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The Importance of Pharmacovigilance - Safety Monitoring of Medicinal Products
(2002; 52 pages) View the PDF document
Table of Contents
View the documentPreface
View the documentChapter 1 - Introduction
View the documentChapter 2 - A Short History of Involvement in Drug Safety Monitoring by WHO
View the documentChapter 3 - Partners in Pharmacovigilance
View the documentChapter 4 - Pharmacovigilance in Drug Regulation
View the documentChapter 5 - Pharmacovigilance in Clinical Practice
View the documentChapter 6 - Pharmacovigilance in International Health
View the documentChapter 7 - Conclusion and considerations for the future
View the documentGlossary
View the documentReferences
View the documentBack Cover
 

References

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2. International Drug Monitoring: The Role of National Centres (WHO Technical Report Series No. 498). Geneva: World Health Organization, 1972.

3. These formative years (1968-1975) have been described in: Venulet J. The WHO Drug Monitoring Programme: The formative years (1968-1975), and in Bankowski Z, Dunne JF (eds). Drug surveillance: International co-operation past, present and future. Proceedings of the XXVIIth CIOMS Conference, Geneva, Switzerland 14-15 September 1993. CIOMS 1994. pp13-21

4. Meyboom RHB, Egberts ACG, Gribnau FWJ, Hekster YA. Pharmacovigilance in perspective. Drug Safety 1999; 21(6): 429-447. Abbing HDCR. Legal aspects of medical devices: Study on regulatory mechanisms for safety control. Health Services Research. IOS Press 1993: 358-361. Fracchia GN, Theofilatou M (eds); Mehta U, Milstien JB, Duclos P, and Folb PI. Developing a national system for dealing with adverse events following immunization. Bulletin of the World Health Organization 2000, 78(2), 170-177. Craven BM, Stewart GT, Khan M. Chan TYK. Monitoring the safety of herbal medicines. Drug Safety 1997; 17(4): 209-215.

5. Effective communications in Pharmacovigilance. The Erice Report. International Conference on Developing Effective Communications in Pharmacovigilance, Erice, Sicily, 24-27 September 1997, at which a policy statement was drawn up known as The Erice Declaration.

6. WHO Medicines Strategy: Framework for Action in Essential Drugs and Medicines Policy 2000-2003. WHO/EDM/2000.1

7. Olsson S. The role of the WHO Programme for International Drug Monitoring in coordinating worldwide drug safety efforts. Drug Safety 1998; 19(1): 1-10.

8. Bate A, Lindquist M, Edwards IR et al. A Bayesian neural network method for ADR signal generation. European Journal of Clinical Pharmacology 1998, 54: 315-321.

9. Coulter DM. The New Zealand intensive medicines monitoring programme in proactive safety surveillance. Pharmacoepidemiology and Drug Safety 2000; 9:273-280; and Mackay FJ. Post-marketing studies: the work of the Drug Safety Research Unit. Drug Safety 1998:19(5): 343-353.

10. Folb PI and ten Ham M. Drug monitoring in developing countries: a drug regulator’s perspective. Drug Information Journal 1995, 29: 303-305.

11. Talbot JCC, Nilsson BS. Pharmacovigilance in the pharmaceutical industry. British Journal of Pharmacology 1998; 45: 427-431.

12. Moore N. The role of the clinical pharmacologist in the management of ADRs. Drug Safety 2001; 24(1): 1-7.

13. Hall M, McCormack P, Arthur N, Feely J. The spontaneous reporting of ADRs by nurses. British Journal of Clinical Pharmacology 1995; 40: 173 - 175.

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20. Angell M. Investigators’ responsibilities for human subjects in developingcountries. New England Journal of Medicine 2000; 342 (13): 967-969.

21. Ioannidis JPA, Lau J. Completeness of safety reporting in randomized trials: An evaluation of 7 medical areas. Journal of the American Medical Association 2001; 285 (4): 437-443.

22. White NJ. Needs in developing countries: Current state of antimalarial drugresistance. Drug surveillance: international cooperation: past, present and future: Proceedings of the XXVIIth CIOMS Conference, Geneva, Switzerland 14-15 September 1993. Bankowski Z, Dunne JF (eds) CIOMS; Geneva 1994: pg126 -135.

23. Shalala D. Protecting research subjects - what must be done. New England Journal of Medicine 2000; 343(11): 808-810.

24. A retrospective analysis conducted by the Medicines Control Agency in the UnitedKingdom found that company-sponsored post-marketing surveillance studies have made only a limited contribution to the assessment of drug safety, largely due to weak study designs and recruitment difficulties. Waller PC, Wood SM, Langman MJS, Breckenridge AM, Rawlins MD. Similarly an audit conducted by a consumer protection organization in the United States shows that in the vast majority of cases where a Phase IV study was required as a condition of registration in the United States, the applicant did not fulfil such obligations. Sasich LD, Lurie P, Wolfe SM. The Drug Industry’s performance in finishing post-marketing research (Phase IV) studies. http://www.citizen.org/hrg/Publications/1520.htm

25. The fifth amendment to the Declaration of Helsinki contains a new statement on theimportance of making the design and findings of clinical research studies open to the public. Editorial: A fifth amendment for the Declaration of Helsinki. Lancet 2000. 356 (9236): 1123. This implicitly includes communication of safety issues that arise during clinical trials. It would encourage improved communication between regulatory agencies in different countries on safety concerns, allowing for better management of patients and for decisions to be made that might minimize future risk. Where serious, unexpected risks are reported, suspension or discontinuation of the trial may be the only option.

26. Meyboom RHB, Egberts ACG, Gribnau FWJ, Hekster YA. Pharmacovigilance in perspective. Drug Safety 1999; 21(6): 429-447.

27. Benefit-risk balance for marketed drugs. Evaluating safety signals: Report of CIOMS working group IV. CIOMS, Geneva. 1998.

28. Editorial: Good manners for the pharmaceutical industry. Lancet 1997; 349: 1635.

29. Editorial: Drug-company influence on medical education in USA. Lancet 2000; 356: 781.

30. Angell M. The pharmaceutical industry - to whom is it accountable? New England Journal of Medicine 2000; 342 (25):1902-4.

31. Dickman TF, Veit HR. Consumerism and Escalating Drug Costs. Drug Benefit Trends 2001; 13 (1): 48-52.

32. Barton C, Silvey J. The Internet and drug safety: What are the implications forpharmacovigilance? Drug Safety 1999; 20(2): 95-107.

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35. Folb PI, Olliaro P. Pharmaceutical policies and regulatory control. WHO Drug Information 2000; 14(2):82-84.

36. Lloyd AJ. The extent of patients’ understanding of the risk of treatments. Quality in Health Care 2001; 10 Suppl 1:i14-8.

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39. Dukes MNG. The importance of adverse reactions in drug regulation. Drug Safety 1990; 5(1): 3-6.

40. Edwards IR. The accelerating need for pharmacovigilance. Journal of the Royal College of Physicians, 2000; 34: 48-51.

41. Wood SM. Postmarketing surveillance: viewpoint from a regulatory authority. Drug Information Journal 1991; 25:191-5

42. Roeser HP, Rohan AP. Postmarketing surveillance of drugs. The spontaneous reporting scheme: role of the ADR advisory committee. Medical Journal of Australia 1990; 153:720-6.

43. Collet JP, MacDonald N, Cashman N, Pless R, and the advisory committee on causality assessment. Monitoring signals for vaccine safety: the assessment of individual adverse event reports by an expert advisory committee. Bulletin of the World Health Organization, 2000; 78(2): 178-85.

44. Barnes J, Mills SY, Abbot NC, Willoughby M, Ernst E. Different standards for reporting ADRs to herbal remedies and conventional OTC medicines: face-to-face interviews with 515 users of herbal remedies. British Journal of Clinical Pharmacology 1998; 45(5): 496-500.

45. Ang-Lee MK, Moss J, Yuan C. Herbal medicines and perioperative care. Journal of the American Medical Association 2001; 286:208-216.

46. Guidelines for the assessment of herbal medicines, WHO/TRM/91.4, WHO Geneva,1991 - this guideline is included in: Quality assurance of pharmaceuticals: A compendium of guidelines and related materials. Volume 1, WHO Geneva, 1997; Good manufacturing practices (GMP): supplementary guidelines for the manufacture of herbal medicinal products, this supplementary guideline is included in: Quality assurance of pharmaceuticals: A compendium of guidelines and related materials. Volume 2: Good manufacturing practices and inspection, WHO Geneva, 1999; General guidelines for methodologies on research and evaluation of traditional medicine, WHO/EDM/TRM/2000.1, WHO Geneva, 2000.

47. Guidelines for safety monitoring of herbal preparations are under development.

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50. Global programme for vaccines and immunization: Expanded Programme onImmunization. Surveillance of adverse events following immunization: Field guide for managers of immunization programmes. Geneva: WHO, 1997.

51. Bovine Spongiform Encephalopathy (BSE); Bovine Spongiform Encephalopathy(BSE) http://www.fda.gov/cber/BSE/BSE.htm. Variant Creutzfeldt-Jakob disease, http://www.who.int/inf-fs/en/fact180.htm.

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53. Meyboom RHB, Hekster YA, Egberts ACG, Gribnau FWJ, Edwards IR. Casual or Causal? The role of causality assessment in pharmacovigilance. Drug Safety 1997; 16:374-389.

54. Leape LL, Brennan TA, Laird N, et al. The nature of adverse events in hospitalized patients: results of the Harvard Medical Practice Study II. New England Journal of Medicine 1991; 324:377-84.

55. Bates DW, Miller EB, Cullen DJ et al. Patient risk factors for ADRs in hospitalized patients. Archives of Internal Medicine 1999; 159: 2553-60.

56. Pouyanne P, Haramburu F, Imbs JL, Bégaud B. Admissions to hospital caused by ADRs: cross sectional incidence study. British Medical Journal 2000; 320:1036.

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58. Buajordet I, Ebbesen J, Erikssen J, Brors O, Hilberg T. Fatal adverse drug events: the paradox of drug treatment. Journal of Internal Medicine 2001; 250 (4): 327-41.

59. Van den Bemt PMLA, Egberts TCG, de Jong-van den Berg LTW, Brouwers JRJB. Drug-related problems in hospitalized patients. Drug Safety 2000; 22(4): 321-333.

60. Lazarou J, Pomeranz BH, Corey PN. Incidence of ADRs in Hospitalized Patients: AMeta-analysis of Prospective Studies. Journal of the American Medical Association 1998; 279:1200-1205.

61. Kelly WN. Potential risks and prevention, Part 1: Fatal adverse drug events. American Journal of Health System Pharmacy 2001 Jul 15; 58(14): 1317-24.

62. Weekes LM, Day RO. The application of ADR data to drug choice decisions made by pharmacy and therapeutics committees: An Australian perspective. Drug Safety 1998; 18(3): 153-9.

63. Evans RS, Pestotnik SL, Classen DC, et al. Preventing adverse drug events inhospitalized patients. Annals of Pharmacotherapeutics 1994; 28: 523-7.

64. Van den Bemt PMLA, Egberts TCG, de Jong-van den Berg LTW, Brouwers JRJB. Drug-related problems in hospitalized patients. Drug Safety 2000; 22(4): 321-333.

65. Chyka PA, McCommon SW. Reporting of ADRs by poison control centers in the US. Drug Safety 2000; 23(1): 87-93.

66. Soumerai SB and Avorn J. Principles of educational outreach ("academic detailing") to improve clinical decision taking. Journal of the American Medical Association 1990; 263: 549-556.

67. Davis DA, Thomson MA, Oxman AD and Haynes RB. Changing physicianperformance: A systematic review of the effect of continuing medical education strategies. Journal of the American Medical Association 1995; 274: 700-705.

68. New Zealand, Sweden, United Kingdom, USA and Canada are some examples ofcountries that have implemented active surveillance systems, with good results. For example in: Chen RT, DeStefano F, Davis RL, Jackson LA, Thompson RS, et al. The vaccine safety data link: immunization research in health maintenance organizations in the USA. Bulletin of the World Health Organization 2000; 78(2): 186-194; Coulter DM. The New Zealand intensive medicines monitoring programme in pro-active safety surveillance. Pharmacoepidemiology and Drug Safety 2000; 9:273-280; and Turner C, Mowat D. Addressing Health Surveillance Data Gaps. Health Canada 1999.

69. Rikken F, Vos R. How ADRs can play a role in innovative drug research: Similarities in ADR profiles of captopril and penicillamine. Pharmacy World and Science 1995; 17(6): 195-200.

70. White TJ, Arakelian A, Rho JP. Counting the costs of drug-related adverse events. Pharmacoeconomics 1999; 15(5): 445-58.

71. Avorn J, Solomon DH. Cultural and economic factors that (mis)shape antibiotic use: The nonpharmacologic basis of therapeutics. Annals of Internal Medicine 2000; 133:128-135.

72. Ball LK, Evans G, Bostrom A. Risky business: Challenges in vaccine riskcommunication. Paediatrics 1998; 101: 453-458.

73. Bapna JS, Tripathi CD, Tekur U. Drug utilization patterns in the third world. Pharmacoeconomics 1996; 9(4): 286-294.

74. Kane et al. Transmission of hepatitis B, hepatitis C, and human immunodeficiency virus through safe injections in the developing world: mode-based regional estimates. Bulletin of the World Health Organization 1999, 78: 801 - 807.

75. De Vries CS, Duggan CA, Tromp TFJ, de Jong-van den Berg LTW. Changing prescribing in the light of tolerability concerns: How is this best achieved? Drug Safety 1999 Sep; 21(3): 153-160.

76. Schwartz RK, Soumerai SB, Avorn J. Physician motivation for non-scientific drug prescribing. Social Science and Medicine 1997; 44(4): 541 -8.

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79. An example of such a collaborative effort is the World Health Organization Global Vaccine Safety Advisory Committee. This committee has the specific goal of conducting independent scientific assessment on the causal association between administration of vaccines and the occurrence of specific reactions. The committee has been allocated a contingency fund to conduct emergency studies, if required, to determine whether causal associations exist. The committee was established in response to vaccine scares and rumours, which had dramatically affected immunization coverage in many countries. Anon. Vaccine Safety: Vaccine Safety Advisory Committee. Weekly Epidemiological Record 1999; 74:337-8.

80. Ioannidis JPA, Lau J. Completeness of safety reporting in randomized trials: An evaluation of 7 medical areas. Journal of the American Medical Association 2001; 285 (4): 437-443.

81. Waller PC, Wood SM, Langman MJS, Breckenridge AM, Rawlins MD. Review of company postmarketing surveillance studies. British Medical Journal 1992; 304: 1470-2.

 

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