Boyle Todd A, Bishop Andrea C, Mahaffey Thomas, Mackinnon Neil J, Ashcroft Darren M, Zwicker Bev, Reid Carolyn
Gerald Schwartz School of Business, St. Francis Xavier University, Antigonish, Nova Scotia, Canada.
Gerald Schwartz School of Business, St. Francis Xavier University, Antigonish, Nova Scotia, Canada.
Res Social Adm Pharm. 2014 Mar-Apr;10(2):387-97. doi: 10.1016/j.sapharm.2013.06.002. Epub 2013 Jul 2.
Given the demanding nature of providing pharmacy services, coupled with the expanded scope of practice of the professions in jurisdictions around the world, greater commitment to continuous quality improvement through adoption of quality-related event (QRE) reporting is necessary to ensure patient safety. Pharmacy regulatory authorities (PRAs) are in a unique position to enhance QRE reporting and learning through the standardization of expected practice.
This study was aimed to gain a better understanding of the perceived roles of PRAs in enhancing QRE reporting and learning in community pharmacies, and identifying regulatory best practices to execute such roles.
A purposive case sampling approach was used to identify PRA staff members from two groups (Deputy registrars and pharmacy inspectors) in 10 Canadian jurisdictions to participate in focus groups in the fall of 2011. Focus groups were used to explore perceptions of the role of PRAs in enhancing and promoting QRE reporting and learning, and perceived barriers to effective implementation in practice. Thematic analysis was used to analyze the qualitative data.
Two focus groups were conducted, one with seven Deputy registrars/Practice managers, and one with nine pharmacy inspectors. Five themes were identified, including (1) defining QRE reporting and compliance, (2) navigating role conflict, (3) educating for enhanced QRE reporting and learning, (4) promoting the positive/removing the fear of QREs, and (5) tailoring QRE reporting and learning consistency.
Overall, participants perceived a strong role for PRAs in enhancing QRE reporting and learning and providing education for pharmacies to support their compliance with reporting standards. However, PRAs must navigate the conflict inherent in both educating and promoting a process for achieving a standard while simultaneously inspecting compliance to that standard. Ensuring pharmacies have autonomy in operationalizing standards may help to mitigate this conflict. Finally, greater education for PRAs themselves to better inspect compliance and in order to better communicate the benefits of QRE reporting and learning to pharmacies would be beneficial.
鉴于提供药学服务的要求苛刻，再加上世界各地各司法管辖区专业人员执业范围的扩大，通过采用质量相关事件（QRE）报告来更坚定地致力于持续质量改进对于确保患者安全而言是必要的。药学监管机构（PRA）处于通过规范预期实践来加强QRE报告和学习的独特地位。
本研究旨在更好地了解PRA在加强社区药房QRE报告和学习方面所感知到的作用，并确定执行此类作用的监管最佳实践。
采用目的抽样法，从加拿大10个司法管辖区的两组人员（副注册官和药房检查员）中确定PRA工作人员，于2011年秋季参加焦点小组讨论。焦点小组用于探讨对PRA在加强和促进QRE报告及学习方面作用的看法，以及在实践中有效实施的感知障碍。采用主题分析法对定性数据进行分析。
进行了两个焦点小组讨论，一个由七名副注册官/实践经理组成，另一个由九名药房检查员组成。确定了五个主题，包括（1）定义QRE报告及合规性，（2）应对角色冲突，（3）为加强QRE报告和学习开展教育，（4）促进积极方面/消除对QRE的恐惧，以及（5）调整QRE报告和学习的一致性。
总体而言，参与者认为PRA在加强QRE报告和学习以及为药房提供教育以支持其遵守报告标准方面发挥着重要作用。然而，PRA必须应对在教育和促进实现标准的过程中同时检查对该标准的遵守情况所固有的冲突。确保药房在实施标准方面拥有自主权可能有助于缓解这种冲突。最后，对PRA自身进行更多教育，以便更好地检查合规情况，并更好地向药房传达QRE报告和学习的益处，将是有益的。
