Need for Antibiotic Policy in Health care �Dr.T.V.Rao MD

Need for Antibiotic Policy in Health care �Dr.T.V.Rao MD

1. Need for Antibiotic Policy in Health care Dr.T.V.Rao MD 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 1

2. Antibiotic Pressure and Resistance in Bacteria What is it and why is it important? How extensive is it? How does it happen? What factors promote the spread of resistant bacteria ? How does it pertain to the development of CA-MRSA infections? What can HCW do to curb this trend? 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 2

3. Antibiotic Pressure and Resistance in Bacteria What is it ? ”Selection pressure of antibiotics has led to the emergence of antibiotic-resistant bacteria.” Antibiotics can effect bacteria unrelated to the targeted infectious agent; these may be “normal” flora, leading to the emergence of resistant mutants inhabiting the same environment. Baquero et al., International Report 1996;23:819 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 3

4. Why We Need to learn more about Antibiotics Antibiotic resistance has developed in almost all classes of bacteria of pathogenic potential. Resistance in organisms of low virulence can emerge as important pathogens. The development of resistant bacteria has driven pharmaceutical research to develop more potent, broad-spectrum antibiotics. Use of these in turn, has fueled the appearance of bacteria with newer modes of resistance. 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 4

5. World has Changed with 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 5

6. 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)

7. 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." 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 7

8. 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 @ Antibiotic policy 8 24-09-2023

9. 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 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 9

10. A Changing Landscape for Numbers of Approved Antibacterial Agents Bars represent number of new antimicrobial agents approved by the FDA during the period listed. 2 4 6 8 10 12 14 16 18 Number of agents approved 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 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 10

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12. 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 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 12

13. Scarcity of New Antibiotics 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 13

14. 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 @ Antibiotic policy 14 24-09-2023

15. Use of antibiotics with no clinical indication ( eg , for viral infections) Use of broad spectrum antibiotics when not indicated Inappropriate choice of empiric antibiotics Inappropriate Antibiotic Use 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 15

16. 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 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 16

17. Poverty and Drug Resistance Poverty encourages drug resistance due to under utilization of appropriate Antibiotics. 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 17

18. 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 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 18

19. 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? 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 19

20. 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. 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 20

21. Chemists real threat Soaring sales of antibiotics at Indian pharmacies are compounding drug-resistance problems 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 21

22. Carbapenems a real threat Source ; Nature ( International Journal of Science) 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 22

23. 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 @ Antibiotic policy 23 24-09-2023

24. Creation of SUPERBUGS Antimicrobial resistance is a serious global challenge. Every continent and country faces the menace of antibiotic resistant “super bugs,” though the extent and the severity of the problem varies. There could be a return to the pre-antibiotic era, where many people could suffer or die from untreatable bacterial infections 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 24

25. Hospital Intensive care units Oncology units Dialysis units Rehab units Transplant units Burn units Settings that Foster Drug Resistance 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 25

26. Treated without Coordination When the patients to be treated by several specialists, multiple antibiotics prescribed, Drug Antagonism 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 26

27. 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% 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 27

28. 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 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 28

29. Why inappropriate use of antibiotics contributes to antibiotic resistance – the “why” Dr.T.V.Rao MD @ Antibiotic policy 29 24-09-2023

30. 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. 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 30

31. 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 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 31

32. 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. 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 32

33. 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 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 33

34. 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. 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 34

35. 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 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 35

36. 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. 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 36

37. 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. 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 37

38. 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 antibiotic and 50% [adapt to national figure where available] of all antibiotic use in hospitals can be inappropriate. Dr.T.V.Rao MD @ Antibiotic policy 38 24-09-2023

39. 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 @ Antibiotic policy 39 24-09-2023

40. Why we Need Antibiotic Policy Dr.T.V.Rao MD @ Antibiotic policy 40 24-09-2023

41. We are Under Scanner for many reasons 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 41

42. 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 @ Antibiotic policy 42 24-09-2023

43. 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 @ Antibiotic policy 43 24-09-2023

44. 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 @ Antibiotic policy 44 24-09-2023

45. 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 @ Antibiotic policy 45 24-09-2023

46. 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. 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 46

47. 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 @ Antibiotic policy 47 24-09-2023

48. 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 @ Antibiotic policy 48 24-09-2023

49. 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 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 49

50. 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. 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 50

51. 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 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 51

52. 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 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 52

53. 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? 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 53

54. 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. 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 54

55. 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. 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 55

56. 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 @ Antibiotic policy 56 24-09-2023

57. 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 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 57

58. Notifying Pan Resistant Microbes Superbugs Pan-drug-resistant Gram-negatives, carbapenem-resistant Gram-Negatives, Vancomycin- resistant Enterococcus and MRSA should be made notifiable 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 58

59. MDR TB a Threat to Everyone 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 59

60. 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? 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 60

61. 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. 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 61

62. 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. 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 62

63. WHONET Documentation Why We Need It 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 63

64. What is WHONET Dr.T.V.Rao MD @ Antibiotic policy 64 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. 24-09-2023

65. 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 @ Antibiotic policy 65 24-09-2023

66. 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 @ Antibiotic policy 66 24-09-2023

67. Clinicians can access data of their patients anytime in the computer just with click of the mouse Dr.T.V.Rao MD @ Antibiotic policy 67 24-09-2023

68. 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 @ Antibiotic policy 68 24-09-2023

69. 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: “ 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 69

70. 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 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 70

71. 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 antibiotics 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 71

72. 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 u seful 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 @ Antibiotic policy 72 24-09-2023

73. 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 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 73

74. 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 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 74

75. 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 ??? 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 75

76. 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 antibiotic 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 76

77. 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 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 77

78. Program file created by Dr.T.V.Rao MD for benefit of Medical Nursing and Health care Professionals [email protected] 24-09-2023 Dr.T.V.Rao MD @ Antibiotic policy 78

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