title: Pharmaceutical risk management in Turkey: the first national overview.
abstract: Risk 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.
authors.affiliation: Department of Risk Management, Turkish Medicines and Medical Devices Agency, Ankara 06520, Turkey.
authors.forename: N D
authors.initials: ND
authors.lastname: Aydinkarahaliloglu
authors.forename: E
authors.initials: E
authors.lastname: Aykac
authors.forename: Y
authors.initials: Y
authors.lastname: Kasap
authors.forename: N
authors.initials: N
authors.lastname: Durmus
authors.forename: C
authors.initials: C
authors.lastname: Babacanoglu
authors.forename: C E
authors.initials: CE
authors.lastname: Basgut
authors.forename: G
authors.initials: G
authors.lastname: Artiran
authors.forename: S
authors.initials: S
authors.lastname: Kerman
mesh_terms: D004348:Drug Labeling / Q000592:standards; D011307:Drug Prescriptions / Q000592:standards / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D033161:Government Regulation; D007722:Health Knowledge, Attitudes, Practice; D010353:Patient Education as Topic / Q000458:organization & administration / Q000592:standards; D055553:Prescription Drugs / Q000009:adverse effects* / Q000592:standards; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D012308:Risk Management / Q000331:legislation & jurisprudence / Q000458:organization & administration* / Q000592:standards / Q000706:statistics & numerical data; D014421:Turkey
chemical_list: D055553:Prescription Drugs
keywords: Drug safety; Risk management actions; Turkey