Pharmacists in the pharmacovigilance system

DOI: https://doi.org/10.29296/25419218-2024-05-06
Issue: 
5
Year: 
2024

Pharmacists in the pharmacovigilance system
A.A. Taube(1, 2), V.A. Morozov(3)
1-FSBEI HE “St. Petersburg Chemical and Pharmaceutical University” of the Ministry of Health of the Russian Federation, Russian Federation, 197376, St. Petersburg, st. Professor Popov, 14, lit. A;
2-FSBE “Scientific Center for Expertise of Medical Products” of the Ministry of Health of the Russian Federation, Russian Federation, 127051, Moscow, Petrovsky Blvd., 8, build. 2;
3-FSBEU HE “North Ossetian State University named after K.L. Khetagurova”, Russian Federation, Republic of North Ossetia-Alania, Vladikavkaz, 362025, st. Vatutina, 44–46

Introduction. In accordance with the rules of the GVP EAEU, good pharmacy practice and the national legislation of Russia, pharmacy organizations, as subjects of circulation of medicines, must collect and send reports of adverse reactions to the authorized body about the information they receive from patients. Objective. Studying the level of knowledge and practical skills, as well as the opinions of pharmacy workers about the pharmacovigilance system in order to develop practical management solutions to increase the participation of the pharmacy link in the pharmacovigilance system. Material and methods. Questionnaire method, descriptive statistics, non-prametric statistics according to the Kendal and Spearman test. Results. A Google link to the questionnaire was sent to 150 pharmacy ratings to complete. Employees of the retail pharmaceutical sector of the Republic of North Ossetia (Alania) took part in the questionnaire. 105 valid completed questionnaires were received. The return rate of the questionnaire is 70%. 62% of the respondents answered that an AR notification should be reported only if there is a proven causal relationship between taking the drug and the resulting AR; 30% believe that it should be sent if a causal relationship is suspected; 1% in free time from other duties; 7% – believe that it is necessary to report if the buyer asks for it. 39 (37,1%) of respondents answered that the decisive factor preventing them from filling out notices is the too long filing procedure, 56 (53,4%) of respondents referred to the lack of time for this procedure, 10 (9,5%) respondents – on the lack of meaning in this activity. The main stimulating factor that, according to the respondents, can motivate the receipt of notices is material. Conclusion. The study revealed an increase in the competencies of pharmacy workers and the search for solutions to motivate them to increase their involvement in the pharmacovigilance system.

Keywords: 
Adverse drug reactions
drug safety; pharmacist; pharmacovigilance
post marketing surveillance

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