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 ORIGINAL ARTICLE
Year : 2015  |  Volume : 33  |  Issue : 3  |  Page : 393-400

Adverse drug reactions profile of antimicrobials: A 3-year experience, from a tertiary care teaching hospital of India


1 Department of Biotechnology, Arni University, Indora, Himachal Pradesh, India
2 Department of Pharmacology and Therapeutics, Government Medical College, Jammu, Jammu and Kashmir, India

Correspondence Address:
S Sharma
Department of Biotechnology, Arni University, Indora, Himachal Pradesh
India
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Source of Support: Indian Pharmacopeia Commision, Gaziabad New Delhi India & WHO, Conflict of Interest: Declared Data is confidential and only property of IPC under PvPI; reflect only suspected events and the data is generated by spontaneous reporting system as proposed by PvPI. There may be many other confounding factors which could have affected the final outcome of the study which were beyond the scope of current retrospective cross-sectional study.


DOI: 10.4103/0255-0857.158564

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Aim of Study: To evaluate adverse drug reaction (ADR) profile of antimicrobials over 3-year period. Material and Methods: A retrospective cross-sectional study was undertaken using suspected adverse drug data collection form available under Pharmacovigilance Programme of India (PvPI). Results: A total of 2,586 ADR events were recorded in 3 years, out of which 392 (15.15%) were because of antimicrobials. Male: female was 1.02:1. Medicine department contributed maximally (98.97%). The intravenous (IV) route of drug administration accounted maximum ADRs (53.32%), followed by oral route (45.41%). Monotherapy was responsible for 80.87%, whereas combination therapy for 19.13%. Combinations therapy was irrational in 79.67%. The most common antibiotic resulting in ADRs was injection ceftriaxone (35.71%), followed by tab. azithromycin (7.39%), tab. ofloxacin + ornidazol (5.35%), ofloxacin (3.57%), ciprofloxacin (2.29%), amoxicillin (2.55%), tab. cefixime (2.29%), inj. linezolid (2.04%). Rash remained the most common ADR, followed by diarrhoea and gastritis. Most common organ system involved was dermatological (47.44%), followed by gastrointestinal (GI) (39.28%), central nervous system (CNS) (5.35%), cardiovascular system (CVS) (3.57%) and renal and genitourinary (1.78%). While 47.96% ADR's were latent, 26.785% were acute and 25.26% were sub-acute. Moreover, 89.79% of ADRs were moderate in nature, whereas 26.88% were severe and 3.33% mild in nature. Furthermore, 92.86% were non-serious and 7.14% serious in nature. Also, 65.06% of antimicrobial caused ADRs were type A and 34.64% were type B reactions. As per World Health Organization-The Uppsala Monitoring Centre (WHO-UMC) scale, 73.98% of ADRs were probable/likely and 26.02% as possible. However, 99.47% of ADRs required intervention. Conclusion: The current study suggest that ADRs due to antimicrobials is a significant health problem.






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2004 - Indian Journal of Medical Microbiology
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