Background: Successful use of antibiotics has brought a revolutionary change in the management of infectious diseases but has also resulted in its irrational use. Indiscriminate use of anti-microbial agents (AMAs) has been well-documented in the ICUs where polypharmacy is a common phenomenon, thus increasing the risk of Adverse Drug Reactions (ADRs). It is extremely imperative to evaluate the prescribing pattern of antimicrobials for enabling suitable modifications in prescribing patterns; to increase the therapeutic benefits and for optimizing the health care services.Methods: With the objective to assess the prescription patterns of AMAs and the rationality of their use this observational study was undertaken in the Intensive Care Unit of a Tertiary Care Hospital for two months.Results: Of the total 127 patients, 80 (62.99%) were male and 47 (37.01%) were female at an average age of 51.3±18.3 years. 102 (80.31%) patients received AMAs at average of 1.71±0.99 and 25 (19.69%) didn’t. Betalactam antibiotics were the most frequently (72.99 %) prescribed class. Meropenem was the most commonly prescribed (41 occasions) agent. The length of stay in ICU per patient was 4.42±3.49 days. 41.63% patients had more than two morbidities. No AMAs were prescribed in generic name. In 28 (27.45%) patients the AMAs prescribing were irrational.Conclusions: The high utilization rates of costly AMAs and irrational prescriptions are matters of great concern and need to be urgently addressed by use of guidelines, surveillance and antibiotic restriction policies and sensitization programs at all level of healthcare.

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Background: India as an important clinical trial hub in the world. In clinical trials, many of the drug issues related to the safety are inadequately studied in highly selected and limited number of patients. Due to introduction of many new drugs in the country, it has become essential to have an effective Pharmacovigilance system nationwide. Under reporting of ADRs is widespread and a daunting challenge in Pharmacovigilance programme of India (PvPI).Methods: A cross sectional study was conducted for two months with the objective to study the pattern of ADRs reporting in two teaching hospitals of Tripura. The data were collected in “Suspected ADR reporting forms” of Indian Pharmacopoeia Commission (IPC). Suspected ADRs were assessed for causality using Naranjo ADR probability scale.Results: 44 ADR reporting forms were received with 58 ADRS. Among them, Gastrointestinal System ADRs were the highest (25.86%). More ADRs were seen in males than females (52.27% vs 47.72%). 68.18% cases had the medication through oral route. Out of all ADRs, 67.24% were Type A reactions. Most of the reactions reported, were mild (90.9%) based on modified Hartwig severity scale. Most of the ADRs reported were of probable causality (score 5-9) measured by Naranjo’s Algorithm.Conclusions: This study would definitely give an insight into the pattern of ADRs in tertiary health care centers and may help to increase awareness of health care provider for further Pharmacovigilance studies.

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