Causality, severity and preventability assessment of adverse drug reactions in patients received anti-retroviral therapy in a tertiary care hospital: A retrospective study

Background: To evaluate the adverse effect profile of spontaneously reported cases of adverse drug reactions due to antiretroviral (ART) drugs in a tertiary care teaching hospital.Methods: A descriptive retrospective study of pattern of ART induced adverse drug reactions (ADRs) spontaneously reported to the Pharmacology department at a tertiary care hospital from January 2011 to December 2016. The details of suspected ADRs including drugs involved, treatment given for ADRs, and the outcome were also documented. These ADRs were analyzed for causality (WHO scale), severity (Hartwig et al. scale), seriousness (ICH E 2A guidelines), preventability (Schumock and Thornton scale) and type based on Edwards and Aronson classification system.Results: Of the 75 cases of ART induced ADRs, reactions were slightly more common in males (52%) and had median age and duration of ART as 36 years and 109 days respectively. Drug induced anemia was the most common presentation followed by cutaneous ADR and zidovudine being the commonest offender. Severity was moderate in 85.3% and causality was probable in 16% and possible in 84% cases. The type reaction was augmented type in 41.3% and not preventable in 76%.Conclusions: Zidovudine is the commonest drug implicated in causing anemia amongst the antiretrovirals. Spontaneous reporting method for antiretroviral pharmacovigilance is insufficient. Targeted spontaneous reporting or cohort event monitoring need to be studied for antiretroviral pharmacovigilance.

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Cutaneous Adverse Drug Reactions: A Two Years Retrospective Study From A Tertiary Care Hospital In Sub Himalayan Region

Journal of Medical Science And clinical Research ◽

10.18535/jmscr/v5i2.94 ◽

2017 ◽

Vol 05 (02) ◽

pp. 17767-17773

Author(s):

Dr Saru Thakur ◽

Keyword(s):

Retrospective Study ◽

Adverse Drug Reactions ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Himalayan Region ◽

Care Hospital ◽

Drug Reactions

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Adverse Drug Reactions: Trends in a Tertiary Care Hospital

Current Drug Safety ◽

10.2174/1574886311207050011 ◽

2013 ◽

Vol 7 (5) ◽

pp. 384-388

Author(s):

Harmeet S. Rehan ◽

Deepti Chopra ◽

Ravinder K. Sah ◽

Ritu Mishra

Keyword(s):

Adverse Drug Reactions ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Care Hospital ◽

Drug Reactions

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ANALYSIS OF ADVERSE DRUG REACTIONS SPONTANEOUSLY REPORTED TO ADVERSE DRUG MONITORING CENTRE OF A TERTIARY CARE HOSPITAL–PROSPECTIVE STUDY

International Journal of Current Pharmaceutical Research ◽

10.22159/ijcpr.2018v10i1.24403 ◽

2018 ◽

Vol 10 (1) ◽

pp. 23

Author(s):

Gajanan P. Kulkarni ◽

Lokesh V. Patil

Keyword(s):

Prospective Study ◽

Adverse Drug Reactions ◽

Causality Assessment ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Care Hospital ◽

Drug Reactions ◽

Monitoring Centre ◽

Organ Systems ◽

A Prospective Study

Objective: To assess ADRs with reference to causative drugs, organ systems involved and seriousness of reactions.Methods: A prospective study conducted over a period of 1 y. The spontaneous adverse drug reactions reported between July 2016 and July 2017 at AMC centre BRIMS, Bidar were analyzed using Naranjo’s scale. Causality assessment of suspected drugs involved, system affected, and seriousness of reactions was assessed.Results: GIT system was most commonly involved, followed by generalized features, skin and appendages, CNS i. e, extrapyramidal system and dizziness, hearing and vestibular systems.Conclusion: Majority of the ADRs reported were mild to moderate severity and 20% can be categorized as severe reactions, which needed to treat under hospitalization

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