Patient safety issues associated with the use of compounded medicines as alternatives to approved pharmaceutical products in Europe and how best practice can improve outcomes

Several case reports/series describing instances of overdose, medication errors and adverse events associated with compounded medications were reviewed. The number of affected patients was relatively small, but many were children and two adult patients experienced permanent sequelae. The number of incidents associated with compounded medicines is unknown, and so these numbers should be interpreted with caution. When licensed medicines are available, the use of compounded medicines can put patients at unnecessary risk which should be avoided. Stricter regulation is necessary to prevent similar cases from occurring in the future as the European market for compounded medications grows. Pharmacists can promote best practices in compounding through professional organisations. Future recommended actions are: 1. Stricter regulation is necessary to prevent similar cases from occurring in the future as the European market for compounded medications grows. 2. A comprehensive pan-European survey to gain a greater understanding of compounding procedures and techniques. This would provide valuable information to the benefit of hospital systems and their patients. 3. The results of the survey can then be used to improve the knowledge and quality control of compounded medicines for the good of patient safety.