Trends in the Utilization of Medicines Sold in the Private Sector Post- Registration in South Africa and the Implications for Similar Countries

Abstract Background Regulatory authorities register medicines for patients to access these within a reasonable amount of time. There is a paucity of data available on the extent to which registered medicines reach the public after market authorisation by the South African Health Products Regulatory Authority (SAHPRA). The present study analysed the time taken for registered medicines to reach patients and further explored the relationship between medicines registered at SAHPRA and those dispensed in private pharmacies. Medicines registered by SAHPRA and those dispensed at retail pharmacies were compared and analysed. Methods A retrospective, descriptive and quantitative investigation was conducted over a period 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 computation of descriptive statistical analysis. Results Of (N = 2175) registered medicines, only 358 (16.5%; 95% CI 15.0% − 18.1%) reached patients and out of 1735 medicines registered during 2015–2019 and 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 the most and dispensed the least at 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 towards ensuring increased medicine access post-registration for new originators especially for priority disease areas to benefit patients. Mental health diseases and improved access to oncology medicines require special attention in South Africa.