title: Specific features of medicines safety and pharmacovigilance in Africa.
abstract: The thalidomide tragedy in the late 1950s and early 1960s served as a wakeup call and raised questions about the safety of medicinal products. The developed countries rose to the challenge putting in place systems to ensure the safety of medicines. However, this was not the case for low-resource settings because of prevailing factors inherent in them. This paper reviews some of these features and the current status of pharmacovigilance in Africa. The health systems in most of the 54 countries of Africa are essentially weak, lacking in basic infrastructure, personnel, equipment and facilities. The recent mass deployment of medicines to address diseases of public health significance in Africa poses additional challenges to the health system with notable safety concerns. Other safety issues of note include substandard and counterfeit medicines, medication errors and quality of medicinal products. The first national pharmacovigilance centres established in Africa with membership of the World Health Organization (WHO) international drug monitoring programme were in Morocco and South Africa in 1992. Of the 104 full member countries in the programme, there are now 24 African countries with a further nine countries as associate members. The pharmacovigilance systems operational in African countries are based essentially on spontaneous reporting facilitated by the introduction of the new tool Vigiflow. The individual case safety reports committed to the WHO global database (Vigibase) attest to the growth of pharmacovigilance in Africa with the number of reports rising from 2695 in 2000 to over 25,000 in 2010. There is need to engage the various identified challenges of the weak pharmacovigilance systems in the African setting and to focus efforts on how to provide resources, infrastructure and expertise. Raising the level of awareness among healthcare providers, developing training curricula for healthcare professionals, provisions for paediatric and geriatric pharmacovigilance, engaging the pharmaceutical industries as well as those for herbal remedies are of primary concern.
authors.forename: Ambrose O
authors.initials: AO
authors.lastname: Isah
authors.forename: Shanthi N
authors.initials: SN
authors.lastname: Pal
authors.forename: Sten
authors.initials: S
authors.lastname: Olsson
authors.forename: Alexander
authors.initials: A
authors.lastname: Dodoo
authors.forename: Rachida Soulayami
authors.initials: RS
authors.lastname: Bencheikh
keywords: Africa; adverse drug reactions; medicines safety; pharmacovigilance
references.citation: South Med Rev. 2009 Apr;2(1):19-23
references.pmid: 23093874
references.citation: J Econ Perspect. 2002 Fall;16(4):67-90
references.pmid: 15179979
references.citation: Lancet. 2002 Mar 30;359(9312):1121-2
references.pmid: 11943262
references.citation: J Trop Med Hyg. 1976 Nov;79(11):241-3
references.pmid: 1011319
references.citation: BMJ. 2007 Sep 8;335(7618):462
references.pmid: 17823149
references.citation: Clin Pharmacol Ther. 2007 Aug;82(2):197-203
references.pmid: 17361129
references.citation: Lancet. 2007 Aug 11;370(9586):465-6
references.pmid: 17693161
references.citation: Drug Saf. 2010 Jul 1;33(7):e1-e23
references.pmid: 20553053
references.citation: BMC Med Genet. 2009 Dec 02;10:124
references.pmid: 19954515
references.citation: Br J Clin Pharmacol. 2009 Jun;67(6):687-90
references.pmid: 19594539
references.citation: Malar J. 2010 May 30;9:148
references.pmid: 20509971
references.citation: Drug Saf. 2010 Aug 1;33(8):689-703
references.pmid: 20635827
references.citation: BMJ. 2006 May 20;332(7551):1163-4
references.pmid: 16709964
references.citation: Bull World Health Organ. 2009 Mar;87(3):225-30
references.pmid: 19377719
references.citation: BMJ. 2006 May 20;332(7551):1177-81
references.pmid: 16679330
references.citation: Indian J Pharmacol. 2008 Feb;40(Suppl 1):S4-9
references.pmid: 21369413