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Primary Elements & History of Pharmacovigilance

Primary Elements & History of Pharmacovigilance. Farrukh Malik M Pharm (UK), MPH (France), PhD [ student at Universite Bordeaux Segalen , France ] Sr. Manager Medical Affairs & Research, PharmEvo farrukh.malik@pharmevo.biz , malikfj@gmail.com. Pharmaco -Vigilance. Pharmaco = medicine

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Primary Elements & History of Pharmacovigilance

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  1. Primary Elements & History of Pharmacovigilance Farrukh Malik M Pharm (UK), MPH (France), PhD [student at UniversiteBordeaux Segalen, France] Sr. Manager Medical Affairs & Research, PharmEvo farrukh.malik@pharmevo.biz, malikfj@gmail.com

  2. Pharmaco-Vigilance Pharmaco=medicine Vigilare=to watch • alert watchfulness • wakefulness • watchfulness in respect of danger; care; caution; circumspection • the process of paying close and continuous attention

  3. What is Pharmacovigilance WHO definition: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. This applies throughout the life cycle of a medicine equally to the pre-approval stage as to the post-approval.

  4. Drug Approval Process

  5. January 1848: Britain • Young girl died after Chloroform administered • Possibly an episode of ventricular fibrillation • Commission was set up in Britain and its colonies by the Lancet to report deaths related to anaesthesia.

  6. Autumn of 1937: US • 107 died in acute renal failure after using sulphanilamide • Neither sulphanilamide nor efficacy was to blame for this tragic event • Solvent in preparation of the so called elixir, diethyleneglycol Toxic effect of this solvent had been well established already six years prior to this event

  7. Food, Drug & Cosmetic Act 1938

  8. Post approval Surveillance • Early 1950 saw series of cases of aplastic anemia associated chloramphenicol after approval. • demonstrated the necessity for surveillance of drugs also after their approval Middle of 1950’s • Thalidomide for Influenza • A case of drug approval on weak scientific grounds

  9. Thalidomide 1960A major Public Health Disaster • Number of cases of limb malformations among babies in 3 reports (Australia, Germany) • Drug partially Withdrawn

  10. Reintroduced • 6-8K were affected with limb malformations. • Treatment for complications in leprosy, erythema nodusum leprosy (ENL).

  11. Birth of modern spontaneous reporting of ADR • Australia, Canada, former Czechoslovakia, Ireland, Netherlands, New Zealand & Sweden. • Set up procedures for a systematic evaluation and collection of adverse drug reactions

  12. UppsalaMonitoring Centre (WHO-UMC) 1968 • Started with 10 countries agreeing to all reports from national centers to WHO drug monitoring Project. • PMS -monitoring of side-effects and suspected adverse effects of the drug (pharmacovigilance), and the observing and recording drug usage and effect (pharmacoepidemiology). • Detection • Assessment • Prevention

  13. Guardian Weekly March 18-24 2004 Allegation: Knew about SSRI being prescribed at unsafe dosages for decades

  14. Classical examples of serious and unexpectedadverse reactions http://apps.who.int/medicinedocs/pdf/s6164e/s6164e.pdf

  15. 15 drugs accounted for 41% of recent serious adverse events in children reported to the U.S. FDA 2008-2012.

  16. Withdrawn Drugs (in the US, since 2000)‏ • Other drugs were restricted in use to exclude some patient populations or indications - Alosetron • Some drugs were withdrawned and reintroduced after further studies or special safety measures – Natalizumab withdrawn in 2005 and reintroduced in 2006

  17. Scope of Pharmacovigilance PV is an activity contributing to the protection of patients’ and public health (EMA 2014) http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/04/WC500165571.pdf

  18. Monitoring the safety of MedicinesKey Partners Consumers/Patients http://apps.who.int/medicinedocs/pdf/s6164e/s6164e.pdf

  19. Personal responsibility (?)‏ Trial with ZhengXiaoyu, former director of State Food and Drug Administration of China (CFDA), Beijing Intermediate Court, May 29, 2007 ZhengXiaoyu was convinced of taking bribes for enabling approval of unsafe medicinal products. He was executed on July 10, 2007

  20. Harm associated with Drugs • a community issue • a family issue • a healthcare issue • an industry issue • a public safety issue We all have a responsibility in addressing them http://www.ccsa.ca/resource%20library/canada-strategy-prescription-drug-misuse-report-en.pdf

  21. Conclusion Drug safety…… YES BUT Patient’s Safety matters the MOST.

  22. 1937

  23. Thank you for your attention!! Farrukh Malik M Pharm (UK), MPH (France), PhD [student at UniversiteBordeaux Segalen, France] Sr. Manager Medical Affairs & Research, PharmEvo farrukh.malik@pharmevo.biz, malikfj@gmail.com

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