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Background 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. Objective This review describes the issues and potential risks associated with compounded medicines and equally importantly identifies best practices. Methods 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. Results 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. Conclusions 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.

There is a rising tide of criminal activity to manufacture and distribute falsified, counterfeit, or fake medicines. The exact size of this problem is unknown but estimates vary from US$75 billion to US$200 billion per year, and evidence clearly demonstrates it is on the increase. Depending on the world region, infiltration into the legitimate supply chain versus the illegitimate (e.g., the internet) varies greatly. However, what is certain is that the direction of travel by regulatory agents is to develop supply chains that allow access to medicines via the World Wide Web. Within this context, there has been a long-running debate about how to correctly describe the various forms of medicines that are fraudulently or otherwise manufactured and distributed. This article attempts to describe the evolution of the definitions and recommends that a consensus be formed to describe such medicines that reach the public: • Falsified medicine: This being the term used and defined in the Falsified Medicines Directive and which is primarily concerned with public health. • Counterfeit medicine: This is closely associated and legally defined within intellectual property legislation and concentrates on trademark protection. • Fake medicine: This is the term that best serves to communicate with the public to raise awareness about the phenomenon.