Department of Pharmaceutics and Central Clinical Pharmacy, Pécsi Tudományegyetem, Pecs, Hungary.
Division of Pharmacoeconomics, Pécsi Tudományegyetem, Pecs, Hungary.
BMJ Open. 2021 Nov 23;11(11):e047193. doi: 10.1136/bmjopen-2020-047193.
OBJECTIVES, SETTING AND PARTICIPANTS: In July 2011, the EU adopted the Falsified Medicines Directive (FMD) primarily aiming to prevent the infiltration of falsified medicines into the legitimate supply chain. Our aim was to measure the cost elements of FMD implementation and operation using an internationally adaptable tool among Hungarian hospital pharmacies.
A 41-item questionnaire was developed to evaluate the implementation process and associated cost consequences leading up to February 2019, and the stabilisation period.
Our representative data are supported by the high response rate, as 44.8% of the Hungarian hospital pharmacies have completed the survey. Human resource requirements related to decommissioning activities were measured as working hours and were expressed in full time equivalent (FTE). We have found an increased workload with extra 0.25 pharmacist and 0.75 technician FTE/institution at the end of the stabilisation period. The entire infrastructural and IT implementation costs were determined as €2173, on average (SD: €3366) and the median was €1506 (range: €0-€20 723). The total IT investment cost per institution was valued at €1410 (SD: €335). We identified a positive correlation (R=0.663) in consideration of the costs, the number of beds and the number of hospital locations with a multivariate linear regression model. At the time of our survey, 76.7% of the respondents experienced drug shortages, 58.1% reported suspected increase in drug costs regarding serialised medications, and 53.5% noticed an increase in packaging size.
Notably, our research is the first complex study depicting FMD cost implications in the hospital pharmacy sector in Central Europe, indicating decommissioning significantly impacted workflow referencing human resources and IT.
目的、背景和参与者：2011 年 7 月，欧盟通过了《伪劣药品指令》（Falsified Medicines Directive，FMD），主要目的是防止伪劣药品渗透到合法的供应链中。我们的目的是使用一种在国际上可适应的工具，来衡量匈牙利医院药房实施和运营 FMD 的成本要素。
我们开发了一个 41 项的问卷，以评估截至 2019 年 2 月的实施过程以及相关的成本后果，还有稳定期的情况。
我们的代表性数据得到了高回应率的支持，因为 44.8%的匈牙利医院药房已经完成了调查。与退役活动相关的人力资源需求被衡量为工作时间，并以全职等效（FTE）表示。我们发现，在稳定期结束时，每个机构增加了 0.25 名药剂师和 0.75 名技术员 FTE。基础设施和 IT 实施的全部成本平均为 2173 欧元（标准差：3366 欧元），中位数为 1506 欧元（范围：0-20723 欧元）。每个机构的总 IT 投资成本为 1410 欧元（标准差：335 欧元）。我们发现，在多元线性回归模型中，考虑到成本、床位数量和医院地点数量，存在正相关关系（R=0.663）。在我们进行调查时，76.7%的受访者经历了药品短缺，58.1%报告称序列化药物的药品成本疑似增加，53.5%注意到包装尺寸增加。
值得注意的是，我们的研究是首次在中欧地区的医院药房部门描绘 FMD 成本影响的复杂研究，表明退役对人力资源和 IT 引用的工作流程产生了重大影响。
