The safety assessment of over-the-counter (OTC) products

In recent years many compounds have become available as Over-The-Counter (OTC) medicine, for self-medication, which were originally marketed as prescription medicines only. This has been coupled with changes in the consumers' behaviour to self treatment and the governments commitment to restrict rising health costs. The safety and safe use of OTC products are important considerations for their wide distribution which is paralleled by diminishing medical supervision. OTC products were generally registered when toxicological requirements differed from the stringent guidelines of today, and their safety assessment thus often involves ongoing evaluation as new data become available. For this, human data must also be integrated for these assessments. However, in some areas, such as mutagenicity and carcinogenicity testing, human data are hardly obtainable and testing in animals or cells, is ultimately the only reliable source for extrapolation to man. Routine toxicological methods have mainly been developed for the assessment of new pharmaceutical entities and often provide 'yes/no' answers only. Data of such tests are, therefore, not directly applicable to the safety assessment of OTC products. Additional information on the kinetics in animal and man are indispensable for such extrapolation. On the other hand, modifications of original test protocols for the assessment of new formulations are indispensable. It was the aim of this workshop to discuss general approaches of safety assessments within the important new area of OTC products, as well as to present specific cases of recently arisen safety issues.