The antibiotic resistance is no longer the issue of the treating physicians but has moved beyond the geographic boundaries of different nations. It becomes a global threat of returning to the post-antibiotic era where there would be no antibiotics to treat even the common infectious conditions. It has been estimated that it can cause 10 million human fatalities annually and 2 to 3.5 per cent decrease in global gross domestic product (GDP) or US $ 100 trillion by 2050. Realizing the gravity of the healthcare, economic and security threat of antibiotic resistance, the world leaders have urged for a collective and concerted action for fighting antibiotic resistance. The World Health Organization has been mandated to take appropriate initiatives.
The World Health Organization has released the 20th Essential Medicine List [2017]. WHO has been ceremoniously revising the list every two years since the release of first list, which was in 1977. The list is basically a guiding document to help countries workout how to prioritize spending on medicines. The philosophy is that some drugs are more important than others and should be independent of cost. During the earlier part especially in 1970s, the development of essential medicine list was dependent on experts’ advice, but now is a much transparent process. The development of essential medicine list follows an evidence based approach and thus brings more credibility. The decision of inclusion or deletion to the essential medicine list is based on drug’s usefulness, its safety and effectiveness, and the quality of evidence supporting it.
In an attempt to optimize the use of antibiotics in human health, the World Health Organization has categorized the listed antibiotics (including other antibacterials) in Essential Medicine List into: Access Group, Watch Group and Reserve Group. The Access Group comprised of antibiotics which can be used as empiric therapy, with first or second choice, for common infectious conditions. The quality medicines of this type should be made available widely at an affordable costs. The first choice antibiotics are usually of narrow spectrum with low resistance potential. On the other hand, the second choice medicines are of broad spectrum either with higher resistance potential or less favourable benefit-risk ratio. In addition to beta-lactum medicines, it contains: amikacin, azithromycin, chloramphenicol, ciprofloxacin, clarithromycin, clindamycin, doxycycline, gentamycin, metronidazole, nitrofurantoin, spectinomycin, sulfamethoxazole+trimethorprim, and vancomycin. The watch group antibiotics are considered to have higher resistance potential but still recommended as first or second line agents for a limited number of conditions. It contains the high priority medicines from the critically important antimicrobials for human medicines. The following seven classes of medicines are grouped under this category: Quinolones and fluoroquinolones, third generation cephalosporins (with or without beta-lactamase inhibitor), Macrolides, Glycopeptides, Anti-pseudomonal penicillins with beta-lactamase inhibitor, Carbapenems, and Penems. The reserve group of antibiotics are considered as last resort of treatment when all others are not feasible. They are tailored to highly specific patients and settings. They should be protected. Their use is restricted. The group has: Aztreonam, fourth and fifth generation cephalosporins, polymyxins, fosfomycin, oxazolidinones, tigecycline and daptomycin.
In India too there have been series of activities as a part of its commitment to combat antimicrobial resistance. It has just launched ‘National Action Plan’ which can be viewed as a milestone step forward in ensuring sustainable action. It plans to bridge the gaps between human, animal and environmental health. The action plan includes finalizing National Infection Control Policy, Setting up of National Surveillance System and Setting up of Governance Structure for Antimicrobial Resistance. The National Centre for Disease Control has been given the responsibility to act as focal point for implementation and coordination of the antimicrobial resistance programme.
In fact, India has started its effort with the publication of ‘National Policy on Antimicrobial Resistance Containment’ in 2011. Now a collective efforts is initiated involving inter-ministerial group. During the inter-ministerial consultation, the Honorable Health Minister echoed “The antimicrobial resistance is a serious threat to global public health that requires action across all government sectors and society. Single and isolated interventions have limited impact and coordinated action is required to minimize the emergence and spread of antimicrobial resistance”. The meeting resulted with ‘Delhi Declaration’ on 19th April 2017 for collectively strategizing to contain antimicrobial resistance. It pledges to adopt a holistic and collaborative approach towards prevention and containment of antimicrobial resistance.
Some of the significant initiatives taken so far include restricting the sale of antibiotics through enacting Schedule H1, creating awareness among consumers through redline campaign, setting up of National Surveillance System and developing National Guidelines for use of antibiotics. Schedule H1 is a newly created schedule made out of Schedule H keeping 46 drugs for which restricted sale is introduced. Schedule H1 contains third and fourth generation cephalosporins, carbapenems, newer fluoroquinolones and first- and second-line antitubercular drugs. The retail pharmacy has to sell these medicines with prescriptions only and is required to maintain a separate register keeping the record of identity of the patient and doctor, and name & quantity of the drug dispensed. The prescription only antibiotics are now labelled with redline in an attempt to discourage the public from using redline medicines without prescription. Redline campaign has been lauded internationally terming it as a model for use by others. National surveillance system is already in place with few laboratories and there is a plan for expansion.
The National Centre for Disease Control has already published National Treatment Guidelines for Antimicrobial Use in Infectious Diseases. India is now regularly revising its National Medicine List. National Medicine List together with updated Treatment Guidelines may reduce the excessive, unnecessary and inappropriate prescribing practices. The National Essential Medicine List and treatment guidelines should be consistent with the World Health Organization’s new categorization of antibiotics. Professor Santanu K Tripathi of Calcutta School of Tropical Medicine beautifully coined the new acronym ‘AWARE’ from the World Health Organization’s new Mantra - 'Access, WAtch and REserve’.
(Authors are with Department of Pharmacy, Annamalai University, Annamalai Nagar – 608 002)