Policy document on antimicrobial stewardship practices in India

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Abstract

Antimicrobial resistance (AMR) in India has become a great threat because of high rate of infectious diseases. One of the key contributing factors is high antibiotic use due to poor prescription practices, self-medication, over-the-counter sale of drugs and lack of awareness. Antimicrobial stewardship programme (AMSP) have been proved to be successful in restraining sale and use of antibiotics to a large extent in many countries. An AMSP programme for a hospital is imperative for rational and evidence-based antimicrobial therapy. The ultimate aim is to improve patient outcomes, reduce emergence of bacterial resistance and ensure longevity of the existing antimicrobials. The primary goal of AMSP is to encourage cautious use of available antibiotics by training the healthcare workers and creating awareness. This article describes the strategies and recommendations for formulation of AMSP policy for India.

Introduction

Antimicrobial resistance (AMR) has become a public health emergency with the exponential increase in resistant microbes. Van Boeckel et al 1 have reported that antibiotic consumption has increased by 35 per cent from 2000 to 2010, with a higher use of last resort antibiotics carbepenems (45%) and polymyxins (13%). Increasing levels of drug resistance seen in pathogens of public health importance and dried up pipeline of new antibiotics have created a situation of emergency in India and globally. Hospitals in India are reporting high levels of resistance to fluoroquinolones and carbapenems and are also documenting increasing resistance to polymyxins such as colistin with an increase in the use of polymyxins in healthcare settings 2 ,3 . India was reported to be the largest consumer of antibiotics in 2010 and contributed to 23 per cent of the increase in retail antibiotic sales among the BRICS (Brazil, Russia, India, China and South Africa) countries 4 . The recent trends of antibiotic resistance in India are alarming with increasing percentage of resistance to last resort antibiotics carbapenems and colistins 5 . There has been an increase in cephalosporin and broad-spectrum penicillin consumption from 2000 to 2015 6 .

Given this compelling situation, there is a need to look for implementation of measures to reduce drug resistance. The World Health Organization (WHO) developed a global action plan (GAP) in 2015, which mandates Member States to produce national strategic plans for AMR through surveillance and reporting, antibiotic stewardship and preventing infection 7 . The WHO has identified antimicrobial stewardship programme (AMSP) as one of the interventions in GAP. AMSP is a systematic approach for using antimicrobials rationally to control AMR and to reduce inappropriate use of antimicrobials 8 . Implementation of AMSP has been found to reduce excessive antibiotic usage and has resulted in reduced resistance rates in many countries 9 . AMS programmes have shown 22-36 per cent reduction in antimicrobial use and significant cost-savings 8 .

Countries such as Australia, Chile, China, France, Scotland, South Africa, South Korea, Sweden, Taiwan, USA and Vietnam have successfully implemented antibiotic stewardship programmes 10 . Successful AMS programmes have demonstrated reduction in resistance rates, mortality and healthcare costs in many countries 11 ,12 . It has also been reported that AMSP implementation positively impacted outbreaks of resistant pathogens in healthcare settings where it was implemented 9 .

Antimicrobial stewardship strategies

AMSP refers to comprehensive strategies designed for rational use of antimicrobial agents (AMAs) by optimal antimicrobial drug, dosing, duration of therapy and route of administration with minimal toxicity. The various AMSP strategies include building capacity for stewardship activities, developing policies and guidelines, establishing systems, educating healthcare workers and introducing useful interventions, specifically customized for the national setting 13 ,14 . The core strategies can be in the form of two major approaches, with the most successful programmes generally implementing a combination of both. The front-end or pre-prescription approach to stewardship uses restrictive prescriptive authority which requires approval to use certain restricted antibiotics, except trained clinicians. The back-end or post-prescription approach to stewardship uses prospective review and feedback. Based on the review and feedback, the clinicians are recommended by the AMSP team to modify or discontinue specific antibiotic use 9 .

The appropriate evidence-based treatment options should be chosen in consultations with inputs from clinical microbiologist on local resistance patterns (hospital antibiograms), using fewest formulary drugs, with minimum side effects, optimum dose and duration. The presence of infectious disease (ID) physicians, clinical pharmacist and infection control nurse is crucial for a functional AMSP programme. AMSP is seen as resource intensive intervention which needs to be supported administratively by allocating sufficient human and financial resources and information technology structures. Hence, countries who implemented evidence-based AMSP in their hospitals found it to be financially self-sustaining 9 .

AMSP-Indian initiative

AMSP capacities in Indian healthcare institutions (HCIs) are rudimentary or rather non-existent and this has been well documented in one of the surveys carried out by ICMR in 2013 among 20 tertiary HCIs about AMSP components, implementation and outcome 15 . It showed that only 40 per cent of HCIs had AMSP written documents, 75 per cent of HCIs had HIC guidelines and 65 per cent had AMAs prescription guidelines. Moreover, only 30 per cent of HCIs had AMSP implementation strategies. Private HCIs showed better performance compared to government HCIs in AMSP that was attributed to the accreditation process. The survey reported the absence of IDs physicians and clinical pharmacists in institutions. This shows a lacuna for AMSP in India and the dire need to implement AMSP as priority 15 .

In March 2017, the National Health Policy 2017 of Ministry of Health and Family Welfare (MoHFW), Government of India, prioritized AMR in India. In response to the call by 71 st UN General Assembly for AMR threat in the meeting of global leaders (September 2016), the Government of India launched the National Action Plan on AMR (2017-2021) in April 2017 with support from WHO India office coordinated by MoHFW. The document notified the governance mechanisms by three groups - an intersectoral coordination committee, a technical advisory group and a core working group on AMR 16 .

Recognizing the need to create AMSP structures in HCIs in the country, the ICMR carried out four workshops on AMSP capacity building across the country in the second quarter of 2017 (http://iamrsn.icmr.org.in/index.php/events/amsp). More than 30 hospitals across the country participated in the workshop. Several deliverables were identified which could be initiated at the earliest Box .

Box

Specific deliverables identified for antimicrobial stewardship practices