New Delhi: Ceftriaxone, among the most prescribed antibiotics in hospitals across India, is a drug with high potential to cause antimicrobial resistance, says a new government survey that studied the pattern of antibiotic usage in 20 government hospitals across 15 states.
The first-of-its-kind survey, released by the Union health ministry’s National Centre for Disease Control (NCDC) Tuesday, showed that 57 percent of the antibiotics prescribed in hospitals had high potential to cause antimicrobial resistance, which the World Health Organization (WHO) listed in 2019 as one of the top 10 threats to public health.
Researchers from Kerala had last year flagged that resistance to ceftriaxone — a third generation cephalosporin effective against numerous gram-negative bacteria, which are more difficult to treat — was increasing.
“This is exactly the point of this survey that analysed antibiotic usage patterns for hospitalised patients across specialities,” a senior NCDC official who was associated with the government survey told ThePrint. “We wanted to understand which antibiotics are being consumed more so that steps can be taken to rationalise their usage,” the official said.
With Ceftriaxone being widely prescribed, a popular brand of the medicine — Monocef, by Mumbai-based Aristo Pharmaceuticals — has been among the top-selling drugs in the country over the last few months, data by market research firm IQVIA shows.
ThePrint reached Aristo Pharma via email for comment on how Monocef managed to capture a large share of the antibiotic market in India — among the largest globally — but had not received a response by the time of publication. This report will be updated if and when a response is received.
Ceftriaxone is usually prescribed to patients with bacterial meningitis, respiratory tract infections, urinary tract infections, soft tissue infections of the bone and joints, and gonorrhoea. Apart from being effective and safe, it is also associated with fewer side effects — except for diarrhoea in some cases — and is not a concern for the majority of the patients consuming it.
“This,” noted the researchers from Kerala who had flagged resistance to ceftriaxone last year, “demands immediate attention”. Based on their findings, the researchers suggested that “resistance prevention mechanisms must be strictly enforced”.
They also advised that ceftriaxone should be considered in the initial treatment of seriously ill patients with infections of unknown aetiology (origin), when gram-negative aerobes are the suspected pathogens, and in patients with gram-negative organisms with suspected or demonstrated resistance to other antibiotics.
Also Read: Antibiotic resistance is the newest ‘silent killer.’ Move over Covid
Best-seller drug
In September and October last year, according to IQVIA, Monocef was the top-selling drug brand in India, followed by another brand of antibiotic, Augmentin by GlaxoSmithKline, which has amoxicillin and clauvinic acid as active ingredients.
In November, however, Augmentin, advised for treating sinusitis, pneumonia, ear infections, bronchitis, urinary tract and infections, and during surgeries, overtook Monocef to become the top-selling drug brand in the country.
But if the popularity of the drug — and the brand — is rising, so is concern around it.
Research from Kerala, however, pointed out that “almost all antibiotics that have been produced have eventually been associated with resistance, and this is also true of cephalosporins, notably ceftriaxone”.
The study lists several pathogens which are depicting signs of resistance to the popular antibiotic. These include Aeromonas bacteria that cause stomach and urinary tract infections, apart from septicaemia in some cases; Neisseria gonorrhoeae bacteria that cause gonorhhoea; Salmonella that leads to typhoid fever; Shigella which causes diarrhoea; and Enterobacter cloacae, a leading cause of hospital acquired infections.
But the problem may not be limited to one or two antibiotics, neither is the concern only about these drugs used in hospitalised patients in government hospitals, as shown in the latest survey.
‘AWaRe’ classification
The government survey was the result of the First Multicentric Point Prevalence Survey of Antibiotic Use at the National Antimicrobial Consumption Network (NAC-NET) — consisting of 35 tertiary-care institutes across India — that has been monitoring antibiotic consumption at these facilities for the past five years.
According to the survey report, the top prescribed antibiotics, apart from ceftriaxone, include metronidazole, amikacin, piperacillin and tazobactam. Three of these medicines, ceftriaxone, piperacillin and tazobactam, are from the ‘watch’ group of antibiotics.
According to the AWaRe classification of antibiotics developed by the WHO in 2017, ‘watch’ antibiotics generally have a higher potential for antimicrobial resistance, and are more commonly used in sicker patients in medical facilities. These medicines, according to the world health body, should be prescribed carefully to avoid misuse.
The classification also includes ‘access’ antibiotics — those with a narrow spectrum of activity, generally with fewer side-effects, and a lower potential for antimicrobial resistance and lower cost. These are suggested for the empiric treatment of most common infections.
Augmentin is an ‘access’ group antibiotic.
This classification also includes a third group, ‘reserve’ antibiotics — last-resort medicines that should only be used to treat severe infections caused by multidrug-resistant pathogens.
Antibiotics prescribed without indication
A 2019 study by researchers associated with the Public Health Foundation of India found that a high proportion of antibiotic prescriptions in the private sector were made for upper respiratory tract infections — acute upper respiratory infections (20.4 percent), cough (4.7 percent), acute nasopharyngitis (4.6 percent), and acute pharyngitis (3.9 percent).
“These are infections which are viral in origin and self-limiting in nature, therefore not requiring antibiotics,” health economist Ashna Mehta, who was one of the authors, told ThePrint.
Another analysis, co-authored by Mehta in 2022 on antibiotic sales in the Indian market, found that access, watch and reserve antibiotics accounted for 47.9 percent, 46.7 per cent and 1 percent of sales, respectively, in the private market.
Of the 78 single antibiotics sold, 50 were watch group and nine were reserve, and among the 112 fixed-dose combination (FDC) antibiotics — which have more than one active ingredient — marketed, 70 were watch group and three were reserve.
“Also worrisome was the fact that 13 of the top-selling 20 FDC antibiotics were on the WHO’s not-recommended list,” Mehta pointed out.
In this context, the time to take urgent action against overuse and abuse of antibiotics may be now.
The new survey also underlines that the antimicrobial resistance has emerged as a silent worldwide pandemic that threatens human and animal health and the environment.
An estimated 1.27 million deaths were a direct result of infections due to microorganisms resistant to antibiotics in 2019, according to the latest survey, which warned that this number could dramatically rise to 10 million by 2050 if timely action was not taken.
(Edited by Nida Fatima Siddiqui)
Also Read: 70% of antibiotic fixed-dose combination drugs sold in India unapproved or banned, finds study