Adverse drug reactions

To identify the adverse drug reactions in the patients. To increase the reporting and awareness among the staffs. To evaluate the causality assessment and severity of ADRs. A prospective study was conducted for a period of one year from February 2019 to January 2020 in the Inpatients of AJ Hospital and Research Centre. Identified and reported ADRs were analyzed. ADR reporting questionnaire was provided to healthcare professionals to assess the knowledge about ADR. ADR causality assessment was carried out using WHO probability scale. Severity assessment of ADRs was done using modified Hartwig and Siegel severity scale. Paired t-test was applied to find the association between the two phases. A total of 100 ADRs were identified from 1120 patients.Causality assessment indicated that most of the ADRs were probably (85%) drug related. Severity of 79% reactions were reported as moderate. Study was categorized into two phases; Phase I and Phase II. Knowledge rate among respondents was found to be 67% in phase-I which had a remarkable increase in phase-II (92%). Common barrier for underreporting of ADR was lack of knowledge regarding ADR. The study concluded that interventions such as implementation of well-established reporting process and continuous training will help to reduce the current underreporting crisis.

The aim of the study was to analyze the incidence of adverse drug reactions (ADRs) at a tertiary care hospital and assess the functioning of the reporting system. The outcome of the study would provide information regarding associated factors and pharmacoeconomic impact of the ADRs. The causality assessment was determined by WHO UMC probability scale and Naranjo’s algorithm. Outcomes of ADR, management and the pharmacoeconomic impact was assessed. Overall incidence of ADRs among the patients was 4.5%. A total of 61 ADRs were detected from 54 patients. As per the WHO UMC scale 44.3% of the ADRs were possible and as per the Naranjo’s scale 53.1% of the ADRs were possible. Majority of the reactions were moderate in severity (47.6%). Most of the ADRs (73.8%) were predictable reactions and 39.3% were probably preventable. Multiple drug therapy (27.77%) was the most common associated factor. Withdrawal of the offending drug was the main line of management.  Symptomatic treatment was required in majority of cases. The total direct cost involved in treatment of ADRs was INR 1, 10,284 (US$ 1730.22) at a rate of INR 2042.29 US$ 32.08 per patient. The direct cost per patient involved in ADR related hospital admissions (INR 2689 i.e US$ 42.30) was higher than ADR during hospitalization (INR 1769.60 i.e US $ 27.83).The ADRs were not recognized and recorded in majority of the cases. Patients on multiple drug therapy are more vulnerable to ADRs. The incidence and alarming pharmacoeconomic impact of the ADRs suggest that there is a need for a continuous monitoring system at tertiary care hospitals.

The present study was carried out to monitor, estimate the prevalence and consequences of ADRs on treatment of TB and to assess causality, predictability, preventability and severity of the ADRs. A prospective observational and active surveillance study was conducted over a period of 9 months. Each reported ADR was assessed for its causality, severity, predictability and preventability as per standard algorithms. The management and outcome of ADRs were determined. A total of 128 ADRs (in 53 patients) were identified out of which the prevalence of ADRs in female was found to be 31.58% and 29.66% in male patients. The causality assessment by Naranjo’s scale showed that out of 128 ADR’s, 128 (100%) ADR’s were probable and based on WHO probability assessment scale 119(92.97%) were possible where as 9(7.03%) were probable. Preventability assessment showed that 125 (97.66%) were not preventable and 03 (2.34%) were definitely preventable. Severity Assessment by Modified Hartwig and Siegel Scale showed that 82 (64.06%) ADRs were mild and 46(35.94%) ADRs were moderate. 128(100%) were found to be predictable. Majority of the ADRs were recovered without giving symptomatic treatment. The study concluded that there is a need of a system for proper monitoring of ADRs caused by anti-TB drugs in RNTCP centre.  The counselling of patients for timely prevention, detection and management of ADRs will helps in further ADR occurrence minimisation.