Assessment of the availabilty and accessibility of information on the websites of selected national medicines regulatory authorities
Date
2016
Authors
Mhaule, Hleliwe Ennie
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Abstract
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.
Description
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
Keywords
National Medicines Regulatory Authorities