Non-interventional studies on drug usage and safety aspects in community pharmacies

In Germany, community pharmacies are the first point of contact in terms of self-medication. By giving advice and support, pharmacists play an important role in decision making of patients' self-treatment and self-medication. Therefore, community pharmacies are especially suited to monitor the use and the safety of OTC drugs in post marketing surveillance studies. However, such pharmacy-based epidemiological studies are still uncommon in Germany. Keeping an increasing trend of self-care in mind, monitoring is valuable for different groups of OTC drugs, in particular for those with a previous prescription-only status. Although the Rx to OTC switch is based on evident criteria, a generally less controlled use has to be expected and monitoring should therefore be made standard practice. For the evaluation of usage patterns and safety aspects under „real-world“ conditions, non-interventional studies (NIS) in community pharmacies are one possible method. These studies are regulated by the German Law of Drugs. Due to this, NIS must not influence pharmacists' advice, the decision on the enrolment of customers as well as the decision, if and to what degree the patients are advised about the appropriate usage of the drug. In addition to the legal requirements on patient recruitment, further attention has to be paid on special methodological aspects of the community pharmacy setting, such as sampling and recruiting of pharmacies (e.g., location and type of pharmacy, motivation of staff, qualification of pharmacists, privacy, team size), data collection or quality assurance. In summary, by carefully planning and carrying out these studies, NIS can provide an important contribution to pharmacy practice research.