History that lead to Pharmacovigilance.pptx

This presentation will give a view on the history that led to the present level of stringent monitoring of adverse drug reaction.

1. History that lead to Pharmacovigilance Lecture by Siraj Sundaran 1

2. Pharmacovigilance Greek work “Pharmakon” mean drug related and Latin word “ Vigilia ” means to watch. Definition : The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine/ biologicals /medical devices related problem thereby reducing the risks and increasing the benefits of the medicine. 2

3. All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use. However, the clinical trial process involves studying these products in a relatively small number of selected individuals for a short period of time. Certain side effects may only emerge once these products have been used by a heterogenous population, including people with other concurrent diseases, and over a long period of time.

4. Pharmacovigilance need for a drug Quantification of risk/s. New ADRs or Signals. Special population risks. Long term use risks. Comorbidity related risks. Drug interaction risks. Improves patient care and safety in relation to the use of medicines. Assess the benefit and risk of the drugs. Can aid in safe, effective (therapy and cost) and rational drug use. Communication to the health care and public. 4

5. Few historical records Adverse reactions has a history that goes beyond 150 years before. 1848- A 15 year old girl (Hannah Greener) was given chloroform as general anesthesia for removing ingrown nail in the toe. Had fibrillation of ventricles and resulted in death. 5

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7. 1863- Lancet initiated the collection of notification of side-effects. 1902- Biological Control Act by USA as a result of death due to contaminated diphtheria vaccine. Then the vaccines were produced from horses. And a horse called Jim contracted tetanus thereby death of many children. 7

8. 1905- Samuel Hopkins Adams published “The Great American Fraud” which exposed many of the false claims by the patents. 1906- USFDA required drug clean and free of contaminations. 1936 to 1937- more than 100 cases of sulphanilamide lethal cases (cause was use of diethylene glycol as solubiliser). Elixir which gave Ad of taste of raspberries was called as taste of death. The Federal Food, Drug and Cosmetic act was formulated in 1938. 8

9. 1938- USFDA gave requirement purity and free of contamination of drugs. 1938- Also saw major issues of acetyl salicylic acid use related melena as a major concern which was published. Although it was not proved then it was confirmed in the year 1955. 1952- Choramphenicol induced hematotoxicity was reported. 9

10. 1957 to 1961- Thalidomide was marketed in 46 countries. Wide use : Sedative hypnotic, antiemetic, anticancer, skin lesions, etc., and the most safe dose. About 10,000 children were born with devastating malformations in various countries worldwide. 1961 two clinicians Lenz and Mcbride , confirmed thalidomide used for morning sickness to be the cause of this crisis. Besides fetal disabilities there were also a lot of large number of abortions reported in women. 1961 November- Thalidomide was withdrawn from most of the countries. 10

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12. 1962- US Kefauver Harris amendment to the law for safety and efficacy of drug. 1964- UK introduced the “Yellow card” system. 1965- European legislation made their attempt for protection of public health. 1968- WHO started the programme of International Drug Monitoring. Ten members participated in this: Australia, UK, USA, Canada, Germany, Ireland, Sweden, Denmark, New Zealand, Netherlands (Italy joined in this venture on 1975). 12

13. 1978- Uppsala monitoring centre was established by the WHO for the International Drug Monitoring. 1982- Benoxaprofen disaster: 61 deaths and nearly 3500 side effects. 13

14. 2006- Elephant man drug trial, 6 healthy men as a part of trial were given with a novel monoclonal antibody. The drug was intended for auto immune disease and leukaemia . The drug was given IV and in sub- clinical dose. Within a span of 60 minutes the subjects showed multiple adverse reactions which were severe and life threatening. This was also leading to the multiple organ failures. Within 16 hours they had go be put in intensive care and about 3 weeks treatment. 14