OVERVIEW OF PHARMACOVIGILANCE

1. ZEHRA ASHRAF
Lecturer at Jinnah University
Faculty of Pharmacy Practice
PhD. Fellow (Pharmacy Practice) Ziauddin University

2. PRESENTED BY
ZEHRA ASHRAF

4. Medicine safety
 To undergo treatment you have to
be very healthy, because apart from
your sickness you have to withstand
the medicine.
“Moliere”

5. What is pharmacovigilance?

7. ASSESSMENT
DETECTION
UNDERSTANDING
PREVENTION OF
ADVERSE EFFECT

8. HOW PHARMACOVIGILANCE WORK?

9. ADR SUSPICION ADR REPORTING ADR ANALYSIS
SHEARINGTO
FINDING
1 2 3 4
HOW PHARMACOVIGILANCEWORK?

11. AIM AND SCOPE OF PHARMACOVIGILANCE

15. HISTORY OF PHARMACOVIGILANCE

16. Biological control Act was passed in USA due
to the death of children caused by
contaminated vaccines
1902
1906
1937
Pure food and drug act passed in the USA
was the first in a series of significant
Consumer Protection law which eventually led
to the creation of the food and drug
administration {FDA{ this act was stated for
preventing the manufacture sale.transportation
of Miss branded or poisonous foods drugs
medicines and liquids
liquids elixir of sulfanilamide was used without
any issue in powder and tablet form, but once it
was dissolved in the liquid it contained
poisonous solvent as the solution was prepared
with diethylene glycol DEG this was then
transported . In result of which a lot of people
faced death .
Due to kidney damage or failure Animal testing
was not required
No regulation requiring pre market safety
testing of new drug by congress (assembly) of
United States
BIOLOGICS CONTROL ACT
PURE FOOD & DRUG ACT
ELIXIR OF SULPHANILAMIDE

17. •Passed by Congress (assembly) of United
States.
•It was formed after disaster of DEG.
1938
1949
1961
•Council for international organizations of
Medical science.
•it is a non profitable non government
organization which is working along with
WHO & United Nations Educational,
Scientific and Cultural Organization
(UNESCO).
•Its main purpose is to advance patient health
through guidance on health research
including ethics, medical product
development and safety•It is used to treat morning sickness during
pregnancy
•It causes severe birth defect
•It is passed in US Congress After response to
thyladimide disaster.
•This law requires evidence of drug efficacy
before marketing
FEDERAL,FOOD,DRUG &
COSMETIC ACT
CIOMS
THALIDOMIDE

18. •Kefauver harris amendments was passed in
the US Congress as a response to the
thalidomide made disaster
•Thiis law required evidence of drug efficacy
and safety before marketing
1962
1964
1967
•The Yellow Card Scheme is the UK system
for collecting information on suspected
Adverse Drug Reaction(ADRs) to medicines.
•The scheme allows the safety of the
medicines and vaccines that are on the
market to be monitored
WHO resolution 20.51 laid basis for the
international system of monitoring ADRS.
KEFAUVER-HARRIS
YELLOW CARD SCHEME
WHO

19. MedicinesAct U(K) to govern the control of
medicines for humans and veterinary
including manufacture and supply
1968
1973
1982
French pharmacovigilance system
implemented
Benoxaprofen was removed from market in
the UK and the USA after 3500 side effects and
61 death ( mainly caused by kidney and liver
failure)
MEDICINES ACT
FRENCH PV SYSTEM
BENOXAPROFEN

20. CIOMS 1: International reporting of adverse
drug reaction released
1990
1991
1995
European Rapid alert system signed into
force to facilitate early exchange of
information concerning possible safety
hazards relating to marketing medicinal
products reducing delay in acting on safety
signals such as the case in elixir of
sulfanilamide in 1937
CIOMS 1
EUROPEAN RAPID ALERT
SYSTEM
European MedicineAgency established to
harmonize the work of existing National
medicine regulatory bodies
EUROPEAN MEDICINES
AGENCY

21. 2001
2009
2009
•A black triangle appears after the trade
name of a British medicine and indicates that
the medicine is new to the market or that
medicine is used for any new reason
•The black triangle also highlights the need
for surveillance of any adverse drug reaction
(ADRs) that might arise from the use of a
new medication
They clarified the
pharmacovigilance responsibility of market
authorization holders.
These are regularly updated according to the
need of reliable public
BLACK TRIANGLE
GvPs
•The EU Clinical Trial Regulation (EU-CTR) was
approved in April 2014
•The EUCTD had approximation of the laws,
regulations and administrative provisions of the
member states relating to the principles of Good
Clinical Practice (GCP) in the conduct of clinical trials
on medicinal products for human use.
EUROPEAN MEDICINES
AGENCY

22. New clinical trial regulation was implemented in
2001 EUCTD
2016
NEW CLINICAL TRIAL
REGULATION

23. METHODS
OF
PHARMACOVIGILANCE

24. EXPENDED REPORT
IFTHERE HAS BEEN SPONTANEOUS REPORTING OF A
SUSPECTED ADVERSE DRUG REACTIONTO
PHARMACEUTICAL COMPANY.
THERE ARE LEGAL OBILIGATION ONTHE COMPANYTO
REPORT SERIOUS REACTIONS
CLINICAL REVIEW OF CASE REPORTS
THE QUANLITY OF REPORTS ISVARIABLE,LARGE
NATIONAL &INTERNATIONALORGANIZATION COLLECT
HUNDREDTOTHOUSAND OF REPORTS EACHYEAR
HIGHLIGHTTHE MOST URGENT PROBLEMS
SPONTONEOUS REPORTING
THE REPORTING MIGHT BE DIRECTLYTOTHE
COMPANY OR REGULARTY
VERBAL REPORT IS ACCEPTABLE IN URGENT SITUATION
BUT WRITTEN SUBMISSION SHOULD BE COMPLETED BY
THE DEADLINE

25. COHORT EVENT MONITORING (CEM)
A PROSPECTIVE LONGITUDINAL OBSEVATIONAL COHORT STUDY OF ADVERSE EVENT ASSOCIATED WITH ONE
OR MORE MONITORED MEDICINES.
DRUG EVENT MONITORING
PATIENTS ARE IDENTIFIED BY ELECTRONIC PRESCRIPITION
DATA. A FOLLOW UP QUESTIONNAIRE CAN BE SENT TO
EACH PHYSICIAN & PATIENT
INFORMATION ON PATIENT DEMOGRAPHICS
INDICATION FOR TREATMENT,DURATION OF
THERAPY,CLINICAL EVENT
PERIODIC SAFETY UPDATE REPORTS
PREMARKETING CLINICAL TRAILS MAY NOT BE SUFFICIENT TO
REFLECT THE PRODUCT SAFETY PROFILE.THEREFORE POST
MARKETING DRUG SAFETY MONITORING PERIOD ON NEW DRUG.
LINCENSE HOLDERS SHALL PROACTIVELY COLLECT
POST MARKETING SAFETY DATA,PERPARE PSUR
&SUBMIT TO HEALTH AUTHORITY.

28. PHARMACOVIGILANCE DURING CLINICALTRAIL PHASES

29. PRE MARKETING &POST MARKETING SUREILLANCE

30. RISK MANAGEMENT PLAN

31. PHARMACOVIGILANCE
IN
SUBCONTINENT

32. PHARMACOVIGILANCE IN BANGLADESH
Bangladesh is an underdeveloped country. But it has a vast population. But the history of pharmaceutical
export from Bangladesh dates back to the late 80’s. So, far we have exported our pharmaceuticals to 55
countries. We are exporting wide range of products covering all major therapeutic class & dosage forms
along with high-tech products like Inhalers, Nasal sprays, Suppositories, IV fluids, Injectable etc.
On the other hand most of the people of Bangladesh are ignorant. They have only a few ideas about their
health. They faces many serious health hazard (several drug induced diseases like- kidney damage, liver
disease etc.). Above these reason pharmacovigilance study is must be required for the safety of the
country people.

33. DIETHYLENE GLYCOLTRAGEDY IN BANGLADESH
Recently 28 children died due to formulation alteration in case of paracetamol syrup, where propylene glycol
replaces by diethylene glycol as a solvent.
In Bangladesh this types of incident occur two times.
Health officials in the country say that so far 26 children aged between 11 months and three years have died
after taking paracetamol (acetaminophen) syrup contaminated with DEG that was manufactured by local drug
producer Rid Pharmaceutical Co.
The trade name of the drug wasTemset (paracetamol suspension).
Bangladesh was also affected by one of the worst cases on record, with 339 deaths attributed to paracetamol
syrup contaminated with DEG from propylene glycol in 1990-92
Al-Muntasir M, Saha D, Paul S, Rahim ZB, Hosen SZ. Studies on pharmacovigilance in Bangladesh: Safety issues. Int J Pharm
Teach Pract. 2013;4:613-21.

34. PHARMACOVIGILANCE IN INDIA

37. PHARMACOVIGILANCE
IN
PAKISTAN

43. Articles published with “ADVERSE” as a keyword in the title (Searched in Pub
Med)
34907
Articles

44. Articles published with “ADVERSE DRUG REACTION” as a keyword in the
title (Searched in Pub Med)
140069
Articles

45. Articles published with “ADVERSE DRUG REACTION IN INDIA ” as a keyword in the title
(Searched in Pub Med)
2748
Articles

46. Articles published with “ADVERSE DRUG REACTION IN BANGLADESH ” as a keyword in
the title (Searched in Pub Med)
(
51
Articles

47. 155
Articles
Articles published with “ADVERSE DRUG REACTION IN PAKISTAN ” as a
keyword in the title (Searched in Pub Med)