Antibiotic Policy

Why We Need It ?
Dr.T.V.Rao MD

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World has Changed with

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Why take antibiotics?

William Osler, MD (1849 - 1919)
"The

desire to take medicine is perhaps the greatest feature which distinguishes man from animals." "One of the first duties of the physician is to educate the masses not to take medicine"
H. Cushing, Life of Sir William Osler (1925)

Fleming Nobel Prize Speech identifies

In his Nobel Prize acceptance speech, Fleming identified the risk of bacteria becoming resistant to antibiotics. If a bacterium carries several resistance genes, it is called multiresistant or, informally, a

"superbug."
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Development of anti-microbials
The development
of anti-infectives

ertapenem tigecyclin daptomicin linezolid telithromicin quinup./dalfop. cefepime ciprofloxacin aztreonam norfloxacin imipenem cefotaxime clavulanic ac. cefuroxime gentamicin cefalotina nalidxico ac. ampicillin methicilin vancomicin rifampin chlortetracyclin streptomycin pencillin G

prontosil

1920
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1930

1940

1950

1960

1970

1980

1990

2000
5

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Antibiotic brands
50 penicillin's 71 cephalosporins 12 tetracycline's 8 aminoglycosides 1 monobactam 5 Carbapenems 9 macrolides 2 streptogramins 3 dihydrofolate reductase inhibitors 1 oxazolidinone 5.5 quinolones
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A Changing Landscape for Numbers of Approved Antibacterial Agents

18 16

Number of agents approved

14 12 10 8 6 4 2 0

Resistance

0
1983-87 1988-92 1993-97 1998-02 2003-05 2008

Bars represent number of new antimicrobial agents approved by the FDA during the period listed.
Infectious Diseases Society of America. Bad Bugs, No Drugs. July 2004; Spellberg B et al. Clin Infect Dis. 2004;38:1279-1286; New14-06-2013 antimicrobial agents. Antimicrob Agents Chemother. 2006;50:1912 Dr.T.V.Rao MD

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Chronology of Development of Antibiotic Resistance

Antibiotic Year introduced
Penicillin Streptomycin Tetracycline Erythromycin Gentamicin Vancomycin 1942 1947 1952 1955 1967 1956

Resistance identified
1940 1947 1956 1956 1970 1987

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Scarcity of New Antibiotics

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What went wrong with Antibiotic Usage

Treating trivial infections / viral Infections with Antibiotics has become routine affair. Many use Antibiotics without knowing the Basic principles of Antibiotic therapy.

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Many Medical practioners are under pressure for short term solutions.
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Pharmaceutical industry Pushes

Commercial interests of Pharmaceutical industry pushing the Antibiotics, more so Broad spectrum and Newer Generation antibiotics. as every Industry has become profit oriented
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Poverty and Drug Resistance

Poverty encourages drug resistance due to under utilization of appropriate Antibiotics.
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ANTIMICROBIAL RESISTANCE: The role of animal feed antibiotic additives

48% of all antibiotics by weight is added to animal feeds to promote growth. Results in low, sub therapeutic levels which are thought to promote resistance. Farm families who own chickens feed tetracycline have an increased incidence of tetracycline resistant fecal flora

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Antibiotics
Biology and Society

About 50% of the antibiotics produced today are used in the livestock industry. What impact does this have on the treatment of human diseases?

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Inappropriate use of antibiotics is a worldwide problem

More than 50% of all medicines are prescribed, dispensed or sold inappropriately, and half of all patients fail to take

medicines correctly.
The overuse, underuse or misuse of medicines harms people and wastes resources. More than 50% of all countries do not implement basic policies to promote rational use of medicines.
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Chemists real threat Soaring sales of antibiotics at Indian pharmacies are compounding drug-resistance problems

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Carbapenems a real threat

Source ; Nature ( International Journal of Science)

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Contribute for Creating Drug Resistance

Every time a person takes antibiotics, sensitive bacteria are killed, but resistant microbes may be left to grow and multiply. Repeated and improper uses of antibiotics are primary causes of the increase in drugresistant bacteria.
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Creation of SUPERBUGS
Antimicrobial resistance is a serious global challenge. Every continent and country faces the menace of antibiotic resistant super bugs, though the extent and the severity of the problem varies. There could be a return to the pre-antibiotic era, where many people could suffer or die from untreatable bacterial infections
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Hospital Settings that Foster Drug Resistance

Intensive care
units

Oncology units Dialysis units Rehab units

Transplant units
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Burn units

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Treated without Coordination

When the patients to be treated by several specialists, multiple antibiotics prescribed, Drug Antagonism
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The Nature Magazine

At the Tata Memorial Centre in Mumbai, at least half of bacterial samples (50%) from patients with infections are resistant to Carbapenems a class of second-line antibiotics used to treat infections that are already resistant to other Cephalosporin group of drugs. Just a few years ago, the resistance rate in such samples was only 30%
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New Delhi metallo-beta-lactamase 1 Indias Famous Superbug

New Delhi Metallobeta-lactamase (NDM1) is a gene that makes bacteria resistant to antibiotics of the Carbapenems family. It encodes a type of betalactamase enzyme called a carbapenemases
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Why inappropriate use of antibiotics contributes to antibiotic resistance the why

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Our Indian Hospitals

Indian hospitals have reported very high Gram-negative resistance rates, with very high prevalence of ESBL (Extended Spectrum Beta Lactamases) producers and also high

carbapenem resistance rates.

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Pan Drug Resistant Infections

Increasing carbapenem resistance will invariably result in increased usage of colistin, currently the last line of defence, with a potential for colistin-resistant and

Pan Drug Resistant bacterial infections

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NABH DATA on Indian Hospitals

As per data available from NABH assessors conclave most accredited hospitals, though having a well written antibiotic policy on paper, are

not compliant in practice.

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Can we tackle the Problem

India, with more than 20,000 hospitals, more than a billion population, wide cultural diversity, socio-economic disparity, and a large medical community of more than three-fourths of a million doctors, will find the resistance problem an issue very difficult to tackle
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Hospital Infection Control Committee (HICC)

All hospitals must have an infection control committee and an antibiotic policy and should initiate or augment efforts towards implementation. Those hospitals with an existing ICC and an antibiotic policy should augment efforts to increase compliance to the policy. Hospitals without a policy must initiate efforts to formulate an ICC and an antibiotic policy. ICC should define an annual target for achievement.
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An antibiotic policy will:

Improve patient care by promoting the best practice in antibiotic prophylaxis and therapy, Make better use of resources by using cheaper drugs where possible Retard the emergence and spread of multiple antibiotic-resistant bacteria.

*Improve education of junior doctors by providing guidelines for appropriate therapy

Eliminate the use of unnecessary or ineffective antibiotics and restrict the use of expensive or unnecessarily powerful ones
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The following key persons should be included in the committee:

The Pharmacist who will report back to the Antibiotic Committee at each meeting on drug utilisation and cost.

The Microbiologist who will report on antibiotic susceptibility patterns of bacteria isolated from major infections.

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Important Participants
Clinical doctors and nurses responsible for
direct patient care who provide a link between clinical practice and the Antibiotic Committee.

Manger(s) who will ensure the resources are available for implementation of the antibiotic policy.
Reciprocal Membership between the Infection Control Committee and the Drugs Committee should be ensured.
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In-patients are at high risk of antibioticresistant infections

Misuse of antibiotics in hospitals is one of the main factors that drive development of antibiotic resistance. Patients in hospitals have a high probability of receiving an antibiotic and 50% [adapt to national figure where available] of all antibiotic use in hospitals can be inappropriate.
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Misuse of Antibiotics Drives Antibiotic Resistance

Studies prove that misuse of antibiotics may cause patients to become colonized or infected with antibiotic-resistant bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE) and highly-resistant Gramnegative bacilli. Misuse of antibiotics is also associated with an increased incidence of Clostridium difficle infections.
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Why we Need Antibiotic Policy

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We are Under Scanner for many reasons

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Aim of Antibiotic Policy

Reduce the Antimicrobial resistance Initiate best efforts in the hospital area as many resistance Bacteria are generated in Hospital areas and in particular critical care areas.

Initiate good hygienic practices so these bacteria do not spread to others Practice best efforts, these resistance strains do not spill into critically ill patients in the Hospital
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Objectives of Antibiotic Policy.

Antibiotics should not be used casually Policy emphasizes, avoiding the use of powerful Antibiotics in the Initial treatments. We should create awareness that we are sparing the powerful Broad spectrum Drugs for later treatment
Patient saves Money Doctors save Lives.
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Aims of the Antibiotic Policy

Create awareness on Antibiotics as misuse is counterproductive. More effective treatments in serious Infections. Reduce Health care associated infections spilling to society and increase of Community associated Infections.
( A growing concern in Developing world )

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Policy Deals on Broad Basis

Clinicians / Microbiologists / Pharmacists and Nurses do take part. Policies are framed on demands of the Clinical areas, depending on recent Infection

surveillance data
contributed from Microbiology Departments.

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 1 Complete ban on OTC sale of antibiotics without prescription throughout the country. 2 Complete ban of OTC sale of antibiotics without prescription in metros and larger cities with a more liberal approach in smaller cities and

The 3 Stratagecies Will it Work ?

villages.
3 A liberal approach throughout the country to start with, with an initial list of antibiotics under restriction and addition of other drugs to the list in a phased manner.
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Education On Antibiotic policy

Acton plan for Education to all concerned clinical staff on Antibiotic prescriptions. Evaluate the feed back of success and failures of the policy.

Create Infection surveillance Data

Developing facilities in Microbiology departments for auditing data and guidance Restrictions in prescribing and Antibiotic availability. A continuous education to Junior Doctors

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Ideal Sample Collection is Essential Requirement

Proper specimen collection is combined responsibility of Clinical and Microbiological Departments. Continuous training of junior staff on sample collection, and is most neglected necessity
A good clinical history is greatly helpful in differentiating community acquired infections from hospital acquired infections.
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Strategies to Address Antimicrobial Resistance (STAAR) Act

It is critical that Congress protect its

investment in the development of new antimicrobials by enacting the STAAR Act, which will strengthen the federal response to antimicrobial resistance through enhanced leadership, surveillance, research, and data collection
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Role of Microbiology Departments

Microbiology labs should issue hospital Antibiogram at pre-defined intervals. Those hospitals without good laboratory support should be willing to outsource samples to better laboratories. Multidrug-resistant bacteria, especially pan-drug resistant bacteria, must be considered as a notifiable entity. Such a reporting system should complementnational antimicrobial resistance surveillance studies.
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India needs An implementable antibiotic policy and

NOT A perfect policy

However, asking for a complete and strict antibiotic policy in a country where there is currently no functioning antibiotic policy at all may not be an intelligent or immediately viable option without the political will to make such a drastic change. A multidisciplinary committee of eminent experts should explore the options available to us. For example, should
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Antibiotic Prescribing Children real Concern

Antibiotics were prescribed in 68% of acute respiratory tract visits and of those, 80% were unnecessary according to CDC guidelines Children are of particular concern because they have the highest rates of antibiotic use.
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Rationalism in Implementation Many choices ?

Introduce step- bystep regulation of antibiotic usage, concentrating on higher end antibiotics first and then slowly extending the list to second and first line antibiotics?
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Monitoring on Colistin
Strict monitoring on the usage of colistin,

currently the most precious antibiotic in

an era of increasing carbapenem resistance, must be implemented on an urgent basis. Colistin prescription should be induplicate, with a copy to be sent to the pharmacy. The prescription must be countersigned by a consultant in 24 hours.
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Role of Microbiology Departments

Microbiology labs should issue hospital Antibiogram at pre-defined intervals. Those hospitals without good laboratory support should be willing to outsource samples to better laboratories Multidrug-resistant bacteria, especially pan-drug resistant bacteria, must be considered as a notifiable entity. Such a reporting system should complement national antimicrobial resistance surveillance studies.
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Better services from Microbiology Departments.

Basic infrastructure should be updated for detection of MRSA and ESBL producers.
Documentation of all Opportunistic infections. and Hospital infection outbreaks
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Notifying Pan Resistant Microbes Superbugs

Pan-drug-resistant Gram-negatives, carbapenemresistant GramNegatives, Vancomycinresistant Enterococcus and MRSA should be made notifiable
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MDR TB a Threat to Everyone

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Bedaquiline
Bedaquilin was the first TB drug to be
discovered in more than 40 years, and the first one specifically for multi-drug resistant TB (MDRTB). MDR-TB arises when the M. tuberculosis bacteria become resistant to two commonly used first-line TB drugs isoniazid and rifampicin. But less than six months after FDA approved the drug under its accelerated approval programme, is the drug a potential candidate for misuse by doctors in India? Will it in any way result in patients developing drug resistance?
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Role of Medical Council of India

One of the main reasons for the inappropriate antibiotic usage by Indian doctors is the lack of adequate training on the subject during undergraduate and postgraduate courses. This deficit in the basic training can only be overcome if there is a change in the curriculum.
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Curriculum change
Structured training in antibiotic usage and infection control should be introduced in both

UG and PG curriculum.
Infectious Diseases training in UG and PG curriculum in all specialties.

Antibiotic stewardship and infection control one week rotation-3rd, 4th, and final year MBBS.
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WHONET
Documentation Why We Need It

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What is WHONET
WHONET is a free software developed by the
WHO Collaborating Centre for Surveillance of Antimicrobial Resistance for laboratory-based surveillance of infectious diseases and antimicrobial resistance. The principal goals of the software are: 1 to enhance local use of laboratory data; and 2 to promote national and international collaboration through the exchange of data.
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Whonet helps us in
The understanding of the local epidemiology of microbial populations; the selection of antimicrobial agents; the identification of hospital and community outbreaks; and the recognition of quality assurance problems in laboratory testing.

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All the Documented results are analyzed in WHONET

The heart of WHONET is a software package designed to collect the results of antibiotic resistance tests. Researchers / Microbiologists feed the results into a computer and look for trends
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Clinicians can access data of their patients anytime in the computer just with click of the mouse

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Implementation of WHONET CAN HELP TO MONITOR RESISTANCE

Legacy computer systems, quality improvement teams, and strategies for optimizing antibiotic use have the potential to stabilize resistance and reduce costs by encouraging heterogeneous prescribing patterns and use of local susceptibility patterns to inform empiric treatment.

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No Private Firms Investing in New

Antibiotics

Drug makers have poured huge sums into applying genomics and proteomics to the problem. It has not worked. Despite the millions spent,, in a paper in Nature a few years ago, his firm and others came up empty-handed: and

losing their Money

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Thirteen national science academies call on G8 to act on drug resistance threat

A more responsible approach to drug prescription for human use Reduced use of antibiotics and other drugs in animal husbandry Incentives for pharmaceutical companies to develop new drugs to fight infectious disease, especially new antibiotics Information and education programmes A global system of control to combat the spread of resistant microorganisms
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Physicians Can Impact

Patients
Other clinicians

Optimize patient evaluation Optimize consultations with Adopt judicious antibiotic other clinicians prescribing practices Use infection control measures Immunize patients Educate others about judicious use of antibiotics 14-06-2013 Dr.T.V.Rao MD 66

Best way to keep the matters in Order

Every Hospital should have a policy which is practicable to their circumstances. The *Seniors physician in the respective departments will make the best policy

Rigid guidelines without coordination will lead to greater failures The only way to keep Antimicrobial agents useful is to use them appropriately and
Judiciously
(Burke A.Cunha, MD,MACP Antimicrobial Therapy. Medical Clinics of

North America NOV 2006)

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Who is A *Senior Physicians

The young physician starts life with 20 drugs for each disease, and the old(Senior ) physician ends life with one drug for 20 diseases.

William Osler
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Our minimal Targets

List of available antibiotics agreed by all clinicians, indicating dosages, routes of administration and toxicities. Guidelines for therapy and prophylaxis. A regimen selection algorithm also might be included in an antibiotic policy. CLSI guidelines are already followed
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IMAGINE A WORLD WITHOUT ANTIBIOTICS

A world without effective antibiotics is a terrifying but real prospect. Overuse of antibiotics has led to dangerous outbreaks of drug resistant disease, and puts us in very real danger of a global pandemic. In future we have to use ???

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Conclusions
Antibiotic resistance is a major problem world-wide

Resistance is inevitable with use

Penicillin attained resistance before it is used

No new class of antibiotic introduced over the last two decades

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Appropriate use is the only way of prolonging the useful life of an antibiotic
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References
The Chennai Declaration "Recommendations of A roadmap- to tackle the challenge of antimicrobial resistance A joint meeting of medical societies of India Ghafur etal, Indian Journal of Cancer | OctoberDecember 2012 | Volume 49 | Issue 4 CDC, Atlanta USA Emerging Infectious Diseases WHO guidelines on Antibiotic use
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