The World Health Organisation distinguishes two categories of illegal medicines, namely substandard and falsified medicines. The latter group can however not be considered as a homogeneous group and could further be subdivided in unauthorized and counterfeit products, imitations and the so called medicines in disguise. All these products can suffer from quality defects as the absence or the wrong dosage of the API, the presence of the wrong API or designer molecules, the presence of impurities, unknown ingredients or microbial contamination, fake packaging, non-uniformity of mass or content as well as galenic issues. All these issues represent health risks for the patient, since they can result in intoxications, treatment failure, antimicrobial resistance, etc. Also in the context of medicines in disguise the risks related to the unknowingly intake of APIs should not be neglected.
Next to the national action plan performed by the Federal Agency of Medicines and Health products in collaboration with Sciensano, also on the European level a coordinated approach in the fight against illegal medicines exist within the General European Official Medicines Control Laboratory Network (GEON). The latter network is composed of over 70 laboratories, representing more than 40 countries. Within this network the Illegal Medicines Working Group coordinates these activities and facilitates the exchange of information and samples, organises specific ring tests, training sessions, symposia and joint market surveillance studies and provides technical guidance for screening and analysis of suspected illegal medicines.
To conclude, both health care workers as the public should be aware of the dangers, since trade in illegal medicines is still growing and intoxications as well as treatment failure can occur with falsified medicines. Also the use of medicines in disguise can result in side-effects and intoxication, which will not immediately be linked to it, nor by the patient, nor by the health professional.
