Perumal-Pillay Velisha Ann, Suleman Fatima
Discipline of Pharmaceutical Sciences, School of Health Sciences, Westville Campus, University of KwaZulu-Natal, Private Bag X54001, Durban, 4000, South Africa.
BMC Health Serv Res. 2017 Jan 7;17(1):17. doi: 10.1186/s12913-016-1946-9.
The South African (SA) public health system has employed an Essential Medicines List (EML) with Standard Treatment Guidelines (STGs) in the public sector since 1996. To date no studies have reported on the process of selection of essential medicines for SA EMLs and how this may have changed over time. This study reports on the decision making process for the selection of essential medicines for SA EMLs, over the years, as described by various members of the National Essential Medicines List Committee (NEMLC) and their task teams.
Qualitative in-depth interviews, guided by an interview questionnaire, were conducted with 11 members of the SA NEMLC and their task teams (both past and present members) during the period January - April 2015. Interviews were recorded and transcribed verbatim. Transcripts were then coded by the first author and verified by the second author before being reconciled and input into NVIVO, a qualitative software, to facilitate analysis of the data.
The interviews conducted suggest that the NEMLC process of medicine selection has been refined over the years. This together with the EML review process is now essentially predominantly an evidence based process where quality, safety and efficacy of a medicine is considered first followed by cost considerations which includes pharmacoeconomic evaluations, and pricing of medicines.
This is the first study in SA to report on how decisions are taken to include or exclude medicines on SA national EMLs and provides insight into the SA EML medicine selection, review and monitoring processes over time. The results show that the NEMLC has undergone tremendous transformation over the years. Whilst the membership of the committee largely remains unchanged, the committee has developed its policies and processes over the years. However there is still a need to strengthen the monitoring and evaluation aspects of the SA EML policy process.
自1996年以来，南非公共卫生系统在公共部门采用了基本药物清单（EML）及标准治疗指南（STG）。迄今为止，尚无研究报告南非基本药物清单中基本药物的选择过程以及这一过程随时间的变化情况。本研究报告了多年来国家基本药物清单委员会（NEMLC）及其各任务组的不同成员所描述的南非基本药物清单中基本药物的选择决策过程。
2015年1月至4月期间，以访谈问卷为指导，对南非国家基本药物清单委员会的11名成员及其任务组（包括过去和现在的成员）进行了定性深入访谈。访谈进行了录音并逐字转录。然后，第一作者对转录本进行编码，第二作者进行核实，之后进行核对并输入到定性软件NVIVO中，以方便数据分析。
所进行的访谈表明，多年来NEMLC的药物选择过程得到了完善。这一过程与基本药物清单审查过程现在基本上主要是一个基于证据的过程，首先考虑药物的质量、安全性和有效性，其次是成本因素，包括药物经济学评估和药品定价。
这是南非第一项报告如何决定将药物纳入或排除在南非国家基本药物清单中的研究，并深入了解了南非基本药物清单药物选择、审查和监测过程随时间的变化。结果表明，多年来NEMLC发生了巨大转变。虽然委员会成员基本保持不变，但委员会多年来制定了其政策和流程。然而，仍有必要加强南非基本药物清单政策过程的监测和评估方面。
