The move is expected to slow or entirely halt the rise of drug-resistant pathogens, which is caused by the indiscriminate use of antibiotics.
Approximately 57 percent of prescribed antibiotics in India belong to a group of drugs highly susceptible to antimicrobial resistance(AMR). (Shutterstock)
The Union Health Ministry has asked all doctors in medical colleges and medical associations to mandatorily mention the indication and reason/justification for prescribing antibiotics.
The Director General of Health Services, Dr Atul Goel, also appealed to all pharmacists to strictly implement the schedule H and H1 of the Drugs and Cosmetics Rules, and stop the over-the-counter sale of antibiotics. They have been asked to sell antibiotics based only on prescriptions.
He wrote to all doctors of medical colleges and medical associations in the country urging them to adhere to the guidelines.
To monitor the indiscriminate use of certain antibiotics and prevent the emerging threat of resistance to antimicrobial agents, the Union government, in 2014, issued the Schedule H and H1 notification.
The notification was an amendment to the Drugs and Cosmetics Rules of 1945 — the law regulating the import, production, sale, prescription, and use of medicines.
Schedule notification controls the over-the-counter sales of certain drugs, such as third- and fourth-generation antibiotics and psychotropic drugs.
The letter, written recently in the backdrop of a study published by India’s National Centre for Disease Control (NCDC), underscored a concerning statistic which said three out of four patients have been prescribed antibiotics, and approximately 57 percent of prescribed antibiotics in India belonged to a group of drugs highly susceptible to antimicrobial resistance (AMR), prompting a call for vigilant monitoring to prevent misuse/overuse.
The study evaluated antibiotic consumption across tertiary care institutes in 15 states and two Union Territories from November 2021 to April 2022. It included 9,652 participants and the result was released last week.
The study also revealed that equally disquieting was the fact that 94 percent of patients received antibiotics before a precise medical diagnosis that would pinpoint the root cause of their infection.
“Misuse and overuse of antimicrobials are the main drivers in the development of drug-resistant pathogens,” Goel said in the letter.
“With a few new antibiotics in the research and development pipeline, prudent antibiotic use is the only option to delay the development of resistance,” he stated.
Antimicrobial resistance has been one of the top global public health threats facing humanity, he added, pointing out that it was estimated that bacterial AMR was directly responsible for 1.27 million global deaths in 2019 and 4.95 million deaths were associated with drug-resistant infections.
The World Health Organization (WHO) has developed the AWaRe classification system to strategically categorise antibiotics into three groups: Access, Watch, and Reserve.
The Access group comprised essential antibiotics vital for treating prevalent and severe infections, emphasising their affordability and lower resistance potential to ensure widespread availability.
Antibiotics in the Watch group possessed a higher propensity for resistance and required cautious and selective use, necessitating monitoring to curb the emergence of antibiotic resistance. Conversely, the Reserve group consisted of last-resort antibiotics, serving as the final line of defence against infections when other treatments fail.
The AWaRe system is aimed at encouraging appropriate antibiotic usage, mitigating the development of antimicrobial resistance, and preserving the efficacy of crucial antibiotics for combating serious infections.
In the study, out of the total antibiotic prescriptions, 57 percent fell within the category labelled as “Watch”, indicating a higher level of concern regarding their potential for misuse and resistance.
Meanwhile, 38 percent of these prescriptions belonged to the “Access” group, comprising antibiotics with a lower likelihood of misuse. These “Access” group antibiotics were more widely available and have been employed in treating a broad spectrum of infections.
Only around two percent of the prescribed antibiotics, categorised as the “Reserve” group, were considered last-resort options used for severe infections caused by multidrug-resistant pathogens.
“It is noteworthy that about three percent of the prescriptions were in the ‘not recommended’ group by the WHO. However, the high use of ‘Watch’ group antibiotics is of concern as these antibiotics have a higher potential to develop antibiotic resistance,” the study noted.
“The initial choice should be antibiotics from the ‘Access’ group, with a shift to ‘Watch’ group antibiotics in uncommon situations, and only resorting to ‘Reserve’ group antibiotics when necessary. This approach is an ongoing process. At present, an increasing number of hospitals are becoming cognizant of this and are formulating policies regarding appropriate antibiotic prescriptions for infections,” Dr Ranga Reddy, President of Infection Control Academy of India, told South First.
With the Union Health Ministry urging doctors to mandatorily mention indications and reasons for prescribing antibiotics, infectious disease specialists said the initiative could help in rationalising antimicrobial usage and avoid indiscriminate consumption.
The practice could also help further an evidence-based approach in medicine, along with improving patient outcomes, and curbing treatment costs and unwarranted side effects, they said.
“Prescribers have to think and document the rationale before prescribing antimicrobials… This will help in the rational prescribing of antimicrobials and avoiding injudicious, indiscriminate usage,” infectious disease specialist and senior consultant at the Yashoda Super Speciality Hospital Dr Chhavi Gupta said.
Dr Mahua Kapoor Dasgupta, director of medical affairs at HaystackAnalytics, a genomics-based diagnostics solutions provider incubated at IIT-Bombay, said it would enable the healthcare ecosystem to design strategies aimed at improving diagnostics, allowing a caregiver to justify the prescribed antimicrobial.
Regular audits and checks would still be necessary to scrutinise the justifications provided, Gupta added.
Studies have shown that air pollution, too, could be driving antibiotic resistance, with the association between particulate matter (PM2.5) air pollution and an increase in antibiotic resistance becoming more pronounced recently.
An international group of researchers, including those from the Indian Council of Medical Research, called for tackling AMR through genomic surveillance in a November 2023 study published in the journal, The Lancet Microbe.
Bengaluru-based Tata Institute of Genetics and Society (TIGS), in collaboration with the BBMP which had deployed wastewater surveillance for the Covid-19 virus in the city, has been planning to add AMR surveillance.
“Environmental surveillance provides insights into real trends that may not be immediately apparent in the physical world. We plan to continue our Covid-19 surveillance for another year. This extended effort aims to establish a comprehensive surveillance system, encompassing a standardised operating procedure (SOP), locally developed technology, and a well-trained team,” Dr Mishra said.
“This system can subsequently be applied to monitor antimicrobial resistance (AMR). The goal is to create a versatile system that can be adapted for use in various cities to monitor sewage and safeguard public health,” he added.
Genomic surveillance was widely employed during the Covid-19 pandemic to inform scientists and authorities about the spread of the viral infection and its variants of concern, among others.
The Non-Communicable Diseases study said the potential of surveillance could be higher for AMR pathogens as the genome data could track outbreaks and predict an effective antibiotic treatment.
“Genomic AMR surveillance helps in defining local epidemiology of drug-resistant bugs and their patterns. Thus, (the tool helps) define the scope of the resistance problem, develop interventions that improve the appropriate application of antimicrobial agents, and decrease resistance selection pressure,” Dr Gupta, added.
Such powerful genomic tools provided a high-resolution picture of the antimicrobial resistance profile of the disease-causing organisms, impacting an individual patient’s therapy and also helping in informed decision-making in hospital infection control, according to Dasgupta.
“These solutions also have the potential to map transmission dynamics, pathogen evolution, lineage mapping, outbreak linkage, predict the capacity of the spread of AMR and pandemic preparedness,” she added.
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