1. Pharmacovigilance
Dr. SURENDRA.S.AKASH MD

2. 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."
ADVERSE DRUG REACTION

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

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
Aims of Pharmacovigilance

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

6. 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.
History

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. 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.
History

10. Why do we need pharmacovigilance?

11. 1959 / 61– Epidemia de focomelia por Talidomida (4. 000 – 10
1959 / 61– Epidemia de focomelia por Talidomida (4.000 – casos no mundo, com 15% de mortos)

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

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
Nimesulide
2011
Hepatotoxicity
Examples of product recalls due to toxicity

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

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

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

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

18. Cost of drug related morbidity and mortality exceeded $177
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
Cost of ADRs in the US?

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

20. Prescription problems

21. Ensuring public confidence
Reason 5

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

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

28. ADR FORM

29. ADR FORM

30. What 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)
What to report?

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. WHO Programme for International Drug Monitoring

33. National PVig Programme

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

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

38. HOW? 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
HOW?

39. 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.
CONCLUSION

40. THANKYOU

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