Scientific Online Resource System

Social Medicine

Comparative analysis of the functionalities of the ADR reporting systems in Bulgaria and other countries in Europe

Bogdan Kirilov, Klara Dokova

Abstract

The aim of the current study is to compare the system of ADRs reporting in Bulgaria, in the context of good European practices.

Material and methods: In order to perform an analysis of the European systems for ADRs reporting, two types of documentary sources of information were used. The content was analyzed in comparative terms:

- Scientific publications in refereed scientific medical journals;

- Websites of national centers for pharmacovigilance.

Information about ADR reporting forms by patients and medical professionals was extracted from the studied sources. The organization of the systems was also studied, including the engagement of additional structures and institutions.

Results and conclusions: The pharmacovigilance system in Bulgaria functions in accordance with European legislation, and despite the common principles of work of individual EU member states, there are different approaches in the organization at the national level.

At least 3 different channels are available for patients and healthcare professionals to report ADRs in all analyzed countries. Online forms for reporting ADRs are readily available on the Internet. Despite the existence of different forms for patients and for health professionals, the basic volume of patient information is guaranteed through both forms.

An important aspect of the activities of the agencies is the promotion of the importance of reporting ADR through various organized information campaigns.


Keywords

adverse drug reactions, pharmacovigilance, ADR reporting forms

Full Text


References

Alka Bansal , Ashish Agrawal , Lokendra Sharma , Smita Jain A comparative study of active and passive adverse drug reaction reporting systems in terms of false reporting rate Scripta Medica 2020, vol. 51, br. 4, str. 223-227.

Weaver J, Willy M, Avigan M. Informatic tools and approaches in postmarketing pharmacovigilance used by FDA. AAPS J. 2008;10(1):35-41.

A. Radecka, L. Loughlin, M. Foy, M. Viana de Ferraz Guimaraes, V. Macolic Sarinic, M. Dimov Di Giusti, M. Lesicar, S. Straus, D. Montero, J. Pallos, J. Ivanovic, J. Raine, Enhancing Pharmacovigilance Capabilities in the EU Regulatory Network: The SCOPE Joint Action.

Worakunphanich, W.; Youngkong, S.; Suwankesawong, W.; Anderson, C.; Thavorncharoensap, M. Comparison of Patient Adverse Drug Reaction Reporting Systems in Nine Selected Countries. Int. J. Environ. Res. Public Health 2022, 19, 4447. https://doi.org/10.3390/ ijerph19084447

World Health Organization. Safety Monitoring of Medical Products: Reporting System for the General Public. Available online:https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance (February 2022).

The Netherlands Pharmacovigilance Centre Lareb - https://www.lareb.nl/en/pages/about-lareb (March 2022).

The Danish Pharmacovigilance Council, Side effects and product information - https://laegemiddelstyrelsen.dk/en/sideeffects/pharmacovigilance-council/ (March 2022).

The Federal Agency for Medicines and Health Products, Pharmacovigilance - https://www.famhp.be/en/human_use/medicines/medicines/pharmacovigilance (March 2022).

Medicines and Healthcare products Regulatory Agency, Yellow card - https://yellowcard.mhra.gov.uk/ (March 2022).




DOI: http://dx.doi.org/10.14748/sm.v0i0.8750

Refbacks

Font Size


|