An analysis of the pattern and profile of adverse drug reactions reported at a tertiary care teaching hospital in Kerala, India: a retrospective record based observational study

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dc.contributor.authorP., Abdul Aslamen_US
dc.contributor.authorPurushothaman, Sangeethaen_US
dc.contributor.authorShajahan, Jihanaen_US
dc.date.accessioned2020-04-23T07:51:32Z
dc.date.available2020-04-23T07:51:32Z
dc.date.issued2018-09
dc.description.abstractBackground: Adverse drug reactions (ADRs) are an important concern in modern therapeutics. Due to limitations in identifying ADRs during research phase, organized post marketing studies are essential. However, there are only few recent studies on this subject available in India. Hence this study was done in a tertiary care hospital in South Kerala to evaluate the profile and causality of ADRs.Methods: The details of patients who developed ADRs during the period from October 2016 to November 2017 were collected. Data collection was done using the suspected drug reactions monitoring form by CDSCO used under PvPI and a retrospective observational cross-sectional analysis was done. The profile and causality of ADRs were evaluated.Results: The total number of ADR events reported was 300. 179 ADRs were hypersensitivity reactions (Aronson Type B) and the remaining 121 reactions were Type A reactions. The individual drug class causing majority of the ADRs was antibiotics (36%). Commonest significant dose related ADR was bleeding (7%) caused by combined use of antiplatelets and anticoagulants. The organ system most affected as per SOC classification was skin and appendages (56%). Causality assessment revealed that majority (76%) belonged to “probable” category, whereas 23.6% were of “possible” type.Conclusions: The development of ADRs can significantly affect treatment course – interruption of drug therapy, use of additional drugs and prolonged hospital stay. Employing monitors dedicated to ADR detection and education of prescribers to closely monitor patients can help manage ADRs effectively.en_US
dc.identifier.affiliationsDepartment of Pharmacology, Government Medical College, Manjeri, Kerala, Indiaen_US
dc.identifier.affiliationsDepartment of Pharmacology, Travancore Medical College, Kollam, Kerala, Indiaen_US
dc.identifier.citationP. Abdul Aslam, Purushothaman Sangeetha, Shajahan Jihana. An analysis of the pattern and profile of adverse drug reactions reported at a tertiary care teaching hospital in Kerala, India: a retrospective record based observational study. International Journal of Basic & Clinical Pharmacology. 2018 Sep; 7(9): 1715-1720en_US
dc.identifier.issn2319-2003
dc.identifier.issn2279-0780
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/199820
dc.languageenen_US
dc.publisherMedip Academyen_US
dc.relation.issuenumber9en_US
dc.relation.volume7en_US
dc.source.urihttps://dx.doi.org/10.18203/2319-2003.ijbcp20183477en_US
dc.subjectAdverse drug reactionsen_US
dc.subjectCausalityen_US
dc.subjectPharmacovigilanceen_US
dc.titleAn analysis of the pattern and profile of adverse drug reactions reported at a tertiary care teaching hospital in Kerala, India: a retrospective record based observational studyen_US
dc.typeJournal Articleen_US
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