This document discusses pharmacovigilance and adverse drug reactions. It defines an adverse drug reaction and explains that the goal of pharmacovigilance is to detect, understand, and prevent such reactions. It outlines who the key partners are in pharmacovigilance efforts, including governments, health professionals, patients, and WHO. The document also explains the importance of pharmacovigilance, citing examples like the thalidomide disaster and significant costs of adverse drug reactions. It emphasizes that pharmacovigilance is needed to promote rational drug use and ensure public safety and confidence in medical treatments.

1. Pharmacovigilance
Dr. SURENDRA.S.AKASH MD

2. ADVERSE DRUG REACTION
•
We define an adverse drug reaction as "an
appreciably harmful or unpleasant reaction,
resulting from an intervention related to the use
of a medicinal product, which predicts hazard
from future administration and warrants
prevention or specific treatment, or alteration of
the dosage regimen, or withdrawal of the
product."

3. 3Pharmacovigilance
•
The science and activities relating to the detection,
evaluation, understanding and prevention of
adverse drug reactions or any other drug-related
problems

4. 4
Aims of
Pharmacovigilance
•
To improve patient care and safety
•
To improve public health and safety
•
To contribute to the assessment of benefit, harm,
effectiveness and risk of medicines
•
To promote understanding, education and clinical
training

5. 5Who are the partners?
•
Government
•
Industry
•
Hospitals and academia
•
Medical and pharmaceutical associations
•
Poisons information centres
•
Health professionals
•
Patients
•
Consumers
•
Media
•
WHO

6. 6History
•
1986 - a formal adverse drug reaction (ADR)
monitoring system consisting of 12 regional
centers, each covering a population of 50 million,
was proposed for India.
•
In 1989, under the aegis of the Drug Controller of
India, six regional centres were set up in
Mumbai, New Delhi, Calcutta, Lucknow,
Pondicherry and Chandigarh.

8. 8
•
In 1997, India joined the WHO Programme for
International Drug Monitoring managed by the
Uppsala Monitoring Centre, Sweden.
•
Of the six centres, only the centres in Mumbai
and New Delhi were active, yet spontaneous
reporting of ADRs was poor.

9. 9History
•
Recognising the need for improved ADR
monitoring in India, the Government of India
sent a proposal to the World Bank for funding.
•
The World Bank approved the proposal with an
annual grant of $US 0.1 million for 5 years and
the National Pharmacovigilance programme was
launched in November 2004.

10. 10
Why do we need
pharmacovigilance?

11. 11
1959 / 61– Epidemia de focomelia por
Talidomida (4.000 – 10.000 casos no mundo,
com 15% de mortos)

12. 12
Reason 1:
•
Humanitarian concern –
•
Insufficient evidence of safety from clinical trials
•
Animal experiments
•
Phase 1 – 3 studies prior to marketing authorization

13. 13
Examples of product recalls due to toxicity
MEDICINE YEAR Examples of serious and
unexpected adverse
events leading to
withdrawal of medicine
Thalidomide 1965 Phocomelia
Practolol 1975 Sclerosing peritonitis
Terfenadine 1997 Torsade de pointes
Rofecoxib 2004 Cardiovascular effects
Veralipride 2007 Anxiety, depression,
movement disorders
Rosiglitazone 2010 Cardiovascular effects
Nimesulide 2011 Hepatotoxicity

14. 14Reason 2
•
Medicines are supposed to save lives
•
Dying from a disease is sometimes unavoidable;
dying from a medicine is unacceptable.
Lepakhin V. Geneva
2005

15. 15
•
More than 3% of all
deaths seem to be
caused by adverse
reactions to medical
drugs, according to
new research.

16. 16
Warfarin,
Insulin and
Digoxin are
the most
Dangerous
drugs in the
elderly.
Do we
believe that?

17. 17Reason 3
•
ADRs are expensive !!
•
6.5% of admissions are due to ADRs

18. 18Cost of ADRs in the US?
•
Cost of drug related morbidity and mortality
exceeded $177.4 billion in 2000 (Ernst FR &
Grizzle AJ, 2001: J American Pharm. Assoc)
•
ADR related cost to the country exceeds the cost
of the medications themselves

19. 19
Reason 4:
•
Promoting rational use of medicines and adherence

20. 20
Prescription problems

21. 21Reason 5
•
Ensuring public confidence

22. 22

23. 23

24. 24

25. 25
•
According to a fact sheet by WHO(May-2010) about the rational use of medicines ,more than 50
percent of all medicines are not correctly prescribed ,dispensed, and sold: and more than 50
percent patients take their drugs incorrectly.

26. 26Reason 6
•
Ethics
•
To know of something that is harmful to another
person who does not know, and not telling, is
unethical

27. 27
•
Not reporting a serious unknown reaction is
unethical

valid for everyone

patient

health professional

manufacturer

authorities

28. 28ADR FORM

29. 29ADR FORM

30. 30What to report?
•
The programme particularly solicits reports of:
•
• All adverse events suspected to have been
caused by new drugs and •drugs of current
interest'
•
(List published by CDSCO {Central Drugs
Standard Control Organization} from time to time)

31. 31
•
• Reactions to any other drugs which are
suspected of significantly affecting a patient's
management, including reactions suspected of
causing:
•
• Death
•
• Life-threatening (real risk of dying)
•
• Hospitalization (initial or prolonged)
•
• Disability (significant, persistent or permanent)
•
• Congenital anomaly
•
• Required intervention to prevent permanent
impairment or damage.

32. 32
WHO Programme for International
Drug Monitoring

33. 33National PVig Programme

34. 34
Travancore
Medical
college
PSG
INSTITUTE,
TAMILNAD
U
AIIMS
newdelhi
UMC Sweden
WHO-
HQ
Geneva
Ministry of
Health India

37. 37SO….WHAT IS OUR ROLE?
SEND NOT ONLY QUANTITY BUT….

38. 38HOW?
•
Monitor clinical status of patients
•
Identify the correct ADRs not side effects
•
Get more information
•
Investigate at hospital level
•
Help practitioners to fill-up the forms
•
Keep patient’s record if more information needed

39. 39CONCLUSION
•
Pharmacovigilance looks at all available
information to assess the safety profile of a drug.
•
Pharmacovigilance should also take the benefit of
the drug in account.
•
Pharmacovigilance is required for systematically
identifying and correlating drugs and side-effects
and taking corrective actions, especially for the
product launching first time in India.

40. 40THANKYOU

41. 41
•
Tegaserod is reported to
increase the risk of heart
attacks by 10 times, while
the use of gatifloxacin in
elderly patients may
increase risk of
developing serious
hyperglycemia 17 times
compared with other anti-
biotics