Safety and risk communication to patients.

Comprehensive and accurate information about the medicines available to them is a key issue for patients to participate in the decision making process of their own healthcare. One aspect of this information is the patient information leaflet provided by the manufacturer, according to national and international guidelines. The comprehensibility and user-friendliness of these manufacturers' leaflets has been tested and criticised. In addition to this information under the laws of national and international authorities, consumer-oriented websites of self-help groups are becoming a more and more relevant source of information. For most patients, the primary sources of information are healthcare professionals, such as the prescribing physicians and/or nurses or the dispensing pharmacist. The information provided for by healthcare professionals has to be tailored according to the patients' needs, where law suits against physicians often address the comprehensiveness and a lack of documentation. Improvement of individualised drug information has been shown to increase patients' satisfaction and treatment adherence, whereas the overall influence on outcome (i.e., reduction of adverse drug events) has still to be demonstrated. However, in order to achieve such a goal, striking changes in the whole system of pharmacovigilance have to be implemented with special emphasis on patients and consumers representation.