School of Pharmacy, Sefako Makgatho Health Sciences University, Pretoria, South Africa.
Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, G4 0RE, UK.
BMC Public Health. 2023 Jan 28;23(1):192. doi: 10.1186/s12889-023-15021-2.
Regulatory authorities register medicines for patients to access them within a reasonable period of time. There is a paucity of available data regarding the extent to which registered medicines reach the public after market authorisation is granted 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.
A retrospective, descriptive and quantitative investigation was conducted for medicines registered between 2014 and 2019. Registered and dispensed medicines were compared to establish accessibility post registration. Data sources included SAHPRA and IQVIA datasets. Microsoft Excel and SAS were used for data storage, analysis, and computation of descriptive statistical analysis.
Of (N = 2175) registered medicines, only 358 (16.5%; 95% CI 15.0%-18.1%) were dispensed to patients, and out of 1735 medicines registered between 2015 and 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 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.
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.
监管机构会注册药物，以便患者在合理的时间内获得药物。然而，关于在南非卫生产品监管局（SAHPRA）批准市场授权后，注册药物在多大程度上能够到达公众手中，这方面的数据非常有限。这一点很重要，因为 SAHPRA 评估那些随后未在南非市场推出的药物所花费的时间是浪费的，这些时间本可以用于评估那些能够满足国家未满足需求的新药。因此，我们最初分析了注册药物到达患者手中所需的时间，以及在 SAHPRA 注册的药物与随后在私人药店配药的药物之间的关系。我们还探讨了多来源注册药物和新专利药物的注册程度。
我们对 2014 年至 2019 年期间注册的药物进行了回顾性、描述性和定量研究。通过比较注册和配药的药物，我们确定了注册后药物的可及性。数据来源包括 SAHPRA 和 IQVIA 数据集。我们使用 Microsoft Excel 和 SAS 存储、分析和计算描述性统计分析的数据。
在（N=2175）注册的药物中，只有 358 种（16.5%；95%CI 15.0%-18.1%）被配给给患者，而在 2015 年至 2019 年期间注册的 1735 种药物中，只有 57 种（3.3%；95%CI 2.5%-4.2%）在研究期间被配药。作用于中枢神经系统的药物在注册和配药方面最多，分别为 21.0%和 18.0%，而抗肿瘤和免疫调节剂的注册和配药比例仅分别为 11.0%和 5.0%。令人担忧的是，只有 13.0%的注册药物是原创药物，其中大多数是仿制药，包括品牌仿制药或伪仿制药。
应实施监管措施，以确保新原创药物在注册后能更方便地获得，特别是在能使患者受益的优先疾病领域。南非需要特别关注精神疾病和改善肿瘤药物的可及性，并进一步对此进行调查。
