ArticleCurrent drug safety2022
ADR in Journals: Are They Translated into Regulatory Frameworks?
Article in Current drug safety, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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3 authors.
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Abstract
introductionAn adverse drug reaction case report refers to a scientific publication that is written by a health care professional who suspects a casual relationship between a drug and an adverse drug reaction (ADR). ADR case reports help to identify potential risks associated with the use of drug. Most of the case reports do not mention about reporting the ADR to regulatory authorities. With this objective, the aim of this study was to analyze the number of Adverse Drug Reactions (ADR) published as case reports (PubMed indexed journals) from January 2018 to June 2019, and observe if they are translated in regulatory frameworks like Vigibase, and package inserts. MATERIALS AND
methods321 ADRs were obtained with the keywords "Adverse Drug Reaction". Out of those, 158 were independently extracted by two investigators, observed and categorized according to classes of the drugs, geographic location, severity, hospitalization, Completeness of ADR, whether reported to the regulatory authority (Vigibase), or listed in the package insert. Literature review articles were excluded.
resultsOut of the 158 ADRs, antibiotics accounted for 12.65%, CNS drugs and monoclonal antibodies11.39%, anticancer drugs 9.49%, CVS drugs 4.43%, anti-viral 3.79%, others 45.56%, respectively. According to geographic region, 26 ADRs published were from USA, Australia 4, Italy 3, India 17, Turkey 9, Singapore and UK 1, China 20, Denmark and Canada 2, Japan 10, France 9, Austria 1, Korea 5, South America 3, Switzerland 2, respectively. Depending upon the severity, causality assessment was done only for 45 ADRs, and not done for 113 ADRs. 41.13% patients (from 65 case reports) were hospitalized. Among the 158 ADRs, 14 ADRs were not found in Vigibase. 32 ADRs were not mentioned in the Drug package inserts. When categorized according to the completeness of case reports, weight accounted for1.89%, lab values and procedure for diagnosis, 96.8%, risk factors, 95.56%, prior exposure, 88.60%, Post ADR status, 60.12%, start-stop medication, route of administration, first dose, last dose, duration of illness accounted for 100%, respectively.
conclusionDepending upon our observation, we have noticed that there is deficiency in reporting of suspected ADRs to regulatory authorities. Reporting can be included as mandatory criteria for ADR case reports. Also, there is an increased need to aware various healthcare workers for reporting ADR.
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