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      Exploring pharmacovigilance practices and knowledge among healthcare professionals: A cross-sectional multicenter study

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          Abstract

          Introduction:

          Healthcare professionals’ awareness of adverse drug reaction reporting and pharmacovigilance practices differ by country. The study assesses healthcare professionals’ knowledge, practice, and potential barriers to pharmacovigilance-related practices and reporting adverse drug reaction.

          Methods:

          A cross-sectional investigation was conducted in government and private healthcare settings. The study included licensed physicians, pharmacists, and nurses. To examine knowledge, practice, and potential barriers to pharmacovigilance-related practices and adverse drug reaction reporting, a 22-item validated questionnaire was used.

          Results:

          The final analysis included 311 healthcare professionals. Most healthcare professionals, 59% ( N = 182), mentioned encountering patients with adverse drug reactions during the last year. On the other hand, most healthcare professionals, 54% ( n = 167), mentioned that they had not reported adverse drug reactions. A good proportion of respondents mentioned that it is essential to report adverse drug reactions ( N = 288, 92.6%), availability of adverse drug reactions reporting forms in practice sites ( N = 216, 69.5%), had awareness regarding how to report adverse drug reactions ( N = 221, 71.1%), the necessity of reporting minor/less important adverse drug reactions ( N = 265, 85.2%), and were trained on how to report adverse drug reactions ( N = 201, 64.6%). Adverse drug reaction reporting program in the United Arab Emirates ( N = 148, 47.6) was known to many healthcare professionals. Lack of time was the major impediment to reporting adverse drug reactions at 42.7% ( N = 133). The predictor variable work experience does add to the model ( p < 0.05) concerning association with filling of adverse drug reaction forms (Estimate = 0.380; SE = 0.452; p = 0.400), professional role (Estimate = 0.454; SE = 0.673; p = 0.500). In addition, the predictor variable practice setting adds to the model ( p < 0.05) concerning the knowledge regarding the availability of adverse drug reaction reporting forms (Estimate = −1.229; SE = 0.298; p = 0.000), training on how to report adverse drug reactions (Estimate = −0.660; SE = 0.294; p = 0.025), and awareness regarding the adverse drug reaction reporting program in the United Arab Emirates (Estimate = −1.032; SE = 0.280; p = 0.000).

          Conclusion:

          Pharmacists had the most knowledge regarding adverse drug reaction reporting and pharmacovigilance. The underreporting of adverse drug reactions was documented among physicians and nurses. Lack of time was the most significant barrier to reporting adverse drug reactions, followed by uncertainty and complicated adverse drug reaction documentation forms.

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          Most cited references36

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          Determination and Quantification Of Content Validity

          MARY LYNN (1986)
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            A technique for the measurement of attitudes

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              A questionnaire study on the knowledge, attitude, and the practice of pharmacovigilance among the healthcare professionals in a teaching hospital in South India

              Objective: The primary objective of this study was to evaluate the knowledge, attitude, and practices (KAP) of the healthcare professionals about pharmacovigilance in Dhanalakshmi Srinivasan Medical College and Hospital (DSMCH), Perambalur (Tamil Nadu), a tertiary care teaching hospital. The second primary objective was to assess the causation of underreporting of adverse drug reactions (ADRs) as it needs to be well-assessed in India. The secondary objective was to compare the findings of this study with the results of the published studies from India on evaluation of the KAP of pharmacovigilance among healthcare professional. Materials and Methods: A cross-sectional study was carried out using a pretested questionnaire. The questionnaire was designed to assess the KAP regarding pharmacovigilance. The healthcare professionals (doctors, nurses, and pharmacists) working in the DSMCH, Perambalur (Tamil Nadu) during the study period were included. Only those who gave their consent to participate were included in the study. The data was analyzed by using the Statistical Package for Social Sciences (SPSS) statistical software, version 16. Results: One hundred and fifty pretested questionnaires were distributed among the healthcare professionals and 101 responded. 62.4% healthcare workers gave correct response regarding the definition of pharmacovigilance. 75.2% of healthcare workers were aware regarding the existence of a National Pharmacovigilance Program of India. 69.3% healthcare professional agreed that ADR reporting is a professional obligation for them. Among the participants, 64.4% have experienced ADRs in patients, but only 22.8% have ever reported ADR to pharmacovigilance center. Unfortunately only 53.5% healthcare workers have been trained for reporting adverse reactions. But, 97% healthcare professionals agreed that reporting of ADR is necessary and 92.1% were of the view that pharmacovigilance should be taught in detail to healthcare professional. Conclusion: This study demonstrated that knowledge and attitude towards pharmacovigilance is gradually improving among healthcare professionals, but unfortunately the actual practice of ADR reporting is still deficient among them.
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                Author and article information

                Journal
                SAGE Open Med
                SAGE Open Med
                SMO
                spsmo
                SAGE Open Medicine
                SAGE Publications (Sage UK: London, England )
                2050-3121
                8 May 2024
                2024
                : 12
                : 20503121241249908
                Affiliations
                [1-20503121241249908]Department of Clinical Pharmacy and Pharmacology, RAK College of Pharmacy, RAK Medical and Health Sciences University, Ras Al Khaimah, United Arab Emirates
                Author notes
                [*]Sathvik B Sridhar, Department of Clinical Pharmacy and Pharmacology, RAK College of Pharmacy, RAK Medical and Health Sciences University, Al Qusaidat, P.O. Box 11172, Ras Al Khaimah, United Arab Emirates. Email: sathvik@ 123456rakmhsu.ac.ae
                Author information
                https://orcid.org/0000-0002-9100-2508
                https://orcid.org/0000-0002-8454-8158
                Article
                10.1177_20503121241249908
                10.1177/20503121241249908
                11080773
                38725923
                26b0822f-f51f-477f-868f-1a34b4bbad43
                © The Author(s) 2024

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                : 12 January 2024
                : 10 April 2024
                Categories
                Original Article
                Custom metadata
                January-December 2024
                ts1

                adverse drug reactions,pharmacovigilance,healthcare providers,clinical pharmacists,pharmacists,physicians,nurses

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