The Role of Pharmaceutical Companies in the Pharmacovigilance System

Abstract

Due to the fact that drug manufacturers have the most complete information on the drug safety, a pilot study was conducted to analyze their role in the functioning of the pharmacovigilance system. The information letters published on the website of Roszdravnadzor for the period 2021-2022 were analyzed. With a survey of specialists from pharmaceutical companies, it was found that on the websites of most drug manufacturers there is a notification form about an adverse drug reaction or the absence of a therapeutic effect. According to 58.1% of respondents, all adverse drug reactions are most often reported through completed notification forms, regardless of the period of registration of the drug. The groups of drugs that most often cause adverse reactions according to representatives of pharmaceutical companies were identified: antibacterial drugs, anticancer drugs, antidepressants and psychostimulants. According to 93.0% of respondents, pharmaceutical and medical workers, and specialists from pharmaceutical companies need to improve their knowledge in the field of pharmacovigilance. For the period January 2021 - December 2022, 97 information letters were published on the Roszdravnadzor website. Most often, companies inform about the presentation of new data on the drug safety in the instructions for use, and submit information materials on the safety of medicines. The study results showed the important role of drug manufacturers in organizing the collection and processing of information on the drug safety and efficacy in the pharmacovigilance system.