Establishing pharmacovigilance programs in resource-limited settings: The example of treating malaria

Expert Review of Clinical Pharmacology

Volumn 3, Issue 4, 2010, Pages 509-525

  Mehta, Ushma ^a   Allen, Elizabeth ^b   Barnes, Karen I ^b  

^a Independent Consultant   (South Africa)

^b UNIVERSITY OF CAPE TOWN   (South Africa)

Author keywords

adverse drug reactions; affordable medicines facility for malaria; antimalarials; artemisinin based combination therapies; drug safety; drug related problem; malaria; middle and low income countries; pharmacovigilance; resource limited settings

Indexed keywords

AMODIAQUINE; ARTEMISININ; ARTESUNATE; QUININE;

CLINICAL RESEARCH; DRUG CONTAMINATION; DRUG INFORMATION; DRUG MONITORING; DRUG STORAGE; DRUG SURVEILLANCE PROGRAM; ENVIRONMENTAL FACTOR; HEALTH CARE ACCESS; HEALTH CARE POLICY; HUMAN; MALARIA; MEDICATION ERROR; POVERTY; REVIEW;

EID: 77954936451     PISSN: 17512433     EISSN: None     Source Type: Journal    
DOI: 10.1586/ecp.10.37     Document Type: Review

References (83)

1. Barnes KI, Chanda P, Ab Barnabas G. Impact of the large-scale deployment of artemether/lumefantrine on the malaria disease burden in Africa: case studies of South Africa, Zambia and Ethiopia. Malar. J. 8(Suppl. 1), S8 (2009).
2. Dondorp A, Nosten F, Stepniewska K, Day N, White N; South East Asian Quinine Artesunate Malarial Trial (SEAQUAMAT) Group. Artesunate versus quinine for treatment of severe falciparum malaria: a randomised trial. Lancet 366(9487), 717-725 (2005).
3. Targett GA, Greenwood BM. Malaria vaccines and their potential role in the elimination of malaria. Malar. J. 7(Suppl. 1), S10 (2008).
4. Nsimba SE. How sulfadoxine- pyrimethamine (SP) was perceived in rural communities after phasing out chloroquine as a first-line drug for uncomplicated malarial in Tanzania: lessons to learn towards moving from monotherapy to fixed combination therapy. J. Ethnobiol. Ethnomed. 2, 5 (2006).
5. Figueras A, Pedros C, Valsecia M, Laporte JR. Therapeutic ineffectiveness: heads or tails? DrugSaf. 25(7), 485-487 (2002).
6. Meyboom RH, Lindquist M, Flygare AK et al. The value of reporting therapeutic ineffectiveness as an adverse drug reaction. Drug Saf 23(2), 95-99 (2000).
7. Staedke SG, Jagannathan P, Yeka A et al. Monitoring antimalarial safety and tolerability in clinical trials: a case study form Uganda. Malar. J. 7, 107 (2008)
8. Pirmohamed M, Atuah K, Dodoo AN, Winstanley P. Pharmacovigilance in developing countries: requires collaboration between stakeholders to develop novel models of funding. BMJ 335, 462 (2007)
9. O'Ryan M, Linhares AC. Update on rotarix: an oral human rotavirus vaccine. Expert Rev. Vaccines 8(12), 1627-1641 (2009).
10. Descamps D, Hardt K, Spiessens B et al. Safety of human papillomavirus (HPV)- 16/18 AS04-adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Hum. Vaccin. 5(5), 332-340 (2009).
11. Selman S, Hayes D, Perin LA, Hayes WS. Pneumococcal conjugate vaccine for young children. Manag. Care 9(9), 49-52,54, 56-57 (2000).
12. Patel MM, Haber P, Baggs J, Zuber P, Bines JE, Parashar UD. Intussusception and rotavirus vaccination: a review of the available evidence. Expert Rev. Vaccines 8(11), 1555-1564 (2009).
13. Wacholder S, Chen BE, Wilcox A et al. Risk of miscarriage with bivalent vaccine against human papillomavirus (HPV) types 16 and 18: pooled analysis of two randomised controlled trials. BMJ 340, C712 (2010).
14. Craft JC. Challenges facing drug development for malaria. Curr. Opin. Microbiol. 11, 428-433 (2008).
15. Gomes MF, Faiz MA, Gyapong JO. Pre-referral rectal artesunate to prevent death and disability in severe malaria: a placebo-controlled trial. Lancet 373(9663), 557-566 (2009).
16. Bukirwa H, Nayiga S, Lubanga R et al. Pharmacovigilance of antimalarial treatment in Uganda: community perceptions and suggestions for reporting adverse events. Trop. Med. Int. Health 13(9), 11143-11152 (2008).
17. Whitty CJ, Chandler C, Ansah E et al. Deployment of ACT antimalarials for treatment of malaria: challenges and opportunities. Malar. J. 7(Suppl. 1), S7 (2008).
18. Custodio E, Descalzo MA, Villamor A et al. Nutritional and socio-economic factors associated with Plasmodium falciparum infection in children Equatorial Guinea: results from a nationally representative survey. Malar. J. 8, 225 (2009).
19. Mehta U, Durrheim D, Mabuza A, Blumberg L, Allen E, Barnes KI. Malaria pharmacovigilance in Africa: lessons from a pilot project in Mpumalanga province, South Africa. Drug Saf. 30(10), 899-910 (2008).
20. Khoo S, Back D, Winstanley P. The potential for interactions between antitmalarial and antiretroviral drugs. AIDS 19(10), 995-1005 (2005). (Pubitemid 40961139)
21. Bretlinger PE, Behrens CB, Kublin JG. Challenges in the prevention, diagnosis, and treatment of malaria in human immunodeficiency virus-infected adults in Sub-Saharan Africa. Arch. Intern. Med. 167(17), 1827-1836 (2007).
22. Dellicour S, Hall S, Chandramohan D, Greenwood B. The safety of artemisinins during pregnancy: a pressing question. Malar. J. 6, 15 (2007).
23. Mubyazi GM, Gonzalez-Block MA. Research influence on antimalarial drug policy change in Tanzania: case study of replacing chloroquine with sulfadoxine- pyrimethamine as the first-line drug. Malar. J. 4, 51 (2005).
24. Ribeira JM, Hausmann-Muela D'Allessasandro U, Grietens KP. Malaria in pregnancy: what can the social sciences contribute? PloSMed. 4(4), E92 (2007).
25. Mubyazi G, Bloch P, Kamugisha M, Kitua A, Ijumba J. Intermittent preventive treatment of malaria during pregnancy: a qualitative study of knowledge, attitude and practices of district health managers, antenatal care staff and pregnant women in Korogwe District North-Eastern Tanzania. Malar. J. 4, 31 (2005).
26. Dodoo A, Adjei S, Couper M, Hugman B, Edwards IR. When rumours derail a mass deworming exercise. Lancet 370 (9586), 465-466 (2007).
27. Wise L, Parkinson J, Raine J, Breckenridge A. New approaches to drug safety: a pharmacovigilance tool kit. Nature Rev. Drug Disc. 8, 779-782 (2009).
28. 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 12(5), 617-628 (2007).
29. Dodoo ANO, Fogg C, Asiimwe A et al. Pattern of drug utilization for treatment of uncomplicated malaria in urban Ghana following national treatment policy change to artemisinin - combination therapy. Malar. J. 8, 2 (2009).
30. Dondorp AM, Nosten F, Yi Pet al. Artemisinin resistance in Plasmodium facliparum malaria. N. Engl. J. Med. 361(5), 455-467. (2009).
31. 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. 63(1-2), 48-55 (2000).
32. Baiden F, Hodgson A, Binka FN. Demographic surveillance sites and emerging challenges in international health. Bull. World Health Organ. 84(3), 163 (2006).
33. Amin AA, Kokwaro GO. Antimalarial drug quality in Africa. J. Clin. Pharm. Ther. 32(5), 429-440 (2007).
34. Amin AA, Snow RW. Brands costs and registration status of antimalarial drugs in the Kenyan retail sector. Malaria J. 4, 36 (2005).
35. Sengaloudeth S, Green MD, Fernandez FM et al. A stratified random survey of the proportion of poor quality oral artesunate sold at medicine outlets in the Lao PDR - implications for therapeutic failure and drug resistance. Malar. J. 8, 172 (2009).
36. Ioset JR, Kaur H. Simple field assays to check quality of current artemisinin-based antimalarial combination formulations. PLoS ONE 4(9), E7270 (2009).
37. A-Elgayoum SM, El-Feki Ael-K, Maghoub BA, El-Rayah el-A, Giha HA. Malaria overdiagnosis and burden of malaria misdiagnosis in the suburbs of central Sudan: special emphasis on artemisinin- based combination therapy era. Diagn. Microbiol. Infect. Dis. 64(1), 20-26 (2009).
38. Barnes KI, Durrheim DN, Little F et al. Effect of artemether-lumefantrine policy and improved vector control on malaria burden in Kwa-Zulu Natal, South Africa. PLoS Med. 2(11), 1123-1134 (2005).
39. Otten M, Aregawi M, Were W et al. Initial evidence of reduction of malaria cases and deaths in Rwanda and Ethiopia due to rapid scale-up of malaria prevention and treatment. Malar. J. 8, 14 (2009).
40. Nosten F, van Vugt M, Price R et al. Effects of artesunate-mefloquine combination on incidence of Plasmodium falciparum malaria and mefloquine resistance in western Thailand: a prospective study. Lancet 356 (9226), 297-302 (2000).
41. Simooya O. The WHO 'Roll Back Malaria Project': planning for adverse event monitoring in Africa. Drug Saf. 28(4), 277-286 (2005).
42. Talisuna O, Staedke SG, D'Allesandro U. Pharmacovigilance of antimalarial treatment in Africa: is it possible? Malar. J. 5, 50 (2006).
43. Strom BL. Pharmacoepidemiology (4th Edition). John Wiley and Sons Ltd, Chichester, UK (2005).
44. Sevene E, Mariano A, Mehta U et al. Spontaneous adverse drug reaction reporting in rural districts of Mozambique. Drug Saf. 31(10), 867-876 (2008).
45. Adachi T, Sakamoto S. Thromboembolism during hormone therapy in Japanese women. Semin. Thromb. Hemost. 31(3), 280 (2005).
46. Coulter DM. The New Zealand intensive medicines monitoring programme in pro-active safety surveillance. Pharmacoepidemiol. Drug Saf. 9(4), 280 (2000).
47. Aurich-Barerra B, Wilton LV, Shakir SA. Use and risk management of carvedilol for the treatment of heart failure in the community in England: results from a modified prescription-event monitoring study. Drug Saf. 32(1), 43-54 (2009).
48. Clark RL. Embryotoxicity of the artemisinin antimalarials and potential consequences for use in women in the first trimester. Reprod. Toxicol. 28, 285-296 (2009).
49. Dellicour S, ter Kuile FO, Stergachis A. Pregnancy exposure registries for assessing antimalarial drug safety in pregnancy in malaria endemic countries. PLoS Med. 5(9), E187 (2008).
50. Brabin BJ, Wasame M, Udeenfeldt-Wort U, Dellicour S, Hill J, Gies S. Monitoring and evaluation of malaria in pregnancy- developing a rational basis for control. Malar. J. 7(Suppl. 1), S6 (2008).
51. Thapa R, Biswas B. Childhood mefloquine- induced mania and psychosis: a case report. J. Child Neurol. 24(8), 1008-1009 (2009).
52. Busari O, Busari O. Ventricular fibrillation in a 5-year-old child on therapeutic dose of quinine dihydrochloride infusion for acute malaria. J. Natl Med. Assoc. 100(9), 1063-1065 (2008).
53. Ugburo AO, Ilombu CA, Temive EO, Fadevibi IO, Akinolai OI. Severe idiosyncratic drug reaction (Lyells syndrome) after ingesting dihydroartemisinin. Niger. J. Clin. Pract. 12(2), 224-227 (2009).
54. Hutagalung R, Htoo H, Nwee P et al. A case-control auditory evaluation of patients treated with artemether-lumefantrine. Am. J. Trop. Med. Hyg. 74(2), 211-214 (2006).
55. Gasasira AF, Kamya MR, Achan J et al. High risk of neutropenia in HIV-infected children following treatment with artesunate plus amodiaquine for uncomplicated malaria in Uganda. Clin. Infect. Dis. 46(7), 985-991 (2008).
56. Cairo J, Durand S, Marquinho W et al. Short report: surveillance of adverse drug reactions to combination antimalarial therapy with sulfadoxine-pyrimethamine plus artesunate in Peru. Am. J. Trop. Med. Hyg. 79(1), 42-44 (2008).
57. Karunajeewa H, Lim C, Hung TY et al. Safety evaluation of fixed dose combination piperaquine plus dihydrartemisinin (artekin) in Cambodian children and adults with malaria. Br. J. Clin. Pharmacol. 57(1), 93-99 (2004).
58. Gomes M, Ribeiro I, Warsame M, Karunjewa H, Petzold M. Rectal artemisinins for malaria: a review of efficacy and safety from individual patient data in clinical studies. BMC Infect. Dis. 8, 39 (2008).
59. Aponte JJ, Schellenberg D, Egan A et al. Efficacy and safety of intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in African infants: a pooled analysis of six randomized, placebo- controlled trials. Lancet 374(9700), 1533-1542 (2009).
60. Bakshi R, Hermelling-Fritz, Gathmann I. An integrated assessment of the clinical safety of artemether-lumefantrine: a new oral fixed-dose combination antimalarial drug. Trans. R. Soc. Trop. Med. Hyg. 94(4), 419-424 (2000).
61. Sagara I, Rulisa S, Mbacham W et al. Efficacy and safety of a fixed dose artesunate-sulphamethoxopyrazine- pyrimethamine compared to artemether- lumefantrine for the treatment of uncomplicated falciparum malaria across Africa: a randomized multi-centre trial. Malar. J. 14(8), 63 (2009).
62. Sirima SB, Tiono AB, Gasane A et al. The efficacy and safety of a new fixed dose combination of amodiaquine and artesunate in young African children with acute uncomplicated Plasmodiu m falciparum. Malar. J. 8, 48 (2009).
63. Abdo-Rabbo A. Household survey of treatment of malaria in Hajjah, Yemen. East Mediterr. Health J. 9(4), 600-606 (2003).
64. Deressa W. Treatment-seeking behaviour for febriles illness in an area of seasonal malaria transmission in rural Ethiopia. Malar. J. 6, 49 (2007).
65. Brinker AD, Beitz J. Spontaneous reports of thrombocytopenia in association with quinine: clinical attributes and timing related to regulatory action. Am. J. Hematol. 70(4), 313-317 (2002).
66. Gimnig JE, MacArthur JR, M'Bang'Ombe M et al. Severe cutaneous reactions to sulfadoxine-pyrtimethamine and trimethoprim-sulfamethoxazole in Blantyre District, Malawi. Am. J. Trop. Med. Hyg. 75(5), 738-743 (2006).
67. Nsimba SE. Assessing prescribing and patient care indicators for children under five years old with malaria and other disease conditions in public primary health care facilities. Southeast Asian J. Trop. Med. Public Health 37(1), 206-214 (2006).
68. Chandler CI, Mwangi R, Mbakilwa H, Olomi R, Whitty CJ, Reyburn H. Malaria overdiagnosis: is patient pressure the problem? Health Policy Plan. 23(3), 170-178 (2008).
69. WHO. WHO World Malaria Report http://who.int/malaria/wmr2008 (Accessed 1 December 2009)
70. WHO. The importance of pharmacovigilance-safety monitoring of medicinal products www.who.int/medicinedocs/en/d/Js4893e/(Accessed 1 December 2009)
71. Pharmaceutical Care Network Europe. PCNE Classification for drug-related problems. V6.2 www.pcne.org/DRP.htm (Accessed 18 April 2010)
72. WHO-MMV joint technical consultation on active pharmacovigilance monitoring with a special focus on AMFm. Pharmacovigilance guidance for countries participating in AMFm Owing 1. www.rollbackmalaria.org/mmss/docs/ PVforAMFM.pdf (Accessed 2 December 2009)
73. EMEA. ICH topic E2E. Pharmacovigilance planning: notice for guidance on planning pharmacovigilance activities www.emea.europa.eu/pdfs/human/ich/ 571603en.pdf (Accessed 1 December 2009)
74. Food and Drug Administration. Draft guidance: guidance for industry. Format and content of proposed risk evaluation and mitigation strategies (REMS assessment and proposed REMS modifications) www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatory Information/Guidances/UCM184128.pdf (Accessed 1 December 2009)
75. Committee on the economics of antimalarial drugs. Institute of Medicine. Saving lives, buying time: economic of malaria in an age of resistance. Arrow KJ, Panosian C, Gelband H (Eds). National academic press, Washington DC, USA www.nap.edu/openbook.php?isbn=0309092183 (Accessed 1 December 2009)
76. Roll Back Malaria. Malaria endemic countries www.rollbackmalaria.org/ endemiccountries.html (Accessed 1 May 2010)
77. Rapid BI. How to write SMART objectives and SMARTER objectives http://rapidbi.com/created/WriteSMARTobjectives.html#usesofSMARTERObjectives (Accessed 1 December 2009)
78. WHO. Guidelines for the treatment of malaria. WHO. Geneva, Switzerland 62-68 (2006) http://apps.who.int/malaria/docs/TreatmentGuidelines2006.pdf (Accessed 1 May 2010).
79. WHO Expanded programme on immunization. Surveillance of adverse events following immunization: field guide for immunization managers www.who.int/vaccines-documents/Docs PDF/www9541.pdf (Accessed 1 December 2009).
80. WHO. A practical handbook on the pharmacovigilance of antimalarial medicines www.who-umc.org/graphics/19449.pdf (Accessed 13 November 2009)
81. WHO. Report of follow-up consultants' training course on pharmacovigilance: Accra 16-19 June 2008 www.who.int/medicines/areas/quality... /GhanaReportofConsultants.pdf (Accessed 1 December 2009).
82. WHO. Assessment of the safety of artemisinin compounds during pregnancy. Report of two informal consultations convened by WHO in 2002 http://apps.who.int/tdr/svc/publications/tdr-research-publications/ artemisinin-compounds-pregnancy-2003 (Accessed 1 December 2009)
83. Uppsala Monitoring Centre. WHO Programme for International Drug Monitoring www.who-umc.org/DynPage. aspx?id=13140&mn=1514 (Accessed 1 May 2010)