Assessment of the availabilty and accessibility of information on the websites of selected national medicines regulatory authorities
Mhaule, Hleliwe Ennie
Accessibility and availability of reliable and accurate information on medicines regulation is of necessity; especially where patients’ treatment is concerned and informed decisions needs to be made. This information, which is now available on the internet is intensifying and originates from varied numerous sources. National Medicines Regulatory Authorities (NMRAs) can play an integral part by publishing accurate information and making it accessible and available to stakeholders. Aim: To assess the availability, accessibility and adequacy of information published on the websites of selected MRAs. Objectives:To evaluate the availability and accessibility of information on the websites of 9 African and 5 non-African who are also part of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S).To assess the navigability of the websites of the selected NMRAs and to further compare the functionality of the websites of the African NMRAs with those of PIC/S MRAs. Method: A quantitative and qualitative desktop review of websites was conducted using a tool adapted from previous studies with 20 assessment criterions, which were divided into two categories, website design functionality and website content. These were set up as a score of either a Yes’ or ‘No’ answer. The websites of 14 Medicines regulatory authorities (MRAs), of which nine were from African countries i.e. South Africa, Zimbabwe, Zambia, Tanzania, Ghana, Kenya, Namibia, Botswana and Nigeria and nine from overseas countries; United Kingdom, Switzerland, Australia, Singapore and Canada were evaluated. Results: Both the PIC/S and African MRA websites scored above 80% onwebsite userfriendliness. While the availability of information on pharmacovigilance and medicinal products, the PIC/S MRAs excelled by achieving a 100% and 92% respectively. The African MRAs websites scored 55% for pharmacovigilance publications on their websites and 13.4 % on availability of information on medicinal products. Notwithstanding that, no information was available regarding PILs and a list of non-propriety pharmaceutical drug names. Other significant findings in the African MRAs websites from the study were a lack of information on approved pharmaceutical manufacturers and guidance for the pharmaceutical industry applicants. On average, the African MRAs achieved 37% and 71% respectively compared to the PIC/S MRA websites, who scored 60% and 100% respectively. Conclusion: There is a lack of ongoing published information on medicines safety alerts and adverse drug reactions in African countries, despite the fact that procedures for reporting adverse drug reactions and events are available in thesewebsites. While PIC/S MRAs share information on practices around GMP, they also seem to share common best practices in regulatory medicines information dissemination.
A research report submitted to the Faculty of Health Sciences University of the Witwatersrand, Johannesburg, in partial fulfillment of the requirements for the Degree: Masters in Pharmaceutical Affairs University of Witwatersrand
National Medicines Regulatory Authorities