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

Abhishek Kumar, Lakhan Majhee, Manju Gari.


Background: The cornerstone of management of patients with human immunodeficiency virus/acquired immunodeficiency syndrome (AIDS) infection is highly active antiretroviral therapy (HAART). However, antiretroviral drugs are highly toxic and are associated with various adverse drug reactions (ADRs). Therefore, many patients require the withdrawal of the drug or even discontinue the treatment resulting in the treatment failure.

Aims and Objectives: To study the demographic details and type of ADRs in patients receiving ART and to do causality, severity, and preventability assessment of the spontaneously reported ADRs.

Materials and Methods: This was a retrospective cross-sectional observational study conducted for 18 months from January 2015 to June 2016 in Rajendra Institute of Medical Sciences, Ranchi. Spontaneously reported ADR data were evaluated for the patient demography, type of ADRs, drugs/regimes responsible, and body system affected. ADRs were assessed for their causality, severity, and preventability as per the standard scales.

Results: Out of 356 patients given ART 197 ADR reports received which showed slight male predominance. 86.80% cases fell in 25-54 years age group with a mean age of 38.38 ± 10.74 years. The majority were neuropsychiatric (29.44%) and gastrointestinal-hepatobiliary (24.87%) followed by hematologic, dermatologic, and metabolic ADRs. Regimen containing tenofovir, lamivudine, and efavirenz were responsible for maximum number of ADRs (49.23%) followed by zidovudine, lamivudine, nevirapine (23.85%). 88.85% of ADRs were possible, 9.14% probable, and 2.03% certain according to the World health organization-Upsala monitoring centre causality assessment. 67.51% ADRs were mild followed by 29.44% moderate and 3.04% severe. 21.82% ADRs were definitely preventable, 37.06% probably preventable, and 41.12% not preventable.

Conclusion: Although HAART is effective in decreasing AIDS-related deaths, it is associated with a number of ADRs. To maintain the patient compliance judicious use of ART and continuous monitoring of ADRs and their effective treatment prevention is advocated.

Key words: ART; ADR; World Health Organization-Upsala Monitoring Centre Causality Assessment; Causality; Severity; Preventability

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