[Cannabis medicines in pain management : Interim analysis of the survey accompanying the prescription of cannabis-based medicines in Germany with regard to pain as primarily treated symptom]. / Cannabisarzneimittel in der Schmerztherapie : Zwischenauswertung der Cannabisbegleiterhebung hinsichtlich der primär behandelten Symptomatik Schmerz.

BACKGROUND: In Germany, physicians who prescribe cannabis-based medicines at the expense of the statutory health insurance are obliged to take part in an accompanying survey. Pain was the most commonly reported diagnosis, making an interim evaluation for the indication of pain feasible. METHODS: Patient-related data was transmitted to the German Federal Institute for Drugs and Medical Devices via an online portal. In addition to demographic data, information on the treated disease or symptoms, the course of therapy, adverse reactions and treatment success were evaluated. RESULTS: A total of 3138 data sets were evaluated for the main diagnosis of pain. Dronabinol was the most frequently (64%) prescribed cannabis-based drug. On average, patients were 57 years old and women and men were equally represented. Patients treated with cannabis flowers were significantly younger (48 years). The proportion of men in this group was 68% and 83% in the group of 18- to 40-year-olds. According to the assessment by treating physicians, pain was significantly improved in 35.5% of the patients. The most frequent side effects (fatigue, dizziness, nausea) corresponded to those already known from the product information of the cannabis-based medicinal products authorized under the pharmaceutical law. Treatment was discontinued in 1179 patients within 1 year. CONCLUSION: Physicians should comply with their legal obligation to participate in the accompanying survey. Pain is by far the most common diagnosis in cannabis drugs. For about one third of these patients, physicians reported a clear improvement in pain. Due to the amount of data hitherto and the limitations in the accompanying survey, the results should not be overinterpreted in terms of efficacy and should always be related to existing reviews. The lower age and higher proportion of men among patients treated with cannabis flowers were remarkable. At 37.6%, the overall drop-out rate was high. The most frequent side effects related to vigilance and are therefore highly relevant in terms of driving ability, work ability and risk of falling. For a differentiated evaluation of treatment success, more data needs to be available.

[Palliative care in the light of legal and regulatory requirements in Germany]. / Palliativversorgung im Blickwinkel gesetzlicher und regulatorischer Vorgaben in Deutschland.

In Germany, palliative care has developed rapidly since the establishment of the first palliative care unit in 1983. More improvements in patient-centered care are only possible if legal requirements as well as education of physicians, nurses, and other professionals involved in palliative care are adapted to current needs. This paper provides an overview of legal and regulatory requirements including a critical appreciation of their influence on palliative care in Germany. Only recently has medical education in palliative medicine been implemented as an integral part of medical studies at German universities. Starting in 2014, physicians applying for a license to practice medicine will have to provide a certificate of basic training in this field. The challenge in upcoming years will be the establishment and enhancement of comprehensive, standardized, and quality-controlled education at the universities. Only six universities have established chairs for palliative medicine, and it will be essential to not only establish more chairs but also to involve medical students in the development of the education. Only minimal requirements are specified for education of nurses in palliative care in the legislation. However, standardized and quality-controlled advanced training courses are available. This training is frequently requested as a prerequisite for nurses working in palliative care. Only limited education programs exist for other professional groups that are an important part of the palliative care team. In addition to the development of palliative care for inpatients with an increasing number of palliative care units, hospices, and first chairs of palliative medicine, different forms of ambulant palliative care services have been developed. Changes in the legislation have influenced the situation for home care enormously in the last 5 years, also making it more complex. With the Law for the Consolidation of the Competition in Compulsory Health Insurance ("Gesetz zur Stärkung des Wettbewerbs in der gesetzlichen Krankenversicherung"), a legal claim for palliative home care has been implemented in the fifth book of the social law in 2007. The ambitious goal of full coverage with comprehensive palliative home care has still not been achieved in most locations. However, after initial negotiation difficulties between palliative care providers and health insurance funds, an increasing number of contracts have been made. As a consequence-in addition to more than 240 palliative care units in Germany-more than one hundred palliative care teams have begun work in the field of specialized palliative home care. Legal regulations for the supply of opioids and other medications for the treatment of patients at home have been adapted recently, thus, facilitating fast and comprehensive medical treatment in emergency situations. Overall, the legislation has been adapted significantly, hence, contributing to improvements for patients requiring palliative care. It remains to be seen whether additional adjustments are required in the future.

[Recording and reporting adverse reactions in clinical trials. New legal provisions according to the 12th Law Amending the German Drug Law (AMG) and the Ordinance on GCP (GCP-V)]. / Erfassung und Anzeige von Nebenwirkungen in klinischen Prüfungen Neue gesetzliche Bestimmungen in der 12. AMG-Novelle und der GCP-Verordnung.

With the 12th Law Amending the German Drug Law and the Ordinance on GCP (GCPV), new legal provisions for clinical trials came into force in August 2004. These include specific definitions and differentiated reporting obligations affecting investigators, sponsors, authorities and ethics committees concerning pharmacovigilance in clinical trials. The definitions according to section sign3 (6-8) GCP-V make clear that these provisions focus on those adverse events and adverse drug reactions, which are related to investigational medicinal products. In the GCP-V for the first time legally binding provisions for investigators are laid down defining obligations to report all serious adverse events to the sponsor. The sponsor of clinical trials plays a decisive role concerning the evaluation, documentation and reporting to the competent higher authorities, ethics committees and investigators involved in the clinical trial. In the GCP-V different time limits concerning the reporting for sponsors are laid down. The requirements concerning expedited reporting focus on suspected unexpected serious adverse reactions (SUSARs), i. e. those adverse serious reactions, which are not described in the information on the investigational medicinal product. The time limit for reporting SUSARs leading to death or life-threatening SUSARs is 7 days, while for other SUSARs the time limit is 15 days. Besides the responsibilities on expedited reporting the sponsor has to submit a line listing of all serious adverse reactions which occurred during the clinical trial and a report on the safety of the trial subjects on an annual basis or on request. On the European level the harmonisation concerning the provisions on pharmacovigilance in clinical trials according to the Directive 2001/20/EC and the Eudravigilance database should contribute to reach a faster and more effective exchange of safety information related to clinical trials between the different competent authorities of the EU member states.