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Content analysis of teaching programs for pharmacovigilance in Bulgaria

Svetoslav Stoev, Konstantin Kalaidjiev, Ilko Getov

Abstract

Modern fast pace of development of pharmaceutical and medical knowledge, drug regulation, pharmacotherapy and innovative approaches to control and treat diseases caused an acute need for a modern system for detection, assessment and prevention of adverse effects of medicinal products or pharmacovigilance.

In this context and to response growing shortage of competent professionals in the field of post-marketing surveillance puts the need of wider implementation of pharmacovigilance and pharmacoepidemiology educational qualification requirements, skills and programs of higher medical schools curricula.

The aim of this study was to establish to what extent the training of pharmacists in Bulgaria meets the current requirements of pharmacoepidemiology and pharmacovigilance, and what are the short and medium term challenges. By the systematic literature review and comparative analysis of regulatory documents and training programs were established the following results: tendency of adequate synchronization between the Bulgarian educational training programs and postgraduate courses and the modern European practices for training of professionals in the field of pharmacovigilance. There are introduced subjects and modules for practical training in pharmacoepidemiology and pharmacovigilance, lectures and classes for risk management, free elective subjects in the field of pharmacovigilance, etc. However, there is still the challenge to strengthen the focus on practical training in the methods of pharmacovigilance. The degree of training is insufficient in the new branches of science for vigilance, namely monitoring the safety of medical devices (materiovigilance), drug information (infovigilance), cosmetics (cosmeticovigilance).

There is no separation of pharmacoepidemiology as an independent discipline and still there is no specific postgraduate training.





DOI: http://dx.doi.org/10.14748/ssp.v1i0.2521

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About The Authors

Svetoslav Stoev
Medical University of Sofia
Bulgaria

Department of Social Pharmacy and Pharmacoeconomics, Faculty of Pharmacy

Konstantin Kalaidjiev
Medical University of Sofia
Bulgaria

Department of Social Pharmacy and Pharmacoeconomics, Faculty of Pharmacy

Ilko Getov
Medical University of Sofia
Bulgaria

Department of Social Pharmacy and Pharmacoeconomics, Faculty of Pharmacy

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