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Antibiotic policy

  1. 1. Antibiotic Policy Why We Need It ? Dr.T.V.Rao MD 14-06-2013 Dr.T.V.Rao MD 1
  2. 2. World has Changed with 14-06-2013 Dr.T.V.Rao MD 2
  3. 3. 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)
  4. 4. 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." 14-06-2013 Dr.T.V.Rao MD 4
  5. 5. 1920 1930 1940 1950 1960 1970 1980 1990 2000 ertapenem tigecyclin daptomicin linezolid telithromicin quinup./dalfop. cefepime ciprofloxacin aztreonam norfloxacin imipenem cefotaxime clavulanic ac. cefuroxime gentamicin cefalotina nalidíxico ac. ampicillin methicilin vancomicin rifampin chlortetracyclin streptomycin pencillin G prontosil The development of anti-infectives … Development of anti-microbials Dr.T.V.Rao MD 514-06-2013
  6. 6. • 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 14-06-2013 Dr.T.V.Rao MD 6
  7. 7. 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 14-06-2013 Dr.T.V.Rao MD 7
  8. 8. 14-06-2013 Dr.T.V.Rao MD 8
  9. 9. Chronology of Development of Antibiotic Resistance Antibiotic Year introduced Resistance identified Penicillin 1942 1940 Streptomycin 1947 1947 Tetracycline 1952 1956 Erythromycin 1955 1956 Gentamicin 1967 1970 Vancomycin 1956 1987 14-06-2013 Dr.T.V.Rao MD 9
  10. 10. Scarcity of New Antibiotics 14-06-2013 Dr.T.V.Rao MD 10
  11. 11. 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. • Many Medical practioners are under pressure for short term solutions. Dr.T.V.Rao MD 1114-06-2013
  12. 12. 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 14-06-2013 Dr.T.V.Rao MD 12
  13. 13. Poverty and Drug Resistance • Poverty encourages drug resistance due to under utilization of appropriate Antibiotics. 14-06-2013 Dr.T.V.Rao MD 13
  14. 14. 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 14-06-2013 Dr.T.V.Rao MD 14
  15. 15. 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? 14-06-2013 Dr.T.V.Rao MD 15
  16. 16. 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. 14-06-2013 Dr.T.V.Rao MD 16
  17. 17. Chemists real threat Soaring sales of antibiotics at Indian pharmacies are compounding drug-resistance problems 14-06-2013 Dr.T.V.Rao MD 17
  18. 18. Carbapenems a real threat Source ; Nature ( International Journal of Science) 14-06-2013 Dr.T.V.Rao MD 18
  19. 19. 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 drug- resistant bacteria. Dr.T.V.Rao MD 1914-06-2013
  20. 20. 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 infections14-06-2013 Dr.T.V.Rao MD 20
  21. 21. Hospital  Intensive care units  Oncology units  Dialysis units  Rehab units  Transplant units  Burn units Settings that Foster Drug Resistance 14-06-2013 Dr.T.V.Rao MD 21
  22. 22. Treated without Coordination • When the patients to be treated by several specialists, multiple antibiotics prescribed, • Drug Antagonism 14-06-2013 Dr.T.V.Rao MD 22
  23. 23. The Nature Magazine • At the Tata Memorial Centre in Mumbai, where the oncologist treat, 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% 14-06-2013 Dr.T.V.Rao MD 23
  24. 24. New Delhi metallo-beta-lactamase 1 India’s Famous Superbug • New Delhi Metallo- beta-lactamase (NDM- 1) is a gene that makes bacteria resistant to antibiotics of the Carbapenems family. It encodes a type of beta- lactamase enzyme called a carbapenemases 14-06-2013 Dr.T.V.Rao MD 24
  25. 25. Why inappropriate use of antibiotics contributes to antibiotic resistance – the “why” Dr.T.V.Rao MD 2514-06-2013
  26. 26. 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. 14-06-2013 Dr.T.V.Rao MD 26
  27. 27. 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 14-06-2013 Dr.T.V.Rao MD 27
  28. 28. 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. 14-06-2013 Dr.T.V.Rao MD 28
  29. 29. 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 14-06-2013 Dr.T.V.Rao MD 29
  30. 30. 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. 14-06-2013 Dr.T.V.Rao MD 30
  31. 31. 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 14-06-2013 Dr.T.V.Rao MD 31
  32. 32. 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. 14-06-2013 Dr.T.V.Rao MD 32
  33. 33. 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. 14-06-2013 Dr.T.V.Rao MD 33
  34. 34. 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 be inappropriate. Dr.T.V.Rao MD 3414-06-2013
  35. 35. 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. • Misuse of antibiotics is also associated with an increased incidence of Clostridium difficle infections. Dr.T.V.Rao MD 3514-06-2013
  36. 36. Why we Need Antibiotic Policy Dr.T.V.Rao MD 3614-06-2013
  37. 37. We are Under Scanner for many reasons 14-06-2013 Dr.T.V.Rao MD 37
  38. 38. 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 Dr.T.V.Rao MD 3814-06-2013
  39. 39. 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 3914-06-2013
  40. 40. 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 ) Dr.T.V.Rao MD 4014-06-2013
  41. 41. 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 4114-06-2013
  42. 42. The 3 Stratagecies Will it Work ? • Complete ban on OTC sale of antibiotics without prescription throughout the country. • Complete ban of OTC sale of antibiotics without prescription in metros and larger cities with a more liberal approach in smaller cities and villages. • 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. 14-06-2013 Dr.T.V.Rao MD 42
  43. 43. 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 4314-06-2013
  44. 44. 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. Dr.T.V.Rao MD 4414-06-2013
  45. 45. 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 14-06-2013 Dr.T.V.Rao MD 45
  46. 46. 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. The system of notification of communicable diseases is a popular, established, though not strictly followed system in the country. 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. 14-06-2013 Dr.T.V.Rao MD 46
  47. 47. 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 14-06-2013 Dr.T.V.Rao MD 47
  48. 48. • 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. Antibiotic Prescribing Children real Concern 14-06-2013 Dr.T.V.Rao MD 48
  49. 49. Rationalism in Implementation Many choices ? • Introduce step- by- step regulation of antibiotic usage, concentrating on higher end antibiotics first and then slowly extending the list to second and first line antibiotics?14-06-2013 Dr.T.V.Rao MD 49
  50. 50. 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. 14-06-2013 Dr.T.V.Rao MD 50
  51. 51. 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. 14-06-2013 Dr.T.V.Rao MD 51
  52. 52. 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 Dr.T.V.Rao MD 5214-06-2013
  53. 53. 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 class A: GES and KPC – Subgroup 3b contains a smaller group of MBLs that preferentially hydrolyze carbapenems • IMP and VIM enzymes that have appeared globally, most frequently in non-fermentative bacteria but also in Enterobacteriaceae 14-06-2013 Dr.T.V.Rao MD 53
  54. 54. Notifying Pan Resistant Microbes Superbugs • Pan-drug-resistant Gram-negatives, carbapenem- resistant Gram- Negatives, Vancomycin- resistant Enterococcus and MRSA should be made notifiable14-06-2013 Dr.T.V.Rao MD 54
  55. 55. MDR TB a Threat to Everyone 14-06-2013 Dr.T.V.Rao MD 55
  56. 56. 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 (MDR- TB). 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? 14-06-2013 Dr.T.V.Rao MD 56
  57. 57. 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 post- graduate courses. This deficit in the basic training can only be overcome if there is a change in the curriculum.14-06-2013 Dr.T.V.Rao MD 57
  58. 58. 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. 14-06-2013 Dr.T.V.Rao MD 58
  59. 59. WHONET Documentation Why We Need It 14-06-2013 Dr.T.V.Rao MD 59
  60. 60. What is WHONET Dr.T.V.Rao MD 60 • 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. 14-06-2013
  61. 61. • 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. Whonet helps us in …… Dr.T.V.Rao MD 6114-06-2013
  62. 62. 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 Dr.T.V.Rao MD 6214-06-2013
  63. 63. Clinicians can access data of their patients anytime in the computer just with click of the mouse Dr.T.V.Rao MD 6314-06-2013
  64. 64. • 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. Implementation of WHONET CAN HELP TO MONITOR RESISTANCE Dr.T.V.Rao MD 6414-06-2013
  65. 65. 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: “ 14-06-2013 Dr.T.V.Rao MD 65
  66. 66. 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 14-06-2013 Dr.T.V.Rao MD 66
  67. 67. Physicians Can Impact Other clinicians Patients Optimize patient evaluation Adopt judicious antibiotic prescribing practices Immunize patients Optimize consultations with other clinicians Use infection control measures Educate others about judicious use of antibiotics14-06-2013 Dr.T.V.Rao MD 67
  68. 68. 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) Dr.T.V.Rao MD 6814-06-2013
  69. 69. 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 14-06-2013 Dr.T.V.Rao MD 69
  70. 70. 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 14-06-2013 Dr.T.V.Rao MD 70
  71. 71. 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 ??? 14-06-2013 Dr.T.V.Rao MD 71
  72. 72. 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  Appropriate use is the only way of prolonging the useful life of an antibiotic14-06-2013 Dr.T.V.Rao MD 72
  73. 73. 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 | October–December 2012 | Volume 49 | Issue 4 • CDC, Atlanta USA Emerging Infectious Diseases • WHO guidelines on Antibiotic use 14-06-2013 Dr.T.V.Rao MD 73
  74. 74. 14-06-2013 Dr.T.V.Rao MD 74

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