Type 2 diabetes mellitus (T2DM) is a progressive disease with multifactorial etiology. The first-line therapy includes monotherapy (with metformin), which often fails to provide effective glycemic control, necessitating the addition of add-on therapy. In this regard, multiple single-dose agents formulated as a single-dose form called fixed-dose combinations (FDCs) have been evaluated for their safety, efficacy, and tolerability. The primary objective of this review is to develop practice-based expert group opinion on the current status and the causes of concern regarding the irrational use of FDCs, in Indian settings. After due discussions, the expert group analyzed the results from several clinical evidence in which various fixed combinations were used in T2DM management. The panel opined that FDCs (double or triple) improve patient adherence, reduce cost, and provide effective glycemic control and, thereby, play an important role in the management of T2DM. The expert group strongly recommended that the irrational metformin FDC's, banned by Indian government, should be stopped and could be achieved through active participation from the government, regulatory bodies, and health ministry, and through continuous education of primary care physicians and pharmacists. In T2DM management, FDCs play a crucial role in achieving glycemic targets effectively. However, understanding the difference between rational and irrational FDC combinations is necessary from the safety, efficacy, and tolerability perspective. In this regard, primary care physicians will have to use a multistep approach so that they can take informed decisions.

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To find out the average direct hospitalization cost and length of hospital stay for patients infected with Carbapenem-resistant Klebsiella pneumonia (CRKp) and compare it with that of patients infected with Carbapenem-sensitive Klebsiella pneumonia (CSKp). MethOds: A cross sectional study was carried out from January-December 2014 and the data for hospitalization cost was collected for the patients with CRKp and CSKp infections from the medicine ICU for 72 patients admitted to the hospital. The data was analyzed for the site of infection, length of stay and average direct hospitalization cost which was then compared between the two groups. Results: During the study period, 101 patients were diagnosed with Klebsiella pneumoniae infection. 61.79% of the infections were respiratory, 24.52% urinary tract-related, 13.2% systemic and 0.47% skin and soft tissue-related. The mean age of the study population was 51.7 ± 15.7 years. The median length of stay for CRKp was 12 (11; 23) days as compared to 8 (5.2; 13.2) days in CSKp patients . The median direct hospitalization cost was calculated to be INR 43,274 (24,898; 16,0315) in case of CRKp versus INR 23,452 (12,489; 47,349) in CSKp patients. cOnclusiOns: We observed that the average cost of overall therapy and the average no. of hospitalization days was higher in CRKp group compared to CSKp group. Antibiotic resistance is a growing phenomenon and the resistance to Carbapenems can lead to increased burden of morbidity and treatment cost for patients.

A113Objectives: Regulatory policies, including economic incentivization through patent extensions, have been implemented to stimulate pediatric research, however disparity exists for the neonatal subpopulation. This analysis was conducted to identify the availability of neonate-specific data for frequently used medications in Neonatal Intensive Care Units (NICUs) and to determine the extent to which pediatric exclusivity has increased information for drugs used in neonates. MethOds: A search was conducted utilizing the FDALabels database to identify all FDAapproved NDA, BLA and ANDAs from 01/01/1980 to 08/01/2013 searching for the terms "neonate", "newborn" and "infant" present in any of the following label sections; "Indication and Usage", "Dosage and Administration" and "Pediatric Use". The results were cross-referenced with a recently published list of 100 frequently prescribed drugs in NICUs and drugs granted pediatric exclusivity by the FDA as of August, 2013. Results: A total of 737 unique labels for 110 distinct drugs were identified (including 18 combination products and 15 modified versions of previously marketed drugs). "Newborn" was identified in 450 labels; "infant" in 414 labels and "neonate" in 167 labels. More than one search term was found in 294 labels. Only 19% of drugs frequently used in NICUs mentioned neonates, newborns or infants on their labels. Mention of neonates, newborns or infants occurred in 4.5% (n= 9) of the drugs with pediatric exclusivity; while 8.7% (n= 17) of drugs granted pediatric exclusivity were used frequently in the NICU. Only two drugs frequently used in NICUs mentioned neonate, newborn or infant on their label and had pediatric exclusivity. cOnclusiOns: Despite regulatory incentives, a paucity of neonatal data exist for drugs frequently used in NICUs. Our data suggest that pediatric exclusivity did not yield sufficient neonatal data.