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药房经营场所许可政策的制定:来自加纳的经验

Pharmacy premises licensing policy formulation: experience from Ghana.

作者信息

Koduah Augustina, Sekyi-Brown Reginald, Nyoagbe Joseph Kodjo Nsiah, Danquah Daniel Amaning, Kretchy Irene

机构信息

Department of Pharmacy Practice and Clinical Pharmacy, School of Pharmacy, University of Ghana, P.O. Box LG43, Legon, Ghana.

, No 001 Community 14 Annex Tema, Teshie Nungua Estates, P.O. Box TNE 644, Accra, Ghana.

出版信息

Health Res Policy Syst. 2021 Feb 8;19(1):16. doi: 10.1186/s12961-021-00680-7.

Abstract

BACKGROUND

Licences to operate pharmacy premises are issued by statutory regulatory bodies. The Health Institutions and Facilities Act (Act 829) and Health Professions Regulatory Bodies Act (Act 857) regulate pharmacy premises and the business of supplying restricted medicines by retail, respectively, and this could create a potential regulatory overlap for pharmacy practice in Ghana. We theorise that the potential overlap of regulation duties stems from how law-makers framed issues and narratives during the formulation of these Acts.

OBJECTIVE

To describe the policy actors involved, framing of narratives and decision-making processes relating to pharmacy premises licensing policy formulation.

METHODS

A qualitative study was conducted and data gathered through interviewing eight key informants and reviewing Hansards, reports, bills, memoranda and Acts 829 and 857. Data were analysed to map decision-making venues, processes, actors and narratives.

RESULTS

The Ministry of Health drafted the bills in July 2010 with the consensus of internal stakeholders. These were interrogated by the Parliament Select Committee on Health (with legislative power) during separate periods, and decisions made in Parliament to alter propositions of pharmacy premises regulations. Parliamentarians framed pharmacies as health facilities and reassigned their regulation from the Pharmacy Council to a new agency. The Pharmacy Council and the Pharmaceutical Society of Ghana could not participate in the decision-making processes in Parliament to oppose these alterations. The laws' contents rested with parliamentarians as they made decisions in venues restricted to others. Legislative procedure limited participation, although non-legislative actors had some level of influence on the initial content.

CONCLUSION

Implementation of these laws would have implications for policy and practice and therefore understanding how the laws were framed and formulated is important for further reforms. We recommend additional research to investigate the impact of the implementation of these Acts on pharmacy practice and business in Ghana and the findings can serve as bargaining information for reforms.

摘要

背景

药房经营许可证由法定监管机构颁发。《卫生机构与设施法案》(第829号法案)和《卫生专业监管机构法案》(第857号法案)分别对药房经营场所及零售受限药品业务进行监管,这可能在加纳的药房业务监管方面造成潜在的监管重叠。我们推测,监管职责的潜在重叠源于立法者在制定这些法案时对问题和叙述的构建方式。

目的

描述参与药房经营场所许可政策制定的政策行为者、叙述框架及决策过程。

方法

开展了一项定性研究,通过采访八位关键信息提供者并查阅议会议事录、报告、法案、备忘录以及第829号和第857号法案来收集数据。对数据进行分析,以梳理决策场所、过程、行为者及叙述。

结果

卫生部在内部利益相关者达成共识的情况下于2010年7月起草了这些法案。议会卫生特别委员会(拥有立法权)在不同时期对这些法案进行了审议,并在议会中做出决定,更改药房经营场所法规的提议。议员们将药房界定为卫生设施,并将其监管权从药房理事会重新分配给一个新机构。药房理事会和加纳制药协会无法参与议会的决策过程以反对这些更改。由于议员们在仅限其他人参与的场所做出决策,所以法律内容由他们决定。立法程序限制了参与,尽管非立法行为者对初始内容有一定程度的影响。

结论

这些法律的实施将对政策和实践产生影响,因此了解这些法律的构建和制定方式对于进一步改革很重要。我们建议开展更多研究,以调查这些法案的实施对加纳药房业务和经营的影响,研究结果可作为改革的谈判信息。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6ab7/7869225/55d100d49e9a/12961_2021_680_Fig1_HTML.jpg

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