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.

The International Journal of Risk & Safety in Medicine
Mike Isles

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, m...Continue Reading

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