This document discusses pharmacovigilance, which refers to monitoring the safety of drugs. It provides definitions of key terms like adverse drug reaction. The aims of pharmacovigilance include improving patient safety, assessing drug risks/benefits, and informing regulators. Major events like the thalidomide disaster led to stricter drug regulations. India has a national pharmacovigilance program involving 150 centers. The document then describes establishing a pharmacovigilance program at JPNATC hospital to monitor adverse drug reactions, provide training to healthcare professionals, and support national drug safety efforts. An initial training session for nurses improved their knowledge and awareness of pharmacovigilance.

1. Dr.Sharad H. Gajuryal
MHATrainee,
AIIMS
Pharmacovigilance: Pillar for Patient
Safety

2. Introduction
Pharmacovigilance = Greek words
Pharmacon= “Drug”
Vigilare =“To keep alert "

3. According to WHO it is the science relating to detection,
assessment, understanding and prevention of adverse drug
reaction or any drugs related problem.
ADR???

4. Adverse drug reaction
A response to a drug that is noxious and unintended
which occurs at a dose normally used in man for
prophylaxis, diagnosis or therapy of disease.

5. Adverse Event
Vs
Adverse Reaction

6. Pharmacovigilance is not only confined to Modern medicine
but also includes Herbal medicines, blood products and
vaccines too.

7. Aim of Pharmacovigilance
To improve patient care and safety in relation to use of
medication
To improve public health and safety in relation to use of
medicine
Contribute to assessment of benefit, harm, effectivemess and
risk of medicines ,encouraging their safe and rational use.
Promote understanding, Educational and clinical Training in
Pharmacovigilance.

8. Guides regulators on whether the drug should beGuides regulators on whether the drug should be
continue in market,continue in market,
be restricted in usages, orbe restricted in usages, or
in worst possiblein worst possible
scenario,withdrawn from the marketscenario,withdrawn from the market

9. DRUGS RECENTLY BANNED IN
INDIA?
Pioglitazone-can cause heart failure and increases risk of
bladder cancer.
Dienxit- Deanxit is a harmful combination
Analgin-causing a sharp fall in white blood cells, a potentially
fatal condition, called agranulocytosis
Others-Sibutramin, Gatifloxacin,Nimuslide

10. History and Evolution
1937 –Sulphanilamide +Diethylglycol Disaster
Death of 105 individuals
Diethyleneglycol was incriminated
Drug and Cosmetic Act, 1938 under which
pharmaceutical product manufacturers would have to
show scientific evidences of the safety of the drugs
before releasing them for sale.

11. 1959-1961 –Thalidomide Disaster
(Max. Seen in Germany)
Linked to a congenital abnormality
phocomelia
In 1962, It was discontinued.
The Kefauver-Harris amendment was
approved, under which scientific evidences
of efficacy and safety of drugs required
before drug test/trail in humans.

12. Thalidomide effect

13. WHO's Programme for International Drug Monitoring was
started in 1968 as a means of pooling existing data on adverse
drug reactions .

14. At the end of 2010, 134 countries were part of the WHO
Pharmacovigilance Programme.
This Program is coordinated by WHO together with its
collaborating centre in Uppsala, Sweden.
The collaborating center is responsible for maintaining the
global ADR database, Vigibase. At present the database
contains more than four million ADR reports
Till Date -149 countries

15. Process in Pharmacovigilance
Collect and Record Adverse Event/ Adverse Drug
Reaction
Causality Assesment and analysis of ADR
Collate and Code in Database
Compute Risk benefit and Suggest regulatory action
Communicate for safe use of drugs among stakeholders.

17. Pharmacovigilance in INDIA
150 Adverse Monitoring Center & NCC (Indian Pharmacopoeia commission)

18. Patient Safety and Performance
Improvement Program @JPNATC

19. PS & PIP-

20. Pharmacovigilance at JPNATC
Objectives:
To Monitor Adverse Drug Reaction seen in JPNATC
Patients
To Create awareness among HCP about the importance of
ADR Reporting
To monitor Benefit risk profile of Medicines
To Support National Pharmacovigilance Center for
formulation of safety related regulatory decision for
Medicine.

21. Pharmacovigilance at JPNATC
Initiated along with Patient Safety Program at JPNATC
Feb 10th
: Meeting conducted at Pharmacology department Main
Hospital AIIMS. The following Stake holders were present at the
meeting.
1. HOD,Pharmacology Department,
2. Add. MS JPNATC,
3. Faculty Incharge IT.
4. HOD,Microbiology
5. Residents Hospital Administration

22. Minutes of Meeting
To Initiate Pharmacovigilance program in JPNATC .
1 Phd Student and two Research Assistant to be appointed
for Pharmacovigilance program.
Adverse Drug Reaction form to be digitalized in
coordination with faculty I/C IT and to be incorporated in E-
Hospital

23. Appropriate Training session to be designed to enhance
knowledge of ADR reporting among Health care
professionals of JPNATC.
Orientation classes to Health care professional for guidance
to Report ADR

24. 13th
March,2015 : Orientation class regarding
pharmacovigilance was given to Nursing Staffs .

29. KAP Survey
Total 25 Participants (Nurses , DNS, ANS ,Grade I and
Grade II)
20 set of question
Designation Frequency (n=25) Percentage
ANS 10 25%
DNS 3 12%
Grade I 8 32%
Grade II 7 28%

30. Result
KNOWELDGE & AWARENESS
12 Questions
Pre-Test Mean Result =5.4
Post-Test Mean Result=9.5

31. Conclusion
Pharmacovigilance program is a helpful tool for protecting
consumers (Patients) from harmful effects of medicines.
ADR Should be considered as professional obligation
Every HCP should be aware of existing pharmacovigilance
mechanism in their country .
It’s the efficient way to boost the confidence for safety.

32. Dying from a disease is sometime
unavoidable, Dying from a
medicine is unacceptable !
-Lepakhin V. Geneva