Published: 2017-01-18

A prospective study on adverse drug reactions in outpatients and inpatients of medicine department in a tertiary care hospital

Harsha Ramakrishnaiah, Vasundara Krishnaiah, H. P. Pundarikaksha, Vedavathi Ramakrishna


Background: No pharmacotherapeutic agent is completely free from noxious and unintended effects and thus adverse drug reactions (ADRs) are inevitable consequences of drug therapy. Incidence of ADRs in Indian population ranges between 1.8% and 25.1%. However, ADR reporting in India is inadequate. Developing awareness inpatients and healthcare professionals (HCPs) will help in reducing the ADRs, its suffering and socioeconomic impact. Hence, the present study of ADR monitoring in the outpatients and inpatients of the medicine department in a tertiary care hospital is undertaken. The main objective of this study was to assess the ADR reporting patterns in outpatient and inpatient of medicine department. The study was also aimed to assess the causality, severity, and preventability of these ADRs and comparison between spontaneous reporting by HCP and patient self-reporting of suspected ADRs.

Methods: This study was a prospective observational study conducted in 111 consecutive patients who experienced ADRs in the department of medicine. The study plan included analysis and assessment of the clinical pattern, spectrum of ADRs reported based on causality, severity, preventability factors. The impact of ADRs on emotional, occupational, and social life of patients was evaluated. The assessments were compared between patient reporting and HCP reporting of ADRs.

Results: The clinical spectrum of ADRs ranged from the more common mild reactions such as skin rashes, itching, nausea, and vomiting to moderately severe reactions prolonging the hospital stay. The predominant causative drugs were antimicrobials, antiretrovirals, non-steroidal anti-inflammatory drugs and antihypertensives. The majority of ADRs were probable in causality assessment, moderate in severity and probably preventable. Comparison of ADR reporting between patient and HCP revealed that ADRs reported by patient’s been less in incidence, similar in qualitative analysis to HCP with very elaborative narration and highlighted emotional and occupational impact due to ADRs than HCP reports.

Conclusion: A wide range of ADRs are possible in medicine department. Adequate awareness of ADR reporting and precautions, while prescribing drugs are essential. Including patients as additional reporters of suspected ADR may add to the benefit of pharmacovigilance.


Adverse drug reactions, Patient self-reporting, Pharmacovigilance

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