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Lookup NU author(s): Dr Alex Green, Dr Rosanna Lyus, Professor Allyson PollockORCiD
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© 2023, The Royal Society of Medicine.Objectives: To audit national drug registers (NDRs) in Kenya, United Republic of Tanzania and Uganda with respect to national Essential Medicine Lists (EMLs) and to conduct an analysis of highly registered products including a sub-analysis of highly registered antimicrobial products. Design: Retrospective analysis of registration of essential medicines and medicinal products on NDRs as of February 2018. Setting: Not applicable. Participants: None. Main outcome measures: Registration status of essential medicines by country, essential medicine status of registered products by country and medicines with more than 50 registrations across all three countries. Results: A high proportion of essential medicines are not registered: Kenya 28% (175/632), United Republic of Tanzania 50% (400/797) and Uganda 40% (266/663). Of registered products on the NDRs, more than half are not essential: Kenya 71% (4350/6151), United Republic of Tanzania 64% (2278/3590) and Uganda 58% (2268/3896). When the three NDRs were combined, there were 42 medicines with over 50 registered products, accounting for 30% (4153/13637) of products, many of which were non-essential. Conclusions: Non-registration of essential medicines is a barrier to availability. Over-registration of medicines, particularly non-essential medicines, diverts regulatory resources towards registering non-priority and, sometimes, clinically sub-optimal medicines. The East African Community Medicines Registration Harmonization Project has the potential to improve access to key medicines if registration of essential medicines is prioritised and registration of non-essential medicines is restricted.
Author(s): Green A, Lyus R, Ocan M, Pollock AM, Brhlikova P
Publication type: Article
Publication status: Published
Journal: Journal of the Royal Society of Medicine
Year: 2023
Volume: 116
Issue: 10
Pages: 331 - 342
Print publication date: 01/10/2023
Online publication date: 21/06/2023
Acceptance date: 02/04/2021
ISSN (print): 0141-0768
ISSN (electronic): 1758-1095
Publisher: Sage Publications Ltd
URL: https://doi.org/10.1177/01410768231181263
DOI: 10.1177/01410768231181263
PubMed id: 37343667
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