Session #7005 Through The Looking Glass: Lab + IPC Create The Pathway To Antimicrobial Stewardship Through Collaboration in Your Workplace

Helen C. Ogden-Grable, BS-MT(ASCP)PBT Susan Jukins Hudson, RN,BSN,MPH,CIC,LHRM

Speaker Disclosure In the past 12 months, I have not had a significant financial interest or other relationship with the manufacturer(s) of the product(s) or provider(s) of the service(s) that will be discussed in my presentation.

PRESENTERS

Susan Jukins Hudson, RN,BSN,MPH,CIC,LHRM Oxford, Connecticut 239-398-1739 smj456766@yahoo.com Helen C. Ogden-Grable, BS-MT(ASCP)PBT Naples, Florida 239-290-3712 hcograble@aol.com 3

Setting The scene ACT 1

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The Origin of Infection Control The scientific study of nosocomial infections in hospitals began during the first half of the 18th century. From that time until the start of the “Bacteriological Era” many of the most notable contributions originated in Scotland. It was 100 years later in 1858 that Florence Nightingale shared her beliefs that hospitals needed serious reform. That doctors and nurses should have everyday sanitary knowledge that will allow them to help their patients avoid disease or to recover from disease. The real understanding of hospital infection followed upon the discoveries of Pasteur, Koch and Lister and the beginning of the Bacteriological Era.

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The Origin of Infection Control Fact: In most communities, a hospital was perceived as good because the doctors who practiced there were perceived as good, not because the hospital's patient outcomes were better than its competitors'. Fact: Most hospitals neither tracked nor had systems in place designed to improve their overall patient outcomes. Fact: The nosocomial staphylococcal epidemics of the 1950s began to change those attitudes. Fact: Hospital microbiology laboratory staff were the observers and recorders of all data pertaining to infection. The pathologists were the communicators. 8

The Origin of Infection Control Before we saw the first advancements in infection control, only conditions that brought patients near death warranted the risk of surgical intervention. Then, the fortunate patients who actually survived these surgical procedures faced the frightening fact that infection was nearly inevitable! The next challenge for these lucky patients was that death by overwhelming sepsis was knocking at their doors; ready to walk in and win the battle with few to no obstacles. Who were the pioneers who helped to develop Infection Control Protocols? The Medical Technologists who specialized in Microbiology. Keeping records,

noting trends and checking unusual & unexpected results in patient cultures. The Pathologists who communicated these facts to the ordering physicians.

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The Origin of Infection Control History did not record who first understood that hospitals are actual communities in which public health principles could be used to prevent and control infections. By the 1960s, hospital-based staff and CDC epidemiologists began to apply a public health model to infections acquired by patients in the hospital setting aka Hospital Acquired Infections – HAIs. One of their most important goals was to develop a systematic surveillance protocol to identify HAIs; along with an ongoing analysis of data to recognize and deal with potential problems. They learned to use investigative techniques with both epidemic and endemic infections. They also tried to implement effective intervention protocols to protect their patients, staff, and visitors. All of whom were at potential risk. During the 1960s, hospital-based infection control efforts had been established in scattered hospitals throughout the United States and quickly became a growing trend.

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The Origin of Infection Control Continuous and exciting changes took place through the 1970s and 1980s: a. Nurses were eager to become practitioners in this new (to them) profession.

There were definite financial advantages for nursing and nurses were used to communicating effectively with their patients.

b. The Association of Practitioners in Infection Control (APIC) was formed to provide continuing professional interaction, education and professional growth. A Certifying program followed in 1980.

c. Hospital epidemiologists then formed their own group, the Society of Hospital Epidemiologists of America (SHEA). Later changed to the Society for Healthcare Epidemiology of America. This group is now open to both physician and non-physician practitioners.

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The Offending Organisms • Antimicrobial resistance has been identified as one of the most serious public

health threats today • Inaction against resistance poses potentially catastrophic consequences

• The loss of effective antibiotics undermines our ability to fight infectious diseases

and manage the infectious complications in vulnerable populations

• Thought to be among the most dangerous antibiotic resistant threats are: Clostridium difficile, Methicillin resistant Staphylococcus aureus (MRSA), Carbepenem-resistant Enterobacteriaceae (CRE), Extended spectrum β-lactamase producing Enterobacteriaceae (ESBLs), Vancomycin-resistant Enterococcus (VRE), Multidrug-resistant Pseudomonas aeruginosa, and drug resistant Streptococcus pneumoniae to name a few

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The Offending Organisms Clostridium difficile

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• A unique bacterial infection that, although not significantly resistant to the drugs used to treat it, is directly related to antibiotic use and resistance.

• Causes greater than 250,000 illnesses each year, in excess of 14,000 deaths each year, and greater than 1,000,000,000 dollars in excess medical costs each year.

• Those most at risk are people, especially older adults, who take antibiotics and also get medical care.

• Take antibiotics exactly and only as prescribed

The Offending Organisms Methicillin resistant Staphylococcus aureus (MRSA)

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• Methicillin-resistant Staphylococcus aureus (MRSA) causes a range of illnesses, from skin and wound infections to pneumonia and bloodstream infections that can cause sepsis and death.

• Staph bacteria, including MRSA, are one of the most common causes of healthcare-associated infections.

• Causes greater than 80,461 severe infections each year and in

excess of 11, 285 deaths each year.

• Promote appropriate antibiotic use

The Offending Organisms Carbepenem-resistant Enterobacteriaceae (CRE)

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• Untreatable and hard-to-treat infections from carbapenem-resistant Enterobacteriaceae (CRE) bacteria are on the rise among patients in medical facilities. CRE have become resistant to all or nearly all the antibiotics we have today.

• Almost half of hospital patients who get bloodstream infections from CRE bacteria die from the infection.

• Causes greater than 9,000 drug resistant infections each year, greater than 7,900 hospital associated infections each year related to carbepenem resistant Klebsiella spp, greater than 1,400 hospital associated infections each year related to carbepenem resistant E. coli, and in excess of 600 deaths each year.

• CRE have become resistant to ALL or NEARLY ALL available antibiotics.

• Take antibiotics only as prescribed

The Offending Organisms Extended spectrum β-lactamase producing Enterobacteriaceae (ESBLS)

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• Extended-spectrum β-lactamase is an enzyme that allows bacteria to become resistant to a wide variety of penicillins and cephalosporins. Bacteria that contain this enzyme are known as ESBLs or ESBL-producing bacteria. ESBL-producing Enterobacteriaceae are resistant to strong antibiotics including extended spectrum cephalosporins.

• Causes greater than 26,000 drug resistant infections each year, greater than 140,000 infections each year related to Enterobacteriaceae, greater than 40,000 dollars in excess medical costs each year for each infection, and in excess of 1,700 deaths each year.

• Promote appropriate antibiotic use

The Offending Organisms Multidrug-resistant Pseudomonas aeruginosa

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• Pseudomonas aeruginosa is a common cause of healthcare-associated infections including pneumonia, bloodstream infections, urinary tract infections, and surgical site infections.

• Some strains of Pseudomonas aeruginosa have been found to be resistant to nearly all or all antibiotics including aminoglycosides, cephalosporins, fluoroquinolones, and carbapenems.

• Causes greater than 6,700 multi drug resistant Pseudomonas infections each year, greater than 51,000 Pseudomonas infections each year, and in excess of 440 deaths from infections each year.

• Take antibiotics only and exactly as prescribed

The Offending Organisms Streptococcus pneumoniae

• S. pneumoniae has developed resistance to drugs in the penicillin and erythromycin groups. Examples of these drugs include amoxicillin and azithromycin (Zithromax, Z-Pak). S. pneumoniae has also developed resistance to less commonly used drugs.

• Pneumococcal disease, whether or not resistant to antibiotics, is a major public health problem.

• Causes greater than 1,200,000 drug resistant infections each year, greater than 19,000 excess hospitalizations and in excess of 7,000 deaths each year.

• S. pneumoniae has been found to cost greater than 96,000,000 dollars in excess medical costs each year.

• Do not ask for antibiotics when your doctor thinks you do not need them

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The Offending Organisms

Drug Resistant Neisseria gonorrhoeae

• Neisseria gonorrhoea is the second most commonly reported notifiable infection in the United States and is easily transmitted. It causes severe reproductive complications and disproportionately affects sexual, racial, and ethnic minorities.

• Emergence of cephalosporin resistance, including ceftriaxone resistance, would significantly limit treatment options and could potentially destroy gonorrhea control efforts.

• Causes greater than 246,000 drug resistant gonorrhoea infections each year, greater than 820,000 gonococcal infections each year, and 188,600 resistant to Tetracycline.

• Prevention of Gonorrhoea is critical to prevention of drug resistance

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Discoveries: How The First Antibiotics Were Discovered !

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Serendipitous Discoveries !

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Discoveries: How The First Antibiotics Were Discovered ! Penicillin: As he returned from a holiday on September 3, 1928, Alexander Fleming began to sort through petri dishes containing colonies of Staphylococcus. This is a bacteria that can cause boils, sore throats and abscesses. He noticed something unusual on one dish. It was dotted with colonies, save for one area where a blob of mold was growing. The zone immediately around the mold, later identified as a rare strain of Penicillium notatum was clear, as if the mold had secreted something that was inhibiting any bacterial growth? Fleming called this his "mold juice“: Capable of killing a wide range of harmful bacteria, such as streptococcus, meningococcus and the diphtheria bacillus. ACS: Chemistry For Life

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Discoveries: How The First Antibiotics Were Discovered ! Streptomycin: Streptomycin was discovered by American biochemists Selman Waksman, Albert Schatz, and Elizabeth Bugie in 1943. They were able to synthesize this new drug from the soil organism Streptomyces griseus. The drug acts by interfering with the ability of a microorganism to synthesize certain vital proteins. It was the first antimicrobial agent developed after penicillin and the first antibiotic effective in treating tuberculosis. Because it was effective against a wide variety of diseases, streptomycin was used often, with the result that many initially sensitive microorganisms, including Mycobacterium tuberculosis, developed resistance to the antibiotic. It is used in combination with penicillin to treat endocarditis {infection of the heart valves}, and with the tetracyclines in the treatment of plague, tularemia, and brucellosis. Encylopaedia Brittanica

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Discoveries: How The First Antibiotics Were Discovered !

Cephalosporins: The first chemical compounds of the cephalosporin group were isolated from Cephalosporium acremonium, a cephalosporin-producing fungus first discovered by Giuseppe Brotzu in 1948 from a sewage outfall off the Sardinian coast. From crude filtrates of the Cephalosporium acremonium culture scientists got new antibacterial activity. It was noted that the crude filtrate could inhibit the growth of Staphylococcus aureus. Further investigations by Abraham and Newton were made in England and isolation of culture fluids from the Sardinian fungus yielded cephalosporin P, N and C. These natural compounds were not found to be potent enough to use as antimicrobial agents. Cephalothin, a first generation Cephalosporin for parenteral use was the first cephalosporin to become available for patients in this country. It was marketed by the pharmaceutical company Eli-Lilly in 1964. Foye's principles of medicinal chemistry. Philadelphia: Lippincott Williams & Wilkins.

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Discoveries: How The First Antibiotics Were Discovered ! Chloramphenicol: In 1947, chloramphenicol was discovered as a natural product secreted by the soil organism Streptomyces venezuelae found in soil and in compost. The new antibiotics efficacy was demonstrated with dramatic results in two typhus outbreaks in Bolivia and Malaysia in 1948. In 1949, chloramphenicol was approved for use by the US Food and Drug Administration as the first broad-spectrum antibiotic. It was easily synthesized, inexpensive to produce, and could be administered orally, parenterally, or topically. Chloramphenicol's excellent tissue and fluid penetration coupled with its broad antimicrobial spectrum led to its rapid worldwide acceptance. In the 1950s, chloramphenicol was used extensively in the treatment of infectious conditions ranging from the common cold, acne, and bronchitis to severe infections such as bacterial meningitis. The 1960’s brought a new awareness that would limit the use of this incredible drug: Doctors, Drug Reps and Free Samples!

Erlich W, Batz Q, Chloromycetin Smith R. a new antibiotic from a soil actinomycete. Science. 1947;106(2757):417–419. PubMed

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Discoveries: How The First Antibiotics Were Discovered !

Gentamycin The Chinese Microbiologist Yue Wang discovered Gentamicin in 1963. He synthesized the drug from cultures of Micromonospora which is a genus of Gram Positive Cocci found in soil and water. When it was first released in the early 1980s, Gentamicin was used for microbiological research; and eventually used to treat bacterial infections in patients. Gentamicin is an antibiotic that fights bacterial infections by stopping bacteria growth. It works by interrupting the protein synthesis of bacteria. The drug is a common treatment for urinary tract infections. Gentamicin is also used for infections in the blood, joints, bones, lungs, and skin. Doctors and patients need to be aware of the possible side effects: Ototoxicity and Nephrotoxicity. WHO: Model List of Effective Medicines: World Health Organization – October 2013

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Gentamycin: Micromonospora

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A Few Words About Phages & Phage Therapy A bacteriophage (informally - phage) is a virus that infects and replicates within a bacteria. The term is derived from 'bacteria' & the Greek phagein "to devour". Bacteriophages are composed of proteins that encapsulate a DNA or RNA genome, and may have relatively simple or elaborate structures. Their genomes may encode as few as four genes, and as many as hundreds of genes. Phage therapy or viral phage therapy is the therapeutic use of bacteriophages to treat pathogenic bacterial infections. Although extensively used and developed mainly in former Soviet Union countries circa 1920, the treatment is not approved in countries other than Russia. Phages are currently being used therapeutically to treat bacterial infections that do not respond to conventional antibiotics, particularly in Russia[ and Georgia. They tend to be more successful than antibiotics where there is a biofilm covered by a polysaccharide layer, which antibiotics typically cannot penetrate.

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Solutions

What are some of the solutions to Antibiotic resistance ?

• preventing infections and preventing the spread of resistance

• tracking resistant bacteria • improving the use of today’s antibiotics • promoting the development of new antibiotics and

developing new diagnostic tests for resistant bacteria

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Solutions

Antimicrobial Stewardship Programs

• Building a program • Sustaining a program • Continued Public Health Strategies

• Immunization • infection control, • Protecting the food supply • reducing person-to-person spread through screening, treatment and

education

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The Battleground of Antimicrobial Resistance

• Lack of physician participation. • Lack of diagnostic facilities. • Absence of formal mechanism of data collection. • Variation between countries. • Lack of cooperation strategies.

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The Battleground: The Bugs vs. The Drugs

• Antimicrobial resistance is one of the greatest threats to human health world wide.

• Methicillin-resistant Staphylococcus aureus (MRSA) kills more Americans every year than emphysema, HIV/AIDS, Parkinson’s disease and homicide combined.

• Almost 2 million Americans per year develop hospital-acquired infections (HAIs) resulting in 99,000 deaths – the vast majority of which are due to antibiotic resistant pathogens.

• Studies of costs of infections caused by antibiotic-resistant pathogens versus antibiotic-susceptible pathogens identified the annual cost to the US health care system of antibiotic resistant infections is $21 billion to $34 billion and more than 8 million additional hospital days.

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The Battleground Bugs vs. Drugs: Continued

• 7 Previous decades of medical advances enabled by antibiotics. • Now advances are threatened by the convergence of relentlessly rising antibiotic

resistance. • An alarming and ongoing withdrawal of most major pharmaceutical companies

from the antibiotic market. • The loss of effective antibiotics will impact diverse fields of medicine including

surgery, care of premature infants, cancer chemotherapy, care of the critically ill and transplantation medicine to name a few.

• Ability to respond to national security threats such as bioterrorism and pandemics is in jeopardy and will result in increased morbidity and mortality rates.

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The Battleground: Who will be responsible?

• Leadership teams: Executive level planning. • Government and Local cooperation. • Hospital Infection Prevention and IT: Sustained education. • Pharmacists: Emphasis on de-escalation. • Quality Teams: Use of care bundles.

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The Battleground: Government and Money • 2006 CDC published the guideline “Management of Multi-Drug Resistant

Organisms in Healthcare Settings.” • February 2006 President Bush signed the Deficit Reduction Act (DRA) of 2005

reducing hospital payments. • 2008 “no pay” rule adopted by the Centers for Medicare and Medicaid Services to

encourage hospitals to stop medical complications. • 2009 CDC launched the “Get Smart for Healthcare Campaign.” • 2011 World Health Organization (WHO) proclaimed antimicrobial resistance the

central focus of World Health Day in 2011. • 2013 CDC highlighted the need to improve antibiotic use as one of four key

strategies required to address the problem of antibiotic resistance in the U.S..

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The Battleground: How We Impact The Quality of Patient Care?

• Improving antibiotic use. • Optimize treatment of infections and reduce adverse events. • Increase infection cure rates. • Reduce treatment failures. • Increase frequency of correct prescribing for therapy and prophylaxis. • Reduce hospital rates of Clostridium difficile infections. • Reduce antibiotic resistance.

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A Closer Look at Antibiotic Therapy Appropriate use of antimicrobial agents involves

a. Obtaining an accurate diagnosis for each patient infection. b. Determining a true need for the use of antimicrobial therapy. c. Understanding how dosing may affect the antimicrobial activities. d. Tailoring treatment to use the narrowest spectrum antimicrobial. e. Ordering the shortest duration of therapy. f. Switching from intravenous therapy to oral agents as soon as possible.

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A Closer Look at Antibiotic Therapy We Need to Consider the Impact on the Patient if We Are Resistant to Change Once an accurate diagnosis has been made we must be open to changing to an antimicrobial with a narrower spectrum. Physicians may be reluctant to make this change especially if they have seen an immediate improvement in their patient.

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Modern medicine has allowed us to make many positive changes in our infectious diseases practice and most have benefited millions of patients. We must continue to ask important questions and be willing to make changes.

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A Closer Look at Antibiotic Therapy

Setting The scene ACT 2

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I Need More Pills & I Want Them Now !

Overuse of antimicrobials Inappropriate use of antimicrobials

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CURRENT EVENTS Seen in Antimicrobial Stewardship

Micro-Organisms Now Having a Threat Level of Urgent! Clostridium difficile. Carbapenem-resistant Enterobacteriaceae. Drug-resistant Neisseria gonorrhoeae.

These bacteria are classified as immediate threat to our public health system! We need to address them with immediate and aggressive action to help us in controlling this threat.

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CURRENT EVENTS Seen in Antimicrobial Stewardship

Every Hospital and Healthcare Facility Needs to Have a Mission

These Missions need to address the common goal of optimizing clinical patient outcomes for those patients who are, or have received antimicrobial therapy.

Optimal selection of antibiotics, using the correct dosage and limiting the duration of administration will result in the best clinical outcome for the treatment or prevention of infection while producing the fewest possible side effects and the lowest risk for subsequent resistance.

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Current Events -- Ebola

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GENEVA — The World Health Organization on Tuesday, August 12, 2014 endorsed the use of untested drugs to combat the Ebola virus, just hours after a Spanish priest who had been supplied with experimental medication became the first European to die in the world’s worst known outbreak of the disease.

Antiviral Drugs: One Class of Antimicrobials

Antiviral drugs are a class of medication used specifically for treating viral infections: Like antibiotics for bacteria, specific antivirals are used for specific viruses. Unlike most antibiotics, antiviral drugs do not destroy their target pathogen; instead they inhibit their development. Antiviral drugs are one class of antimicrobials, a larger group which also includes antibiotics (also termed antibacterial), antifungal and antiparasitic drugs, or antiviral drugs based on monoclonal antibodies. Most antivirals are considered relatively harmless to the host, and therefore can be used to treat infections. They must be distinguished from viricides, which are not medications - but deactivate or destroy virus particles, either inside or outside the body. Antivirals also can be found in essential oils of some herbs, such as Eucalyptus oil and now Tobacco!

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BUILDING YOUR PROGRAM

• Establishing the need for an Antimicrobial Stewardship Program (ASP).

• Different types of ASP programs.

• Defining your Antimicrobial Stewardship Program.

• Identify Challenges.

• Measuring Objectives.

• Maintaining a successful program. 46

BUILDING YOUR PROGRAM

The Threat of Drug Resistance • Bugs, Drugs, People

• Microbes have globalized along with their hosts, both human and animal • Antimicrobial consumption by both humans and food-producing animals has

exploded • Education for providers and consumers requires further defining

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BUILDING YOUR PROGRAM

The Threat of Drug Resistance • Globalization

• Ability and ease of both people and microbes to move around the globe • Globally, antimicrobials are urgently needed, yet in recent decades

pharmaceutical companies have abandoned antimicrobial discovery/development due to high cost and low yield

• Suboptimal infection control • Horizontal and vertical infection control strategies can be costly and

often limited to high income countries

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BUILDING YOUR PROGRAM Establishing the Need

• Alarming number of increasingly drug resistant organisms. • Lack of new antimicrobials. • Antimicrobial resistance results in increased morbidity, mortality and

healthcare costs. • Government and Insurance reimbursement changes. • Changes in patient safety goals.

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BUILDING YOUR PROGRAM Different types of Antimicrobial Stewardship Programs

A multidisciplinary team approach (disciplines work as a team designing and executing).

• Multi-faceted expertise/multi- disciplinary approach; collaboration among all members; patient focused; program focused; reduces barriers.

• Can be limited by availability and resources. Infectious Disease Clinical Pharmacist led team (Infectious Disease Clinical Pharmacist and ID physician design and execute with other disciplines in the periphery).

• Multi-faceted expertise/multi- disciplinary approach; fewer barriers. • Can be limited by resources; determined focus: patient focused vs program focused.

Clinical Pharmacist led team (Clinical Pharmacist designs and executes with all members in the periphery).

• Lowers overhead and reduces resources. • Can be less efficient; may limit program scope; competing with other initiatives.

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BUILDING YOUR PROGRAM

Antimicrobial Stewardship

Reduce Resistance

Antimicrobial development

and appropriate

use

Improve Infection Control

Strategies

Improve Outcomes

and control costs

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BUILDING YOUR PROGRAM

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Building Your Program To be truly effective an Antimicrobial Stewardship Program requires an integrated, multidisciplinary and collaborative system. Fundamental to the success of such a system is the partnership between the Antimicrobial Stewardship Program team and the Clinical Laboratory Microbiology Team. The clinical microbiology laboratory provides essential data on micro-organism identification and susceptibility patterns for all organisms found in patient cultures.

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BUILDING YOUR PROGRAM The Laboratory As a Key Player in All Antimicrobial Stewardship Efforts

The clinical laboratory staff are key due to their ability to help guide the Antimicrobial Stewardship Team in ordering the appropriate laboratory tests for each patient. They are also experts in the interpretation of and the flow of the numerous laboratory test results. Laboratorians may also play a key role in helping to guide empiric therapy by their ability to create and to help interpret the microbiology laboratory antibiograms. antibiogram (anˈ·tē·bīˑ·ō·gram), a method of testing the efficacy of antibiotics by introducing one

or more antibiotic discs onto a bacteria-laden petri dish. A clear zone indicates the bactericidal activity. The greater the diameter of the zone, the higher the efficacy of the antibiotic.

Jonas: Mosby's Dictionary of Complementary and Alternative Medicine. (c) 2005, Elsevier.

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BUILDING YOUR PROGRAM Preparation of antibiograms specific to certain patient care areas, especially the hospital intensive care units, may allow identification of “local problems” allowing for focused antimicrobial stewardship and infection control efforts. Also, by having the resistance data available on a monthly and quarterly basis allows for the closer tracking of any trends. It will also facilitate well-designed studies of interventions. The Laboratory Staff can also help the committee as they make decisions as to which antimicrobials to target for restriction or ongoing review. If the laboratory processes samples from outpatient clinics, it will be an easy task for the laboratory staff to exclude all data generated from outpatient cultures and sensitivity testing to allow for a better sense of the true state of resistance within the hospital.

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Building Your Program Microbiology laboratories are in the first line of defense with their ability to

detect new antibiotic resistance patterns. They may be our “first responders” in community outbreaks of foodborne illness,

and also help in our efforts to handle threats of bioterrorism. We must maintain high quality clinical microbiology laboratories in our hospitals

as they offer the best approach in managing the problems that we face with the many emerging infectious diseases and antimicrobial resistance: They also help us in our ongoing mission of providing good patient outcomes.

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Building Your Program Hospital Acquired Infections: Detection, Surveillance & Delivery

Clinical laboratory test results (data) are an integral part of HAI Surveillance. It would be fair to say that one of the most important roles of the clinical laboratory is to accurately and efficiently detect any nosocomial pathogenic organisms by culture and to then perform antibiotic sensitivity testing. Our clinical laboratories must also work hand in hand with the hospital Infection Control and Prevention Department and the hospital Information Technology Department to look at how clinical laboratory data is sent, delivered and linked with other surveillance data. Their coordinated observations and analysis may result in the possibility of streamlining the process and making improvements.

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Building Your Program

The Clinical Laboratory and The Infection Prevention Alliance:

It is imperative that the Clinical Microbiologist or the Microbiology Supervisor is invited to be a member of the Infection Prevention Committee and to be encouraged to act as an active consultant to the hospital Infection Prevention team members. The clinical microbiology team will be able to provide expertise in the interpretation of culture results and to offer advice about the best way to handle any current infection control problem within the hospital environment. The benefits of close collaboration and interaction are very significant. The clinical microbiology team will also produce monthly and annual antibiograms to help alert all to current and evolving resistance issues.

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Building Your Program Understand Where Clinical Microbiology is Heading in the Near & Distant Future: Changes in the availability of skilled laboratory personnel. New technologies, and the problematic financial environment. The ability to diagnose anaerobic infections may decline as a consequence of current and

future changes resulting in a lack of expertise in our clinical laboratory scientists. Physicians should anticipate a difficult time in the years between the loss of expertise in

traditional methods and the development of reliable and accurate molecular assays. Several converging factors will have major impacts on diagnostic microbiology laboratory

testing in the near future, defined as the next 5 years, and in the more distant future. The ideas expressed on this slide are the personal opinions of the authors and are based

on our experience and observations along with information shared by colleagues.

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BUILDING YOUR PROGRAM Defining an Antibiotic Stewardship Program

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Define (Goals and Objectives)

Measure (Map the current

process)

Analyze (Identify the cause of the

problem)

Improve (Implement

and verify the solution)

Control (Communicate and maintain

success)

BUILDING YOUR PROGRAM

Define Goals and Objectives • Improved patient outcomes • Decrease antimicrobial resistance and unnecessary antimicrobial use • Decrease length and duration of antimicrobial therapy • Patient focused vs program focused goals

• De-escalation practices; identification of sub-optimal therapies; generate disease specific guidelines and order sets; staff education; service line needs

• Adopt economic incentives and value based reimbursement strategies • Identify roles/responsibilities

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BUILDING YOUR PROGRAM

Measure • Map the current state/process • Obtain baseline data – Analyze to isolate and understand issues • Identify the available tools/resources in the current, future and

ideal state • Use of automated surveillance systems to obtain, track and analyze data

over time Bad Bugs, No Drugs: As Antibiotic Discovery Stagnates, A Public Health Crisis Brews … - Infectious Disease Society of America

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BUILDING YOUR PROGRAM

Analyze • Identify the cause of the problem • Identify challenges

• Resources, staff turnover, physician resistance, leadership buy in, lack of accountability

• Create ASP structure

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BUILDING YOUR PROGRAM Solutions

Elements of a comprehensive ASP program:

• Core multi-disciplinary members including: Infectious Disease Physician, Infectious Disease Clinical Pharmacist, Clinical Microbiologist, Information Specialist, Infection Control Specialist, Hospital Epidemiologist

• Collaboration between Antimicrobial Stewardship team and hospital

Infection Control and Pharmacy Therapeutics Committees • Support and collaboration of hospital administration, medical staff

leadership, and local providers

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BUILDING YOUR PROGRAM Solutions

Elements of a comprehensive ASP program:

• Negotiate with hospital administration to obtain adequate authority and expected program outcomes

• Hospital administrative support for necessary infrastructure to measure

antimicrobial use and track use on an ongoing basis • Core strategies : prospective audit with intervention/feedback and

formulary restriction and preauthorization • Education and guideline development

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BUILDING YOUR PROGRAM

Improve • Establish baseline process • Understand the goals/objectives • Implement the program • Continue to gather data • Review

• Relationships to quality, patient safety, Infection Prevention, Pharmacy; review of improvement to outcomes; priorities

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BUILDING YOUR PROGRAM

Control and Communicate • Continue to analyze data • Validate measurement systems

• What measurement elements, how often, how is data obtained, how will it be presented and where

• Verify process improvement through data analysis • Implement process controls and change as needed • Sustain program success • Communicate, communicate, communicate

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BUILDING YOUR PROGRAM

Control and Communicate • Continue the process improvement process

• defining, measuring, analyzing, improving and controlling • Communicate and Collaborate

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Antibiotic Stewardship :

Clinical Patient Outcomes

Regulatory Compliance

Cost Awareness

Setting The scene ACT 3

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You Have To Help Me – I Need More Pills - Now !

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RECAP: SUMMARY OF PROGRAM Proven Fact: Hospital Leadership Must Commit to Ensure Program Success:

Leadership support is critical to the success of any Antibiotic Stewardship Program and can take a number of forms, including those listed below: • Formal statements that the facility supports efforts to improve and monitor antibiotic

use. • Including stewardship-related duties in job descriptions and annual performance reviews. • Ensuring that the staff from relevant departments are given sufficient time and necessary

tools to allow them to contribute to their antimicrobial stewardship activities. • Support, develop and provide system wide training and education. • Ensuring participation from the many groups that can support stewardship activities. • Financial support greatly augments the capacity and impact of a stewardship program

and stewardship programs will often pay for themselves, through savings in both antibiotic expenditures and the indirect costs involved in patient treatment.

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RECAP: SUMMARY OF PROGRAM Results Are Good When You Provide Effective Education For Healthcare Employees:

Antibiotic stewardship programs should provide regular updates on how antibiotics are being prescribed, antibiotic resistance, and all infectious disease issues in the hospital or other facility. Sharing facility-specific information on antibiotic use is a tool to motivate improved prescribing, particularly if wide variations in the patterns of use exist among patient care locations. There are many options for providing education on antibiotic use such as in house educational presentations which may be presented in either a formal or an informal setting, information on posters and flyers, and internal newsletters or e-mails to facility staff. Reviewing patient cases about current antibiotic therapy is another useful approach, particularly if the discussion includes the need to change the drugs being used. A variety of web-based educational resources are available that can help hospitals and other facilities in their efforts to develop educational programs. Education has been found to be most effective when paired with corresponding interventions and measurement of patient outcomes.

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RECAP: SUMMARY OF PROGRAM Evidence Seen in Hospitals & Healthcare Facilities Using an Antimicrobial Stewardship Protocol:

Evidence demonstrates that hospital based programs that are dedicated to the improvement of antibiotic use, (commonly referred to as “Antibiotic Stewardship Programs”) have optimized the treatment of infections and have helped to reduce adverse events associated with the use of some antibiotics. These programs have also helped the ordering physicians to improve the quality of patient care and patient safety. We have also seen an increase in cure rates along with fewer treatment failures. There has also been a reduction of hospital acquired infections with Clostridium difficile. Moreover these programs achieve the above benefits and usually result in considerable cost savings for hospitals and other healthcare facilities. In 2014 CDC recommended that all acute care hospitals implement Antibiotic Stewardship Programs.

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RECAP: SUMMARY OF PROGRAM Showing The Importance of Measuring All Clinical Outcomes:

When clinical outcomes are measured we can easily see proof that intervention improves the selection and usage of antibiotics and this has proven to have a significant impact on rates of hospital acquired Clostridium difficile. Another option for measurement is antibiotic resistance. The development and spread of resistance is determined by many factors and the impact of stewardship intervention is best determined when measurement is focused on the pathogenic bacteria that are cultured from patients following their admission to the hospital or other facility. We also need to monitor resistance that shows what percent of patients develop resistant “super infections.” It is important to measure antibiotic costs, and to assess the pace at which costs were rising before the implementation of the stewardship program. Initially you should see significant cost savings followed by a stabilization of antibiotic use patterns and savings. It is very important to ensure support for continuation of your programs.

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RECAP: SUMMARY OF PROGRAM

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Effective Policies & Interventions Have Improved Antibiotic Use a. Implement policies that help you optimize the use of each antibiotic for each patient.

b. The dose of each antibiotic, the duration of usage and the specific indicator for choosing

the antibiotic must be documented for every patient.

c. Your intervention plan must be structured to allow for three main categories: I. BROAD ALL ENCOMPASSING INTERVENTIONS. II. PHARMACY DRIVEN INTERVENTIONS. III. INFECTION, SYMPTOM AND SYNDROME SPECIFIC INTERVENTIONS.

RECAP: SUMMARY OF PROGRAM Effective Policies & Interventions Continued

Broad Intervention Techniques may include “Antibiotic Time Out” to allow for reassessment that will help determine if there is a need to continue this particular antibiotic. Was it the best choice? We are able to see a clearer picture as we now have more information. We must ask and answer these key questions: 1. Will the infection respond to antibiotic therapy? 2. Is the patient on the right antibiotic? Is the dose adequate, and are we using the most

efficient route of administration? 3. Could we improve treatment by a change to a more “targeted” antibiotic?

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RECAP: SUMMARY OF PROGRAM Effective Policies & Interventions Continued

Pharmacy Driven Interventions may include one or more of the following: 1. Changing from intravenous to oral administration which also improves patient safety

by eliminating the need for intravenous access. 2. Adjusting to a lower dose to help protect the patient’s organs. 3. To alert the physician when there are any unnecessary duplications involving multiple

antibiotics with overlapping spectra. (Gram Negatives or Anaerobes) 4. To detect and prevent any drug-drug interactions e.g. interactions between some

fluoroquinolones (taken orally), and certain vitamins.

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RECAP: SUMMARY OF PROGRAM Effective Policies & Interventions Continued

Infection, Symptom and Syndrome Interventions may include the following: 1. Patients admitted with Community Acquired Pneumonia.

2. Patients who develop Urinary Tract Infections.

3. Patients admitted with or who develop Methicillin Resistant Staph aureus Infections: (MRSA)

4. Patients who develop Clostridium difficile Infections. Invasive infections (e.g. blood stream infections) present good opportunities for interventions to improve antibiotic use because they are easily identified from microbiology results. The Culture and Susceptibility Test often provides information needed to tailor antibiotic therapy, or even discontinue antibiotics.

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References

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ACS: Chemistry for Life: Phone: 1-800-333-9511 (Toll Free in the US) Phone: 614-447-3776 (Outside of the US) service@acs.org Encyclopædia Britannica, Inc.: a general knowledge English-language encyclopaedia. In 2012, it was announced that the 2010 edition was the last printed edition that would be published. It is written by about 100 full-time editors and more than 4,000 contributors, including 110 Nobel Prize winners and five American presidents. It is regarded as one of the most scholarly English-language encyclopaedias. www.encyclopaediabritannica.com CDC: Centers For Disease Control and Prevention: 1600 Clifton Road, Atlanta, GA 30333 800-CDC-INFO | (800-232-4636) | TTY: (888) 232-6348 www.cdc.gov

References Mayo Clinic Proc. Feb 2011; 86(2): 156–167. General Principles of Antimicrobial Therapy. Surbhi Leekha, MBBS, Christine L. Terrell, MD, and Randall S. Edson, MD. www.mayoclinc.org Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Kumar A, Roberts D, Wood KE, Light B, Parrillo JE, Sharma S, Suppes R, Feinstein D, Zanotti S, Taiberg L, Gurka D, Kumar A, Cheang M. Critical Care Med. 2006 Jun; 34(6):1589-96. www.sccm.org Centers For Disease Control and Prevention: Drug Resistance & Threat Report. http://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf#page=11

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References Florence Nightingale,12 May 1820 – 13 August 1910) was a celebrated English social reformer and statistician, and the founder of modern nursing. She came to prominence while serving as a nurse during the Crimean War where she tended to wounded soldiers. She was known as "The Lady with the Lamp" after her habit of making rounds at night. Wilfrid Laurier University Press ISBN 0889204691 Compost Fundamentals: Washington State University. Quizlet LLC, P.O. Box 77164, San Francisco, CA 94107 510-495-6550 info@quizlet.com

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References Pub Med: National Center for Biotechnology Information U.S. National Library of Medicine 8600 Rockville Pike, Bethesda MD, 20894 USA www.pubmed.gov Centers for Disease Control and Prevention. Antibiotic audit forms. 2013; accessed 3/3/14. http://www.cdc.gov/getsmart/healthcare/implementation.html Centers for Disease Control & Prevention. getsmart/healthcare/implementation. http://www.cdc.gov/getsmart/healthcare/implementation/core-elements.html

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References Patel SJ, Saiman L, Duchon JM, Evans D, Ferng YH, Larson E. Development of an antimicrobial stewardship intervention using a model of actionable feedback. Interdisciplinary perspectives on infectious diseases. 2012;2012:150367. Schechner V, Temkin E, Harbarth S, Carmeli Y, Schwaber MJ. Epidemiological interpretation of studies examining the effect of antibiotic usage on resistance. Clinical microbiology reviews. Apr 2013;26(2):289-307. Show me the money: long-term financial impact of an antimicrobial stewardship program. Infection control and hospital epidemiology : The official journal of the Society of Hospital Epidemiologists of America. Beardsley JR, Williamson JC, Johnson JW, Luther VP, Wrenn RH, Ohl CC. Apr 2012;33(4):398-400.

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References Centers For Medicare & Medicaid Services 7500 Security Boulevard Baltimore, Maryland 21244 http://cms.gov Clinical & Laboratory Standards Institute CLSI: National Committee for Clinical Laboratory Standards (NCCLS) 950 West Valley Road, Suite 2500 Wayne, PA 19087 USA www.clsi.org

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References

S. Karger AG P.O Box, CH-4009 Basel (Switzerland) Allschwilerstrasse 10, CH-4055 Basel Tel. + 41 61 306 11 11 Fax + 41 61 306 12 34 karger@karger.com www.karger.com Bacteriophage and Phage Therapy: S. Mc Grath and D. van Sinderen (editors)-(2007). Bacteriophage: Genetics and Molecular Biology (1st ed.). Caister Academic Press. ISBN 978-1-904455-14-1

Bad Bugs, No Drugs. 2004. Infectious Diseases Society of America. www.idsociety.org

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References

Antimicrobial Resistance and Infection Control: 2013, 2:31. Antimicrobial resistance: A global view from the 2013 World Healthcare Associated Infections Forum. Angela Huttner, Stephan Harbath, Jean Carlet, Sara Cosgrove, Herman Goosens, Alison Holmes, Vincent Jarlier, Andreas Voos, Didier Pittet. For the World Healthcare Associated Infections Forum Participants. http://www.aricjournal.com IDSA Guideline: Timothy H. Dellit, Robert C. Owens, John E. McGowan, Dale N. Gerding, Robert A. Weinstein, John P. Burke, W. Charles Huskins, David L. Paterson, Neil O. Fishman, Christopher F. Carpenter, P. J. Brennan, Marianne Billeter, and Thomas M. Hooton. Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America Guidelines for Developing an Institutional Program to Enhance Antimicrobial Stewardship Clinical Infectious Diseases (2007) 44 (2): 159-177 doi:10.1086/510393

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Discussion: Q & A

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The End !

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