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.

Abstract

Pharmaceutical compounding allows individuals with special requirements access to medicines. Compounding can also be used to provide cheaper alternatives to commercially produced medicines which may be less strictly regulated than those commercially produced as they do not require marketing authorisation. This review describes the issues and potential risks associated with compounded medicines and equally importantly identifies best practices. To establish reports about lack of effectiveness, adverse events and medication errors occurring with compounded pharmaceuticals, a literature search was conducted of PubMed, Embase and MEDLINE databases for relevant cases in European countries which were published between 2003 and 2018. Case reports/series that described instances of successful use of compounded medicines over the same period were also identified. Overall, 12 case reports/case series describing problems associated with compounded medicines in Europe have been identified. Sources of patient risk associated with compounded medicines include lack of quality, safety and efficacy data, preparation and labelling errors, and improper storage and handling practices. 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.