Entwicklung eines Leitfadens zur Durchführung nicht-interventioneller Studien in Apotheken

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 safety of OTC drugs in post marketing surveillance studies. However, such pharmacy-based epidemiological studies are still uncommon in Germany. For the evaluation of usage patterns and safety aspects under real-world conditions, non-interventional studies (NIS) in community pharmacies are one possible method. However, the recommendations for NIS to date focus first and foremost on the medical setting. The aims of this work were to characterise the regulatory requirements of non-interventional studies in Europe and Germany, to evaluate methodological issues of pharmacy-based non-interventional studies in Germany and to analyse key aspects in the conduct of international pharmacy-based observational studies. The results should be summarised in a guide for managing and conducting non-interventional studies in German community pharmacies. In a first step, European and German legal requirements were identified and analysed with regard to previously published recommendations on NIS. Second, a worldwide systematic literature review was accomplished to include national and international community pharmacy-based studies. Publications were selected based on predefined criteria, methodological particularities of those studies were reviewed by a standardised record form and summarised. Based on all these steps, requirements for the conduct of pharmacy-based non-interventional studies in Germany were merged into a criteria catalogue. Substantial parts of this catalogue were implemented in two pilot studies in order to ensure their practicability and feasibility. Both pilot projects were performed in the field of self-medication to analyse different methodological aspects (longitudinal study on the usage of a homeopathic medicine for the treatment of common cold symptoms, cross-sectional study on the usage of an antacid in the treatment of acid-related symptoms). Based on the results, the criteria catalogue was critically discussed and summarised in a guide for managing and conducting pharmacy-based non-interventional studies in Germany. NIS are regulated by European Directives, European Rules and the German Law of Drugs, respectively. Required by law and related to the pharmacy setting, 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 Germany, pharmacy-based (drug-related) NIS concentrated, for the most part, on self-medication of minor illnesses such as common cold, headache or skin disorders. Basically, they differ from physician-based NIS in the following terms: utilisation of prescription only medicines, indication field, number of participants, or duration of treatment/observation. The evaluation of NIS in Germany showed the following drawbacks: restricted characterisation of recruited patients/pharmacies, nonparticipants or nonresponders, inadequate implementation of quality assurance measures, misinterpretation of results, and insufficient discussion of study limitations. Different emphases were extracted from publications of international pharmacy-based observational studies. Those corresponded to problems indentified in German NIS, for example, sampling and recruiting of patients/pharmacies, response rates, non-participants/non-responders, piloting, bias, training/qualification of pharmacists, financing/remuneration, data collection and ethics. Therefore, approaches for methodological issues in the conducting of NIS in Germany could be deduced from the international observational studies. Feasibility and practicability of different methodological aspects of the criteria catalogue were demonstrated in both pilot studies. Moreover, for the German setting novel insights were gained from the data, e.g., general aspects on patient recruitment and the usage of a logbook for non-participant characteristics. Finally, results from the literature surveys and both pilot studies were discussed and summarised in a guideline for non-interventional studies in German community pharmacies. In summary, by carefully planning and carrying out these studies, NIS can provide an important contribution to pharmacy practice research. To facilitate the practical implementation of NIS in Germany, different regulatory requirements and recommendations as well as studies from the recent literature were covered. Methodological key aspects of pharmacy-based NIS were extracted, discussed and their feasibility was examined in two pilot studies. The results of this work were merged into a guide for non-interventional studies in community pharmacies in Germany.