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      Healthcare professionals knowledge, attitude and practice of adverse drug reactions reporting in Ethiopia: a cross-sectional study

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          Abstract

          Objective

          This study aimed to assess the knowledge, attitude and practice of adverse drug reactions (ADRs) reporting and identify factors associated with ADRs reporting among healthcare professionals (HCPs) working in Tigray region, Ethiopia.

          Materials and methods

          A cross-sectional study was conducted between January and March of 2019 in a tertiary care hospital in Tigray region, Ethiopia. A self-administered, pretested questionnaire was administered to HCPs. Data were summarised using descriptive statistics. Logistic regression analysis was used to identify factors associated with poor ADRs reporting practices.

          Results

          In total, 362 questionnaires were distributed, and the response rate was 84.8% (n=307). Of all respondents, 190 (61.9%) were nurses, 63 (20.5%) were pharmacist and 54 (17.6%) were physicians. About 58.3% of HCPs had poor knowledge of ADRs reporting. The majority of the respondents had a positive attitude (59.9%), and only a few (32.1%) respondents have good ADRs reporting practices. Poor knowledge (adjusted OR (AOR)=2.63, 95% CI: 1.26 to 5.45) and lack of training on ADRs reporting (AOR=7.31, 95% CI: 3.42 to 15.62) were both negatively associated with ADRs reporting practice, whereas higher work experience (≥10 years) (AOR=0.36, 95% CI: 0.13 to 0.97) was positively associated with ADRs reporting practice.

          Conclusions

          The majority of HCPs had poor knowledge and practice, but a positive attitude towards ADRs reporting. Poor knowledge, less work experience and lack of training were associated with poor ADRs reporting practice. Hence, strategies to improve the knowledge and practice of ADRs reporting should be implemented, particularly for untrained and less experienced HCPs.

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          Most cited references30

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          Determinants of under-reporting of adverse drug reactions: a systematic review.

          A voluntary reporting system of adverse drug reactions (ADRs) is fundamental to drug safety surveillance but under-reporting is its major limitation. This bibliographic review sought to assess the influence of personal and professional characteristics on ADR reporting and to identify knowledge and attitudes associated with ADR reporting. A systematic review was conducted using the MEDLINE and EMBASE databases. We included papers that were published in English, French and Spanish, and covered a study population made up of health professionals. In each case, the following data were extracted: study population; workplace; study type; sample size; type of questionnaire; type of scale for measuring knowledge; response rate; personal and professional factors; and knowledge and attitudes (based on Inman's 'seven deadly sins') associated with reporting. Based on a search of computerized databases, we identified a total of 657 papers in MEDLINE and 973 in EMBASE. In all, the review covered 45 papers that fulfilled the inclusion criteria. Medical specialty was the professional characteristic most closely associated with under-reporting in 76% of studies involving physicians. Other factors associated with under-reporting were ignorance (only severe ADRs need to be reported) in 95%; diffidence (fear of appearing ridiculous for reporting merely suspected ADRs) in 72%; lethargy (an amalgam of procrastination, lack of interest or time to find a report card, and other excuses) in 77%; indifference (the one case that an individual doctor might see could not contribute to medical knowledge) and insecurity (it is nearly impossible to determine whether or not a drug is responsible for a particular adverse reaction) in 67%; and complacency (only safe drugs are allowed on the market) in 47% of studies. While personal and professional factors display a weak influence, the knowledge and attitudes of health professionals appear to be strongly related with reporting in a high proportion of studies. This result may have important implications in terms of public health, if knowledge and attitudes are viewed as potentially modifiable factors.
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            Strategies to improve adverse drug reaction reporting: a critical and systematic review.

            Underreporting is the major limitation of a voluntary adverse drug reaction (ADR) reporting system. Many studies have assessed the effectiveness of different interventions designed to reduce underreporting.
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              A Comparison of Active Adverse Event Surveillance Systems Worldwide

              Post-marketing drug surveillance for adverse drug events (ADEs) has typically relied on spontaneous reporting. Recently, regulatory agencies have turned their attention to more preemptive approaches that use existing data for surveillance. We conducted an environmental scan to identify active surveillance systems worldwide that use existing data for the detection of ADEs. We extracted data about the systems’ structures, data, and functions. We synthesized the information across systems to identify common features of these systems. We identified nine active surveillance systems. Two systems are US based—the FDA Sentinel Initiative (including both the Mini-Sentinel Initiative and the Federal Partner Collaboration) and the Vaccine Safety Datalink (VSD); two are Canadian–the Canadian Network for Observational Drug Effect Studies (CNODES) and the Vaccine and Immunization Surveillance in Ontario (VISION); and two are European–the Exploring and Understanding Adverse Drug Reactions by Integrative Mining of Clinical Records and Biomedical Knowledge (EU-ADR) Alliance and the Vaccine Adverse Event Surveillance and Communication (VAESCO). Additionally, there is the Asian Pharmacoepidemiology Network (AsPEN) and the Shanghai Drug Monitoring and Evaluative System (SDMES). We identified two systems in the UK—the Vigilance and Risk Management of Medicines (VRMM) Division and the Drug Safety Research Unit (DSRU), an independent academic unit. These surveillance systems mostly use administrative claims or electronic medical records; most conduct pharmacovigilance on behalf of a regulatory agency. Either a common data model or a centralized model is used to access existing data. The systems have been built using national data alone or via partnership with other countries. However, active surveillance systems using existing data remain rare. North America and Europe have the most population coverage; with Asian countries making good advances. Electronic supplementary material The online version of this article (doi:10.1007/s40264-014-0194-3) contains supplementary material, which is available to authorized users.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2020
                25 February 2020
                : 10
                : 2
                : e034553
                Affiliations
                [1] departmentDepartment of Clinical Pharmacy, School of Pharmacy , College of Health Sciences, Mekelle University , Mekelle, Ethiopia
                Author notes
                [Correspondence to ] Kidu Gidey; kidupharm@ 123456gmail.com
                Author information
                http://orcid.org/0000-0002-7363-1327
                Article
                bmjopen-2019-034553
                10.1136/bmjopen-2019-034553
                7046472
                32102821
                a0c6daa0-d2e1-4c2f-8d60-24bd2ae3190f
                © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 26 September 2019
                : 13 January 2020
                : 04 February 2020
                Categories
                Pharmacology and Therapeutics
                1506
                1723
                Original research
                Custom metadata
                unlocked

                Medicine
                adverse drug reaction,healthcare professionals,knowledge,practice
                Medicine
                adverse drug reaction, healthcare professionals, knowledge, practice

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