School of Pharmacy, The University of Auckland, Auckland, New Zealand.
School of Pharmacy and Pharmacology, Griffith University, Queensland, Australia.
Res Social Adm Pharm. 2019 Apr;15(4):387-394. doi: 10.1016/j.sapharm.2018.06.004. Epub 2018 Jun 13.
Widening access to medicines through reclassification ('switching') of medicines from prescription to non-prescription is an international trend generally welcomed by community pharmacists. Research has focused on scheduling and committee deliberations affecting reclassification, rather than industry aspects, despite industry's role in driving reclassifications. The research aimed to identify how pharmaceutical industry and product-related factors influence reclassification, and to explore stakeholder acceptability of government or third-party driven reclassifications.
Sixty-five in-depth, semi-structured interviews were conducted with 80 key informants (including representatives from regulatory bodies, industry, pharmacy and medicine) in developed countries including the United States, the United Kingdom, Japan, Australia, and New Zealand. The questions explored barriers and enablers to reclassification at the local (micro-), regional (meso-) and global (macro-) levels. Analysis of transcribed interviews entailed descriptive and thematic approaches.
Pharmaceutical industry decisions to drive medicine reclassification reflect characteristics of the company, product, and external environment at all levels. For the company, financial factors, company focus (e.g. on prescription business versus non-prescription business), and capability in non-prescription medicines and reclassification were common influences. Products with significant non-prescription market potential and a well-known prescription medicine brand name most suited reclassification, usually near patent expiry. Barriers included immediate generic entry post-reclassification, and a short-term profitability and/or prescription business focus. Some countries allow government or a third-party (including pharmacy) to drive reclassifications, with examples of successful reclassifications ensuing. Some industry and other participants held concerns about this practice, particularly in the United States. Concerns included insufficient resourcing, and the pharmaceutical company's business, potentially encouraging product withdrawal or legal challenge.
This study is the first to explore both pharmaceutical industry factors affecting reclassification and acceptability of alternate drivers of reclassification. Factors beyond clinical safety and efficacy and the local reclassification environment can influence reclassification. Pharmacy-driven reclassification might be one alternative.
通过将药品从处方药重新分类为非处方药来扩大药品的可及性是一种国际趋势，普遍受到社区药剂师的欢迎。尽管制药业在推动重新分类方面发挥了作用，但研究主要集中在影响重新分类的时间表和委员会审议上，而不是制药业方面。本研究旨在确定制药业和产品相关因素如何影响重新分类，并探讨政府或第三方驱动的重新分类的利益相关者可接受性。
在美国、英国、日本、澳大利亚和新西兰等发达国家，对 80 名关键信息提供者（包括监管机构、制药业、药店和医药代表）进行了 65 次深入的半结构化访谈。这些问题探讨了在地方（微观）、区域（中观）和全球（宏观）层面重新分类的障碍和促成因素。对转录访谈的分析采用了描述性和主题性方法。
制药业决定推动药品重新分类反映了公司、产品和外部环境在各个层面的特点。就公司而言，财务因素、公司重点（如处方药业务与非处方药业务）以及非处方药和重新分类方面的能力是常见的影响因素。具有显著非处方药市场潜力和知名处方药品牌的产品最适合重新分类，通常在专利到期前。障碍包括重新分类后立即出现的通用产品进入，以及短期盈利能力和/或处方药业务重点。一些国家允许政府或第三方（包括药店）推动重新分类，随后出现了一些成功的重新分类案例。一些行业和其他参与者对这种做法表示担忧，特别是在美国。他们的担忧包括资源不足，以及制药公司的业务，这可能会鼓励产品撤市或法律挑战。
本研究首次探讨了影响重新分类的制药业因素和重新分类替代驱动因素的可接受性。除了临床安全性和疗效以及当地重新分类环境之外，其他因素也会影响重新分类。药店驱动的重新分类可能是一种替代选择。
