ABSTRACT
BACKGROUND: Off-label drug use refers to any use of an approved or cleared drug that is not included in that product's approved labeling or cleared indications for use. It may be in terms of indication, age group, dosage, or route of administration. Off-label drug prescriptions are common neurology practice. AIM: The aim of the study is to evaluate the prevalence pattern of off-label drug use in neurology. SUBJECTS AND METHODS: A prospective, observational, cross-sectional study was carried out in the neurology outpatient department of tertiary care teaching hospital. Data of patients above 18 years were recorded after obtaining their informed consent. The National Formulary of India (NFI) and British National Formulary (BNF) guidelines were used as tools for evaluation of the prevalence of off-label drug use. RESULTS: A total of 709 drugs were recorded from the prescription data of 205 patients collected in the duration of 2 months. The results reported 145 (20.45%) and 317 (44.71%) drugs as off-label as per the NFI and BNF, respectively. Prescriptions with minimum 1 off-label drug use were 78.05% - BNF and 46.83% - NFI. The indication was one of the most common causes of drugs being off-label. Out of the total 317 off-label drug uses reported, 84 were unlicensed drug use as per the BNF. There is strong and positive correlation established between the age of the patients, number of drugs prescribed, and total off-label drugs prescribed per patient in the given study. The most common off-label drug use noted was with clonazepam and amitriptyline. CONCLUSION: Off-label prescriptions practice is common in the field of neurology.
ABSTRACT
INTRODUCTION: Assessment for practical skills in medical education needs improvement from subjective methods to objective ones. An Objective Structured Practical Examination (OSPE) has been considered as one such method. This study is an attempt to evaluate the feasibility of using OSPE as a tool for the formative assessment of undergraduate medical education in pharmacology. MATERIALS AND METHODS: Students of second year MBBS, at the end of the first term, were assessed by both the conventional practical examination and the Objective Structured Practical Examination (OSPE). A five-station OSPE was conducted one week after the conventional examination. The scores obtained in both were compared and a Bland Altman plot was also used for comparison of the two methods. Perceptions of students regarding the new method were obtained using a questionnaire. RESULTS: There was no significant difference in the mean scores between the two methods (P = 0.44) using the unpaired t test. The Bland Altman plot comparing the CPE (conventional practical examination) with the OSPE showed that 96% of the differences in the scores between OSPE and CPE were within the acceptable limit of 1.96 SD. Regarding the students' perceptions of OSPE compared to CPE, 73% responded that OSPE could partially or completely replace CPE. OSPE was judged as an objective and unbiased test as compared to CPE, by 66.4% of the students. CONCLUSION: Use of OSPE is feasible for formative assessment in the undergraduate pharmacology curriculum.
ABSTRACT
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.
