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      Adverse Drug Reaction Reporting in Ethiopia: Systematic Review

      review-article
      1 , , 2
      BioMed Research International
      Hindawi

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          Abstract

          Adverse drug reactions are major global public health problems and an important cause of mortality. Problems related to medicines safety can emerge from real-life medication use due to increasing access to complex treatment of concomitant infectious and noncommunicable diseases, hence leading to a higher prevalence of drug-related problems. The objective of this review was to assess the knowledge, attitude, and practice of adverse drug reaction reporting among health care professionals in Ethiopia. Relevant literatures were searched from Google Scholar, PubMed, Hinari, Web of Science, Scopus, and Science Direct using inclusion and exclusion criteria. From 133 searched studies, 13 studies were reviewed. The knowledge and attitude of health care professionals towards adverse drug reaction reporting ranged from 22.68% -60.33% and 47.22% -67.14%, with averages of 41.50% and 57.18%, respectively. While 46.93% encountered adverse drug reactions and 41.8% reported in the last 12 months. One-third (34.15%) of health care professionals do not know how to report adverse drug reactions. Fearing to report, uncertainty about the adverse drug reaction, concern about reporting generating extra work, thinking that one report does not make any difference, nonavailability of reporting forms, and lack of feedback from regulatory authority were the stated reasons for underreporting. We conclude that the knowledge, attitude, and practice of health care professionals towards spontaneous ADR reporting were low. Conducting awareness and educational training and implementation of electronic reporting can improve the ADR reporting practice.

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          Most cited references33

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          Incidence of fatal adverse drug reactions: a population based study.

          * Although drugs generally are safe and effective therapies for numerous diseases, adverse drug reactions do occur and may even be fatal. * The incidence of fatal adverse drug reactions in hospitalized patients has been estimated to be approximately 5%. * In previous studies the incidence of fatal adverse drug reactions in hospitalized patients has been reported, but the incidence of fatal adverse drug reactions in the general population is largely unknown. * Fatal adverse drug reactions account for approximately 3% of all deaths in the general population. * Haemorrhages amount to almost two-thirds of the fatal adverse drug reactions and antithrombotic agents are implicated in more than half of the suspected fatal adverse drug reactions. * Fatal adverse drug reactions are estimated to be the seventh most common cause of death in Sweden. To determine the incidence of fatal adverse drug reactions (FADRs) in a Swedish population. Every seventh randomly selected deceased in three counties in South-east Sweden during 1 January 2001-31 December 2001 was identified in the Cause of Death Register. Relevant case records (hospitals and/or primary care centres and medicolegal files) were reviewed to identify suspected drug-related fatalities. Of 1574 deceased study subjects, 49 (3.1%; 95% CI 2.2%, 4.0%) were suspected to have died from FADRs. The most common suspected FADRs were gastrointestinal haemorrhages (n = 18; 37%), central nervous system haemorrhages (n = 14; 29%), cardiovascular disorders (n = 5; 10%), other haemorrhages (n = 4; 8%) and renal dysfunction (n = 3; 6%). The drugs most commonly implicated in FADRs were antithrombotic drugs (n = 31; 63%), followed by nonsteroidal anti-inflammatory drugs (NSAIDs) (n = 9; 18%), antidepressants (n = 7; 14%) and cardiovascular drugs (n = 4; 8%). Of all the 639 fatalities in hospital 41 (6.4%; 95% CI 4.5%, 8.3%) were suspected to be due to FADRs. The medical burden of FADRs is significant. Haemorrhages were seen in a majority of the FADRs; antithrombotic agents or NSAIDs were implicated in most of these events. These results suggest that preventive measures should be taken to reduce the number of deaths caused by drugs.
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            Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital.

            To describe the opinions of hospital physicians concerning problems regarding the spontaneous reporting of adverse drug reactions (ADRs) and ways to solve them. A qualitative study was carried out. Fifteen focus groups were conducted among physicians working in a tertiary teaching hospital. A total of 208 physicians from different medical specialities participated. The focus group discussions were recorded by three different observers and the transcripts of each session were analysed for issues and themes emerging from the text. Four types of obstacles to spontaneous reporting were considered particularly important: (i) problems with the ADR(S) diagnosis; (ii) problems with the usual workload and lack of time; (iii) problems related to the organization and activities of the pharmacovigilance system; (iv) and problems related to potential conflicts. The potential solutions suggested for improving spontaneous reporting were to define the kind of ADR(S) which should be reported, to facilitate an easy contact and quick access to the hospital pharmacovigilance system, to facilitate information and support for reporting and feedback of pharmacovigilance activities. The perception of the different obstacles by the hospital physicians is an important factor in determining the causes of the underreporting of ADRs and addressing these obstacles could lead to an improvement in spontaneous reporting. A closer relationship between the doctors and the pharmacovigilance centre is suggested as a means of solving these problems. More information is needed to improve the spontaneous reporting of ADR(S) in specialized healthcare.
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              Adverse drug event reporting systems: a systematic review

              Aim Adverse drug events (ADEs) are harmful and unintended consequences of medications. Their reporting is essential for drug safety monitoring and research, but it has not been standardized internationally. Our aim was to synthesize information about the type and variety of data collected within ADE reporting systems. Methods We developed a systematic search strategy, applied it to four electronic databases, and completed an electronic grey literature search. Two authors reviewed titles and abstracts, and all eligible full‐texts. We extracted data using a standardized form, and discussed disagreements until reaching consensus. We synthesized data by collapsing data elements, eliminating duplicate fields and identifying relationships between reporting concepts and data fields using visual analysis software. Results We identified 108 ADE reporting systems containing 1782 unique data fields. We mapped them to 33 reporting concepts describing patient information, the ADE, concomitant and suspect drugs, and the reporter. While reporting concepts were fairly consistent, we found variability in data fields and corresponding response options. Few systems clarified the terminology used, and many used multiple drug and disease dictionaries such as the Medical Dictionary for Regulatory Activities (MedDRA). Conclusion We found substantial variability in the data fields used to report ADEs, limiting the comparability of ADE data collected using different reporting systems, and undermining efforts to aggregate data across cohorts. The development of a common standardized data set that can be evaluated with regard to data quality, comparability and reporting rates is likely to optimize ADE data and drug safety surveillance.
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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
                2020
                10 August 2020
                : 2020
                : 8569314
                Affiliations
                1Department of Pharmacy, Dessie Health Science Collage, Dessie, Ethiopia
                2Department of Pharmacy, College of Medicine and Health Science, Wollo University, Dessie, Ethiopia
                Author notes

                Academic Editor: Ronald E. Baynes

                Author information
                https://orcid.org/0000-0003-2353-9503
                https://orcid.org/0000-0002-6498-8455
                Article
                10.1155/2020/8569314
                7439161
                32851089
                086b195b-b0ea-49fd-a2e2-90090c3c0990
                Copyright © 2020 Abel Demerew Hailu and Solomon Ahmed Mohammed.

                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
                : 4 June 2020
                : 26 July 2020
                : 31 July 2020
                Categories
                Review Article

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