Direct reporting of adverse drug reactions by healthcare consumers in Africa: a narrative review.

Abstract

Background The challenges of under-reporting of adverse drug reactions have been identified as a major setback for the pharmacovigilance system worldwide. Direct reporting by health care consumers has been adopted in some developed and developing countries with a positive impact in improving pharmacovigilance activities through increased reporting rate. There are limited reports on direct reporting and its outcome in Africa. Aim of the review The study aimed to identify and present the available evidence on direct reporting of adverse drug reactions by healthcare consumers in Africa. Methods A review guided by Cochrane handbook was conducted. Electronic scientific databases such as PubMed, Cumulative Index to Nursing and Allied Health Literature, Embase and Cochrane Library were searched. Google scholar, general Google search engine, the website for the regulatory resources for Africa and World Health Organisation-Uppsala Monitoring were also searched for available guidelines, documents and publications. The review period was January 1992 to October 2019. The results were analysed descriptively. Results This study identified 16 African countries that have included healthcare consumers as eligible to report adverse drug reactions in their policy/guidelines. There is low awareness of healthcare consumers on pharmacovigilance system. Eight (8) out of thirty-six (36) African countries that are members of the World Health Organisation Programme for International Drug Monitoring have formally launched direct reporting by healthcare consumers which are 14.2% of African countries. There is a wide range of difference between the rate of adverse drug reactions report submitted by health care consumers as compared with healthcare workers. Paper form, text messages, telephone and web application-based reporting system have been used by different countries that have launched direct reporting. Poor infrastructure, low awareness and lack of a reporting culture are major challenges while the availability of common reporting methods is a potential opportunity of promoting direct reporting in African countries. Conclusions Few African countries have adopted and launched direct reporting. Reporting rate through direct methods is still relatively low when compared with reporting by healthcare workers. Published legal framework, policies, guidelines and studies on direct reporting are limited. Availability of a system and reporting method are opportunities to improve and overcome probable challenges.