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      Evaluation of health care professionals’ knowledge, attitudes, practices and barriers to pharmacovigilance and adverse drug reaction reporting: A cross-sectional multicentral study

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          Abstract

          Background

          Healthcare professionals’ involvement and reporting of adverse drug reactions are essential for the success of a pharmacovigilance program. The aim of this study was to assess healthcare professionals (medical doctors, pharmacists, nurses, dentists, midwives, and paramedics) current knowledge, attitude, practices, and barriers regarding pharmacovigilance and adverse drug reactions reporting in multicentral healthcare settings.

          Methods

          A cross-sectional face-to-face survey was conducted among currently working healthcare professionals in various hospitals in ten districts of Adana province, Türkiye from March to October 2022. A self-administered, pretested questionnaire (Cronbach’s alpha = 0.894 for knowledge, attitudes and practices variables) was used for data collection. The questionnaire’s final draft included five sections (sociodemographic/general information, knowledge, attitude, practices, and barriers) with 58 questions. The collected data was analyzed in SPSS (version 25) using descriptive statistics, the chi-square test, and logistic regression.

          Results

          Of the total 435 distributed questionnaires, 412 completed the entire questionnaire, yielding a 94% response rate. The majority of healthcare professionals (60.4%; n = 249) had never received pharmacovigilance training. Among healthcare professionals 51.9% (n = 214), 71.1% (n = 293) and 92.5% (n = 381) had poor knowledge, positive attitudes and poor practices, respectively. Only 32.5% of healthcare professionals kept the record of an adverse drug reaction and only 13.1% reported adverse drug reactions. The profession (medical doctors, pharmacists, nurses, dentists, midwives, and paramedics) of healthcare professionals and a lack of training were predictors of poor adverse drug reaction reporting (p < 0.05). A statistically significant difference in healthcare professionals and knowledge, attitude and practices scores was also observed (p < 0.05). The main barriers which were supposed to discourage adverse drug reactions reporting by the healthcare professionals were higher workload (63.8%) followed by thinking that a single adverse drug reaction report makes no impact (63.6%) and lack of a professional atmosphere (51.9%).

          Conclusion

          In the current study, most healthcare professionals had poor knowledge and practice, but they had a positive attitude toward pharmacovigilance and adverse drug reactions reporting. Barriers to under-reporting of adverse drug reactions were also highlighted. Periodic training programs, educational interventions, systematic follow-up of healthcare professionals by local healthcare authorities, interprofessional links between all healthcare professionals, and the implementation of mandatory reporting policies are critical for improving healthcare professionals knowledge, practices, patient safety and pharmacovigilance activities.

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          Most cited references73

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          Under-reporting of adverse drug reactions : a systematic review.

          The purpose of this review was to estimate the extent of under-reporting of adverse drug reactions (ADRs) to spontaneous reporting systems and to investigate whether there are differences between different types of ADRs. A systematic literature search was carried out to identify studies providing a numerical estimate of under-reporting. Studies were included regardless of the methodology used or the setting, e.g. hospital versus general practice. Estimates of under-reporting were either extracted directly from the published study or calculated from the study data. These were expressed as the percentage of ADRs detected from intensive data collection that were not reported to the relevant local, regional or national spontaneous reporting systems. The median under-reporting rate was calculated across all studies and within subcategories of studies using different methods or settings. In total, 37 studies using a wide variety of surveillance methods were identified from 12 countries. These generated 43 numerical estimates of under-reporting. The median under-reporting rate across the 37 studies was 94% (interquartile range 82-98%). There was no significant difference in the median under-reporting rates calculated for general practice and hospital-based studies. Five of the ten general practice studies provided evidence of a higher median under-reporting rate for all ADRs compared with more serious or severe ADRs (95% and 80%, respectively). In comparison, for five of the eight hospital-based studies the median under-reporting rate for more serious or severe ADRs remained high (95%). The median under-reporting rate was lower for 19 studies investigating specific serious/severe ADR-drug combinations but was still high at 85%. This systematic review provides evidence of significant and widespread under-reporting of ADRs to spontaneous reporting systems including serious or severe ADRs. Further work is required to assess the impact of under-reporting on public health decisions and the effects of initiatives to improve reporting such as internet reporting, pharmacist/nurse reporting and direct patient reporting as well as improved education and training of healthcare professionals.
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            Instrument translation process: a methods review.

            Cross-cultural and international collaborative studies are needed in nursing research. Therefore, it is necessary to translate research instruments into the language of the culture being studied. In this methods review, different processes of instrument translation and evaluation of translation adequacy in published nursing research are described and classified into a hierarchy. Studies including translation of quantitative research instruments were reviewed. Forty-seven studies were included. These were classified into six categories. Studies were classified into categories as follows: forward-only translation (2), forward-only translation with testing (7), back-translation (13), back-translation with monolingual test (18), back-translation with bilingual test (3), and back-translation with both monolingual and bilingual test (4). Strengths and weaknesses are analysed. The studies reviewed used diverse methods of varying quality. There is need for consensus among researchers in how to achieve quality of instrument translation in cross-cultural research. Researchers should carefully attend to achieving and reporting evidence of the accuracy and validity of instrument translation. When back-translation fails to achieve semantic equivalence, the instrument development process should be replicated in the target language.
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              Sampling methods in Clinical Research; an Educational Review

              Clinical research usually involves patients with a certain disease or a condition. The generalizability of clinical research findings is based on multiple factors related to the internal and external validity of the research methods. The main methodological issue that influences the generalizability of clinical research findings is the sampling method. In this educational article, we are explaining the different sampling methods in clinical research.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: InvestigationRole: MethodologyRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Formal analysisRole: MethodologyRole: SupervisionRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: SoftwareRole: ValidationRole: VisualizationRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS One
                plos
                PLOS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                24 May 2023
                2023
                : 18
                : 5
                : e0285811
                Affiliations
                [1 ] Department of Medical Pharmacology, Faculty of Medicines, Çukurova University, Adana, Türkiye
                [2 ] Faculty of Medicines, Balcali Hospital, Adana, Türkiye
                [3 ] Department of Community Medicine, Khyber Medical College, Peshawar, Pakistan
                University of Gondar, ETHIOPIA
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Author information
                https://orcid.org/0009-0005-4078-9864
                Article
                PONE-D-23-05280
                10.1371/journal.pone.0285811
                10208525
                37224133
                6ea7d07b-6f3e-40e1-8358-180d18339cb9
                © 2023 Khan et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 22 February 2023
                : 29 April 2023
                Page count
                Figures: 0, Tables: 8, Pages: 27
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/501100002964, Çukurova Üniversitesi;
                Award ID: ÇÜ-BAP No: TDK-2021-14258
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/501100002964, Çukurova Üniversitesi;
                Award ID: ÇÜ-BAP No: TDK-2021-14258
                Award Recipient :
                This study is supported by the PhD project (ÇÜ-BAP No: TDK-2021-14258), Çukurova University, Adana, Türkiye awarded to YK and ZK. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Research Article
                Medicine and Health Sciences
                Pharmacology
                Adverse Reactions
                People and Places
                Population Groupings
                Professions
                Medical Personnel
                Pharmacists
                Medicine and Health Sciences
                Health Care
                Health Care Providers
                Physicians
                People and Places
                Population Groupings
                Professions
                Medical Personnel
                Physicians
                People and Places
                Population Groupings
                Professions
                Medical Personnel
                Nurses
                Medicine and Health Sciences
                Health Care
                Health Care Providers
                Nurses
                Medicine and Health Sciences
                Health Care
                Health Care Providers
                Allied Health Care Professionals
                People and Places
                Population Groupings
                Professions
                Medical Personnel
                Midwives
                Medicine and Health Sciences
                Pharmacology
                Drug Research and Development
                Drug Safety
                People and Places
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                All relevant data are within the paper and its Supporting information files.

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