Utrecht WHO Collaborating Centre for Pharmaceutical Policy and Regulation, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands.
Utrecht WHO Collaborating Centre for Pharmaceutical Policy and Regulation, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands
BMJ Glob Health. 2023 Sep;8(9). doi: 10.1136/bmjgh-2023-012309.
The effectiveness of a health system in providing access to medicines is in part determined by the alignment of several core pharmaceutical processes. For South Africa's public health sector, these include the registration of medicines, selection and subsequent procurement through national tenders. Registration, selection and reimbursement are key processes in the private sector. This study assessed the alignment of forementioned processes for essential paediatric oncology medicines in South Africa.
A selection of priority chemotherapeutics, antiemetics and analgesics in the treatment of five prevalent childhood cancers in South Africa was compared with those listed in 1) the WHO Essential Medicines List for Children (WHO EMLc) 2021, 2) the registered health products database of South Africa, 3) the relevant South African National Essential Medicines Lists (NEML), 4) bid packs and awarded tenders for oncology medicines for 2020 and 2022 and 5) oncology formularies from the leading Independent Clinical Oncology Network (ICON) and two private sector medical aid schemes. Consistency between these sources was assessed descriptively.
There was full alignment for 25 priority chemotherapeutics for children between the NEML, the products registered in South Africa and those included on tender. Due to unsuccessful procurement, access to seven chemotherapeutics was potentially constrained. For antiemetics and analgesics, eight of nine active ingredients included on the WHO EMLc were also registered in South Africa and on its NEML. An exploratory assessment of private sector formularies showed many gaps in ICON's formulary and two medical scheme formularies (listing 33% and 24% of the chemotherapeutics, respectively).
Despite good alignment in public sector pharmaceutical processes, access constraints to essential chemotherapeutics for children may stem from unsuccessful tenders. Private sector formularies show major gaps; however, it is unclear how this translates to access in clinical practice.
卫生系统在提供药物方面的有效性部分取决于几个核心制药流程的一致性。对于南非的公共卫生部门，这些流程包括药品注册、通过国家招标进行的选择和随后采购。注册、选择和报销是私营部门的关键流程。本研究评估了南非基本儿科肿瘤药物上述流程的一致性。
南非五种常见儿童癌症治疗中选择的一组优先化疗药物、止吐药和镇痛药，与以下列出的进行了比较：1）世界卫生组织儿童基本药物清单（世卫组织儿童基本药物清单）2021 年，2）南非注册的卫生产品数据库，3）相关的南非国家基本药物清单（NEML），4）2020 年和 2022 年肿瘤药物招标包和中标标书，以及 5）领先的独立临床肿瘤学网络（ICON）和两个私营部门医疗补助计划的肿瘤学处方集。使用描述性方法评估了这些来源之间的一致性。
NEML、南非注册的产品和招标中包含的 25 种儿童优先化疗药物之间完全一致。由于采购不成功，七种化疗药物的获取可能受到限制。对于止吐药和镇痛药，世卫组织儿童基本药物清单中包含的 9 种活性成分中的八种也在南非注册并在其 NEML 中列出。对私营部门处方集的探索性评估显示，ICON 处方集和两个医疗计划处方集（分别列出了 33%和 24%的化疗药物）存在许多差距。
尽管公共部门制药流程一致性良好，但儿童基本化疗药物的获取可能受到招标不成功的限制。私营部门处方集存在重大差距；然而，尚不清楚这在临床实践中如何转化为获取。
