Usage Pattern of Fixed-dose Combinations at ICMR Network of Rational Use of Medicine Centres across India: Recommendations for Policymakers and Prescribers

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.

Impact of recent regulatory notifications on an institutional ethics committee.

The Government of India came out with a slew of notifications to streamline clinical research in the beginning of 2013 in response to the Supreme Court’s orders and a Parliamentary Standing Committee’s report. The notifications greatly influenced the structure, review process, outcomes and administration of ethics committees across India. In this study, we attempted to objectively evaluate the impact of these notifications on our institutional ethics committee’s (IEC) structure, review process, outcomes and administration. The results revealed that though the number of regulatory studies reviewed by our IEC remained the same, the number of studies actually approved decreased with an increase in the turnover time. The number of serious adverse events (SAEs) reported also fell, although the number of meetings held to discuss these SAEs increased significantly. The administrative workload rose with increased documentation. Though the annual income of the IEC fell marginally, the expenses shot up. We believe that the notifications definitely had an impact on the structure, review process, outcomes and administration of our IEC, although it remains to be seen whether they had a real impact on the research participants’ safety and well-being.

Rotational Training Programme For Postgraduate Students Of Pharmacology: Our Experience.

Background: Rotational training programme for the postgraduate students of pharmacology should be planned with the aim of making them competent as pharmacologist. Thus in the present study we decided to develop a rotational duty programme and evaluate perception and attitude of postgraduate student towards it. Methodology: We developed a rotational duty programme at our department which was structured by defining objectives to be achieved, content to be learnt, weekly targets to be accomplished and assessment to provide feedback to the students. The perception and attitude were recorded using a questionnaire in which their adequacy of duration of posting; adequacy, relevance and implementation of weekly time table; adequacy and relevance of the training imparted in the posting; quality and pattern of assessment and their perceived benefit from the rotational training program were assessed. Results: Postgraduate students found the programme adequate and relevant in terms of duration, implementation of weekly targets, training imparted and quality of assessment. Students also perceived the programme as beneficial. Suggestions were given by the students in the areas they considered modification is required. Conclusion: Suggestion given by the students along with discussion by faculty members were incorporated in improving the standard and strengthening the programme. There is a need for development of such programmes to improve the standards in postgraduate teaching in pharmacology. These programmes also need to undergo relevant amendments in order to improvise them.

Efficacy and safety of a polyherbal formulation in hemorrhoids.

Background: The medical management of hemorrhoids should include an integrated approach. This integrated approach can be achieved by polyherbal formulations containing anti-inflammatory, styptics, analgesics, and laxative effect which reduce inflammation, pain, and bleeding, and increase gastro-intestinal motility and soften stools. One such polyherbal kit is “Arshkeyt™, a 7 day kit,” which consists of oral tablets and powder along with topical cream. Objective: Efficacy and safety of Arshkeyt™, a 7 day kit, a marketed polyherbal formulation was evaluated in comparison with conventional therapy practiced in surgery outpatient departments. Materials and Methods: Patients (n = 90) with hemorrhoids were randomly allocated to receive either Arshkeyt™ or standard therapy (combination of oral Isabgul powder and 2% lidocaine gel) for 14 days. Assessment on the basis of rectal symptoms and proctoscopic examination was done on day 0, 7, and 14 to derive a “composite score” which ranged from 0 to 25 by a blinded evaluator. The primary endpoint was number of patients achieving composite score 0 at the end of therapy (day 14). Inter-group analysis was done using Chi-square test. Results: On day 14, the composite score of 0 was achieved in 15 patients of Arshkeyt™ group versus 6 patients receiving standard therapy. The symptoms and signs which showed significant improvement in Arshkeyt™ group compared to standard treatment group were the tenesmus (visual analog score) score (P = 0.047), anal sphincter spasm (P = 0.0495) and a decrease in the grade of hemorrhoids (P = 0.0205) on day 14. Arshkeyt™ was also more beneficial in case of bleeding hemorrhoids as compared to nonbleeding hemorrhoids (P < 0.05). The incidence of adverse drug reactions in both groups was comparable and no patient required any treatment for the same. Conclusion: “Arshkeyt™, a 7 day kit,” was effective in the treatment of hemorrhoids and had a good safety profile.

Evaluation Of Antidepressant Activity Of Statins Alone And In Combination With Fluoxetine In Acute And Chronic Behavioural Models Of Depression.

Context: To study the role of statins (Atorvastatin, Simvastatin, and Pravastatin) as novel pharmacological option in treatment of depression. Aim: To evaluate antidepressant activity of statins (HMG-CoA reductase inhibitor) in combination with Fluoxetine in acute and chronic forced swim test in rats. Design: An experimental animal study. Materials and methods : Male albino wistar rats of either sex with weight range 150-250 grams were used. Part 1 is Dose finding study in acute forced swim test with three doses of Atorvastatin (2.5 mg/kg, 5 mg/ kg, 10 mg/kg), Simvastatin (2.5 mg/kg, 5 mg/kg, 10 mg/kg), and Pravastatin (10 mg/kg, 20 mg/kg, 40 mg/ kg) each were done. Part 2 was conducted to study the effects of statins (Atorvastatin, Simvastatin, and Pravastatin) and Fluoxetine (10 mg/kg) per se and in combination, on immobility of rats in acute forced swim test were compared. In part 3 effects of statins (Atorvastatin, Simvastatin, and Pravastatin) and Fluoxetine per se and in combination on immobility of rats in chronic forced swim test were compared. Open field test was performed to discriminate between the general behavioural stimulation (false positives) and antidepressant effect of study drugs. All study drugs were given orally. In Part 2 & 3 maximum effective dose of statin from part 1 was utilised. Statistics: ANOVA with post-hoc Tukeys test, significant effects were analyzed further using post hoc Newman-Keuls tests. Results: In part 1 of dose finding study most effective doses for Atorvastatin, Simvastatin and Pravastatin were 10 mg/kg, 10 mg/kg and 40 mg/kg respectively. In this part acute forced swim test showed, no statistically significant reduction in duration of immobility by any of the statins (Atorvastatin, Simvastatin, and Pravastatin) as compared to control. In Part 2 acute forced swim test, When combined with Fluoxetine, Atorvastatin (157.83 ± 10.51) and Simvastatin (167.66 ± 7.71) showed significant reduction in duration of

Perception of Medical Students towards Teaching of Pharmacology through Reinforcing Learning Model.

Abstract: Background: There is need of novel methods of teaching subject of pharmacology, which will increase curiosity and retention of knowledge. At the same time, the new method should be student friendly and well accepted. Hence reinforcing learning model (RLM) was developed and current study is conducted to assess perception of students about this method. Methodology: The perception of students was assessed on Likert scale using a 15 point questionnaire. The data was analysed descriptively. Results: Majority of the students (more than 50 %) gave favourable opinion about the module. Majority of them gave neutral opinion (40 %) when asked whether the session should be optional in the curriculum. Conclusion: RLM followed by discussion can be a valuable tool to reinforce didactic method of teaching pharmacology.

Perception of postgraduate (PG) students and teachers on seminar as teaching-learning tool.

Background: The postgraduate education depends on self learning. Knowledge acquisition among postgraduate students is through seminars which form essential part of their training programme. Methodology : This study assesses the role of seminar as a teaching-learning tool amongst students & teachers by recording their perception through a questionnaire based survey. Results : The scores for most of the items in an 18 point questionnaire were above 3 indicating that learning from seminar is satisfactory. There were two items where there was significant difference among students & teachers perception. Conclusion : We found that both the postgraduate students and the postgraduate teachers feel that the technique is useful amidst lots of suggestion to improve the quality. Thus the postgraduate seminar method is a teaching-learning method that is effective and well-accepted among the postgraduate students and postgraduate teachers alike..