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Rational use of antibiotics & antibiotic policy

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Rational use of antibiotics, antibiotic policy, antimicrobial stewardship, CARAT criteria, WHONET

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Rational use of antibiotics & antibiotic policy

  1. 1. Rational use of antibiotics & antibiotic policy By – Dr. Vikas S. Sharma Dept. Of Pharmacology GMC, Nagpur 1 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  2. 2. Overview i. Introduction ii. Antimicrobial resistance & Antimicrobial resistance cycle iii. Rational use of drugs iv. Irrational use of antimicrobial v. General principles in use of antibiotics vi. The Council for Appropriate & Rational Antibiotic Therapy (CARAT) vii. Promoting rational prescription viii.National antibiotic policy ix. Antimicrobial stewardship x. Summary 2 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  3. 3. “Medicines are nothing in themselves, if not properly used, but the very hands of Gods, if employed with reason and prudence.” - Herophilus, Greek Physician 3 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  4. 4. History of chemotherapy • Chemotherapy: • Pre-Ehrlich era: Before 1891 E.g. - Mouldy curd by Chinese in boils Cinchona bark in malaria Mercury in syphilis Use of chemical compounds in treatment of infectious diseases, so as to destroy offending organisms & parasites without damaging host tissues 4 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  5. 5. • Period of Paul Ehrlich (1891-1935): Dyes and organometallic compounds – “magic bullets” E.g. methylene blue for malaria Arsenic for syphilis • Period after 1935: Discovery of sulfonamides and antibiotics 5 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  6. 6. Antibiotic Era • Antibiotics - “miracle drugs” in 1940s • Penicillin, wonder drug, saved millions of lives in World war II & many mothers were saved from puerperal sepsis • Their widespread availability & success led to dramatic reduction in morbidity & mortality 6 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  7. 7. Antibiotic Resistance • As if proving the saying – “What doesn’t kill you, only makes you stronger” Bacteria underwent a rapid unprecedented evolution to circumvent this menace to their survival • WHO – 7 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017 Microorganism’s resistance to an antibiotic drug that was once able to treat an infection by that microorganism
  8. 8. Mechanism of resistance and its transfer 1. Enzymatic alteration 2. Decreased permeability 3. Efflux 4. Alteration of target site 5. Protection of target site- Tetracycline, quinolones 6. Overproduction of target- Sulphonamides, trimethoprim, glycopeptide 7. Bypass of inhibited process- Sulphonamides, trimethoprim 8. Bind up antibiotic- Glycopeptide β Lactams, Aminoglycosides, Macrolides, Quinolones, Chloramphenicol 8 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  9. 9. 9 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  10. 10. What is Rational Use of Drugs? 10 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017 Requires that patients receive medicines appropriate to their clinical needs, in doses to meet individual requirements, for an adequate period of time, at the lowest cost to them & the community – WHO (1985)
  11. 11. What is causing antimicrobial resistance ? • Irrational use – • Irrational prescribing -  Taking antibiotics without prescription  Skipping doses of antibiotics  Taking antibiotics at irregular intervals  Saving antibiotics to use them later  Unnecessary prescription of antibiotics  Wrong selection of antibiotics  Inappropriate dose or duration of antibiotics 11 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  12. 12. What is causing antimicrobial resistance ??? • Indiscrimate use of Antibiotics in Animals • R plasmids spread among co- inhabiting bacterial flora in animals ( in gut ) • R plasmids may be mainly involved in animals spread to human commensal - E. coli followed by spread to more important human pathogens Eg Shigella spp. 12 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  13. 13. Irrational prescribing = "pathological" prescribing • Use of drugs when no drug therapy is indicated • Use of wrong drug for specific condition • Use of drugs with doubtful or unproven efficacy • Use of drugs of uncertain safety status • Failure to provide available, safe & effective drugs • Use of correct drugs with incorrect administration, dosages & duration • Use of unnecessarily expensive drugs 13 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  14. 14. Examples of inappropriate prescribing practices • Overuse of antibiotics & antidiarrheals for nonspecific childhood diarrhea • Indiscriminate use of injections, e.g. in malaria treatment • Multiple or over-prescription • Excessive use of antibiotics for treating minor acute respiratory tract infections 14 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  15. 15. Factors Underlying Irrational Use of Drugs • Patients:  Drug misinformation  Misleading beliefs  Patient demands/expectations  Marketing pressures  Economic considerations  Lack of access to proper health care 15 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  16. 16. Factors Underlying Irrational Use of Drugs... • Prescribers:  Lack of education and training  Inappropriate role models  Lack of objective drug information  Generalization of limited experience  Misleading beliefs about drugs efficacy  Delayed lab results, fear of clinical failure  Inappropriate peer norms  Local medical culture  Economic incentives  Patient demand of “quick fix” 16 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  17. 17. Factors Underlying Irrational Use of Drugs... • Workplace: • Drug Supply System:  Heavy patient load  Pressure to prescribe  Lack of adequate lab capacity  Insufficient staffing  Unreliable suppliers  Drug shortages  Expired drugs supplied 17 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  18. 18. Factors Underlying Irrational Use of Drugs... • Drug Regulation: • Industry:  Nonessential drugs available  Informal prescribers  Lack of rational drug policy  Lack of infrastructure  Lack of regulation enforcement  Promotional activities  Misleading claims 18 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  19. 19. Consequences of irrational use of antibiotics • Reduction in quality of drug therapy - ↑ morbidity & mortality • Waste of resources - ↓ availability of other vital drugs & ↑ costs • ↑ risk of unwanted effects - ADRs & emergence of antimicrobial resistance • Psychosocial impacts - “a pill for every ill” - apparent ↑ demand for drugs • ↑ Treatment failures 19 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  20. 20. General principles in use of antibiotics • Appropriate Antibiotic Therapy: 1. Perception of need Is an antibiotic necessary? 2. Choice of antibiotic What is the most appropriate antibiotic? 3. Choice of regimen What dose, route, frequency & duration are needed? 4. Monitoring efficacy Is the treatment effective? 20 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  21. 21. General principles I. Host factors: 1. Age – Some drugs are contraindicated in children like tetracycline - discolor teeth – Renal function and creatinine clearance ↓ elderly - ↓ doses 2. Renal and hepatic function: – Aminoglycosides and glycopeptides - carefully even in mild renal failure – Macrolides, metronidazole, rifampicin & INH - doses ↓ in liver failure 21 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  22. 22. Host factors… 3. Pregnancy & lactation – Aminoglycosides & tetracyclines should be avoided – Penicillins, cephalosporins & erythromycin appear to be safe – Drugs like trimethoprim, metronidazole & macrolides enter breast milk 4. Site of infection – Antibiotics need to achieve sufficient local conc. – Abscesses will require drainage, necrotic material to be debrided 22 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  23. 23. Host factors… 5. Immune status – AIDS, hematological malignancies; influence both likelihood of infection & its likely etiology 6. Presence of prosthetic material – Rarely respond to antibiotic therapy – Usually require removal of device 7. Allergy – Determination of previous allergic drug reactions – Drug of choice for syphilis in patient allergic to penicillin is tetracycline 23 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  24. 24. II. Likely infecting agent:  Clinical assessment may allow likely source of infection  Empirical treatment is aimed at these organisms  Bacteriological examination supports to establish definitive microbiological diagnosis (a) Bacteriological services are not available (b) Bacteriological services are available, but treatment cannot be delayed (c) Bacteriological services are available & treatment can be delayed for a few days 24 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  25. 25. III. Drug related factors 1. Spectrum of activity: For definitive therapy - narrow-spectrum drug For empirical therapy - broad-spectrum drug 2. Type of activity: Severe acute infections - cidal than a static drug Bactericidal antibiotic - superior (impaired host defence, life-threatening infections, infections at less accessible sites or when carrier state is possible) 25 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  26. 26. Drug related factors... 3. Sensitivity of the organism: Assessed on basis of MIC values & postantibiotic effect 4. Relative toxicity: Less toxic antibiotic is preferred e.g. β-lactam over aminoglycoside 5. Pharmacokinetic profile: For optimum action antibiotic has to be present at site of infection in sufficient conc. for adequate length of time 26 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  27. 27. Drug related factors...  For many organisms, aminoglycosides, fluoroquinolones & metronidazole - ‘concentration-dependent inhibition’  For many organisms, β-lactams, glycopeptides & macrolides - ‘time-dependent inhibition’  Penetration to site of infection - drug which penetrates better & attains higher conc. at site of infection 6. Cost: Less expensive drugs are to be preferred 27 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  28. 28. Drug related factors... 7. Routes of administration:  Parenteral therapy: • Seriously ill patient, where effective drug conc. are required rapidly at site of infection • Drugs not orally absorbed e.g. aminoglycosides • Oral route is contraindicated  Oral therapy  Topical therapy • Superficial skin infections, mucosal candidiasis, middle ear & superficial ocular infections 28 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  29. 29. Drug related factors... 8. Dosage regimens: – Dose influenced by severity of infection, age & weight – Standard treatment guidelines should be followed 9. Encouraging compliance: – Less frequency improves compliance 10. Length of treatment: – Depends upon site & severity of infections, causative organisms & patient’s response to treatment 29 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  30. 30. Combination therapy • Objectives: 1. To achieve synergism: Manifests in terms of ↓ in MIC of one antimicrobial agents in presence of another or MICs of both may be ↓ • General guidelines: (a) Two bacteriostatic agents are often additive, rarely synergistic (b) Two bactericidal drugs are frequently additive & sometime synergistic if organism is sensitive to both 30 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  31. 31. Combination therapy… (c) Combination of a bactericidal with bacteriostatic drug may be synergistic or antagonistic depending on organism  If organism is highly sensitive to cidal drug—response to combination is equal to static drug given alone (apparent antagonism)  If organism has low sensitivity to cidal drug—synergism 31 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  32. 32. Combination therapy… 2. To reduce severity or incidence of adverse effects: Possible only if combination is synergistic - doses can be ↓ 3. To prevent emergence of resistance:  Principle of using two or more antimicrobial agents together is valid primarily for chronic infections needing prolonged therapy  If incidence of resistant mutants of bacillus infecting individual for drug A is 105 and for drug B is 107, then only one out of 1012 bacilli will be resistant to both 32 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  33. 33. Combination therapy… 4. To broaden spectrum of antimicrobial action (a) Treatment of mixed infection - aerobic & anaerobic organisms sensitive to different drugs are often involved (b) Initial treatment of severe infections - drugs covering gram-positive and gram-negative (in certain situations anaerobes as well) (c) Topically - AMAs which are not used systemically, are poorly absorbed from local site & cover broad range of bacteria 33 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  34. 34. Disadvantages of combinations • Foster casual rather than rational outlook in diagnosis of infections & choice of antimicrobial agents • ↑ incidence & variety of ADRs. Toxicity of one agent may be enhanced by another • ↑ chances of superinfections • If inadequate doses of non-synergistic drugs are used— emergence of resistance • Higher cost of therapy 34 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  35. 35. The Council for Appropriate and Rational Antibiotic Therapy (CARAT) • CARAT is independent, multidisciplinary panel of healthcare professionals, clinicians as well as scientists, established to advocate appropriate & accurate use of antibiotics 35 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  36. 36. CARAT criteria  Evidence based results  Therapeutic benefits  Safety  Cost-Effectiveness  Optimal drug dose and duration 36 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  37. 37. Evidence based results • In choosing an antibiotic, clinicians should consider clinical evidence –  Drug is clinically and microbiologically appropriate  Efficacy of drug in well-designed clinical trials  Antibiotic resistance pattern of local region • Well conducted, randomized, controlled clinical trials provide highest quality information for making decisions 37 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  38. 38. Therapeutic Benefits • Key to applying evidence-based results & making appropriate therapeutic choices for each patient involves determining correct diagnosis & analyzing therapeutic benefits of possible treatments • To maximize patient health & reduce unnecessary prescribing, therapeutic benefits of each drug should be considered relative to status of patient’s infection 38 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  39. 39. Therapeutic Benefits… • Clinician must consider any evidence that particular antibiotic can result in clinical & microbiologic cure as well as treatment failures associated with absence of drug treatment • If possible, clinician should identify causative pathogen & use surveillance data on regional antibiotic resistance patterns in selecting optimal therapeutic agent 39 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  40. 40. Safety • Clinically applicable treatment strategies should be chosen to maximize efficacy while minimizing side effects • In study, between 1975 and 2000, 548 new chemical entities were approved for use in US; 45 of these (8.2%) acquired new black-box warnings & 16 (2.9%) were withdrawn from market during this time • Of 16 withdrawn from market, 8 were withdrawn within 2 years after their introduction • E.g. Temafloxacin was withdrawn 0.3 years after introduction and grepafloxacin was withdrawn 2.0 years after introduction 40 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  41. 41. Cost effectiveness • Choosing inappropriate therapy is associated with increased costs, including cost of antibiotic & increases in overall costs of medical care Due to treatment failures and adverse events • Using optimal course of antibiotics can have economic as well as clinical advantages • Outpatients may experience faster return to their normal daily routine & earlier return to work 41 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  42. 42. Optimal Drug for Optimal Duration • Optimal drug selection requires finding antimicrobial class & specific member of that class • Because empiric therapy is used in most cases: - Etiologic agent - gram +VE or gram –VE ? - Narrow or broad-spectrum agent ? - Resistance patterns of likely pathogen to this drug, both nationally and regionally & - Individual patient’s medical history, including recent antibiotic exposure 42 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  43. 43. Optimal Drug for Optimal Duration… • Optimal duration: Prescribing selected drug for shortest amount of time required for clinical & microbiologic efficacy – Decreased side effects – Increased patient adherence – Decreased promotion of resistance – Decreased cost 43 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  44. 44. The pipeline is drying up! US FDA approval of new antibacterials down 56% from 1983 to 2002  Infectious diseases are still most common cause of death worldwide  We are effectively living in post-antibiotic era  Therefore, we must manage carefully and responsibly what we have 44 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  45. 45. Science magazine; July 18, 2008 The last decade has seen inexorable proliferation of a host of antibiotic resistant bacteria, or bad bugs, not just MRSA, but other insidious players as well… For these bacteria, the pipeline of new antibiotics is verging on empty. 'What do you do when you're faced with an infection, with a very sick patient, and you get a lab report back and every single drug is listed as resistant?' asked Dr. Fred Tenover, Centers for Disease Control and Prevention (CDC). 'This is a major blooming public health crisis.’ 45 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  46. 46. Best way to keep the matters in order • Nearly 50% of hospitalized patients receive antimicrobial agents • Every hospital should have a policy which is practicable to their circumstances • Rigid guidelines without coordination will lead to greater failures • Only way to keep antimicrobial agents useful is to use them appropriately & judiciously 46 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  47. 47. National Policy • Government of India - National policy for containment of antimicrobial resistance in 2011 • Aims & objectives: 1. Understanding emergence & spread of antimicrobial resistance & the factors influencing it 2. Establish nationwide well coordinated antimicrobial program with well defined & interlinked responsibilities & functions of different arms of program 47 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  48. 48. National policy for containment of antimicrobial resistance in 2011... 3. Rationalizing usage of available antimicrobials 4. Reducing antibiotic selection pressures by appropriate control measures 5. Promotion of discovery of newer & effective antimicrobials based on current knowledge of resistance mechanisms 6. Rapid and accurate diagnosis of infections & infectious diseases 48 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  49. 49. Antibiotic policy • A corporate document that is designed to further the aim of the hospital to provide a high standard of patient care • Principles of antibiotic policy were laid down in 1980s 49 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  50. 50. Antibiotic policy… • Educational programs designed to improve antibiotic uses • Controls operated through Pharmacy department – Creation of hospital pharmacopeia – Written justification for costlier & broader spectrum antibiotics – Introduction of concept of stop orders – Automatic changes from IV to oral antibiotic therapy – Sponsoring of antibiotics according to their usage e.g. prophylaxis, specific therapy, therapeutic trials etc. 50 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  51. 51. Antibiotic policy… • Controls through laboratory in form of reporting, regular issue of resistance / susceptibility patterns & active consultations • Establishment of antibiotic advisory service in hospitals • Publication of consensual antibiotic policy for special use e.g. prophylaxis & specialized clinical units • Audit of antibiotic usage; antibiotics as a class of drugs accounts for largest expenditure in health care system 51 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  52. 52. Antibiotic policy… • Promotion of ethical relationship between the pharmaceutical companies, prescribers and pharmacists • Regulation of antibiotic usage in veterinary practices. All veterinary antibiotics should need prescription • Monitoring of antibiotic residues in food of animal origin • Encourage research to develop new molecules Infectious Disease Society of America’s “10 × ‘20 initiative” 52 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  53. 53. What can we do ? 53 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  54. 54. Promoting rational prescribing • Standard treatment guidelines - when evidence- based, developed with end-users, with active dissemination & follow-up • Essential medicines lists - when linked to treatment guidelines & used for training & supply • Hospital Drugs & Therapeutic Committees • Undergraduate training • Comprehensive approach, with all components 54 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  55. 55. Possible interventions in private sector • Regulation: Market approval, re-licensing, re-evaluation per therapeutic category, regulation of promotion, ban over-the-counter (OTC) sale of antimicrobials • Training: Basic training, national clinical guidelines, CMEs by universities & professional bodies, re-licensing of professionals on basis of education points, medical audit, patient information leaflets, public education 55 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  56. 56. Possible interventions in private sector... • Financial incentives: Separate prescribing from dispensing, dispensing fee (flat or tiered), price controls on generic / brand drugs, contracting out • Insurance: Reimbursement limited to essential medicines, reference pricing 56 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  57. 57. Educating Practitioners • Seminars • Panel discussion • Updates 57 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  58. 58. Don’t let the advertisements block our intelligence !!! ***Read the fine prints  The drug is 10 times more potent but may cause renal damage in some  The most effective antibiotic For what? At what cost? What duration? 58 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  59. 59. Educating Consumers No self medication No own antibiotic kit Emphasis on dose and duration 59 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  60. 60. Standard Treatment Guidelines  A systematically developed statement to assist practitioners in making decisions about appropriate health care for specific clinical conditions  These guidelines should be tailored to local situations and specific to levels of care  From national level to hospital level 60 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  61. 61. Key features of standard treatment guidelines • Simplicity • Credibility • Same standard for all levels • Drug supply based on standard treatment guidelines • Introduce in pre-service training • Dynamic (regular updates) • Handy pocket books 61 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  62. 62. Increasing use of diagnostic tests • Lack of adequate, well equipped laboratory facilities • Under-utilization of microbiological labs • Ministry of Health & Family Welfare recommends for increase in utilization of diagnostic tests in clinical practice • Newer rapid molecular diagnostic tests –  Peptide nucleic acid technology  Matrix-assisted laser desorption/ionization technology  rapid polymerase chain reaction 62 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  63. 63. Surveillance • Two complementary types of surveillance - – Surveillance for antibiotic resistance – Surveillance for antibiotic use • Knowing resistance levels & tracking them over period of time is powerful tool to support real changes • Once link between resistance & antibiotic is accepted, tracking antibiotic use can be used as surrogate for changes in antibiotic resistance 63 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  64. 64. Surveillance…  Sentinel surveillance for antimicrobial resistance: • Provides only indicative data, but the same can be extrapolated to rest of population • Suitable mode of surveillance when prolonged & detailed data is needed • Best approach for our country 64 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  65. 65. WHONET Software • Free Windows-based database software • Developed for management & analysis of microbiology laboratory data with special focus on analysis of antimicrobial susceptibility test results • Used by clinical, public health, veterinary & food laboratories in over 90 countries to support local & national surveillance programs 65 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  66. 66. Proposed care bundles for antibiotic prescribing • Acute care: initiation of therapy  Document clinical rationale for antibiotic initiation  Collect & send appropriate specimens to microbiology laboratory  Select antibiotic therapy according to local policies (i.e., local antimicrobial susceptibilities) & risk group (exclude drug allergy)  Consider removal of foreign body/drainage of pus/surgical intervention 66 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  67. 67. Proposed care bundles for antibiotic prescribing... • Acute care: continuation of therapy  On daily basis, consider de-escalation, parenteral-to-oral conversion, or discontinuation of antibiotic therapy based on clinical signs & symptoms and laboratory test results  Monitor serum antibiotic conc. in accordance with local policies 67 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  68. 68. Proposed care bundles for antibiotic prescribing... • Surgical prophylaxis:  Select antibiotic therapy based on local guidelines (i.e., local antimicrobial susceptibilities) & type of surgery (exclude drug allergy)  Give first dose within guideline-defined time before incision  Discontinue antibiotic therapy within guideline defined time after first preoperative dose or surgical end time 68 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  69. 69. Infection prevention & control methods for controlling antimicrobial resistance in hospitals • Hand hygiene • Contact (i.e. barrier) precautions • Active surveillance for and decolonization (i.e. eradication) of multidrug-resistant organisms • Preoperative antimicrobial prophylaxis 69 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  70. 70. Infection prevention & control methods for controlling antimicrobial resistance in hospitals... • Implementation of best practices for invasive procedures & devices (e.g., removal of unnecessary central catheters) • Disinfection & sterilization of medical devices • Environmental cleaning 70 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  71. 71. Antimicrobial stewardship • Definition – The optimal selection, dosage & duration of antimicrobial treatment that results in the best clinical outcome for the treatment or prevention of infection, with minimal toxicity to the patient and minimal impact on subsequent resistance 71 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  72. 72. Goals of antimicrobial stewardship • To work with health care practitioners to help each patient receive most appropriate antimicrobial with correct dose and duration • To prevent antimicrobial overuse, misuse & abuse • To minimize development of resistance • Reduction of health care costs without adversely impacting quality of care 72 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  73. 73. Antibiotic stewardship team Collaboration between antimicrobial stewardship team, hospital infection control, pharmacy, therapeutics committees & hospital administration is essential  Infectious Disease Physician  Clinical Pharmacist with infectious disease training  Clinical Microbiologist  Information system specialist  Infection control professional  Hospital epidemiologist (Optional) 73 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  74. 74. Antibiotic stewardship team… • Functions- – Providing high standard of patient care – Improving rational utilization of antibiotic – Pharmacovigilance of antimicrobial – Effective utilization of financial resources in purchase of antimicrobials – Curbing emergence of microbial resistance 74 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  75. 75. The Antibiotic Resistance Declaration • May 2014, Antibiotic Resistance Coalition - ‘Declaration on Antibiotic Resistance’ to advocate for policy change & action to prevent post-antibiotic era from becoming a bleak reality • Chennai Declaration: December 2012 A document, prepared by representatives of various stakeholders and eminent experts in India, to tackle the challenge of anti-microbial resistance from an Indian perspective 75 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  76. 76. Use of antibiotics wisely - The only solution • Before taking any antibiotic ask your physician if it is required & beneficial • Always take antibiotics as prescribed by physician • Take antibiotics to treat only bacterial infections • Don’t take antibiotics in viral infections such as cold, cough or flu • Don’t repeat same antibiotic for next time you get sick 76 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  77. 77. Use of antibiotics wisely - The only solution... • Don’t stop antibiotic before complete prescribed course of treatment • Don’t skip doses • Don’t copy antibiotic with same diseases which is prescribed for someone else • Educate yourself & talk to your physician about antibiotic resistance 77 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  78. 78. 78 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  79. 79. 79 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  80. 80. “The public will demand [the drug and] … then will begin an era … of abuses. The microbes are educated to resist penicillin and a host of penicillin-fast organisms is bred out which can be passed to other individuals and perhaps from there to others until they reach someone who gets a septicemia or a pneumonia which penicillin cannot save. In such a case the thoughtless person playing with penicillin treatment is morally responsible for the death of the man who finally succumbs to infection with the penicillin-resistant organism. I hope the evil can be averted.” - Alexander Fleming, 1945 80 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  81. 81. Summary • Infectious diseases are still serious problem, compounded by development of antibiotic resistance in many bacteria & relative lack of newer antimicrobial agents to combat these multi-resistant organisms • Appropriate aggressive short-course treatment is recommended for ensuring clinical & microbiologic cure, optimal patient adherence & minimal generation of antibiotic resistance 81 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  82. 82. • Ideally, institution of 5 CARAT criterias will optimize safe & well-tolerated treatment regimens, curb unnecessary prescribing of antibiotics, decrease treatment costs & increase adherence • By making antimicrobial stewardship part of our daily practice, we can improve patient safety & care, reduce unnecessary use of valuable resources & reduce resistance • Thus, antibiotic prescribing should be prudent, thoughtful & rational 82 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  83. 83. References • Goodman & Gilman’s The Pharmacological Basis of Therapeutics 12th Edition • R.S. SATOSKAR. PHARMACOLOGY AND PHARMACOTHERAPEUTICS 24th EDITION • Bertram G. Katzung & Anthony J. Trevor’s Basic & Clinical Pharmacology 13th Edition • National policy for containment of antimicrobial resistance, India 2011. 1 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  84. 84. References... • Vance MA, Millington WR. Principles of irrational drug therapy. Int J Health Serv. 2010;16(3):355–61. • National Nosocomial Infections Surveillance (NNIS) System Report, data summary from January 1992 through June 2003, issued August 2003. Am J Infect Control. 2003;31(8):481-498 • Dellit TH, Owens RC, McGowan JE Jr, et al. IDSA and SHEA guidelines for developing an institutional program to enhance antimicrobial stewardship. Clin Infect Dis. 2007;44(2):159-177 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  85. 85. References... • Gerding DN. The search for good antimicrobial stewardship. Jt Comm J Qual Improv. 2001;27(8):403- 404 • Thomas G. Slama et al. A clinician’s guide to the appropriate and accurate use of antibiotics: the Council for Appropriate and Rational Antibiotic Therapy (CARAT) criteria. doi:10.1016/j.amjmed.2005.05.007 • “Chennai Declaration” Team. “Chennai Declaration”: 5-year plan to tackle the challenge of anti-microbial resistance. IJMM, (2014) 32(3): 221-2281 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  86. 86. Thank you !!! Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017

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