Adverse drug responses (ADRs) are unanticipated and adverse effects that occur at standard therapeutic doses. They greatly increase hospital admissions, morbidity, and mortality. It is estimated that ADRs account for 5-10% of hospital admissions worldwide1,2.

Pharmacovigilance is essential for recognising, monitoring, and preventing adverse drug reactions. Structured procedures have been created in India to improve ADR monitoring yet, under-reporting continues to be a major issue.

Teaching hospitals are good for ADR monitoring due to their high patient load, polypharmacy, and engagement of trained healthcare workers. This study aimed to assess ADR trends and reporting methods in such a situation3,4.

The purpose of this prospective observational study was to analyse the monitoring, reporting, and assessment of adverse drug reactions (ADRs) in a tertiary-care teaching hospital. After receiving approval from the Institutional Ethics Committee, the study was conducted during a predetermined study period. Based on predetermined eligibility criteria, all suspected ADR instances found during the study period were included.

Patients of all ages and genders who experienced suspected adverse drug reactions (ADRs) while receiving therapy in both inpatient and outpatient settings were included in the study cohort. The study eliminated patients with substance abuse-related events, poisoning instances, and inadequate clinical data. Both active surveillance (ward rounds, case sheet review, and direct patient engagement) and passive surveillance (involuntary reporting by medical workers such as physicians, nurses, and chemists) were used to find ADRs.

A structured ADR reporting form was used to gather data for each ADR case. Demographic information, clinical diagnosis, suspected medication or drugs, dosage, mode of administration, length of therapy, reaction description, onset time, management, and result were among the factors gathered. For accurate assessment, concurrent medications and pertinent laboratory tests were also documented.

Each ADR was evaluated on recognised pharmacovigilance scales. The WHO-Uppsala Monitoring Centre (WHO-UMC) scale was used to determine causality, the Hartwig and Siegel scale for severity, and the modified Schumock and Thornton scale for preventability. All data was imported into Microsoft Excel and analysed with descriptive statistics. Categorical data were expressed as frequency and percentage, whereas continuous variables were expressed as mean ± SD. The study was descriptive in nature; hence no inferential statistical tests were used.

Table 1: Inclusion and Exclusion Criteria

Table 2: Methods Used for ADR Assessment

Table 3: Data Collection Variables

The study ensured strict maintenance of patient confidentiality and followed ethical guidelines throughout the research process. Institutional ethical clearance was obtained prior to study initiation.

210 adverse drug reactions (ADRs) were reported and analysed over the six-month research period. The age group 21-40 years (41.9%) had the most ADRs, followed by 41-60 years (28.1%), while patients under 20 years and over 60 years had 15.2% and 14.8% of ADRs, respectively. A small male predominance was noted, with 56.2% of ADRs recorded in men and 43.8% in women.

The General Medicine department reported the most ADRs (34.3%), followed by Dermatology (16.2%), Surgery (15.2%), Paediatrics (11.9%), and Obstetrics & Gynaecology (10.0%), with other departments accounting for 12.4%.

Antibiotics were the most usually implicated drug class (31.0%), followed by analgesics (19.0%), antitubercular medicines (12.9%), antihypertensives (11.0%), and antidiabetic drugs (8.1%). The remaining 18.0% of ADRs were ascribed to different medication groups.

Skin reactions were the most commonly reported (36.2%), followed by gastrointestinal reactions (23.8%), central nervous system manifestations (14.3%), and hypersensitivity reactions (11.9%), with other reactions accounting for 13.8%.

The Hartwig scale was used to measure the severity of ADRs, and 48.1% were mild, 37.1% were moderate, and 14.8% were severe, showing that the majority of reactions were not problematic. Causality assessment using the WHO-UMC scale found that 46.2% of ADRs were evaluated as probable, 39.0% as plausible, 9.0% as certain, and 5.8% as unlikely, indicating a strong relationship between the suspected drug and the adverse event in most cases.

The preventability assessment revealed that 13.8% of ADRs were certainly preventable, 36.2% were probably preventable, and 50.0% were not preventable, implying that almost half of ADRs may be avoided with suitable interventions^8,9.
In terms of outcomes, 61.9% of patients recovered completely, 20.0% were in the process of recovering, and 10.0% had not recovered at the time of reporting, with 1.9% of ADRs being fatal and 6.2% having uncertain outcomes.

In terms of reporting pattern, doctors accounted for the bulk of ADR reports (60.0%), followed by nurses (25.2%) and chemists (14.8%), indicating that other healthcare professionals were less involved in ADR reporting.
Overall, the study indicated that ADRs were most commonly related with antibiotics, typically appeared as skin responses, and were mostly mild to moderate in severity, with a considerable proportion being preventable and a high rate of recovery following adequate therapy^10,11

This study found that ADRs are widespread in clinical practice, especially among adults. The prevalence of ADRs in the 21-40 age group could be attributed to increasing medication exposure and polypharmacy.

Antibiotics were the most usually implicated medicines, in line with earlier research. Skin responses were the most common ADRs, likely due to their ease of detection.The majority of adverse drug reactions were mild to moderate, indicating adequate monitoring and early response. The majority of plausible causality points to a substantial link between medications and reactions¹².A large number of ADRs were preventable, emphasising the necessity of rational prescribing and pharmacovigilance.

Under-reporting remains an issue, especially among non-physician healthcare personnel. Awareness initiatives and training are critical for improving reporting.

ADRs are a major clinical problem, and many are avoidable. Improved patient safety can be achieved by strengthening pharmacovigilance protocols, increasing awareness, and encouraging reporting

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