Malaria pharmacovigilance in Africa: Lessons from a pilot project in Mpumalanga Province, South Africa

Drug Safety

Volumn 30, Issue 10, 2007, Pages 899-910

  Mehta, Ushma ^a,b   Durrheim, David ^b,c   Mabuza, Aaron ^d   Blumberg, Lucille ^e   Allen, Elizabeth ^a   Barnes, Karen I ^a  

^a UNIVERSITY OF CAPE TOWN   (South Africa)

^b JAMES COOK UNIVERSITY   (Australia)

^c HUNTER NEW ENGLAND POPULATION HEALTH   (Australia)

^d Department of Health and Social Services ^*  (South Africa)

^e NATIONAL INSTITUTE FOR COMMUNICABLE DISEASES   (South Africa)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIMALARIAL AGENT; ARTEMISININ; ARTESUNATE; BETA LACTAM ANTIBIOTIC; COTRIMOXAZOLE; FANSIDAR; QUININE;

ADVERSE OUTCOME; ANEMIA; ARTICLE; CONFUSION; DEVELOPING COUNTRY; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG FATALITY; DRUG HYPERSENSITIVITY; DRUG MONITORING; DRUG SURVEILLANCE PROGRAM; DYSPNEA; FOLLOW UP; HEADACHE; HEALTH PRACTITIONER; HEMATURIA; HOME MONITORING; HOSPITAL ADMISSION; HUMAN; HYPOTENSION; MALARIA; MALARIA CONTROL; MONOTHERAPY; NAUSEA; PANCYTOPENIA; PILOT STUDY; PRACTICE GUIDELINE; PRIORITY JOURNAL; RASH; RESPIRATORY DISTRESS; RIGOR; RURAL POPULATION; SOUTH AFRICA; TREATMENT RESPONSE; VOMITING;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIMALARIALS; ARTEMISININS; CHILD; CHILD, PRESCHOOL; DRUG COMBINATIONS; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; INFANT; MALARIA; MALE; MIDDLE AGED; PILOT PROJECTS; PRODUCT SURVEILLANCE, POSTMARKETING; PYRIMETHAMINE; SESQUITERPENES; SOUTH AFRICA; SULFADOXINE;

EID: 34748893542     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200730100-00008     Document Type: Article

References (33)

1. Trape JF. The public health impact of chloroquine resistance in Africa. Am J Trop Med Hyg 2001; 64 (1-2 Suppl.): 12-7
2. Breman JG, Alilo MS, Mills A. Conquering the intolerable burden of malaria: what's new, what's needed: a summary. Am J Trop Med Hyg 2004; 71 Suppl. 2: 1-15
3. World Health Organization. Guidelines for the treatment of malaria. Geneva: World Health Organization, 2006
4. Lang T, Hughes D, Kanyok T, et al. Beyond registration: measuring the public health potential of new treatments for malaria in Africa. Lancet Infect Dis 2006; 6: 46-52
5. Simooya O. The WHO 'Roll Back Malaria Project': planning for adverse event monitoring in Africa. Drug Saf 2005; 28 (4): 277-86
6. Talisuna AO, Staedke SG, D' Alessandro U. Pharmacovigilance of antimalarial treatment in Africa: is it possible? Malar J 2006; 5 (1): 50
7. World Health Organization Roll Back Malaria and TDR. Assessment of the safety of artemisinin compounds in pregnancy: report of 2 informal consultations convened by WHO in 2002 [online]. Available from URL: http://www.who.int/tdr/ publications/publications/artemisinin-pregn.htm [Accessed 2006 Nov 27]
8. McGready R, Cho T, Keo NK, et al. Artemisinin antimalarials in pregnancy: a prospective treatment study of 539 episodes of multidrug-resistant plasmodium falciparum. Clin Infect Dis 2001; 33 (12): 2009-16
9. Deen JL, von Seidlein L, Pinder M, et al. The safety of the combination artesunate and pyrimethamine-sulfadoxine given during pregnancy. Trans R Soc Trop Med Hyg 2001 Jul-Aug; 95 (4):424-8
10. Brewer TG, Peggins JO, Grate SJ, et al. Neurotoxicity in animals due to arteether and artemether. Trans R Soc Trop Med Hyg 1994 Jun; 88 Suppl. 1: S33-6
11. Miller LG, Panosian CB. Ataxia and slurred speech after artesunate treatment for falciparum malaria. N Engl J Med 1997; 336 (18): 1328
12. Lonardi E, Gilvary G, White NJ, et al. Severe allergic reactions to oral artesuante: a report of 2 cases. Trans R Soc Trop Med Hyg 2001; 95 (2): 182-3
13. Athan E, Dürrheim DN, Barnes K, et al. Effectiveness of short-course quinine and single-dose sulfadoxine-pyrimethamine in the treatment of Plasmodium falciparum malaria in Mpumalanga Province, South Africa. S Afr Med J 2001 Jul; 91 (7): 592-4
14. National Department of Health, South Africa: Issues: malaria [online]. Available from URL: http://www.doh.gov.za/issues/index.html [Accessed 2006 Jul 12]
15. Malaria control programme. Nelspruit: Mpumalanga Department of Health and Social Services, 2006. (Data on file)
16. National Department of Health, South Africa. Statistics: malaria [online]. Available from URL: http://www.doh.gov.za/issues/malaria/99-05-july. pdf [Accessed 2007 Aug 16]
17. Mabuza A, Govere J, La Grange K, et al. Therapeutic efficacy of sulfadoxine-pyrimethamine for Plasmodium falciparum malaria. S Afr Med J 2005; 95 (5): 346-9
18. World Health Organization Roll Back Malaria. Facts on ACTs (artemisinin-based combination therapies). January 2006 update [online]. Available from URL: http://www.rbm.who.int/cmc_upload/0/000/015/364/ RBMInfosheet_9.pdf [Accessed 2007 Aug 16]
19. Navaratnam V, Mansor SM, Sit NW, et al. Pharmacokinetics of artemisinin-type compounds. Clin Pharmacokinet 2000 Oct; 39 (4): 255-70
20. International artemsinin study group. Artesunate combinations for treatment of malaria: meta-analysis. Lancet 2004; 363: 9-17
21. von Seidlein L, Milligan P, Pinder M, et al. Efficacy of artesunate plus pyrimethamine-sulphadoxine for uncomplicated malaria in Gambian children: a double-blind, randomised, controlled trial. Lancet 2000; 355 (9201): 352-7
22. Edwards IR, Biriell C. Harmonization in pharmacovigilance. Drug Saf 1994; 10 (2): 93-102
23. Mehta U, Durrheim DN, Blumberg L, et al. Malaria deaths as sentinel events to monitor healthcare delivery and antimalarial drug safety. Trop Med Int Health 2007; 12 (5): 617-28
24. Schneemann M. Antiprotozoal drugs. In: Dukes MNG, Aronson JK, editors. Meyler's side effects of drugs. 14th ed. Amsterdam: Elsevier, 2000: 959
25. Newton PN, McGready R, Fernandez F, et al. Manslaughter by fake artesunate in Asia: will Africa be next? PLoS Med 2006 Jun 13; 3 (6): e197
26. Govere J, Durrheim D, la Grange K, et al. Community knowledge and perceptions about malaria and practices influencing malaria control in Mpumalanga Province, South Africa. S Afr Med J 2000; 90 (6): 611-6
27. Khoza S, Madungwe I, Nyambayo P, et al. Adverse drug reactions reporting at a referral hospital in Zimbabwe. Cent Afr J Med 2004; 50 (11-12): 104-7
28. Directorate: Communicable Disease Control. South African Department of Health. Guidelines for the treatment of malaria in South Africa. August 2002 [online]. Available from URL: http://www.doh.gov.za/docs/factsheets/guidelines/ malaria/treatment/ [Accessed 2006 Jan 16]
29. Gimnig JE, MacArthur JR, M'bang'ombe M, et al. Severe cutaneous reactions to sulfadoxine-pyrimethamine and trimethoprim-sulfamethoxazole in Blantyre District, Malawi. Am J Trop Med Hyg 2006 May; 74 (5): 738-43
30. Franco-Paredes C, Dismukes R, Nicolls D, et al. Neurotoxicity due to antimalarial therapy associated with misdiagnosis of malaria. Clin Infect Dis 2005; 40 (11): 1710
31. Panossian LA, Garga NL, Pelletier D. Toxic brainstem encephalopathy after artemisinin treatment for breast cancer. Ann Neurol 2005; 58 (5): 812-3
32. Van Vugt M, Angus BJ, Price RN, et al. A case-control auditory evaluation of patients treated with artemsinin derivatives for multidrug-resistant plasmodium falciparum malaria. Am J Trop Med Hyg 2000; 62 (1): 65-9
33. Kissinger E, Hien TT, Hung NT, et al. Clinical and neurophysiological study of the effects of multiple doses of artemisinin on brain-stem function in Vietnamese patients. Am J Trop Med Hyg 2000; 63 (1): 48-55