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Background : Therapeutic drug monitoring for mycophenolic acid (MPA) is increasingly being advocated. Thepresent therapeutic range relates to the 12-hour area under the serum concentration time profile (AUC).However, this is a cumbersome, tedious, cost restricting procedure. Is it possible to reduce this samplingperiod? Aim : To compare the AUC from a reduced sampling strategy with the full 12-hour profile for MPA. Settings and Design : Clinical Pharmacology Unit of a tertiary care hospital in South India. Retrospective, paireddata. Materials and Methods : Thirty-four 12-hour profiles from post-renal transplant patients on Cellcept (R) wereevaluated. Profiles were grouped according to steroid and immunosuppressant co-medication and the timeafter transplant. MPA was estimated by high performance liquid chromatography with UV detection. From the12-hour profiles the AUC up to only six hours was calculated by the trapezoidal rule and a correction factorapplied. These two AUCs were then compared. Statistical Analysis : Linear regression, intra-class correlations (ICC) and a two-tailed paired t-test were appliedto the data. Results : Comparing the 12-hour AUC with the paired 6-hour extrapolated AUC, the ICC and linear regression(r2) were very good for all three groups. No statistical difference was found by a two-tailed paired t-test. Nobias was seen with a Bland Altman plot or by calculation. Conclusion : For patients on Cellcept (R) with prednisolone +/- cyclosporine the 6-hour corrected is an accuratemeasure of the full 12-hour AUC. [ABSTRACT FROM AUTHOR]

Background: e-Pharmacy can potentially solve problems related to the quality of services and products, cost, and access to medicines in low- and middle-income countries. This review aims to understand the facilitators and barriers to the implementation of e-pharmacy in India., Objective: This scoping review aimed (1) to understand the facilitators and barriers to the use of e-pharmacy in India and (2) to estimate the potential for e-pharmacy in India for improving access to medication, improving the quality of services and medicines, and decreasing costs of medications., Methods: All published and gray literature from July 1, 2011, to June 30, 2021, relating to e-pharmacy, was searched from MEDLINE, Scopus, ProQuest, and Google using a systematic search strategy., Results: In total, 1464 titles and abstracts were screened, of which 47 full-texts were included in the review. e-Pharmacy can potentially improve access to medications for remote areas, and old and debilitated individuals. e-Pharmacies can enable lean supply chain management, lower cost, and allow easy tracking of dispensed medicines. There is potential for integration of e-pharmacy services into the national program of Bhartiya Jan Aushadhi Pariyojana. However, the country is not adequately regulated to prevent the growth of illicit e-pharmacies. Lack of global accreditation and internet coverage, digital literacy, and transnational access are other challenges., Conclusions: E-pharmacy has the potential to improve universal health coverage in India by improving access to medicines and lowering the overall cost of health care. However, future growth will need specific regulations and accreditation mechanisms., Trial Registration: Open Science Forum; https://doi.org/10.17605/OSF.IO/6R9YQ., (©Aditi Apte, Heber Rew Bright, Sandeep Kadam, Thambu David Sundarsanam, Sujith J Chandy. Originally published in the Online Journal of Public Health Informatics (https://ojphi.jmir.org/), 09.10.2024.)

The Bellagio Group for Accelerating AMR Action met in April 2024 to develop the ambitious but achievable 1-10-100 unifying goals to galvanize global policy change and investments for antimicrobial resistance mitigation: 1 Health; 10 million lives saved; and 100% sustainable access to effective antimicrobials. High profile political goals such as the Paris Agreement's objective to keep global warming well below 2° Celsius compared to pre-industrial levels, UNAIDS' 90-90-90 goal, and the Sustainable Development Goals challenge global norms, direct attention towards relevant activities, and serve an energizing function to motivate action over an extended period of time. The 1-10-100 unifying goals propose to unite the world through a One Health approach to safeguard human health, animal welfare, agrifood systems, and the environment from the emergence and spread of drug-resistant microbes and infections; save over 10 million lives by 2040 through concerted efforts to prevent and appropriately treat infections while preserving the vital systems and services that depend on sustained antimicrobial effectiveness; and commit to ensuring that antimicrobials are available and affordable for all, used prudently, and secured for the future through innovation. Compared to existing technical targets, these unifying goals offer advantages of focusing on prevention, encouraging multisectoral action and collaboration, promoting health equity, recognizing the need for innovation, and integrating with Sustainable Development Goals. By committing to 1 Health, 10 million lives saved, and 100% sustainable access to effective antimicrobials, we can protect lives and livelihoods today and safeguard options for tomorrow., (© 2024. The Author(s).)

Purpose: We examined the efficacy of topical capsaicin in reducing delayed chemotherapy-induced nausea and vomiting (CINV)., Methods: Adults on highly emetogenic chemotherapy regimens applied 2 g of capsaicin ointment (0.075%) or matching placebo four times a day to the abdomen for 5 days in addition to standard antiemetic regimen in this blinded randomized controlled trial. Patients were monitored for nausea and vomiting in the immediate (day 1), delayed (days 2-5), and extended phases (days 2-15). Self-reported incidence and daily episodes of CINV were compared between the groups. Onset, severity, need for rescue antiemetics, cumulative vomiting episodes, and safety were also compared., Results: In total, 160 patients were enrolled. The final modified intention-to-treat population included 75 patients each in the capsaicin and placebo groups. Fewer patients experienced nausea (36.0% [n = 27] v 53.3% [n = 40]; P = .033) and vomiting (28.0% [n = 21] v 42.7% [n = 32]; P = .060) in the capsaicin arm during the delayed phase. During the extended phase, there was a significantly lower incidence of nausea (44% v 64.0%; P = .014) in the capsaicin arm. No difference in nausea (26.7% v 25.3%) or vomiting (22.7% v 18.7%) was evident in the immediate phase. The average daily episodes of nausea and vomiting were significantly fewer in the capsaicin arm during the delayed and extended phases. With capsaicin, no grade 3 nausea (9.3% v 0.0%; P = .007) was observed, and the time to first nausea and vomiting was significantly prolonged. There were no differences between the groups with respect to rescue antiemetics, unscheduled hospital visits, and adverse events., Conclusion: Topical capsaicin reduced the incidence of nausea and the average number of vomiting episodes during delayed and extended phases without increasing adverse effects.

Competing Interests: All authors declare no conflict of interest. None of the authors received any payments for this particular manuscript. PM received honorarium for writing op-eds on issues of public health importance (including Antimicrobial Resistance) from Moneycontrol (A subsidiary of Network 18). The authors were formerly affiliated with ReAct Asia Pacific, funded through the Swedish International Developmental Co-operation Agency (SIDA) routed through Uppsala University.

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., (Copyright © 2024 Copyright: © 2024 Indian Journal of Pharmacology.)

Antibiotic resistance (ABR) is increasing the mortality and morbidity associated with infectious diseases, besides increasing the cost of healthcare, saturating health system capacity, and adversely affecting food security. Framing an appropriate narrative and engaging local communities through the 'One Health' approach is essential to complement top-down measures. However, the absence of objective criteria to measure the performance of ABR interventions in community settings makes it difficult to mobilize interest and investment for such interventions. An exercise was therefore carried out to develop an indicator framework for this purpose. A comprehensive list of indicators was developed from experiences gathered through community engagement work in a local panchayat (small administrative area) in Kerala, India and a consultative process with health, veterinary, environment, and development experts. A prioritization exercise was carried out by global experts on ABR, looking at appropriateness, feasibility, and validity. A 15-point indicator framework was designed based on the prioritization process. The final set of indicators covers human health, animal health, environment management, and Water Sanitation and Hygiene (WASH) domains. The indicator framework was piloted in the panchayat (located in Kerala), which attained a score of 34 (maximum 45). The score increased when interventions were implemented to mitigate the ABR drives, indicating that the framework is sensitive to change. The indicator framework was tested in four sites from three other Indian states with different socioeconomic and health profiles, yielding different scores. Those collecting the field data were able to use the framework with minimal training. It is hoped that, this indicator framework can help policymakers broadly understand the factors contributing to ABR and measure the performance of interventions they choose to implement in the community as part of National Action Plan on AMR.

Objectives: Vietnam was the first country from the WHO Western Pacific Region to adopt a national action plan (NAP) on antimicrobial resistance (AMR) in 2013. The multilayered nature of AMR requires coordination across 'One Health' sectors, dedicated financing, multistakeholder involvement, and widespread community engagement to implement the action plans. This study explores the perceived impact of NAP implementation at the community level., Methods: Key informant interviews (KIIs) were used for data collection during 2021. An interview tool was used for the KIIs and purposive sampling was used to identify study participants from Vietnam. The study participants were those engaged with a substantial scale of antimicrobial usage, diagnosis of infections or concerned with antimicrobial content in effluents in their professional life. Twelve KIIs were conducted with participants from human health, animal health and the environmental sector. The data were entered into Microsoft Excel, and manifest and latent content analysis was done., Results: The analysis highlighted themes such as limited public awareness of AMR, ongoing capacity building and quality assurance initiatives, implementation of guidelines and regulations for AMR containment, sustained investment in improving infrastructure, and challenges relating to accountability whilst prescribing and selling antibiotics., Conclusions: There were many positive critical developments during the NAP implementation period in Vietnam towards AMR mitigation. For better impact, there is a need to revitalize the implementation machinery of NAPs by improving the enforcement capacity of regulations, cross-sectoral collaboration and promoting community ownership., (© The Author(s) 2023. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy.)

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., (© Journal of the Association of Physicians of India 2011.)

Medical ethics education along with attitude and communication training has been incorporated into the regular MBBS curriculum in India from 2019, so as to encourage a caring and communicative approach by doctors towards patients. It would be important to understand the relevance of the educational module in the form of cases to ensure an optimal learning process for future students and doctors in the making. We selected three cases and conducted online debates among small groups of second year MBBS students. Students submitted narratives and their reflections after discussing each case and gave overall feedback. Our findings suggested that the students recognised the complexity of taking decisions when presented with ethical dilemmas and appreciated the opportunity to voice opposing views. The online platform was effective and may be considered in the future as a medium to help integrate discussions on medical ethics alongside clinical work.

Rising antimicrobial resistance (AMR) is causing therapeutic failures with antibiotics. Inappropriate use is a contributing factor. One such antibiotic on the radar is faropenem, a broad spectrum antibiotic approved in 2005 in India. Recently, faropenem sodium suspension was approved for use in children. There is a potential danger of overuse due to the convenience of oral administration. Other carbapenems such as meropenem are used parenterally. Overuse of faropenem may promote cross-resistance with other carbapenems making them ineffective.

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., Competing Interests: None

Purpose: Over-the-counter (OTC) sale of antibiotics have contributed to the growing threat of antibiotic resistance. The Government of India has instituted regulatory measures, such as Schedule H1 and public campaigns such as Red Line Campaign, to limit such sales. This study was conducted to assess the perceptions of stakeholders regarding their effectiveness., Methods: To assess Schedule H1, pharmacists who own retail pharmacies in the state of Kerala, India, were interviewed using a pre-prepared question guide. In the next phase, healthcare professionals and patients in a hospital were shown the Red Line on an antibiotic blister pack and asked about its significance. Finally, 100 patients were shown a blister pack of Amoxicillin, and asked to identify the medicine or its use., Results: It was observed that there is poor awareness about antibiotic regulations and a perception of laxity in enforcement. Regarding the Red Line, only 7% of healthcare professionals could describe its significance and none among patients. Among the 100 patients who were shown Amoxicillin, only 42 could identify it as an antibiotic or describe its use., Conclusions: There is a general perception that regulations are poorly enforced and all are not aware of the Red Line campaign including healthcare professionals. Greater awareness at all levels about appropriate antibiotic use through prescriptions followed by greater efforts towards regulatory implementation and compliance should form parts of a multi-modal strategy to contain OTC sales of antibiotics. This will greatly help to aid physicians in improving overall healthcare through safe and effective prescribing., Competing Interests: There are no conflicts of interest., (Copyright: © 2022 Journal of Family Medicine and Primary Care.)

Background: The objectives of the study were to investigate the organizational characteristics of acute care facilities worldwide in preventing and managing infections in surgery; assess participants' perception regarding infection prevention and control (IPC) measures, antibiotic prescribing practices, and source control; describe awareness about the global burden of antimicrobial resistance (AMR) and IPC measures; and determine the role of the Coronavirus Disease 2019 pandemic on said awareness., Methods: A cross-sectional web-based survey was conducted contacting 1432 health care workers (HCWs) belonging to a mailing list provided by the Global Alliance for Infections in Surgery. The self-administered questionnaire was developed by a multidisciplinary team. The survey was open from May 22, 2021, and June 22, 2021. Three reminders were sent, after 7, 14, and 21 days., Results: Three hundred four respondents from 72 countries returned a questionnaire, with an overall response rate of 21.2%. Respectively, 90.4% and 68.8% of participants stated their hospital had a multidisciplinary IPC team or a multidisciplinary antimicrobial stewardship team. Local protocols for antimicrobial therapy of surgical infections and protocols for surgical antibiotic prophylaxis were present in 76.6% and 90.8% of hospitals, respectively. In 23.4% and 24.0% of hospitals no surveillance systems for surgical site infections and no monitoring systems of used antimicrobials were implemented. Patient and family involvement in IPC management was considered to be slightly or not important in their hospital by the majority of respondents (65.1%). Awareness of the global burden of AMR among HCWs was considered very important or important by 54.6% of participants. The COVID-19 pandemic was considered by 80.3% of respondents as a very important or important factor in raising HCWs awareness of the IPC programs in their hospital. Based on the survey results, the authors developed 15 statements for several questions regarding the prevention and management of infections in surgery. The statements may be the starting point for designing future evidence-based recommendations., Conclusion: Adequacy of prevention and management of infections in acute care facilities depends on HCWs behaviours and on the organizational characteristics of acute health care facilities to support best practices and promote behavioural change. Patient involvement in the implementation of IPC is still little considered. A debate on how operationalising a fundamental change to IPC, from being solely the HCWs responsibility to one that involves a collaborative relationship between HCWs and patients, should be opened., (© 2022. The Author(s).)

The COVID-19 pandemic has underlined the importance of an efficient and equitable supply of and access to essential health products. These factors are equally pertinent to the antimicrobial resistance pandemic, in which access to a portfolio of existing and pipeline antimicrobials plus complementary diagnostics is crucial. This Viewpoint focuses on market shaping in low-income and middle-income countries (LMICs), where the need for effective antimicrobials and complementary diagnostics is most acute. We propose the creation of a subscription and pooled procurement model that consolidates the growing demand for a portfolio of antimicrobials and diagnostics in LMICs. Anchored by regional market leaders, these pooling mechanisms would guarantee consistent private-sector and public-sector access in participating countries, while creating conditions for long-term best practice in stewardship. Supported by data from South Africa and India, this proposal sets out an innovative approach to tackle the antimicrobial resistance crisis in LMICs., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Securing equitable antibiotic access as an essential component for health system resilience and pandemic preparedness requires a systems perspective. This article discusses key components that need to be coordinated and paired with adequate financing and resources to ensure antibiotic effectiveness as a global public good, which should be central while discussing a new global agreement.

Competing Interests: On behalf of all authors, the corresponding author states that there is no conflict of interest.

Antimicrobial resistance (AMR) threatens to undermine nearly a century of progress since the first use of antimicrobial compounds. There is an increasing recognition of the links between antimicrobial use and AMR in humans, animals, and the environment (i.e., One Health) and the spread of AMR between these domains and around the globe. This systematic review applies a One Health approach-including humans, animals, and the environment-to characterize AMR in Escherichia coli in India. E. coli is an ideal species because it is readily shared between humans and animals, its transmission can be tracked more easily than anaerobes, it can survive and grow outside of the host environment, and it can mobilize AMR genes more easily than other intestinal bacteria. This review synthesized evidence from 38 studies examining antimicrobial-resistant E. coli (AR-E) across India. Studies of AR-E came from 18 states, isolated from different sample sources: Humans ( n = 7), animals ( n = 7), the environment ( n = 20), and combinations of these categories, defined as interdisciplinary ( n = 4). Several studies measured the prevalence of AMR in relation to last-line antimicrobials, including carbapenems ( n = 11), third-generation cephalosporins ( n = 18), and colistin ( n = 4). Most studies included only one dimension of the One Health framework, highlighting the need for more studies that aim to characterize the relationship of AMR across different reservoirs of E. coli .

Multidrug-resistant Gram-negative bacterial infection is a serious global concern and especially in low and middle-income countries (LMIC) such as India. Colistin, an antimicrobial once abandoned following reports of organ toxicity, has re-emerged as an essential therapeutic agent in the management of these infections. A retrospective review of 162 inpatients was done, focusing on culture-proven multidrug-resistant infections requiring colistin. The overall clinical outcome in 58% of patients was found to be good, with nephrotoxicity and neurotoxicity occurring only in 8 (5%) and 4 (2.5%) patients, respectively. Multivariate analysis revealed an elevated lactate and raised urea to be independent factors associated with poor clinical response. In conclusion, there appears to be strong evidence supporting the use of colistin in the management of multidrug-resistant Gram-negative bacterial infections.

Although the individual and societal consequences of antibiotic resistance spiral upwards, coordinated action has not kept pace on a global scale. The COVID-19 pandemic has highlighted the need for resilient health systems and has resulted in an unprecedented rate of collaboration in scientific, medical, social, and political dimensions. The pandemic has also created a renewed awareness of the importance of infectious diseases and is a substantial entry point for reigniting the momentum towards containing the silent pandemic of antibiotic resistance. In this Viewpoint, we discuss the limitations in the current narrative on antibiotic resistance and how it could be improved, including concerted efforts to close essential data gaps. We discuss the need for capacity building and coordination at the national and global levels to strengthen the understanding of the importance of sustainable access to effective antibiotics for all health systems that could generate tangible links to current processes for global health and development., Competing Interests: Declaration of interests All authors report grants from ReAct, during the conduct of the study. OC is a former member of the Strategic and Technical advisory group on antimicrobial resistance for WHO and a former member of the ad hoc UN Interagency Coordination Group on Antimicrobial Resistance. ADS has received financial support for research and policy work related to antibiotic resistance from the Open Society Foundation, the Greenwall Foundation, and WHO; and has served as co-convener of the ad hoc UN Interagency Coordination Group on Antimicrobial Resistance and participated in multiple WHO expert consultations on antimicrobial resistance., (Copyright © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

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., Competing Interests: None

COVID-19 has affected the daily activities of people across the globe. The effects of the pandemic have not just been medical, but also societal and economical. The responses of government and the public have varied in different countries. Measures have ranged from improving hygiene, information dissemination, and social distancing to more radical measures such as social isolation, quarantine and lockdown. The disease and human responses have had consequences on the way we live, work, eat and rest. Life and livelihoods have been affected. This article highlights how the response to the pandemic has affected various aspects of healthcare and ethical dilemmas this has raised. As the pandemic progresses, awareness and evaluation of the unintended consequences of the pandemic and responses on our health and healthcare systems are needed. Discussing these points and being aware of the ethical issues may help countries and policy makers plan suitable strategies to mitigate these collateral effects, especially as the pandemic continues. It is hoped that this article will support healthcare workers, especially those in primary and secondary healthcare, as they overcome various challenges to treat patients with existing and prior diseases, and encourage them to advocate for robust and sustainable healthcare systems for public health. This would then help effectively combat future epidemics. Most importantly, it can mitigate the adverse collateral effects on healthcare that the public are experiencing and the treatment dilemmas that family and primary care physicians are facing., Competing Interests: There are no conflicts of interest., (Copyright: © 2021 Journal of Family Medicine and Primary Care.)

Improving evidence for action is crucial to tackle antimicrobial resistance. The number of interventions for antimicrobial resistance is increasing but current research has major limitations in terms of efforts, methods, scope, quality, and reporting. Moving the agenda forwards requires an improved understanding of the diversity of interventions, their feasibility and cost-benefit, the implementation factors that shape and underpin their effectiveness, and the ways in which individual interventions might interact synergistically or antagonistically to influence actions against antimicrobial resistance in different contexts. Within the efforts to strengthen the global governance of antimicrobial resistance, we advocate for the creation of an international One Health platform for online learning. The platform will synthesise the evidence for actions on antimicrobial resistance into a fully accessible database; generate new scientific insights into the design, implementation, evaluation, and reporting of the broad range of interventions relevant to addressing antimicrobial resistance; and ultimately contribute to the goal of building societal resilience to this central challenge of the 21st century., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Introduction: Implementing a sustainable and effective Antimicrobial Stewardship (AMS) programme in secondary level hospitals, in Low-Middle Income Country (LMIC) contexts, has numerous challenges. It is important to understand these challenges so that the stewardship initiatives can be tailored according to the unique requirements thrown up by these healthcare facilities. This study explores the experiences of implementing AMS in secondary level hospitals in the state of Kerala, India. Methods: A qualitative study was planned to map the challenges in implementing AMS in the secondary level hospitals. Toward the end of the 1 year followup period, the nodal officers at each hospital were interviewed using a semi-structured interview guide. The in-depth interviews were transcribed and later subjected to content analysis using N-Vivo 11.0, a popular software tool used for qualitative analysis. Results: Many physicians cite perceived patient satisfaction as one of the reasons for increased antibiotic use, as many patients consider antibiotics as standard of care. Also, the distance traveled by the patient and advancing age are factors which increase antibiotic use. The physician factors which determine use include empiric treatment needs, outbreak of diseases, absence of education programmes in antibiotic usage to fill in the knowledge gap and fear of litigation. The promotional activities by companies and antibiotics being a major source of income for small hospitals, affects use patterns. The factors which determine antibiotic selection includes conformism, experience of the physician, perceived resistance to certain antibiotics, emergence of specific diseases, and promotional activities related to antimicrobial agents. The challenges in implementing a sustainable stewardship programme is multifactorial. It includes competition between doctors, time constraints faced by physicians, absence of a champion, sub-optimal interdepartmental cooperation, absence of supporting facilities, dysfunctional regulatory systems, and unreliability of antibiograms. Discussion: AMS in resource-limited setting is going to be a challenge, especially in terms of financing, access to technologies and capacity building. Political and regulatory willpower of international partnerships should be effectively harnessed for designing solutions for LMIC contexts. Also, models for stewardship from elsewhere should undergo an adaptation process before implementation in low resource settings., (Copyright © 2020 Mathew, Ranjalkar and Chandy.)

Antimicrobial resistance (AMR) is a multifaceted complex problem with momentous consequences for individuals as well as health-care systems. Understanding the gravity of the problem, the World Health Assembly has adopted the Global Action Plan on AMR in the year 2015 as a part of the tripartite collaboration with World Health Organization, Food and Agricultural Organization, and World Organization for Animal Health. India's National Action Plan (NAP) for AMR was released in April 2017 by the Union Ministry of Health and Family Welfare. The objectives of the NAP include improving awareness, enhancing surveillance measures, strengthening infection prevention and control, research and development, promoting investments, and collaborative activities to control AMR. On the basis of the NAP, various states have begun the process of initiating their State Action Plans. The aim of this article is to highlight some of the main components of the NAP and to make family physicians, general practitioners, and other stakeholders aware of the issue of AMR and its factors and what can be done. The article also discusses some of the challenges in implementation of NAP such as varied perceptions about antibiotic use and AMR among key stakeholders, inappropriate antibiotic use owing to a number of reasons, lack of diagnostic facilities, widespread use of antibiotics in various sectors, environmental contamination because of pharmaceutical industry, agricultural and hospital waste, gaps in infection prevention and control, and difficulty in enforcing regulations. Similar to other low-middle income countries (LMICs), lack of sufficient finances remains a major challenge in NAP implementation in India as well. Overall, a strong political will, inter-sectoral co-ordination between public and private sectors and comprehensive strengthening of the healthcare systems are necessary to achieve the desired forward momentum., Competing Interests: There are no conflicts of interest.

Background: Cisplatin is a commonly used chemotherapy agent known to induce serious adverse reactions that may require hospital readmission. We aimed to analyze the extent and factors associated with unplanned hospital admissions due to cisplatin-based chemotherapy regimen-induced adverse reactions., Methods: Retrospective review of medical records of those patients who received at least one cycle of chemotherapy with cisplatin-based regimen during a six-month period from March to August 2017., Results: Of the 458 patients who received cisplatin during the study period, 142 patients did not meet inclusion criteria. The remaining 316 patients had a total of 770 episodes of primary admissions for chemotherapy administration. Overall, 187 episodes (24%) of intercycle unplanned hospital admission were recorded of which a major proportion (n=178; 23%) was due to chemotherapy-induced adverse reactions. Underweight patients had higher odds of unplanned admission (OR 1.77, 95% confidence interval [CI] 1.11 to 1.77). Significantly, more number of patients with cancers of head and neck and cancers of musculoskeletal were readmitted (p<0.001). Compared to high-dose cisplatin, low- and intermediate-dose cisplatin had lesser odds of unplanned admission (OR 0.52 and 0.77; 95% CI, 0.31 to 0.88 and 0.41 to 1.45, respectively). Patients without concomitant radiotherapy, drug-drug interaction and initial chemotherapy cycles had lesser odds of unplanned admission (OR 0.38, 0.50 and 0.52; 95% CI, 0.26 to 0.55, 0.25 to 0.99 and 0.32 to 0.84 respectively). Unplanned admissions were mainly due to blood-related (31%) and gastrointestinal (19%) adverse reactions. Among chemotherapy regimens, cisplatin monotherapy (34%) and cisplatin with doxorubicin (20%) regimens resulted in a major proportion of unplanned admissions., Conclusion: These findings highlight risk factors that help identify high-risk patients and suggest that therapy modifications may reduce hospital readmissions due to cisplatin-based chemotherapy-induced adverse reactions., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Background: The University of Dundee and the BSAC developed a massive open online course (MOOC) to address the global need for education to support antimicrobial stewardship in low- and middle-income countries., Methods: An interactive course, Antimicrobial Stewardship: Managing Antibiotic Resistance, was developed and delivered via the FutureLearn© platform. The course ran over four 6 week periods during 2015 and 2016 supported by educators and was evaluated via data on uptake and feedback from learners on impact on clinical practice., Results: In total, 32 944 people, 70% of them healthcare professionals, from 163 countries joined the course from Europe (49%), Asia (16%), Africa (13%), North America (9%), Australia (8%) and South America (5%). Between 33% and 37% of joiners in each run completed at least one step in any week of the course and 219 participants responded to a post-course survey. The course was rated good or excellent by 208 (95%) of the participants, and 83 (38%) intended to implement stewardship interventions in their own setting. A follow-up survey 6 months later suggested that 49% had implemented such interventions., Conclusions: The MOOC has addressed a global learning need by providing education free at the point of access, and learning from its development will help others embarking upon similar educational solutions. Initial quantitative and qualitative feedback suggests it has engaged participants and complements traditional educational methods. Measuring its real impact on clinical practice remains a challenge. The FutureLearn© platform offers flexibility for MOOCs to be sustainable through modification to remove educator facilitation but maintain active participant discussion.

[This corrects the article DOI: 10.1186/s13017-016-0089-y.].

Background: Antimicrobial Stewardship Programs (ASPs) have been promoted to optimize antimicrobial usage and patient outcomes, and to reduce the emergence of antimicrobial-resistant organisms. However, the best strategies for an ASP are not definitively established and are likely to vary based on local culture, policy, and routine clinical practice, and probably limited resources in middle-income countries. The aim of this study is to evaluate structures and resources of antimicrobial stewardship teams (ASTs) in surgical departments from different regions of the world., Methods: A cross-sectional web-based survey was conducted in 2016 on 173 physicians who participated in the AGORA (Antimicrobials: A Global Alliance for Optimizing their Rational Use in Intra-Abdominal Infections) project and on 658 international experts in the fields of ASPs, infection control, and infections in surgery., Results: The response rate was 19.4%. One hundred fifty-six (98.7%) participants stated their hospital had a multidisciplinary AST. The median number of physicians working inside the team was five [interquartile range 4-6]. An infectious disease specialist, a microbiologist and an infection control specialist were, respectively, present in 80.1, 76.3, and 67.9% of the ASTs. A surgeon was a component in 59.0% of cases and was significantly more likely to be present in university hospitals (89.5%, p  < 0.05) compared to community teaching (83.3%) and community hospitals (66.7%). Protocols for pre-operative prophylaxis and for antimicrobial treatment of surgical infections were respectively implemented in 96.2 and 82.3% of the hospitals. The majority of the surgical departments implemented both persuasive and restrictive interventions (72.8%). The most common types of interventions in surgical departments were dissemination of educational materials (62.5%), expert approval (61.0%), audit and feedback (55.1%), educational outreach (53.7%), and compulsory order forms (51.5%)., Conclusion: The survey showed a heterogeneous organization of ASPs worldwide, demonstrating the necessity of a multidisciplinary and collaborative approach in the battle against antimicrobial resistance in surgical infections, and the importance of educational efforts towards this goal.

Objective: A rising number of medicines and minimal emphasis on rational prescribing in the medical curriculum may compromise medication safety. There is no focused module in the curriculum dealing with factors affecting safety such as quality, medicines management, rational use, and approach to adverse effects. Creating awareness of these issues would hopefully plant a seed of safe prescribing and encourage pharmacovigilance. A study was therefore done to determine the need for such a module., Method: A quasi-experimental pre-post module study. Medical students ( n = 88) completing pharmacology term were recruited after informed consent. A questionnaire containing 20 questions on various themes was administered and scored. Subsequently a module was developed and relevant safety themes taught to the students. After one month, the questionnaire was re-administered., Results: The pre module score was 9.52/20. Knowledge about the various themes, adverse effects, medication management, quality issues and rational use were similar though poor knowledge was evident in specific areas such as clinical trials, look alike-sound alike medicines (LASA) and medicine storage. The post module score was 12.24/20. The improvement of score was statistically significant suggesting the effectiveness of the module., Conclusion: The relatively poor knowledge and improvement with a specific educational module emphasizes the need of such a module within the medical curriculum to encourage safe use of medicines by Indian Medical Graduates (IMG). It is hoped that the policy makers in medical education will introduce such a module within the medical curriculum., Competing Interests: There are no conflicts of interest.

Intra-abdominal infections (IAI) are an important cause of morbidity and are frequently associated with poor prognosis, particularly in high-risk patients. The cornerstones in the management of complicated IAIs are timely effective source control with appropriate antimicrobial therapy. Empiric antimicrobial therapy is important in the management of intra-abdominal infections and must be broad enough to cover all likely organisms because inappropriate initial antimicrobial therapy is associated with poor patient outcomes and the development of bacterial resistance. The overuse of antimicrobials is widely accepted as a major driver of some emerging infections (such as C. difficile), the selection of resistant pathogens in individual patients, and for the continued development of antimicrobial resistance globally. The growing emergence of multi-drug resistant organisms and the limited development of new agents available to counteract them have caused an impending crisis with alarming implications, especially with regards to Gram-negative bacteria. An international task force from 79 different countries has joined this project by sharing a document on the rational use of antimicrobials for patients with IAIs. The project has been termed AGORA (Antimicrobials: A Global Alliance for Optimizing their Rational Use in Intra-Abdominal Infections). The authors hope that AGORA, involving many of the world's leading experts, can actively raise awareness in health workers and can improve prescribing behavior in treating IAIs.

The need to revise the curriculum for the postgraduate course (M.D.) in Pharmacology has been perceived by the academicians in India since quite some time. The changing professional requirements of the graduating students, the current scenario vis a vis animal experimentation and the emphasis of the Medical Council of India on a competency based curriculum has triggered this felt need. In spite of the fact that most medical institutions and universities in India offer postgraduate courses in pharmacology, the curriculum lacks uniformity with extreme variations observed at some places. This article attempts to analyze the existing curricula in pharmacology in India and suggest modifications that could be recommended to the suitable regulatory bodies for implementation. A revision of objectives in the three domains of learning, development of skills that help develop suitable competencies, adoption of teaching learning methods in addition to the conventional methods, and a rethink on the assessment methods have been recommended. Development and validation of alternatives skill-based modules in lieu of animal experiments are recommended. Additional skills like medical writing and communication skills, professionalism and ethics, multi and inter-disciplinary integration and collaboration and a wider exposure of students to the pharmaceutical, academic, regulatory and research institutions for onsite learning were also recommended to fulfill their future career requirements.

Introduction: Rising antibiotic resistance may negatively affect the health and cost of care for patients. This study aimed to determine the impact of antibiotic resistance on costs and health consequences for patients., Methodology: A one-year observational study was conducted at Christian Medical College, Vellore, a tertiary care hospital, on patients admitted into medical wards with a preliminary diagnosis of suspected sepsis. Patients with confirmed bacteremia were analysed in two groups - resistant and susceptible - based on susceptibility of causative bacteria to the empiric antibiotics administered. Clinical data and details about costs incurred were collected from hospital records. Costs and health consequences were compared using Mann-Whitney U test and Fisher's exact test. For median difference in costs, 95% bootstrap confidence interval was determined., Results: Overall, 220 patients were included. The median difference between resistant and susceptible groups in overall costs, antibiotic costs, and pharmacy costs was rupees (INR)/USD 41,993/700 (p = 0.001), 8,315/139 (p < 0.001) and 21,492/358 (p < 0.001), respectively. Health consequences such as intensive care admissions, complications, mortality, and length of stay were significantly higher in the resistant group as compared to susceptible group: 44% vs. 21% (p < 0.001), 56% vs. 37% (p = 0.006), 12% vs. 2% (p = 0.011), and 14 vs. 11 days (p = 0·027), respectively., Conclusions: Antibiotic resistance has a significant impact on cost and health consequences. These findings provide a key message for policymakers and other stakeholders to initiate feasible strategies to tackle resistance and reduce the burden.

Introduction: Antibiotic pressure contributes to rising antibiotic resistance. Policy guidelines encourage rational prescribing behavior, but effectiveness in containing antibiotic use needs further assessment. This study therefore assessed the patterns of antibiotic use over a decade and analyzed the impact of different modes of guideline development and dissemination on inpatient antibiotic use., Methods: Antibiotic use was calculated monthly as defined daily doses (DDD) per 100 bed days for nine antibiotic groups and overall. This time series compared trends in antibiotic use in five adjacent time periods identified as 'Segments,' divided based on differing modes of guideline development and implementation: Segment 1--Baseline prior to antibiotic guidelines development; Segment 2--During preparation of guidelines and booklet dissemination; Segment 3--Dormant period with no guidelines dissemination; Segment 4--Booklet dissemination of revised guidelines; Segment 5--Booklet dissemination of revised guidelines with intranet access. Regression analysis adapted for segmented time series and adjusted for seasonality assessed changes in antibiotic use trend., Results: Overall antibiotic use increased at a monthly rate of 0.95 (SE = 0.18), 0.21 (SE = 0.08) and 0.31 (SE = 0.06) for Segments 1, 2 and 3, stabilized in Segment 4 (0.05; SE = 0.10) and declined in Segment 5 (-0.37; SE = 0.11). Segments 1, 2 and 4 exhibited seasonal fluctuations. Pairwise segmented regression adjusted for seasonality revealed a significant drop in monthly antibiotic use of 0.401 (SE = 0.089; p<0.001) for Segment 5 compared to Segment 4. Most antibiotic groups showed similar trends to overall use., Conclusion: Use of overall and specific antibiotic groups showed varied patterns and seasonal fluctuations. Containment of rising overall antibiotic use was possible during periods of active guideline dissemination. Wider access through intranet facilitated significant decline in use. Stakeholders and policy makers are urged to develop guidelines, ensure active dissemination and enable accessibility through computer networks to contain antibiotic use and decrease antibiotic pressure.

Antimicrobial resistance and hospital infections have increased alarmingly in India. Antibiotic stewardship and hospital infection control are two broad strategies which have been employed globally to contain the problems of resistance and infections. For this to succeed, it is important to bring on board the various stakeholders in hospitals, especially the clinical pharmacologists. The discipline of clinical pharmacology needs to be involved in themes such as antimicrobial resistance and hospital infection which truly impact patient care. Clinical pharmacologists need to collaborate with faculty in other disciplines such as microbiology to achieve good outcomes for optimal patient care in the hospital setting. The ASPIC programme was initiated by the Indian Council of Medical Research (ICMR) in response to the above need and was designed to bring together faculty from clinical pharmacology, microbiology and other disciplines to collaborate on initiating and improving antibiotic stewardship and concurrently curbing hospital infections through feasible infection control practices. This programme involves the participation of 20 centres per year throughout the country which come together for a training workshop. Topics pertaining to the above areas are discussed in addition to planning a project which helps to improve antibiotic stewardship and infection control practices in the various centres. It is hoped that this programme would empower hospitals and institutions throughout the country to improve antibiotic stewardship and infection control and ultimately contain antimicrobial resistance.

Background: Cyclo-oxygenase (COX)-2 inhibitors have been the target of severe criticism, more so following the withdrawal of Rofecoxib. Post-marketing surveillance of Celecoxib in Asian Indians, who are predisposed to premature athero-thrombotic events, has not been studied., Aims: To study the adverse effects of Celecoxib and compare them with those of other non-steroidal anti-inflammatory drugs (NSAIDs) in an Asian Indian cohort., Materials and Methods: This is a retrospective chart review with convenience sampling of patients on NSAIDs (at least five tablets a week, for at least 3 months prior to the study), attending the Rheumatology clinic of a tertiary care institution in south India between June 2004 and November 2004. Those with pre-existing heart disease, hypertension, thrombo-embolic disease, peptic ulcer and patients on corticosteroids were excluded. All the recorded adverse events were noted and compared between the Celecoxib and non-selective NSAID users. Univariate analysis using Chi-square test was performed., Results: Of the 1387 patients included, 915 were on Celecoxib. In the NSAID group, 204 had used multiple NSAIDs in sequence. Of the Celecoxib users, 164 had switched over to an NSAID during the study period. New onset of hypertension was significantly higher in the Celecoxib users as compared to non-selective NSAID users (3.06% vs. 1.27%, P = 0.04). However, those who had switched over to NSAIDs did not show this trend. NSAID users, on the other hand, had significant gastrointestinal (GI) toxicity (2.54% vs. 0.327%, P = 0.001). A significant number of Celecoxib users who switched over to NSAIDs also developed GI toxicity (6.1% vs. 1.21%, P = 0.018) over a shorter time span, as compared to the continuous NSAID users. Multiple NSAID users had higher adverse events (6.37% vs. 2.23%, P = 0.023) as compared to single NSAID users., Conclusion: Celecoxib significantly increased the incidence of new onset hypertension in this cohort of Indian patients with rheumatic diseases. No thromboembolic events were documented., (© 2013 The Authors International Journal of Rheumatic Diseases © 2013 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.)

Inappropriate antibiotic use and resistance are major public health challenges. Interventional strategies require ascertaining the perceptions of major stakeholders and documenting the challenges to changing practice. Towards this aim, a qualitative study was conducted in Vellore, South India, using focus group discussions among doctors, pharmacists and public. There were eight groups with six to eight participants each. The themes explored were: understanding of infections, antibiotics and resistance; practices and pressure driving antibiotic use; and strategies for appropriate use. Data were transcribed, analysed, verified and a summary prepared with salient features and quotations. It was found that the public had minimal awareness of resistance, antibiotics and infections. They wanted symptomatic relief. Doctors reported prescribing antibiotics for perceived patient expectations and quick recovery. Business concerns contributed to antibiotics sales among pharmacists. Pharmaceutical industry incentives and healthcare provider competition were the main ethical challenges. Suggested interventional strategies by the participants included creating public awareness, better healthcare provider communication, improved diagnostic support, strict implementation of guidelines, continuing education, and strengthening of regulations. Perceived patient benefit, unrestricted autonomy and business-cum-industry pressures are promoting inappropriate use of antibiotics. Strategies improving responsible use will help preserve their effectiveness, and provide distributive justice and benefit for future generations.

Objectives: To assess exposure to marketing of unhealthy food products and its relation to food related behavior and BMI in children aged 3-13, from different socioeconomic backgrounds in a south Indian town., Methods: Child-parent pairs (n=306) were recruited at pediatric clinics. Exposure to food marketing was assessed by a digital logo recognition test. Children matched 18 logos of unhealthy food (high in fat/sugar/salt) featured in promotion material from the food industry to pictures of corresponding products. Children's nutritional knowledge, food preferences, purchase requests, eating behavior and socioeconomic characteristics were assessed by a digital game and parental questionnaires. Anthropometric measurements were recorded., Results: Recognition rates for the brand logos ranged from 30% to 80%. Logo recognition ability increased with age (p<0.001) and socioeconomic level (p<0.001 comparing children in the highest and lowest of three socioeconomic groups). Adjusted for gender, age and socioeconomic group, logo recognition was associated with higher BMI (p=0.022) and nutritional knowledge (p<0.001) but not to unhealthy food preferences or purchase requests., Conclusions: Children from higher socioeconomic groups in the region had higher brand logo recognition ability and are possibly exposed to more food marketing. The study did not lend support to a link between exposure to marketing and poor eating behavior, distorted nutritional knowledge or increased purchase requests. The correlation between logo recognition and BMI warrants further investigation on food marketing towards children and its potential role in the increasing burden of non-communicable diseases in this part of India.

Antibiotic resistance, a global concern, is particularly pressing in developing nations, including India, where the burden of infectious disease is high and healthcare spending is low. The Global Antibiotic Resistance Partnership (GARP) was established to develop actionable policy recommendations specifically relevant to low- and middle-income countries where suboptimal access to antibiotics - not a major concern in high-income countries - is possibly as severe a problem as is the spread of resistant organisms. This report summarizes the situation as it is known regarding antibiotic use and growing resistance in India and recommends short and long term actions. Recommendations aim at (i) reducing the need for antibiotics; (ii) lowering resistance-enhancing drug pressure through improved antibiotic targeting, and (iii) eliminating antibiotic use for growth promotion in agriculture. The highest priority needs to be given to (i) national surveillance of antibiotic resistance and antibiotic use - better information to underpin decisions on standard treatment guidelines, education and other actions, as well as to monitor changes over time; (ii) increasing the use of diagnostic tests, which necessitates behavioural changes and improvements in microbiology laboratory capacity; (iii) setting up and/or strengthening infection control committees in hospitals; and (iv) restricting the use of antibiotics for non-therapeutic uses in agriculture. These interventions should help to reduce the spread of antibiotic resistance, improve public health directly, benefit the populace and reduce pressure on the healthcare system. Finally, increasing the types and coverage of childhood vaccines offered by the government would reduce the disease burden enormously and spare antibiotics.