194

APPENDICES

195

APPENDIX A

The ADR report form

by Thai Food and Drug Administration

196

197

APPENDIX B

Flowchart of the operating system in ADR Monitoring

198

Flowchart of the operating system in ADR Monitoring

ADR detected by a ADR detected by ADR detected by Pharmacist in the ward health professionals patients themselves A pharmacist in-charge A pharmacist incharge at At ADRM center detects ADRM ADRMC monitors the ADRs The ADR by using Center particularly among the patient Alerting order who are in high risk or have Been using the high risk drugs Collect completely All the relevant data Perform data analysis Perform causality assessment which Determines the association between Suspected ADR and suspected drug Record in patient Complete the spontaneous Provide counseling and Medical record report form ADR card to the patient Send the report to Summarize the data and Send the report to The Thai FDA file the reports the network center Disseminate the information through

• Case report • Bulletins, newsletters

ADR = Adverse Drug Reaction ADRM = Adverse Drug Reaction Monitoring Alerting orders = the doctor’s order which could be related to ADR or

drug prescribed for treating ADR

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APPENDIX C

Naranjo’s Algorithm

200

Naranjo’s Algorithm. (Naranjo et al., 1981).

Questions Yes No Do not know

Score

Are there previous conclusive reports on this reaction?

+1 0 0

Did the adverse event appear after the suspected drug was administered?

+2 -1 0

Did the adverse reaction improve when the drug was discontinued or a specific antagonist was administered

+1 0 0

Did the adverse reaction reappear when the drug was readministered?

+2 -1 0

Are there alternative causes (other than the drug) that could on their own have caused the reaction?

-1 +2 0

Did the reaction reappear when a placebo was given?

-1 +1 0

Was the drug detected in the blood (or other fluid) in concentration known to be toxic?

+1 0 0

Was the reaction more severe when the dose was increased, or less severe when the dose was decreased?

+1 0 0

Did the patient have a similar reaction to the same or similar drugs in any previous exposure?

+1 0 0

Was the adverse event confirmed by any objective evidence?

+1 0 0

Total

201

APPENDIX D

The Incidence of ADRS in Hospitalized Patients :

A Prospective Observational Study in

21 Selected Thai Hospitals Project.

202

203

204

205

206

207

208

209

210

211

212

213

214

215

216

217

218

219

220

221

222

223

224

225

226

227

APPENDIX E

Drug classes and sub-classes (MIMS Classification)

causing Adverse Drug Reactions

228

Drug classes and Sub-classes responsible for ADRs.

1. Gastrointestinal & Hepatobiliary System a. Antacids & Antiulcerants b. GIT Regulators, Antiflatulents & Anti-inflammatories c. Antispasmodics d. Antidiarrheals e. Laxatives, Purgatives f. Digestives g. Cholagogues, Cholelitholytics & Hepatic Protectors h. Anorectal Preparations 2. Cardiovascular & Hematopoietic System a. Cardiac Drugs b. Anti-Anginal Drugs c. ACE Inhibitors d. Beta-Blockers e.Calcium Antagonists f. Angiotensin II Antagonists g. Other Antihypertensives h. Diuretics i. Antidiuretics j. Peripheral Vasodilators & Cerebral Activators k. Vasoconstrictors l. Antimigranine Preparations m. Haemostatics n. Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics) p. Phlebitis & Varicose Preparations q. Haemorrheologicals r. Haematopoietic Agents s. Other Cardiovascular Drugs 3. Respiratory System a. Respiratory Stimulants b. Antiasthmatic & COPD Preparations c. Cough & Cold Remedies d. Decongestants & Other Nasal Preparations e. Other Drugs Acting on Respiratory System 4. Neuromuscular System a. Anti-inflammatory Enzymes b. Analgesics & Antipyretics c. Antirheumatic, Anti-inflammatory Analgesics d. Gout Preparations e. Anxiolytics f. Antipsychotics g. Hypnotics & Sedatives h. Anticonvulsants i. Antidepressants

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j. CNS Stimulants & Agents for ADHD k. Nootropics & Neurotonics l. Antiemetics & Antivertigo Drugs m. Neurodegenerative Disease Drugs n. Antiparkinsonian Drugs p. Neuromuscular Disorder Drugs q. Muscle Relaxants 5. Hormones a. Androgens & Related Synthetic Drugs b. Oestrogens & Progesterones & Related Synthetic Drugs c. Combined Sex Hormones d. Corticosteroid Hormones e. Trophic Hormones & Related Synthetic Drugs f. Anabolic Agents g. Other Hormone Related Drugs 6. Contraceptive Agents a. Depot Contraceptives b. oral Contraceptives c. Other Contraceptives 7. Antibiotics a. Aminoglycosides b. Cephalosporins c. Chloramphenicols d. Macrolides e. Penicillins f. Other Beta-Lactams g. Quinolones h. Tetracyclines i. Antifungals j. Antibacterial Combinations k. Other Antibiotics 8. Other Chemotherapeutics a. Antituberculous Agents b. Sulphonamides c. Antiamoebics d. Anthelmintics e. Antileprotics f. Antivirals g. Antineoplastics h. Antimalarials i. Leishmaniacides, Trypanocides j. Filaricides

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9. Genito-Urinary System a. Preparations for Vaginal Conditions b. Urinary Antiseptics c. Drugs Acting on Uterus d. Drugs for Erectile Dysfunction e. Other Drugs Acting on Genito-Urinaty System 10. Endocrine & Metabolic System a. Insulins b. Oral Antidiabetic Agents c. Thyroid Preparations d. Antithyroids e. Antihyperlipidaemic Agents f. Agents Affecting Bone Metabolism g. Other Agents Affecting Metabolism 11. Vitamins & Minerals a. Vitamins A,D,E b. Vitamin B’s/with C c. Vitamin C d. Calcium/with Minerals e. Multivitamins/with Minerals f. Vitamins with Hormones/Geriatric Preparations g. Paediatric Vitamins & Minerals h. Electrolytes & Minerals i. Antianemics/Per & Post Natal Vitamins 12. Nutrition a. Infant Nutritional Products b. Enteral/Nutritional Products c. Parenteral Nutrition d. Supplements & Adjuvant Therapy e. Appetite Stimulants f. Antiobesity Agents 13. Eye a. Eye Anti-infectives & Antiseptics b. Eye Corticosteroids c. Eye Antiseptics with Corticosteroids d. Mydriatic Drugs e. Miotic Drugs f. Glaucoma Preparations g. Other Eye Preparations Ear h. Ear Anti-infectives & Antiseptics i. Ear Corticosteroids j. Ear Antiseptics with Corticosteroids k. Other Ear Preparations

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Mouth/Throat l. Mouth/Throat preparations 14. Dermatologicals a. Topical Anti-infectives b. Topical Anti-infectives with Corticosteroids c. Topical Corticosteroids d. Acne Treatment Preparations e. Antiseptics & Disinfectants f. Medicated Surgical Dressings g. Topical Fungicides & Antiparasites h. Psoriasis, Seborrhea & Ichthyosis Preparations i. Topical Antivirals j. Keratolytics k. Skin Protectives l. Topical Antihistamines/Antipruritics m. Topical Analgesics & Anti-inflammatories n. Other Dermatologicals 15. Anaesthetics-Local & General 16. Diagnostic Agents 17. Allergy & Immune System a. Antihistamines & Antiallergics b. Vaccines, Antisera & Immunologicals c. Immunosuppressants 18. Antidotes, Detoxifying Agents & Drugs Used In Substance Dependence 19. Intravenous & Other Sterile Solutions 20. Miscellaneous

232

APPENDIX F

WHO System organ classification

233

WHO System-organ classes

No System-organ classes 1 Skin and appendages 2 Musculo-skeletal system 3 Collagen 4 Central & peripheral nervous system 5 Autonomic nervous system 6 Vision 7 Hearing and vestibular 8 Special sense other 9 Psychiatric 10 Gastro-intestinal system 11 Liver and biliary system 12 Metabolic and nutritional 13 Endocrine 14 Cardiovascular 15 Myo-, endo-pericardial & valve 16 Heart rate and rhythm 17 Vascular (extracardiac) 18 Respiratory system 19 Red blood cell 20 White cell 21 Platelet, bleeding & clotting 22 Urinary system 23 Reproductive, male 24 Reproductive, female 25 Foetal 26 Neonate and infancy 27 Neoplasms 28 Body as a whole-general 29 Application site 30 Resistance mechanism

234

APPENDIX G

An ADR Alert Card

235

แสดงบตัรทกุครั้งที่เขารบับริการ

“อยากรูเรื่องยา ถามหาเภสัชกร” โครงการความปลอดภัยดานยา กลุมงานเภสัชกรรมโรงพยาบาลแพร

บัตรเฝาระวงั เพ่ือลดการแพยาที่รุนแรง

ยาท่ีทานไดรับนี้ มีความจําเปนอยางยิ่งตอการรักษา มีประสิทธิภาพและปลอดภัยในการรักษาโรคของทาน โปรดใชยาตามขนาดท่ีแพทยส่ังอยางเครงครัด

คอยสังเกตอาการผิดปกติท่ีอาจเกิดขึ้นดังกลาวอยางใกลชิด ระหวางการใชยา

หากมีอาการดังกลาวหรือสงสัยวาเกิดการแพยา สอบถามเภสัชกรไดท่ี กลุมงานเภสัชกรรม โรงพยาบาลแพร

โทรศัพท 054-533500 ตอ 1614 หรือมาพบแพทย หรือเภสัชกรทันที พรอมท้ังแสดงบัตรนี้

การปฏิบัติตัว

ชื่อ-สกุล ล HN N ชื่อยาท่ีเฝาระวัง ง วันท่ีเริ่มใชยา ม

กลุมยาซัลฟา - Cotrimoxazole - Sulfadiazine กลุมยากันชัก - Carbamazepine - Phenytoin - Phenobarbital กลุมยาเกาท - Allopurinol กลุมยาตานไวรัส - NVP, EFV - GPO-VIR กลุมยาตานวณัโรค

อาการที่ฮาจนําไปสูอาการแพยาท่ีรุนแรง คือ มีไขสูง ปวดเม่ือย เจ็บคอ หรือมีอาการคลายหวัด ที่ไมใชอาการที่มีอยูเดิม รวมกับอาการดังตอไปน้ี

ผ่ืน, ตุมพอง หรือจุดแดงบริเวณผิวหนัง มีตุมนํ้า หรือแผลในปาก/หู/จมูก/กน/อวัยวะเพศ

เจ็บตา หนังตาบวมแดง เยื่อตาอักเสบ

ขอสังเกต

อาการเหลาน้ีไมไดเกิดกับทุกคนท่ีไดรับยาดังกลาว

การมีอาการเหลาน้ีบางคร้ังอาจไมใชการแพยา

รายการยาท่ีเฝาระวัง

236

CURRICULUM VITAE NAME : Kannika Thiankhanithikun

DATE OF BIRTH : October 12, 1966

PLACE OF BIRTH : Phrae Province, Thailand

EDUCATION : Chiang Mai University, Chiang Mai, Thailand

Bachelor of Pharmacy 1985-1990

Chiang Mai University, Chiang Mai, Thailand

Master of Public Health 1995-1997

SCHOLARSHIPS AND AWARDS :

- Best Student Award of Chiang Mai University, 1989

- Best Student Award of Faculty of Pharmacy, Chiang Mai University, 1989

- Fund by Republic of Korea : Korea International Cooperation Agency :

KOICA “Workshop on Safety of Drugs and Cosmetics”

Seoul, Republic of Korea. March - April, 2001

- Fund by Thai Food and Drug Administration, Ministry of Public Health

“Twenty-sixth meeting of National Centers participating in the WHO

Program for International Drug Monitoring”

New Delhi, India. December, 2003

- Fund by WHO. “Thai FDA. Adverse Drug Reaction Algorithm Project”

237

SCIENTIFIC PRESENTATIONS :

- “Preventable Adverse Drug Reactions in Hospitalized Patient:A Study in 21

Selected Thai Hospitals” Oral Presentation in “Twenty-sixth meeting of

National Centers participating in the WHO Program for International Drug

Monitoring” New Delhi, India, December, 2003

- “Preventable Adverse Drug Reactions in Hospitalized Patient : A Study in

Thai Hospitals” Poster Presentation in Second International Conference on

Improving Use of Medicines (ICIUM 2004), Chiang Mai, Thailand,

March 30-April 2, 2004

- “Adverse drug reactions monitoring of the lung cancer patients undergoing

treatment with chemotherapy at the chemotherapy ward, Maharajnakorn

Chiangmai Hospital” Poster Presentation in The 1st Asia-Pacific Oncology

Pharmacy Congress, The Siam City Hotel, Bangkok, August 3-5, 2006

- “Anticonvulsant Hypersensitivity Syndrome” Oral Presentation in Thai

FDA Annual meeting of Adverse Product Reaction Monitoring, Ministry of

Public Health, 2001

- “ Paracetamol Anaphylaxis : A Case Report” Oral Presentation in Thai

FDA Annual meeting of Adverse Product Reaction Monitoring, Ministry of

Public Health, 2002

- “Steven Johnson Syndrome : A Case Report of Repeat-ADR.” Oral

Presentation in Thai FDA Annual meeting of Adverse Product Reaction

Monitoring, Ministry of Public Health, 2003

238

- “Preventable Adverse Drug Reaction” Oral Presentation in The 11st

Academic Annual Meeting, Ministry of Public Health, 2003

RESEARCH EXPERIENCES :

- Incidence of Adverse Drug Reactions (ADRs) in Hospitalized Patient :

A Study in 21 Selected Thai Hospitals

- Preventable Adverse Drug Reactions in Phrae Hospital.

- Food Safety Monitoring Project in The Northern Part of Thailand

- Unit cost of out-patient-department and Activity Base Costing : ABC

PUBLICATIONS :

- Practice Guideline for Adverse Drug Reaction Monitoring, Thai Food and

Drug Administration, Ministry of Public Health,2001 ISBN: 974-244-013-1

- Standard Operating Procedure (SOP) of Adverse Drug Reaction Monitoring

Thai Food and Drug Administration, Ministry of Public Health, 2001

- “Paracetamol Anaphylaxis” in Medical and Health Product Bulletin ISSN

1513-0207 July-September 2001. 4(3):21 -23

- “Anticonvulsant Hypersensitivity Syndrome : AHS”. in Medical and Health

Product Bulletin ISSN 1513-0207 January-March 2003. 6(1):26 -29

- “Toxic Epidermal Necrolysis (TEN) : Learning from a case report” in the

process of manuscript preparation

- “Preventable Adverse Drug Reactions : A Study in Phrae Hospital” in

the process of manuscript preparation

239

- “Prevention Model for Adverse Drug Reactions” in the process of

manuscript preparation

- “Steroid Psychosis:A Case Report”in the process of manuscript preparation

WORK EXPERIENCES :

- Pharmacist of Community-Pharmacy-Department, Ban Luang Hospital,

Nan Province, 1990-1991

- Pharmacist of Pharmacy Department, Nan Hospital, Nan Province, 1991

- Pharmacist of Pharmacy Department, Phrae Hospital, 1991-2004

- Part-time Lecturer of Uttradit Nursing College, 2002-2004

- Part-time Lecturer of Rajchapat Uttradit University, 2002-2004

- Lecturer of Department of Pharmaceutical Care, Faculty of Pharmacy,

Chiang Mai University, 2004- Present