1. 1. CDC; Antibiotic resistance threats in the United States, 2013 ANTIBIOTIC STEWARDSHIP 2
2. 2. National Center for Emerging and Zoonotic Infectious Diseases Division of Healthcare Quality Promotion Used with permission from: Centers for Disease Control and Prevention; CDC 24/7: Savings Lives, Protecting People TM
3. 3. Mission- Get Smart for Healthcare To optimize the use of antimicrobial agents in in- patient healthcare settings.
4. 4. Antibiotics are misused in hospitals It has been recognized for several decades that up to 50% of antimicrobial use is inappropriate. IDSA/SHEA Guidelines for Antimicrobial Stewardship Programs http://www.journals.uchicago.edu/doi/pdf/10.1086/510393
5. 5. Why we need to improve in-patient antibiotic use Antibiotics are misused in hospitals Antibiotic misuse adversely impacts patients and society Improving antibiotic use improves patient outcomes and saves money Improving antibiotic use is a public health imperative
6. 6. Antibiotics are misuse in a variety of ways Given when they are not needed Continued when they are no longer necessary Given at the wrong dose Broad spectrum agents are used to treat very susceptible bacteria The wrong antibiotic is given to treat an infection
7. 7. Antibiotic misuse adversely impacts patients- C. difficile Antibiotic exposure is the single most important risk factor for the development of Clostridium difficile associated disease (CDAD).1 Up to 85% of patients with CDAD have antibiotic exposure in the 28 days before infection.1 1. Chang HT et al. Infect Control Hosp Epidemiol 2007; 28:926931.
8. 8. Antibiotic exposure increases the risks of resistance Pathogen and Antibiotic Exposure Increased Risk Carbapenem Resistant Enterobactericeae and Carbapenems 15 fold 1 ESBL producing organisms and Cephalosoprins 6- 29 fold 3,4 Patel G et al. Infect Control Hosp Epidemiol 2008;29:1099-1106 Zaoutis TE et al. Pediatrics 2005;114:942-9 Talon D et al. Clin Microbiol Infect 2000;6:376-84
9. 9. Antibiotic misuse adversely impacts patients- resistance Increasing use of antibiotics increases the prevalence of resistant bacteria in hospitals. Antibiotic resistance increases mortality. Getting an antibiotic increases a patients chance of becoming colonized or infected with a resistant organism.
10. 10. Antibiotic misuse adversely impacts patients - adverse events In 2008, there were 142,000 visits to emergency departments for adverse events attributed to antibiotics.1 National estimates for in-patient adverse events are not available, but there are many reports of serious adverse events (aside from C. difficile infection) from in-patient antibiotic use. 1 Shehab N et al. Clinical Infectious Diseases 2008; 15:735-43
11. 11. Clinical outcomes better with antimicrobial management program 0 20 40 60 80 100 Appropriate Cure Failure AMP UP RR 2.8 (2.1-3.8) RR 1.7 (1.3-2.1) RR 0.2 (0.1-0.4) Percent AMP = Antibiotic Management Program UP = Usual Practice Fishman N. Am J Med. 2006;119:S53.
12. 12. Improving antibiotic use saves money Comprehensive programs have consistently demonstrated a decrease in antimicrobial use with annual savings of $200,000 - $900,000 IDSA/SHEA Guidelines for Antimicrobial Stewardship Programs http://www.journals.uchicago.edu/doi/pdf/10.1086/510393
13. 13. Improving antibiotic use is a public health imperative Antibiotics are the only drug where use in one patient can impact the effectiveness in another. If everyone does not use antibiotics well, we will all suffer the consequences. Antibiotics are a shared resource, (and becoming a scarce resource). Using antibiotics properly is analogous to developing and maintaining good roads.
14. 14. Goals- Get Smart for Healthcare Improve patient safety through better treatment of infections. Reduce the emergence of anti-microbial resistant pathogens and Clostridium difficile. Heighten awareness of the challenges posed by antimicrobial resistance in healthcare and encourage better use of antimicrobials as one solution.
15. 15. Development of the National Action Plan 16
16. 16. Development of the National Action Plan The National Action Plan was developed in response to Executive Order 13676: Combating Antibiotic - Resistant Bacteria which was issued by President Barack Obama on September 18, 2014 in conjunction with the National Strategy for Combating Antibiotic- Resistant Bacteria. 17
17. 17. The goals of the National Action Plan Significant Outcomes of Goal 1 Reduction of inappropriate antibiotic use by 50% in outpatient settings and by 20% in inpatient settings. 18
18. 18. The goals of the National Action Plan 1. Slow the emergence of resistant bacteria and prevent the spread of resistant infections. 2. Strengthen national One-Health Surveillance efforts to combat resistance. 19
19. 19. The goals of the National Action Plan 3. Advance development and use of rapid and innovative diagnostic tests for identification and characterization of resistant bacteria. 20
20. 20. The goals of the National Action Plan 4. Accelerate basic and applied research and development for new antibiotics, other therapeutics and vaccines. 5. Improve international collaboration and capacities for antibiotic-resistance prevention, surveillance, control, and antibiotic research and development. 21
21. 21. The goals of the National Action Plan Sub-Objective 1.1.1B: Get Smart: Know When Antibiotics Work. Many antibiotics prescribed in doctors offices, clinics, and other outpatient settings are not needed. This program focuses on appropriate antibiotic prescribing and use for common illnesses in children and adults. 22
22. 22. The goals of the National Action Plan Sub-Objective 1.1.1B: Get Smart for Healthcare. Many patients in hospitals, nursing homes, and other healthcare facilities receive antibiotics to fight infections, but these drugs are often prescribed incorrectly. 23
23. 23. The goals of the National Action Plan Sub-Objective 1.1.1B: Get Smart for Healthcare. This program helps clinicians prescribe the right drugs for the right patients at the right doses and times. 24
24. 24. Antibiotic Stewardship Antibiotics 25
25. 25. Antibiotics Myth 1. They can cure colds and the flu. Not so. Antibiotics work against only bacterial infections, not viral ones such as colds, the flu, most sore throats, and many sinus and ear infections. 26 STOP SUPERBUGS NOW; Myths about antibiotics; No, they won't help with the cold or flu, and other common misconceptions. Teresa Carr; Consumer Reports; Published: June 25, 2015
26. 26. Antibiotics Myth 2. They have few side effects. Almost 1 in 5 emergency-room visits for drug side effects stems from antibiotics. In children, the drugs are the leading cause of such visits. 27 STOP SUPERBUGS NOW; Myths about antibiotics; No, they won't help with the cold or flu, and other common misconceptions. Teresa Carr; Consumer Reports; Published: June 25, 2015
27. 27. Antibiotics Those side effects include diarrhea, yeast infections, and in rare cases, nerve damage, torn tendons. Allergic reactions that include rashes, swelling of the face or throat, and breathing problems. 28 STOP SUPERBUGS NOW; Myths about antibiotics; No, they won't help with the cold or flu, and other common misconceptions. Teresa Carr; Consumer Reports; Published: June 25, 2015
28. 28. Antibiotics The drugs can kill off good bacteria, increasing the risk of some infections, including C. difficile. At least 250,000 people a year now develop C. diff. infections linked to antibiotic use, and 14,000 die as a result. 4 29 STOP SUPERBUGS NOW; Myths about antibiotics; No, they won't help with the cold or flu, and other common misconceptions. Teresa Carr; Consumer Reports; Published: June 25, 2015
29. 29. Antibiotics Myth 3. A full course lasts at least a week. Not always. A shorter course can work for some infections, such as certain urinary tract, ear, and sinus infections. So ask your doctor for the shortest course and lowest dose of antibiotics necessary to treat your infection. 30 STOP SUPERBUGS NOW; Myths about antibiotics; No, they won't help with the cold or flu, and other common misconceptions. Teresa Carr; Consumer Reports; Published: June 25, 2015
30. 30. Antibiotics Myth 4. Its OK to take leftover medication. Nope. First, you may not need an antibiotic at all. And if you do, the leftovers may not be the right type or dose for your infection. 31 STOP SUPERBUGS NOW; Myths about antibiotics; No, they won't help with the cold or flu, and other common misconceptions. Teresa Carr; Consumer Reports; Published: June 25, 2015
31. 31. Antibiotics Taking them could allow the growth of harmful and resistant bacteria. Return unused antibiotics to the pharmacy or mix them with coffee grounds or cat litter and toss in the trash. 32 STOP SUPERBUGS NOW; Myths about antibiotics; No, they won't help with the cold or flu, and other common misconceptions. Teresa Carr; Consumer Reports; Published: June 25, 2015
32. 32. Antibiotics Myth 5. All bacterial infections require drugs. Mild ones sometimes clear up on their own. So ask your doctor whether you could try waiting it out. 33 STOP SUPERBUGS NOW; Myths about antibiotics; No, they won't help with the cold or flu, and other common misconceptions. Teresa Carr; Consumer Reports; Published: June 25, 2015
33. 33. Antibiotics Myth 6. The more bacteria a drug kills, the better. Wrong. So-called broad-spectrum drugs, such as ceftriaxone, cipro- floxacin and levofloxacin, should be reserved for hard-to-treat infections. 34 STOP SUPERBUGS NOW; Myths about antibiotics; No, they won't help with the cold or flu, and other common misconceptions. Teresa Carr; Consumer Reports; Published: June 25, 2015
34. 34. Pathogen Cases Streptococcus pneumoniae 20-60% Haemophilus influenza 3-10% Staphylococcus aureus 3-5% Gram-negative bacilli 3-10% Legionella species 2-8% Mycoplasma pneumoniae 1-6% Chlamydia pneumoniae 4-6% Viruses 2-15% Aspiration 6-10% Others 3-5% Adapted from Mandell LA, Bartlett JG, Dowell SF, et al: Update of practice guidelines for the management of community-acquired pneumonia in immunocompetent adults. Clin Infect Dis 2003;37:1405-1433. Many pathogens: Which to treat? 35
35. 35. Methods Used Today 36
36. 36. Medical history Physical exam Chest x-rays Blood tests Blood culture Sputum collection CT chest computed tomography Current methods to determine if patients have pneumonia 37 Current methods to determine if patients have pneumonia
37. 37. Thoracentesis Pleural fluid culture Pulse oximetry Nasal swab Throat swab Urine antigen Bronchoscopy - BAL Current methods to determine if patients have pneumonia 38 Current methods to determine if patients have pneumonia
38. 38. Specimens are very often contaminated from the upper respiratory resulting in many false positives. This leads to broad antibiotic treatment because the actual pathogen causing the pneumonia is usually never identified. 39 Current sampling data is not reliable or accurate
39. 39. Chest x-rays can reveal areas of opacity (seen as white) which represent consolidation. Pneumonia is not always seen on x- rays, either because the disease is only in its initial stages, or because it involves a part of the lung not easily seen by x-ray. X-rays cannot identify pathogens. Routine chest x-rays 40
40. 40. PneumoniaChecktm 41
41. 41. Glossary Disruptive technology: Introducing new technology to current technology which will change the way things are done. 42
42. 42. The Need 43
43. 43. The Need Pneumonia is a leading cause of death in children worldwide. Over 2 million children die from pneumonia each year and one child dies every 20 seconds. The problem with current diagnosis methods is one of sampling. Mouth and nose samples have contaminating bacteria, which result in many false positives. 44
44. 44. The Need Additionally, the samples are unable to identify the pathogen; hospital stays are lengthened increasing the chances that cases will become complicated. Since the pathogen cannot be identified, patients receive broad- spectrum antibiotics, which are often unnecessary and can cause antibiotic resistance. 45
45. 45. The Need Other methods, such as a chest x-ray, can identify fluid in the lungs, but cannot identify the specific pathogen causing the pneumonia. 46
46. 46. The Need Antibiotic resistance is one of the world's most pressing public health threats. Antibiotics are the most important tool we have to combat life- threatening bacterial disease, but using antibiotics can also result in side effects. 47
47. 47. The Need Antibiotic use leads to new drug- resistant germs and increased risks to patients. Patients, healthcare providers, hospital administrators and policy makers must work together to employ safe and effective strategies for improving antibiotic use ultimately saving lives. 48
48. 48. The Need Antimicrobial resistance is one of our most serious health threats. Infections from resistant bacteria are now too common, and some pathogens have even become resistant to multiple types or classes of antibiotics. Dr. Tom Frieden, MD, MPH Director, U.S. Centers for Disease Control and Prevention Meeting the Challenges of Drug-Resistant Diseases in Developing Countries Committee on Foreign Affairs Subcommittee on Africa, Global Health, Human Rights, and International Organizations United States House of Representatives April 23, 2013 49
49. 49. The Solution 50
50. 50. Pneumonia kills more children than any other disease. Unfortunately, the pathogen cannot be identified in most patients. Thepathogens causing pneumonia are difficult to identify because a high quality specimen from the lower lung is difficult to obtain due to contamination of the sample. Development of PneumoniaCheck 51
51. 51. PneumoniaCheck was developed and designed to collect aerosolspecimens selectively from the lower lung generated during deep cough. This technology allows PneumoniaCheck to effectively separate the upper respiratory tract from the aerosols in the lung by >90%. Development of PneumoniaCheck 52
52. 52. PneumoniaCheck utilizes a separation reservoir and specially designed mouthpiece to segregate contents from the upper airway and the lower lungs. Development of PneumoniaCheck 53
53. 53. PneumoniaCheck includes several specially designed features to exclude oral contaminants from the sample and a filter to collect theaerosolized pathogens from the lower lungs. The filter can collect >99.97% of virus and bacteria sized particles from the sampled lower lung aerosols. Development of PneumoniaCheck 54
54. 54. PC saves time and money diagnosing pneumonia; however, it is NOT a diagnostic device. Development of PneumoniaCheck 55
55. 55. PneumoniaCheck - The Device 56
56. 56. The Device PneumoniaCheck uses fluid mechanics to separate the upper airway particles from the lower airway particles. The separation means that only a lung specimen is captured on the filter media at the end of the device. 57
57. 57. The Device This filter can then be analyzed using traditional microbiology methods or more sensitive molecular DNA analysis to identify the specific pathogen causing pneumonia, or other lower respiratory infections. 58
58. 58. The Device The ability to identify the specific pathogen will allow for more targeted antibiotic treatment or none at all if viral, which should reduce antibiotic resistance and other complications. 59
59. 59. The Device PneumoniaCheck is an easy-to-use, noninvasive, disposable solution for collecting respiratory specimens to help reduce one of the worlds largest health problems. PneumoniaCheck may be used on patients three feet and taller. 60
60. 60. 61
61. 61. To use PneumoniaCheck, a patient simply coughs deeply into the mouthpiece and expels the remaining air in his or her lungs. This action can be repeated as many times as necessary to collect a sufficient sample of lower respiratory aerosolized pathogens. Recommend collecting 10 coughs 62
62. 62. The air from the upper respiratory is collected in a reservoir, and aerosols from the lower respiratory are captured on a microbial filter. The filter can then be sent to a laboratory to be tested for the presence of various pathogens. 63
63. 63. PneumoniaCheck uses fluid mechanics to isolate lung pathogens onto the filter. Fluid mechanics is the branch of physics that studies fluids (liquids, gases, and plasmas) and the forces on them. 64
64. 64. 65
65. 65. 66
66. 66. 67
67. 67. The air from the upper respiratory is collected in a reservoir, and aerosols from the lower respiratory are captured on a microbial filter. PneumoniaCheck is then sent to a laboratory to be tested for the presence of various pathogens. 68
68. 68. The link from diagnosis to treatment 69
69. 69. 70
70. 70. Questions? ARC Medical Inc. PneumoniaCheck arcmedical.com 71