Treatment and disposal practices of pharmaceutical effluent containing potential antibiotic residues in two states in India and perceptions of various stakeholders on contribution of pharmaceutical effluent to antimicrobial resistance: a qualitative study.

BACKGROUND: Antimicrobial resistance (AMR) is a looming pandemic, demanding prompt actions to avert catastrophic consequences. Effluents from pharmaceutical industries containing antimicrobial residues could serve as one of the entry points of these drugs to the environment. This qualitative study explores the treatment and disposal practices of pharmaceutical effluent (PE) containing potential antibiotic residues (ARs) by interviewing major stakeholders. In addition, we assessed their knowledge and perception on contribution of PE to AMR. METHODS: The study was conducted in the two Indian states, Haryana and Telangana and at the federal level. Data was collected by semi-structured in-depth interviews of 29 participants from 17 stakeholders/organizations viz. Central Pollution Control Board (CPCB), State Pollution Control Boards (SPCBs) of Telangana and Haryana, civic body, pharmaceutical manufacturers, pharmaceutical associations and civil society. Data was analyzed using thematic analysis. RESULTS: The effluent treatment and disposal practices varied with the multinational companies (MNCs) having advanced technologies whereas the small and medium-scale pharmaceutical companies (SMPCs) having effluent treatment plants as per the regulations but often under-utilized. The presence of ARs in the PE was considered inconsequential by SPCBs and SMPCs and majority of stakeholders imputed other causes as major contributors to AMR. However, the MNCs were well aware of the contribution of PE to AMR and CPCB also considered ARs as direct source of AMR. The central regulators as well as MNCs expressed concerns regarding the current regulations lacking maximum ARs in the PE. CONCLUSION: Setting up regulatory standards for maximum ARs in PE, their implementation and monitoring is an urgent need to curb environmental contribution of ARs to AMR. The findings of our study will help in systematic approach in policy making, awareness programs and capacity-building in dealing with the ARs in PE to combat AMR.

Strengthening antimicrobial stewardship activities in secondary and primary public healthcare facilities in India: Insights from a qualitative study with stakeholders.

PURPOSE: Examining the existing federal and state policies in place that could strengthen antimicrobial stewardship (AMS) activities in district and sub-district hospitals in India. METHODS: In-depth interviews were conducted with national and state level policy makers and various stakeholders at a district hospital. For national level, officials from the National Health Systems Resource Centre (NHSRC) were approached. The state of Haryana was selected and officials from Haryana State Health Systems Resource Centre (HSHRC), a state-level counterpart of the NHSRC, along with officials from the Health Department and relevant stakeholders from one of the district hospitals of the Haryana state were selected as participants. The recorded interviews were transcribed verbatim and thematic analysis was done. RESULTS: Several measurable elements within the existing policies such as National Quality Assurance Program (NQAP) and Kayakalp program, could be leveraged to strengthen AMS activities in district and sub-district hospitals, were identified. These cover aspects such as infection control, standard treatment guidelines (STGs), prescription auditing, essential medicine list (EML), availability of antimicrobials and incentives for meeting quality standards. Revising the EML based on WHO AWaRe classification, incorporating the STGs for common clinical infections from the WHO AWaRe antibiotic book and Indian Council of Medical Research (ICMR), program mandated requirements for dedicated staff/standards for AMS activities and antimicrobial-specific prescription audits as per WHO AMS tool-kit and ICMR AMS guidelines are identified as opportunities for strengthening AMS activities. Further, hindrances in executing existing policies were also identified such as shortage of human resources, reluctance to follow STGs, and limited availability of diagnostic microbiology laboratory services. CONCLUSION: Implementing NQAS and Kayakalp program in public healthcare facilities are identified as existing well working key programs that aid in improving AMS activities with incorporation of WHO and ICMR recommended practices.

India's ban on antimicrobial fixed-dose combinations: winning the battle, losing the war?

BACKGROUND AND OBJECTIVES: India, the country with the largest market availability of antimicrobial fixed-dose combinations (FDCs), banned certain antimicrobial FDCs in September 2018. Our objective was to examine the impact of Government ban on the sales of antimicrobial FDCs. METHODS: The sales patterns of 14 of the 26 banned antimicrobial FDCs were analyzed using monthly private sector drug sales data from IQVIA (a comprehensive and nationally representative drug sales database) between January 2018 and December 2019. We carried out descriptive analyses to evaluate the trend in sales over time for banned and non-banned antimicrobial FDCs using cumulative sales volumes. RESULTS: Overall, the cumulative sales volume of banned antimicrobial FDCs declined by 75% between January and September 2018 and the same months of 2019, although some banned FDCs continued to be available in significant volumes. The effectiveness of the ban was offset by several pathways. First, the sales of combinations containing moieties belonging to the same drug-classes as the antimicrobials in the banned FDCs increased after the ban. Second, while certain formulations of particular combinations were banned, the sales of other non-banned formulation of these combinations increased. Third, in some cases, products containing new non-antimicrobial components added to the banned combinations remained available. INTERPRETATION AND CONCLUSIONS: While sales of the banned antimicrobial FDCs decreased in 2019, we identified several mechanisms that counterbalanced the ban, including implementation failure, rising sales of congeners, and products with additional non-antimicrobial components.

Marketing and Distribution System Foster Misuse of Antibiotics in the Community: Insights from Drugs Wholesalers in India.

Antibiotic misuse is one of the major drivers of antimicrobial resistance (AMR). In India, evidence of antibiotic misuse comes largely from retailers as well as formal and informal healthcare providers (IHCPs). This paper presents the practices and perspectives of drug wholesalers, a critical link between manufacturers and last-mile dispensers. Four experienced wholesalers and an ex-State Drug Controller (ex-SDC) were interviewed in depth, using semi-structured guides in the National Capital Region of Delhi, India, between November 2020 and January 2021. Four main findings were that wholesalers (i) have limited knowledge about wholesale licensing and practice regulations, as well as a limited understanding of AMR; (ii) directly supply and sell antibiotics to IHCPs; (iii) facilitate medical representatives (MRs) of pharmaceutical companies and manufacturers in their strategies to promote antibiotics use in the community; and (iv) blame other stakeholders for unlawful sale and overuse of antibiotics. Some of the potential solutions aimed at wholesalers include having a minimum education qualification for licensing and mandatory Good Distribution Practices certification programs. Decoupling incentives by pharmaceutical companies from sales targets to improve ethical sales practices for MRs and optimize antibiotic use by IHCPs could alleviate wholesalers' indirect actions in promoting antibiotic misuse.

Is the education of human and animal healthcare professionals about antimicrobial resistance and stewardship adequate during their pre-service training?

PURPOSE: This paper explores inclusion of topics on antimicrobial resistance (AMR) and antimicrobial stewardship (AMS) in pre-service human and animal healthcare professional curricula as mandated in the first strategic objective of National Action Plan on Antimicrobial Resistance. METHODS: Online versions of pre-service medical [Bachelor of Medicine, Bachelor of Surgery (MBBS)], dental [Bachelor of dental sciences (BDS)], pharmacy [Bachelor of Pharmacy (B Pharm)], veterinary [Bachelor of veterinary science and animal husbandry (B.V.Sc. & A.H.)] and post graduate medical [Doctor of medicine (MD), Master of surgery (MS) and post graduate (PG) medical diploma courses] curricula and hardcopy of nursing (Bachelor of science (BSc) Nursing-Basic) curricula were assessed. Validated search terms were used for identifying individual learning topics, domains of learning and number of hours of learning related to AMS and AMR. Recent edition of commonly referred medical textbooks were manually checked for inclusion of chapters or separate sections on AMR and AMS. RESULTS: Low coverage and poor depth with no mention of required duration of learning for AMR and AMS was observed across the majority of curricula. MS, BDS, B Pharm and BSc nursing curricula did not include AMR and AMS. Out of twenty-three textbooks assessed, only six textbooks included AMS. Gynecology, Obstetrics, Orthopedic and Surgery textbooks did not include separate section on AMR or AMS. CONCLUSIONS: Our study documented inadequate inclusion of AMR and AMS in pre-service medical, dental, nursing, pharmacy and veterinary curricula and post graduate medical curriculum. Standardized education regarding AMR and AMS in multi-professional curricula by educational councils across sectors and updating of medical textbooks of all the subjects by authors/publishers for adequate emphasis on these topics is urgently needed for success of 'One health' in combating AMR.

Over-the-Counter Sale of Antibiotics in India: A Qualitative Study of Providers' Perspectives across Two States.

India has one of the highest rates of antimicrobial resistance (AMR) worldwide. Despite being prescription drugs, antibiotics are commonly available over-the-counter (OTC) at retail pharmacies. We aimed to gain insight into the OTC sale of antibiotics at retail pharmacies and to elucidate its underlying drivers. We conducted face-to-face, in-depth interviews using convenience sampling with 22 pharmacists and 14 informal dispensers from 36 retail pharmacies across two Indian states (Haryana and Telangana). Thematic analysis revealed that antibiotics were often dispensed OTC for conditions e.g., fever, cough and cold, and acute diarrhea, which are typically viral and self-limiting. Both Access and Watch groups of antibiotics were dispensed for 1-2 days. Respondents had poor knowledge regarding AMR and shifted the blame for OTC practices for antibiotics onto the government, prescribers, informal providers, cross practice by alternative medicine practitioners, and consumer demand. Pharmacists suggested the main drivers for underlying OTC dispensing were commercial interests, poor access to public healthcare, economic and time constraints among consumers, lack of stringent regulations, and scanty inspections. Therefore, a comprehensive strategy which is well aligned with activities under the National Action Plan-AMR, including stewardship efforts targeting pharmacists and evidence-based targeted awareness campaigns for all stakeholders, is required to curb the inappropriate use of antibiotics.

Sales of antibiotics and hydroxychloroquine in India during the COVID-19 epidemic: An interrupted time series analysis.

BACKGROUND: We assessed the impact of the coronavirus disease 2019 (COVID-19) epidemic in India on the consumption of antibiotics and hydroxychloroquine (HCQ) in the private sector in 2020 compared to the expected level of use had the epidemic not occurred. METHODS AND FINDINGS: We performed interrupted time series (ITS) analyses of sales volumes reported in standard units (i.e., doses), collected at regular monthly intervals from January 2018 to December 2020 and obtained from IQVIA, India. As children are less prone to develop symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, we hypothesized a predominant increase in non-child-appropriate formulation (non-CAF) sales. COVID-19-attributable changes in the level and trend of monthly sales of total antibiotics, azithromycin, and HCQ were estimated, accounting for seasonality and lockdown period where appropriate. A total of 16,290 million doses of antibiotics were sold in India in 2020, which is slightly less than the amount in 2018 and 2019. However, the proportion of non-CAF antibiotics increased from 72.5% (95% CI: 71.8% to 73.1%) in 2019 to 76.8% (95% CI: 76.2% to 77.5%) in 2020. Our ITS analyses estimated that COVID-19 likely contributed to 216.4 million (95% CI: 68.0 to 364.8 million; P = 0.008) excess doses of non-CAF antibiotics and 38.0 million (95% CI: 26.4 to 49.2 million; P < 0.001) excess doses of non-CAF azithromycin (equivalent to a minimum of 6.2 million azithromycin treatment courses) between June and September 2020, i.e., until the peak of the first epidemic wave, after which a negative change in trend was identified. In March 2020, we estimated a COVID-19-attributable change in level of +11.1 million doses (95% CI: 9.2 to 13.0 million; P < 0.001) for HCQ sales, whereas a weak negative change in monthly trend was found for this drug. Study limitations include the lack of coverage of the public healthcare sector, the inability to distinguish antibiotic and HCQ sales in inpatient versus outpatient care, and the suboptimal number of pre- and post-epidemic data points, which could have prevented an accurate adjustment for seasonal trends despite the robustness of our statistical approaches. CONCLUSIONS: A significant increase in non-CAF antibiotic sales, and particularly azithromycin, occurred during the peak phase of the first COVID-19 epidemic wave in India, indicating the need for urgent antibiotic stewardship measures.

Over-the-counter sale of antibiotics - Using Net-Map to identify and segment stakeholders as the first step towards the development of smart regulation.

INTRODUCTION: Antimicrobial resistance (AMR) is a complex public health problem requiring coordinated efforts by a multitude of public and private sector stakeholders. Over-the-counter (OTC) antibiotics sale is contributing to rising AMR. We applied NetMap, a research tool to identify, prioritize and assess relationships among stakeholders, also to identify the stakeholders that must be engaged for regulating antibiotic OTC sale for humans in India. METHODS: Through a one-day workshop, a team of expert facilitators engaged with a mixed group of stakeholders-regulators, drug manufacturers, retailers and consumers of antibiotics to identify and rank stakeholders based on their role, power/interest and influence. Stakeholders were listed and grouped as per the type of agency represented. Carrom discs were stacked against each stakeholder with the height of stack reflecting perceived power. RESULTS: A total of 25 stakeholders were identified from government, non-government, private/corporate, academic and research agencies and the general public. Based on the stacking exercise, a power/interest matrix was developed with six stakeholders having high power and high interest, five having high power but low interest, six having low power but high interest and eight having low power. A visual NetMap was developed to position the stakeholders as proximal, middle and distal based on their perceived influence. CONCLUSIONS: NetMap can be used with stakeholders with varying skill sets. It is a useful project initiation tool that was successfully used to prioritize stakeholders for reaching out, for targeted outreach and development of customized tools for developing innovative regulation for tackling OTC sale of antibiotics. It also pre-empted any conflict of interests.

Pharmaceutical effluent: a critical link in the interconnected ecosystem promoting antimicrobial resistance.

Antimicrobial resistance (AMR) is a complex global health issue and will push twenty-four million people into extreme poverty by 2030, risking the sustainable development goals (SDGs) 2, 3, 6, 9, 12, and 17 if not addressed immediately. Humans, animals, and the environment are the reservoirs that contribute and allow AMR to propagate in interconnected ecosystems. The emergence of antibiotic-resistant bacteria and antibiotic-resistant genes in the water environment has become an important environmental health issue. One of the major influencers from environment sector is the pharmaceutical industry which is growing globally to meet the ever-increasing demand of antibiotics, especially in low- and middle-income countries. The pharmaceutical effluent has a mix of large concentrations of antibiotics and antibiotic resistance genes, and these sites act as hotspots for environmental contamination and the spread of AMR. Inadequate treatment of the effluent and its irresponsible disposal leads to unprecedented antibiotic contamination in the environment and their persistent presence in the environment significantly modulates the bacterial genomes' expression that is responsible for increase and spread of AMR. However, not much interventions are suggested in the National Action Plan developed on AMR by many countries. There are no regulations across the globe till date for the level of antibiotic residues in pharmaceutical effluent for the growing pharmaceutical industry. This review put together the work done showing several detrimental effects of the antimicrobial residues in the pharmaceutical effluent which leads to rise in development of AMR. The environment risk approach and need to have indicators to measure environment risk is a way forward for all countries engage in antibiotic manufacturing. Overall, efforts to address the problem are isolated and fragmented. Policymakers, regulators, manufacturers, researchers, civil society, and the community need to collaborate so that antibiotics are produced sustainably and continue to stay effective in treating bacterial infections.

Adopting an intersectoral One Health approach in India: Time for One Health Committees.

Following the several episodes of zoonotic disease outbreaks and the more recent COVID-19 pandemic, the Indian policy initiatives are committed to institutionalize One Health (OH) approaches and promote intersectoral, transdisciplinary collaboration and cooperation. The OH principle needs to be visualized beyond the scope of zoonoses. While conservation, ecological and veterinary professions are getting increasingly engaged with OH, most of the medical/clinical and social sciences professions are only peripherally aware of its nuances. The OH initiatives, by their essentially multidisciplinary nature, entail working across ministries and navigating tacit institutional hierarchies and allocating leadership roles. The logical operational step will be the constitution of One Health Committees (OHC) at the State and district levels. Here, we outline the key foundational principles of OHC and hope that the framework for implementation shall be deliberated through wider consultations and piloted and adopted in a phased manner.

Knowledge and behavior of consumers towards the non-prescription purchase of antibiotics: An insight from a qualitative study from New Delhi, India.

BACKGROUND: In Low-and Middle-Income Countries, including India, consumers often purchase antibiotics over-the-counter (OTC) from retail pharmacies. This practice leads to the inappropriate use of antibiotics in the community which is an important driver for the development of antimicrobial resistance. A better understanding of consumers' views towards this grave public health concern is critical to developing evidence-based intervention programs for awareness among the general population. OBJECTIVE: To explore knowledge, practice and, behavior of consumers towards antibiotics, antibiotic use, antimicrobial resistance, purchasing behavior of consumers for antibiotics, and to gain insight which will help in developing evidence-based policy interventions. METHODS: 72 in-depth consumer interviews were conducted in all 11 districts of the National Capital Territory of Delhi. The qualitative data were analyzed using thematic analysis. RESULTS: Our study found that retail pharmacies were the first point of consultation for common ailments for patients/consumers once home remedies failed; they were largely unaware of the threat of antimicrobial resistance. Consumers' knowledge of antibiotic use and about antimicrobial resistance was low, they used old prescriptions, and bought antibiotics OTC to save time and money. Despite the presence of regulations constituted to regulate the sale of antibiotics by the Government and the implementation of national campaigns, the practice of self-medication and behaviors such as OTC purchase, non-adherence to prescribed antibiotics was prevalent. Consumers perceive that antibiotics provide quick relief and accelerate the curing process and retail pharmacy shops try to protect their retail business interests by honoring old prescriptions and self-medication for antibiotics. CONCLUSIONS: The lack of awareness and insufficient knowledge about what antibiotics are and issues such as antimicrobial resistance or antibiotic resistance resulted in misuse of antibiotics by consumers. Limited access to public healthcare and affordability of private healthcare are factors that contribute towards the self-medication/OTC purchase of antibiotics. The regular misuse of antibiotics through irrational use reinforces the need for strong enactment of strategies like continuous community awareness campaigns. Mitigation efforts should focus upon educating consumers continuously and sustainably for the understanding of antibiotic misuse, antimicrobial resistance, and promote better compliance with regulations.

Knowledge and behavior of consumers towards the non-prescription purchase of antibiotics: an insight from a qualitative study from New Delhi, India

BACKGROUND: In Low-and Middle-Income Countries, including India, consumers often purchase antibiotics over-the-counter (OTC) from retail pharmacies. This practice leads to the inappropriate use of antibiotics in the community which is an important driver for the development of antimicrobial resistance. A better understanding of consumers' views towards this grave public health concern is critical to developing evidence-based intervention programs for awareness among the general population. OBJECTIVE: To explore knowledge, practice and, behavior of consumers towards antibiotics, antibiotic use, antimicrobial resistance, purchasing behavior of consumers for antibiotics, and to gain insight which will help in developing evidence-based policy interventions. METHODS: 72 in-depth consumer interviews were conducted in all 11 districts of the National Capital Territory of Delhi. The qualitative data were analyzed using thematic analysis. RESULTS: Our study found that retail pharmacies were the first point of consultation for common ailments for patients/consumers once home remedies failed; they were largely unaware of the threat of antimicrobial resistance. Consumers' knowledge of antibiotic use and about antimicrobial resistance was low, they used old prescriptions, and bought antibiotics OTC to save time and money. Despite the presence of regulations constituted to regulate the sale of antibiotics by the Government and the implementation of national campaigns, the practice of self-medication and behaviors such as OTC purchase, non-adherence to prescribed antibiotics was prevalent. Consumers perceive that antibiotics provide quick relief and accelerate the curing process and retail pharmacy shops try to protect their retail business interests by honoring old prescriptions and self-medication for antibiotics. CONCLUSIONS: The lack of awareness and insufficient knowledge about what antibiotics are and issues such as antimicrobial resistance or antibiotic resistance resulted in misuse of antibiotics by consumers. Limited access to public healthcare and affordability of private healthcare are factors that contribute towards the self-medication/OTC purchase of antibiotics. The regular misuse of antibiotics through irrational use reinforces the need for strong enactment of strategies like continuous community awareness campaigns. Mitigation efforts should focus upon educating consumers continuously and sustainably for the understanding of antibiotic misuse, antimicrobial resistance, and promote better compliance with regulations

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Terminalia catappa Fruit Extract Reverses Streptozotocin-Induced Diabetic Retinopathy in Rats.

OBJECTIVE AND BACKGROUND: Diabetic retinopathy is amongst the most common microvascular complications associated with diabetes. Controlling blood glucose level alone cannot manage diabetes associated complications. Thus, mechanisms that additionally prevent diabetes associated complications are the need of the hour, driving the researchers towards herbal therapies. Terminalia catappa is renowned for its anti-inflammatory, antioxidant, anti-hyperglycemic and anti-angiogenic activity. The current study explores the effect of Terminalia catappa fruit extract on streptozotocin-induced diabetic retinopathy in rats. METHODS: Streptozotocin-induced chronic diabetic rat model was utilized in the study. The hydroalcoholic fruit extract of T. catappa in 20mg/kg, 30mg/kg and 40mg/kg dose and standard anti-diabetic drug, glibenclamide (10mg/kg) was given orally. Retinopathy was evaluated by monitoring lenticular, fundus images and measuring arteriole and venule tortuosity index. Oxidative, angiogenic and inflammatory biomarkers were assessed at the 12th week in the retinal homogenate. Histopathological changes in the retina were also examined. Data was analyzed using one-way Repeated Measure ANOVA followed by the Mann-Whitney test. RESULTS: The hydro-alcoholic fruit extract of T. catappa significantly decreased blood glucose (p<0.001) in a dose-dependent manner in diabetic rats. Cataract lens was observed in all experimental groups and became clear (grade 0) with 40mg/kg and with 40mg/kg along with glibenclamide at the eighth and sixth week, respectively. The hydro-alcoholic fruit extract in all three doses significantly reduced (p<0.01) arteriole and venule tortuosity in diabetic rats. T. catappa in all three doses in diabetic rats showed a modulatory effect in oxidative, angiogenic and inflammatory biomarkers. CONCLUSION: T. catappa reverses diabetes-induced retinopathy by anti-hyperglycemic, anti-oxidant, anti-angiogenic and anti-inflammatory actions, and thus has a potential to be used in diabetes-induced retinopathy.

Withdrawal Notice: Reconnoitering the Role of Endothelin in Obesity

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Potential pharmacological agents for COVID-19.

A novel coronavirus disease 2019 (COVID-19) infection caused by severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) first emerged in December 2019 in Wuhan, China, has become a global pandemic. Currently, the management of COVID-19 infection is mainly supportive. Several clinical trials worldwide are evaluating several drugs approved for other indications, as well as multiple investigational agents for the treatment and prevention of COVID-19. Here, we give a brief overview of pharmacological agents and other therapies which are under investigation as treatment options or adjunctive agents for patients infected with COVID-19 and for chemoprophylaxis for the prevention of COVID-19 infection. At the time of writing this commentary, there is no peer-reviewed published evidence from randomized clinical trials of any pharmacological agents improving outcomes in COVID-19 patients. However, it was reported that remdesivir an investigational antiviral agent hastens clinical recovery, but a study is yet to be published in peer-reviewed medical journal.

Promoting quality use of medicines in South-East Asia: reports from country situational analyses.

BACKGROUND: Irrational use of medicines is widespread in the South-East Asia Region (SEAR), where policy implementation to encourage quality use of medicines (QUM) is often low. The aim was to determine whether public-sector QUM is better in SEAR countries implementing essential medicines (EM) policies than in those not implementing them. METHODS: Data on six QUM indicators and 25 EM policies were extracted from situational analysis reports of 20 country (2-week) visits made during 2010-2015. The average difference (as percent) for the QUM indicators between countries implementing versus not implementing specific policies was calculated. Policies associated with better (> 1%) QUM were included in regression of a composite QUM score versus total number of policies implemented. RESULTS: Twenty-two policies were associated with better (> 1%) QUM. Twelve policies were associated with 3.6-9.5% significantly better use (p < 0.05), namely: standard treatment guidelines; formulary; a government unit to promote QUM; continuing health worker education on prescribing by government; limiting over-the-counter (OTC) availability of systemic antibiotics; disallowing public-sector prescriber revenue from medicines sales; not charging fees at the point of care; monitoring advertisements of OTC medicines; public education on QUM; and a good drug supply system. There was significant correlation between the number of policies implemented out of 22 and the composite QUM score (r = 0.71, r2 = 0.50, p < 0.05). CONCLUSIONS: Country situational analyses allowed rapid data collection that showed EM policies are associated with better QUM. SEAR countries should implement all such policies.