School of Pharmacy, The University of Auckland, Auckland, New Zealand.
Austrian Federal Office for Safety in Health Care, BASG/Austrian Agency for Health and Food Safety, AGES, Vienna, Austria.
PLoS One. 2021 Jan 25;16(1):e0245504. doi: 10.1371/journal.pone.0245504. eCollection 2021.
Austria has high health resource use compared to similar countries. Reclassifying (switching) medicines from prescription to non-prescription can reduce pressure on health resources and aid timely access to medicines. Since Austria is less progressive in this area than many other countries, this research aimed to elucidate enablers and barriers to it reclassifying medicines and make recommendations for change in the context of similar research conducted elsewhere.
Qualitative research using a heuristic approach was conducted in Austria in 2018. Informed by their own "insider" and "outsider" knowledge, the authors identified themes from personal interviews with 24 participants, including reclassification committee members, government officials and stakeholders, before comparing these themes with earlier research findings.
Significant barriers to reclassification included committee conservatism, minimal political support, medical negativity and few company applications. Insufficient transparency about committee decisions, expectations of adverse committee decisions and a limited market discouraged company applications. Austria's 'social partnership' arrangement and consensus decision making aided a conservative approach, but the regulator and an alternative non-committee switch process were enabling. Pharmacy showed mixed interest in reclassification. Suggested improvements include increasing transparency, committee composition changes, encouraging a more evidence-based approach by the committee, more pharmacy undergraduate clinical training, and companies using scientific advisory meetings and submitting high quality applications.
Removing barriers to reclassification would facilitate non-prescription availability of medicines and encourage self-care, and could reduce pressure on healthcare resources.
与其他相似国家相比,奥地利的卫生资源使用量较高。将药品从处方药重新分类(转换)为非处方药可以减轻卫生资源的压力,并有助于及时获得药品。由于奥地利在这方面的进展不如许多其他国家,因此这项研究旨在阐明重新分类药品的促进因素和障碍,并根据在其他地方进行的类似研究提出变革建议。
2018 年在奥地利进行了定性研究,采用启发式方法。作者根据自己的“内部”和“外部”知识,从 24 名参与者(包括重新分类委员会成员、政府官员和利益相关者)的个人访谈中确定主题,然后将这些主题与早期的研究结果进行比较。
重新分类的重大障碍包括委员会的保守主义、政治支持不足、医学上的消极态度以及很少有公司申请。委员会决策的透明度不足、对委员会不利决策的期望以及有限的市场阻碍了公司的申请。奥地利的“社会伙伴关系”安排和共识决策有助于采取保守的方法,但监管机构和替代非委员会转换过程具有推动作用。药店对重新分类表现出混合兴趣。建议的改进措施包括提高透明度、改变委员会组成、鼓励委员会采取更基于证据的方法、增加药学本科临床培训、以及公司利用科学咨询会议和提交高质量的申请。
消除重新分类的障碍将促进非处方药的供应,并鼓励自我保健,从而减轻医疗保健资源的压力。