Medicines for an aging population: The EMA perspective and policies.

The European Medicines Agency adopted their Geriatric Medicines Strategy more than a decade ago. The strategy aims at elucidating the evidence basis for marketing authorization of new medicines which will be used in the older population, and at ensuring the appropriate communication of findings to the patient and healthcare provider. During the past decade new tools and data sources have emerged to support the strategy goals, and their use should be considered. Possible concrete actions are presented to improve the design of clinical trials, the data collection both pre- and post-approval, the assessment of the findings, and the communication to assist informed prescription and safe medicine taking. Implementation and prioritization of these actions should be done from the perspective of addressing the needs of patients while maximizing efficient use of resources, with the aim of integrating geriatric aspects into routine medicines development and assessment.

Enhancing Pharmacovigilance Capabilities in the EU Regulatory Network: The SCOPE Joint Action.

In November 2013, a team of European regulators initiated the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action. Funded by the Health Programme of the European Union, and with contributions from the involved Member States, SCOPE gathered information and expertise on how regulators in Member States run their national pharmacovigilance systems to meet the requirements of the pharmacovigilance legislation that came into effect in June 2012. The SCOPE project evaluated then-current practices and developed tools to further improve the skills and capability in the pharmacovigilance network. The project was divided into eight separate work streams, five of which concentrated on pharmacovigilance topics-collecting information on suspected adverse drug reactions, identifying and managing safety issues (signals), communicating risk and assessing risk minimisation measures, supported by effective quality management systems. The other three work streams focused on the functional aspects-coordination, communication and evaluation of the project. Through the project, SCOPE delivered guidance, training in key aspects of pharmacovigilance, and tools and templates to support best practice. The deliverables provide practical guidance that those working in the European national competent authorities can take to strengthen their national systems. The SCOPE outputs can be useful for other stakeholders involved in pharmacovigilance activities, including the pharmaceutical industry, healthcare professionals, patient and consumer organisations, and academia.

[Postoperative vomiting]. / A posztoperatív hányásról.

INTRODUCTION: Nausea and vomiting following general anaesthesia are among the most frequent adverse reactions causing complications, the relief of which is an absolute demand. 5-HT3 receptor antagonists, such as ondansetron, belonging to the latest class of antiemetics were launched more than a decade ago. PATIENTS/METHODS: Efficacy and tolerability of ondansetron injection in prevention of postoperative nausea and vomiting were investigated in a prospective, randomised, double-blind, placebo controlled, three-armed clinical study in 148 patients undergoing laparoscopic cholecystectomy. Moreover the authors also investigated the effect of timing of dosing, i.e. whether the administration of antiemetic drug before starting anaesthesia has any advantage comparing its use at the end of operation. RESULTS: While using a standard surgical and anaesthesia method vomiting after laparoscopic cholecystectomy occurred in a frequency of 44.7% of the patients in the placebo group, whereas the figures decreased significantly after administration of 4 mg ondansetron at the end (28.9%) or before (25.5%) anaesthesia. Inclusively the frequency of severe cases decreased from 19.2% of control group up to 8.9% and 4.3% in the active groups, respectively. CONCLUSIONS: Intravenous administration of 4 mg ondansetron effectively reduces vomiting occurring in more than 40% of patients after laparoscopic cholecystectomy, especially the frequency of severe cases, and mainly if administered before operation. The preparation is safe; no clinical or laboratory adverse reactions, complications have been observed in the studied patients.