antibiotic policy = why we need it

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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 distinguishesman from animals."

"One of the first duties

of the physician is toeducate the masses

not to take medicine"

H. Cushing, Life of Sir William Osler (1925)


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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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1920 1930 1940 1950 1960 1970 1980 1990 2000

ertapenem tigecyclin

daptomicinlinezolid

telithromicin

quinup./dalfop.cefepime

ciprofloxacinaztreonam

norfloxacinimipenem

cefotaximeclavulanic ac.

cefuroximegentamicin

cefalotinanalidxico ac.

ampicillinmethicilin

vancomicinrifampin

chlortetracyclinstreptomycin

pencillin Gprontosil

The development

of ant i -infectives

Development of anti-microbials

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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

Antibiotic brands

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A Changing Landscape for

Numbers of Approved Antibacterial Agents

Bars represent number of new antimicrobial agents approved by the FDA during the period listed.

0

0

2

4

6

8

10

12

14

16

18

Numberofagentsapproved

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

Infectious Diseases Society of America. Bad Bugs, No Drugs. July 2004; Spellberg B et al. Clin Infect Dis. 2004;38:1279-1286;New antimicrobial agents. Antimicrob Agents Chemother. 2006;50:1912

Resistance

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Chronology of Development of

Antibiotic Resistance

Antibiotic Year introduced Resistance identified

Penicillin 1942 1940

Streptomycin 1947 1947

Tetracycline 1952 1956Erythromycin 1955 1956

Gentamicin 1967 1970

Vancomycin 1956 1987

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Scarcity of New Antibiotics

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What went wrong with

Antibiotic Usage

Treating trivial infections / viralInfections with Antibiotics has

become routine affair. Many use Antibiotics without

knowing the Basic principles of

Antibiotic therapy. Many Medical practioners are

under pressure for short term

solutions.Dr.T.V.Rao MD 1114-06-2013


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Pharmaceutical industry

Pushes

Commercial interests

of Pharmaceutical

industry pushing the

Antibiotics, more so

Broad spectrum and

Newer Generation

antibiotics. as everyIndustry has become

profit oriented

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Poverty and Drug Resistance

Poverty

encourages drug

resistance dueto 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 arethought to promote resistance.

Farm families who own chickens feed

tetracycline have an increased incidence oftetracycline resistant fecal flora

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Antibiotics Biology and Society

About 50% of the antibiotics producedtoday 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 notimplement basic policies to promote rationaluse of medicines.

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Chemists real threat


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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 threatSource ; 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 resistantmicrobes may be left to

grow and multiply.

Repeated and improper

uses of antibiotics areprimary causes of the

increase in drug-

resistant bacteria.Dr.T.V.Rao MD 1914-06-2013


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Creation of SUPERBUGS

Antimicrobial resistance is a serious

global challenge. Every continent and

country faces the menace of antibioticresistant super bugs, though the extent

and the severity of the problem varies.

There could be a return to thepre-antibiotic era, where many people

could suffer or die from untreatable

bacterial infections14-06-2013 Dr.T.V.Rao MD 20


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Hospital

Intensive care

units

Oncology units

Dialysis units

Rehab units

Transplant units

Burn units

Settings that Foster Drug Resistance

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Treated without Coordination

When the patients

to be treated by

several specialists,

multiple

antibioticsprescribed,

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 anti-biotics used to treat infections that are

already resistant to other Cephalosporin

group of drugs. Just a few years ago, theresistance rate in such samples was only 30%

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New Delhi metallo-beta-lactamase 1

Indias Famous Superbug

New Delhi Metallo-

beta-lactamase (NDM-

1) is a gene that makes

bacteria resistant toantibiotics of the

Carbapenems family. It

encodes a type of beta-

lactamase enzymecalled a

carbapenemases

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Why inappropriateuse of antibiotics

contributes toantibiotic resistance

the why

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Our Indian Hospitals

Indian hospitals have reported

very high Gram-negative

resistance rates, with very highprevalence of ESBL (Extended

Spectrum Beta Lactamases)producers and also high

carbapenem resistance rates.14-06-2013 Dr.T.V.Rao MD 26


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Pan Drug Resistant Infections

Increasing carbapenem resistancewill invariably result in increased

usage ofcolistin, currently thelast line of defence, with apotential for colistin-resistant and

Pan Drug Resistant bacterialinfections

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NABH DATA on Indian Hospitals

As per data availablefrom NABH assessorsconclave most

accredited hospitals,though having a wellwritten antibioticpolicy on paper, are

not compliant inpractice.

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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 antibioticpolicy 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 bestpractice in antibiotic prophylaxis and therapy,

Make better use of resources by using cheaperdrugs where possible

Retard the emergence and spread of multipleantibiotic-resistant bacteria.

*Improve education of junior doctors byproviding guidelines for appropriate therapy

Eliminate the use of unnecessary or ineffectiveantibiotics and restrict the use of expensive orunnecessarily 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 fordirect patient care who provide a link betweenclinical practice and the Antibiotic Committee.

Manger(s) who will ensure the resourcesare available for implementation of theantibiotic policy.

Reciprocal Membership between the InfectionControl Committee and the Drugs Committeeshould be ensured.

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In-patients are at high risk of antibiotic-

resistant 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 antibioticand 50% [adapt to

national figure where available] of all

antibiotic use in hospitals can beinappropriate.

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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 Staphylococcusaureus(MRSA), vancomycin-resistant

enterococci(VRE) and highly-resistant Gram-

negative bacilli. Misuse of antibiotics is also associated with an

increased incidence ofClostridium 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 aregenerated in Hospital areas and inparticular critical care areas.

Initiate good hygienic practices sothese bacteria do not spread toothers

Practice best efforts, theseresistance strains do not spill intocritically 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 spectrumDrugs for later treatment

Patient saves MoneyDoctors 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 Clinicalareas, depending onrecent Infection

surveillance datacontributed fromMicrobiologyDepartments.

Dr.T.V.Rao MD 4114-06-2013

The 3 Stratagecies


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The 3 Stratagecies

Will it Work ? 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 amore liberal approach in smaller cities andvillages.

3 A liberal approach throughout the country to

start with, with an initial list of antibiotics underrestriction and addition of other drugs to the listin a phased manner.

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Education On Antibiotic policy

Acton plan for Education to all concerned clinical staff onAntibiotic prescriptions.

Evaluate the feed back of success and failures of the policy.

Create Infection surveillance Data

Developing facilities in Microbiology departments for auditing data andguidance

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 indifferentiating 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 hospitalAntibiogram at pre-defined intervals. Thosehospitals without good laboratory support

should be willing to outsource samples tobetter laboratories. Multidrug-resistantbacteria, especially pan-drug resistantbacteria, must be considered as a notifiable

entity. Such a reporting system shouldcomplementnational antimicrobial resistancesurveillance 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 immediatelyviable option without the political will to make

such a drastic change. A multidisciplinary

committee of eminent experts should explorethe options available to us. For example,

should

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A tibi ti P ibi


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Antibiotics were

prescribed in 68% of

acute respiratory tract

visits and of those, 80%

were unnecessaryaccording to CDC

guidelines

Children are of particular

concern because theyhave the highest rates of

antibiotic use.

Antibiotic Prescribing

Children real Concern

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Monitoring on Colistin

Strict monitoring on the usage ofcolistin,

currently the most precious antibiotic inan 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 aconsultant 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 betterlaboratories 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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B tt i f Mi bi l


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Better services from Microbiology

Departments.

Basic infrastructureshould be updated fordetection ofMRSA

and ESBL producers.

Documentation of allOpportunistic

infections. andHospital infectionoutbreaks

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Notif ing Pan Resistant Microbes


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Notifying Pan Resistant Microbes

Superbugs

Pan-drug-resistant

Gram-negatives,

carbapenem-

resistant Gram-Negatives,

Vancomycin-

resistantEnterococcus and

MRSA should be

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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 firstone specifically for multi-drug resistant TB (MDR-TB). MDR-TB arises when the M. tuberculosis

bacteria become resistant to two commonly usedfirst-line TB drugs isoniazid and rifampicin.

But less than six months after FDA approved thedrug under its accelerated approval programme,

is the drug a potential candidate for misuse bydoctors in India? Will it in any way result inpatients 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 ofadequate training on the subject

during undergraduate and post-

graduate courses. This deficit in thebasic training can only be overcome

if there is a change in the curriculum.14-06-2013 Dr.T.V.Rao MD 56


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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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WHONETDocumentation

Why We Need It

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What is WHONET

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WHONET is a free software developed by theWHO Collaborating Centre for Surveillance of

Antimicrobial Resistance for laboratory-based

surveillance of infectious diseases and antimicrobialresistance.

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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The understanding ofthe local epidemiologyof microbialpopulations; the

selection ofantimicrobial agents;the identification ofhospital and communityoutbreaks; and the

recognition of qualityassurance problems inlaboratory testing.

Whonet helps us in

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All th D t d lt l d


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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 antibioticresistance tests.

Researchers /

Microbiologists feed

the results into acomputer and look for

trends

Dr.T.V.Rao MD 6114-06-2013

l d f h


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Clinicians can access data of their patients anytime in

the computer just with click of the mouse

Dr.T.V.Rao MD 6214-06-2013

I l t ti f WHONET CAN HELP TO


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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 toinform empiric treatment.

Implementation ofWHONET CAN HELP TOMONITOR RESISTANCE

Dr.T.V.Rao MD 6314-06-2013

No Private Firms Investing in New


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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: andlosing their Money

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Thirteen national science academies call


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Thirteen national science academies call

on G8 to act on drug resistance threat

A more responsible approach to drug prescription forhuman use

Reduced use of antibiotics and other drugs in animal

husbandryIncentives for pharmaceutical companies to developnew drugs to fight infectious disease, especially newantibiotics

Information and education programmesA global system of control to combat the spread ofresistant microorganisms

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Physicians Can Impact

Other clinicians

Patients

Optimize patient evaluationAdopt judicious antibiotic

prescribing practicesImmunize patients

Optimize consultations withother clinicians

Use infection control measuresEducate others about

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Best way to keep the matters in Order

Every Hospital should have a policy whichis practicable to their circumstances.

The *Seniors physician in the respectivedepartments will make the best policy

Rigid guidelines without coordinationwill lead to greater failuresThe only way to keep Antimicrobialagents useful is to use them appropriately andJudiciously

(Burke A.Cunha, MD,MACP Antimicrobial Therapy. Medical Clinics ofNorth America NOV 2006)

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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


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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 realdanger of a global pandemic. In future we

have to use ???

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C l i


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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 introducedover the last two decades

Appropriate use is the only way of

prolonging the useful life of an antibiotic14-06-2013 Dr.T.V.Rao MD 71

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References

The Chennai Declaration "Recommendationsof A roadmap- to tackle the challenge ofantimicrobial resistance A joint meeting of

medical societies of India Ghafur etal, IndianJournal of Cancer | OctoberDecember 2012 |Volume 49 | Issue 4

CDC, Atlanta USA Emerging Infectious

Diseases WHO guidelines on Antibiotic use

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antibiotic policy = why we need it

Documents