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Pharmacovigilance WHO definition

Pharmacovigilance WHO definition. The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Why pharmacovigilance?. Humanitarian concerns Hippocrates’ admonition “at least do not harm”

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Pharmacovigilance WHO definition

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  1. PharmacovigilanceWHO definition The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem

  2. Why pharmacovigilance? • Humanitarian concerns • Hippocrates’ admonition “at least do not harm” • Economical concerns

  3. Why pharmacovigilance? • Drug monitoring • Drug surveillance • Pharmacovigilance • check if drugs on the market fulfil their intended role in society i.e. if resources spent on drugs produce optimal results in terms of • alleviating human suffering • reduce disease related economical loss

  4. animal experiments clinical trials epidemiological methods spontaneous reporting case reports case series Post-Marketing Surveillance (PMS) prescription event monitoring cohort studies intensive hospital monitoring case - control studies record - linkage meta-analysis How knowledge about safety problems is created

  5. acute toxicity organ damage dose dependence metabolism kinetics carcinogenicity mutagenicity teratogenicity species specificity Animal Tests

  6. Incidence of Spontaneous Minimum number ADR to be background of patients to be detected incidence exposed 1 in 100 0 360 1 in 10 000 520 1 in 1 000 730 1 in 100 2 000 1 in 500 0 1 800 1 in 10 000 3 200 1 in 1 000 6 700 1 in 100 35 900 Statistical considerations Incidence of Spontaneous Minimum number ADR to be background of patients to be detected incidence exposed 1 in 1 000 0 3 600 1 in 10 000 7 300 1 in 1 000 20 300 1 in 100 136 400 1 in 5 000 0 18 200 1 in 10 000 67 400 1 in 1 000 363 000 1 in 100 3 255 000

  7. Limitations of clinical trials • limited size • narrow population • narrow indications • short duration

  8. fine tuning of dosage recommendations reappraisal of indications extension or restriction Topics to be studied after approval

  9. assessment of side effects detection of unexpected adverse effects and interactions identification of risk factors quantitative measurement of (un)safety long term safety/toxicity study of potential risk groups (children/elderly, pregnant women etc) detection of unexpected beneficial effects Topics to be studied after approval - continued

  10. characteristics of drug use and drug users inappropriate drug use e.g. addiction, non-compliance, medication error, intoxication quality of life and utility assessment cost assessment Topics to be studied after approval - continued

  11. pharmaceutical defects and counterfeiting further kinetic, pharmacological and mechanistic studies assessment of long-term efficacy e.g. when surrogate endpoints used for approval Topics to be studied after approval - continued

  12. Need for information Health authority to monitor: • Medicines of adequate quality • Medicines suitable for intended purpose benefit/risk balance 3. Medicines used rationally science and experience

  13. Rational therapy Need for information (2) Health practitioner • Each patient a therapeutic challenge 1. Knowledge 2. Therapeutic tools • diet • surgery • medicines • etc 3. Knowledge and tools changing • need for up-dating

  14. Patient Experience report Drug Information Health professional Drug experience report Drug Information Drug info/ADR reporting Centre Drug Authority

  15. Spontaneous ADR reporting Principle The alert health professional connects an undesirable medical event with drug exposure SUSPICION Reports suspicion to information collecting centre

  16. International differencesQuantitative and Qualitative • Disease prevalence • Genetic • Social • Cultural • Health care systems • Health practices • Indication for and use of medicines • Pharmaceutical formulations • Drug monitoring practices

  17. Size and severity of the ADR problemMeta-analysis • 39 prospective studies from US hospitals • Overall incidence of serious ADRs = 6.7% • Overall incidence of fatal ADRs = 0.32% (106 000 individuals) • 4th - 6th leading cause of death Lazarou et al JAMA 1998;279: 1200 - 1205

  18. ADRs in hospital patiens Wiffen P et al. Bandolier Extra 2002; June: 1 - 16

  19. Size and severity of the problem 25 studies 1970-75 • Hospital admissions due to ADRs • 4.2 - 6.0% with a median of 5.8% Pharmacoepidem & Drug Safety 6; suppl 3: s71-s77 (1997)

  20. US estimate for 2000 • Cost of drug-related morbidity and mortality >177.4 billion US$ Ref. Ernst & Grizzle J Am Pharm Assoc. 41: 192(2001)

  21. Direct costs of ADRs13 studies 1980-95 • Median length of stay in hospital = 8.7 days • Total estimated cost of ADRs in Germany = 588 million $/year • 30.7% of admissions estimated to be preventable Pharmacoepidemiol & Drug Safety 6; suppl 3: S79-S90 (1997)

  22. Burden of ADRsEngland • 6.5% of hospital admissions • 4% of hospital bed capacity • 0.15% fatality • 70% avoidable • Cost to NHS £466 million/year • Pirmohamed M. et al. Br Med J 329:15-19 (2004)

  23. Ethics in pharmacovigilance • To know of something that is harmful to another person, who does not know, and not telling, is unethical Modifiers • knowledge - suspicion • if other person should have known • seriousness • distance

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

  25. Pharmacovigilance Major Aims • early detection of unknown safety problems • detection of increases in frequency • identification of risk factors • quantifying risks • preventing patients from being affected unnecessarily Rational and Safe use of Medicines

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