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Aim: Irrational use of medicines is a global problem. In India, one contributing factor is the availability of a large number of fixed-dose combinations (FDCs). To improve rational use and to strengthen policies, it is important to assess the usage patterns and rationality of FDCs. Methods: This study was conducted as part of a 1-year prospective cross-sectional analysis of prescriptions in the outpatient clinics of broad specialities from 13 tertiary care hospitals across India. Five most commonly prescribed FDCs in each center were analyzed. In addition, all the prescribed FDCs were classified as per the Kokate Committee classification and it was noted whether any of the FDCs were irrational or banned as per the reference lists released by regulatory authorities. Results: A total of 4,838 prescriptions were analyzed. Of these, 2,093 (43.3%) prescriptions had at least one FDC. These 2,093 prescriptions had 366 different FDCs. Of the 366 FDCs, 241 were rational; 10 were irrational; 14 required further data generation; and the remaining 96 FDCs could not be categorized into any of the above. Vitamins and minerals/supplements, antibacterial for systemic use, and drugs for gastroesophageal reflux disease (GERD) and peptic ulcer were the most used FDCs. Conclusion: Based on the finding that some prescriptions contained irrational FDCs, it is recommended that a rigorous, regular, and uniform method of evaluation be implemented to approve/ban FDCs and that prescribers be periodically notified about the status of the bans.
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WHO-TDR and the Indian Council of Medical Research recommend site visits by institutional ethics committees (IECs) for continued oversight, to ensure the ethical conduct of research. Our IEC conducted seven site visits in 2008-2009 using a standardised format to monitor adherence to protocol and the informed consent process.
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INTRODUCTION: Acute liver failure due to acute hepatitis E carries a high mortality. METHODS: Clinical and laboratory parameters of 42 pregnant women (median age 25.5 years) with acute liver failure due to acute hepatitis E were retrospectively analyzed. RESULTS: 22 women delivered, whereas pregnancy continued in 20 women. The maternal mortality in these two groups was similar (9/22 [41%] versus 14/20 [70%], p=0.056). However, in patients with grade I, II or III hepatic encephalopathy, delivery of fetus was associated with reduced mortality in those who delivered as against those who continued pregnancy (5/16 (31%) vs. 13/20 (65%), p=0.046). On multivariate analysis, higher grade of encephalopathy at admission was associated with risk of death (p=0.005). CONCLUSION: Mortality in pregnant women with acute liver failure with acute hepatitis E is high, especially in patients who present with higher grades of encephalopathy.