Affiliation:
1. Sefako Makgatho Health Sciences University
2. University of Strathclyde
Abstract
Abstract
Background: Regulatory authorities register medicines for patients to access within a reasonable time. There is a paucity of available data regarding the extent to which registered medicines reach the public after market authorisation by the South African Health Products Regulatory Authority (SAHPRA). This is important since time spent by SAHPRA assessing medicines that are subsequently not launched onto the South African market means time wasted, which could be spent on assessing new medicines that address an unmet need in the country. Consequently, we initially analysed the time taken for registered medicines to reach patients and the relationship between medicines registered at SAHPRA and those subsequently dispensed in private pharmacies. The extent of registration of multiple sourced versus new patented medicines was also explored.
Methods: A retrospective, descriptive and quantitative investigation was conducted for medicines registered between 2014 -2019. Registered and dispensed medicines were compared to establish accessibility post registration. Data sources included SAHPRA and IQVIA datasets. Microsoft Excel and SAS (SAS Institute Inc, Carey, NC, USA), Release 9.4.was used for data storage, analysis, and computation of descriptive statistical analysis.
Results: Of (N=2175) registered medicines, only 358 (16.5%; 95% CI 15.0% - 18.1%)were dispensed to patients, andout of 1735 medicines registered during 2015 – 2019 only 57 (3.3%; 95% CI 2.5% - 4.2%) were dispensed during the study period. Medicines acting on the central nervous system were registered and dispensed the most at 21.0% and 18.0%, respectively, whereas antineoplastic, and immunomodulation agents were registered and dispensed at only 11% and 5%, respectively. A concern was that only 13.0% of registered medicines were originators, with most either as generics, including branded generics, or pseudo-generics.
Conclusion: Regulatory measures should be implemented to ensure increased medicine access post-registration for new originators, especially for priority disease areas that benefit patients. Mental health diseases and improved access to oncology medicines require special attention and further investigation in South Africa.
Publisher
Research Square Platform LLC
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