Prescription-based cost analysis of medicines for cardiovascular risk factors at Indian Council of Medical Research-Rational Use of Medicine Centre Hospitals of India.

OBJECTIVES: India has taken several initiatives to provide health care to its population while keeping the related expenditure minimum. Since cardiovascular diseases are the most prevalent chronic conditions, in the present study, we aimed to analyze the difference in prices of medicines prescribed for three cardiovascular risk factors, based on (a) listed and not listed in the National List of Essential Medicines (NLEM) and (b) generic and branded drugs. MATERIALS AND METHODS: Outpatient prescriptions for diabetes mellitus, hypertension, and dyslipidemia were retrospectively analyzed from 12 tertiary centers. The prices of medicines prescribed were compared based on presence or absence in NLEM India-2015 and prescribing by generic versus brand name. The price was standardized and presented as average price per medicine per year for a given medicine. The results are presented in Indian rupee (INR) and as median (range). RESULTS: Of the 4,736 prescriptions collected, 843 contained oral antidiabetic, antihypertensive, and/or hypolipidemic medicines. The price per medicine per year for NLEM oral antidiabetics was INR 2849 (2593-3104) and for non-NLEM was INR 5343 (2964-14364). It was INR 806 (243-2132) for generic and INR 3809 (1968-14364) for branded antidiabetics. Antihypertensives and hypolipidemics followed the trend. The price of branded non-NLEM medicines was 5-22 times higher compared to generic NLEM which, for a population of 1.37 billion, would translate to a potential saving of 346.8 billion INR for statins. The variability was significant for sulfonylureas, angiotensin receptor blockers, beta-blockers, diuretics, and statins (P < 0.0001). CONCLUSION: The study highlights an urgent need for intervention to actualize the maximum benefit of government policies and minimize the out-of-pocket expenditure on medicines.

Evaluation of prescriptions from tertiary care hospitals across India for deviations from treatment guidelines & their potential consequences.

BACKGROUND OBJECTIVES: Irrational prescribing practices have major consequences on patient safety and also increase the economic burden. Real-life examples of impact of irrational prescription have potential to improve prescribing practices. In this context, the present study aimed to capture and evaluate the prevalence of deviations from treatment guidelines in the prescriptions, potential consequence/s of the deviations and corrective actions recommended by clinicians. METHODS: It was a cross-sectional observational study conducted in the outpatient departments of tertiary care hospitals in India wherein the 13 Indian Council of Medical Research Rational Use of Medicines Centres are located. Prescriptions not compliant with the standard treatment guidelines and incomplete prescriptions with respect to formulation, dose, duration and frequency were labelled as 'prescriptions having deviations'. A deviation that could result in a drug interaction, lack of response, increased cost, preventable adverse drug reaction (ADR) and/or antimicrobial resistance was labelled as an 'unacceptable deviation'. RESULTS: Against all the prescriptions assessed, about one tenth of them (475/4838; 9.8%) had unacceptable deviations. However, in 2667/4838 (55.1%) prescriptions, the clinicians had adhered to the treatment guidelines. Two thousand one hundred and seventy-one prescriptions had deviations, of which 475 (21.9%) had unacceptable deviations with pantoprazole (n=54), rabeprazole+domperidone (n=35) and oral enzyme preparations (n=24) as the most frequently prescribed drugs and upper respiratory tract infection (URTI) and hypertension as most common diseases with unacceptable deviations. The potential consequences of deviations were increase in cost (n=301), ADRs (n=254), drug interactions (n=81), lack of therapeutic response (n=77) and antimicrobial resistance (n=72). Major corrective actions proposed for consideration were issuance of an administrative order (n=196) and conducting online training programme (n=108). INTERPRETATION CONCLUSIONS: The overall prevalence of deviations found was 45 per cent of which unacceptable deviations was estimated to be 9.8 per cent. To minimize the deviations, clinicians recommended online training on rational prescribing and administrative directives as potential interventions.

An observational multi-centric COVID-19 sequelae study among health care workers.

Background: India has seen more than 43 million confirmed cases of COVID-19 as of April 2022, with a recovery rate of 98.8%, resulting in a large section of the population including the healthcare workers (HCWs), susceptible to develop post COVID sequelae. This study was carried out to assess the nature and prevalence of medical sequelae following COVID-19 infection, and risk factors, if any. Methods: This was an observational, multicenter cross-sectional study conducted at eight tertiary care centers. The consenting participants were HCWs between 12 and 52 weeks post discharge after COVID-19 infection. Data on demographics, medical history, clinical features of COVID-19 and various symptoms of COVID sequelae was collected through specific questionnaire. Finding: Mean age of the 679 eligible participants was 31.49 ± 9.54 years. The overall prevalence of COVID sequelae was 30.34%, with fatigue (11.5%) being the most common followed by insomnia (8.5%), difficulty in breathing during activity (6%) and pain in joints (5%). The odds of having any sequelae were significantly higher among participants who had moderate to severe COVID-19 (OR 6.51; 95% CI 3.46-12.23) and lower among males (OR 0.55; 95% CI 0.39-0.76). Besides these, other predictors for having sequelae were age (≥45 years), presence of any comorbidity (especially hypertension and asthma), category of HCW (non-doctors vs doctors) and hospitalisation due to COVID-19. Interpretation: Approximately one-third of the participants experienced COVID sequelae. Severity of COVID illness, female gender, advanced age, co-morbidity were significant risk factors for COVID sequelae. Funding: This work is a part of Indian Council for Medical Research (ICMR)- Rational Use of Medicines network. No additional financial support was received from ICMR to carry out the work, for study materials, medical writing, and APC.

Use of drugs not listed in the National List of Essential Medicines: Findings from a prescription analysis by the Indian Council of Medical Research-Rational Use of Medicines Centres Network in tertiary care hospitals across India.

BACKGROUND: The concept of listing essential medicines can lead to improved supply and access, more rational prescribing, and lower costs of drugs. However, these benefits hinge on the prescription of drugs from an Essential Medicines List (EML). Several studies have highlighted the problem of underutilization of EMLs by prescribers. Therefore, as part of prescription research by the Indian Council of Medical Research-Rational Use of Medicines Centres Network, we evaluated the extent of prescription of drugs not listed in the National List of Essential Medicines (NLEM). MATERIALS AND METHODS: Prescriptions of outpatients from participating centers were included after obtaining verbal/written informed consent as approved by the Ethics Committee, and evaluated for prescription of drugs from the NLEM 2015. RESULTS: Analysis of 4838 prescriptions from 13 tertiary health-care institutes revealed that 2677 (55.33%) prescriptions had at least one non-NLEM drug prescribed. In all, 5215 (31.12%) of the total 16,758 drugs prescribed were not in NLEM. Of these, 2722 (16.24%) were single drugs and 2493 (14.88%) were fixed-dose combinations (FDCs). These comprised 700 different drug products - 346 single drugs and 354 FDCs. The average number of non-NLEM drugs prescribed per prescription was 1.08, while the average number of all drugs prescribed was 3.35 per prescription. It was also found that some of the non-NLEM drugs prescribed had the potential to result in increased cost (for example, levocetirizine), increased adverse effects (dextromethorphan), and less effectiveness (losartan) when compared to their NLEM counterparts. Nonavailability of an essential drug (oral hydroxocobalamin) was another important finding of our study. CONCLUSION: This study highlights the extent and pattern of drugs prescribed from outside the NLEM at the tertiary health-care level and the need for training and enhanced awareness among prescribers for greater utilization of the NLEM.

Internal Assessment in New MBBS Curriculum: Methods and Logistics.

Assessment is a pivotal element of competency-based curriculum. The implementation of competency-based undergraduate medical curriculum in India requires proper implementation of updates in assessment for which universities, colleges, and teachers need to plan and design internal assessment (IA) modules as well as guidelines. IA provides opportunity to assess many competencies and hence should be implemented judiciously. Multiple assessment methods should be used to improve utility of IA. The process should involve all the teachers of a subject and all competencies. Capacity building trainings should be organized by institutes in basic concepts of assessment as well as training in methods such as the objective structured clinical/practical examination, direct observation of procedural skills, and mini-clinical evaluation exercises. The culture of providing regular feedback needs to be instilled at institute levels. The learners who are not able to achieve competencies and required criteria in university examination should be provided predecided remedial measures for improving their performance. The article discusses all these aspects in detail.

Chloroquine: Can it be a Novel Drug for COVID-19.

Coronavirus disease 2019 (COVID-19) has been declared a pandemic by the World Health Organization. The United States Food and Drug Administration has not approved any drug or vaccine for the treatment of COVID-19; however, reports have emerged from different parts of the world about the potential therapeutic benefits of existing drugs. Chloroquine and phosphate hydroxychloroquine are the drugs currently in the limelight, and recently, the National Task Force for COVID-19 constituted by the Indian Council of Medical Research has recommended the use of antimalarial drug hydroxychloroquine for prophylaxis of severe acute respiratory syndrome-coronavirus 2 infection in selected high-risk individuals. This short write-up explores the potential efficacy and established safety of chloroquine in COVID-19.

Anaphylactic reaction induced by intravenous diclofenac: A case report.

Among the immune-mediated reactions, anaphylaxis is the most severe form. As a postoperative analgesia, diclofenac sodium, and nonsteroidal anti-inflammatory drug is commonly used. Intravenous (IV) diclofenac sodium-induced anaphylaxis is very rare. We are presenting a case of IV diclofenac-induced anaphylactic reaction, occurred during the surgery in a female patient of 21 years of age. The sign and symptoms of the reaction resembled an anaphylactic reaction. Temporal relationship with IV diclofenac administration and development of the clinical features of the reaction found to be probable. The health-care professionals should be aware of such rare and serious reactions so that it can be diagnosed and treated early. The clinical importance associated with the case encouraged us to report this rare complication of IV diclofenac.

Efficacy of oral terbinafine versus itraconazole in treatment of dermatophytic infection of skin - A prospective, randomized comparative study.

OBJECTIVES: Dermatophytic infections are the common fungal infections aggravated by hot and humid climate. Terbinafine and itraconazole are commonly used oral antifungal agents for the same. However, resistance to these drugs is being seen increasingly when used in the conventional doses and duration. Therefore, this study was designed to compare the efficacy of terbinafine and itraconazole in increased dosages and duration in the treatment of tinea corporis and tinea cruris. MATERIALS AND METHODS: In this randomized comparative study, patients of tinea cruris and tinea corporis were randomly divided into two groups of 160 each and were given oral terbinafine (Group I) and oral itraconazole (Group II) for 4 weeks. The scores and percentage change in scores of pruritus, scaling, and erythema were evaluated at 2 and 4 weeks. RESULTS: At the end of week 4, mycological cure was seen in 91.8% after 4 weeks in the itraconazole group as compared to 74.3% of patients in the terbinafine group. There was a significant improvement in percentage change in pruritus, scaling, and erythema in both the groups from 0 to 4 weeks. On comparing groups, the percentage change was significantly different in scaling from 0 to 2 weeks (5.4 vs. -4.8) and 2-4 weeks (16.7 vs. 29.6) between Group I and Group II, respectively. Clinical global improvement was better with itraconazole. Mild adverse effects such as gastrointestinal upset, headache, and taste disturbances were observed which were comparable in both the groups. CONCLUSIONS: Itraconazole and terbinafine seem to be equally effective and safe in the treatment of tinea cruris and tinea corporis.

Phenytoin-induced bradycardia and hypotension.

Phenytoin is an anticonvulsant which is also a Class IB antiarrhythmic. Its common adverse drug reactions (ADRs) include gastrointestinal symptoms, psychiatric disorders, gingival hyperplasia, and rash. Bradycardia and hypotension following intravenous (IV) phenytoin are rare ADRs. We report the case of a 62-year-old female with subarachnoid hemorrhage and right bundle branch block, who developed sinus bradycardia and hypotension on administration of IV phenytoin. This case report serves as a note for caution on patient selection for the administration of phenytoin and highlights the need for specific guidelines on the same.

Impact of regulatory spin of pioglitazone on prescription of antidiabetic drugs among physicians in India: A multicentre questionnaire-based observational study.

Background & objectives: Pioglitazone was suspended for manufacture and sale by the Indian drug regulator in June 2013 due to its association with urinary bladder carcinoma, which was revoked within a short period (July 2013). The present questionnaire-based nationwide study was conducted to assess its impact on prescribing behaviour of physicians in India. Methods: Between December 2013 and March 2014, a validated questionnaire was administered to physicians practicing diabetes across 25 centres in India. Seven hundred and forty questionnaires fulfilling the minimum quality criteria were included in the final analysis. Results: Four hundred and sixteen (56.2%) physicians prescribed pioglitazone. Of these, 281 used it in less than the recommended dose of 15 mg/day. Most physicians (94.3%) were aware of recent regulatory events. However, only 333 (44.8%) changed their prescribing pattern. Seventeen of the 416 (4.1%) physicians who prescribed pioglitazone admitted having come across at least one type 2 diabetes mellitus patient (T2DM) who had urinary bladder carcinoma, and of these 13 said that it was in patients who took pioglitazone for a duration of more than two years. Only 7.8 per cent of physicians (n=58) categorically advocated banning pioglitazone, and the rest opined for its continuation or generating more evidence before decision could be taken regarding its use in T2DM. Interpretation & conclusions: Majority of the physicians though were aware of the regulatory changes with regard to pioglitazone, but their prescribing patterns were not changed for this drug. However, it was being used at lower than the recommended dose. There is a need for generating more evidence through improved pharmacovigilance activities and large-scale population-based prospective studies regarding the safety issues of pioglitazone, so as to make effectual risk-benefit analysis for its continual use in T2DM.

Concept maps: A tool for knowledge management and synthesis in web-based conversational learning.

Web-based conversational learning provides an opportunity for shared knowledge base creation through collaboration and collective wisdom extraction. Usually, the amount of generated information in such forums is very huge, multidimensional (in alignment with the desirable preconditions for constructivist knowledge creation), and sometimes, the nature of expected new information may not be anticipated in advance. Thus, concept maps (crafted from constructed data) as "process summary" tools may be a solution to improve critical thinking and learning by making connections between the facts or knowledge shared by the participants during online discussion This exploratory paper begins with the description of this innovation tried on a web-based interacting platform (email list management software), FAIMER-Listserv, and generated qualitative evidence through peer-feedback. This process description is further supported by a theoretical construct which shows how social constructivism (inclusive of autonomy and complexity) affects the conversational learning. The paper rationalizes the use of concept map as mid-summary tool for extracting information and further sense making out of this apparent intricacy.

Cultivating Lifelong Learning Skills During Graduate Medical Training.

Lifelong learning is referred to as learning practiced by the individual for the whole life, is flexible, and is accessible at all times. Medical Council of India has included lifelong learning as a competency in its new regulations for graduate medical training. Acquisition of metacognitive skills, self-directed learning, self-monitoring, and reflective attitude are the main attributes of lifelong learning; and all of these can be inculcated in the students by using appropriate instructional methodologies. It is time to deliberate upon the instructional designs to foster the lifelong learning skills and behaviors in medical graduates. In this communication, we aim to debrief the concept of lifelong learning, particularly in context with medical training and detailing the process that can be explicitly used to cultivate the attitude of lifelong learning in medical graduates.

Bupropion as an augmenting agent in patients of depression with partial response.

The objective of this study is to evaluate the effects of bupropion as an add-on therapy to selective serotonin reuptake inhibitor (SSRI) on patients of major depressive disorder with partial response. This prospective, randomized, controlled and single-blind study was conducted in sixty patients suffering from major depressive disorder as per Diagnostic and Statistical Manual (DSM)-IV TR criteria, who were having Hamilton depression rating scale (HDRS) score ≥16 after 4 weeks of treatment with SSRIs. Group A received SSRI plus placebo and group B received SSRI plus bupropion. Evaluation was performed based on changes in HDRS score, Montgomery and Asberg depression rating scale (MADRS), Amritsar depressive inventory (ADI) and spontaneously reported adverse effects. There was a significant decrease in the HDRS, MADRS and ADI scores as compared to baseline in both groups. However, the mean decrease in depression score was more in group B than in group A. The percentage decrease of remitters was also significantly more in group B (60% as per HDRS score and 63% as per MADRS score), as compared to group A (24% as per HDRS score and 27% as per MADRS score) (p < 0.05), at the end of treatment. In conclusion, bupropion add-on can act as augmenting agent in patients of depression with partial response to SSRIs.