Surveillance of adverse drug reactions at two multidisciplinary hospitals and an outpatient specialty clinic in India

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Abstract Context Adverse drug reaction (ADR) reporting is under-developed in India, with only two of six national reporting centres currently functioning. Objective To introduce an ADR monitoring programme at two hospitals and an outpatient skin specialty clinic in South India and to evaluate the programme. Design An ADR monitoring programme was introduced in three participating centres and ADRs were documented and analysed over a period of six months. All unplanned admissions, all inpatients of the two participating hospitals and all outpatients of the skin specialty clinic were included in the study. A clinical pharmacist (the investigator) interviewed all patients on admission to identify suspected ADRs. For inpatients and clinic outpatients, suspected ADRs were documented by the treating doctor. A panel of four judges, including the investigator and the physician treating the patient with the suspected ADR, assessed the cases. Confirmed ADRs were then classified and categorised. Key findings In total, 152 ADRs were documented. The percentage of patients with a reported ADR at each of the three centres was 3.5, 3.7 and 2.3. The gender of patients with reported ADRs was 53.9 per cent male and 46.1 per cent female. Most of the patients had a type “A” reaction (110, 72.4 per cent). Using Naranjo's probability scale, 25.7 per cent of ADRs were categorised as “probable” and 74.3 per cent as “possible.” Of the ADRs reported in the two hospitals, 31.1 per cent related to unplanned medication-related hospital admissions and 68.9 per cent occurred during the hospital stay. Antibiotics (32.2 per cent), psychotropic drugs, steroids and non-steroidal anti-inflammatory drugs (11.8 per cent each) were the most common drugs that caused ADRs. General medicine (37.5 per cent) and dermatology (35.5 per cent) departments accounted for the highest number of ADRs. Pruritic rash (36.7 per cent) was the most common ADR reported at the skin clinic while pruritic rash, gastritis and diarrhoea (10.7 per cent each) and akathisia and hypoglycaemia (7.8 per cent) were the most common ADRs reported in the hospitals. Conclusion This is the first study to evaluate an ADR reporting programme in India. Introduction of the ADR monitoring programme improved health care practitioners' awareness of the importance of pharmacovigilance. Occurrence of ADRs seemed to be similar to those reported in the developed world, with the exception of the proportion of severe ADRs (25 per cent), which was higher than reported elsewhere in published studies.