POSSIBILITIES OF EFFECTIVE INTERACTION IN THE PHARMACOVIGILANCE SYSTEM AT REGISTERING UNDESIRABLE MEDICINAL REACTIONS IN SENIOR PATIENTS

In the recent years, complications of drug therapy are an important medical problem. Data on adverse drug reactions (ADRs) in older patients were analyzed. The object of the study was notification cards for NR received from medical organizations (MO) of Irkutsk region for a five-year period. The Narangio scale was used to assess the causality (SST) between ADR and LS. Of the 1068 ADR notifications in patients over 60 years of age, 2/3 (705) are presented with ADR notifications in women, 363 (34.0 %) – in men. The presence of background diseases was registered in 940 notifications (88.0 %). There were no gender differences except for a higher incidence of chronic obstructive pulmonary disease in men (7.2 % and 3.5 %, respectively, p < 0.05) and diabetes mellitus in women (14.0 % and 3.5 %, respectively, p < 0.05). ARs for antibacterial agents amounted to 31.8 %, drugs for the treatment of cardiovascular diseases – 10.5 %, cases of therapeutic inefficiency – 5.4 %. The ADR data statement was in line with the recommended form of 76 %. The most common filling defect was incomplete patient information. The validity of the Narango PSS was high. The deadlines for reporting data were observed in 93 %. For effective interaction in the pharmacovigilance system, it is necessary for each MO to constantly inform about the procedure for pharmacovigilance, types of ADRs, the rules for their detection and the timing of data reporting. The work should be supervised by a trained specialist.

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Journal
Vestnik of North-Eastern Federal University Medical Sciences
Published
2025-01-09
DOI
https://doi.org/10.25587/2587-5590-2024-4-79-87
Primary Topic
Pharmacovigilance and Adverse Drug Reactions
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article
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article

POSSIBILITIES OF EFFECTIVE INTERACTION IN THE PHARMACOVIGILANCE SYSTEM AT REGISTERING UNDESIRABLE MEDICINAL REACTIONS IN SENIOR PATIENTS

E. O. Kochkina, Н. В. Верлан, Л. О. Бессонова, A. A. Konovalova
Vestnik of North-Eastern Federal University Medical Sciences
Pharmacovigilance and Adverse Drug Reactions
article

POSSIBILITIES OF EFFECTIVE INTERACTION IN THE PHARMACOVIGILANCE SYSTEM AT REGISTERING UNDESIRABLE MEDICINAL REACTIONS IN SENIOR PATIENTS

E. O. Kochkina, Н. В. Верлан, Л. О. Бессонова, A. A. Konovalova
article en

Abstract

In the recent years, complications of drug therapy are an important medical problem. Data on adverse drug reactions (ADRs) in older patients were analyzed. The object of the study was notification cards for NR received from medical organizations (MO) of Irkutsk region for a five-year period. The Narangio scale was used to assess the causality (SST) between ADR and LS. Of the 1068 ADR notifications in patients over 60 years of age, 2/3 (705) are presented with ADR notifications in women, 363 (34.0 %) – in men. The presence of background diseases was registered in 940 notifications (88.0 %). There were no gender differences except for a higher incidence of chronic obstructive pulmonary disease in men (7.2 % and 3.5 %, respectively, p < 0.05) and diabetes mellitus in women (14.0 % and 3.5 %, respectively, p < 0.05). ARs for antibacterial agents amounted to 31.8 %, drugs for the treatment of cardiovascular diseases – 10.5 %, cases of therapeutic inefficiency – 5.4 %. The ADR data statement was in line with the recommended form of 76 %. The most common filling defect was incomplete patient information. The validity of the Narango PSS was high. The deadlines for reporting data were observed in 93 %. For effective interaction in the pharmacovigilance system, it is necessary for each MO to constantly inform about the procedure for pharmacovigilance, types of ADRs, the rules for their detection and the timing of data reporting. The work should be supervised by a trained specialist.

Vestnik of North-Eastern Federal University Medical Sciences(4)
Ministry of Health of the Russian Federation (RU), Irkutsk State Medical University (RU)
Good health and well-being
Openalex Percentile: Top 100%
Pharmacovigilance and Adverse Drug Reactions
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POSSIBILITIES OF EFFECTIVE INTERACTION IN THE PHARMACOVIGILANCE SYSTEM AT REGISTERING UNDESIRABLE MEDICINAL REACTIONS IN SENIOR PATIENTS — E. O. Kochkina, Н. В. Верлан, et al. · Vestnik of North-Eastern Federal University Medical Sciences (2025) | TGRS Research Map | TGRS