ABSTRACT
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.
ABSTRACT
Drug induced Neuropathy is seen commonly in patients undergoing treatment with drugs like phenytoin, dapsone, isoniazid etc. Carbamazepine is a drug used in the treatment in the treatment of focal seizure, generalized tonic - clonic seizure and trigeminal neuralgia. It is presented a case of carbamazepine induced vitamin B12 deficiency and neuropathy. A 21 year old male presented to our hospital with complaints of history of slipping of footwear while walking, numbness, impairment of balance and unsteadiness of gait in both lower limbs. Detailed history revealed the patient was on treatment with carbamazepine for tonic - clonic seizure for three months. He is non- smoker, non -alcoholic, not on treatment with other drugs and there is no family history of diabetes mellitus/ sensory neuropathy. On examination power was normal on both lower limbs, vibration sensation was decreased in both lower limbs, sensation was reduced, joint position was affected in bilateral toe and ankle reflex was absent. Vitamin B12 level was found to be 83pg/ml. The patient was discontinued from carbamazepine and started on vitamin B12 therapy and the symptoms subsides slowly. Causality assessment done by WHO- UMC probability method and Naranjo Adverse Drug Reactions Probability Scale showed “Probable” association.