title: Adverse Drug Reaction Reporting in Africa and a Comparison of Individual Case Safety Report Characteristics Between Africa and the Rest of the World: Analyses of Spontaneous Reports in VigiBase®.
abstract: BACKGROUND
  Following the start of the World Health Organization (WHO) Programme for International Drug Monitoring (PIDM) by 10 member countries in 1968, it took another 24 years for the first two African countries to join in 1992, by which time the number of member countries in the PIDM had grown to 33. Whilst pharmacovigilance (PV), including the submission of individual case safety reports (ICSR) to VigiBase(®), the WHO global ICSR database, is growing in Africa, no data have been published on the growth of ICSR reporting from Africa and how the features of ICSRs from Africa compare with the rest of the world (RoW).
  
  
  OBJECTIVE
  The objective of this paper was to provide an overview of the growth of national PV centres in Africa, the reporting of ICSRs by African countries, and the features of ICSRs from Africa, and to compare ICSRs from Africa with the RoW.
  
  
  METHODS
  The search and analysis interface of VigiBase(®)--VigiLyze(®)--was used to characterise ICSRs submitted by African countries and the RoW. The distribution of ICSRs by African countries was listed and characterised by anatomic therapeutic chemical (ATC) code, Medical Dictionary for Regulatory Activities (MedDRA(®)) system organ class (SOC) classification, and patient age and sex. The case-defining features of ICSRs between Africa and the RoW were also compared.
  
  
  RESULTS
  The number of African countries in the PIDM increased from 2 in 1992 to 35 at the end of September 2015, and African PIDM members have cumulatively submitted 103,499 ICSRs (0.88 % of global ICSRs) to VigiBase(®). The main class of products in African ICSRs are nucleoside and nucleotide reverse transcriptase inhibitors (14.04 %), non-nucleoside reverse transcriptase inhibitors (9.09 %), antivirals for the treatment of HIV infections (5.50 %), combinations of sulfonamides and trimethoprim (2.98 %) and angiotensin-converting enzyme (ACE) inhibitors (2.42 %). The main product classes implicated in ICSRs from the RoW are tumour necrosis factor-α (TNFα) inhibitors (5.29 %), topical nonsteroidal anti-inflammatory preparations (2.26 %), selective immunosuppressants (2.08 %), selective serotonin reuptake inhibitors (2.04 %) and HMG CoA reductase inhibitors (1.85 %). The main SOCs reported from Africa versus the RoW include skin and subcutaneous tissue disorders (31.14 % vs. 19.58 %), general disorders and administration site conditions (20.91 % vs. 30.49 %) and nervous system disorders (17.48 % vs. 19.13 %). The 18-44 years age group dominated ICSRs from Africa, while the 45-64 years age group dominated the RoW. Identical proportions of females (57 % Africa and the RoW) and males (37 % Africa and the RoW) were represented.
  
  
  CONCLUSIONS
  As at the end of September 2015, 35 of 54 African countries were Full Member countries of the PIDM. Although the number of ICSRs from Africa has increased substantially, ICSRs from Africa still make up <1 % of the global total in VigiBase(®). The features of ICSRs from Africa differ to those from the RoW in relation to the classes of products as well as age group of patients affected. The gender of patients represented in these ICSRs are identical.
authors.affiliation: WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance, School of Medicine and Dentistry, University of Ghana, P.O Box GP 4236, Accra, Ghana. haggar.ampadu@who-pvafrica.org.|Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands. haggar.ampadu@who-pvafrica.org.
authors.forename: Haggar H
authors.initials: HH
authors.lastname: Ampadu
authors.affiliation: Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
authors.forename: Jarno
authors.initials: J
authors.lastname: Hoekman
authors.affiliation: Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
authors.forename: Marieke L
authors.initials: ML
authors.lastname: de Bruin
authors.affiliation: Safety and Vigilance, World Health Organization, Geneva, Switzerland.
authors.forename: Shanthi N
authors.initials: SN
authors.lastname: Pal
authors.affiliation: Uppsala Monitoring Centre, Uppsala, Sweden.
authors.forename: Sten
authors.initials: S
authors.lastname: Olsson
authors.affiliation: Uppsala Monitoring Centre, Uppsala, Sweden.
authors.forename: Daniele
authors.initials: D
authors.lastname: Sartori
authors.affiliation: Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
authors.forename: Hubert G M
authors.initials: HG
authors.lastname: Leufkens
authors.affiliation: WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance, School of Medicine and Dentistry, University of Ghana, P.O Box GP 4236, Accra, Ghana.
authors.forename: Alexander N O
authors.initials: AN
authors.lastname: Dodoo
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000349:Africa; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000009:adverse effects; D019380:Anti-HIV Agents / Q000009:adverse effects; D062313:Databases, Pharmaceutical; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance; D018894:Reverse Transcriptase Inhibitors / Q000009:adverse effects; D055815:Young Adult
chemical_list: D000806:Angiotensin-Converting Enzyme Inhibitors; D019380:Anti-HIV Agents; D018894:Reverse Transcriptase Inhibitors