IMA releases draft norms to curb rampant antibiotics misuse

Expressing concern over the growing resistance to antibiotics in the country, the Indian Medical Association (IMA) has come out with a draft policy on use of antibiotics in human healthcare aiming at reining in anti-microbial resistance (AMR).

As per the policy, which applies to all IMA members, antibiotics should not be prescribed for fever with rash, cough or cold, suspected or confirmed dengue, malaria, chikungunya, viral hepatitis or any viral syndrome, unless clinically warranted, Pharmabiz.com reports.

Any antibiotic prescribed should be highlighted in a box in patient prescriptions, so that the patient can identify the antibiotic. All prescriptions should be accompanied with a rider stating 'no refill without doctor's prescription' (which could be printed on the prescription pad as footer).

The draft policy has recommended etiology-based treatment of infections instead of syndromic management; with focus on strengthening and utilising microbiology laboratory services, especially culture sensitivity, and making antibiotic consent a part of the informed patients' consent process.

It also recommends shifting of Schedule H antibiotics to H1, and H1 antibiotics to Schedule X.

The total number of antibiotic tablets / capsules to be taken for the prescribed duration should be mentioned in the prescription and not just the dose administration schedule. Appropriate antibiotics should be prescribed at the earliest to manage suspected sepsis, meningitis, pneumonia or positive cases of tuberculosis.

Every medical establishment can draw its own antibiotic policy (IV to oral antibiotic switch, antibiotic preference based on local antibiogram, infection prevention and control, reuse of medical devices and safe syringe practices).

MDR TB and XDR TB are required to be notified to health authorities and surveillance teams. Doctors need to ensure root cause analysis for any outbreak of MDR infection in hospital/healthcare facility.

All food products must be labelled with ''Antibiotic status''. Antibiotic waste disposal policy should be developed to prevent contamination of the environment; preventing discharge of untreated waste into soil and rivers, it added.

The draft policy was discussed at the antimicrobial resistance conference supported by the World Health Organization (WHO) on 11 November. The ministry of health & family welfare has identified AMR as one of the top 10 priorities for its collaborative work with WHO.

India's National Action Plan on Antimicrobial Resistance (NAP-AMR), was launched at the 'Inter-Ministerial Consultation on Antimicrobial Resistance containment' on 19 April this year.

Dr K K Aggarwal, national president of IMA, said, ''Costlier and newer antibiotics do not mean they are more effective. No antibiotic treatment of fatal diseases -TB, HIV, HCV - should be initiated unless proven by laboratory based diagnosis. No antibiotic therapy should be started without a positive laboratory-based diagnosis for bacterial infection(s). We need to adhere to recommended immunisation schedules and hygiene practices (hand hygiene, infection prevention and control practices, sanitation) in health care settings as well as in the community.''

There has been a rise in irrational use of antibiotics in the healthcare system of the country leading to drug resistance among people. Some of the reasons responsible for the malaise include regulatory gaps, inability to enforce the existing regulations, over the counter availability of antibiotics, lack of awareness amongst prescribers and patients, and lack of quality assured laboratory testing facilities to support evidence based antibiotic prescriptions.

Dr Aggarwal said antibiotic resistance is a significant public health problem and has made it difficult to treat many infections such as TB, typhoid, pneumonia, gonorrhea. Antibiotic resistance increases duration of hospitalisation, probability of adverse drug reactions as well as risk of therapeutic failure and associated mortality. No age group is exempt from antibiotic resistance.

Second- or third-line drugs are expensive and result in increased costs of treatment. These drugs may also be less effective and have more side effects.

We are on the verge of a post-antibiotic era because many antibiotics that were previously effective against bacteria are no more so. As a result, many common infections can become life threatening and may bring us back to the pre-antibiotic era.

WHO's list of antibiotic-resistant "priority pathogens", which included 12 classes of bacteria that pose the greatest threat to human health, aims to prioritize research against gram negative organisms especially those causing infections in the community. These pathogens are increasingly becoming resistant to existing antibiotics and in urgent need of newer treatments, said IMA national president.

The antibiotics R&D pipeline is dry, with very little new research being done on antibiotics. A report released by WHO in September 2017 says, ''Antibacterial agents in clinical development – an analysis of the antibacterial clinical development pipeline, including tuberculosis'' shows a serious lack of new antibiotics under development to combat the growing threat of antimicrobial resistance.

Most of the drugs currently in the clinical pipeline are modifications of existing classes of antibiotics and are only short-term solutions.