINICAL TRIAL SITE INSPECTIONS

BILANGAN PEMERIKSAAN TAPAK KAJIAN KLINIKAL (GCP)

34NUMBER OF INSPECTIONS ON BIOEQUIVALENCE CENTRE (BE)

BILANGAN PEMERIKSAAN PUSAT KAJIAN BIOEKUIVALENS (BE)

17NUMBER OF DIALOGUES

CARRIED OUT WITH THE LOCAL INDUSTRY

BILANGAN DIALOG BERSAMA INDUSTRI

30KEBENARAN MENGILANG

CLINICAL TRIAL EXEMPTION

197CLINICAL TRIAL IMPORT LICENSE

IMPORT PERCUBAAN KLINIKAL

1,275LESEN PEMBORONG

WHOLESALER LICENSE

517LESEN PENGIMPORTIMPORTER LICENSE

310LESEN PENGILANG

MANUFACTURER LICENSE

205294VAKSIN | VACCINE PLASMA | PLASMA

BILANGAN LESEN DIKELUARKAN:NUMBER OF LICENSES ISSUED:

BILANGAN PERMOHONAN LOT RELEASE:NUMBER OF APPLICATIONS FOR

LOT RELEASE:

9415DALAM NEGARA | LOCAL LUAR NEGARA | INTERNATIONAL

BILANGAN PEMERIKSAAN AMALAN PERKILANGAN BAIK (APB):NUMBER OF GOOD MANUFACTURING PRACTICE (GMP) INSPECTIONS:

122,656BILANGAN PERMOHONAN NOTIFIKASI KOSMETIKNUMBER OF NEW COSMETIC PRODUCT NOTIFICATION APPLICATION

3,675BILANGAN PRODUK

YANG SIAP DIUJINUMBER OF

PRODUCTS TESTED

29,983BILANGAN LAPORAN ADR/ AEFI YANG DITERIMA NUMBER OF ADR/ AEFI REPORT RECEIVED

CTIL CTE


NATIONAL PHARMACEUTICAL REGULATORY AGENCYBAHAGIAN REGULATORI FARMASI NEGARA


Bahagian Regulatori Farmasi Negara (NPRA) merupakan sebuah badan regulatori kerajaan di bawah Kementerian Kesihatan Malaysia yang bertanggungjawab dalam memastikan kualiti, keberkesanan dan keselamatan produk farmaseutikal serta kualiti dan keselamatan produk semulajadi dan kosmetik yang dipasarkan di Malaysia.

NPRA yang dahulunya mula dikenali sebagai Makmal Pengawalan Farmaseutikal Kebangsaan, telah ditubuhkan pada Oktober 1978. Institusi ini telah ditubuhkan untuk melaksanakan kawalan kualiti ke atas produk farmaseutikal. Infrastruktur dan kemudahan institusi ini direkabentuk bagi memenuhi keperluan aktiviti kawalan dan pengujian kualiti yang dijalankan.

Bermula tahun 1985, NPRA bertanggungjawab untuk memastikan kualiti, keberkesanan dan keselamatan produk farmaseutikal melalui penilaian data saintifik dan ujian makmal. Sistem untuk memantau produk-produk di pasaran juga telah ditubuhkan. Sejak itu, NPRA telah memperluaskan kawalan kualiti dan keselamatan ke atas produk-produk bukan preskripsi, tradisional, kosmetik, veterinari, bahan aktif farmaseutikal (API) dan seterusnya kawalan ke atas produk vaksin melalui aktiviti Vaccine Lot Release.

Sejajar dengan perkembangan serta keperluan semasa, NPRA telah melaksanakan perubahan struktur organisasi melalui proses pengstrukturan semula yang telah berkuat kuasa mulai 2 Disember 2019. Proses ini melibatkan perubahan utama di mana tujuh pusat asal dalam NPRA telah disusun semula menjadi empat pusat sahaja bagi menyelaraskan semula semua aktiviti utama NPRA mengikut fungsi pusat. Dengan pelaksanaan pengstrukturan semula ini, pihak NPRA akan terus berusaha untuk menambahbaik lagi kualiti perkhidmatan yang diberikan demi mencapai misinya untuk menjamin kesihatan rakyat melalui kawalan regulatori ubat-ubatan dan kosmetik berlandaskan kecemerlangan saintifik.

National Pharmaceutical Regulatory Agency (NPRA) is a government agency that is responsible in ensuring the quality, safety and efficacy of pharmaceutical products as well as the quality and safety of traditional and cosmetic products marketed in the Malaysia.

NPRA, formerly known as the National Pharmaceutical Control Laboratory, was set up in October 1978. This institution was established to implement quality control on pharmaceutical products. The infrastructure and facilities were designed to meet the requirements for testing and quality control activities.

Starting from 1985, NPRA was given the task of ensuring the quality, efficacy and safety of pharmaceuticals through evaluation of scientific data and laboratory tests. A system to monitor products in the market was also established. Over the years, NPRA has extended the control of the quality and safety of non-prescription medicines, traditional products, cosmetics, veterinary products, active pharmaceutical ingredients (API) including the quality control of vaccine through Vaccine Lot Release activities.

In line with current developments, NPRA underwent a major restructuring process which came into effect on the 2nd of December 2019, whereby the previous seven centres have been rearranged to four centres, and the main activities of NPRA have been streamlined according to the each centre’s function. Through this restructuring exercise, the NPRA will continuously strive to improve the services provided as we seek to achieve our mission to safeguard the nation’s health through scientific excellence in the regulatory control of medicinal products and cosmetics.


Berikut merupakan empat pusat di NPRA dengan tugasan masing-masing:Below are the four centres in NPRA with respective responsibilities:

Pusat Komplians dan Kawalan KualitiCentre of Compliance and Quality Control

Pengujian makmal bagi semua kategori produk•Laboratory testing

Strategik RegulatoriPusat Koordinasi & Perancangan

Centre of Regulatory Coordination &Strategic Planning

Perancangan halatuju, penyelidikan, pelan strategik dan penambahbaikan aktiviti serta prosedur kerja regulatori

•

Future, research, strategic planning and improvement activities as well as regulatory work procedures

Penjanaan lesen dan sijil termasuk Lesen Pengilang, Lesen Memborong, Lesen Mengimport, dan Sijil APB

•

To generate licenses and certificate including manufacturer’s license, wholesaler’s license, import license and GMP certificate

Pengendalian latihan dalam dan luar negara, pengurusan sumber manusia (Pegawai Farmasi), peruntukan dan perkembangan kerjaya

•

Handing local & international trainings, human resource, allocations and career development

Menyelaraskan sistem pengurusan kualiti jabatan termasuk bagi pensijilan MS ISO 9001

•

Coordinates the quality management system including MS ISO 9001

Pembangunan Industri & Komunikasi (One Stop Centre)

•

Industry Development & Communication (One Stop Centre)

Pengendalian dan pemantauan sistem pendaftaran produk dan notifikasi kosmetik atas talian (online), laman web dan mobile apps NPRA

•

Handling & monitoring of the online productregistration and cosmetic notification system, website and NPRA mobile apps

Penilaian data validasi•Analytical validation data evaluation

Validasi kaedah pengujian baru•Validation of new testing methods

Pemeriksaan ke atas tapak pengilangan produk•Inspection on manufacturing sites

Aktiviti surveilans pasca pendaftaran produk•Post registration surveillance activities

Farmakovigilans•Pharmacovigilance

Pemeriksaan ke atas tapak percubaan klinikal•Conduct inspections on clinical trial sites

Pemeriksaan ke atas pusat kajian Bioequivalence•Conduct inspections on Bioequivalence centres

Notifikasi kosmetik•Cosmetic Notifications

•

Evaluation and issuance of licences for Clinicial

BE studies notificationTrial Import License, Clinical Trial Exemption and

Penilaian permohonan serta penjanaan lesen import untuk Produk Percubaan Klinikal (CTIL), Kebenaran Mengilang Produk Percubaan Klinikal (CTX) dan Notifikasi Kajian Bioekuivalens (BE)

Pusat Penilaian Produk dan KosmetikCentre of Product and Cosmetic Evaluation

Penilaian ke atas dossier untuk pendaftaran produk

•

Dossier evaluation for product registration

Pusat PentadbiranCentre of Administration

Aktiviti pentadbiran dan kewangan •Administrative and financial activities

PENGARAHDIRECTOR


PENDAFTARAN PRODUK NPRA bertanggungjawab untuk memproses permohonan pendaftaran untuk produk entiti baru kimia/ ubat-ubatan baru, biologik, preskripsi, bukan preskripsi, supplemen kesihatan, produk tradisional dan juga veterinar.

Sepanjang 2019, sebanyak 1,324 produk telah didaftarkan daripada 1,557 permohonan yang diterima. Produk-produk ini terdiri daripada 49.26 peratus produk tempatan dan 50.74 peratus produk yang diimport. Kumulatif produk yang masih berdaftar sehingga Disember 2019 adalah 23,655 produk.

PRODUCT REGISTRATIONNPRA is responsible for processing registration applications for new chemical entities / new drugs, biologics, prescription, non-prescription, health supplements, traditional as well as veterinary products.

Throughout 2019, a total of 1,324 products were registered out of 1,557 applications received. These products comprises of 49.26 percent local products and 50.74 percent imported products. The cumulative number of registered products up to December 2019 is 23,655 products.


Kategori ProdukProduct Category 2015 2016 2017 2018 2019

Produk PreskripsiPrescription Products 280 263 325 354 187

Produk Bukan PreskripsiNon-Prescription Products 41 40 61 79 66

Produk TradisionalTraditional Products 569 648 651 738 679

Supplemen KesihatanHealth Supplements 236 238 242 322 315

Produk VeterinarVeterinary Products 94 79 68 73 77

JumlahTotal 1,220 1,268 1,347 1,566 1,324

Jadual 27: Bilangan Produk Yang Didaftarkan 2015-2019 Table 27: Number of Registered Products, 2015-2019

AKTIVITI PASCA PENDAFTARAN PRODUK NPRA menjalankan pemantauan secara berterusan ke atas produk berdaftar di pasaran tempatan bagi memastikan produk tersebut menepati keperluan keselamatan, keberkesanan dan kualiti. Pada tahun 2019, Program Pemantauan Kesan Advers Ubat (ADR) Kebangsaan telah menerima sebanyak 29,983 laporan, peningkatan 14.8 peratus berbanding tahun sebelumnya.

Pengawasan pasaran dan pengendalian aduan produk adalah untuk memantau produk perubatan berdaftar dan kosmetik dimaklumkan di Malaysia, memastikan bahawa mereka mematuhi standard kualiti dan keselamatan yang ditetapkan oleh Kementerian Kesihatan.

Sebanyak 4,053 produk telah disampel sepanjang 2019 di bawah Pengawasan Pasaran Produk Berdaftar dan Program Kosmetik Termaklum. Sebanyak 1,135 laporan aduan kualiti produk berdaftar diterima sepanjang tahun 2019. Aduan produk yang diterima telah dinilai, disiasat, dan tindakan berkenaan telah diambil berdasarkan hasil siasatan. Lima tindakan regulatori telah diambil – dua arahan panggil balik dan tiga amaran telah dikeluarkan. Pada masa yang sama, lima produk telah dipanggil balik secara sukarela dari pasaran oleh pemegang pendaftaran produk.

PRODUCT POST-REGISTRATION ACTIVITIESNPRA continuously monitors registered products in the local market to ensure that the products adhere to safety, efficacy and quality requirements. In 2019, the National Adverse Drug Reactions (ADR) Monitoring Program received a total of 29,983 reports, an increase of 14.8 percent compared to the previous year.

Market surveillance and handling of product complaints are in place to monitor registered medicinal products and notified cosmetics in Malaysia, ensuring that they comply with the quality and safety standards set by the Ministry of Health.

A total of 4,053 products were sampled throughout 2019 under the Market Surveillance for Registered Products and Notified Cosmetics Programme. A total of 1,135 registered products quality complaint reports were received throughout 2019. Products complaints received were evaluated, investigated, and necessary actions were taken based on the findings. Five regulatory actions were taken – two recalls and three warnings were issued. At the same time, five products were voluntarily recalled from the market by product registration holders.


2015 2016 2017 2018 2019

Bila

ngan

lapo

ran

ADR

/Nu

mbe

r of A

DR re

port

s

0

5000

10000

15000

20000

25000

30000

35000

13,675 13,78915,936

26,110

29,983

Rajah 20: Bilangan Laporan ADR yang Diterima, 2015-2019Figure 20: Number of ADR Reports Received, 2015-2019

Kategori Produk 2015 2016 2017 2018 2019

Produk PreskripsiPrescription Products 832 768 652 657 843

Produk Bukan PreskripsiNon-Prescription Products 315 201 160 159 251

Produk TradisionalTraditional Products 889 947 1,220 699 817

Supplemen KesihatanHealth Supplements 254 169 99 173 176

Produk KosmetikCosmetic Products 1,755 2,292 1,799 2,023 1966

JumlahTotal 4,045 4,377 3,930 3,711 4,053

Jadual 28: Bilangan Produk yang Disampel, 2015-2019Table 28: Number of Products Sampled, 2015-2019

Kategori Produk 2015 2016 2017 2018 2019

Produk FarmaseutikalPharmaceutical Products 793 613 838 991 885

Produk TMHSTMHS Products 18 6 3 22 250

JumlahTotal 811 619 841 1,013 1,135

Jadual 29: Bilangan Aduan Produk Berdaftar yang Diterima, 2015-2019Table 29: Number of Registered Product Complaints Received, 2015-2019


AKTIVITI KOMPLIANS DAN PELESENAN Pemeriksaan Amalan Perkilangan Baik (APB) ke atas pengilang produk berdaftar dan kosmetik bertujuan memastikan pematuhan mereka terhadap keperluan APB manakala Pemeriksaan Amalan Pengedaran Baik (AEB) bagi memastikan pematuhan pengimport dan pemborong terhadap keperluan AEB semasa. Sepanjang tahun 2019, sebanyak 385 pemeriksaan APB dan 179 pemeriksaan AEB telah dijalankan. Selain itu, perkhidmatan melibatkan khidmat nasihat dan penilaian pelan susun atur premis juga disediakan untuk pengilang.

COMPLIANCE AND LICENSING ACTIVITIESGood Manufacturing Practice (GMP) inspections on the manufacturer of registered products and notified cosmetics are carried out to ensure their compliance with the current GMP requirements while Good Distribution Practice (GDP) inspections ensure adherence of importers and wholesalers to the current GDP requirements. There were 385 GMP inspections and 179 GDP inspections conducted in the year 2019. Additional services such as technical guidance and premise plan layout reviews were also provided to manufacturers.

AktivitiActivity 2015 2016 2017 2018 2019

Pemeriksaan APBGMP Inspections 350 470 433 440 385

Pemeriksaan AEBGDP Inspections 124 221 154 192 179

Semakan Pelan PremisPremise Plan Review 63 84 106 127 99

Panduan TeknikalTechnical Guidance 200 86 113 51 39

Jadual 30: Bilangan Pemeriksaan Premis, Semakan Pelan Premis serta Panduan Teknikal yang Dijalankan, 2015-2019Table 30: Number of GMP Inspections, Premise Pan Review and Technical Guidance, 2015-2019

Pada tahun 2019, sebanyak 543 Lesen Pengilang, 919 Lesen Pengimport dan 1,302 Lesen Pemborong telah dikeluarkan.

In 2019, 543 Manufacturer Licenses, 919 Importer Licenses and 1,302 Wholesaler Licenses were issued.

Pengilang Pengimport Pemborong

0

200

400

600

800

1000

1200

1400

1600

1800

Bila

ngan

Les

en /

Num

ber o

f Lic

ence

s

2015 2016 2017 2018 2019

266

455

1164 1203

430

200304

464

1110

483

799

543

919

1302

1613

Rajah 21: Bilangan Lesen yang Dikeluarkan, 2015-2019Figure 21: Number of License Issued, 2015-2019


PENGUJIAN MAKMALPengujian sampel ke atas produk farmaseutikal, produk semulajadi serta kosmetik dijalankan mengikut standard regulatori global. Tugas-tugas ini dijalankan oleh kakitangan makmal yang cekap dan terlatih.

Pengujian produk dijalankan untuk tujuan pendaftaran bagi produk semulajadi, untuk tujuan pengawasan bagi produk berdaftar dan kosmetik bernotifikasi, sampel yang menyebabkan kesan advers (ADR) serta sampel aduan dan sampel penguatkuasaan.

LABORATORY TESTINGSampel testing is carried out on pharmaceutical products, traditional products and cosmetics in accordance with global regulatory standard. These duties are carried out by trained and competent laboratory personnel.

Product testing is carried out for the purpose of registration for traditional products, for the purpose of surveillance for registered products and notified cosmetic products, samples with adverse drug reactions (ADR) as well as complaint and enforcement samples.

Preskripsi Bukan Preskripsi Semulajadi Suplemen Kesihatan Kosmetik

Jum

lah

Sam

pel

Pendaftaran Pengawasan Aduan ADR CPF Lain-lain0

100

200

300

400

500

600

700

800

900

1000

0 0 0

650 660

282

903

81616

4

0 0 0 0 0 0 0 0 0 0 039

9 11 5 5 8 10 93767

Rajah 22: Sampel Yang Diuji Mengikut Kategori UntukTahun 2019Figure 22: Samples Tested Based on Category For Year 2019

Pada tahun 2019, pecahan sampel mengikut kategori produk digambarkan dalam carta di atas. Sampel Pengawasan mencatatkan bilangan sampel diuji tertinggi iaitu berjumlah 2,825 sampel dengan bilangan sampel tertinggi untuk kategori produk semulajadi iaitu sebanyak 903 sampel.

In the year 2019, the breakup of samples tested according to categories are depicted in the chart above. Surveillance samples recorded the highest number of samples at a total of 2,825 with the highest number of samples coming from the natural products category at 903 samples.

Bilangan sampel diuji Bilangan sampel gagal pengujian

0

500

1000

1500

2000

2500

3000

3500

4000

2015 2016 2017 2018 2019

3,216

263 326227 320 269

3,567

3,317

3,5663,675

Jum

lah

Sam

pel

Rajah 23: Bilangan Sampel Diuji dan Bilangan Sampel Gagal Pengujian, 2015-2019Figure 23: Number of Sample Tested & Number of Failed Samples, 2015-2019


Untuk tahun 2019, pengujian makmal telah dijalankan ke atas 3,675 sampel yang merupakan bilangan tertinggi dicatatkan sejak tahun 2015. Bilangan sampel yang gagal pengujian ialah 269 sampel sahaja iaitu 7.3 peratus daripada jumlah sampel yang diuji.

For the year 2019, laboratory testing has been conducted on 3,675 samples which is the highest number recorded since 2015. The number of samples which failed testing amounted to 269 samples only, equivalent to 7.3 percent of the total number of samples tested.

2015 2016 2017 2018 2019

Jum

lah

Ujia

n

0

10000

20000

30000

40000

50000

60000

70000

48,528 48,14152,129

58,023

64,839

Rajah 24: Bilangan Ujian yang Dijalankan, 2015-2019Figure 24: Number of Test Performed, 2015-2019

Bilangan ujian juga didapati meningkat pada tahun 2019 iaitu berjumlah 64,839 ujian selaras dengan pertambahan bilangan sampel yang diuji.

The number of tests also showed an increase in the year 2019 at a total of 64,839 tests in accordance with the increase in the number of samples tested.


MESYUARAT ASEAN CONSULTATIVE COMMITTEE FOR STANDARDS AND QUALITY - PHARMACEUTICAL PRODUCT WORKING GROUP (ACCSQ- PPWG) YANG KE-27Melalui NPRA, Malaysia sentiasa aktif menghadiri mesyuarat-mesyuarat kumpulan kerja ASEAN. Setiap negara anggota ASEAN akan bergilir-gilir untuk menganjurkan mesyuarat ini yang diadakan dua kali setahun.

Pada kali ini, NPRA telah menjadi tuan rumah bagi mesyuarat ASEAN Consultative Committee for Standards and Quality - Pharmaceutical Product Working Group yang ke-27. Mesyuarat ini telah diadakan di Hotel G Gurney, Pulau Pinang bermula 24 sehingga 27 Jun 2019. Lebih 250 peserta, termasuk pegawai agensi regulatori ubat-ubatan serta pihak industri farmaseutikal daripada negara anggota ASEAN telah menghadiri program yang berlangsung selama empat (4) hari ini. Sidang mesyuarat ini telah dirasmikan pada 25 Jun 2019 oleh Pengarah Kanan Perkhidmatan Farmasi, Dr. Ramli Zainal.

Objektif utama mesyuarat ACCSQ-PPWG adalah untuk mewujudkan harmonisasi dalam skim peraturan produk farmaseutikal yang dapat digunapakai oleh negara anggota ASEAN, serta turut membantu mencapai objektif ASEAN Free Trade Area (AFTA) iaitu mengurangkan halangan teknikal sedia ada tanpa menjejaskan kualiti, keselamatan dan efikasi produk tersebut.


THE 27TH ASEAN CONSULTATIVE COMMITTEE FOR STANDARDS AND QUALITY - PHARMACEUTICAL PRODUCT WORKING GROUP (27TH ACCSQ- PPWG)Through the NPRA, Malaysia has always actively participated in the ASEAN product working group meetings. Each ASEAN member state will take turn to host these meetings which convene twice a year.

This time, NPRA hosted the 27th ASEAN Consultative Committee for Standards and Quality - Pharmaceutical Product Working Group (ACCSQ - PPWG) Meeting. The meeting was held at G Hotel Gurney, Penang from 24 to 27 June 2019. Over 250 participants, including regulators as well as members of the pharmaceutical industry from the ASEAN member states attended this four-day program. The meeting was formally officiated on 25 June 2019 by the Senior Director of Pharmaceutical Services, Dr Ramli Zainal.

The main objectives of the ACCSQ-PPWG meeting are to develop a harmonization schemes of pharmaceutical regulations to be commonly implemented by the ASEAN member states, to facilitate the objective of ASEAN Free Trade Area (AFTA) which is to elimination of technical barriers to trade that are posed by these regulations without compromising on drug quality, safety and efficacy.

Mesyuarat ACCSQ-PPWG ke-27 telah dirasmikan oleh Pengarah Kanan Perkhidmatan Farmasi, Dr. Ramli Zainal

The 27th ACCSQ-PPWG Meeting was officiated by the Senior Director of Pharmaceutical Services, Dr. Ramli

Zainal

Ketua Perwakilan daripada negara anggota ASEANThe Heads of Delegates from the ASEAN member states

Delegasi Malaysia (Kiri-kanan: Datin Dr. Faridah Aryani Md Yusof, Pn. Noraisyah Mohd Sani, Pn. Jenny Thong Che Ni)Malaysian Delegation (Left-right: Datin Dr. Faridah Aryani

Md Yusof, Pn. Noraisyah Mohd Sani, Pn. Jenny Thong Che Ni)

Sesi Mesyuarat ACCSQ-PPWG ke-27The 27th ACCSQ-PPWG Meeting in session


MESYUARAT ASEAN CONSULTATIVE COMMITTEE FOR STANDARDS AND QUALITY - TRADITIONAL MEDICINES AND HEALTH SUPPLEMENTS PRODUCT WORKING GROUP (ACCSQ- TMHS) YANG KE-32Selain daripada menganjurkan Mesyuarat ACCSQ-PPWG ke-27 pada Jun 2019, NPRA juga telah menganjurkan Mesyuarat ACCSQ-TMHS PWG yang bertempat di Royale Chulan Damansara Hotel, Selangor daripada 4 hingga 8 November 2019.

Pegawai kerajaan daripada Agensi Regulatori Ubat-ubatan Kebangsaan serta ahli industri TMHS dari negara anggota ASEAN telah menghadiri program yang berlangsung selama lima (5) hari ini. Jumlah peserta bagi mesyuarat ini adalah sebanyak 118 orang. Sidang mesyuarat ini telah dirasmikan pada 25 Jun 2019 oleh Pengarah Kanan Perkhidmatan Farmasi, Dr. Ramli Zainal.

Objektif utama mesyuarat ACCSQ-TMHS PWG adalah untuk mewujudkan harmonisasi dalam skim keperluan teknikal dan garis panduan regulatori untuk produk TMHS bagi mengurangkan halangan teknikal di dalam perdagangan di antara negara anggota ASEAN dan menyumbang kepada inisiatif Integrasi Ekonomi ASEAN tanpa menjejaskan kualiti, keselamatan dan efikasi produk.

THE 32ND ASEAN CONSULTATIVE COMMITTEE FOR STANDARDS AND QUALITY - TRADITIONAL MEDICINES AND HEALTH SUPPLEMENTS PRODUCT WORKING GROUP (32ND ACCSQ-TMHS PWG 2019)Apart from hosting the 27th ACCSQ-PPWG meeting in June 2019, NPRA also hosted the 32nd ASEAN Consultative Committee for Standards and Quality - Traditional Medicines and Health Supplements Product Working Group (ACCSQ-TMHS PWG) meeting, which was held at Royale Chulan Damansara Hotel, Selangor from 4th to 8th November 2019.

Government officials from the National Drug Regulatory Agencies as well as members of the TMHS industry from all the ASEAN member states attended the five-day programme. The total amount of participants was 118. The meeting was formally officiated on 7 November 2019 by Dr. Ramli Zainal, Senior Director of Pharmaceutical Services, Ministry of Health.

The main objective of the ACCSQ-TMHS PWG meeting is to harmonize the technical requirements and guidelines for TMHS products in order to reduce technical barriers to trade in the ASEAN region and contribute to the ASEAN Economic Integration initiatives without compromising the safety, quality and efficacy/claimed benefits of the products.

Sesi Perasmian Mesyuarat ACCSQ-TMHS PWG ke-32 oleh Pengarah Kanan Perkhidmatan Farmasi, Dr. Ramli Zainal

The 32nd ACCSQ-TMHS PWG Meeting was officiated by the Senior Director of Pharmaceutical Services, Dr. Ramli Zainal

Ketua Perwakilan daripada negara anggota ASEANThe Heads of Delegates from the ASEAN member states

Peserta Mesyuarat ASEAN TMHS GMP TaskforceParticipants of the ASEAN TMHS GMP Taskforce Meeting

Majlis makan malam sempena Mesyuarat ACCSQ-TMHS PWG ke-32

Dinner reception in conjunction to the 32nd ACCSQ-THMS PWG Meeting


PROGRAM LATIHAN VACCINE LOT RELEASE UNTUK AGENSI REGULATORI NEGARA-NEGARA OICNPRA telah menganjurkan Program Latihan Vaccine Lot Release khas untuk Agensi Regulatori di Negara-negara Anggota Kerjasama Islam (OIC) dari 21 hingga 23 Oktober 2019 bertempat di Best Western Petaling Jaya Hotel. Program latihan ini dibiayai sepenuhnya oleh Bank Pembangunan Islam (IsDB). Pihak penganjur telah mendapat sambutan yang menggalakkan daripada semua negara anggota, tetapi penganjur hanya dapat menerima 21 peserta untuk latihan ini berdasarkan peruntukan kewangan

21 peserta dari 20 negara telah menghadiri program latihan ini. Negara-negara tersebut adalah – Azerbaijan, Comoros, Mesir, Guinea, Jordan, Bahrain, Mali, Maghribi, Mozambique, Niger, Nigeria, Oman, Senegal, Sierra Leon, Somalia, Gambia, Togo, Turki, Uzbekistan dan Yemen.

Program latihan ini merupakan salah satu inisiatif Malaysia dari segi pembangunan kapasiti di dalam Thematic Area 4 - Vaccines, Pharmaceuticals & Medical Technologies under the OIC Strategic Health Programme of Action (SHPA).

Ini adalah program latihan ke-4 yang telah dianjurkan oleh NPRA sejak tahun 2013 di bawah inisiatif OIC SHPA. Tujuan program ini adalah untuk membantu negara anggota memperkukuhkan kawalan regulatori mereka terhadap ubat-ubatan di negara-negara OIC.

Sebelum ini, Malaysia telah menganjurkan tiga (3) sesi latihan bertajuk “Pharmaceutical Regulatory System Training Programme”. Sesi pertama diadakan pada 25 dan 26 November 2013 dan melibatkan 13 peserta dari Sembilan (9) negara. Sesi kedua diadakan pada 14 hingga 18 Mac 2016 dan melibatkan lapan (8) peserta dari lapan (8) negara. Sesi ketiga diadakan pada 25 hingga 29 September 2017 dan melibatkan 12 peserta dari 10 negara.

Program ini bertujuan untuk memperkenalkan sistem regulatori yang digunapakai di Malaysia yang selaras dengan keperluan antarabangsa serta menunjukkan komitmen Malaysia dalam memastikan produk perubatan di pasaran selamat untuk digunakan, berkesan & berkualiti.

Sesi latihan pertama dan kedua merangkumi topik berkaitan proses pendaftaran produk, aktiviti pasca pendaftaran produk termasuk pengawasan & farmakovigilans, pemeriksaan APB, clinical trials dan pengujian makmal. Sesi ini juga memberi peluang kepada para peserta untuk melawat salah satu pengilang farmaseutikal di Malaysia.

Program latihan ketiga lebih fokus kepada pendaftaran vaksin & produk darah, keperluan biosimilar serta keperluan rantai sejuk. Latihan ke-4 ini pula memberi tumpuan kepada aktiviti vaccine lot release. Matlamatnya adalah untuk peserta memahami konsep vaccine lot release dan dapat melaksanakan aktiviti ini sebagai salah satu mekanisme kawalan kualiti vaksin di negara masing-masing. Untuk latihan kali ini, para peserta berpeluang melawat salah satu pengimport terkemuka di Malaysia.

VACCINE LOT RELEASE TRAINING PROGRAMME FOR REGULATORY AUTHORITIES IN THE ORGANISATION OF ISLAMIC COOPERATION (OIC) MEMBER STATESNPRA organised The Vaccine Lot Release Training Programme for Regulatory Authorities in the Organisation of Islamic Cooperation (OIC) Member States from 21 to 23 October 2019 at Best Western Petaling Jaya Hotel. The training programme is fully funded by the Islamic Development Bank (IsDB). The organisers have received overwhelming responses from all the member states, but due to the available budget allocation, the organisers are only able to receive 21 participants for this training.

21 participants from 20 countries attended this training programme. The countries are – Azerbaijan, Comoros, Egypt, Guinea, Jordan, Kingdom of Bahrain, Mali, Morocco, Mozambique, Niger, Nigeria, Oman, Senegal, Sierra Leon, Somalia, The Gambia, Togo, Turkey, Uzbekistan and Yemen.

This training programme is one of Malaysia’s capacity building initiatives in the Thematic Area 4 - Vaccines, Pharmaceuticals & Medical Technologies under the OIC Strategic Health Programme of Action (SHPA).

This is the 4th training programme organised by NPRA since 2013 under the OIC SHPA initiatives. The aim of these programmes is to assist the member states to strengthen their regulatory control of medicines in the OIC region.

Previously, Malaysia has organised three (3) training sessions entitled the “Pharmaceutical Regulatory System Training Programme”. The first session was held on 25 and 26 November 2013 and it involved 13 participants from nine (9) countries. The second session was held on 14 to 18 March 2016 and it involved eight (8) participants from eight (8) countries. The third session was held on 25 to 29 September 2017 and it involved 12 participants from 10 countries.

The programme aims to share Malaysia’s regulatory systems which in line international requirements and Malaysia’s commitment in ensuring the medicinal products in the market are safe for consumption, effective & of good quality.

The first and second training sessions include presentation on Product Registration Process, Post Registration Activities including surveillance & pharmacovigilance, GMP Inspection, Clinical Trials and laboratory testing. The sessions also provided an opportunity for participants to visit Malaysia’s leading pharmaceutical manufacturer.

The third training programme focused on Vaccine & blood product registration, biosimilars requirements as well as cold chain requirements. The 4th training focused on vaccine lot release activities. The aim is for the participants to understand the concept of Vaccine Lot Release and able to implement this activity as one of the mechanisms of quality control of vaccines in their respective countries. This session provided an opportunity for participants to visit Malaysia’s leading pharmaceutical importer.


Peserta Program Latihan Vaccine Lot ReleaseParticipants of the Vaccine Lot Release Training

Programme

Kata-kata aluan oleh Pengarah NPRA, Datin Dr. Faridah Aryani Md Yusof

Welcoming address by the Director of NPRA, Datin Dr. Faridah Aryani Md Yusof

Sesi kerja kumpulanGroup discussion session

Lawatan ke gudang penyimpanan untuk melihat akiviti Lot Release

Site visit to the warehouse to observe the lot release activity

PENYERTAAN KURSUS LUAR NEGARASepanjang tahun 2019, NPRA telah menghantar beberapa orang pegawai untuk menghadiri latihan di luar negara bagi meningkatkan dan memperkukuhkan pengetahuan serta memastikan pegawai NPRA mempunyai maklumat terkini berkaitan amalan regulatori yang digunapakai di peringkat antarabangsa.

PARTICIPATION IN OVERSEAS COURSESThroughout 2019, NPRA sent several officers to attend training overseas to enhance and strengthen their knowledge and to ensure the officers are equipped with the latest information on internationally adopted regulatory practices.

Bil.No.

Tajuk LatihanTraining Topic

TarikhDate

PenganjurOrganiser

LokasiVenue

Nama pegawaiOfficer’s name

1

Workshop to Develop the Knowledge on the Principle of Traditional Chinese Medicine and Quality Control of Traditional & Complementary Medicine Products

22 to 23 April 2019

Department of Thai Traditional & Alternative Medicine (DTAM), Ministry of Public Health, Thailand

Ministry of Public Health, Thailand

Mohamed Shahrizan Shahrir

2APEC LSIF RHSC CoE in Regulatory Sciences Pilot Workshop on Pharmacovigilance

23 to 25 April 2019

Peking University Haidian, China

Ng Wan NingBavahrni Subramaniam

3 Global Bio Conference 2019 26 to 28 June 2019

Ministry of Food and Drug Safety (MFDS) Republic of Korea

Grand InterContinental Seoul Parnas, Korea

Aida Haryati Abdul RahimChhua Hui Ming

4 APEC Pilot CoE in Advance Therapies 30 July to 2 August 2019 APEC Korea

Cheong Ooi JinAmirul Mohd Mahfuz


Bil.No.

Tajuk LatihanTraining Topic

TarikhDate

PenganjurOrganiser

LokasiVenue

Nama pegawaiOfficer’s name

5 19th International Vaccinology Course2 to 6 September 2019

International Vaccine Institute

International Vaccine Institute (IVI), Seoul National University

Liew Carmen

6APEC Good Registration Management Regulatory Science Centre of Excellence Workshop

17 to 19 September 2019

APEC Taipei, Taiwan

Elizabeth Chong May FoongKhirul Falisa

7 Global Learning Opportunity: Vaccine Lot Release Training

15 to 24 October 2019

NIFDS, South Korea/WHO

NIFDS, Osong Campus, South Korea

Tan Kuan ChuanNee Yuan Qi

8

WHO Implementation Workshop on Regulatory Preparedness for provision and marketing authorisation of human pandemic influenza vaccines is non-producing countries

5 to 8 November 2019

WHO Manila, Phillipines

Jenny Thong Chen NiSunitha Esther

9APEC LSIF RHSC CoE in Regulatory Science Workshop (MRCT and GCP-related Considerations

11 to 14 November 2019

Peking University Haidian, China Dr. Zaril Harza

Nicholas Leow

10 APEC Centre of Excellence in Biotherapeutics Training

3 to 5 December 2019

APECBoston, United States of America

Tan Yun MinCher Chae Miang

11 PMDA-ATC Quality Control (Herbal Medicines) Seminar 2019

10 to 12 December 2019

Pharmaceutical and Medical Devices Agency (PMDA), Japan

Toyama Prefectural Hall, Toyama City, Japan

Nik Juzaimah Juhari

Selain daripada menyertai seminar luar negara, NPRA berbesar hati menerima pelawaan menjadi penceramah bagi seminar anjuran agensi regulatori luar negara. Senarai penceramah adalah seperti di bawah:

In addition to participating in overseas seminars, NPRA officers were also invited to be speakers for seminars organized by overseas regulatory agencies. The list of speakers is as below:

Bil.No.

Tajuk CeramahPresentation Topic

TarikhDate

PenganjurOrganizer

LokasiVenue

PenceramahSpeaker

1 CoRE’s Chemistry, Manufacturing and Controls (CMC) 20 Mac 2019

Centre of Regulatory Excellenc (CoRE)-DUKE-NUS

Singapore Lim Bee Yee

2 Access To Innovative Medicine (ATIM): post approval changes 9 April 2019

Japan Pharmaceutical Manufacturing Association (JPMA)

Tokyo, Japan Siti Hidayah binti Kasbon

3National Regulatory Agency of Malaysia and our Role in Improving Patient’s Access to Biologics Products

28 June 2019 WHO Seoul, South

Korea Chua Hui Ming

4 Requirement of the Registration of New Products

8 September 2019

China-Asean Summit For Drug Development And Cooperation

Guangxi, China Majidah binti Abd Rahman

5 Regulatory innovation at NPRA, Malaysia 12 October 2019

Asian Society of Neuropsychopharmacology

Fukuoka, JapanDr. Yvonne Khoo Siew Khoon


Bil.No.

Tajuk CeramahPresentation Topic

TarikhDate

PenganjurOrganizer

LokasiVenue

PenceramahSpeaker

6Regulatory Preparedness on Authorisation for use of Influenza vaccines

5 November 2019 WHO Manila,

PhilippinesJenny Thong Chen Ni

7 The Appropriate Use of Drugs in Asia Countries, Especially in Elderly Patients

11 November 2019

Drug Information Association Tokyo, Japan Azri Bin

Nasruddin

LAWATAN DARIPADA AGENSI DALAM DAN LUAR NEGARA SERTA PELAJAR UNIVERSITINPRA telah mendapat pengiktirafan antarabangsa sebagai “WHO Collaborating Centre for Regulatory Control of Pharmaceuticals” pada tahun 1996. Pengiktirafan ini telah diberikan oleh World Health Organization untuk sumbangan NPRA dalam bidang regulatori farmasi. Sepanjang 2019, NPRA telah menerima kunjungan daripada 41 orang pelawat antarabangsa daripada 9 negara - Bangladesh, Brunei, China, Kenya, Taiwan, Tanzania, Thailand, Uganda dan Vietnam.

Skop latihan termasuk Pemeriksaan Amalan Pengilangan Baik (GMP), validasi kaedah pengujian dan peralatan makmal, penguijan kimia & mikrobiologi ke atas produk farmaseutikal, suplemen kesihatan, produk tradisional dan produk kosmetik serta aktiviti pasca pendaftaran termasuk survelens dan farmakovigilans ubat-ubatan.

VISITS BY LOCAL AND INTERNATIONAL AGENCIES AS WELL AS UNIVERSITY STUDENTSThe NPRA has been given an international recognition as a “WHO Collaborating Centre for Regulatory Control of Pharmaceuticals” in the year 1996. This recognition is an acknowledgement from World Health Organization (WHO) for NPRA’s contribution in the field of regulatory affairs. This recognition has attracted foreign regulatory agencies to undergo training in NPRA. Throughout 2019, NPRA has received visits from 41 international visitors from 9 countries - Bangladesh, Brunei, China, Kenya, Taiwan, Tanzania, Thailand, Uganda dan Vietnam.

The scope of training includes Good Manufacturing Practice inspection, equipment qualification & validation, Chemical & microbiological testing on Pharmaceutical, Health Supplements, Traditional Products & Cosmetics as well as the post-registration activities such as surveillance & pharmacovigilance of medicines.

Latihan sangkutan oleh pegawai daripada National Drug Authority Uganda utuk mempelajari Kawalan regulatori

ubat-ubatan tradisional (15 hingga 19 April 2019)Training attachment by officers from the National Drug

Authority Uganda to learn on regulatory control of traditional medicines (15 to 19 April 2019)

Lawatan kerja oleh pegawai daripada Food and Drug Administration of Guangxi Zhuang Autonomous Region

China (24 Jun 2019)Work Visit from officers of the Food and Drug

Administration of Guangxi Zhuang Autonomous Region China (24 June 2019)

Sepanjang tahun 2019, NPRA telah menerima lawatan kerja daripada seorang orang pegawai daripada Makmal Kesihatan dan Keselamatan Makanan dan dua orang pegawai farmasi daripada Pusat Panggilan Farmasi Kebangsaan (NPCC). Lawatan ini bertujuan untuk memahami dengan lebih mandalam proses kerja di NPRA bagi membantu pegawai-pegawai ini dalam tugasan harian mereka.

Selain itu, NPRA juga menerima lawatan sambal belajar daripada 82 orang pelajar daripada universiti dan kolej tempatan iaitu pelajar sarjana muda Biologi Farmaseutikal dan pelajar ijazah sarjana Kesihatan Awam daripada Universiti Malaya serta pelajar sarjana muda jurusan farmasi daripada Kolej MAHSA.

Throughout the year 2019, NPRA received work visits from one officer from the Food and Health Safety Laboratory and two pharmacists from the National Pharmacy Call Center. This visit aims to gain a deeper understanding of the work processes in NPRA to assist these officers in their daily tasks.

In addition, NPRA also received study visits from 82 students from local universities and colleges which are the Pharmaceutical Biology undergraduate students and Public Health postgraduate students from the University of Malaya as well as undergraduate students in the pharmacy program from MAHSA College.


Lawatan kerja oleh pegawai daripada Makmal Kesihatan dan Keselamatan Makanan (31 Julai 2019)

Work visit by officers from the Food and Health Safety Laboratory (31 July 2019)

Lawatan akademik oleh pelajar ijazah sarjana Kesihatan Awam daripada Universiti Malaya (12 Disember 2019)

Academic visit from Public Health postgraduate students from the University of Malaya (12 December 2019)

Latihan sangkutan oleh pegawai daripada Drug Administration of Vietnam untuk mempelajari penggunaan aplikasi IT di dalam proses pendaftaran produk (1 hingga

2 Julai 2019)Training attachment by officers from the Drug

Administration of Vietnam to learn on training for evaluators and IT application in drug registration (1 to 2

July 2019)

Lawatan akademik oleh pelajar sarjana muda Biologi Farmaseutikal, University Malaya (8 April 2019)

Academic Visit by the Pharmaceutical Biology undergraduate students from University Malaya (8 April 2019)


NPRA telah mendapat pengiktirafan antarabangsa sebagai “WHO Collaborating Centre for Regulatory Control of Pharmaceuticals” pada tahun 1996. Pengiktirafan ini telah diberikan oleh World Health Organization untuk sumbangan NPRA dalam bidang regulatori farmasi.

Melalui NPRA, Malaysia juga merupakan negara anggota Pharmaceutical Inspection Co-operation Scheme (PIC/S) sejak Januari 2002. Sejak itu, NPRA terlibat secara aktif dalam program Amalan Perkilangan Baik (APB) dan program Jaminan Kualiti Antarabangsa. Tujuan PIC/S ini adalah untuk membantu jaringan kerjasama di antara badan regulatori negara-negara ahli di dalam pertukaran maklumat dan pengalaman di dalam bidang APB serta latihan pemeriksa APB.

Melalui NPRA, Malaysia telah diterima sebagai ahli penuh Organisation for Economic Cooperation and Development Good Laboratory Practice Mutual Acceptance of Data System (OECD MAD) mulai 29 Mac 2013. Data bukan klinikal yang dijalankan di bawah Program Pemonitoran Komplians GLP NPRA akan diterima oleh semua negara OECD dan bukan OECD yang mematuhi system MAD.

Malaysia juga telah diterima sebagai pemerhati kepada International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) sejak Jun 2018. ICH merupakan platform yang menyatukan pihak regulatori dan industri farmaseutikal untuk membincangkan aspek saintifik dan teknikal pendaftaran ubat-ubatan. Misi ICH adalah untuk mencapai harmonisasi seluruh dunia bagi memastikan ubat-ubatan yang selamat, berkesan, dan berkualiti tinggi dapat didaftarkan dengan cara yang paling efisien. Sebagai pemerhati, Malaysia akan dapat memastikan bahawa standard kawalan regulatori farmaseutikal yang digunapakai di negara ini adalah setanding dengan piawaian antarabangsa. Malaysia juga layak untuk melantik seorang pegawai untuk menjadi sebahagian daripada Kumpulan Kerja Pakar dalam merangka garis panduan keperluan teknikal untuk penilaian produk farmaseutikal yang berkaitan.

Bagi memaparkan perkhidmatan yang berkesan dan berkualiti, NPRA telah memperolehi pensijilan MS ISO 9001 dari pihak SIRIM QAS Sdn. Bhd. NPRA telah berjaya mengekalkan pensijilan MS ISO selama 19 tahun berturut-turut (2001 hingga 2019) bermula dari versi MS ISO 9002:1994, diikuti dengan versi MS ISO 9001:2000, MS ISO 9001:2008 dan terkini dengan pensijilan versi MS ISO 9001:2015 pada tahun 2017 dengan nombor sijil adalah QMS 00894 dan sah sehingga 24 Mei 2022.

Selain pensijilan MS ISO 9001, makmal-makmal di NPRA diakreditasi oleh Jabatan Standard Malaysia kerana mempunyai kompetensi untuk beroperasi selaras dengan MS ISO/IEC 17025. NPRA telah berjaya mengekalkan akreditasi MS ISO/IEC 17025:2005 selama 10 tahun berturut-turut (2010 hingga 2019) dalam skop pengujian kimia dan mikrobiologi dengan nombor akreditasi No. SAMM 450 yang sah sehingga 30 November 2020.


NPRA has been given an international recognition as a “WHO Collaborating Centre for Regulatory Control of Pharmaceuticals” in the year 1996. This recognition is an acknowledgement from World Health Organization for NPRA’s contribution in the field of regulatory affairs.

Malaysia (through NPRA is also a Member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) since 1st January 2002. Since then, NPRA has been actively involved in international Good Manufacturing Practice (GMP) and Quality Assurance Programme. The purpose of PIC/S is to facilitate the networking between participating authorities in the exchange of information and experience in the field of GMP and related areas and training of GMP inspectors.

Through NPRA, Malaysia has been accepted as a full adherent member to Organisation for Economic Cooperation and Development Good Laboratory Practice Mutual Acceptance of Data System (OECD MAD) for Good Laboratory Practice (GLP) starting 29 March 2013. The non-clinical data conducted under the NPRA Compliance Monitoring Programme shall be accepted by all OECD countries and non-OECD countries that adhere to the MAD System.

Malaysia has been accepted to become an observer to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use since June 2008. ICH brings together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. As an observer, Malaysia will be able to ensure that the standard of pharmaceutical regulatory control practiced in this country is equivalent to internationally standards. Malaysia is also eligible to appoint a relevant officer to be part of the Expert Working Group in drafting the technical requirement guideline for the evaluation of relevant pharmaceutical products.

In order to ensure high quality and efficient service, NPRA has obtained the MS ISO 9001 certification from SIRIM QAS Sdn. Bhd. NPRA has successfully maintained the MS ISO certification for 19 consecutive years (2001 to 2019) starting with version MS ISO 9002: 1994, followed by the MS ISO 9001: 2000, MS ISO 9001: 2008 and most recently with the certification of version MS ISO 9001:2015 in 2017 with certificate number QMS 00894 which is valid until 24 May 2022.

In addition to MS ISO 9001 certification, NPRA laboratories are accredited by the Department of Standard Malaysia for their competence and ability to operate in accordance with MS ISO / IEC 17025. NPRA has successfully maintained MS ISO / IEC 17025: 2005 accreditation for the past 10 years (2010 to 2019) in the scope of chemical and microbiological testing with accreditation number No. SAMM 450 which is valid until 30th November 2020.


PENGIKTIRAFAN KEPADA NPRA BAGI PELAKSANAAN DASAR NEGARA BAGI PEMBANGUNAN DAN PELAKSANAAN PERATURAN (NPDIR)NPRA sedang mempromosikan Amalan Pengawalsaliaan Baik (GRP) dalam pembangunan dasar dan garis panduan baru selaras dengan persetujuan antarabangsa daripada OECD-GLP-MAD, PIC/S dan kumpulan kerja ASEAN. NPRA telah diberi sijil penghargaan untuk sumbangan aktif dan komitmen yang tinggi terhadap perlaksanaan Dasar Negara Bagi Pembangunan dan Pelaksanaan Peraturan (NPDIR) selama dua tahun berturut-turut (tahun 2018 dan 2019) pada Konvensyen Kebangsaan Amalan Pengawalseliaan Baik yang telah dianjurkan oleh Malaysian Productivity Corporation. Anugerah ini diberikan untuk terus memupuk kepentingan pelaksanaan GRP khususnya bagi pembuat dasar terutamanya dalam memastikan kualiti dasar dan peraturan kerajaan dapat meningkatkan pertumbuhan ekonomik dan produktiviti di Malaysia.

RECOGNITION TO THE NPRA FOR THE IMPLEMENTATION OF THE NATIONAL POLICY FOR DEVELOPMENT AND IMPLEMENTATION OF REGULATIONS (NPDIR)NPRA is promoting Good Regulatory Practices (GRP) in approaching new policies and guidelines that are in line with the international consensus from the OECD-GLP-MAD, PIC/S and ASEAN TWG committee platforms. NPRA received a certificate of recognition for its active contribution and high commitment to the implementation of National Policies for the Development and Implementation of Regulations for two years in row (2018 and 2019) in the National Convention on Good Regulatory Practice (GRP) program organized by the Malaysian Productivity Corporation. The award was given to continuously foster the importance of the GRP for the policy makers especially in ensuring the quality of government policies and regulations for a higher economic growth and productivity in Malaysia.

Pengarah NPRA, Datin Dr. Faridah Aryani (empat dari kiri) menerima sijil bagi pihak NPRADirector of NPRA, Datin Dr. Faridah Aryani (fourth from the left) accepting the certificate on behalf of NPRA

PEMBANGUNAN MONOGRAF HERBA MALAYSIAPembangunan Monograf Herba Malaysia (MHM) adalah projek progresif yang melibatkan pelbagai agensi dan kementerian dari Bahagian Industri Tanaman, Ternakan dan Perikanan Kementerian Pertanian dan Industri Asas Tani, Institut Penyelidikan Perubatan (IMR), Bahagian Regulatori Farmasi Negara (NPRA), Institut Penyelidikan Perhutanan Malaysia (FRIM), Institut Penyelidikan dan Kemajuan Pertanian Malaysia (MARDI), dan institusi pengajian tinggi tempatan seperti Universiti Putra Malaysia (UPM), Universiti Kebangsaan Malaysia (UKM) dan Universiti Sains Malaysia (USM).

Inisiatif pembangunan MHM adalah bertujuan untuk menyediakan rujukan penting untuk memberikan maklumat yang menyeluruh dan tidak ternilai berhubung identifikasi spesies herba, keperluan kawalan kualiti, kegunaan dari segi perubatan tradisional dan data keselamatan untuk herba tempatan yang bernilai tinggi. Oleh itu, MHM adalah wahana yang amat berguna khususnya untuk industri ubat tradisional, agensi regulatori, para penyelidik dan orang awam amnya.

DEVELOPMENT OF THE MALAYSIAN HERBAL MONOGRAPHThe Malaysia Herbal Monograph (MHM) development is a progressive project carried out by various agencies and ministries including Ministry of Agriculture and Agro-based Industry, Institute of Medical Research (IMR), National Pharmaceutical Regulatory Agency (NPRA), Forest Research Institute Malaysia (FRIM), Malaysian Agricultural Research and Development Institute (MARDI) and academia such as Universiti Putra Malaysia (UPM), Universiti Kebangsaan Malaysia (UKM) and Universiti Sains Malaysia (USM).

MHM serves as a crucial reference that provides invaluable, comprehensive information regarding identification of herbs, quality control requirements, medicinal usage and safety information for high value local herbal plants, which are extremely useful for the traditional medicines industry, regulatory agencies, researchers and general public.


Sebahagian daripada Monograf Herba MalaysiaA portion of the Malaysian Herbal Monograph

Dukung Anak (Aerial)Phyllanthus Urinaria (UKM)

Kulat Susu Rimau (Sclerotium)Lignosus Rhinocerus (NPRA)

Kayu Manis (Daun)Cinnamomum Verum (USM)

Serai WangiCymbopogon Nardus (USM)

Kucing Galak (Aerial)Acalypha Indica (USM)

Urang-aring (Daun)Eclipta Prostrata (MARDI)

Belimbing BuluhAverrhoa Bilimbi (UPM)

Dukung Anak (Aerial)Phyllanthus Amarus (UKM)

Manggis (Kulit)Garcinia Mangostana (UPM)

Peranan NPRA dalam pembangunan Monograf Herba Malaysia adalah termasuk:

a) Pengerusi silih ganti bagi Jawatankuasa Induk dan Jawatankuasa Teknikal MHM

b) Menjalankan ujian verifikasi bagi data yang diperoleh daripada institusi pembangunan monograf

c) Menyokong aktiviti Sekretariat MHM yang diketuai oleh IMR (Menjalankan latihan untuk industri tradisional tempatan dan juga untuk jawatankuasa MHM).

Sejumlah dua (2) monograf diterbitkan pada tahun 2019 iaitu Belimbing Buluh (Averrhoa Bilimbi) dan Serai Wangi (Cymbopogon Nardus). Dari 2011 hingga 2019, sebanyak 76 monograf telah diterbitkan dan dimuat naik di laman web Global Information Hub on Integrated Medicine (GlobinMed).

The roles of NPRA, Ministry of Health (MOH) Malaysia in the development of the Malaysian Herbal Monograph include:

a) Co-chair the MHM Main Committee and MHM Technical Committee

b) To verify testing methods and data obtained by the developer of the monograph

c) To support the MHM Secretariat activities led by IMR (Conduct training for the local traditional industry as well as for the MHM committee).

A total of two (2) monographs were published in 2019 namely Belimbing Buluh (Averrhoa Bilimbi) and Serai Wangi (Cymbopogon Nardus). From 2011 until 2019, 76 monographs have been published and uploaded on Global Information Hub on Integrated Medicine (GlobinMed) website.


PENGLIBATAN NPRA DI DALAM KUMPULAN KERJA ASEANASEAN Consultative Committee for Standards and Quality (ACCSQ) telah ditubuhkan pada tahun 1992 bagi memudahkan pencapaian objektif Perjanjian Perdagangan Bebas ASEAN. Pada tahun 2004, ACCSQ telah ditugaskan untuk menjalankan aktiviti-aktiviti yang berkaitan dengan penubuhan ASEAN Economic Community (AEC).

AEC dilancarkan pada 2015 dengan tujuan untuk mewujudkan pengeluaran asas dan pasaran tunggal di kalangan negara-negara ASEAN. Ini akan membolehkan pergerakan bebas barangan, perkhidmatan, buruh mahir dan pelaburan di kalangan 10 negara anggota ASEAN serta memudahkan aliran bebas modal. Pengharmonian peraturan-peraturan teknikal dan Mutual Recognition Agreements (MRA) adalah antara strategi yang akan digunapakai oleh AEC untuk mengurangkan kos perdagangan.

Melalui NPRA Malaysia mengambil bahagian secara aktif dalam tiga kumpulan kerja yang bertujuan untuk membangunkan skim pengharmonian produk farmaseutikal, ubat-ubatan tradisional dan supplemen kesihatan serta peraturan kosmetik di negara-negara ASEAN. Terdapat tiga kumpulan kerja di bawah ACCSQ, iaitu Pharmaceutical Product Working Group (PPWG), the Traditional Medicines and Health Supplements Product Working Group (TMHS PWG) dan the ASEAN Cosmetic Committee (ACC).

Pada tahun 2019, NPRA berpeluang menganjurkan dua mesyuarat kumpulan kerja ACCSQ iaitu Mesyuarat ACCSQ-PPWG yang ke-27 di Pulau Pinang dan Mesyuarat ACCSQ-TMHS PWG yang ke-32 di Selangor.

5.0 KOLABORASI DAN PENGLIBATAN ANTARABANGSA COLLABORATION AND INTERNATIONAL PARTICIPATION

NPRA’S PARTICIPATION IN ASEAN WORKING GROUPSThe ASEAN Consultative Committee for Standards and Quality (ACCSQ) was formed in 1992 to facilitate the accomplishment of the objectives of the ASEAN Free Trade Agreement. In 2004, the ACCSQ was tasked to undertake activities in relation to the establishment of an ASEAN Economic Community (AEC).

Launched in 2015, the AEC aims to eventually create a single market and production base within ASEAN countries. This will allow for the free movement of goods, services, skilled labour and investment among the 10 ASEAN member nations and facilitate the free flow of capital. Harmonisation of technical regulations and mutual recognition agreements (MRA) are among the strategies that will be adopted by the AEC to reduce trade cost.

Through the NPRA, Malaysia actively participates in three product working groups which aim to develop harmonisation schemes of pharmaceuticals, traditional medicines and health supplements as well as cosmetics regulations in ASEAN countries. There are three working groups under the ACCSQ – the Pharmaceutical Product Working Group (PPWG), the Traditional Medicines and Health Supplements Product Working Group (TMHS PWG) and the ASEAN Cosmetic Committee (ACC).

In the year 2019, NPRA had the opportunity to organise two meetings for the ACCSQ working group which are the 27th ACCSQ-PPWG Meeting in Penang and the 32nd ACCSQ-TMHS PWG Meeting in Selangor.

Berikut merupakan mesyuarat peringkat ASEAN yang telah dihadiri oleh pegawai NPRA sepanjang tahun 2019:

Below are the ASEAN meetings attended by NPRA officers in the year 2019:

Bil.No.

MesyuaratMeeting

TarikhDate

TempatVenue

1The 30th Meeting of the ASEAN Consultative Committee for Standards and Quality on Traditional Medicines and Health Supplements Product Working Group (ACCSQ TMHS PWG Meeting)

29 April to 3 May 2019 Lao PDR

2 The 13th ASEAN Cosmetic Testing Laboratory Meeting 18 to 19 June 2019 Myanmar

3 The 30th ASEAN Cosmetic Committee (ACC) 18 to 21 June 2019 Myanmar

4 The 31st ASEAN Cosmetic Committee (ACC) 12 to 15 November 2019 Philippines

5 Joint Sectoral Committee for ASEAN Mutual Recognition Agreement for GMP Inspection of Manufacturers of Medicinal Products Meeting

15 to 21 December 2019 Indonesia

6 28th ACCSQ Pharmaceutical Product Working Group & its Related Meetings 15 to 21 December 2019 Indonesia

7 4th Joint Assessment Coordinating Group (JACG) Meeting 16 to 20 December 2019 Indonesia


MESYUARAT TEKNIKAL DUA HALA

Mesyuarat Dua Hala di antara Bahagian Regulatori Farmasi Negara (NPRA) dan Pharmaceutical and Medical Device Agency (PMDA), JepunMesyuarat Teknikal di antara Bahagian Regulatori Farmasi Negara (NPRA) dan The Pharmaceutical and Medical Device Agency (PMDA), Jepun telah diadakan pada 12 September 2019 bertempat di Bilik Mesyuarat Delima, Pejabat Program Perkhidmatan Farmasi. Delegasi Malaysia telah diketuai oleh YBhg. Dr. Ramli Zainal, Pengarah Kanan Perkhidmatan Farmasi, manakala delegasi PMDA diketuai oleh Dr. Nobumasa Nakashima, Pengarah, Pengarah Kanan Program Antarabangsa, PMDA.

Mesyuarat ini merupakan susulan kepada mesyuarat di antara kedua-dua agensi yang telah diadakan pada 8 April 2019 di PMDA, Jepun yang telah dihadiri oleh YBhg. Dr. Ramli Zainal dan seorang pegawai NPRA, Pn. Noraisyah Mohd Sani. Mesyuarat kali ini telah membincangkan kajian rintis untuk facilitated registration bagi beberapa produk dimana PMDA akan berkongsi laporan penilaian mereka dengan NPRA bagi mempercepatkan proses pendaftaran produk tersebut di Malaysia. Selain itu, mesyuarat membincangkan perancangan aktiviti latihan pada masa akan datang.

BILATERAL TECHNICAL MEETINGS

Bilateral Meeting between the National Pharmaceutical Regulatory Agency (NPRA) and Pharmaceutical and Medical Device Agency (PMDA), JapanThe Bilateral Meeting between the National Pharmaceutical Regulatory Agency (NPRA) and The Pharmaceutical and Medical Device Agency (PMDA), Japan was held on 12 September 2019 at the Delima Meeting Room, Pharmaceutical Services Programme. The Malaysian delegation was headed by YBhg. Dr. Ramli Zainal, Senior Director of Pharmaceutical Services, Ministry of Health Malaysia, whereas the Japanese delegation was led by Dr. Nobumasa Nakashima, Senior Director for International Programs, PMDA.

The meeting was a follow-up from another meeting between the two agencies held on 8th April 2019 in PMDA, Japan which was attended by YBhg. Dr. Ramli Zainal and an NPRA officer, Pn. Noraisyah Mohd Sani. This bilateral meeting discussed on the pilot study for facilitate registration for some products whereby PMDA will share their evaluation report with NPRA to expedite the process of registering the product in Malaysia. In addition, the meeting also discussed plans for future training activities.

Mesyuarat Dua Hala di antara Bahagian Regulatori Farmasi Negara dan Pharmaceutical and Medical Device

Agency pada 12 September 2019 di Petaling Jaya, Selangor

Bilateral Meeting between National Pharmaceutical Regulatory Agency and Pharmaceutical and Medical Device

Agency on 12 September at Petaling Jaya, Selangor

Mesyuarat Dua Hala di antara Bahagian Regulatori Farmasi Negara dan Pharmaceutical and Medical Device

Agency pada 12 September 2019 di Petaling Jaya, Selangor

Bilateral Meeting between National Pharmaceutical Regulatory Agency and Pharmaceutical and Medical Device

Agency on 12 September at Petaling Jaya, Selangor

MESYUARAT TEKNIKAL DUA HALA KE-7 DI ANTARA BAHAGIAN REGULATORI FARMASI NEGARA (NPRA) DAN HEALTH SCIENCES AUTHORITY (HSA), SINGAPURAMesyuarat Teknikal Ke-7 di antara Bahagian Regulatori Farmasi Negara (NPRA), Kementerian Kesihatan Malaysia (KKM) dan Health Sciences Authority (HSA), Singapura telah diadakan pada 12 November 2019 bertempat di premis Bilik Persidangan, Hospital Permai, Johor Bahru. Delegasi Malaysia telah diketuai oleh YBhg. Dr. Ramli Zainal, Pengarah Kanan Perkhidmatan Farmasi, KKM manakala delegasi Singapura telah diketuai oleh Associate Professor. Chan Cheng Leng, Pengarah, Bahagian Regulatori Produk Kesihatan, HSA Singapura.

7TH TECHNICAL BILATERAL MEETING BETWEEN THE NATIONAL PHARMACEUTICAL REGULATORY AGENCY (NPRA), MINISTRY OF HEALTH MALAYSIAThe 7th Technical Bilateral Meeting between the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia and Health Sciences Authority (HSA), Singapore was held on 12 November 2019 at the Conference Room, Permai Hospital, Johor Bahru.

The Malaysian delegation was headed by YBhg. Dr. Ramli Zainal, Senior Director of Pharmaceutical Services, Ministry of Health Malaysia, whereas the Singapore delegation was led by Associate Professor. Chan Cheng Leng, Group Director of the Health Product Regulation Group.


Mesyuarat telah membincangkan maklumat regulatori terbaru daripada kedua-dua agensi termasuk perkongsian aktiviti mengesan dan mengendalikan situasi yang memerlukan tindakbalas segera serta kerjasama berterusan dalam pelbagai bidang termasuk aktiviti workshare model dan perancangan aktiviti latihan pada masa akan datang.

The meeting discussed regulatory updates from both agencies including a sharing session on the detection and handling of situations that require immediate response as well as the continuous collaboration between the two agencies in various fields including the on-going workshare model activity and future training activities.

Mesyuarat Teknikal Dua Hala Ke-7 di antara Bahagian Regulatori Farmasi Negara dan Health Sciences Authority

pada 12 November 2019 di Johor BahruThe 7th Technical Bilateral Meeting between National

Pharmaceutical Regulatory Agency and the Health Sciences Authority on 12 November 2019 at Johor Bahru

Sesi pemberian hadiah semasa penutup Mesyuarat Teknikal Dua Hala Ke-7 di antara Bahagian Regulatori

Farmasi Negara dan Health Sciences Authority pada 12 November 2019 di Johor Bahru

Gift exchange during the closing of the 7th Technical Bilateral Meeting between National Pharmaceutical

Regulatory Agency and the Health Sciences Authority on 12 November 2019 at Johor Bahru

PENGLIBATAN NPRA DI DALAM AKTIVITI-AKTIVITI DI PERINGKAT OICSesi ke-4 Persidangan Islam Menteri-menteri Kesihatan (ICHM), yang telah diadakan di Jakarta pada 22 hingga 24 Oktober 2013, telah menerimapakai OIC Strategic Health Programme of Action 2014 hingga 2023 (OIC-SHPA), yang telah disediakan dan dikemukakan oleh SESRIC dengan kerjasama negara-negara ahli OIC dan pertubuhan antarabangsa yang berkaitan.

OIC-SHPA telah disediakan dengan tujuan untuk mengukuhkan dan meningkatkan kerjasama dalam pelbagai isu kesihatan di peringkat OIC dan peringkat antarabangsa. OIC-SHPA telah mengenalpasti enam bidang tematik untuk tindakan bersama dan Malaysia telah dilantik untuk manjadi penyelaras utama bagi Thematic Area 4: Medicine, Vaccine and Medical Technologies. Sebagai penyelaras utama, Malaysia bertanggungjawab memastikan aktiviti yang dirancang di bawah Thematic Area ini dilaksanakan mengikut perancangan. Malaysia juga mengambil bahagian dan memberikan input bagi Thematic Area lain apabila diperlukan.

Malaysia melalui NPRA aktif menjalankan aktiviti seperti sesi latihan yang mendalam untuk membantu negara-negara anggota OIC meningkatkan kawalan regulatori mereka terhadap ubat-ubatan dan vaksin di negara masing-masing. NPRA percaya bahawa negara yang mempunyai sistem kawalan regulatori yang kukuh akan menggalakkan akses yang lebih baik kepada ubat-ubatan dan vaksin yang berkualiti, berkesan dan selamat.

NPRA’S INVOLVEMENT IN ACTIVITIES AT THE OIC LEVELThe 4th Session of the Islamic Conference of Ministers of Health (ICHM), which was held in Jakarta on 22 to 24 October 2013, adopted the OIC Strategic Health Programme of Action 2014 to 2023 (OIC-SHPA), which was prepared and submitted by SESRIC in collaboration with OIC member countries and relevant international organisations.

The OIC-SHPA was prepared with a view to strengthen and enhance cooperation and collaboration on various health issues at both OIC and international level. The OIC-SHPA identified six thematic areas for joint action and Malaysia was elected as the lead country coordinator for Thematic Area 4: Medicine, Vaccine and Medical Technologies. As the lead country, Malaysia ensures the activities planned under this Thematic Area are carried out in a timely manner. Malaysia also participates and gives input for other Thematic Areas when required.

Malaysia through NPRA actively carries out activities such as in-depth training sessions to assist OIC member states to improve the regulatory control of medicines and vaccines in their country. NPRA believes that having a strong regulatory control system in place will promote better access to good quality, effective and safe medicines and vaccines.


Malaysia juga mengambil bahagian secara aktif dalam mesyuarat-mesyuarat OIC seperti Lead Country Coordinators (LCC) Meeting and the Steering Committee of Health Meeting (SCH) yang dijalankan setiap tahun serta International Conference of the Health Ministers Meeting (ICHM) yang diadakan sekali setiap dua tahun.

Pada tahun 2019, wakil NPRA, Pn. Syuhadah Mohamed Hassan telah menghadiri Mesyuarat LCC ke-6 dan Mesyuarat SCH ke-13 yang telah diadakan di Abu Dhabi, United Arab Emirates pada 7-8 Oktober 2019.

Dalam mesyuarat ini, Malaysia telah mengundur diri secara rasmi daripada menjadi LCC bagi Thematic Area 4 setelah menduduki jawatan ini selama 6 tahun, yang merupakan tempoh maksimum sesebuah negara dapat menjadi LCC untuk satu Thematic Area. Negara jiran, Indonesia akan meneruskan program yang telah dirancang di bawah Thematic Area 4 bermula pada tahun 2020.

Pada masa yang sama, Malaysia telah membuat permohonan untuk menjadi LCC yang Thematic Area 3: Maternal, New-born and Child Health and Nutrition. Program pada masa akan dating di bawah Thematic Area ini akan diketuai oleh Bahagian Perkembangan Kesihatan Awam, Kementerian Kesihatan Malaysia.

Malaysia also actively participates in the OIC meetings such as the Lead Country Coordinators Meeting (LCC) and the Steering Committee of Health Meeting (SCH) which is carried out annually, as well as the International Conference of the Health Ministers Meeting (ICHM) which is held once in every two years.

In 2019, NPRA’s representative, Mdm. Syuhadah Mohamed Hassan attended the 6th LCC meeting as well as the 13th SCH Meeting held in Abu Dhabi, United Arab Emirates from the 7-8 October 2019.

During this meeting, Malaysia officially resigned from being the LCC for Thematic Area 4 after leading it for 6 years, which is the maximum length of time for a country to lead a Thematic Area. Our neighboring country, Indonesia, will continue the program planned under Thematic Area 4 beginning in 2020.

At the same time, Malaysia has applied to become the LCC for Thematic Area 3: Maternal, New-born and Child Health and Nutrition. Future programs under this Thematic Area will be led by the Public Health Development Division, Ministry of Health Malaysia.

Mesyuarat Lead Country Coordinators pada 7 October 2019 di Abu Dhabi, UAE

Lead Country Coordinators Meeting held on 7 October 2019 at Abu Dhabi, UAE

Mesyuarat Steering Committee of Health pada 8 October 2019 di Abu Dhabi, UAE

Steering Committee of Health Meeting held on 8 October 2019 at Abu Dhabi, UAE

PENGLIBATAN NPRA SELAKU AHLI PASUKAN PENILAI ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT (OECD) DALAM ON-SITE EVALUATION (OSE) KE ATAS UNITED STATES FOOD & DRUG ADMINISTRATION (USFDA)OECD Working Group on Good Laboratory Practice (GLP) telah melantik Malaysia dan Republik Czech sebagai negara pasukan penilai OECD bagi OECD On-Site Evaluation (OSE) ke atas Unites States Food & Drug Administration (USFDA). Pasukan penilai OECD bagi OSE USFDA tersebut telah diwakili oleh Cik Fadhilah Hasbullah dari NPRA Malaysia bersama seorang inspektor GLP State Institute for Drug Control (SUKL), Republik Czech. OSE USFDA tersebut telah dijalankan pada 5 hingga 9 Ogos 2019 di Ibu Pejabat USFDA, Washington, D.C.

Penyertaan inspektor NPRA mewakili Malaysia dalam OSE tersebut merupakan satu pengiktirafan OECD kepada Program Komplians GLP NPRA dan kompetensi inspektor NPRA.

NPRA AS EVALUATION TEAM FOR ECONOMIC CO-OPERATION AND DEVELOPMENT (OECD) IN THE ON-SITE (OSE) EVALUATION OF THE UNITED STATES FOOD & DRUG ADMINISTRATION (USFDA)OECD Working Group on Good Laboratory Practice (GLP) has appointed Malaysia and Czech Republic to be the OECD evaluation team for the On-Site Evaluation (OSE) of the United States Food & Drug Administration (USFDA). OECD evaluation team was represented by Ms. Fadhilah Hasbullah from NPRA Malaysia, and one GLP inspector from State Institute for Drug Control (SUKL), Czech Republic. The USFDA OSE took place in USFDA Head Quarters, Washington, D.C. from 5 to 9 August 2019.

NPRA participation in the OSE is a form of recognition by the OECD to the NPRA GLP Compliance Programme and NPRA inspector’s competency.


Cik Fadhilah Hasbullah (kiri) selaku wakil pasukan penilai OECDMs. Fadhilah Hasbullah (left) as a representative of the OECD evaluation team

LAWATAN SEMPENA CAPACITY BUILDING ACTIVITIES BERSAMA TAIWAN FOOD AND DRUG ADMINISTRATION (TFDA)NPRA telah menerima jemputan dari Taiwan Food and Drug Administrations (TFDA) untuk mengambil bahagian dalam Good Laboratory Practice (GLP) Capacity Building Activities, di Taipei pada 1 hingga 6 Julai 2019. Kolaborasi di antara TFDA dan NPRA ini bertujuan untuk meningkatkan capacity building inspektor-inspektor GLP kedua-dua agensi. Lawatan tersebut telah dihadiri oleh tiga inspektor GLP NPRA iaitu Pn. Poh Wen Tsin, Cik Fadhilah Hasbullah dan Pn. Nur Amani Shaari. Antara agenda lawatan adalah menjadi pemerhati semasa pemeriksaan GLP oleh TFDA serta menghadiri Experience Exchange and Technical Discussion Meeting bersama pihak TFDA.

CAPACITY BUILDING ACTIVITIES VISIT WITH TAIWAN FOOD AND DRUG ADMINISTRATION (TFDA)NPRA was invited by Taiwan Food and Drug Administrations (TFDA) to participate in Good Laboratory Practice (GLP) Capacity Building Activities Visit in Taipei, from 1 to 6 July 2019. Collaboration between these two agencies is to enhance the capacity building of GLP inspectors among the two agencies. Three NPRA GLP inspectors, Ms. Poh Wen Tsin, Ms. Fadhilah Hasbullah and, Ms. Nur Amani Shaari attended the capacity building visit. Among activities performed during the visit include observing TFDA on-site GLP inspection, and experience exchange and technical discussion meeting with TFDA

Pegawai NPRA bersama pegawai TFDA di Taipei, TaiwanNPRA officers along with TFDA officers in Taipei, Taiwan


Salah satu fungsi utama NPRA adalah untuk memastikan produk farmaseutikal, suplemen kesihatan, dan produk tradisional yang dipasarkan dalam negara adalah selamat dan berkualiti untuk para pengguna. NPRA juga turut memainkan peranan penting dalam industri kosmetik negara memandangkan kesemua produk kosmetik yang dipasarkan perlu dinotifikasi dengan pihak NPRA bagi memastikan keselamatan para pengguna terjamin.

Justeru, pihak NPRA sedia cakna akan tanggungjawab yang perlu digalas dalam memupuk kesedaran dalam kalangan pengguna akan kepentingan aktiviti kawalan regulatori ke atas produk farmaseutikal, suplemen kesihatan, produk tradisional, dan juga produk kosmetik. Seiring dengan perkembangan dan kemajuan dunia digital seantero dunia, NPRA yakin bahawa penglibatan menerusi platform digital dan atas talian akan dapat memudahkan lagi aktiviti penyebaran maklumat dijalankan.

NPRA telah menerbitkan beberapa bahan rujukan dan risalah bagi menyampaikan maklumat-maklumat relevan yang terkini kepada pihak-pihak berkepentingan dan juga para pengguna yang kesemuanya boleh diakses di bawah topik “Maklumat” dan “Newsletters” di laman sesawang rasmi NPRA. Penerbitan – penerbitan ini termasuklah, risalah Berita Ubat-ubatan (BUU) dan buletin MADRAC serta eBrochures yang sangat informatif yang baru diperkenalkan sejak 2019. eBrochures ini menyentuh topik seperti fungsi utama NPRA, asas pendaftaran produk, dan juga beberapa isu hangat semasa seperti vaksin dan produk kosmetik. Kini, maklumat seperti ini dapat diakses dengan mudah oleh pelbagai lapisan masyarakat dari serata pelusuk negara pada bila-bila masa.

Maklumat dalam eBrochures akan dikemaskini mengikut keperluan dari masa ke masa, dengan harapan naskhah-naskhah ini yang padat dengan informasi dan maklumat dapat menarik minat masyarakat untuk lebih cakna berkenaan aktiviti regulatori produk farmaseutikal, suplemen kesihatan, produk tradisional, dan kosmetik dalam negara.

Sepanjang tahun 2019, sebanyak dua edisi BUU, dua edisi buletin MADRAC dan enam e-brosur telah diterbitkan.

Untuk maklumat berkaitan isu-isu keselamatan berkaitan penggunaan ubat-ubatan pula, pengguna boleh merujuk kategori “Ahli Professional Kesihatan” dan rujuk di bawah topik “Amaran Keselamatan”.


One of NPRA’s key roles is to ensure that all pharmaceutical products, health supplements, and traditional products available in the country are safe for the consumers and are of good quality. NPRA also plays an important role in the cosmetic industry as all cosmetic products intended for the local market are required to be notified with NPRA for the safety of the consumers.

Consequently, we understand that it is also part of our duty to raise a more profound awareness among the public on the importance and nature of regulatory control on pharmaceutical, health supplements, traditional products, and cosmetics. With the world moving and evolving fast into an enormous digital, online community, it is only wise that we join the crowd, reach out to a broader audience, and benefit from technology.

NPRA has published several reference materials and newsletters to disseminate relevant and updated information to consumers as well as its stakeholders. These materials can be accessed by clicking the “Newsletter” tab under the “Information” tab on NPRA official website. These include the DCA newsletter known as Berita Ubat-ubatan (BUU) and MADRAC Bulletin as well as the newly introduced informative e-brochure which started in 2019.

eBrochures contains a description and overview of our general roles and functions, basic product registration information, and issues related to current hot topics such as vaccines and cosmetic products. People from all walks of life across the country can now have access to this information, just at the click of a button.

Information on the eBrochures will be regularly updated and revised as necessary, in the hope that these concise packs of information, bundled in a variety of eye-catching designs could help engage and interest the public, to get to know more about regulatory control on pharmaceutical, health supplements, traditional products, and cosmetics in Malaysia.

Throughout 2019, a total of two editions of BUU, two editions of MADRAC Bulletin and six e-brochures were published.

For information on security issues related to the use of medicines, consumers may refer to the “Health Professionals” tab and refer to the “Safety Alerts” topic.

Berita Ubat-ubatan | Berita Ubat-ubatan (BUU) Buletin MADRAC | MADRAC Bulletin


PHARMACY BOARD MALAYSIA DIVISION

BAHAGIAN LEMBAGA FARMASI MALAYSIA

PHARMACY BOARD MALAYSIA DIVISIONBAHAGIAN LEMBAGA FARMASI MALAYSIA


Bahagian Lembaga Farmasi Malaysia (BLFM) berperanan untuk memastikan bahawa pendaftaran ahli farmasi dan pertubuhan perbadanan memenuhi keperluan Akta Pendaftaran Ahli Farmasi 1951 dan Peraturannya. Dalam memastikan standard bagi pendidikan, latihan dan etika ahli farmasi dipatuhi, BLFM juga bertindak sebagai sekretariat kepada Lembaga Farmasi Malaysia yang ditubuhkan mengikut peruntukan di bawah Akta Pendaftaran Ahli Farmasi 1951.

Pharmacy Board Malaysia Division (PBMD) has a role to ensure registration of pharmacists and bodies corporate is in accordance to the Registration of Pharmacists Act 1951 and its regulations. In ensuring that the standard for education, training and ethics for pharmacists are met, PBMD functions as a secretariat for Pharmacy Board Malaysia which was established under the Registration of Pharmacists Act 1951.



Terdapat dua (2) buah Cawangan di bawah BLFM iaitu Cawangan Pendaftaran dan Cawangan Pengiktirafan & Etika. Fungsi dan peranan kedua-dua Cawangan ini ialah seperti berikut:

There are two (2) branches under the PBMD, namely Registration Branch and Recognition & Ethics Branch. The functions and activities of both divisions are as below:

CAWANGAN PENDAFTARANREGISTRATION BRANCH

Pendaftaran AhliFarmasiRegistration ofPharmacist

Pengeluaran SijilTahunanIssuance of AnnualCertificate

Peperiksaan KelayakanMengamal Farmasi

Qualifying Examination ToPractice As A Pharmacist

Meluluskan PremisLatihan PRP

Approval of PRPTraining Premise

Audit Premis Latihan PRPAudit of PRP Training Premise

LEMBAGA FARMASI MALAYSIA

Pengiktirafan Ijazah FarmasiRecognition of PharmacyDegree

Siasatan Salah LakuEtika

Ethical and MisconductInvestigation

Pelaporan StatistikStatistical Reports

MoA Latihan SangkutanPelajar

MoA For StudentAttachment

Urusetia MesyuaratLFMSecretariat of PBMMeeting

Pematuhan danPemantauan GarispanduanRevision And ComplianceTo The Standards

LEMBAGA FARMASI MALAYSIA

CAWANGAN PENGIKTIRAFAN & ETIKARECOGNITION & ETHICS BRANCH


Lembaga Farmasi Malaysia (LFM) telah ditubuhkan di bawah peruntukan Seksyen 3, Akta Pendaftaran Ahli Farmasi (APAF) 1951. Keanggotaan LFM adalah seperti berikut:

BLFM yang berperanan sebagai sekretariat kepada LFM bertindak menguruskan semua perkara berkaitan mesyuarat LFM dan menjalankan tugas berkaitan LFM seperti dinyatakan dalam Akta Pendaftaran Ahli Farmasi 1951.

Pharmacy Board of Malaysia (PBM) is established in accordance with the provisions of Section 3, Registration of Pharmacists Act (ROPA) 1951. Members of PBM is as followed:

PBMD has a role as a secretariat to the PBM and is responsible to organize all meetings pertaining to PBM and conduct relevant tasks as specified under the Act.

Ketua Pengarah Kesihatan Malaysia (ex-officio)Director General of Health (ex-officio)

YBhg. Datuk Dr. Noor Hisham Bin Abdullah

Pengarah Kanan Perkhidmatan Farmasi (ex-officio)Senior Director of Pharmaceutical Services (ex-officio)

YBrs. Dr. Ramli Bin Zainal

Lapan (8) orang Ahli Farmasi Berdaftar dariSektor Perkhidmatan Awam

Eight (8) Registered Pharmacists in the Public Service

Encik Tan Ann LingYBrs. Dr. Hasenah Binti Ali

YBrs. Dr. Roshayati Binti Mohamad SaniEncik Leong Weng Choy

Puan Zubaidah Binti Che’ EmbeeEncik Abu Hassan Alashaari Bin Abd. Jabar

YBhg. Brig. Jeneral Dato’ Dr. A Halim Bin Hj BasariPuan Che Zuraini Binti Sulaiman

Tiga (3) orang Ahli Farmasi Berdaftar dariInstitusi Pengajian Tinggi (IPT) yang menawarkan

Program Ijazah FarmasiThree (3) registered pharmacists from any higher

educational institution offering a course orprogramme in pharmacy

YBhg. Prof. Dato’ Dr. Abu Bakar Bin Abd. MajeedYBhg. Prof. Dr. Habibah A Wahab

YBhg. Prof. Madya Dr. Mohd Zulkefeli Bin Mat Jusoh

Dua (2) orang Ahli Farmasi Berdaftar BUKAN darisektor perkhidmatan awam

Two (2) registered pharmacists not in the public service

Encik Amrahi Bin BuangEncik Ewe Kheng HuatEncik Wong Sie Sing

Tiga (3) orang Ahli Farmasi Berdaftar BUKAN darisektor perkhidmatan awam yang dicalonkan

oleh persatuan-persatuanThree (3) Registered Pharmacist NOT in the Public

Service, nominated by the associationrepresenting Pharmacists

Puan Parakkal Sumita a/p C KochukKrishnanPuan Sharifah Fauziyah Binti Syed Mohthar

Ketua Pengarah Kesihatan Malaysia (ex-officio)Director General of Health (ex-officio)

YBhg. Datuk Dr. Noor Hisham Bin Abdullah

Pengarah Kanan Perkhidmatan Farmasi (ex-officio)Senior Director of Pharmaceutical Services (ex-officio)

YBrs. Dr. Ramli Bin Zainal

Lapan (8) orang Ahli Farmasi Berdaftar dariSektor Perkhidmatan Awam

Eight (8) Registered Pharmacists in the Public Service

Encik Tan Ann LingYBrs. Dr. Hasenah Binti Ali

YBrs. Dr. Roshayati Binti Mohamad SaniEncik Leong Weng Choy

Puan Zubaidah Binti Che’ EmbeeEncik Abu Hassan Alashaari Bin Abd. Jabar

YBhg. Brig. Jeneral Dato’ Dr. A Halim Bin Hj BasariPuan Che Zuraini Binti Sulaiman

Tiga (3) orang Ahli Farmasi Berdaftar dariInstitusi Pengajian Tinggi (IPT) yang menawarkan

Program Ijazah FarmasiThree (3) registered pharmacists from any higher

educational institution offering a course orprogramme in pharmacy

YBhg. Prof. Dato’ Dr. Abu Bakar Bin Abd. MajeedYBhg. Prof. Dr. Habibah A Wahab

YBhg. Prof. Madya Dr. Mohd Zulkefeli Bin Mat Jusoh

Dua (2) orang Ahli Farmasi Berdaftar BUKAN darisektor perkhidmatan awam

Two (2) registered pharmacists not in the public service

Encik Amrahi Bin BuangEncik Ewe Kheng HuatEncik Wong Sie Sing

Tiga (3) orang Ahli Farmasi Berdaftar BUKAN darisektor perkhidmatan awam yang dicalonkan

oleh persatuan-persatuanThree (3) Registered Pharmacist NOT in the Public

Service, nominated by the associationrepresenting Pharmacists

Puan Parakkal Sumita a/p C KochukKrishnanPuan Sharifah Fauziyah Binti Syed Mohthar


PENDAFTARAN AHLI FARMASI DAN PERTUBUHAN PERBADANAN TAHUN 2019

REGISTRATION OF PHARMACISTS AND BODIES

CORPORATE IN 2019

1,647

1 : 1,858

18,968

1,947

15,348 8

Jumlah Kumulatif Ahli Farmasi Berdaftar (sejak 1951)Cumulative number of registeredpharmacists (since 1951)

Jumlah Ahli Farmasi Berdaftar Sementara 2019Number of TemporaryRegistered Pharmacists in 2019

Jumlah Kumulatif Pertubuhan Perbadanan (sejak 1951)Cumulative number of registered

* Nisbah berdasarkan populasi penduduk Malaysia seramai 32.6 juta orang*The ratio is based on 32.6M population of Malaysia

bodies corporates (since 1951)Nisbah Ahli Farmasi kepada populasi*

Ratio of pharmacists topopulation*

Jumlah Ahli Farmasi Provisional 2019

Number of ProvisionallyRegistered Pharmacists in 2019

Jumlah Ahli Farmasi Memegang Sijil Tahunan 2019

Number of Pharmacists with 2019Annual Certificate

1,192Jumlah Pertubuhan Perbadanan

Memegang Sijil Tahunan 2019Number of Bodies Corporate with

Annual Certificate 2019

Rajah 25: Pendaftaran Ahli Farmasi dan Pertubuhan Perbadanan bagi tahun 2019Figure 25: Registration of pharmacists and bodies corporate in 2019

PENGIKTIRAFAN PROGRAM IJAZAH

FARMASIRECOGNITION OF

PHARMACY DEGREE PROGRAMME

21

77

Jumlah Institusi Pengajian Tinggi Dalam NegaraNumber of Local Higher LearningInstitutions

Jumlah Institusi Pengajian Tinggi Luar NegaraNumber of Higher LearningInstitutions from overseas

Rajah 26: Jumlah institusi pengajian tinggi yang menawarkan Program Ijazah Farmasi yang diiktiraf oleh LFMFigure 26: Number of higher learning instituitions having Degree in Pharmacy which are recognised by the PBM



SENARAI IJAZAH FARMASI DIIKTIRAF OLEH LEMBAGA FARMASI MALAYSIALIST OF RECOGNIZED PHARMACY DEGREE BY PHARMACY BOARD OF MALAYSIA

NegaraCountry

Nama InstitusiName of Institution

Nama ProgramProgramme Name

Malaysia

Universiti Sains Malaysia (USM) Sarjana Muda Farmasi (Kepujian)

Universiti Kebangsaan Malaysia (UKM) Sarjana Muda Farmasi (Kepujian)

Universiti Malaya (UM) Sarjana Muda Farmasi (Kepujian)

Universiti Teknologi MARA (UiTM) Sarjana Muda Farmasi (Kepujian)

Universiti Islam Antarabangsa Malaysia (UIAM) Bachelor of Pharmacy (Hons)

International Medical University (IMU) Bachelor of Pharmacy (Hons)

International Medical University (IMU) (twinning with University of Strathclyde) Master of Pharmacy

University of Nottingham Malaysia Campus (UNMC) Master of Pharmacy

AIMST University Bachelor of Pharmacy (Hons)

UCSI University Bachelor of Pharmacy (Hons)

Cyberjaya University College of Medical Sciences (CUCMS) Bachelor of Pharmacy (Hons)

MAHSA University Bachelor of Pharmacy (Hons)

Management & Science University (MSU) Bachelor of Pharmacy (Hons)

Monash University Sunway Campus (MUSC) Bachelor of Pharmacy Bachelor of Pharmacy (Hons)

Segi University Bachelor of Pharmacy (Hons)

Asia Metropolitan University (AMU) Bachelor of Pharmacy (Hons) (Recognised on 10 July 2017)

Lincoln University College Bachelor of Pharmacy (Hons) (Recognised on 1 June 2017)

Taylor’s University Bachelor of Pharmacy (Hons)(Recognised on 7 July 2015)

University Kuala Lumpur – Royal College of Medicine Perak

Bachelor of Pharmacy (Hons)(Recognised on 8 September 2017)

KPJ University College Bachelor of Pharmacy (Hons)(Recognised on 19 July 2017)

QUEST International University Perak (QIUP) Bachelor of Pharmacy (Hons)(Recognised on 8 February 2019)

Arab SaudiSaudi Arabia University of Riyadh / King Saud University Bachelor of Pharmacy

Australia

University of Adelaide Bachelor of Pharmacy

Monash University, Victorian College of Pharmacy Bachelor of Pharmacy

University of Sydney Bachelor of Pharmacy

University of Queensland Bachelor of PharmacyBachelor of Pharmacy (Honours)

The University of South Australia Bachelor of Pharmacy

The University of Tasmania Bachelor of Pharmacy

Curtin University of Technology Bachelor of Pharmacy

KanadaCanada

University of British Columbia Bachelor of Science (Pharmacy)

University of Alberta Bachelor of Science (Pharmacy)

Dalhousie University Bachelor of Science (Pharmacy)


NegaraCountry



United Kingdom

University of Bath Bachelor of Science (Pharmacy), Master of Pharmacy

University of Aston in Birmingham Bachelor of Science (Pharmacy), Master of Pharmacy

University of Bradford Bachelor of Science (Pharmacy), Master of Pharmacy

University of Brighton Bachelor of Science (Pharmacy), Master of Pharmacy

University of Wales’ College of Cardiff Cardiff University

Bachelor of Pharmacy, Master of Pharmacy

De Montfort University Leicester Bachelor of Science (Pharmacy), Master of Pharmacy

Liverpool John Moores University Bachelor of Science (Pharmacy), Master of Pharmacy

University of London· King’s College of London· The School of Pharmacy· Chelsea College

Bachelor of Pharmacy, Master of Pharmacy

University of Manchester Bachelor of Science (Pharmacy), Master of Pharmacy

University of Nottingham Bachelor of Pharmacy, Master of Pharmacy

University of Portsmouth Bachelor of Science (Pharmacy), Master of Pharmacy

University of Sunderland Bachelor of Science (Pharmacy), Master of Pharmacy

University of Strathclyde Bachelor of Science (Pharmacy), Master of Pharmacy

Robert Gordon’s Institute of Technology, Aberdeen Bachelor of Science (Pharmacy), Master of Pharmacy

Heriot-Watt University of Edinburgh Bachelor of Science (Pharmacy), Master of Pharmacy

University of Reading Master of Pharmacy(Recognised on 12 December 2015)

University College London Master of Pharmacy(Recognised on 17 October 2017)

University of East Anglia (UEA)

Master of Pharmacy (MPharm)(Recognised on 1 January 2022)

Master of Pharmacy with Placement (MPharm)(Recognised on 1 January 2023)

Ireland

The Queen`s University of Belfast, Northern Ireland

Bachelor of Science (Pharmacy), Master of Pharmacy

University of Dublin Bachelor of Science (Pharmacy)

Royal College of Surgeons of Ireland (RCSI) Master of Pharmacy (Recognised on 12 December 2015)


NegaraCountry



Indonesia

Bandung Institute of Technology

Sarjana Sains FarmasiSarjana Muda Farmasi (Pharmaceutical Science

and Technology Programme) (Recognised from 17 April 2014 until 31 December 2018)

Sarjana Muda Farmasi (Clinical and Community Pharmacy Programme) (Recognised on 1 January

2018)

Gadjah Mada University Sarjana Sains Farmasi, Sarjana Farmasi

Airlangga Soerabaya UniversitySarjana Sains Farmasi

Sarjana Farmasi (Recognised on 16 April 2018)

Padjadjaran UniversitySarjana Sains Farmasi

Sarjana Farmasi (Recognised on 16 April 2018)

Universiti Sumatera Utara (USU)

Sarjana Muda Farmasi (Pharmaceutical Science and Technology Programme) (Recognised on 30

May 2014) Sarjana Muda Farmasi (Clinical and Community Pharmacy Programme) (Recognised on 30 May

2014)

Iraq University of Baghdad Bachelor of Science (Pharmacy)

JepunJapan

Kyoto University Bachelor of Pharmaceutical Science

Nagoya City University Bachelor of Science (Pharmacy)

Kumamoto University Bachelor of Pharmaceutical Science

Tohuku University Bachelor of Pharmacy

Hokkaido University Bachelor of Pharmacy

Tokyo University of Science Bachelor of Pharmacy

New Zealand University of Otago Bachelor of Pharmacy

MesirEgypt

Cairo University Bachelor of Pharmaceutical Science

Alexandria UniversityBachelor of Pharmaceutical Science

Bachelor of Pharmacy (Clinical Pharmacy) (Recognised on 19 May 2015)

Mansoura UniversityBachelor of Pharmaceutical Science

Bachelor of Pharmacy (Clinical Pharmacy) (Recognised on 19 May 2015)

Zagazig university

Bachelor of Pharmaceutical ScienceBachelor of Pharmaceutical Science (Clinical

Pharmacy) (Recognised on 19 May 2015)Bachelor of Pharmacy (Clinical Pharmacy)

(Recognised on 10 July 2017)

SingapuraSingapore National University of Singapore Bachelor of Science (Pharmacy)

TurkiTurkey

University of Ankara Bachelor of Pharmacy

Hacettepe University Bachelor of Pharmacy

University of Istanbul Bachelor of Pharmacy


NegaraCountry



USA

University of Wisconsin Bachelor of Science (Pharmacy), Doctor of Pharmacy

University of Iowa Bachelor of Science (Pharmacy), Doctor of Pharmacy

University of Kansas Bachelor of Science (Pharmacy), Doctor of Pharmacy

South Western Oklahoma State University Bachelor of Science (Pharmacy), Doctor of Pharmacy

Ohio State University Bachelor of Science (Pharmacy), Doctor of Pharmacy

Massachusetts College of Pharmacy and Allied Health Sciences

Bachelor of Science (Pharmacy), Doctor of Pharmacy

Northeast Lousiana University / University of Lousiana

Bachelor of Science (Pharmacy), Doctor of Pharmacy

Medical University of South Carolina Bachelor of Science (Pharmacy), Doctor of Pharmacy

Idaho State University Doctor of Pharmacy

University of Toledo Bachelor of Pharmacy, Doctor of Pharmacy

Butler University, Indiana Bachelor of Pharmacy, Doctor of Pharmacy

University of North Carolina Doctor of Pharmacy

IndiaBanaras Hindu University Bachelor of Pharmacy

Nagpur University Bachelor of Pharmacy

Pakistan Punjab University, Lahore / University of the Punjab Allama Iqbal Campus

Bachelor of Pharmacy, Doctor of Pharmacy

Taiwan

National Taiwan University Bachelor of Science (Pharmacy) (before 4th July 1997, excluded from recognition)

Kaohsiung Medical College / Kaohsiung Medical University

Bachelor of Science (Pharmacy) (before 30th November 1998, excluded from

recognition)

Taipei Medical College / Taipei Medical University

Bachelor of Science (Pharmacy) (before 4th November 1999, excluded from

recognition)

United Arab Emirates Gulf Medical University Doctor of Pharmacy (Hons)

Jadual 31: Senarai ijazah farmasi yag diiktiraf oleh LFMTable 31: List of recognized pharmacy degree by the PBM


Hospital dan Institusi KKMHospital and

Instituition underthe MOH

124Klinik Kesihatan

AwamPublic Health

Clinic

181Hospital Awam(Bukan KKM)

Public Hospital(Non-MOH)

7

Farmasi KomunitiCommunity Pharmacy

624Private HospitalHospital Swasta

35R&D Akademia

9

Industri Farmaseutikal(Mengilang)

Pharmaceutical Industry

(Manufacturing)

20Industri Farmaseutikal

(Tidak Mengilang)Pharmaceutical

Industry(Non-Manufacturing)

26

Rajah 27: Bilangan premis latihan bagi Ahli Farmasi Provisional (PRP)Figure 27: Number of training premises for Provisionally Registered Pharmacist (PRP)


BENGKEL PENGENDALIAN BUKU LOG PRP KKMBengkel Pengendalian buku log KKM telah diadakan sebanyak enam (6) sesi mengikut zon iaitu Zon Tengah, Zon Utara, Zon Selatan, Zon Sabah & Wilayah Persekutuan Labuan, Zon Pantai Timur dan Zon Sarwak. Objektif bengkel ini adalah seperti berikut:

i. Mengukuhkan kefahaman preseptor di dalam mengendalikan latihan Ahli Farmasi Provisional (PRP) bagi setiap modul latihan buku log di fasiliti hospital Kementerian Kesihatan Malaysia (KKM) dan Klinik Kesihatan.

ii. Memberi panduan dan pendedahan mengenai penyeragaman pemberian markah penilaian buku log di kalangan preseptor PRP KKM.


PRP LOG BOOK MANAGEMENT WORKSHOPThese workshops have been conducted in six (6) different zones; the Federal Territory of Kuala Lumpur and Selangor zone, northern zone, southern zone, Sabah and the Federal Territory of Labuan zone, east coast zone and Sarawak zone. The objectives of this workshop are:

i. Reinforces the preceptors’ understanding in conducting the training for Provisionally Registered Pharmacist (PRP) at the Ministry of Health (MOH) training facilities; hospitals and health clinics.

ii. To provide guidance and exposure on the standardisation of PRP log book appraisal among preceptors.

Bil. No.

TarikhDate

TempatVenue

1 18 hingga 19 Februari 2019 Zon Tengah | Federal Territory of Kuala Lumpur and Selangor Zone: Hotel Empress, Sepang

2 20 hingga 21 Februari 2019 Zon Utara | Northern ZoneHotel Jerai, Alor Setar

3 27 hingga 28 Februari 2019 Zon Selatan | Southern Zone Hotel MITC, Ayer Keroh, Melaka

4 13 hingga 14 Mac 2019Zon Sabah dan Wilayah Persekutuan Labuan | Sabah and the Federal Territory of Labuan Zone Hotel Klagan, Kota Kinabalu, Sabah

5 19 hingga 20 Mac 2019 Zon Pantai Timur | East Coast Zone Hotel Crown Garden, Kota Bharu, Kelantan

6 21 hingga 22 Mac 2019 Zon Sarawak | Sarawak Zone Hotel Harbour View, Kuching, Sarawak

Jadual 32: Bengkel Pengendalian Buku Log PRP KkmTable 32: PRP Logbook Management Workshop

Bengkel Pengendalian Buku Log PRP KKM – Zon Pantai Timur

PRP Logbook Management Workshop – East Coast Zone

Bengkel Pengendalian Buku Log PRP KKM – Zon SarawakPRP Logbook Management Workshop – Sarawak Zone


BENGKEL QUALIFYING EXAMBengkel Qualifying Exam telah diadakan pada 23 Julai 2019 di Dewan Serai Wangi, Bahagian Regulatori Farmasi Negara. Objektif bengkel ini adalah untuk membincangkan dan mendapatkan input-input berkenaan kesesuaian pelaksanaan Qualifying Exam. Antara wakil-wakil yang telah menghadiri bengkel ini ialah daripada:

i. Cawangan Penjagaan Farmaseutikal, Bahagian Amalan dan Perkembangan Farmasi

ii. Cawangan Perundangan, Bahagian Penguatkuasaan Farmasi

iii. Bahagian Regulatori Farmasi Negara

iv. Bahagian Perkembangan Kesihatan Awam

v. Agensi Kelayakan Malaysia (MQA)

vi. Institusi Pengajian Awam (IPTA)

vii. Institusi Pengajian Swasta (IPTS)

viii. Malaysian Pharmaceutical Society (MPS)

ix. Malaysian Academy of Pharmacy

x. Malaysian Community Pharmacy Guild (MCPG)

xi. Pharmaceutical Association of Malaysia (PhAMA)

xii. Malaysian Organisation of Pharmaceutical Industries (MOPI)

Bahagian LFM juga telah menjemput wakil dari Malaysian Medical Council (MMC) iaitu Dr. Arulalan Tan Sri Kumaran untuk berkongsi pengalaman mengenai pelaksanaan Examination for Provisional Registration dan cadangan untuk melaksanakan Common Licensing Examination untuk graduan bidang perubatan.

QUALIFYING EXAM WORKSHOPQualifying Exam Workshop has been held on the 23 of July 2019 in Dewan Serai Wangi, National Pharmaceutical Regulatory Agency. The objective of this workshop was to gain some insights on the feasibility of implementing the Qualifying Exam for Pharmacy graduates. Representatives who have attended this workshop were from:

i. Pharmaceutical Care Branch, Pharmacy Practice & Development Division

ii. Legislation Branch, Pharmacy Enforcement Division

iii. National Pharmaceutical Regulatory Agency

iv. Public Health Development Division

v. Malaysian Qualifications Agency (MQA)

vi. Public Institution of Higher Learning

vii. Private Institution of Higher Learning

viii. Malaysian Pharmaceutical Society (MPS)

ix. Malaysian Academy of Pharmacy

x. Malaysian Community Pharmacy Guild (MCPG)

xi. Pharmaceutical Association of Malaysia (PhAMA)

xii. Malaysian Organisation of Pharmaceutical Industries (MOPI)

Pharmacy Board of Malaysia has also invited a speaker from the Malaysian Medical Council (MMC), Dr. Arulalan Tan Sri Kumaran, who have been sharing their experience in implementing the Examination for Provisional Registration and the way forward; to implement the Common Licensing Examination for medical graduates.

Bengkel Qualifying Exam

Qualifying Exam Workshop


TUTORIAL PEPERIKSAAN KELAYAKAN UNTUK MENGAMAL FARMASI LFM telah mengadakan tiga sesi tutorial sepanjang tahun 2019 untuk calon-calon Peperiksaan Kelayakan Untuk Mengamal Farmasi (PKUMF). Tujuan tutorial ini diadakan adalah untuk memberi tunjuk ajar dan panduan kepada calon-calon PKUMF.

TUTORIAL FOR QUALIFYING EXAMINATION TO PRACTICE PHARMACYPharmacy Board of Malaysia has held three tutorial sessions throughout the year of 2019 for the Qualifying Examination to Practice Pharmacy candidates. The purpose of this tutorial is to provide some guidance and enlightments for the exam candidates.

Bil. No.

TarikhDate

TempatVenue

1 11 Februari 2019 Tutorial PKUMF Sesi 1 | Tutorial for Qualifying Examination to Practice Pharmacy Session 1 Dewan Serai Wangi, Bahagian Regulatori Farmasi Negara

2 17 Jun 2019 Tutorial PKUMF Sesi 2 | Tutorial for Qualifying Examination to Practice Pharmacy Session 2 Dewan Serai Wangi, Bahagian Regulatori Farmasi Negara

3 16 Oktober 2019 Tutorial PKUMF Sesi 3 | Tutorial for Qualifying Examination to Practice Pharmacy Session 3 Dewan Serai Wangi, Bahagian Regulatori Farmasi Negara

Jadual 33: Sesi Tutorial Peperiksaan Kelayakan Untuk Mengamal FarmasiTable 33: Qualifying Examination To Practice Pharmacy Tutorial Sessions

BENGKEL ‘TRAINING OF PRECEPTORS’ KEPADA ‘PRINCIPAL PRECEPTOR’ DAN ‘MASTER PRECEPTOR’ BAGI LATIHAN LIBERALISASI AHLI FARMASI PROVISIONAL (PRP) 2018 Bengkel “Training of Preceptors” telah diadakan sebanyak dua (2) kali di Dewan Serai Wangi, Bahagian Regulatori Farmasi Negara seperti di Jadual 34. Objektif bengkel ini adalah untuk:

i. Memberi panduan dan latihan kepada ‘Principal’ dan ‘Master Preceptor’ yang akan membimbing latihan PRP di fasiliti latihan liberalisasi, iaitu di farmasi komuniti, hospital swasta, industri farmaseutikal mengilang, industri farmaseutikal tidak mengilang dan R&D Akademia.

ii. Memberi penerangan dan latihan secara terperinci tentang penggunaan dan pengisian buku log latihan PRP di sektor terbabit.

“TRAINING OF PERCEPTORS” WORKSHOP FOR PRINCIPAL AND MASTER PRECEPTORS FOR LIBERALISATION OF PROVISIONALLY REGISTERED PHARMACIST (PRP) TRAINING 2018This workshop was held two (2) times at Dewan Serai Wangi, National Pharmaceutical Regulatory Agency as stated in Table 34. The objectives of this workshop are:

i. To provide guidance and training to the Principal and Master preceptors from liberalised training facilities i.e community pharmacies, private hospitals, the pharmaceutical industry (manufacturing), pharmaceutical industry (not-manufacturing) and R&D Academia.

ii. To provide detailed information and training for the usage and filling in of the training logbooks in the relevant sector.

Bil. No.

TarikhDate

TempatVenue

1 31 Julai 2019 Dewan Serai Wangi, Bahagian Regulatori Farmasi Negara

2 1 Ogos 2019 Dewan Serai Wangi, Bahagian Regulatori Farmasi Negara

Jadual 34: Bengkel ‘Training Of Preceptors’ Kepada ‘Principal Preceptor’ Dan ‘Master Preceptor’ Liberalisasi Latihan Ahli Farmasi Provisional (PRP) 2018

Table 34: “Training Of Perceptors” Workshop For Principal And Master Preceptors Liberalisation Of Provisionally Registered Pharmacist (PRP) Training 2018


TAKLIMAT BERKENAAN TATACARA PENYIASATAN YANG BERKESAN DI BAWAH PERATURAN-PERATURAN PENDAFTARAN AHLI FARMASI 2004Taklimat berkenaan tatacara penyiasatan yang berkesan di bawah Peraturan-Peraturan Pendaftaran Ahli Farmasi 2004 telah diadakan pada 12 September 2019. Ia telah dihadiri oleh 23 orang Ahli Farmasi yang merupakan Ahli-ahli Jawatankuasa Siasatan yang telah dilantik oleh Lembaga Farmasi Malaysia. Sesi taklimat telah disampaikan oleh wakil daripada Cawangan Perundangan, Bahagian Penguatkuasaan Farmasi. Tujuan taklimat ini diadakan adalah bagi menambahbaik prosedur penyiasatan dan membantu Ahli-Ahli Jawatankuasa Siasatan untuk menjalankan penyiasatan dengan berkesan, tepat, adil serta dapat menyediakan laporan siasatan yang lengkap.

EFFECTIVE INVESTIGATING PROCEDURE UNDER THE REGISTRATION OF PHARMACISTS REGULATIONS 2004 TALK SESSIONA talk on Effective Investigating Procedure under the Registration of Pharmacists Regulations 2004 was held on 12 September 2019. 23 participants who are members of the Comittee of Inquiry attended the session. The talk was conducted by an officer from the Pharmacy Enforcement Divison, Ministry of Health. The objectives of the session were to help the committee in improving their investigating skills and to help them to produce a complete investigation report.

Para Peserta Taklimat Tatacara Penyiasatan Yang Berkesan Di Bawah Peraturan-Peraturan Pendaftaran Ahli

Farmasi 2004Partipants Of The Effective Investigating Procedure Under

The Registration Of Pharmacists Regulations 2004 Talk Session

KURSUS PEMBINAAN PASUKANBahagian Lembaga Farmasi Malaysia telah mengadakan kursus Pembinaan Pasukan kepada semua kakitangan yang telah diadakan pada 11 hingga 13 Oktober 2019 di Bentong, Pahang. Kursus selama tiga (3) hari ini bertujuan mengukuhkan semangat kerjasama di kalangan kakitangan di samping memberi motivasi untuk berkerja dengan lebih cekap dan memberi perkhidmatan terbaik kepada pelanggan.

TEAMBUILDING COURSE Pharmacy Board Malaysia Divison conducted a team building course on 11 to 13 October 2019 at Bentong, Pahang. The three (3) days course was organized in order to strenghthened the team spirit among the staff and to motivate them in becoming a high performance team towards better services to the nation.

Para Peserta Kursus Pembinaan PasukanPartipants of Teambuilding Course

BENGKEL PEMURNIAN STANDARD KELULUSAN DAN PENGIKTIRAFAN PROGRAM DIPLOMA FARMASI, LEMBAGA FARMASI MALAYSIA 2019Objektif bengkel ini adalah untuk menyemak, mengemaskini dan memuktamadkan Standard Kelulusan Dan Pengiktirafan Program Ijazah dan Diploma Farmasi. Bengkel ini telah diadakan bermula dari 14 sehingga 16 Ogos 2019 di Dewan Serai Wangi, Bahagian Regulatori Farmasi Negara (BRFN) dan melibatkan seramai 30 orang perserta.

WORKSHOP ON REVISION OF THE STANDARDS ON APPROVAL AND RECOGNITION OF PHARMACY DIPLOMA PROGRAMME, PHARMACY BOARD OF MALAYSIA 2019The objective of the workshop was to revise and finalize the Standards on Approval and Recognition of Pharmacy Diploma Programme. This workshop was held from 14th-16th August 2019 at Dewan Serai Wangi, National Pharmaceutical Regulatory Agency (NPRA). A total number of 30 participants attended this workshop.


LATIHAN SANGKUTAN UNTUK MEMPELAJARI PROGRAM LATIHAN SISWAZAH BAGI GRADUAN FARMASI DI AUSTRALIA 2019Tujuan utama LFM menghantar seorang delegasi ke Australia pada 8 Mei 2019 sehingga 17 Mei 2019 adalah bagi mempelajari aspek-aspek seperti berikut agar penambahbaikan yang bersesuaian dapat dilaksanakan terhadap program latihan provisional di Malaysia.

a) Peranan Australian Pharmacy Council (APC) dalam mengakreditasi program latihan siswazah yang disediakan oleh pihak-pihak yang berkepentingan (penyedia latihan siswazah (Inter Training Provider (ITP)) seperti Pharmacy Guild of Australia (PGA), Pharmaceutical Society of Australia (PSA) dan National Alliance for Pharmacy Education (NAPE) untuk memastikan kualiti latihan adalah di tahap antarabangsa

b) Cara-cara penyedia latihan siswazah (ITPs) seperti PSA, PGA dan NAPSA dalam merangka modul latihan siswazah bagi memastikan kompetensi ahli farmasi adalah selaras dengan National Competency Standards Framework For Pharmacist in Australia 2016 yang menerangkan kemahiran pengamal, sikap dan sifat-sifat pengamal (e.g. nilai dan kepercayaan) berdasarkan pengetahuan yang diperolehi melalui cara pembelajaran dan juga pengalaman adalah memadai untuk mengamal sebagai ahli farmasi yang kompeten.

c) Peranan Australian Health Practitioner Regulatory Agency (AHPRA) dalam menetapkan syarat-syarat latihan siswazah terutamanya tempoh latihan, komponen latihan, peperiksaaan, kelayakan preseptor dan premis dan perekodan latihan siswazah yang perlu dipatuhi oleh ahli farmasi yang sedang menjalani latihan siswazah untuk didaftarkan sebagai Ahli Farmasi Berdaftar Penuh (registered pharmacist)

d) Cara APC mengendali peperiksaan menulis yang wajib perlu diduduki oleh graduan farmasi semasa menjalani latihan siswazah

e) Cara AHPRA mengendali peperiksaan oral yang di penguhujung latihan siswazah

SHORT COURSE TRAINING ON INTERN PROGRAM FOR PHARMACY GRADUATE IN AUSTRALIA 2019The main intention of PBM to send a delegate to Australia on 8th May 2019 till 17 May 2019 is to learn aspects mentioned below and to do necessasry and suitable improvemnet on the intern Training Program in Malaysia

a) The role of Australian Pharmacy Council (APC) in accrediting the intern training programme and the intern training providers (ITPs) such as Pharmacy Guild of Australia (PGA), Pharmaceutical Society of Australia (PSA) dan National Alliance for Pharmacy Education (NAPE) as to ensure the quality of training is always in par with international standards.

b) The methods used by the ITPs such as PSA, PGA and NAPSA in designing the training module as to ensure the competency of a pharmacist is in accordance to the National Competency Standards Framework For Pharmacist in Australia 2016 which describes the individual practitioner’s skills, attitudes and attributes (e.g. values and beliefs) based on knowledge (gained through study) and experience (gained through practice) that can be considered to be sufficient to enable an individual to practice as a competent registered pharmacist

c) The role of Australian Health Practitioner Regulatory Agency (AHPRA) in setting requirement for an intern to fulfill in order to complete an approved intern training program such as duration of training, training components, registration examinations, preceptor qualification, training site qualification and record keeping for supervised practice hours in order to be registered as registered pharmacist

d) Methods used by APC to conduct written examination which is a compulsory examinatipn for an intern to attempt while undergoing the intern training program

e) Methods of AHPRA conducting the oral examination towards the end of intern training program

Puan Datcayani A/P Ramadoo Dari BLFM (Keempat dari Kiri) Bersama-Sama Cik Glenys Wilkonson (Ketiga dari Kanan, Barisan Hadapan) Pengarah Eksekutif, Majlis Farmasi Australia

Madam Datcayani A/P Ramadoo From PBMD (Fourth from Left) With Miss Glenys Wilkonson (Third from Right; Front Row) Executive Director, Australian Pharmacy Council


STANDARDS ON APPROVAL AND RECOGNITION OF PHARMACY PROGRAMME, 2018Standards on Approval and Recognition of Pharmacy Programme 2018 oleh Lembaga Farmasi Malaysia (LFM) menyenaraikan standard yang perlu dipatuhi oleh Pemberi Pendidikan Tinggi (PPT) yang menawarkan program ijazah farmasi bagi menghasilkan graduan ahli farmasi yang kompeten dan berkualiti. Tarikh berkuatkuasa Standards on Approval and Recognition of Pharmacy Programme 2018 ini adalah pada 1 April 2019. Penggunaan format baharu Standards on Approval and Recognition of Pharmacy Programme 2018 bagi penghantaran dokumen permohonan penilaian pengiktirafan (baru atau pembaharuan) oleh PPT adalah pada 1 Januari 2020.


STANDARDS ON APPROVAL AND RECOGNITION OF PHARMACY PROGRAMME, 2018The Standards on Approval and Recognition of Pharmacy Program 2018 by the Pharmacy Board Malaysia (PBM) lists the standards that Higher Education Providers (HEPs) must meet in order to deliver quality education for producing competent and quality pharmacists. The effective date of this standard is on 1 April 2019. The adoption of the new format for submission of the accreditation documents (new or renewal) by the HEPs is on 1 January 2020.


CATATAN


03-7841 3200

www.pharmacy.gov.my

Program PerkhidmatanFarmasi KKM

Program Perkhidmatan FarmasiKEMENTERIAN KESIHATAN MALAYSIA

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www.pharmacy.gov.my

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