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药品短缺:临床影响与负担——一项包括关键利益相关者的三国多方法研究

Drug shortages: clinical implications and burdens - a trinational multiple-methods study including key stakeholders.

作者信息

Rose Olaf, Hoti Kreshnik, Isufi Blete, Wachinger Matthias, Pachmayr Johanna, Hartl Alexander, Giesen Heinz, Clemens Stephanie

机构信息

Institute of Pharmacy, Pharmaceutical Biology and Clinical Pharmacy, Paracelsus Medical University Salzburg, Salzburg, Austria.

Center of Public Health and Health Services Research, Paracelsus Medical University, Salzburg, Austria.

出版信息

J Pharm Policy Pract. 2025 Sep 23;18(1):2555731. doi: 10.1080/20523211.2025.2555731. eCollection 2025.

DOI:10.1080/20523211.2025.2555731
PMID:41001073
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12459160/
Abstract

BACKGROUND

As the prevalence of drug shortages has markedly escalated in recent years, this study seeks to investigate the associated clinical implications and burdens in Austria, Germany and Kosovo where healthcare systems differ significantly.

METHODS

The research was conducted as a trinational, multiple-methods study utilising questionnaires and in-depth interviews for different stakeholders, including patients, physicians, pharmacists and manufacturers. Descriptive statistics were applied to summarise and analyse the quantitative dataset, providing key insights into central tendencies and overall data distribution, while qualitative data were analysed using the summarising approach based on Mayring's qualitative content analysis.

RESULTS

Manufacturers expressed concerns regarding the intense pressure on pricing amid global inflation. Proposed mitigation strategies were anticipated to incur higher costs, with increased stockpiling in one major country adversely affecting others. Pharmacists across all three nations reported significant disruptions to their clinical practice, with up to fifty per cent of patient encounters being affected by drug shortages, requiring considerable amounts of time to resolve. They expressed feelings of frustration and anger, citing bureaucratic obstacles and excessive regulation as impediments to effective problem-solving. Physicians reported similar challenges in their practice, often resorting to self-initiated solutions and advocating for improved information regarding drug availability. While most patients have been exposed to drug shortages, the majority of these issues were resolved with moderate interruptions to their therapy. The root causes of these problems were primarily attributed to political factors.

CONCLUSION

The results show that drug shortages have significantly disrupted clinical practice across all three countries, with pharmacists and physicians reporting major impacts on patient care and increased time spent resolving issues. Economic pressures, political factors and regulatory obstacles were identified as key causes exacerbating the crisis and highlighting the need for coordinated mitigation strategies.

摘要

背景

近年来,药品短缺的发生率显著上升,本研究旨在调查奥地利、德国和科索沃的相关临床影响及负担,这三个国家的医疗体系差异显著。

方法

该研究采用三国多方法研究,对不同利益相关者(包括患者、医生、药剂师和制造商)进行问卷调查和深入访谈。应用描述性统计方法对定量数据集进行总结和分析,以深入了解集中趋势和整体数据分布,而定性数据则采用基于梅林定性内容分析的总结方法进行分析。

结果

制造商对全球通胀下的定价压力表示担忧。预计缓解策略将带来更高成本,一个主要国家增加库存会对其他国家产生不利影响。所有三个国家的药剂师都报告称其临床实践受到重大干扰,高达50%的患者问诊受到药品短缺影响,需要花费大量时间解决。他们表达了沮丧和愤怒的情绪,称官僚障碍和过度监管是有效解决问题的阻碍。医生在实践中也报告了类似挑战,经常采取自行解决的办法,并主张改善药品供应信息。虽然大多数患者都经历过药品短缺,但这些问题大多在对其治疗造成适度干扰的情况下得到解决。这些问题的根本原因主要归因于政治因素。

结论

结果表明,药品短缺严重扰乱了这三个国家的临床实践,药剂师和医生报告称对患者护理产生了重大影响,解决问题的时间增加。经济压力、政治因素和监管障碍被确定为加剧危机的关键原因,并凸显了协调缓解策略的必要性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b5f/12459160/9baf6c6da988/JPPP_A_2555731_F0005_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b5f/12459160/9bcb6b3309ef/JPPP_A_2555731_F0001_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b5f/12459160/403932a347a9/JPPP_A_2555731_F0002_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b5f/12459160/1999666d3f19/JPPP_A_2555731_F0003_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b5f/12459160/112e460d0cfb/JPPP_A_2555731_F0004_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b5f/12459160/9baf6c6da988/JPPP_A_2555731_F0005_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b5f/12459160/9bcb6b3309ef/JPPP_A_2555731_F0001_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b5f/12459160/403932a347a9/JPPP_A_2555731_F0002_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b5f/12459160/1999666d3f19/JPPP_A_2555731_F0003_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b5f/12459160/112e460d0cfb/JPPP_A_2555731_F0004_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b5f/12459160/9baf6c6da988/JPPP_A_2555731_F0005_OC.jpg

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Influence of drug shortages on the well-being at work of pharmacists practicing in community pharmacies.药品短缺对社区药房执业药剂师工作幸福感的影响。
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BMJ. 2024 Jun 28;385:q1448. doi: 10.1136/bmj.q1448.
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Drug Shortages Prior to and During the COVID-19 Pandemic.药品短缺:新冠疫情前后
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