BACKGROUND: The lack of specific medicines and labeling recommendations for the pediatric population is a long-standing problem. Using data from an observational study of adverse drug reactions (ADRs) among pediatric inpatients, we aimed to test the hypothesis that off-label status is a risk factor for ADRs. METHODS: A prospective intensive surveillance was conducted at a pediatric ward of a public teaching hospital. Adverse events to labeled and off-label use were assessed for incidence, severity and predictors. A multivariate Cox proportional hazards regression model used to assess off-label use is a risk factor for ADR occurring. RESULTS: Off-label and labeled use were responsible for 34 (67%) and 17 (33%) ADRs respectively. Medicines which lacked complete pediatric labeling had the greatest odds for ADRs (9.21% of medicines in this category were implicated, OR 2.84 (95% CI 1.37-7.09). Number of off-label medicines given to patient significantly increased the hazard of an ADR (hazard ratio (HR) 1.28, 95% CI 0.43-3.78, P = 0.002). Number of medicines given also significantly increased the hazard (HR 1.2, 95% CI 0.80-1.71, P < 0.001). CONCLUSIONS: Use of off-label medicines were more likely to be implicated in an ADR than labeled medicines. This off-label use would be acceptable if evidence of potential benefits outweighs ADRs risk.

Objective:To evaluate prevalence, types, and severity of potential adverse drug-drug interaction in medicine out-patient department.Materials and Methods:A single-point, prospective, and observational study was carried out in medicine OPD. Study began after obtaining approval Institutional Ethics Committee. Data were collected and potential drug-drug interactions (pDDIs) were identified using medscape drug interaction checker and were analyzed.Result:A total of 350 prescriptions with mean age 52.45 ± 14.49 years were collected over a period of 5 months. A total of 2066 pDDIs were recorded with mean of 5.90 ± 6.0. The prevalence of pDDI was 83.42%. Aspirin was most frequently prescribed drug in 185 (10.15%) out of total of 1821 drugs It was also the most frequent drug implicated in pDDI i.e. in 48.16%. The most common pDDI identified was metoprolol with aspirin in 126 (6.09%). Mechanism of interactions was pharmacokinetic in 553 (26.76%), pharmacodynamic in 1424 (68.92%) and 89 (4.30%) having an unknown mechanism. Out of all interactions, 76 (3.67%) were serious, 1516 (73.37%) significant, and 474 (22.94%) were minor interaction. Age of the patients (r = 0.327, P = 0.0001) and number of drugs prescribed (r = 0.714, P = 0.0001) are significantly correlated with drug interactions.Conclusion:Aspirin being the most common drug interacting. The use of electronic decision support tools, continuing education and vigilance on the part of prescribers toward drug selection may decrease the problem of pDDIs.

Introduction:Diabetes mellitus is on alarming rise in India. Drug utilization studies help to identify the adherence to standard treatment guidelines and to evaluate the rational drug usage.Objective:To study prescription pattern, calculate the cost of antidiabetic drugs and to evaluate the adherence to treatment guidelines in diabetic patients attending the medicine outpatient department in a tertiary care teaching hospital.Materials and Methods:A prospective observational study was carried out for a period of 5 months. The diabetic patients who visited the medicine outdoor department were included. Demographic data and complete prescription details were recorded in the structured case record form. Cost of the drug therapy was calculated from the patient's bills. Indian Council for Medical research guidelines-2005 for diabetes management was used to evaluate the adherence.Results:A total of 250 patients were enrolled in the study with mean age 57.91 ± 9.37. Out of 250 patients 126 (50.4%) were male and rest were female. A total of 1,391 drugs were prescribed, with mean of 5.56 ± 2.52 drugs and out of which 539 drugs were antidiabetics with mean of 2.18 ± 0.96. In monotherapy, metformin was frequently 218 (40.45%) prescribed. Glimepiride and metformin was the most frequently prescribed in 119 (76.28%) out of 156 antidiabetic drug combinations. Most commonly used drugs other than antidiabetics were aspirin 146 (18.9%) and atorvastatin 119 (15.41%). Mean cost of therapy for a month for a diabetic patient was 354.60 ± 305.72 INR. Majority 209 (83.6%) of prescriptions was in accordance to guidelines.Conclusion:Metformin was the most frequently prescribed drug in the diabetes patient. Metformin and glimeperide being the most frequent combination used. Majority of the prescriptions followed standard guidelines.

Background. In the absence of standard pediatric prescribing information, clinicians often use medicines in an off-label way. Many studies have been published across the globe reporting different rates of off-label use. There is currently no study based on Indian drug formulary. Methods. The prospective observational study included pediatric patients in ages between 0 and 12 years admitted in a tertiary care hospital. Off-label use was assessed using the National Formulary of India (NFI). Predictors of off-label use were determined by logistic regression. Results. Of the 1645 medications prescribed, 1152 (70%) were off-label based on 14 possible off-label categories. Off-label medicines were mainly due to dose difference and use in restricted age limits as indicated in NFI. Respiratory medicines (82%), anti-infectives (73%), and nervous system medicines (53%) had higher off-label use. Important predictors of off-label prescribing were pediatric patients in age of 0 to 2 years (OR 1.68, 95% CI; P < 0.001) and hospital stay of six to 10 days (OR 1.91, 95% CI; P < 0.001). Conclusion. Off-label prescribing is common among pediatric patients. There is need to generate more quality data on the safety and efficacy of off-label medicines to rationalize pediatric pharmacotherapy.

Objective:Paracetamol and ibuprofen are widely used for fever in children as monotherapy and as combined therapy. None of the treatments is proven clearly superior to others. Hence, the study was planned to compare the efficacy of paracetamol, ibuprofen and paracetamol-ibuprofen combination for treatment of febrile children.Materials and Methods:This was an investigator blind, randomized, comparative, parallel clinical trial conducted in 99 febrile children, 6 months to 12 years of age, allocated to three groups. First group received paracetamol 15 mg/kg, second group received ibuprofen 10 mg/kg and third group received both paracetamol and ibuprofen, all as a single dose by the oral route. Patients were followed-up at intervals of 1, 2, 3 and 4 h post dose by tympanic thermometry.Results:Mean tympanic temperature after 4 h of drug administration was significantly lower in the combination group compared with paracetamol group (P < 0.05); however, the difference was not clinically significant (<1°C). The rate of fall of temperature was highest in the combination group. Number of afebrile children any time post dose until 4 h was highest in the combination group. Difference between combination and paracetamol was significant for the 1st h (P = 0.04). Highest fall of temperature was noted in the 1st h of drug administration in all the groups. No serious adverse events were observed in any of the groups.Conclusion:Paracetamol and ibuprofen combination caused quicker temperature reduction than either paracetamol or ibuprofen alone. If quicker reduction of body temperature is the desired goal of therapy, the use of combination of paracetamol + ibuprofen may be advocated.