Akansh Khurana, CEO & Co-founder, THB, writes about the surge in antimicrobial resistance in India, misuse of antibiotics, and discusses some effective ways by which this issue can be tackled
Antimicrobial resistance (AMR) is a global health emergency. Every year, more than 750,000 people die from AMR infections and this figure is projected to reach 10 million by 2050. In India, AMR is a major public health threat due to misuse/overuse of antibiotics, poor sanitation, and high infection rates. Pneumonia, tuberculosis, gonorrhoea, and salmonellosis are becoming difficult to treat due to the growing incidences of resistant bacteria. Medical procedures like major surgery, organ transplant, cancer treatment, and diabetes management carry a high risk of drug-resistant infections as no new class of antibiotic has been discovered in the last few decades. Despite these growing challenges, India has no public database of mortality caused due to AMR.
Why is there a growing trend of antibiotic resistance? India is the world’s biggest consumer of antibiotics. The incessant use of antibiotics through prescriptions and over-the-counter sales is primarily driving AMR in this country. Other drivers of antibiotic use are poor public health infrastructure and growing disposable income. The Saviors – Antibiotic Stewardship, Surveillance and Real-World Evidence.
Antimicrobial stewardship is an approach to optimise the use of antimicrobials. It is used to achieve the best clinical outcome with minimal toxicity in the prevention of AMR. These programmes help clinicians to improve patient care, safety, treatment failures, and correct antibiotic prescriptions for treatment and prophylaxis.
Antimicrobial surveillance is the monitoring of AMR and antibiotic usage. The extent of AMR in terms of regional prevalence and trends, resistance phenotypes or species can be determined through a well-organised infrastructure of a surveillance network. An efficient surveillance network remains a challenge in most developing countries, especially India.
Real-world evidence (RWE) obtained from real-world data (RWD) is a way forward to understand the usage and region-wise impacts of antibiotics and can help in structuring a reliable surveillance network. Surveillance data from the networks of clinical laboratories and EHRs is consolidated and analysed at a local and national level to detect resistant genes in clusters of AMR profiles.
Real-world clinical data, machine learning, and AI-powered tools are the new-age key to track, monitor, and report antibiotic prescribing and resistance patterns. The evidence generated can then be used to educate the healthcare community about resistance and employ antibiotics that are safest and most effective. Patient profiles that will get the most benefit can then be identified and targeted for better treatment and outcomes.
FDA’s new strategy
Regulatory agencies are increasingly using RWE-backed technologies for decision making. FDA plans to bolster improved tracking of AMR outbreaks and is working on the development of next-generation sequencing-basedd diagnostics. This will enable healthcare professionals to target the right pathogen. FDA-ARGOS database of microbial reference genomes has been used to develop this infrastructure.
Real-world evidence-backed study on sensitivity patterns of Amoxi-Clav
THB — India’s leading clinical intelligence and data analytics company performed a real-world evidence (RWE) study to evaluate sensitivity patterns of Amoxi-Clav combination in urinary tract infection (UTI).
Amoxicillin + clavulanic acid (Amoxi-Clav) is one of the most frequently used antibiotics in emergency departments and primary care centres. For this analysis, data of patients with >90 per cent UTI causing pathogens (Escherichia coli, Klebsiella pneumonia, Proteus spp, Pseudomonas aeruginosa) was pooled together from four major cities in India – Delhi (North), West Bengal (East), Maharashtra (West), and Karnataka (South). The outcome was classified into good (>60 per cent), moderate (>40 per cent to 60 per cent), and poor (<40 per cent) sensitivity to Amoxi-Clav combination.
RWE analysis found that good sensitivity to Amoxi-Clav combination was not found in any of the four states.
Maharashtra and Karnataka registered moderate sensitivity at 46.10 per cent and 55.10 per cent, respectively. Delhi and West Bengal showed poor sensitivity at 23.6 per cent and 19 per cent, respectively.
These results can be interpreted to study micro-markets for targeted strategies and to make medical practitioners aware of the changing trends. It can also help in practising fair, scientific, and patient-centric selling.
Conclusion
Unregulated use and prescription of strong antibiotics require stringent monitoring. Stakeholders need to emphasise on RWE-backed data to improve antimicrobial surveillance and understand how one class of drug performs differently in different demographics. Like other industries, pharma companies are increasingly investing in technology platforms centred around RWD analysis and insights. These platforms integrate big data from clinical centres and use advanced analytics to visualise AMR outbreaks based on antibiotic drug class, resistance genes, and their relation to geographic locations.