Pharmacovigilance and new essential drugs in Africa: Zambia draws lessons from its own experiences and beyond

Global Public Health

Volumn 2, Issue 2, 2007, Pages 184-203

  Huff Rousselle, M ^a,b,c   Simooya, O ^d   Kabwe, V ^e   Hollander, I ^a,b,c   Handema, R ^f   Mwango, A ^g   Mwape, E ^h  

^a Social Sectors Development Strategies Inc   (United States)

^b TULANE UNIVERSITY   (United States)

^c KEELE UNIVERSITY   (United Kingdom)

^d Lulea University of Technology   (Zambia)

^e ABT ASSOCIATES   (United States)

^f UNIVERSITY OF ZAMBIA   (Zambia)

^g MINISTRY OF HEALTH   (Zambia)

^h Pharmaceutical Regulatory Authority   (Zambia)

Author keywords

Antimicrobial resistance; Drug reactions and interactions; Pharmacovigilance; Post marketing drug surveillance; Substandard and counterfeit drugs

Indexed keywords

ANTIRETROVIRUS AGENT; ARTEMETHER PLUS BENFLUMETOL; TUBERCULOSTATIC AGENT;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; AFRICA; ANTIBIOTIC RESISTANCE; ARTICLE; CLINICAL TRIAL; DRUG EFFICACY; DRUG INFORMATION; DRUG MONITORING; DRUG QUALITY; DRUG RESEARCH; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG USE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE NEED; HEALTH SERVICE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MALARIA; PRIORITY JOURNAL; TUBERCULOSIS; UNITED KINGDOM; UNITED STATES; WORLD HEALTH ORGANIZATION; ZAMBIA;

DRUG TOXICITY; DRUGS, ESSENTIAL; DRUGS, INVESTIGATIONAL; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; QUALITY CONTROL; ZAMBIA;

EID: 34248380839     PISSN: 17441692     EISSN: 17441706     Source Type: Journal    
DOI: 10.1080/17441690601063299     Document Type: Article

References (64)

1. Abraham, J. (2003) The Science and Politics of Medicines Control. Drug Safety, 26, pp. 135-143.
2. (2003) Supporting Legislation for Independent Post-marketing (Phase IV) Comparative Evaluation of Pharmaceuticals. APHA Policy Statement 2003-1
3. Avorn, J. (2005) FDA Standards: Good Enough for Government Work?. New England Journal of Medicine, 353, pp. 969-972.
4. Bates, D.W., Cullen, D.J., Laird, N., Petersen, L.A., Small, S.D. and Servi, D. (1995) Incidence of Adverse Drug Events and Potential Adverse Drug Events, Implications for Prevention. Journal of American Medical Association, 274, pp. 29-34.
5. Bates, D.W., Spell, N., Cullen, D.J., Burdick, E., Laird, N. and Petersen, L.A. (1997) The Cost of Adverse Events in Hospitalized Patients. Journal of American Medical Association, 277, pp. 307-311.
6. Biriell, D. and Edwards, J.R. (1997) Reasons for Reporting Adverse Drug Reactions-Some Thoughts Based on an International Review. Pharmacoepidemiology Drug Safety, 6, pp. 21-26.
7. (2005) Zambia. The World Factbook
8. (2002) Zambia Demographic and Health Survey, Government Printers
9. Chikwenya, N., Mtonga, S., Bwembya, M., Andala, R., Chansa, C. and Broms, C. (2004)
10. Classen, D.D., Pestonik, S.L., Evans, R.S., Lloyd, J.F. and Burke, J.P. (1997) Adverse Events in Hospitalized Patients: Excess Length of Stay, Extra Costs and Attributable Mortality. Journal of American Medical Association, 277, pp. 301-306.
11. Clavel, F. and Hance, A.J. (2004) HIV Drug Resistance. New England Journal of Medicine, 350, pp. 1023-1035.
12. (2002)
13. DeAngelis, C.D., Fontanarosa, P.B. and Flanagin, A. (2001) Reporting Financial Conflicts of Interest and Relationships Between Investigators and Research Sponsors. Journal of American Medical Association, 286, pp. 89-91.
14. Drucker, P.F. (1967) The Effective Decision. The Harvard Business Review
15. Edwards, I.R. and Biriell, C. (1994) Harmonisation in Pharmacovigilance. Drug Safety, 10, pp. 93-102.
16. Egberts, T.C.G., Smulders, M., De Koning, F.H., Meyboom, R.H. and Leufkens, H.G. (1996) Can Adverse Drug Reactions be Detected Earlier? A Comparison of Reports by Patients and Professionals. British Medical Journal, 313, pp. 530-531.
17. Einarson, T.R. (1993) Drug Related Hospital Admissions. The Annals of Pharmacotherapy, 27, pp. 832-840.
18. Fontanarosa, P.B., Rennie, D. and DeAngelis, C.D. (2004) Postmarketing Surveillance-Lack of Vigilance, Lack of Trust. Journal of American Medical Association, 292, pp. 2647-2650.
19. (2005) Guidance for Industry: E2E Pharmacovigilance Planning. US Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research.
20. (2005) Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemilogic Assessment. US Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research.
21. (2005) Reviewer Guidance: Evaluating Risks of Drug Exposure in Human Pregnancies. US Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research.
22. Gaynor, C. (2005) Structural Injustice and the MDGs: A Critical Analysis of the Zambian Experience. Trócaire Development Review, pp. 57-84.
23. (2004) pp. 91-128.
24. (2004)
25. (2005)
26. Hagopian, A., Ofosu, A., Fatusi, A., Biritwum, R., Essel, A. and Hart, L.G. (2005) The Flight of Physicians from West Africa: Views of African Physicians and Implications for Policy. Social Science and Medicine, 61, pp. 1750-1760.
27. Hollander, I. (2006) Viagra's Rise Above Women's Health Issues: An Analysis of the Social and Political Influences on Drug Approvals in the United States and Japan. Social Science and Medicine, 62, pp. 683-693.
28. Horton, R. (2001) Lotronex and the FRD: An Erosion of Integrity. Lancet, 357, pp. 1544-1545.
29. Huff-Rousselle, M. (2005)
30. Huff-Rousselle, M. and Kabwe, V. (2006)
31. Huff-Rousselle, M., Kabwe, V. and Chikwenya, N. (2006)
32. Huff-Rousselle, M., Kabwe, V., Nunn, A. and Simooya, O. (2005)
33. (2005)
34. Kaunda, B. (2005) Doctors' Go-Slow Continues. Zambia Daily Mail
35. Khoo, S., Back, D. and Winstanley, P. (2005) The Potential for Interactions Between Antimalarial and Antiretroviral Drugs. AIDS, 19, pp. 995-1005.
36. Kombe, G., Galaty, D., Mtonga, V. and Banda, P. (2005)
37. Krasner, J. (2002) FDA Rule Changes in Contention Benefits, Dangers of Shorter Drug Review at Center of Debate. The Boston Globe
38. Lasser, K.E., Allen, P.D., Woolnahdler, S.J., Himmelstein, D.U., Wolfe, S.M. and Bor, D.H. (2002) Timing of New Black Box Warnings and Withdrawals for Prescription Medications. Journal of American Medical Association, 287, pp. 2215-2220.
39. Lazarou, J., Pomeraz, B.H. and Corey, P.N. (1998) Incidence of Adverse Drug Reactions in Hospitalized Patients, A Meta Analysis of Prospective Studies. Journal of American Medical Association, 279, pp. 1200-1205.
40. Lenzer, J. (2004) FDA is Incapable of Protecting US 'Against Another Vioxx'. British Medical Journal, 329, p. 1253.
41. Lindquist, M. (2004)
42. Malenga, G., Palmer, A., Staedke, S., Kazadi, W., Mutabingwa, T. and Ansah, E. (2005) Antimalarial Treatment with Artemisinin Combination Therapy in Africa. British Medical Journal, 331, pp. 706-707.
43. (2004)
44. Meyboom, R.H.B., Egberts, A.C.G., Gribnau, F.W.J. and Hekster, Y.A. (1999) Pharmacovigilance in Perspective. Drug Safety, 21, pp. 429-447.
45. Meyboom, R.H.B., Lindquist, M. and Egberts, A.C.G. (2000) An ABC of Drug Related Problems. Drug Safety, 22, pp. 415-423.
46. (2005) Ministry of Health
47. Moore, N.D., Lecointre, D., Noblet, C. and Mabille, M. (1998) Frequency and Cost of Serious Adverse Drug Reactions in a Department of General Medicine. British Journal of Clinical Pharmacology, 45, pp. 301-308.
48. Pirmohamed, M., Breckenridge, A.M., Kitteringham, N.R. and Park, B.K. (1998) Adverse Drug Reactions. British Medical Journal, 316, pp. 1295-1298.
49. Psaty, B.M., Furberg, C.D., Ray, W.A. and Weiss, N.S. (2004) Potential for Conflict of Interest in the Evaluation of Suspected Adverse Drug Reactions: Use of Cerivastatin and Risk of Rhabdomyolysis. Journal of American Medical Association, 292, pp. 2622-2631.
50. Roberts, P. (1994)
51. Sasich, L.D. (2000)
52. Simooya, O. (2005) The WHO 'Roll Back Malaria Project' Planning for Adverse Event Monitoring in Africa. Drug Safety, 28, pp. 277-286.
53. (2004)
54. (2000)
55. (2002)
56. (2006)
57. Wayne, A.W. and Stein, C.M. (2006) Reform of Drug Regulation - Beyond an Independent Drug-Safety Board. New England Journal of Medicine, 354, pp. 194-201.
58. Whittington, C.J., Kendall, T., Fonagy, P., Cottrell, D., Cotgrove, A. and Boddington, E. (2004) Selective Serotonin Reuptake Inhibitors in Childhood Depression: Systematic Review of Published versus Unpublished Data. Lancet, 363, pp. 1341-1345.
59. Willman, D. (2000) How a New Policy Led to Seven Deadly Drugs. Los Angeles Times, p. 1.
60. Wong, I.C.K. (1999) Pharmacovigilance Resources in the United Kingdom. Pharmaceutical Journal, 7059, pp. 285-288.
61. (1998)
62. (2002)
63. (2004)
64. (2004)