Jacobsen Solveig Nordahl, Møller-Jensen Simone Eggert, Sporrong Sofia Kälvemark
Social and Clinical Pharmacy, Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 2, 2100 Copenhagen, Denmark.
J Pharm Policy Pract. 2020 Jul 8;13:29. doi: 10.1186/s40545-020-00226-2. eCollection 2020.
Pharmacies in Europe have undergone considerable changes in their regulation over the last decades, also regarding nonprescription medicines (NPMs). In 2001, selected NPMs were released for sale outside pharmacies in Denmark. To ensure consumer safety, it was decided that NPMs must be stored behind the counter. In 2018, an amending act came into force, which allowed self-selection of NPMs. The purpose of this study was to examine the rationales and related arguments, including their validity and relevance, behind the policy on self-selection of NPMs in Denmark.
A qualitative study design, combining document analysis and individual interviews with key stakeholders, was used. Legislative documents were retrieved from the Parliaments' homepage. Interviewees were recruited through purposeful sampling. Interviews were analyzed using directed content analysis. Rationales and supporting arguments were identified, thematized and analyzed as to their validity and relevance.
In total, 24 stakeholders (including political parties) were represented in the documents, whereof 7 were interviewed. Ten supported the new policy and 13 were against; 1 was on both sides. Six rationales and 9 supportive arguments were found. The advocates' main rationale was increased accessibility and arguments related to freedom of choice and discretion. The opponents' main rationale for not adopting the policy was consumer safety and arguments related to perception of NPMs and counseling. The validity and relevance were questionable in both advocates' and opponents' arguments, yet slightly better in the case of the opponents'. Although not mentioned in the documents, economic interests were probably behind some stakeholders' position.
The formal rationale behind the adoption of self-selection of NPMs was increased accessibility. However, bearing in mind the rationales and their supporting arguments, economic interests and previous changes within the sector, it could be argued that an underlying rationale behind adopting the policy was to liberalize the Danish pharmacy sector even further.
在过去几十年里，欧洲的药店在监管方面经历了相当大的变化，非处方药（NPMs）的监管也是如此。2001年，丹麦选定的非处方药被允许在药店以外的地方销售。为确保消费者安全，决定非处方药必须存放在柜台后面。2018年，一项修订法案生效，允许消费者自行选择非处方药。本研究的目的是探讨丹麦非处方药自选政策背后的理由及相关论点，包括其有效性和相关性。
采用定性研究设计，将文献分析与对关键利益相关者的个人访谈相结合。从议会主页检索立法文件。通过目的抽样招募受访者。采用定向内容分析法对访谈进行分析。确定理由和支持性论点，进行主题化处理，并分析其有效性和相关性。
文件中总共代表了24个利益相关者（包括政党），其中7人接受了访谈。10人支持新政策、13人反对；1人持中立态度。共发现6条理由和9条支持性论点。支持者的主要理由是提高了可及性以及与选择自由和自主决定权相关的论点。反对者不采纳该政策的主要理由是消费者安全以及与非处方药认知和咨询相关的论点。支持者和反对者的论点在有效性和相关性方面都存在疑问，但反对者的情况略好一些。尽管文件中未提及，但经济利益可能是一些利益相关者立场背后的原因。
采用非处方药自选政策的正式理由是提高了可及性。然而，考虑到理由及其支持性论点、经济利益以及该行业先前的变化，可以认为采纳该政策的一个潜在理由是进一步放宽丹麦的药店行业。
