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      Nurses' Knowledge, Attitudes, and Practice in Relation to Pharmacovigilance and Adverse Drug Reaction Reporting: A Systematic Review

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          Abstract

          Aim

          To describe and synthesize aspects of knowledge, attitudes, and practice regarding pharmacovigilance and adverse drug reaction (ADR) reporting and to explore associated barriers from a nurse perspective.

          Methods

          A systematic review was conducted. Electronic databases including MEDLINE, Embase, Scopus, and Web of Knowledge from January 2010 to October 2020 were searched. Original observational studies that were written in English and which focused on nurses' knowledge, attitudes, practice, and perceived barriers regarding pharmacovigilance and ADR reporting in various healthcare settings were included.

          Results

          Twenty-three studies published in English from 2010 to 2020 were retrieved during the search process. Overall, in the knowledge domain, the median percentages of nurses who were aware of the definitions of ADRs were 74.1%, while only 26.3% were aware of the adverse drug reaction reporting form. In the attitude domain, 84.6% of nurses believed ADR reporting to be important for patient/medicine safety and 37.1% had a fear of legal liability following ADR reporting. Although 67.1% of nurses encountered ADRs during their professional life, only 21.2% had a history of ADR reporting. In addition, lack of knowledge/training (median: 47.1%) was identified as the most common barrier in ADR reporting from a nursing viewpoint.

          Conclusion

          Despite positive nurse attitudes, knowledge and practice in relation to pharmacovigilance activities and ADR reporting did not occur regularly or often. Improving nurses' knowledge through in-service training and degree-level education and addressing the main barriers of ADR reporting may help to achieve an improved level of reporting.

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          Most cited references82

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          The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration.

          Systematic reviews and meta-analyses are essential to summarize evidence relating to efficacy and safety of health care interventions accurately and reliably. The clarity and transparency of these reports, however, is not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users. Since the development of the QUOROM (QUality Of Reporting Of Meta-analysis) Statement--a reporting guideline published in 1999--there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realizing these issues, an international group that included experienced authors and methodologists developed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions. The PRISMA Statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this Explanation and Elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA Statement, this document, and the associated Web site (http://www.prisma-statement.org/) should be helpful resources to improve reporting of systematic reviews and meta-analyses.
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            Appraising the evidence: reviewing disparate data systematically.

            The authors describe a method of systematically reviewing research from different paradigms. They draw on the methods adapted, developed, and designed during a study concerned with the delivery of care across professional boundaries. Informed by the established method of systematic review, the authors undertook the review in distinct stages. They describe the methods developed for each stage and outline the difficulties encountered, the solutions devised, and the appraisal tools developed. Although many of the problems encountered were related to the critical assessment of qualitative research, the authors argue that the method of systematic review can be adapted for use with different data andacross disciplines.
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              Hospital admissions associated with adverse drug reactions: a systematic review of prospective observational studies.

              To determine the prevalence of hospital admissions associated with ADRs and examine differences in prevalence rates between population groups and methods of ADR detection. Studies were identified through electronic searches of Cumulative Index to Nursing and Allied Health Literature, EMBASE, and MEDLINE to August 2007. There were no language restrictions. A systematic review was conducted of prospective observational studies that used the World Health Organization ADR definition. Subgroup analysis examined the influence of patient age groups and methods of ADR detection on reported ADR admission rates. All statistical analyses were performed using STATA v 9.0. Twenty-five studies were identified including 106,586 patients who were hospitalized; 2143 of these patients had experienced ADRs. The prevalence rates of ADRs ranged from 0.16% to 15.7%, with an overall median of 5.3% (interquartile range [IQR] 2.7-9.0%). Median ADR prevalence rates varied between age groups; for children, the ADR admission rate was 4.1% (IQR 0.16-5.3%), while the corresponding rates for adults and elderly patients were 6.3% (IQR 3.9-9.0%) and 10.7% (IQR 9.6-13.3%), respectively. ADR rates also varied depending on the methods of ADR detection employed in the different studies. Studies that employed multiple ADR detection methods, such as medical record review and patient interview, reported higher ADR admission rates compared with studies that used medical record review alone. Anti-infective drugs were most often associated with ADR admissions in children; cardiovascular drugs were most often associated with ADR admissions in adults and elderly patients. Approximately 5.3% of hospital admissions were associated with ADRs. Higher rates were found in elderly patients who are likely to be receiving multiple medications for long-term illnesses. The methods used to detect ADRs are also likely to explain much of the variation in the reported ADR prevalence rates between different studies.
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                Author and article information

                Contributors
                Journal
                Biomed Res Int
                Biomed Res Int
                BMRI
                BioMed Research International
                Hindawi
                2314-6133
                2314-6141
                2021
                9 April 2021
                : 2021
                : 6630404
                Affiliations
                1Nursing Care Research Center, Department of Nursing Management, School of Nursing & Midwifery, Iran University of Medical Sciences, Tehran, Iran
                2Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran
                3School of Nursing & Midwifery, Tehran University of Medical Sciences, Tehran, Iran
                4Nursing Care Research Center, Department of Medical Surgical Nursing, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran
                Author notes

                Academic Editor: Muhammad Hassham Hassan Bin Asad

                Author information
                https://orcid.org/0000-0003-3481-9180
                https://orcid.org/0000-0002-5292-4219
                https://orcid.org/0000-0003-0372-1383
                https://orcid.org/0000-0001-9017-380X
                https://orcid.org/0000-0003-2861-6037
                Article
                10.1155/2021/6630404
                8062168
                33937402
                f8131667-d449-419b-a422-b54bd543b9a2
                Copyright © 2021 Tahmine Salehi et al.

                This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 1 December 2020
                : 23 March 2021
                : 29 March 2021
                Categories
                Review Article

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