An Overview of the Pharmacovigilance System in Ghana

• Published in: Drug safety 2022-10, Vol.45 (10), p.1148-1148
• Main Authors: Onasanya, S, Yamoah, P, Oosthuizen, F
• Format: Article
• Language: English
• Subjects: Adverse events; Drugs; Global health; Health care; Indicators; Laboratories; Ordination; Pharmaceuticals; Pharmacology; Pharmacovigilance; Public health; Quality control; Risk analysis; Risk factors
• ISSN: 0114-5916; 1179-1942

Introduction: The goals of Pharmacovigilance (PV) includes early detection of adverse events (AE) and interactions with other drugs/- food, detection of frequency of a known adverse effect, Identification of risk factors and mechanisms behind adverse events, continuous monitoring for risk-benefit ratio of investigational product (IP) and distribution of information about discovered AEs and interactions(1) Ghana joined the WHO PV program as the 65th member in 2001 and as the first country in West-Africa. The use of pharmaceuticals preparations has become one of the fast growing components of global health care expenditure in Ghana (2). Objective: To study the PV system in Ghana using World Health Organization (WHO) indicators Methods: This study was directed towards the Ghana Food and Drugs Authority (FDA) which is the National Pharmacovigilance Coordination Center that also house the National Pharmacovigilance Centre in Ghana. A review of the government's National Policy on Pharmacovigilance and Implementation Framework was carried out using the WHO core and complimentary indicators as the basis. The Indicator- based Assessment Tool (IPAT), developed by WHO was used to assess Ghana's PV system Results: Regulatory framework for PV activities was present in Ghana. Quality Control (QC) laboratory with a clear mandate and functioning, but the QC laboratory is yet to be prequalified by WHO. The budget for PV is available with a medicine safety advisory committee present and functioning. The system for co-ordination of PV data and adverse drugs reactions (ADR) reports collation is available but majorly online. Consumer reporting forms and suspected ADR reporting forms are available and being put to use but no product quality reporting form, medication error form and treatment failure form Conclusion: Ghana FDA is mandated to regulate the development, manufacturing, importation and marketing of medicinal products in Ghana, with remarkable improvement since inception. The provision of national policy on PV and the recognition of Ghana FDA as WHO Global Benchmark Tool (GBT) performance maturity level 3 is a positive step in the right direction and with the continuous support from the government, the PV system in Ghana can only get better despite some shortcomings as identified by the WHO indicators