A prospective study on causality, severity and preventability assessment of adverse drug reactions in a tertiary care hospital in India

Abstract

Background: The present study was undertaken to evaluate the incidence and pattern of adverse drug reaction (ADRs), causality, severity and preventability of ADRs.Methods: Data was collected and analyzed with the information such as patients’ demographic details, associated co-morbid conditions and detailed drug related information gathered from ADR reporting forms. World Health Organization (WHO) scale was used for assessing causality, modified Hartwig scale was used for assessing severity and modified Schumock and Thorntons scale were used for assessing preventability of ADRs. Data was analyzed using descriptive statistics.Results: Total 154 ADRs were reported in a period of one year (August 2016- July 2017). Out of 154 ADRs analyzed, 120 (77.9%) were in adults, 33 (21.4%) pediatric and 01 (0.7%) in geriatric patients. The most common ADR recorded was cutaneous reactions (43.5%) and the most common causative class of drugs for the same was found to be antimicrobials (46.7%) followed by non-steroidal anti-inflammatory drugs (15.6%). Causality assessment scale indicated 68.8% ADRs possible and 24% ADRs as probable. Severity assessment revealed that 45.5 % were mild, 50.6% moderate and 3.9% ADRs severe. Preventability assessment showed 84.4% of the cases were probably non-preventable.Conclusions: In this study it was found that, most of the ADRs were of possible category with mild to moderate severity and majority being non-preventable. Antimicrobial drugs being the most common offending drug class causing ADRs. Strategies targeting appropriate and cautious use of this class of drugs may benefit in reducing the number of ADRs and therefore the cost involved in the treatment.

The pattern of reported adverse drug reactions with reference to specific drug class and organ system

“…15 The present study was done to analyze the ICSR forms (n=382) collected from various departments, shows equal distribution of ADRs among both the genders. This was a comparable finding to that reported by Jose and Belhekar et al 15,16 However, the spontaneous reporting studies in our country had observed high percentage of ADRs in females. [17][18][19][20][21][22] The various factors influence the drug metabolism and response of individuals which include differences in body mass index, genetic constitution and differences in levels of various enzymes responsible for drug metabolism.…”

“…23 In present study, 21.46% of ADRs were reported in age group of 40-49 years, 17.54% of ADRs were reported in age group 50-59 years and 19.12% of ADRs were reported in the elderly group. Since previous studies have stated that advanced age increases the risk of ADR due to pharmacokinetic and pharmacodynamics changes, the present study was comparable to the findings reported by Scheneiderjk, Belhekar, David, Ramesh, and Arulmani et al 6,[16][17][18][19]24,25 The seriousness criteria as observed in the present study is 27.2% (n=382). The present study reports of seriousness criteria were different from the studies reported by Singh, Venkatasubbaiah and Sneha et al which was 14.93% (n=154); 5.12% (n=254) and 39% (n=177) respectively.…”

“…The involvement of skin, GI system, central and peripheral nervous system in that order in our study was similar to that of other previous studies Belhekar and Lihite et al also reported skin is the most commonly affected organ system. 4,6,12,16,18,20,38 The limitation of our study is that, re-challenge test was not done in any case due to medical and ethical issues and it's a retrospective study which is descriptive in nature. The ADRs are spontaneously reported so that the true incidence of ADRs cannot be determined by using this data.…”

Adverse Drug Reaction Profile of Drugs Prescribed in Coronavirus Disease - 19 Patients – A Cross-Sectional Study

“…Considering causality assessment our end result showed that 70% ADRs were probable and 30% were possible as per the WHO causality assessment scale which changed into contrary from the questionary primarily based totally Naranjo's algorithm, where 36% ADRs were probable and 64% were possible and additionally contrary to observe performed through Melo et al where 19.8% ADRs were probable and 67.4% were possible. According to Hartwig's severity scale, mild ADRs have been described as those which does not by itself require prolongation of hospitalization and could be managed by simple measures, moderate were those ADRs which needed prolongation of hospital stay of the patient for treatment of the same and severe were life-threatening ADRs [23].…”