NDM-1 Challenges in Medical Microbiology

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NDM-1 GROWING CONCERNS Need for Modernization of Diagnostic Microbiology Laboratories:

Dr.T.V.Rao MD 1 NDM-1 GROWING CONCERNS Need for Modernization of Diagnostic Microbiology Laboratories Dr.T.V.Rao MD

The Lancet Opens the Pandora box:

The Lancet Opens the Pandora box Gram-negative Enterobacteriaceae with resistance to carbapenems conferred by New Delhi metallo- β- lactamase 1 (NDM-1) are potentially a major global health problem. We investigated the prevalence of NDM-1, in multidrug-resistant Enterobacteriaceae in India, Pakistan, and the UK. Dr.T.V.Rao MD 2

Travel makes patients venerable:

Travel makes patients venerable The superbug called New Delhi metallo-beta-lactamase, or NDM-1, was identified in 50 people who traveled to India or Pakistan for surgery and then returned to the United Kingdom, British scientists reported in the journal Lancet Infectious Diseases Dr.T.V.Rao MD 3

Naming the strain as New Delhi creates controversy:

Naming the strain as New Delhi creates controversy The gene was named after New Delhi, the capital city of India, as it was first described by Yong et al. in 2009 in a Swedish national who fell ill with an antibiotic-resistant bacterial infection that he acquired in India . The infection was unsuccessfully treated in a New Delhi hospital and after the patient's repatriation to Sweden, a carbapenem-resistant Klebsiella pneumoniae strain bearing the novel gene was identified. The presenting authors concluded that the new resistance mechanism "clearly arose in India, but there are few data arising from India to suggest how widespread it is." Dr.T.V.Rao MD 4

Bugs becomes Superbugs:

Bugs becomes Superbugs Antibiotic resistance develops through gene action or plasmid exchange between bacteria of the same species. If a bacterium carries several resistance genes, it is called multiresistant or, informally, a superbug. Dr.T.V.Rao MD 5

CDC Reports:

CDC Reports Three Enterobacteriaceae isolates carrying a newly described resistance mechanism, the New Delhi metallo-beta-lactamase (NDM-1) , were identified from three U.S. states at the CDC antimicrobial susceptibility laboratory. This is the first report of NDM-1 in the United States, and the first report of metallo-beta-lactamase carriage among Enterobacteriaceae in the United States Dr.T.V.Rao MD 6

Mark Toleman of Britain's Cardiff University School of Medicine, creates concerns ?:

Mark Toleman of Britain's Cardiff University School of Medicine , creates concerns ? The inhabitants of New Delhi are continually being exposed to multidrug-resistant and NDM 1-positive bacteria," said Mark Toleman of Britain's Cardiff University School of Medicine, who published the findings in a study on Thursday. Dr.T.V.Rao MD 7

Toleman’s Study a Concern to India:

Toleman’s Study a Concern to India Toleman’s study, carried out with Cardiff University’s Timothy Walsh and published in The Lancet Infectious Diseases journal, investigated how common NDM 1-producing bacteria are in community waste seepage — such as water pools or rivulets in streets — and tap water in urban New Delhi. Dr.T.V.Rao MD 8

Facts Reported on the Present Study:

In September and October 2010, Walsh’s research team collected 50 samples from public drinking water taps in New Delhi and 171 samples from “seepage,” standing water that had pooled near public areas, both of which are used by residents for drinking, washing and/or other household functions. The scientists found bacterial strains with the NDM-1 mutation in two of the drinking water samples and in 51 of the seepage samples. For comparison, they collected 70 samples from Cardiff’s water supply and found no evidence of bacteria with NDM-1 mutations. Dr.T.V.Rao MD 9 Facts Reported on the Present Study

Facts on NDM-1 are Concern to the National Health :

Facts on NDM-1 are Concern to the National Health Speech is silver Silence is Gold Ignoring the facts is Dangerous NDM - 1 Dr.T.V.Rao MD 10

Why Microbiologists are Important in the Changing Scenario:

Why Microbiologists are Important in the Changing Scenario Adequate clinical management of infectious diseases relies primarily on the accurate identification of the causal micro­organism and the production of reliable information on its antimicrobial susceptibility Dr.T.V.Rao MD 11

Now Clinicians Need Faster Diagnostic Information:

Now Clinicians Need Faster Diagnostic Information Tra­ditional diagnostic methods in microbiology have lim­ited the ability of laboratories to provide doctors with timely and clinically relevant information, but recent technology provides results in minutes or hours rather than days or weeks. Dr.T.V.Rao MD 12

Improving the Standards in Diagnostic Microbiology:

Improving the Standards in Diagnostic Microbiolo gy Dr.T.V.Rao MD 13

Safety of the Laboratory Personal A Top Priority:

Safety of the Laboratory Personal A Top Priority The protection of personnel and the immediate laboratory environment from exposure to infectious agents is provided by both good microbiological technique and the use of appropriate safety equipment. The use of vaccines may provide an increased level of personal protection. Dr.T.V.Rao MD 14

Let our Policy to start with Containment:

Let our Policy to start with Containment The term "containment" is used in describing safe methods for managing infectious materials in the laboratory environment where they are being handled or maintained. The purpose of containment is to reduce or eliminate exposure of laboratory workers, other persons, and the outside environment to potentially hazardous agents. Dr.T.V.Rao MD 15

Implementing Biosaftey at Medical Establishments in India :

Dr.T.V.Rao MD 16 Implementing Biosaftey at Medical Establishments in India It is time to educate on Biosafety issues. Document the Information regarding the Biosaftey equipment available in the Hospital, Colleges, if not, to do at the earliest, and concerns of the Health of the Laboratory personal should be made mandatory.

Specimen collection :

Specimen collection Continues to be Most Neglected part of Diagnostic Microbiology Can be Improved Dr.T.V.Rao MD 17

Collecting the correct specimen most neglected part of Diagnostic Microbiology:

Endocervical swabs for GC Per nasal swabs for pertussis whole EMU for TB Sputum , not saliva Blood culture bottles, not clotted blood Correctly timed Gentamicin assays Pus, not swabs Major value of the Diagnostic Microbiology is lost in unscientific methods, left casually to ill trained staff Collecting the correct specimen most neglected part of Diagnostic Microbiology Dr.T.V.Rao MD 18

Getting the specimen to the laboratory:

Getting the specimen to the laboratory Problems in delay or inappropriate storage• delay in diagnosis & treatment pathogens die contaminants overgrow Blood cultures directly into incubator not refrigerator! CSF straight to lab Don't put an entire surgical specimen into formalin! Send a portion to microbiology in a sterile container Dr.T.V.Rao MD 19

Collecting the specimen correctly:

Collecting the specimen correctly Take an mid-stream urine avoids contamination with perineal flora CSF Avoid contamination Avoid bloody tap Throat swab Make the patient gag! Blood cultures Avoid contamination with skin organisms Dr.T.V.Rao MD 20

Labelling Specimens & Infection Control:

Labelling Specimens & Infection Control Please be considerate to lab staff!! Label hazardous specimens Don't send specimens to the lab without proper packing Leaking or blood-stained specimens are not acceptable!!! Dr.T.V.Rao MD 21

Factors limiting usefulness of bacteriological investigations What is going Wrong:

Factors limiting usefulness of bacteriological investigations What is going Wrong W rong sample e.g. saliva instead of sputum D elay in transport / inappropriate storage e.g. CSF Overgrowth by contaminants e.g. blood cultures I nsufficient sample / sampling error e.g.in mycobacterial disease P atient has received antibiotics Dr.T.V.Rao MD 22

ANTIMICROBIAL SUSCEPTIBILITY TESTING:

ANTIMICROBIAL SUSCEPTIBILITY TESTING The major control on use , misuse of Antibiotics can be controlled with Good Practices Dr.T.V.Rao MD 23

ANTIMICROBIAL SUSCEPTIBILITY TESTING:

The role of antimicrobial susceptibility tests to guide empirical therapy , to refine therapy once pathogens have been isolated and identified, and to detect new types of antimicrobial resistance is well established. Other roles of antimicrobial susceptibility testing for patient care, such as development of cumulative Antibiograms, creation of antimicrobial formularies, and detection of new antimicrobial resistance strains or trends, are also well established. ANTIMICROBIAL SUSCEPTIBILITY TESTING Dr.T.V.Rao MD 24

Quality Control on Antimicrobial testing is crucial:

Quality Control on Antimicrobial testing is crucial G enerating accurate and reproducible antimicrobial susceptibility test data requires perhaps the most extensive QC program used in clinical laboratories today Dr.T.V.Rao MD 25

Adherence to CLSI Guidelines ..:

The CLSI publishes guidelines for the QC of antimicrobial susceptibility tests . These guidelines are extensive and require rigorous adherence to each step of testing for results to be accurate and reproducible. Specific guidelines have been developed not only for different categories of bacteria and fungi (e.g ., members of the Enterobacteriaceae family) but also for individual species. Perhaps the most important guidelines published by CLSI are that antimicrobial agents should be tested against different microbial pathogens Adherence to CLSI Guidelines .. Dr.T.V.Rao MD 26

Why All Diagnostic Laboratories should adhere to:

The information used to develop these guidelines is based on clinical , pharmacologic, and microbiologic data. It is strongly recommended that clinical microbiology laboratories and providers both adhere to these guidelines ; testing antimicrobial agent–pathogen combinations that are not recommended may generate antimicrobial susceptibility test results that either are misleading or cannot be interpreted. In general, it is also strongly recommended that new antimicrobial agents should not be tested in clinical laboratories until there are sufficient data for CLSI guidelines to be developed and published Why All Diagnostic Laboratories should adhere to Dr.T.V.Rao MD 27

Reporting newer pattern of Resistance needs reference Methods:

Reporting newer pattern of Resistance needs reference Methods Detection of new types or patterns of antimicrobial resistance may be fortuitous or the result of active surveillance. The former should not be used to guide patient care until the data are confirmed by a reference method; published reports of new types or patterns of resistance typically reflect extensive confirmatory testing . Dr.T.V.Rao MD 28

Follow current practices as per CLSI guidelines:

Follow current practices as per CLSI guidelines M ost microbiology laboratories use commercial systems for antimicrobial susceptibility testing, which may or may not yet have the capability of detecting newer forms of resistance, reliable means of detecting new types or patterns of antimicrobial resistance often lag behind published information . Dr.T.V.Rao MD 29

Implementation of WHONET CAN HELP TO MONITOR RESISTANCE:

Dr.T.V.Rao MD 30 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.

World Antibiotic Resistance Network:

World Antibiotic Resistance Network WHO has also started another program, WARN (the World Antibiotic Resistance Network), to help gather and analyse the data generated by the people who use WHONET. Dr.T.V.Rao MD 31

Recent advances Diagnostic Microbiology:

Recent advances Diagnostic Microbiology Are We Using It – How much we use them ? Dr.T.V.Rao MD 32

Up gradation to Automation in Critical samples:

Automated and semi automated systems have been available for some years but without full realization of their potential for rapid diagnosis. They fall into two main groups: identification and susceptibility testing instruments and blood culture systems. Whereas some identification and susceptibility testing instruments take as long as traditional methods, others provide results within a single working day . Up gradation to Automation in Critical samples Dr.T.V.Rao MD 33

Automation in Blood Culturing reduces mortality and Morbidity:

Blood culture systems have had considerable impact on the ability to detect bacteremia. Growth is detected through generation of a radiometric signal or a fluorescent or colorimetric indicator . Most true posi­tive results are detected within 24 to 36 hours. Identifi­cation and susceptibility results may be obtained in many blood culture isolates within the same time when a blood culture system is combined with an automated identification or susceptibility testing instrument Automation in Blood Culturing reduces mortality and Morbidity Dr.T.V.Rao MD 34

Several Life threating conditions can the treated Promptly:

B lood culture systems have been adapted for the automated or semi automated culture of Mycobacterium tuberculosis and other mycobacteria. These commercial systems reduce the traditional dependence on bio­ chemical reactions to identify organisms; avoid the and mycobacteria among others. Nucleic acid amplifica­tion systems are available for the direct detection in clinical specimens of hepatitis C virus, HIV, M tuberculo­ sis , C trachomatis , and N gonorrhea since more than a decade. Several Life threating conditions can the treated Promptly Dr.T.V.Rao MD 35

Molecular techniques :

Molecular techniques M olecular biological techniques have increased the speed and sensitivity of detection methods, as well as allowing laboratories to identify organisms that do not grow or grow slowly in culture . These techniques also allow microbiologists to identify genes that result in resistance to antibiotics and to “fingerprint” individual isolates for epidemiological tracking. Dr.T.V.Rao MD 36

New technologies enable to …:

New technologies enable to … New technologies enable microbiology results to be available in minutes or hours rather than days. Early diagnosis better prognosis and lesser costs in treatments Dr.T.V.Rao MD 37

Molecular biological methods:

Molecular biological methods Nucleic acid probe hybridization, the polymerase chain reaction , the ligase chain reaction, transcription medi­ated amplification, other evolving amplification meth­ods , and nucleic acid sequencing form the basis of detecting and characterizing an ever increasing range of viruses , bacteria, fungi, and protozoa Dr.T.V.Rao MD 38

Immunoassays have benefits:

Immunoassays have benefits Immunoassays have benefits of technical simplicity , rapidity, specificity, and cost effectiveness but often have poor sensitivity and low negative predictive value Dr.T.V.Rao MD 39

Molecular Methods helps in New trends in…:

Molecular Methods helps in New trends in … Recognition of newly emerging infectious diseases and control of antibiotic resistance in Streptococcus pneumoniae , Haemophilus influenza Morax­ ella catarrhalis , Staphylococcus aureus , and Common Gram negative bacilli will rely heavily on these new technologies. Dr.T.V.Rao MD 40

Limitations of Molecular Methods:

Limitations of Molecular Methods The introduction of molecular diagnostic methods in the microbiologic diagnostic laboratory is subject to a number of practical and financial constraints requiring the elaboration of a sound strategy. Validation of the tests may require the use of an expanded gold standard or the application of novel statistical methods such as latent class analysis. Dr.T.V.Rao MD 41

Limitations of Molecular Methods ?:

The procedures should be constantly evaluated for false positive an false negative results. The introduction of molecular methods will not only depend on their performance for each individual microorganism, but also on the clinical relevance of the diagnostic question asked , the prevalence of the clinical problem and whether the new methods are added to the procedures in use or will replace them. Therefore no general rules can be proposed, strategies have to be elaborated for each infectious agent or clinical syndrome Limitations of Molecular Methods ? Dr.T.V.Rao MD 42

Microbiologists must plan and Execute for change:

Microbiologists must plan and Execute for change With increase in availability of cost effective commercial systems, laboratories will be able to capitalize on the extreme specificity, high sensitivity, and rapidity of these molecular approaches. Dr.T.V.Rao MD 43

Better Diagnosis in Emerging and Reemerging Infection:

Better Diagnosis in Emerging and Reemerging Infection An ever increasing range of viruses, bacteria fungi , and protozoa can be detected and characterized by molecular biological methods Dr.T.V.Rao MD 44

DO WE HAVE ANTIBIOTIC POLICY ? DO WE HAVE CONTROL OF ANTIBIOTIC USAGE ?:

DO WE HAVE ANTIBIOTIC POLICY ? DO WE HAVE CONTROL OF ANTIBIOTIC USAGE ? Dr.T.V.Rao MD 45

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 Gram-negative bacilli . 13-14 Misuse of antibiotics is also associated with an increased incidence of Clostridium difficile infections. 15-17 Misuse of Antibiotics Drives Antibiotic Resistance Dr.T.V.Rao MD 46

Spread of Antibiotic Resistance:

Spread of Antibiotic Resistance Indiscrimate use of Antibiotics in Animals and Medical practice R plasmids spread among co-inhabiting Bacterial flora in Animals ( in gut ) R plasmids may be mainly evolved in Animals spread to Human commensal, - Escherichia coli followed by spread to more important human pathogens Eg Shigella spp. Dr.T.V.Rao MD 47

What is Misuse of Antibiotics?:

Misuse of antibiotics can include any of the following When antibiotics are prescribed unnecessarily; When antibiotic administration is delayed in critically ill patients; When broad-spectrum antibiotics are used too generously, or when narrow-spectrum antibiotics are used incorrectly; When the dose of antibiotics is lower or higher than appropriate for the specific patient; When the duration of antibiotic treatment is too short or too long; When antibiotic treatment is not streamlined according to microbiological culture data results. What is Misuse of Antibiotics ? Dr.T.V.Rao MD 48

Aim of Antibiotic Policy:

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 To prevent spill into Society, as they present as community associated infections.. Dr.T.V.Rao MD 49

Objectives of Antibiotic Policy.:

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 . Dr.T.V.Rao MD 50

Policy Deals on Broad Basis:

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 . Dr.T.V.Rao MD 51

Education On Antibiotic policy:

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 Dr.T.V.Rao MD 52

Staff Education on Antibiotic Policy:

Staff Education on Antibiotic Policy Staff education is most Important principle in success Draw your own plans according to nature of patients, your past experiences Induction training for new staff Continuing Medical Education to both Junior and Senior Doctors Include nursing staff, pharmacists for the success of the Programme Dr.T.V.Rao MD 53

Make your conclusions and contribute to Antibiotic Policy:

Make your conclusions and contribute to Antibiotic Policy It is true to say that there is no absolute proof of causative association between antibiotic use and resistance, But many authorities believe the association to be virtually certain. It is pragmatic and essential approach to control of antibiotic resistance with control of antibiotic use. Make every one a partner in prevention of Antibiotic resistance, and success will follow . Dr.T.V.Rao MD 54

Modernising strategy based on the use of technology:

Modernising strategy based on the use of technology Dr.T.V.Rao MD 55

Reasons for Forming a Network To improve quality, efficiency and effectiveness of the service leading to better patient care. :

Implementing better training and development opportunities for all staff and improved recruitment and improve quality standards to produce Centres of Excellence for Microbiology, with an increased pool of consultant expertise across sites More efficient utilisation of facilities and equipment Reasons for Forming a Network To improve quality, efficiency and effectiveness of the service leading to better patient care. Dr.T.V.Rao MD 56

Modernising Strategy:

Modernising Strategy Managed Microbiology networks providing a wider strategic context for planning Microbiology services. Modernisation strategies to support service development. Integrating Microbiology into wider service developments Redesigning systems Making effective use of IT and new technologies – Medical Informatics Improving information management Dr.T.V.Rao MD 57

Modernisation Principles for Microbiology:

Modernisation Principles for Microbiology Patient-centred Appropriate Develops staff Integrated Effective Efficient Dr.T.V.Rao MD 58

Our changing Role:

Our changing Role Microbiologists can and should play an important role in assuring the quality of results that are generated by clinical microbiology laboratories . Their most important role is to help correlate clinical, laboratory, and radiographic data, to determine the clinical relevance, if any, of microbiology test results Dr.T.V.Rao MD 59

Use of automation to improve and develop services:

Use of automation to improve and develop services Opportunity to develop new HR Strategy Reduced staff where employment difficult Better use of qualified staff Multidisciplinary use of staff Improved Terms and Conditions Develop services Point of Care Testing Molecular Biology Diagnostic technicians Greater efficiency Shift systems Extended role for non-professional staff Better access times More efficient and effective service Laboratory Ward Community Dr.T.V.Rao MD 60

NDM-1 superbugs found in seepage, tap water :

NDM-1 superbugs found in seepage, tap water Gram-negative bacterial strains with NDM-1 (New Delhi Metallo-beta-lactamase-1) gene, also called the superbug, have now been detected in drinking water and seepage water samples collected from several sites in New Delhi. Seepage samples were collected from water pools found in streets or rivulets. Dr.T.V.Rao MD 61

Our Role Has changed with NDM-1 ?:

Our Role Has changed with NDM-1 ? Our role relates to the timely reporting of accurate test results, which depends on the practice of rigorous QC. There is no compelling reason to deviate from this practice, particularly because any test results that would be generated are likely to be clinically irrelevant, misleading, or even dangerous to patients . Dr.T.V.Rao MD 62

Core Functions of Microbiology Laboratories :

Core Functions of Microbiology Laboratories Communicable disease surveillance, prevention and control Outbreak and emergency response to communicable diseases Environmental health and food safety Reference testing, specialized screening and diagnostic testing Biosafety, containment, and biohazard response Integrated communicable disease data management Public health policy development and evaluation Laboratory Quality Assurance Training and education of health care workers Public health related research and development Dr.T.V.Rao MD 63

Surveillance & Outbreak Response Core Function:

Systematic data collection & interpretation of clinical and lab information Multidisciplinary team approach Labs in community, hospitals, public health all report to local public health Public health analyses and responds Surveillance & Outbreak Response Core Function Dr.T.V.Rao MD 64

Surveillance & Outbreak Response Core Function:

Surveillance & Outbreak Response Core Function Why? Ongoing watchfulness Microbes impact quickly and widely Microbes know no borders, change quickly New patterns, novel pathogens, new tests Alert for early diagnosis, intervention and prevention NDM -1 should be approached with multidisciplinary approach Dr.T.V.Rao MD 65

Research & Training Core Function:

Research & Training Core Function Faculty and staff carry out public health research and training New knowledge about communicable diseases (CDs) When novel pathogens appear, critical skills (capacity) Need to keep abreast of rapidly advancing technologies Many educational/training activities Dr.T.V.Rao MD 66

Best way to keep the matters in Order:

Best way to keep the matters in Order Every Hospital should have a policy which is practicable to their circumstances. 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) Dr.T.V.Rao MD 67

How to Overcome NDM-1:

India is a country of 1.21 Billion population with complex problems and unequal Medical Care. However we have a responsibility to bring the concerns of Antibiotic misuse both to the Professionals and Common man. Let us strengthen the Diagnostic Microbiology Laboratories A good direction from Professionals on Antibiotic policy. Net working and faster Education to all Health care workers. Better working conditions for Laboratory personal, frequent training on quality of services Above all Technicians need better standard of Living to improve the Laboratory services. Dr.T.V.Rao MD 68 How to Overcome NDM-1

References:

CDC & HHS Select Agents List http://www.cdc.gov/od/sap/docs/salist.pdf ABSA Risk Group Classification http://www.absa.org/resriskgroup.html References Dr.T.V.Rao MD 69

Slide 70:

Created by Dr.T.V.Rao MD on emerging concerns on NDM-1 Email [email protected] Dr.T.V.Rao MD 70