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.

Impact of SARS-CoV-2 Pandemic on Glycaemic Control, Metabolic Status, Treatment Adherence, Quality of Life in Diabetes Mellitus Patients in Tertiary Care Hospital of Eastern India.

Introduction: Many medical and social challenges have been noticed during lockdowns and restrictions in the course of the COVID-19 pandemic. These restrictions had a profound impact on people's lifestyle and caused psychological distress. In the management of type 2 diabetes mellitus, lifestyle modifications, such as nutritional intervention and proper physical activity, are important aspects. Aims/objective:To study the effect of lockdown or self-imposed restrictions due to pandemic on glycaemic control in diabetes mellitus patients and the possible determinants, including diet, sleep, physical activity, psychological status and adherence to treatment. Materials and methods:A comparative analysis of the glycaemic status and metabolic parameters (such as random blood glucose, glycated haemoglobin, weight, hypoglycaemia and lipid profile), lifestyle and psychological changes and treatment adherence was done in 103 patients. Retrospective pre-lockdown data was collected from the clinical records and interviews (offline, online or by telephone). Prospective lockdown/restrictions data was questionnaire based. Chi-square test was used to analyse categorical data and ANOVA for continuous data. Results:The majority of patients were in the age group of 40-60 years. Most of them reported disturbance in their adherence to proper diet, physical activity, sleep and medication schedule. These differences of opinion were statistically significant (p <0.00001). There were more patients who reported stress and anxiety and this difference was statistically significant. Deterioration of glycaemic control and lipid profile was highly significant (p <0.00001). Mean body weight was increased by 6.67% at the end of the study and the difference was statistically significant. Conclusion:In patients with diabetes, pandemic-related restrictions had a profound impact on the glycaemic control, metabolic status, adherence to medication and quality of life. This highlights the need for a multidisciplinary approach in managing patients with diabetes, focusing on various issues, including prevalence of poor diet control, physical inactivity and psychological stress, via various awareness and counselling programs, preferably through online mode.

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.

A double-blind, placebo-controlled randomized comparison of pre and postoperative administration of ketorolac and tramadol for dental extraction pain.

OBJECTIVE: To compare the analgesic efficacy and safety of single-dose oral ketorolac and tramadol administered pre and postoperatively for dental extraction pain. MATERIALS AND METHODS: 74 patients undergoing third molar extraction (impacted or other causes) were recruited into the study, over a period of 1 year. The patients were divided into six groups and they were given ketorolac (20 mg), tramadol (100 mg), or placebo either preoperatively or postoperatively (half an hour before or half an hour after the procedure). Placebo was glucose powder filled in empty capsule. Pain assessment was done using a modified Verbal Rating Scale (VRS) at 30 min, 2, 4, and 6 h after the procedure. A record of whether rescue analgesic (ibuprofen 400 mg) was taken during the 6 h study period, along with the time it was taken, was made. Record of any adverse effects experienced by the patient was also kept. Maximum pain scores for each of the six study groups, over the 6 h study period, were noted. RESULTS: Ketorolac and tramadol were significantly better than placebo in relieving molar tooth extraction pain. Postoperative administration of tramadol was found to be more efficacious than preoperative administration in relieving the pain, whereas the preoperative administration of ketorolac was better than its postoperative administration. CONCLUSION: This study demonstrated that tramadol is equally effective to ketorolac in relieving pain in the first 6 h after molar extraction and therefore can be tried in patients who are intolerant to nonsteroidal anti-inflammatory drugs.