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.

Surveying the Indian research ethics committee response to the COVID-19 pandemic.

Research ethics committees (RECs) have played a crucial role in expediting the review of research protocols amidst the COVID-19 pandemic. To improve their performance and identify areas of enhancement, a multicentric study was conducted in India by the Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP). The study aimed to evaluate the preparedness of Indian RECs during the COVID-19 outbreak while conducting protocol reviews and comprehend the challenges they encountered. After obtaining ethics committee approval, a cross-sectional observational study was conducted using two validated questionnaires, one for REC member secretaries/chairpersons and another for REC members. The questionnaires consisted of 13 multiple-choice questions, 10 yes or no questions, and 2 open-ended questions each. The study was distributed to multiple RECs. A total of 109/200 participants, including 13 REC member secretaries, 12 chairpersons and 84 REC members from a total of 34 REC's, consented to participate in the study. During the COVID-19 pandemic, 23/25 (92%) of the RECs conducted online meetings. The most common challenges faced by RECs included risk-benefit analysis (12/25 RECs), review of informed consent (12/25 RECs), and protocols involving vulnerable populations (10/25 RECs). 65% of the REC members reported the need for ethics review training, and 66/84 REC members agreed or strongly agreed that RECs require training in COVID-19 protocol review. Additionally, 62/84 REC members agreed or strongly agreed that central/joint RECs should review multicenter COVID-19 protocols. RECs in India encountered difficulties while reviewing risk-benefit analyses, informed consent documents (ICDs), and COVID-19 protocols and they suggested providing training on these topics.

Safety of hydroxychloroquine in healthcare workers for COVID-19 prophylaxis.

BACKGROUND & OBJECTIVES: Hydroxychloroquine (HCQ), reported to inhibit severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) replication in in vitro studies, has been recommended for prophylaxis of COVID-19 in healthcare workers (HCWs). The objective of this study was to assess short-term adverse events (AEs) of HCQ in HCWs. METHODS: This cross-sectional study among consenting HCWs taking prophylaxis and working in hospitals with COVID-19 patients used online forms to collect details of HCWs, comorbidities, prophylactic drugs used and AEs after the first dose of HCQ. Verification of dose and AEs was done by personal contact. Multivariate logistic regression analysis was done to determine the effect of age, gender and dose of HCQ on AE. RESULTS: Of the 1303 HCWs included, 98.4 per cent (n=1282) took HCQ and 66 per cent (n=861) took 800 mg as first day's dose. Among the 19.9 per cent (n=259) reporting AEs, 1.5 per cent (n=20) took treatment for AE, none were hospitalized and three discontinued HCQ. Gastrointestinal AEs were the most common (172, 13.2%), with less in older [odds ratio (OR) 0.56, 95% confidence interval (CI) 0.35-0.89], with more in females (OR 2.46, 95% CI 1.78-3.38) and in those taking a total dose of 800 mg on day one compared to a lower dose. Hypoglycaemia (1.1%, n=14), cardiovascular events (0.7%, n=9) and other AEs were minimal. INTERPRETATION & CONCLUSIONS: HCQ prophylaxis first dose was well tolerated among HCWs as evidenced by a low discontinuation. For adverse effects, a small number required treatment, and none required hospitalization. The study had limitations of convenience sampling and lack of laboratory and electrocardiography confirmation of AEs.

Prescription Pattern of Drugs Used for Neuropathic Pain and Adherence to NeuPSIG Guidelines in Cancer.

OBJECTIVE: The objective of the present research was to evaluate the prescription pattern of the drugs used in the pharmacological treatment of cancer-related neuropathic pain (CRNP) and to assess the adherence of the physicians to the Neuropathic Pain Special Interest Group (NeuPSIG) Guidelines. MATERIALS AND METHODS: This was a cross-sectional, observational study where patients who presented to the pain and palliative care outpatient clinic of the tertiary care hospital with CRNP were prospectively recruited. Participants were screened for neuropathic pain using DN4 questionnaire. Demographic details, diagnosis, medication details, and adherence to NeuPSIG guidelines were assessed using a validated questionnaire. RESULTS: Of 300 patients screened, 64% were male and 36% were female, with a mean age of 48.26 ± 13.05 years. The predominant symptoms found were pin-and-needle sensation (99%) followed by tingling sensation (98.66%). The most common diagnosis was head-and-neck cancers (37.3%) followed by bone cancers (17.3%) and lung cancers (15.3%). Among the first-line drugs recommended in NeuPSIG for CRNP, pregabalin (78.7%) was the most common drug prescribed followed by amitriptyline (67%). The most common co-prescribed drugs were acid suppressants drugs (50.7%). Tapentadol, which is not part of the NeuPSIG guidelines, was prescribed on 51 occasions for neuropathic pain. Underdosing was observed in 272 prescriptions. Only 12 prescriptions completely adhered, while 275 had partial, and 13 prescriptions had poor adherence to NeuPSIG guidelines. CONCLUSION: The most commonly used drugs in the treatment of CRNP were pregabalin and amitriptyline. Most physician partially or did not adhere to the NeuPSIG guideline in the management of CRNP.

A systematic review of standard treatment guidelines in India.

Background & objectives: Standard treatment guidelines (STGs) are the cornerstone to therapeutics. Multiple agencies in India develop STGs. This systematic review was conducted to find out STGs available in India, evaluate if these were as per World Health Organization (WHO) recommendations for STGs and compare these with National Institute for Health and Care Excellence (NICE) guidelines. Information on legal authority and responsibility for formulating STGs was also sought. Methods: PRISMA guidelines were followed. Publications from PubMed and Google Scholar were searched for STGs using terms 'Standard Treatment Guidelines AND India'. Data from STGs were compiled in excel as per the WHO and authors' criteria for STGs and compared with NICE guidelines. Results: PubMed and Google Scholar search provided 56 publications (out of 1695 search results) mentioning 27 STGs. Google search and replies from authors led us 36 STGs, totalling to 63 STGs. No STG mentioned any specific period of revision, eight STGs were not evidence-based, 55 had some Indian references, 48 STGs were for single disease and the remaining multi-disease, three STGs did not include diagnostic criteria, 16 STGs did not give prescribing information of recommended treatment and 16 STGs provide no referral criteria for patients. Fifty five STGs did not mention level of health care. While NICE is a single legal authority in England and guidelines are as per WHO recommendations for STGs, in India although Acts and rules do not vest authority, National Health Systems Resource Center is generally designated responsible for STGs. Interpretation & conclusions: In India, although there are multiple STGs developed by various authorities and professionals for the same conditions, these fulfil WHO recommendations only partially. Authority with statutory duty collaborating with professional organizations, a standard methodology for adopting international guidelines, Indian data for evidence base, attention to local needs will help in developing better STGs and their acceptance.

Prescription pattern & adverse drug reactions of prokinetics.

Background & objectives: Prokinetics are extensively prescribed leading to several adverse events (AEs). The aim of this study was to assess the prescription pattern in patients receiving prokinetics, and characteristics of adverse drug reactions (ADRs) in an outpatient department set up in a tertiary care hospital in western India. Methods: Patients attending outpatient departments of a tertiary care hospital and who had received prokinetic agent for at least seven days over the last one month were enrolled. Causality assessment of AEs was done and assessed for severity, preventability, seriousness and predictability. Results: A total of 304 patients [161 males (52.96%); 143 females (47.04%)] were enrolled. Most prescriptions (299/304, 98%) included domperidone, most commonly prescribed as fixed-dose combination (FDC) with pantoprazole (274/304, 90%). Prokinetic dose was not mentioned in 251/304 (83%) prescriptions, and 18/304 (6%) did not mention frequency. Of the 378 AEs reported from 179 patients (47.35%), 306 (81%) were mild, all non-serious; 272 (72%) not preventable and 291 (77%) predictable in nature. Decreased appetite (n=31, 8.2%) and fatigue (n=27,7.14%) were most commonly reported. Causality assessment by the World Health Organization-Uppsala Monitoring Centre scale showed that 180 AEs were related to suspected drug (17 probable and 163 possible ADRs). Significant correlation was observed for AEs with increasing number of drugs per prescription (Spearman's R=+0.8, P =0.05) and with increasing therapy duration (Spearman's R=+1.00, P <0.001). Interpretation & conclusions: Our findings showed that prokinetics were often prescribed as FDCs, with incomplete prescriptions. Domperidone was found to be associated with multiple AEs. It is suggested that regular prescription monitoring should be done in hospitals to encourage rational use of drugs.

Analysis of warning letters issued by the US Food and Drug Administration to clinical investigators, institutional review boards and sponsors: a retrospective study.

The US Food and Drug Administration (FDA) issues warning letters to all research stakeholders if unacceptable deficiencies are found during site visits. Warning letters issued by the FDA between January 2011 and December 2012 to clinical investigators and institutional review boards (IRBs) were reviewed for various violation themes and compared to similar studies in the past. Warning letters issued to sponsors between January 2005 and December 2012 were analysed for the first time for a specific set of violations using descriptive statistics. Failure to protect subject safety and to report adverse events to IRBs was found to be significant compared to prior studies for clinical investigators, while failure to follow standard operating procedures and maintain documentation was noted as significant in warning letters to IRBs. Failure to maintain minutes of meeting and to follow written procedures for continuing review were new substantial violations in warning letters issued to IRBs. Forty-six warning letters were issued to sponsors, the most common violations being failure to follow a monitoring schedule (58.69%), failure to obtain investigator agreement (34.78%), failure to secure investigators' compliance (30.43%), and failure to maintain data records and ship documents to investigators (30.43%). Appropriate methods for handling clinical trial procedural violations should be developed and implemented worldwide.

Impact of the COVID pandemic on functioning of the institutional ethics committee: A comparison study.

Purpose and Aim: In COVID 19 pandemic, it was essential to document the functioning of the institutional ethics committee (IEC), how the organization adapted and faced challenges posed, thus forming the rationale behind this particular audit. The objectives were to assess the impact of the pandemic on the structure, review process, outcomes, and administration of IEC and to compare the same during its functioning in the prepandemic stage. Subject and Methods: The study was conducted as a retrospective audit. After exemption from ethics review, the data were collected from the IEC office situated in KEM Hospital and were segregated into four domains: structure, review process, outcomes, and administration. The data were analyzed using descriptive statistics. Mann-Whitney U-test was used to compare the turnover time for approval of projects between the two study periods at 5% level of significance. SPSS software version 22 was used to analyze the data. Results: Constitution changed , more protocols pertaining to COVID 19 studies were reviewed, meetings frequency doubled, and Standard Operating Procedures was amended to incorporate the changes faced during pandemic. Significant decrease in turnover time was noticed with respect to submission to query letter and study completion. There were more protocol deviations. Financial burden and expenditure decreased due to less paperwork and meetings being held online. Conclusion: The ethics committee infrastructure and functioning had to undergo a paradigm shift to adapt to the various changes and overcome the various hurdles occurring during the COVID-19 pandemic.

Academic Clinical Trials Submitted to an Institutional Ethics Committee at a Tertiary Care Center: A Retrospective Analysis.

Background The role of academia in clinical research has given rise to the concept of academic clinical trials (ACTs), which are vital in generating evidence. Through the implementation of the New Drugs and Clinical Trials Rules-2019 (NDCTR-2019) rules, the Institutional Ethics Committee (IEC) has obtained a quasi-regulatory role. The study aims to assess the challenges the IEC faced when processing, approving, and monitoring ACTs. The other objectives included the number of ACTs submitted to the IEC, as well as administrative, scientific, and ethical issues stated by the IEC and the Drug Controller General of India (DCGI) authorities. We also aimed to provide some insight into the type of decision made by IEC and DCGI - the delay or inconsistency between the queries. Methods This retrospective study was conducted in the IEC of a tertiary care hospital, Mumbai, Maharashtra, India. A comprehensive search of the IEC database was carried out by the study team, and only those protocols of ACTs submitted to IEC between January 2015 and December 2021 were included. The studies submitted between January 2015 and February 2019, i.e., before the release of NDCTR-2019, were classified as the "Before" category. All subsequently submitted protocols were grouped together as the "After" group. Descriptive statistics were used to represent the data, while comparison between the two timeframes were made using the Mann-Whitney U test with a level of significance at 5%. Results This six-year study showed that merely 1.4% (34/2400) trials fulfilled the criteria of an ACT. An increase in the ACT protocol submission was noted in the "After" group (20 vs. 14). Most ACTs were drug trials, with 67.6% (23/34) trials conducted majorly in the Department of Anesthesiology. There was a statistical increase in time query reply by the principal investigator to IEC and the time between submission and approval in the "After" group (p<0.05). IEC sent out 94 administrative, 565 scientific, and 216 ethical queries. On IEC monitoring, protocol deviations were noted; nonetheless, no ACTs reported protocol deviations or serious adverse events. Conclusions Since the implementation of NDCTR-2019, IEC has taken on a quasi-regulatory function, and there has been an increase in the caliber of IEC monitoring and adherence to ethical norms.

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.

Factors determining success and the cost of materials used in securing intravenous access in an emergency setting: A prospective observational study.

INTRODUCTION: Multiple failed attempts at securing intravenous catheter access cause increased patient dissatisfaction and higher costs. We aimed to identify the factors leading to multiple failed attempts and estimate the cost of resources wasted. METHODS: Participants were recruited from the emergency department for a prospective, observational study. Healthcare workers inserting peripheral intravenous catheters were observed. Patient characteristics and the number of attempts needed were recorded. RESULTS: Three hundred thirty-four patients were enrolled, and an average of 1.74 ± 1.026 (Range: 1 - 5) access attempts were needed per patient. Only 56.28% of the insertions were successful on the first attempt. On multivariate linear regression with attempts as the outcome variable, age (ß = 0.01, 95%CI 0.004 - 0.014, p = 0.0006), catheter calibre (ß 20G = -0.25, 95%CI -0.45 - -0.07, p = 0.008), visibility (ß = 0.23, 95%CI 0.02 - 0.44, p = 0.026) and palpability (ß = 0.44, 95%CI 0.21 - 0.66, p = 0.0001) of the vein were statistically significant predictors. The average total cost of materials required was $6.4 USD per patient, of which $1.76 USD was spent towards unsuccessfully inserted catheters that were consequently thrown away. CONCLUSIONS: Our study shows that securing IV access often requires multiple attempts, with nearly 30% of the total cost amounting towards materials wasted. The risk of multiple attempts is highest for older patients with invisible and non-palpable veins.

A Retrospective Study of Ethics Committee Monitoring Checklists of the Audiovisual Consent Process: An Ethical Perspective.

Clinical trial regulations for new drugs in India released a gazette notification for obtaining audiovisual (AV) consent from all trial participants in November 2013. The reports of AV recordings of the studies from October 2013 to February 2017 submitted to the institutional ethics committee were analyzed in view of the Indian regulations on AV consenting. The reports of AV recording were checked: number of AV consents for each project, adequacy of AV recording, number of persons in the video, informed consent document elements (ICD) covered as per Schedule Y, confirmation of understanding by the participant, the time taken to complete the procedure, maintenance of confidentiality, and whether reconsent was taken. Seven studies of AV consent were monitored. Eighty-five (85) AV-consented and filled checklists were evaluated. The AV recording was not clear in 31/85, ICD elements were missing in 49/85 consents, time taken to complete the procedure was 20.03 ± 10.83 with the number of pages being 14.24 ± 7.52 (R= 0.29 p<0.041). In 19/85 consents, privacy was not maintained and on 22 occasions, reconsent were taken. There were deficits found in the AV consent process.

Evaluation of Issues Affecting Time Between Study Completion, Manuscript Submission, Acceptance, and Publication in Medical Journals.

INTRODUCTION: Difficulty in finding the appropriate journal, adherence to the formatting differences between various journals, publication fees, delay in acceptance/rejection, etc., are a few reasons due to which much research is not published or when published the data in the research may become outdated. There are no studies to find out the issues which affect the time delay between study completion, submission to the journal, acceptance by the journal, and publication. With this background, we conducted this study. METHODS: This study was exempted by the Ethics committee as it was based on online data. Journal Citation Reports (JCR) 2020 (Clarivate analytics), CiteScore, and Google Scholar were used to sort the high-, moderate-, and low-impact factor journals. Forty-five journals each from high-, medium- and low-impact factors (h-index median, Google Scholar Metrics h5-index) were selected. Similarly, 15 predatory scientific journals were chosen. Journals with medical science backgrounds were chosen by randomization. Only original research articles were included. From each journal, five articles were chosen randomly from the latest issue pre-pandemic. The search was performed from April 2021 to June 2021. Variables analyzed were indexing of the journal, publication fees, level of impact factor, specialty domain, number of editors, frequency per year, date of study completion, date of submission, date of acceptance, date of publication, and h-index median. Data were compiled in Microsoft Excel Workbook (Microsoft, Redmond, WA, USA) and analyzed using IBM Corp. Released 2019. IBM SPSS Statistics for Windows, Version 26.0. Armonk, NY: IBM Corp. Variables of time were represented as median and interquartile range, and the number of journals and processing fees for publication were descriptively analyzed. RESULTS: Out of 60 journals selected, 300 original articles were analyzed. There were 26 specialty-wise journals; the commonest was multispecialty journals. The fastest time from study completion to submission, submission to acceptance, submission to publication, and acceptance to publication was 15.5, 30, 61, and 0 days, respectively, and the slowest duration was 1636, 452, 615, and 456 days, respectively. PubMed indexed journals had a higher number of editors, h5-index, and h5 median, and slower time for acceptance and publication compared to non-PubMed indexed journals (p<0.05). Predatory journals had a lower h5-index and h5 median along with faster time to acceptance and publication compared to high and moderate impact factor journals (p<0.05). Journal with faster acceptance had faster publication as well (r=0.85), but no impact of the number of editors, number of issues per year (frequency), and publication fees with time to acceptance and publication. CONCLUSION: Though PubMed indexed journals with a greater number of editors and high fees are slower to publish articles but they are a safe option for researchers. The impact factor does not effect the speed of publication for non-predatory journals. Paying high fees and choosing a journal with more issues per year does not ensure quick publication to the researchers.

Drug use evaluation of cephalosporins in a tertiary care hospital.

BACKGROUND: Infectious disease burden in India is among the largest in the world. Cephalosporins are being used extensively in the current scenario, both empirically and as definitive treatment. With this information, we tried to evaluate the prescription pattern of drugs for infections in medicine and general surgical wards of a tertiary care hospital and evaluate the utilization of cephalosporins in the same. METHODOLOGY: The study was conducted for a duration of 3 months in a tertiary care hospital after approval from the Institutional Ethics Committee, and permission of the respective heads of the surgery and medicine departments was obtained. After satisfying the inclusion criteria, participants' demographic details and the prescription notes by the treating doctor were noted and analyzed. The WHO prescription indicators were analyzed and the prescriptions were evaluated for the completeness of them. The utilization of cephalosporins was evaluated based on the institutional standard treatment guideline (STG) - Guidelines for Antimicrobial Therapy and Prophylaxis, 2014. Data were analyzed using descriptive statistics. RESULTS: A total of 600 patients were recruited, of which 350 were male and 250 were female. A total of 4341 drugs were prescribed. On an average, 7 drugs per prescription were found. The generic drugs prescribed were 27% (1163). Among the drugs prescribed, 19% (850) were antibiotics, of which 36.94% (314) were cephalosporins and 81% (3491) were other drugs. Ninety-four percent (565) prescriptions were incomplete (in terms of dose, frequency, duration, or dosage form). After referring to the STG, we found that cephalosporins were prescribed empirically in 40% (126) cases, of which medicine prescriptions accounted for it the most. CONCLUSION: Cephalosporins are extensively prescribed in medicine and surgery wards of the tertiary care hospital.

A prospective, single centre, open label, single arm pilot study to evaluate the efficacy and safety of Amlapitta Mishran Suspension in participants with endoscopic gastritis.

BACKGROUND: Endoscopic gastritis is associated with symptoms of gastritis, along with endoscopic findings. Amlapitta Mishran has multiple active components that act via various mechanisms in patients with gastritis symptoms. We planned to conduct this study to find out the efficacy and safety of Amlapitta Mishran in patients with endoscopic gastritis. OBJECTIVES: To find out efficacy of Amlapitta Mishran in patient with endoscopic gastritis. MATERIALS AND METHODS: This study was an open-label, prospective, single-center study. Thirty participants were recruited, and Amlapitta Mishran Suspension was given for 30 days. Blood investigations for safety were performed at baseline (Visit 1), on Visit 3 and Visit 4. Endoscopy was performed at baseline and Visit 4, and stomach erosion score was recorded. Amlapitta Symptom Rating Scale score, Postprandial Distress Syndrome (PPDS) score, and Epigastric Pain Syndrome (EPS) score were efficacy endpoints. RESULTS: Out of the 30 participants recruited, 28 participants completed the study. The median age of participants in the study was 26.50 years. A statistically significant (P<0.05) reduction was seen in endoscopy score at Visit 4 as compared to baseline (Visit 1) by Wilcoxon Signed Rank test. Amlapitta Symptom Rating Scale score, PPDS score, EPS score also exhibited significant reduction (P < 0.05) at Visit 3 and Visit 4 as compared to baseline by Friedman's test with post hoc analysis. No statistically significant reduction was seen in these scores from Visit 3 to Visit 4, except for the EPS score. At the end of Visit 4, 18 (64%) participants had an endoscopy score of 1 (no erosions). At the end of Visit 4, ≥ 50% improvement was seen in Amlapitta Symptom Rating Scale score in 27 (96%) participants, PPDS score improved by ≥ 50% in 25 (89%) participants, and EPS score improved by ≥ 50% in 26 (93%) participants. All safety variables including laboratory investigation were within the normal range in all visits. CONCLUSION: Amlapitta Mishran Suspension effectively reduced endoscopic gastritis scores in the participants and reduced the symptoms of gastritis measured by the Amlapitta Symptom Rating Scale, PPDS, and EPS scores with no adverse events.

Challenges in the governance of biomedical and health research after publication of the New Drugs and Clinical Trial Rules, 2019.

This article pertains to the governance of biomedical and health research after the publication of the New Drugs and Clinical Trial Rules, 2019. The new regulations cover all types of research. However, those concerning biomedical and health research may fall short on certain counts regarding: reviewing studies with vulnerable populations, undertaking risk benefit analysis, finding relatedness in case of serious adverse events, and providing compensation. The challenges faced by ethics committees from the inception of a study to its completion are discussed. There is a need for rigorous training of all members involved in the ethics committee's functioning.

Assessment of the quality and trend of reporting of health economic evaluation research in India.

Objectives: This study was conducted to assess the reporting quality of health economic evaluation studies using Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement along with an analysis of their trend in India.Methods: Following ethical review exemption, PubMed and Google scholar were searched for Indian studies published in 5 years (2014-2019). Keywords used were cost-effectiveness, cost-benefit, cost-utility, and cost-minimization analysis, economic evaluation, and India. CHEERS statement was used to assess the reporting quality and trend was studied using variables like a published year, type of analysis, therapy area, intervention. Data were analyzed using descriptive statistics.Results: Of the 39 studies analyzed, 17 scored less than 18 (represents 75% compliance) with a minimum score of 9 and a maximum of 23. The reporting quality was deficient with respect to heterogeneity characterization (25 studies), discount rate (18 studies), model choice, and assumptions (18 studies). Cost - effectiveness was the most common PE analysis (27 studies). The most commonly studied therapy area was infectious disorders (10) followed by oncology (5), and the commonest intervention was drugs (22).Conclusion: Inadequacy in reporting quality of health economic evaluation studies is evident. The trend revealed cost-effectiveness to be the most commonly performed type of analysis.Expert Opinion: Health economic evaluation research has gained considerable importance in healthcare decision making. Reporting quality is critical to enable efficient interpretation of health economic evaluation research. These studies have many elements, each of which have a significant impact on the conduct and outcome of the study. Hence, it is advisable to refer to any of the available guidelines [eg. CHEERS checklist] while preparing the manuscript so as to ensure all crucial elements of the study have been reported.

An Audit of Clinical Studies Involving Elderly Population Registered in Clinical Trials Registry of India.

CONTEXT: The elderly in India form a heterogeneous subset of the population with significant disease burden variations. However, there are no data available regarding the type of research studies conducted in an elderly population in India. AIMS: The aim of this study was to analyze the research studies conducted in the elderly population in India based on data from the Clinical Trials Registry of India (CTRI). SETTINGS AND DESIGN: This was an "audit" of available data on the CTRI website. PARTICIPANTS AND METHODS: Following exemption from the Institutional Ethics Committee, all studies in the elderly population registered in CTRI from its inception (July 2007 to August 2019) were reviewed. Data captured with respect to geographical distribution, study designs used, therapy area, trial registration, and funding. STATISTICAL ANALYSIS USED: The variables were analyzed using descriptive statistics using SPSS version 16.0. RESULTS: Out of a total of 21,400 studies in CTRI, a total of 99 (0.46%) studies involved only elderly patients. Of these studies, 60 (60.6%) were interventional, whereas 39 (39.4%) were observational. Of all the interventional studies, 17 (28%) tested drugs, 26 (43%) tested a lifestyle intervention, and the rest were nutraceuticals, Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy, and physiotherapy. Postgraduate theses constituted 60 (60.6%) studies. Eighty-seven (87.9%) were academic projects, eight (8.1%) were government-funded studies, and only four (4%) were pharmaceutical-sponsored studies. The most commonly studied therapy area was the central nervous system, followed by community medicine and orthopedics. CONCLUSIONS: This study depicts the underrepresentation of the geriatric population in clinical studies.

An observational study to evaluate the prescription pattern of analgesics used in the perioperative period in a tertiary care hospital.

BACKGROUND AND AIMS: Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage. There are limited observational prescription pattern studies of analgesics in perioperative period in tertiary care hospitals for which this study was carried out in orthopedic, general surgery, and plastic surgery departments. The primary aim was to study the prescription pattern of analgesics in the perioperative period with the secondary aim to study the specific use of opioids and pain relief using the Visual Analog Scale (VAS). METHODS: A total of 250, 250, and 100 patients were taken from orthopedic, general surgery, and plastic surgery departments, respectively. The analgesics commonly used in preoperative, intraoperative, and postoperative period were observed. The use of opioids in the perioperative period, the number of fixed drug combinations used, the number of generic drug prescription, and pain relief postoperatively were also observed. The analysis was done using descriptive statistics. RESULTS: Total analgesics prescribed were 1168, 117, and 369 in orthopedic, general surgery, and plastic surgery departments, respectively, and were maximum in the intraoperative period. Most commonly used analgesic in the preoperative and postoperative period was paracetamol and that in intraoperative period was fentanyl. Nonsteroidal anti-inflammatory drugs (NSAIDs) were mainly prescribed by the general surgery department in postoperative period. The amount of pain in postoperative period after treatment with analgesics was mild to moderate as per the VAS. CONCLUSION: This study revealed that in preoperative and postoperative period, the most common analgesic used is paracetamol. In the intraoperative period, maximum patients received fentanyl. Diclofenac is an established NSAID used in the management of acute and chronic pain states. In our study, we found that the usage of paracetamol was more than NSAIDs and the usage of opioid was maximum during intraoperative period.

Compassionate drug use: Current status in India.

The World Health Organization defines compassionate use (CU) as a "program that is intended to provide potentially life-saving experimental treatments to patients suffering from a disease for which no satisfactory authorized therapy exists and/or who cannot enter a clinical trial. For many patients, these programs represent their last hope." Over the years, an increasing number of requests and isolated cases have paved the way for more robust CU programs by pharmaceutical companies and guidelines by eminent regulatory bodies globally. In India, although there is no formal mention of the term "Compassionate Use" by the Central Drugs Standard Control Organization, there are provisions in the Drugs and Cosmetics Act 1940 and Rules 1945 to allow drugs to be imported as and when necessary. Such applications can be submitted to the Drug Controller General of India by a hospital, patient, or a pharmaceutical company. The evidence of such use of drugs is underlined by the availability of bedaquiline and delamanid for extensively drug-resistant tuberculosis (TB) and multidrug-resistant TB patients, respectively. CU is in its nascent stage in India owing to the lack of policies and laws needed to govern it. There is a need for regulatory bodies and pharmaceutical companies to work together to extend the spectrum of CU of drugs for the betterment of needy patients.