[Improving the quality of compounded medicines through self-assessment: proof of concept].

Abstract

A systematic quality control of compounded medicines, and an associated guidance of community pharmacists, was identified as a complementary opportunity to improve and guarantee the quality of compounded medicines. Before implementing this on a national scale, a pilot project was organized. Fifty pharmacies prepared the same formula and had it checked regarding labelling, preparation reports and analytical parameters. This proof of concept demonstrated that the organisation of quality control of compounded medicines by the professional body itself is feasible. Such audits fit well in de quality assurance systems in place in community pharmacy, where any corrective measures are properly documented and implemented. This form of self-regulation has a preventive character for detecting defects and contributes to improving the quality of the preparations and thus to the patient safety.