ArticleJournal of pharmacy & bioallied sciences
Retrospective Assessment of the Reporting of Adverse Drug Reactions in a Malaysian Clinical Training Center: A Short Communication.
Article in Journal of pharmacy & bioallied sciences. 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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Authors and funding
4 authors.
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Abstract
objectivesThis study aimed to assess the completeness and quality of adverse drug reaction (ADR) reports that were submitted to the Pharmacovigilance Unit (PVU) in clinical training center (CTC), Faculty of Medicine, UiTM Sungai Buloh Campus. MATERIALS AND
methodsA retrospective study was conducted using all ADR reports that were submitted to the PVU in CTC from December 31, 2000, to December 31, 2018. The completeness was assessed by reviewing all the required elements to be filled in the ADR reports. The quality was assessed by investigating the required information in the ADR reporting form. Descriptive statistics have been used to present the findings. KEY
findingsIn a total of 31 reports that were submitted to the PVU in CTC, 98.9% of patient's information and 100% of ADR descriptions were completed. Suspected drug information and the reporter's details were completed by 52.2% and 79.6%, respectively. Of 58.0% of the information about seriousness recorded, 38.9% (
conclusionFurther efforts and relevant interventions should be considered to increase the reporting frequency and to enhance the completeness and the quality of the ADR reports in the study setting.
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