• N D Aydinkarahaliloglu, E Aykac, Y Kasap, N Durmus, C Babacanoglu, C E Basgut, G Artiran, and S Kerman.
• Department of Risk Management, Turkish Medicines and Medical Devices Agency, Ankara 06520, Turkey.
• Regul. Toxicol. Pharmacol. 2013 Dec 1; 67 (3): 344-50.

AbstractRisk management plans and actions aim to limit the known risks of drugs and provide valuable data to evaluate actual risks and pre-disposing factors for adverse drug reactions. In this study, it is aimed to evaluate and summarize the risk management actions in Turkey between 2005 and 2013 for the first time. The drugs monitored with a risk management plan and actions taken are evaluated by examining the records of the Turkish Pharmaceuticals and Medical Devices Agency retrospectively. Various risk management actions such as provision of information, summary of product characteristics and patient information leaflets, direct communication with healthcare professionals, patient and physician brochures, change of the legal status of the drug, education of doctors and pharmacists, control of number and validity of prescriptions, using informed consent forms, using "drug safety surveillance form" for the TNF blockers (firstly on the world), using web-based monitoring system, web-based prescription and web-based adverse reaction monitoring system were used for safe use of drugs during and after authorization in Turkey. Although, most of the actions are similar to those of international health authorities, the remaining are specific to the conditions of Turkey such as "drug safety surveillance form" for the TNF blockers. Copyright © 2013 Elsevier Inc. All rights reserved.

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