drug and therapy bulletinhpspc.in/pdf/issue10_drug_therapy.pdfon the eve of doctor's day that...

H.P. STATE

COUNCIL

DRUG AND THERAPYBULLETIN

Toll Free 18001210443

DRUG INFORMATION CENTERHIMACHAL PRADESH STATE

PHARMACY COUNCIL

Editorial |

Drug Updates |

Pharma News |

Pharma Jobs |

Pharma Expo India |

Which kind of queries can be asked from Drug Information Center? |

Issue: 10 ● Volume: 2 ● Jul 2018

LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: [email protected], [email protected]

Contents |

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL LAUREATE INSTITUTE OF PHARMACY, KATHOG. DISTT. KANGRA. HP. 177101,

Toll Free 18001210443 Phone: 09218428042, 9459220253. E-mail: [email protected], [email protected]

2

DRUG AND THERAPY BULLETIN

Content

EDITORIAL

Patron

Mr. Gopal Krishan Sharma and Dr. Ran Singh

Editor-in-chief

Dr. Kamlesh Naik and Dr. M.S. Ashawat

Co-Editors

Dr. Vinay Pandit and Mr. Ankush Sharma

Advisory Board

Dr. Navneet Marwah, Mr. Sanjeev Pandit, Dr. Manoj Kumar, Dr. Ranjit Singh, Prof. CPS Verma, Dr. Poonam Sandhu, Dr. Rajender Guleria,

Mr. Arvind Kumar, Mr. Bihari Lal Gupta, Mr, Hemant Sharma, Mr. Rakesh Chandel, Mr. Praveen Upadhya, Mr. Kamashwar Chauhan, Mr.

Lokesh Kumar, Mr. Vishal Kumar, Mr. Y.S.Chandel, Mr. Birbal Sharma, Mr. Manoj Kumar, Mr. Yogesh Verma, Mr. Surender Nadda,

Dr. Parshuram

Drug Updates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Pharma News . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Pharma Jobs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Others. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

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DRUG UPDATES



Zemdri for complicated UTI

On June 26, 2018, the US FDA approved Zemdri™

(plazomicin) IV injection indicated for the treatment of

complicated UTI, including pyelonephritis, caused by

certain Enterobacteriaceae in adult patients who have

limited or no alternative treatment options. Zemdri, the

first once-daily aminoglycoside approved for this

indication, demonstrated similar efficacy to meropenem

for achieving composite cure (resolution or improvement

of clinical symptoms and microbiological eradication) in

a noninferiority clinical trial of patients with complicated

UTI.

Prescribing information can be found at: https://www.

accessdata.fda.gov/drugsatfda_docs/label/2018/2103

03Orig1s000lbl.pdf.

Marijuana derived Epidiolex approved

On June 25, 2018, the US FDA approved Epidiolex(R)

(cannabidiol) oral solution indicated for the treatment of

seizures associated with Lennox-Gastaut syndrome or

Dravet syndrome in patients 2 years of age or older.

Epidiolex, which is the first marijuana-derived drug to

gain FDA approval, demonstrated a greater reduction in

seizure frequency when administered along with other

drugs compared with placebo in 3 clinical trials.



65lbl.pdf.

Nocdurna sublingual tablets approved

On June 21, 2018, the US FDA approved Nocdurna(R)

(desmopressin acetate) sublingual tablets indicated to

treat nocturia due to nocturnal polyuria in adults who

awaken at least 2 times per night to void. Nocdurna,

which is the first sublingual desmopressin product for

this indication, has gender-specific dosing and carries a

boxed warning for hyponatremia.



17s000lbl.pdf.

Keytruda, Tecentric: urothelial cancer restricted use

On June 20, 2018, the US FDA issued an alert that

Keytruda(R) (pembrolizumab) IV injection and

Tecentriq(R) (atezolizumab) IV injection use is being

restricted for patients with locally advanced or

metastatic urothelial cancer who are not eligible for

cisplatin-containing therapy. This restricted use is in

response to a May 18, 2018 FDA alert. Based on an

early review of 2 ongoing clinical trials, the Data

Monitoring Committees found that patients in the

monotherapy arms with protein programmed death

ligand 1 (PD-L1) low status had decreased survival

compared with those who received cisplatin- or

carboplatin-based chemotherapy.

The prescribing information can be found at https://

www.accessdata.fda.gov/drugsatfda_docs/label/2018/

125514s043lbl.pdf and https://www.accessdata.

fda.gov/drugsatfda_docs/label/2018/761034s010lbl.

pdf.

Moxidectin for river blindness

On June 13, 2018, the US FDA approved moxidectin

oral tablets for the treatment of onchocerciasis (river

blindness) due to Onchocerca volvulus in patients 12

years of age or older. Moxidectin, which received a

priority review designation from the FDA, demonstrated



4


a significantly greater suppression of microfilariae in the

skin compared with the current standard of care in 2

clinical trials.



67lbl.pdf.

Avastin plus chemo for Advanced ovarian Cancer

On June 13 2018, the US FDA approved Avastin(R)

(bevacizumab) IV injection in combination with

chemotherapy (carboplatin and paclitaxel), followed by

bevacizumab as a single agent, for the treatment of

women with advanced (stage III or IV) ovarian cancer

following initial surgical resection. Avastin demonstrated

efficacy in a clinical trial in which progression-free

survival was significantly greater with bevacizumab plus

chemotherapy followed by bevacizumab alone

compared with bevacizumab plus chemotherapy

followed by placebo alone or chemotherapy alone.



85s323lbl.pdf.

Keytruda for advanced cervical cancer

On June 12 2018, the US FDA approved a new

indication for Keytruda(R) (pembrolizumab) IV injection

to treat patients with recurrent or metastatic cervical

cancer with disease progression on or af ter

chemotherapy whose tumors express PD-L1 (combined

positive score greater than or equal to 1) as determined

by an FDA-approved test. Keytruda is the first anti-PD-1

therapy to gain FDA approval for patients with advanced

cervical cancer and disease progression during or after

chemotherapy.



14s034lbl.pdf.

Venclexta with Rituximab for CLL or SLL

On June 8 2018, the US FDA approved an expanded

indication for Venclexta(R) (venetoclax) oral tablets in

combination with rituximab for the treatment of patients

with chronic lymphocytic leukemia (CLL) or small

lymphocytic lymphoma (SLL), with or without 17p

deletion, who have received at least 1 prior therapy.

Venclexta, which was granted priority review and

breakthrough therapy designations from the FDA,

demonstrated a significant improvement in progression-

free survival in patients with relapsed/refractory CLL

patients compared with bendamustine in combination

with rituximab in a clinical trial.



73s004s005lbl.pdf

Rituxan for Pemphigus vulgaris

On June 7 2018, the US FDA approved a new indication

for Rituxan(R) (rituximab) IV injection for the treatment

of adult patients with moderate to severe pemphigus

vulgaris (PV). Rituxan, the first biologic therapy to gain

FDA approval for PV, is also indicated to treat 4

autoimmune diseases: non-Hodgkin's lymphoma,

chronic lymphocytic leukemia, rheumatoid arthritis, and

g ranu lomatos i s w i th po lyang i i t i s (Wegener

granulomatosis) and microscopic polyangiitis.

Prescribing information can be found at: http://www.

gene.com/gene/products/information/pdf/rituxan-

prescribing.pdf.

Alimta expands NSCLC indication

On June 5 2018, the US FDA approved an expanded

5



Reference: www.micromedexsolutions.com

indication for Alimta(R) (pemetrexed) IV injection to

include in combination with carboplatin and

pembrolizumab for the initial treatment of patients with

metastatic nonsquamous non-small cell lung cancer

(NSCLC), irrespective of PD-L1 expression status.

Alimta, which was approved for this expanded indication

under accelerated approval, demonstrated a significant

improvement in objective response rate in combination

with carboplatin and pembrolizumab versus in

combination with carboplatin.

Prescribing information can be found at: http://pi.lilly.

com/us/alimta-pi.pdf.

Fulphila: First biosimilar to Neulasta

On June 4, 2018, the US FDA approved Fulphila(TM)

(pegfilgrastim-jmdb) indicated to decrease the incidence

of infection, as manifested by febrile neutropenia, in

patients with non-myeloid malignancies receiving

myelosuppressive anti-cancer drugs associated with a

clinically significant incidence of febrile neutropenia.

Fulphila is the first biosimilar to Neulasta(R)

(pegfilgrastim) to gain FDA approval; these two drugs are

not interchangeable.



75s000lbl.pdf.



6


PHARMA NEWS

FDA approves novel device for treating breathing difficulty from severe emphysema

The U.S. Food and Drug Administration approved a new

device, the Zephyr Endobronchial Valve (Zephyr Valve),

intended to treat breathing difficulty associated with

severe emphysema. Emphysema, including severe

emphysema, is a type of chronic obstructive pulmonary

disease (COPD) due to damage to the air sacs (alveoli) in

the lungs. Lung damage from emphysema is irreversible.

The damaged alveoli can cause used air to become

trapped in the lungs during exhalation. This can cause the

diseased parts of the lung to get larger and put pressure on

the healthy part of the lung, which makes it difficult to

breathe. As a result, the body may not get the oxygen it

needs. Using a flexible bronchoscope, a doctor places

Zephyr Valves, similar in size to pencil erasers, into the

diseased areas of the lung airways during a procedure in a

hospital setting. Design of the device is intended to prevent

air from entering the damaged parts of the lung and allow

trapped air and fluids to escape. During inhalation, the

valves close, preventing air from entering the damaged

part of the lung and during exhalation, the valves open,

letting out trapped air, which is intended to relieve

pressure. The Zephyr Valve device is contraindicated for

patients with active lung infections; those who are allergic

to nitinol, nickel, titanium or silicone; active smokers and

those who are not able to tolerate the bronchoscopic

procedure. Patients who have had major lung procedures,

heart disease, large bubbles of air trapped in the lung or

who have not responded to other treatments should talk

with their providers to determine if the Zephyr Valve device

is appropriate for them.

Ref: www.pharmatutor.org

Mobile apps for vaccination launched

On the eve of Doctor's Day that falls on Sunday, Indian

Academy of Pediatrics (IAP) in association with Kolkata-

based startup Medewise Technology Solutions Private

Limited launched mobile applications for child health

management and immunization in Vadodara on

Saturday. “IAP had pioneered the Immunize India

reminder service to increase vaccination compliance and

provide better care and coverage to children all over the

country. With the launch of MedEPed and Medewise

Kids Pro – the two mobile apps for child healthcare, we

are taking child healthcare to the next level by leveraging

technology, connectivity and data,” said IAP president Dr

Santosh Soans.


CDSCO proposal to include all implantable medical devices & other high end equipment under the definition of 'drug’

The Central government has moved forward with its plan

to bring all implantable medical devices and other critical

medical equipment under the purview of Section 3 (b)

(iv) of the Drugs and Cosmetics (D&C) Act 1940 to

ensure quality and reliability. The list also includes CT

scan equipment, MRI equipment, Defibrillators, Dialysis

machine, PET equipment, X-Ray machine and Bone

marrow cell separator. The step, which is expected to

address concerns regarding patient safety, was backed

by the Drug Technical. These devices will be defined as

'drugs' under the D&C Act for the purpose of price and

quality control and regulated using the Medical Device

Rules 2017.

Ref: www.cdsco.nic.in

Oxytocin manufacturing ban for domestic use to come into effect from 1st July 2018

The Ministry of Health and Family Welfare has restricted

7



the manufacture of Oxytocin formulations for domestic

use to public sector only from 1st July 2018. It has also

banned the import of Oxytocin and its formulations.

From 1st July 2018, no private manufacturer will be

allowed to manufacture the drug for domestic use.

Oxytocin is a naturally-occurring hormone that causes

uterine contractions during labour and helps new

mothers lactate.

However, the drug is heavily misused in the dairy

industry where livestock are injected with oxytocin to

make them release milk at a time convenient to farmers.

The hormone is also used to increase the size of

vegetables such as pumpkins, watermelons, brinjals,

gourds and cucumbers.

Only Karnataka Antibiotics & Pharmaceuticals Ltd

(KAPL), a publ ic-sector company, would be

manufacturing this drug for domestic use from that date.

The Oxytocin formulations meant for domestic

consumption will be supplied by the manufacturer, i.e.

KAPL, to the registered hospitals and clinics in public and

private sector directly. Oxytocin in any form or name will

not be allowed to be sold through retail Chemist.

All the registered hospitals and clinics in public and

private sector in the country are advised to contact KAPL

and place their orders with the company as the drug will

not be available with retail chemists or any other

manufacturer.


CDSCO held meeting on introducing 'trace and track' mechanism for top 300 brands

The Central Drugs Standard Control Organisation

(CDSCO) has taken step to introduce an effective “trace

and track” mechanism on top 300 brands, which would

be included in the initiative. Under this proposal, the

company will print a 14-digit unique number on each

strip or bottle of the drug. It will also print a phone

number where the customer can dial and enter the

aforesaid unique number. A consumer can get the name

and address of the manufacturer, the batch number,

manufacturing and expiry date of the medicine. A

consumer can easily check the genuineness and quality

of a drug. However, the initiative will be implemented on

a voluntary basis, according to the minutes of the DTAB

meeting.

Ref: www.cdsco.nic.in

Separate rack for generic medicines in retail shop

The central government has ordered pharmacies to

display generic drugs on separate shelves so that

consumers can opt for generic medicine to expensive

brand name drugs. The Drugs Technical Advisory Board

(DTAB) agreed to keep a separate rack/shelf reserved

solely for the storage of generic medicines in a part of the

premises separated from other medicines, which shall be

visible to consumers. Doctors will now be required to

prescribe generic formulations of medicines, as opposed

to specific brands. The Prime Minister has announced

that prescription of medicines by their generic names will

be mandatory. The government had launched the Jan

Aushadhi Scheme in 2015 to sell generic drugs at an

affordable rate at affordable prices in Jan Aushadhi

Stores (JAS). There are around 3,500 Jan Aushadhi

Stores across the country.


Retail prices of 22 formulations revised by NPPA under DPCO, 2013

The National Pharmaceutical Pricing Authority (NPPA)

has revised retail prices of 22 formulations under Drugs

(Prices Control) Order, 2013 in a notification dated 12

June 2018.



8


Name of the formulations are methylcobalamin + alpha

lipoic acid + pyridoxine hydrochloride+folic acid +

vitamin D3 1000IU tablet, cefixime + cloxacillin+lactic

acid tablet (ZIFI LBX +200), omeprazole +

domperidone capsule (OZSON – DSR), clotrimazole+

beclomethasone cream (CZSON- B), clotrimazole+

beclomethasone+ neomycin cream (CZSON- NB),

linezolid suspension (ZIFI TURBO KID), suspension

(LIZOFLY), rosuvastatin + clopidogrel tablet (ROSUVAS

CV 10), olmesartan + amlodipine + amlodipine tablet

(Triolmezest CH 20), olmesartan+ amlodipine +

amlodipine tablet (Triolmezest CH 40), telmisartan +

amlodipine + chlorthalidone tablet (Telvas 3D CT

40/6.25), telmisartan+ amlodipine+ chlorthalidone

tablet (Telvas 3D CT 80/6.25), Alpha lipoic + vitamin

D3 + pyridoxine + mecobalamin + folic acid + biotin

tablet (Nervijen D3 ) Omega - 3 ( Eicosapentaenoic +

Docosahexaenoic) + mecobalamine + pyridoxine +

folic acid + vitamin E + vitamin C + zinc

sulphate+sodium selenite capsule (Omegaful), thiamine

mononi t ra te + pyr idox ine hydroch lo r ide +

cyanocobalamin + nicot inamide + calc ium

pantothenate + riboflavin + vitamin C + folic acid tablet

(Sioneuron F), tenofovir disoproxil fumarate +

lamividine + efavirenz tablet (AVONZA), diclofenac +

methyl salcylate + menthol (Volini Maxx Spray in 55gm

pack).

Every retailer and dealer shall display price list and the

supplementary price list, if any, as furnished by the

manufacturer, on a conspicuous part of the premises

where he carries on business in a manner so as to be

easily accessible to any person wishing to consult the

same.




9

PHARMA JOBS

Recruitment for Pharmacists (66 posts) in HPSSSB - Government Jobs

The eligible candidates can apply online through HP

Staff Selection Commission's website http://www.

hpsssb.hp.gov.in. Applications received through any

other mode will not be accepted and will be rejected

straightway. Essential qualification(s), eligibility

conditions, breakup of posts and examination Fee etc.

have been mentioned in the detailed advertisement.

Online Recruitment Applications (ORA) can be filled up

w.e.f. 05.07.2018 to 04.08.2018 till 11.59 p.m.


Job openings for Pharmacists (54 posts) in District Health Society | Government Jobs

Uttar Pradesh has been working towards strengthening

its health systems through various initiatives since the

beginning of the National Health Mission (NHM). The

State has been making continuous efforts the health

objectives set out for it and a multi-pronged strategy has

been adopted. Capacity building for professional

development of existing doctors in collaboration with

leading institutions of the country has been an integral

part for strengthening human resources.

Post: Pharmacist

Programme Name: NUHM

Essential Qualification: Intermediate with Diploma In

Pharmacy having Registration under UP State Medical

Faculty

Ref: www. pharmatutors.org

Himachal Pradesh Drug Inspector Recruitment

Himachal Pradesh HPPSC invites applications from the

Pharmacy Degree qualified Professionals for the

available Drug Inspector Jobs in HP Health and Family

Welfare Department. There are total 13 Drug Inspector

jobs in this HPPSC Recruitment 2018. Mode of

application is online for this HPPSC Drug Inspector Posts

recruitment. Last date to apply online for this HP HFWD

Drug Inspector jobs is 09-07-2018. Official website to

apply online is www.hppsc.hp.gov.in. Candidates

selection is based on screening test or interview only for

this Drug Inspector vacancy of HPPSC.

Ref: www.hppsc.hp.gov.in.




10

PHARMA EXPO

PharmaB2B Expo 2018

PHARMAB2B EXPO, organized by WellDone Media is a premier trade show that provides opportunity to connect

latest, innovative products and services to pharmaceutical companies.

The WellDone Media has already organized five editions of PharmaB2B Expo in different parts of India. Overwhelmed

by the positive feedback and demand from the manufacturers, exhibitors and visitors, it is presenting 6th Edition of

PharmaB2BExpo in the picturesque and historical place, Vijayawada. Vijayawada is the Southeast Indian, second-

most-populous city of Andhra Pradesh. PharmaB2B Expo at Vijayawada would be organized from July 21-22,

2018 at Sri Sesha Sai Kalyana Vedika. For more information, please visit www.pharmab2bexpo.com

Indian Pharma Expo & Business Excellence Awards 2018

Indian Pharma Expo & Business Excellence Awards 2018 will be held on 07-09 August 2018 in New Delhi, India.

Indian Pharma Expo (IPE) will provide an opportunity for the participating companies to display their products &

services to the gamut of visitors, globally from pharma and healthcare industries.

Profile of exhibit based on pharma machinery, ayurvedic / herbal products, allopathic products, nutraceuticals,

dietary supplements, cosmetics, veterinary drugs, bio pharmaceuticals, chemicals, API Active pharma ingredients,

natural extracts, flavors and fragrances, diagnostic reagents, laboratory equipment and chemicals.

Which kind of queries can be asked from Drug

Information Center?

It is the matter of pride for all the population of Himachal

Pradesh that there is drug information center (DIC) in the

state which is giving the services to promote the rational

drug use. Maximum population of state knows that there is

DIC, but they are unaware about the services of the DIC.

They all are confused that which kind of queries they can ask.

There is no any restriction to take the drug query

information by any one. Any person (physician, pharmacist,

nurse, patient, people of community, old persons, students,

researchers etc.) can come in or call in the DIC office to take

drug information.

Following kinds of queries regarding drugs can be asked

from DIC:

Ÿ If patient is administering two medicines at the same

time then he/she before administering the medicine,

can confirm from DIC that this combination is safe or not

safe. If combination will be not safe then it may also be

life threatening.

Ÿ If patient is administering a medicine then he/she can

confirm which kinds of foods have to be avoided.

Ÿ Someone can confirm that use of any specific medicine

in particular condition (like as pregnancy/lactation) is

safe or not safe.

Ÿ General information about drug identification can also

be taken from the DIC, like as use and side/adverse

effects , t ime of administrat ion, durat ion of

administration, dose in different age groups etc. about

any drug.

Ÿ Information about substituted drugs with different

prices can also be provided by DIC.

Ÿ Any updation about medicines can be confirmed from

DIC.

DIC will provide the accurate information on request

without any fear and favor. In short, we can say that DIC can

provide any kind of information about any medicine to

anyone without any cost. Personnel can assess directly, can

call in the DIC office, sent the query by post, by E-mail



11

Toll Free 18001210443, Phone: 09218428042, 9459220253

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Personnel can assess directly, can call in the DIC office, sent the query by post, by E-mail on following address.

Note: If any want to publish his/her article in the monthly bulletin of Drug Information Center regarding Pharma updates, they can send their articles with their full address and professional status on the following reference before 25th of every month.

Toll Free 18001210443

DRUG INFORMATION CENTER

HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Jwala Ji, Distt. Kangra HP 177101

Website: www.hpspc.in | Mail ID: [email protected], [email protected]

drug and therapy bulletinhpspc.in/pdf/issue10_drug_therapy.pdfon the eve of doctor's day that...

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