Duties and responsibilities of the Pharmacovigilance Department
An important aspect of drug regulation in Kosovo is “pharmacovigilance”, which is the science and activity that deals with the detection, assessment, understanding, and prevention of side effects or any other drug-related problem.
Pharmacovigilance is an integral part of public health programs in many countries around the world and an important part of drug policy within a country.
It was established in 2006, and as a department it began operating in 2007 with Administrative Instruction No. 2006/08 “Pharmacovigilance of Medicinal Products for Human Use”
This department aims to increase patient care and safety in relation to the use of medicines and all medical and paramedical interventions, raise the level of Public Health and safety in relation to the use of medicines, detect problems related to the use of medicines and communicate them adequately and in a timely manner, contribute to the assessment of the benefit, harm, effectiveness and risk from the use of medicines, in terms of preventing harmful effects and enhancing the benefit of drug use, encourage and promote the safe, rational and more effective use (including cost-effectiveness) of medicines, and promote the methodology of reporting side effects, educate and clinical train medical staff and patients in pharmacovigilance and effectively communicate these reports to the public.
An important source of new information for achieving these objectives is the reporting of suspected side effects of medicinal products by healthcare professionals.
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