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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

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            A technique for the measurement of attitudes.

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              Factors that influence under-reporting of suspected adverse drug reactions among community pharmacists in a Spanish region.

              The spontaneous reporting system is the most efficient warning system of adverse drug reactions (ADRs). Pharmacists can play an important role in the detection and reporting of ADRs. The factors that affect under-reporting among these professionals are unknown in Spain. To identify the factors that influence community pharmacists' ADR under-reporting in Navarra, a Northern Spanish region. A case-control study was conducted on a population of 802 community pharmacists working in Navarra. Cases were pharmacists who had reported at least two ADRs to the region's drug surveillance unit between 2003 and 2005 and who agreed to participate in the study (18/20; 90%). A random sample of 60 controls was selected from the 762 pharmacists who had not reported any ADR during the same period of time. Factors positively associated with ADR reporting were age, years of work experience as a pharmacist, participation in educational activities related to the detection and resolution of drug-related problems, the habit of detecting ADRs as part of pharmacists' duties, having the basic knowledge needed to report ADRs, and disagreement with the common belief among healthcare professionals that 'to report an ADR it is necessary to be sure that the reaction is related to the use of a particular drug'. The most frequently mentioned reasons for not reporting ADRs were the ADR is not serious, the ADR is already known, uncertainty concerning the causal relationship between the ADR and the drug, forgetting to report the ADR and a lack of time. Pharmacists' knowledge, beliefs, behaviour and motivation play an important role in ADR reporting. Under-reporting might be improved through activities focused on modifying such factors.
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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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