Results of Surveying Cardiologists and Clinical Pharmacologists on the Selection and the Efficacy and Safety Evaluation of Pharmacotherapy for Cardiovascular Diseases
The state policy for the safety of medicinal products involves analysis of specialists' competence in identifying adverse drug reactions (ADRs) during the use of medicinal products. It is of particular importance for the group of essential medicines, including those used in cardiology.The aim o...
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| Format: | Article |
| Language: | Russian |
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Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2022-12-01
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| Series: | Безопасность и риск фармакотерапии |
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| Online Access: | https://www.risksafety.ru/jour/article/view/282 |
| _version_ | 1797224537850380288 |
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| author | Yu. R. Bolsunovskaya V. V. Arkhipov |
| author_facet | Yu. R. Bolsunovskaya V. V. Arkhipov |
| author_sort | Yu. R. Bolsunovskaya |
| collection | DOAJ |
| description | The state policy for the safety of medicinal products involves analysis of specialists' competence in identifying adverse drug reactions (ADRs) during the use of medicinal products. It is of particular importance for the group of essential medicines, including those used in cardiology.The aim of the study was to assess ADR-reporting skills of doctors managing cardiology patients, with anti-arrhythmics as a case study.Materials and methods: from October 2019 to June 2021, the authors surveyed a sample of 223 practitioners that treated cardiology patients in Moscow and the Moscow region (36 of the respondents took the survey in person, and 187 participated on-line). The questionnaire inquired about selection criteria for the medicinal products, their assessment in terms of efficacy and safety in real-life clinical practice, and the competence and active involvement of the doctors in reporting identified ADRs.Results: most of the survey participants were high-level professionals (60.99% had 10 and more years of experience). Most of the doctors (90.13%) admitted having encountered ADRs in their practice, placing substandard quality of cardiovascular medicinal products among the causes. Moreover, 1.79% of the respondents faced such quality problems on a regular basis. Only 52.91% were familiar with the current documents regulating pharmacovigilance. A total of 61.88% applied information from Russian and foreign ADR databases in their practice. In 2021, 80.72% of the surveyed did not report data on the identified ADRs. According to the respondents, the main reasons for low reporting activity were high workload and lack of evidence for causality between a product and an ADR.Conclusion: the study demonstrated the need to intensify the work with practitioners on the safety of medicinal products and ADR identification, particularly, to train them in pharmacovigilance. According to the study results, it is feasible to develop and implement simple and user-friendly risk-oriented information systems for analysis and systematisation of ADR case reports. |
| first_indexed | 2024-03-08T22:26:27Z |
| format | Article |
| id | doaj.art-75cb790bcff74684b203c864eb60e0a8 |
| institution | Directory Open Access Journal |
| issn | 2312-7821 2619-1164 |
| language | Russian |
| last_indexed | 2024-04-24T13:54:42Z |
| publishDate | 2022-12-01 |
| publisher | Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Безопасность и риск фармакотерапии |
| spelling | doaj.art-75cb790bcff74684b203c864eb60e0a82024-04-03T17:56:38ZrusMinistry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Безопасность и риск фармакотерапии2312-78212619-11642022-12-0110441141910.30895/2312-7821-2022-10-4-411-419269Results of Surveying Cardiologists and Clinical Pharmacologists on the Selection and the Efficacy and Safety Evaluation of Pharmacotherapy for Cardiovascular DiseasesYu. R. Bolsunovskaya0V. V. Arkhipov1Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsThe state policy for the safety of medicinal products involves analysis of specialists' competence in identifying adverse drug reactions (ADRs) during the use of medicinal products. It is of particular importance for the group of essential medicines, including those used in cardiology.The aim of the study was to assess ADR-reporting skills of doctors managing cardiology patients, with anti-arrhythmics as a case study.Materials and methods: from October 2019 to June 2021, the authors surveyed a sample of 223 practitioners that treated cardiology patients in Moscow and the Moscow region (36 of the respondents took the survey in person, and 187 participated on-line). The questionnaire inquired about selection criteria for the medicinal products, their assessment in terms of efficacy and safety in real-life clinical practice, and the competence and active involvement of the doctors in reporting identified ADRs.Results: most of the survey participants were high-level professionals (60.99% had 10 and more years of experience). Most of the doctors (90.13%) admitted having encountered ADRs in their practice, placing substandard quality of cardiovascular medicinal products among the causes. Moreover, 1.79% of the respondents faced such quality problems on a regular basis. Only 52.91% were familiar with the current documents regulating pharmacovigilance. A total of 61.88% applied information from Russian and foreign ADR databases in their practice. In 2021, 80.72% of the surveyed did not report data on the identified ADRs. According to the respondents, the main reasons for low reporting activity were high workload and lack of evidence for causality between a product and an ADR.Conclusion: the study demonstrated the need to intensify the work with practitioners on the safety of medicinal products and ADR identification, particularly, to train them in pharmacovigilance. According to the study results, it is feasible to develop and implement simple and user-friendly risk-oriented information systems for analysis and systematisation of ADR case reports.https://www.risksafety.ru/jour/article/view/282pharmacovigilancecardiovascular diseasesanti-arrhythmicsefficacy of pharmacotherapysafety of pharmacotherapyadverse drug reactions |
| spellingShingle | Yu. R. Bolsunovskaya V. V. Arkhipov Results of Surveying Cardiologists and Clinical Pharmacologists on the Selection and the Efficacy and Safety Evaluation of Pharmacotherapy for Cardiovascular Diseases Безопасность и риск фармакотерапии pharmacovigilance cardiovascular diseases anti-arrhythmics efficacy of pharmacotherapy safety of pharmacotherapy adverse drug reactions |
| title | Results of Surveying Cardiologists and Clinical Pharmacologists on the Selection and the Efficacy and Safety Evaluation of Pharmacotherapy for Cardiovascular Diseases |
| title_full | Results of Surveying Cardiologists and Clinical Pharmacologists on the Selection and the Efficacy and Safety Evaluation of Pharmacotherapy for Cardiovascular Diseases |
| title_fullStr | Results of Surveying Cardiologists and Clinical Pharmacologists on the Selection and the Efficacy and Safety Evaluation of Pharmacotherapy for Cardiovascular Diseases |
| title_full_unstemmed | Results of Surveying Cardiologists and Clinical Pharmacologists on the Selection and the Efficacy and Safety Evaluation of Pharmacotherapy for Cardiovascular Diseases |
| title_short | Results of Surveying Cardiologists and Clinical Pharmacologists on the Selection and the Efficacy and Safety Evaluation of Pharmacotherapy for Cardiovascular Diseases |
| title_sort | results of surveying cardiologists and clinical pharmacologists on the selection and the efficacy and safety evaluation of pharmacotherapy for cardiovascular diseases |
| topic | pharmacovigilance cardiovascular diseases anti-arrhythmics efficacy of pharmacotherapy safety of pharmacotherapy adverse drug reactions |
| url | https://www.risksafety.ru/jour/article/view/282 |
| work_keys_str_mv | AT yurbolsunovskaya resultsofsurveyingcardiologistsandclinicalpharmacologistsontheselectionandtheefficacyandsafetyevaluationofpharmacotherapyforcardiovasculardiseases AT vvarkhipov resultsofsurveyingcardiologistsandclinicalpharmacologistsontheselectionandtheefficacyandsafetyevaluationofpharmacotherapyforcardiovasculardiseases |