Background Pharmacy practice is evolving to incorporate a patient-centred approach to the scientific background. Regulatory audits often take the form of a policing exercise. This method may not always produce optimal outcomes. In parallel with the pharmaceutical patient advice process, advancing from compliance, adherence to concordance, an exercise is carried out to examine the application of this concept in regulatory policies to enhance patient safety.

Purpose To develop and implement a tool for regulatory audits and identify case studies from these audits to recommend improvements in patient safety.

Material and methods The method is based on retrospective analysis of 512 audit reports and interviews with 12 pharmacists to develop an audit tool for regulatory audits. The audit consisted of a documentation phase that entailed the identification of deficiencies related to regulatory requirements and an observation phase for the provision of pharmaceutical care provided by the pharmacist. Interactive educational discussions with the practising pharmacists identified desirable patient-related improvements. Seven case studies on the identified deficiencies related to patient safety were addressed.

Results The tool was applied in 85 audits (January–November 2017). Opportunities for improvement related to patient safety were identified and addressed in seven case studies namely: four dispensing problems (errors, near misses, lack of proper prescription, unsupervised pharmacy staff); two inventory deficiencies (expired items, inappropriate storage temperature); and one equity of treatment between private and government-sponsored patients. Concordance with the pharmacist was reached and 46 corrective and preventive actions were taken to address the deficiencies. Examples of actions identified included: development of standard operating procedures, such as for temperature monitoring; implementing precautions to avoid dispensing errors especially for cytotoxic and high-alert medicines, such as labelling of shelves and implementing methods of alert for ‘sound-alike’, ‘look-alike’ and ‘written-alike’ medicines; ensuring double-checking before dispensing; and performing routine stock rotation to prevent dispensing of expired medicines.

Conclusion A tool was developed, validated and implemented for regulatory audits. Follow-up audits confirmed that an approach that emphasises on reaching concordance with the pharmacist through identifying opportunities for improvement, rather than non-compliance, improves pharmacist motivation, patient safety and care outcomes. Future studies may include the harmonisation of actions across all pharmacy services.

References and/or acknowledgements Nil.

No conflict of interest.