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.

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.

Background:Drug-related problems (DRPs) frequently occur in modern medical practice, increasing the morbidity and mortality as well as increasing cost of care.Objective:The study is to evaluate the incidence of DRPs in patients admitted to a psychiatric department.Materials and Methods:A prospective observational study was conducted for a period of 4 months at Baliga psychiatric hospital. All prescriptions of the study population were screened for DRPs such as adverse drug reactions (ADRs) and potential drug-drug interactions (pDDIs) by using computerized database system.Results:Out of 120 patients, 19 patients had observed 26 DRPs. Out of 33 patients, 19 patients had observed 26 ADRs and 14 patients had observed 24 pDDIs. The overall incidence of DRPs was 15.83%. Female patients outnumbered the male patients, in which 12 women constitute 10% followed by men 7 (5.83%). The common ADRs observed were hyponatremia and headache. Considering the outcomes, 20 (76.9%) cases recovered from ADRs and 20 (76.9%) of the ADRs were definitely preventable. Majority of ADRs were probable and were found to be mild to moderately severe.Conclusions:Age, female gender and polypharmacy were the risk factors for the developing DRPs.

Background: Chronic Obstructive Pulmonary Disease (COPD) is a disease of significantly increasing in terms of economic burden due to its increasing prevalence and high costs. In India because of growing pressure on the health care budget, appropriate reasoning of current expenditure and future investments in public health care becoming a priority. Objective: To evaluate Burden of cost in patients of Chronic Obstructive Pulmonary disease. Material Method: A prospective, observational, non-interventional, cohort study was carried out over a period of six months for Chronic Obstructive Pulmonary Disease (COPD) inpatients at medical wards of Sheth V. S. hospital, Ahmedabad, Gujarat, India. Burden of cost had been evaluated as a part of Pharmacoeconomic. Direct medical and non-medical cost were included in the burden of cost. From the drug rate manual of hospital, cost for drugs and investigation were calculated. Result: Total numbers of 70 patients in which 53 were male and 17 were female with mean age of 60.21 ± 10.29. Minimum total direct medical cost was Rs. 864.00 and maximum was Rs. 5876.00 with a mean ± SD 2418.12 ± 839.73, in which medicine cost was high. Minimum total direct non-medical cost was Rs. 149.00 and maximum was Rs. 1069.00 with a mean ± SD 528.10 ± 212.72, in which additional charges was high. Minimum total direct cost was Rs. 1103.00 and maximum was Rs. 6945.00 with a mean ± SD 2946.22 ± 1009.23. Direct medical cost contribute 82% and direct non-medical costs contribute 18% of total direct cost. Conclusion: COPD has a substantial impact on health-care costs particularly for hospitalization. Pharmacoeconomic evaluation of COPD is essential to obtain optimal therapy at lowest price and alternative treatment plans to gain appropriate health care services Costs of COPD were exceptionally low in India compared to data obtained from developed countries.

Objective: The contribution of Indian pharmacy research is unremarkable in the world. Hence, we aimed to determine the research involvement and research productivity of Indian pharmacy faculties. Methods: A questionnaire evaluating research involvement and research productivity of the faculties was developed, validated and sent to 7536 email addresses. The main question categories in the questionnaire were-demographics, journal related research activities, conference related research activities, opinions about research and others. Results: We received 295 responses with the response rate of 3.91%. The male: female ratio was 2.78. The important average values in the survey were-experience in teaching/research= 12.51 years, Time spent on research/related activities=131.56 min/day, Research based publications= 34.3, Patents received=0.90. Conclusion: Although our study generates huge 'quantitative' data, serious inputs are needed to improve the overall 'quality' of Indian pharmacy academic research. Further research is indeed required to strengthen the field.