Koduah Augustina, Kusu Ndinda, Ahimon Herodias, Brown Andrew, Njeru Nancy, Menge Tom, Ouattara Mahama, Upadhyay Nijan, Upadhyaya Madan Kumar, Jiha Melissa, Hodgson Robbie, Nfor Emmanuel, Aboagye-Nyame Francis, Hafner Tamara
School of Pharmacy, University of Ghana, Accra, Ghana.
USAID Medicines, Technologies, and Pharmaceutical Services Program, Management Sciences for Health, Nairobi, Kenya.
J Pharm Policy Pract. 2024 Dec 13;17(1):2430438. doi: 10.1080/20523211.2024.2430438. eCollection 2024.
National pharmaceutical services units (NPSUs) - organisational units within the central government usually responsible for pharmaceutical services and management - have an increasingly narrow mandate. Anecdotal evidence points to an increasing focus, almost exclusively, on logistics management, while pharmaceutical care and policy oversight have become fragmented. This study examined NPSUs' current functions and mandates, and proposed what should be the critical functions and roles of these units going forward.
Using case studies of Côte d'Ivoire, Kenya and Nepal, the study relied on a literature review and in-depth interviews. We triangulated and synthesised the findings to identify NPSUs by level in the health ministry's hierarchy and reporting line, mandate, and function.
We identified medicine regulation, procurement and supply chain management, selection and rational use of medicines, and pharmacy practice regulation as four broad sets of functions that NPSUs commonly have as their mandate. A clear position in the Ministry of Health's hierarchical structure, the legal or administrative framework that mandates an NPSU's functions, and national pharmaceutical policies and regulations to guide the pharmaceutical sector are three critical factors for effective functioning. It is essential to have a legislative framework that at a minimum identifies one NPSU as responsible for pharmaceutical policy and governance, serving as the steward for the pharmaceutical system. This role encompasses pharmaceutical system coordination and administrative functions, formulating and implementing policies for organising, managing, financing, regulating, monitoring, and evaluating the pharmaceutical system. As such, we recommend that NPSUs should at a minimum have four broad sets of functions: pharmaceutical policy and governance, medicine regulation, pharmacy practice regulation and procurement and supply chain management.
The study substantiates the need for a pharmaceutical policy and governance unit that stewards the pharmaceutical system and is empowered to monitor and evaluate system performance and coordinate efforts for system strengthening.
国家药品服务单位（NPSUs）——中央政府内通常负责药品服务和管理的组织单位——的职责范围日益狭窄。传闻证据表明，几乎完全越来越侧重于物流管理，而药品照护和政策监督已变得分散。本研究考察了国家药品服务单位目前的职能和职责，并提出了这些单位未来应具备的关键职能和作用。
该研究以科特迪瓦、肯尼亚和尼泊尔的案例研究为基础，依靠文献综述和深入访谈。我们对研究结果进行三角互证和综合分析，以按卫生部层级中的级别、报告线路、职责和职能来确定国家药品服务单位。
我们确定药品监管、采购与供应链管理、药品的选择与合理使用以及药房业务监管为国家药品服务单位通常作为其职责的四大类职能。在卫生部层级结构中的明确地位、规定国家药品服务单位职能的法律或行政框架以及指导药品部门的国家药品政策和法规是有效运作的三个关键因素。必须有一个立法框架，至少确定一个国家药品服务单位负责药品政策和治理，充当药品系统的管理者。这一角色包括药品系统协调和行政职能，制定和实施用于组织、管理、资助、监管、监测和评估药品系统的政策。因此，我们建议国家药品服务单位至少应具备四大类职能：药品政策和治理、药品监管、药房业务监管以及采购与供应链管理。
该研究证实需要设立一个药品政策和治理单位，以管理药品系统，并有权监测和评估系统绩效以及协调加强系统的工作。
