Advertisement

Pharmacy World and Science

, Volume 19, Issue 4, pp 186–190 | Cite as

Good Practice in the Postmarketing Surveillance of Medicines.

  • R.H.B. Meyboom
Article

Abstract

In addition to Good Clinical Trial Practice for the study of experimental drugs, regulations are also needed for good practice in the assessment of medicines after approval (Good PMS Practice, GPP). GPP has to protect the interests of public health at large as well as those of individual patients, investigators and pharmaceutical companies. GPP may be the natural way to solve threatening conflicts between privacy legislation and the public interest.

Postmarketing surveillance Pharmacovigilance Adverse drug reactions Good practice Medical ethics 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Guidelines for good clinical practice (GCP) for trials on phar maceutical products. WHO Technical Report Series, No. 850, 1995. World Health Organization Geneva, Switzerland.Google Scholar
  2. 2.
    Note for guidance for good clinical practice for trials on medicinal products in the European Community. Commission of the European Communities, III/3976/88; 1990.Google Scholar
  3. 3.
    Spilker B. Guide to clinical trials. New York: Raven Press, 1991.Google Scholar
  4. 4.
    Gezondheidsraad: Commissie Postmarketing Surveillance. Postmarketing Surveillance in Nederland. Den Haag: Gezondheidsraad, 1991; Publicatienummer 1991/12.Google Scholar
  5. 5.
    Bégaud B, Chaslerie A, Fourrier A, Haramburu F, Miremont G, eds. Methodological approaches in pharmacoepidemiology Application to spontaneous reporting. Amsterdam: Elsevier Science Publishers, 1993.Google Scholar
  6. 6.
    Inman WHW, Gill EP, eds. Monitoring for Drug Safety. Lancaster: MTP Press, 1986.Google Scholar
  7. 7.
    Stephens MDB. The detection of new adverse drug reactions. 2nd ed. London: The Macmillan Press, 1992.Google Scholar
  8. 8.
    Strom BL, ed. Pharmacoepidemiology. 2nd ed. Chichester: John Wiley, 1994.Google Scholar
  9. 9.
    Meyboom RHB, Gribnau FWJ, Hekster YA, De Koning GHP, Egberts ACG. Characteristics of topics in pharmacovigilance in the Netherlands. Clin Drug Invest 1996; 4: 207–19.Google Scholar
  10. 10.
    Commission of the European Communities. Notice to applicants for marketing authorisations for medicinal products for human use in the European Community. III/5429/96, May 1996.Google Scholar
  11. 11.
    International Drug Monitoring: The Role of National Centres. World Health Organization Technical Report Series, No. 498, Geneva, 1972.Google Scholar
  12. 12.
    Royer RJ, Lagier G. La Pharmacovigilance. Paris: Editions Medicales SPECIA/PIL, 1986.Google Scholar
  13. 13.
    Mann RD, ed. Adverse Drug Reactions. Carnforth: Parthenon Publishing Group, 1987.Google Scholar
  14. 14.
    Griffin JP, Weber JCP. Voluntary systems of adverse reaction reporting. In: Griffin JP, D'Arcy PF, Harron DWG, eds. Medicines: regulation, research and risk. Antrim: Greystone Books, 1989.Google Scholar
  15. 15.
    Rawlins MD. Spontaneous reporting of adverse drug reac tions. Brit J Clin Pharmacol 1988; 26: 1–11.Google Scholar
  16. 16.
    Wiholm BE, Olsson S. Spontaneous reporting systems outside the United States. In: Strom BL, ed. Pharmacoepidemiology. New York: Churchville Livingstone, 1989: 119.Google Scholar
  17. 17.
    Meyboom RHB. Spontaneous monitoring of adverse reac tions to drugs, procedures and experiences in the Netherlands. In: Strom BL, Velo G, eds. Drug epidemiology and post-marketing surveillance. New York: Plenum Press, 1992: 21.Google Scholar
  18. 18.
    McEwen J, Vrhovac B. Panel on management of ADR reports in selected national centres. Drug Information Journal 1985; 19: 329–44.Google Scholar
  19. 19.
    Meyboom RHB, Royer RJ. Causality classification at pharmac ovigilance centres in the European Community. Pharmacoepidemiology and Drug Safety 1992; 1: 87–97.Google Scholar
  20. 20.
    Gezondheidsraad: Beraadsgroep Gezondheidsethiek en Gezondheidsrecht. Privacy bij Postmarketing surveillance. Den Haag: Gezondheidsraad, 1993; publicatie nr 1993/08.Google Scholar
  21. 21.
    Council Regulation (EEC) No 2309/93, Articles 19 - 22.Google Scholar
  22. 22.
    Council Directive 75/319/EEC as amended, Chapter Va, Articles 29b to 29d.Google Scholar
  23. 23.
    Notice to applicants for marketing authorisations for medici nal products for human use in the European (Draft). Chapter V, Pharmacovigilance of medicinal products for human use. Commission of the European Communities. Community. III/5944/94, December 1994.Google Scholar
  24. 24.
    Inman WHW. PEM News, No. 5, 1988. Drug Safety Research Unit, Bursledon Hall, Southampton, SO3 8BA.Google Scholar
  25. 25.
    McNamee D. Speaking about pharmacovigilance. Lancet 1996; 348: 908.Google Scholar
  26. 26.
    Roscam Abbing HDC. Informatie en toestemming in de gezondheidszorg; recente ontwikkelingen. Ned Tijdschr Geneeskd 1994; 138: 2561–4.Google Scholar
  27. 27.
    Mann RD. Databases, privacy, and confidentiality-the effect of proposed new legislation on pharmacoepidemiology and drug safety monitoring. In: Aronson JK, Van Boxtel CJ, eds. Side Effects of Drugs Annual 18. Amsterdam: Elsevier, 1995 (xxi–xxxv).Google Scholar
  28. 28.
    De Wit MEC, Porsius AJ, Stricker BHCh. The use of confiden tial medical data and postmarketing surveillance: a survey of the opinion of patients. Pharmacoepidemiology and Drug Safety 1996; 5: 321–4.Google Scholar
  29. 29.
    Edwards IR, Biriell C. Harmonisation in pharmacovigilance. Drug Safety 1994; 10: 93–102.Google Scholar
  30. 30.
    Edwards R, Lindquist M, Wiholm BE, Napke E. Quality criteria for early signals of possible adverse drug reactions. Lancet 1990; 336: 156–8.Google Scholar
  31. 31.
    Edwards IR, Danan G, Biriell C, Bénichou C. Proposed Improvement to the WHO Adverse Reaction Terminology (WHO-ART). Pharmacoepidemiology and Drug Safety 1993; 2: 177–84.Google Scholar
  32. 32.
    Bonnes Pratiques de Pharmacovigilance. December 1994, Agence du Médicament, 143–147 boulevard Anatole France, Saint-Denis.Google Scholar
  33. 33.
    GPMSP, Notification No. 646. Standard for implementation of the post-marketing surveillance for the reexamination applications of new drugs. Director General, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare (Japan), 18 June 1991.Google Scholar
  34. 34.
    International Reporting of Adverse Drug Reactions, Final Report of CIOMS Working Group I, Geneva, 1990.Google Scholar
  35. 35.
    International Reporting of Periodic Drug-Safety Update Summaries. Final Report of CIOMS Working Group II, Geneva, 1992.Google Scholar
  36. 36.
    Basic requirements for the use of terms for reporting adverse drug reactions. Council for International Organizations of Medical Sciences (CIOMS). Pharmacoepidemiology and Drug Safety 1992;v 1: 39–45.Google Scholar
  37. 37.
    Guideline on adverse reactions reporting by marketing authorisation holders. Committee for Proprietary Medicinal Products. Commission of the European Communities. III/3174/93-EN, Draft no. 4, 1993.Google Scholar
  38. 38.
    Guideline for marketing authorisation holders on periodic drug safety update reports. Committee for Proprietary Medicinal Products. Commission of the European Communities III/3175/93-EN, Draft no. 4, 1993.Google Scholar
  39. 39.
    Draft guideline for marketing authorisation holders on company-sponsored post-marketing safety studies. Committee for Proprietary Medicinal Products. Commission of the European Communities III/3176/93-EN, Draft no. 3, 1993.Google Scholar
  40. 40.
    Guideline for marketing authorisation holders on on-going pharmacovigilance evaluation during the post-marketing period. Committee for Proprietary Medicinal Products. Commission of the European Communities III/3177/93-EN, Draft no. 4, 1993.Google Scholar
  41. 41.
    Wood KL. The Medical Dictionary for Drug Regulatory Affairs (MEDDRA) Project. Pharmacoepidemiology and Drug Safety 1994; 3: 7–13.Google Scholar
  42. 42.
    Bénichou C. Towards and adverse drug reactions dictionary. Should existing terminologies be harmonized? Pharmacoepidemiology and Drug Safety 1993; 2: 185–8.Google Scholar
  43. 43.
    Bénichou C, ed. Adverse drug reactions. A practical guide to diagnosis and management. Chichester: John Wiley, 1994.Google Scholar
  44. 44.
    Mundell I. ICH guidelines finalised for 2 further aspects of ADR reporting. Inpharma 18 March 1995: 20–21.Google Scholar
  45. 45.
    Rawlins MD, Fracchia GN, Rodriguez-Farré E. EURO-ADR: Pharmacovigilance and research. A European perspective. Pharmacoepidemiology and Drug Safety 1992: 1: 261–8.Google Scholar
  46. 46.
    Waller PC, Wood SM, Breckenridge AM, Rawlins MD. Why the Safety Assessment of Marketed Medicines (SAMM) guidelines are needed. Br J Clin Pharmacol 1994; 38: 93.Google Scholar
  47. 47.
    ISPE Notice. Guidelines for Good Epidemiology Practices for Drug, Device and Vaccine Research in the United States. Pharmacoepidemiology and Drug Safety 1996; 5: 333–8.Google Scholar
  48. 48.
    WHO Collaborating Centre for International Drug Monitoring (Uppsala). Report Type Q No 23, New to the system-documentation grading, October-December 1996.Google Scholar

Copyright information

© Kluwer Academic Publishers 1997

Authors and Affiliations

  • R.H.B. Meyboom
    • 1
  1. 1.Pharmacovigilance Foundation LAREBTilburgThe Netherlands

Personalised recommendations