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Antibiotic PolicyWhy We Need It ?Dr.T.V.Rao MD14-06-2013 Dr.T.V.Rao MD 1

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World has Changed with14-06-2013 Dr.T.V.Rao MD 2

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Why take antibiotics?William Osler, MD (1849 - 1919)• "The desire to takemedicine is perhapsthe greatest featurewhich distinguishesman from animals."• "One of the first dutiesof the physician is toeducate the massesnot to take medicine"H. Cushing, Life of Sir William Osler (1925)

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Fleming Nobel Prize Speechidentifies• In his Nobel Prizeacceptance speech,Fleming identified the riskof bacteria becomingresistant to antibiotics. Ifa bacterium carriesseveral resistance genes,it is called multiresistantor, informally, a"superbug."14-06-2013 Dr.T.V.Rao MD 4

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1920 1930 1940 1950 1960 1970 1980 1990 2000ertapenemtigecyclindaptomicinlinezolidtelithromicinquinup./dalfop.cefepimeciprofloxacinaztreonamnorfloxacinimipenemcefotaximeclavulanic ac.cefuroximegentamicincefalotinanalidíxico ac.ampicillinmethicilinvancomicinrifampinchlortetracyclinstreptomycinpencillin GprontosilThe developmentof anti-infectives …Development of anti-microbialsDr.T.V.Rao MD 514-06-2013

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• 50 penicillins• 71 cephalosporins• 12 tetracyclines• 8 aminoglycosides• 1 monobactam• 5 Carbapenems• 9 macrolides• 2 streptogramins• 3 dihydrofolatereductaseinhibitors• 1 oxazolidinone• 5.5 quinolonesAntibiotic brands14-06-2013 Dr.T.V.Rao MD 6

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A Changing Landscape forNumbers of Approved Antibacterial AgentsBars represent number of new antimicrobial agents approved by the FDA during the period listed.0024681012141618Numberofagentsapproved1983-87 1988-92 1993-97 1998-02 2003-05 2008Infectious 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;50:1912Resistance14-06-2013 Dr.T.V.Rao MD 7

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Chronology of Development ofAntibiotic ResistanceAntibiotic Year introduced Resistance identifiedPenicillin 1942 1940Streptomycin 1947 1947Tetracycline 1952 1956Erythromycin 1955 1956Gentamicin 1967 1970Vancomycin 1956 198714-06-2013 Dr.T.V.Rao MD 9

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Scarcity of New Antibiotics14-06-2013 Dr.T.V.Rao MD 10

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What went wrong withAntibiotic Usage• Treating trivial infections / viralInfections with Antibiotics hasbecome routine affair.• Many use Antibiotics withoutknowing the Basic principles ofAntibiotic therapy.• Many Medical practioners areunder pressure for short termsolutions. Dr.T.V.Rao MD 1114-06-2013

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Pharmaceutical industryPushes• Commercial interestsof Pharmaceuticalindustry pushing theAntibiotics, more soBroad spectrum andNewer Generationantibiotics. as everyIndustry has becomeprofit oriented14-06-2013 Dr.T.V.Rao MD 12

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Poverty and Drug Resistance• Povertyencourages drugresistance dueto underutilization ofappropriateAntibiotics.14-06-2013 Dr.T.V.Rao MD 13

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ANTIMICROBIAL RESISTANCE:The role of animal feed antibiotic additives• 48% of all antibiotics by weight is added toanimal feeds to promote growth. Results inlow, sub therapeutic levels which arethought to promote resistance.• Farm families who own chickens feedtetracycline have an increased incidence oftetracycline resistant fecal flora14-06-2013 Dr.T.V.Rao MD 14

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Antibiotics• Biology and SocietyAbout 50% of the antibiotics producedtoday are used in the livestock industry.What impact does this have on thetreatment of human diseases?14-06-2013 Dr.T.V.Rao MD 15

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Inappropriate use of antibioticsis a worldwide problem• More than 50% of all medicines areprescribed, dispensed or sold inappropriately,and half of all patients fail to takemedicines correctly.• The overuse, underuse or misuse of medicinesharms people and wastes resources.• More than 50% of all countries do notimplement basic policies to promote rationaluse of medicines.14-06-2013 Dr.T.V.Rao MD 16

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Chemists real threatSoaring sales of antibiotics at Indianpharmacies are compounding drug-resistanceproblems14-06-2013 Dr.T.V.Rao MD 17

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Carbapenems a real threatSource ; Nature ( International Journal of Science)14-06-2013 Dr.T.V.Rao MD 18

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Contribute for Creating DrugResistance• Every time a persontakes antibiotics,sensitive bacteria arekilled, but resistantmicrobes may be left togrow and multiply.Repeated and improperuses of antibiotics areprimary causes of theincrease in drug-resistant bacteria.Dr.T.V.Rao MD 1914-06-2013

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Creation of SUPERBUGS• Antimicrobial resistance is a seriousglobal challenge. Every continent andcountry faces the menace of antibioticresistant “super bugs,” though the extentand the severity of the problem varies.There could be a return to thepre-antibiotic era, where many peoplecould suffer or die from untreatablebacterial infections14-06-2013 Dr.T.V.Rao MD 20

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Hospital Intensive careunits Oncology units Dialysis units Rehab units Transplant units Burn unitsSettings that Foster Drug Resistance14-06-2013 Dr.T.V.Rao MD 21

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Treated without Coordination• When the patientsto be treated byseveral specialists,multipleantibioticsprescribed,• Drug Antagonism14-06-2013 Dr.T.V.Rao MD 22

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The Nature Magazine• At the Tata Memorial Centre in Mumbai,where the oncologist treat, at least half ofbacterial samples (50%) from patients withinfections are resistant to Carbapenems — aclass of ‘second-line’ antibiotics used to treatinfections that are already resistant to otherCephalosporin group of drugs. Just a few yearsago, the resistance rate in such samples wasonly 30%14-06-2013 Dr.T.V.Rao MD 23

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New Delhi metallo-beta-lactamase 1India’s Famous Superbug• New Delhi Metallo-beta-lactamase (NDM-1) is a gene that makesbacteria resistant toantibiotics of theCarbapenems family. Itencodes a type of beta-lactamase enzymecalled acarbapenemases14-06-2013 Dr.T.V.Rao MD 24

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Why inappropriateuse of antibioticscontributes toantibiotic resistance– the “why”Dr.T.V.Rao MD 2514-06-2013

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Our Indian Hospitals• Indian hospitals have reportedvery high Gram-negativeresistance rates, with very highprevalence of ESBL (ExtendedSpectrum Beta Lactamases)producers and also highcarbapenem 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 increasedusage of colistin, currently thelast line of defence, with apotential for colistin-resistant andPan Drug Resistant bacterialinfections14-06-2013 Dr.T.V.Rao MD 27

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NABH DATA on Indian Hospitals• As per data availablefrom NABH assessorsconclave mostaccredited hospitals,though having a wellwritten antibioticpolicy on paper, arenot compliant inpractice.14-06-2013 Dr.T.V.Rao MD 28

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Can we tackle the Problem• India, with more than20,000 hospitals, morethan a billion population,wide cultural diversity,socio-economic disparity,and a large medicalcommunity of more thanthree-fourths of a milliondoctors, will find theresistance problem anissue very difficult totackle14-06-2013 Dr.T.V.Rao MD 29

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Hospital Infection ControlCommittee (HICC)• All hospitals must have an infection controlcommittee and an antibiotic policy and shouldinitiate or augment efforts towards implementation.• Those hospitals with an existing ICC and an antibioticpolicy should augment efforts to increase complianceto the policy. Hospitals without a policy mustinitiate efforts to formulate an ICC and an antibioticpolicy.• ICC should define an annual target for achievement.14-06-2013 Dr.T.V.Rao MD 30

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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 ones14-06-2013 Dr.T.V.Rao MD 31

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The following key persons shouldbe included in the committee:• The Pharmacist who will report backto the Antibiotic Committee at eachmeeting on drug utilisation and cost.• The Microbiologist who will report onantibiotic susceptibility patterns ofbacteria isolated from major infections.14-06-2013 Dr.T.V.Rao MD 32

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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 theresources are available forimplementation of the antibiotic policy.• Reciprocal Membership between the InfectionControl Committee and the Drugs Committeeshould be ensured.14-06-2013 Dr.T.V.Rao MD 33

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In-patients are at high risk of antibiotic-resistant infections• Misuse of antibiotics in hospitals is one of themain factors that drive development ofantibiotic resistance.• Patients in hospitals have a high probability ofreceiving an antibioticand 50% [adapt tonational figure where available] of allantibiotic use in hospitals can beinappropriate.Dr.T.V.Rao MD 3414-06-2013

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Misuse of Antibiotics DrivesAntibiotic Resistance• Studies prove that misuse of antibiotics maycause patients to become colonized orinfected with antibiotic-resistant bacteria,such as methicillin-resistant Staphylococcusaureus (MRSA), vancomycin-resistantenterococci (VRE) and highly-resistant Gram-negative bacilli.• Misuse of antibiotics is also associated with anincreased incidence of Clostridium difficleinfections. Dr.T.V.Rao MD 3514-06-2013

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Why we Need AntibioticPolicyDr.T.V.Rao MD 3614-06-2013

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We are UnderScanner for many reasons14-06-2013 Dr.T.V.Rao MD 37

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Aim of Antibiotic Policy• Reduce the Antimicrobial resistance• Initiate best efforts in the hospital areaas 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 HospitalDr.T.V.Rao MD 3814-06-2013

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Objectives of Antibiotic Policy.• Antibiotics should not be used casually• Policy emphasizes, avoiding the use ofpowerful Antibiotics in the Initialtreatments.• We should create awareness that we aresparing the powerful Broad spectrumDrugs for later treatmentPatient saves MoneyDoctors save Lives.Dr.T.V.Rao MD 3914-06-2013

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Aims of the Antibiotic Policy• Create awareness on Antibiotics as misuse iscounterproductive.• More effective treatments in serious Infections.• Reduce Health care associated infections spillingto society and increase of Community associatedInfections.( A growing concern in Developing world )Dr.T.V.Rao MD 4014-06-2013

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Policy Deals on Broad Basis• Clinicians /Microbiologists /Pharmacists and Nursesdo take part.• Policies are framed ondemands of the Clinicalareas, depending onrecent Infectionsurveillance datacontributed fromMicrobiologyDepartments.Dr.T.V.Rao MD 4114-06-2013

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The 3 StratageciesWill it Work ?• Complete ban on OTC sale of antibiotics withoutprescription throughout the country.• Complete ban of OTC sale of antibiotics withoutprescription in metros and larger cities with amore liberal approach in smaller cities andvillages.• A liberal approach throughout the country tostart with, with an initial list of antibiotics underrestriction and addition of other drugs to the listin a phased manner.14-06-2013 Dr.T.V.Rao MD 42

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Education On Antibiotic policy• Acton plan for Education to all concerned clinical staffon Antibiotic prescriptions.• Evaluate the feed back of success and failures of thepolicy.• Create Infection surveillance Data• Developing facilities in Microbiology departments forauditing data and guidance• Restrictions in prescribing and Antibiotic availability.• A continuous education to Junior DoctorsDr.T.V.Rao MD 4314-06-2013

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Ideal Sample Collection is EssentialRequirement• Proper specimen collection is combinedresponsibility of Clinical and MicrobiologicalDepartments.• Continuous training of junior staff on samplecollection, and is most neglected necessity• A good clinical history is greatly helpful indifferentiating community acquired infectionsfrom hospital acquired infections.Dr.T.V.Rao MD 4414-06-2013

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Strategies to Address AntimicrobialResistance (STAAR) Act• “It is critical that Congress protect itsinvestment in the development of newantimicrobials by enacting the STAAR Act,which will strengthen the federalresponse to antimicrobial resistancethrough enhanced leadership,surveillance, research, and datacollection14-06-2013 Dr.T.V.Rao MD 45

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Role of Microbiology Departments• Microbiology labs should issue hospitalAntibiogram at pre-defined intervals. Thosehospitals without good laboratory support shouldbe willing to outsource samples to betterlaboratories. The system of notification ofcommunicable diseases is a popular,established, though not strictly followed systemin the country. Multidrug-resistant bacteria,especially pan-drug resistant bacteria, must beconsidered as a notifiable entity. Such a reportingsystem should complementnational antimicrobialresistance surveillance studies.14-06-2013 Dr.T.V.Rao MD 46

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India needs “An implementable antibiotic policy” andNOT “A perfect policy”• However, asking for a complete and strictantibiotic policy in a country where there iscurrently no functioning antibiotic policy at allmay not be an intelligent or immediatelyviable option without the political will to makesuch a drastic change. A multidisciplinarycommittee of eminent experts should explorethe options available to us. For example,should14-06-2013 Dr.T.V.Rao MD 47

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• Antibiotics wereprescribed in 68% ofacute respiratory tractvisits – and of those, 80%were unnecessaryaccording to CDCguidelines• Children are of particularconcern because theyhave the highest rates ofantibiotic use.Antibiotic PrescribingChildren real Concern14-06-2013 Dr.T.V.Rao MD 48

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Rationalism in ImplementationMany choices ?• Introduce step- by-step regulation ofantibiotic usage,concentrating onhigher endantibiotics first andthen slowlyextending the list tosecond and first lineantibiotics?14-06-2013 Dr.T.V.Rao MD 49

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Monitoring on Colistin• Strict monitoring on the usage of colistin,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. Theprescription must be countersigned by aconsultant in 24 hours.14-06-2013 Dr.T.V.Rao MD 50

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Role of Microbiology Departments• Microbiology labs should issue hospitalAntibiogram at pre-defined intervals. Thosehospitals without good laboratory support shouldbe willing to outsource samples to betterlaboratories Multidrug-resistant bacteria,especially pan-drug resistant bacteria, must beconsidered as a notifiable entity. Such a reportingsystem should complement nationalantimicrobial resistance surveillance studies.14-06-2013 Dr.T.V.Rao MD 51

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Better services from MicrobiologyDepartments.• Basic infrastructureshould be updated fordetection of MRSAand ESBL producers.• Documentation of allOpportunisticinfections. andHospital infectionoutbreaksDr.T.V.Rao MD 5214-06-2013

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Carbapenemases• Ability to hydrolyze penicillins,cephalosporins,monobactams, and carbapenems• Resilient against inhibition by all commercially viable ß-lactamase inhibitors– Subgroup 2df: OXA (23 and 48) carbapenemases– Subgroup 2f : serine carbapenemases from molecular classA: GES and KPC– Subgroup 3b contains a smaller group of MBLs thatpreferentially hydrolyze carbapenems• IMP and VIM enzymes that have appeared globally, mostfrequently in non-fermentative bacteria but also inEnterobacteriaceae14-06-2013 Dr.T.V.Rao MD 53

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Notifying Pan Resistant MicrobesSuperbugs• Pan-drug-resistantGram-negatives,carbapenem-resistant Gram-Negatives,Vancomycin-resistantEnterococcus andMRSA should bemade notifiable14-06-2013 Dr.T.V.Rao MD 54

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MDR TB a Threat to Everyone14-06-2013 Dr.T.V.Rao MD 55

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Bedaquiline• Bedaquilin was the first TB drug to bediscovered in more than 40 years, and the firstone specifically for multi-drug resistant TB (MDR-TB). MDR-TB arises when the M. tuberculosisbacteria 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?14-06-2013 Dr.T.V.Rao MD 56

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Role of Medical Council of India• One of the main reasons for theinappropriate antibiotic usage byIndian doctors is the lack ofadequate training on the subjectduring undergraduate and post-graduate courses. This deficit in thebasic training can only be overcomeif there is a change in the curriculum.14-06-2013 Dr.T.V.Rao MD 57

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Curriculum change• Structured training in antibiotic usage andinfection control should be introduced in bothUG and PG curriculum.• Infectious Diseases training in UG and PGcurriculum in all specialties.• Antibiotic stewardship and infectioncontrol one week rotation-3rd, 4th, andfinal year MBBS.14-06-2013 Dr.T.V.Rao MD 58

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WHONETDocumentationWhy We Need It14-06-2013 Dr.T.V.Rao MD 59

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What is WHONETDr.T.V.Rao MD 60• WHONET is a free software developed by theWHO Collaborating Centre for Surveillance ofAntimicrobial Resistance for laboratory-basedsurveillance 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 internationalcollaboration through the exchange of data.14-06-2013

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• The understanding ofthe local epidemiologyof microbialpopulations; theselection ofantimicrobial agents;the identification ofhospital and communityoutbreaks; and therecognition of qualityassurance problems inlaboratory testing.Whonet helps us in ……Dr.T.V.Rao MD 6114-06-2013

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All the Documented results are analyzedin WHONET• The heart of WHONET isa software packagedesigned to collect theresults of antibioticresistance tests.Researchers /Microbiologists feedthe results into acomputer and look fortrendsDr.T.V.Rao MD 6214-06-2013

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Clinicians can access data of their patients anytime inthe computer just with click of the mouseDr.T.V.Rao MD 6314-06-2013

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• Legacy computer systems,quality improvement teams,and strategies foroptimizing antibiotic usehave the potential tostabilize resistance andreduce costs by encouragingheterogeneous prescribingpatterns and use of localsusceptibility patterns toinform empiric treatment.Implementation of WHONET CAN HELP TOMONITOR RESISTANCEDr.T.V.Rao MD 6414-06-2013

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No Private Firms Investing in NewAntibiotics• Drug makers have poured hugesums into applying genomics andproteomics to the problem. It hasnot worked. Despite the millionsspent,, in a paper in Nature a fewyears ago, his firm and others cameup empty-handed: “14-06-2013 Dr.T.V.Rao MD 65

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Thirteen national science academies callon G8 to act on drug resistance threatA more responsible approach to drug prescription forhuman useReduced use of antibiotics and other drugs in animalhusbandryIncentives for pharmaceutical companies to developnew drugs to fight infectious disease, especially newantibioticsInformation and education programmesA global system of control to combat the spread ofresistant microorganisms14-06-2013 Dr.T.V.Rao MD 66

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Physicians Can ImpactOther cliniciansPatientsOptimize patient evaluationAdopt judicious antibioticprescribing practicesImmunize patientsOptimize consultations withother cliniciansUse infection control measuresEducate others aboutjudicious use of antibiotics14-06-2013 Dr.T.V.Rao MD 67

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Best way to keep the matters in OrderEvery Hospital should have a policy whichis practicable to their circumstances.The *Seniors physician in the respectivedepartments will make the best policyRigid 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)Dr.T.V.Rao MD 6814-06-2013

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Who is A *Senior Physicians• The young physicianstarts life with 20drugs for eachdisease, and theold(Senior )physician ends lifewith one drug for 20diseases.• William Osler14-06-2013 Dr.T.V.Rao MD 69

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Our minimal Targets• List of available antibiotics agreed by allclinicians, indicating dosages, routes ofadministration and toxicities.Guidelines for therapy and prophylaxis.• A regimen selection algorithm also might beincluded in an antibiotic policy.• CLSI guidelines are already followed14-06-2013 Dr.T.V.Rao MD 70

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IMAGINE A WORLD WITHOUTANTIBIOTICS• A world without effective antibiotics is aterrifying but real prospect. Overuse ofantibiotics has led to dangerous outbreaks ofdrug resistant disease, and puts us in very realdanger of a global pandemic. In future wehave to use ???14-06-2013 Dr.T.V.Rao MD 71

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Conclusions Antibiotic resistance is a majorproblem world-wide Resistance is inevitable with use Penicillin attained resistance before it isused No new class of antibiotic introducedover the last two decades Appropriate use is the only way ofprolonging the useful life of an antibiotic14-06-2013 Dr.T.V.Rao MD 72

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References• The Chennai Declaration "Recommendationsof “A roadmap- to tackle the challenge ofantimicrobial resistance” – A joint meeting ofmedical societies of India Ghafur etal, IndianJournal of Cancer | October–December 2012 |Volume 49 | Issue 4• CDC, Atlanta USA Emerging InfectiousDiseases• WHO guidelines on Antibiotic use14-06-2013 Dr.T.V.Rao MD 73

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