Patient-centred regulatory audits in community pharmacy

Abstract

The pharmacy profession is a patient-centred practice, where the pharmacist translates science to regulated practice. Pharmacy practice has evolved from compliance and adherence to concordance. Could regulation adopt the same concept? The objectives of this research were to: (1) Retrospectively analyse community pharmacy regulatory audit (CPRA) reports, (2) develop, validate and implement an updated tool for CPRAs, and (3) identify and analyse case studies from CPRAs to recommend improvements in patient safety. The methodology involved: (1) retrospective analysis of CPRA reports to extract features that could lead to identification of patient-related deficiencies in community pharmacy practice, (2) development of an updated audit tool using data from the retrospective analysis and interviews with community pharmacists, (3) validation of the audit tool by eight auditors from the Malta Medicines Authority and two community pharmacists, (4) implementation of the audit tool in routine CPRAs, (5) identifying desirable patientrelated improvements through observation, and (6) engaging in informal educational discussions with the practicing pharmacists during CPRAs. Case studies on deficiencies related to patient safety were identified and evaluated. Dossiers, European Public Assessment Reports and consultation with the Marketing Authorisation Holders were sources that provided the background for the case studies analysis. A total of 512 CPRA reports for a 57-month period (January 2012-September 2016) were analysed. Interviews with 12 community pharmacists were performed extracting 14 patient-focused recommendations. The audit tool was implemented during CPRAs in 85 pharmacies over an 11-month period (January-November 2017). Seven case studies were evaluated and analysed including 4 dispensing problems (errors, near misses, lack of proper prescription, unsupervised pharmacy staff), 2 inventory deficiencies (expired items, inappropriate storage temperature) and 1 inequity of treatment between private and government-sponsored patients. Concordance with the pharmacist was reached and actions (N=46) with a patient-centred focus were taken to address the identified deficiencies. Standard operating procedures were developed, such as for temperature recording and for referral of patients to the pharmacist for ailments requiring medicines. Methods for alerts were devised and communication with patients, including when a possible error is detected, were identified. An educational approach by the auditor in CPRAs, reaching concordance to regulation as distinct to forceful compliance, may improve pharmacist motivation and patient care outcomes.