Naughton Bernard, Roberts Lindsey, Dopson Sue, Brindley David, Chapman Stephen
Institute of Science and Technology in Medicine, Keele University, Keele, UK.
Said Business School, University of Oxford, Oxford, UK.
BMJ Open. 2017 May 6;7(5):e013838. doi: 10.1136/bmjopen-2016-013838.
This study aims to establish expert opinion and potential improvements for the Falsified Medicines Directive mandated medicines authentication technology.
A two-round Delphi method study using an online questionnaire.
Large National Health Service (NHS) foundation trust teaching hospital.
Secondary care pharmacists and accredited checking technicians.
Seven-point rating scale answers which reached a consensus of 70-80% with a standard deviation (SD) of <1.0. Likert scale questions which reached a consensus of 70-80%, a SD of <1.0 and classified as important according to study criteria.
Consensus expert opinion has described database cross-checking technology as quick and user friendly and suggested the inclusion of an audio signal to further support the detection of counterfeit medicines in secondary care (70% consensus, 0.9 SD); other important consensus with a SD of <1.0 included reviewing the colour and information in warning pop up screens to ensure they were not mistaken for the 'already dispensed here' pop up, encouraging the dispenser/checker to act on the warnings and making it mandatory to complete an 'action taken' documentation process to improve the quarantine of potentially counterfeit, expired or recalled medicines.
This paper informs key opinion leaders and decision makers as to the positives and negatives of medicines authentication technology from an operator's perspective and suggests the adjustments which may be required to improve operator compliance and the detection of counterfeit medicines in the secondary care sector.
本研究旨在就《假药指令》规定的药品认证技术确立专家意见及潜在改进措施。
采用在线问卷进行两轮德尔菲法研究。
大型国民医疗服务体系（NHS）基础信托教学医院。
二级医疗药剂师和经认可的检查技术员。
七点量表答案达成70 - 80%的共识，标准差（SD）<1.0。李克特量表问题达成70 - 80%的共识，标准差<1.0，且根据研究标准归类为重要问题。
专家共识意见认为数据库交叉核对技术快速且用户友好，并建议加入音频信号以进一步支持二级医疗中假药的检测（70%达成共识，标准差0.9）；标准差<1.0的其他重要共识包括审查警告弹出屏幕中的颜色和信息，以确保它们不会被误认为是“此处已配药”弹出窗口，鼓励配药人员/检查人员对警告采取行动，并强制要求完成“采取行动”文件记录流程，以改善对潜在假药、过期药或召回药品的隔离。
本文从操作人员的角度告知关键意见领袖和决策者药品认证技术的优缺点，并提出可能需要进行的调整，以提高操作人员的合规性并加强二级医疗部门中假药的检测。
