Move Over Pscyhotropics Here Come the Antibiotics

Move Over Pscyhotropics Here Come the

Antibiotics! Jennifer L. Hardesty, PharmD, FASCP Chief Clinical Officer,

Corporate Compliance Officer Remedi SeniorCare

William M. Vaughan BSN, RN

Vice President, Education and Clinical Affairs Remedi SeniorCare

Disclosure / Contact

• Jennifer Hardesty has no relevant disclosures

• William Vaughan is a contractor to CMS (QAPI) and a member of the Institute for Safe Medication Practices clinical advisory board (Long-Term Care Advise ERR)

• Contact : • [email protected]

• [email protected]

“Welcome to the ISMP Long-Term Care Advise-ERR, a medication safety newsletter designed specifically to

meet the needs of administrators, nursing directors, and nurses who transcribe medication orders, administer medications, monitor the effects of medications on

residents, and/or supervise those who carry out these important tasks.”

http://www.ismp.org/Newsletters/longtermcare/default.aspx

Objectives

• Discuss current and proposed federal regulations which impact the use of antibiotics in nursing homes.

• Identify three clinical practices which maximize the benefits and minimize the risks associated with the use of antibiotics in long term care residents.

• Describe the concept of antibiotic stewardship and identify four core elements of an antibiotic stewardship program.

Regulatory “Priorities”

Antibiotics

“However, with the recent emergence of resistant organisms, pediatric organizations have strongly recommended initial antibiotics only for certain children” - Merck Manual

“90% – 98% of rhinosinusitis cases are viral, and antibiotics are not guaranteed to help even if the causative agent is bacterial.” - CDC

“Although warranted in some cases, antibiotics are greatly overused.” - American Academy of Family Physicians

Nursing Homes

• ~ 4 million admissions / year

• ABT use common (up to 70% / year)

• Inappropriate prescribing (up to 75%) • Unnecessary

• Wrong drug, dose or duration

• Colonization common

Source: CDC (http://www.cdc.gov/media/releases/2015/p0915-nursing-home-antibiotics.html)

In the Crosshairs: Urinary Tract “Infections”

• Generalized change in condition (falls, mental status, etc.) • Adverse drug reaction ("Any symptom in an elderly

patient should be considered a drug side effect until proven otherwise.”– Gurwitz et al)

• Fluid / electrolyte imbalance

• Infection • + urine culture Antibiotics

colonization


• “Don’t obtain a urine culture unless there are clear signs and symptoms that localize to the urinary tract.” • AMDA

• “Don’t use antimicrobials to treat bacteriuria in older adults unless specific urinary tract symptoms are present.” • AGS

Guidance to Surveyors – F 315 (what's old is new again)

“In someone with nonspecific symptoms such as a change in function or mental status, bacteriuria alone does not necessarily warrant antibiotic treatment. Additional evidence that could confirm a UTI may include hematuria, fever (which could include a variation from the individual’s normal or usual temperature range), or evidence of pyuria (either by microscopic examination or by dipstick test). In the absence of fever, hematuria, pyuria, or local urinary tract symptoms, other potential causes of nonspecific general symptoms, such as fluid and electrolyte imbalance or adverse drug reactions, should be considered instead of, or in addition to, a UTI …”


• A patient with advanced dementia may be unable to report urinary symptoms … In this situation, it is reasonable to obtain a urine culture if there are signs of systemic infection such as fever … leukocytosis, or a left shift or chills in the absence of additional symptoms (e.g., new cough) to suggest an alternative source of infection. • AMDA

Other High Risk Areas

Current Regulations

• F 281 (Profession standards of quality) • “Standards published by professional organizations”

• F 329 (Unnecessary Drugs) • Indication

• Dose

• Duration

• Monitoring

• Adverse consequences (c. diff)

Inappropriate prescribing (up to 75%) Unnecessary Wrong drug, dose or duration - CDC on ABT (2105)

No Absolutes Rationale for Care Based on: • Evidence

• Thoughtful risk / benefit analysis

• Resident / surrogate involvement

Document especially in high risk situations

June 28, 2016

Cipro 500 mgs. PO q day x 7 days UTI

- VO Dr. Smith

76 year old Female : SDAT, HTN , DM, CHF

Actions to Consider

• Engage Medical Directors / Consultant Pharmacists

• Educate • Prescribers

• Nursing staff

• Residents / surrogates /families • “But what if your wrong?”

• Discuss / document goals of care

Actions to Consider

• Don’t succumb to perceived regulatory pressure to “do something” • Watchful waiting

• Antibiotic “time out”

• Quality assurance • Consistency of prescribing practices

• Type of antibiotic (broad spectrum)

• Duration of therapy

• Choosing Wisely (www.choosingwisely.org)

Proposed Regulations

• Infection and Prevention Control Officer

• Infection Prevention and Control Program • Antibiotic stewardship

• Quality Assurance Performance Improvement

QAPI: Think Like a Squirrel

http://www.ascp.com/resources/nhsurvey/upload/FTag%20441%20summary.pdf

Antibiotics- Some Facts

Each Year in the US:

• ~2 million people become infected with resistant bacteria

• At least 23,000 people die each year as a direct result of these infections

• 250,000 patients (hospitalization) get Clostridium difficile each year,

• C. difficile kills at least 14,000 people each year

Resistance Develops….Survival of the Fittest

Antibiotic Resistance Spreads…..

Fast-paced resistance

Resistance develops quickly:

• Methicillin: o developed in 1960 o resistance by 1962

• Linezolid o developed in 2000 o resistance by 2001

Adverse Drug Reactions: Antibiotic Overuse

• Adverse Drug Events N/V/D

Myalgias

Blood dyscrasias

Candidiasis

C. Difficile

Systemic Adverse Effects of Common Antibiotics

Antibiotic Class Most Common Side Effects

Penicillins rash, diarrhea, abdominal pain, nausea/vomiting, hypersensitivity reactions

Cephalosporins rash, diarrhea, nausea/vomiting (rare), hypersensitivity reactions, vaginal candidiasis

Aminoglycosides renal toxicity, ototoxicity, dizziness, nausea/vomiting, nystagmus

Carbapenems diarrhea, nausea/vomiting, headache, rash, liver toxicity, eosinophilia

Vancomycin flushing, hypotension, itching, phlebitis, taste alteration, nausea/vomiting, headache, dizziness

Macrolides abdominal pain, diarrhea, anorexia, nausea/vomiting, taste alterations

Sulfonamides nausea/vomiting, diarrhea, anorexia, abdominal pain, rash, photosensitivity, headache, dizziness

Tetracyclines nausea/vomiting, diarrhea, anorexia, abdominal pain, liver toxicity

Quinolones myalgias, tendonitis, nausea/vomiting, diarrhea, abdominal pain, headache, lethargy, insomnia, photosensitivity

Lincosamide colitis,diarrhea, nausea/vomiting, rash, hypersensitivity, jaundice

Additional Problems: Clostridium Difficile

Clostridium Difficile

C.Difficile - Treatment Drug Treatment:

• Metronidazole $ • Vancomycin $$-$$$ • Fidaxomicin (Dificid) $$$$

Recurrence -can occur in up to 25% of patients (another episode of C. difficile within 8 weeks)

• Relapse of the initial infection • Re-infection with a new strain

Recurrence Treatment:

• First recurrence- the same medication • Second recurrence, a tapered or pulsed oral vancomycin • Third recurrence fecal transplant should be considered

Long-term care facility residents are particularly at risk for C. Difficile complications

CDC: What Can the Health Care Community Do?

CDC: What Can the Health Care Community Do?

Antimicrobial Stewardship

Patients receive the right antibiotic, at the right dose, at the right time, and for the right duration

Coordinated interventions designed to improve and measure the

appropriate use of antimicrobial agents by promoting the

selection of the optimal antimicrobial drug regimen

Antibiotic Stewardship Programs are a “win‐win” for all involved!

Antibiotic Stewardship will: • Decrease antibiotic resistance

• Decrease C. difficile infections

• Decrease costs

• Increase good patient outcomes

http://www.cdc.gov/getsmart/healthcare/factsheets/antibiotic-use.html

LTC Core Elements for Antibiotic Stewardship

http://www.cdc.gov/longtermcare/prevention/antibiotic-stewardship.html






Leadership Commitment

• Write statements in support of improving antibiotic use to be shared with staff, residents and families

• Include stewardship-related duties in position descriptions: o Medical Director o Clinical nurse leads, DON o Consultant pharmacist

• Communicate with nursing staff, prescribing clinicians o Expectations about use of antibiotics o Monitoring and enforcement of stewardship policies

• Create a culture which promotes antibiotic stewardship o Messaging o Education o Celebrating improvement

Accountability

• Medical Director: set standards for antibiotic prescribing practices for all clinical providers

• Director of Nursing: set the practice standards for assessing, monitoring and communicating changes in a resident’s condition by front-line nursing staff.

• Infection prevention program coordinator: o Track antibiotic starts o Monitor adherence to evidence-based published criteria o Review antibiotic resistance patterns in the facility

• Consultant pharmacist : support antibiotic stewardship oversight through quality assurance activities

• Laboratory Services: o Alerting facility if certain antibiotic-resistant organisms are identified, o Educate staff on the differences in diagnostic tests available o Antibiogram

Drug Expertise

• Partner with antibiotic stewardship program leads at the hospitals within your referral network

• Infectious Disease practitioners and consultants in your community

• Consultant Pharmacists

Action Through Policy/Practice Change

Policies that support optimal antibiotic use o Require dose, duration, indication for every order o Viewing culture data

Broad interventions to improve antibiotic use o Improving the evaluation and communication of clinical signs/symptoms

o “Communication Tool” o INTERACT Tools

o “Antibiotic time-out” o Developing antibiotic monitoring and infection management guidance

Infection and syndrome specific interventions to improve antibiotic use

o Asymptomatic bacteriuria (ASB) o Urinary tract infection prophylaxis o Lower Respiratory Tract Infections (Viral vs Bacterial)

Tools and Protocols: INTERACT Programs

https://interact2.net/tools_v4.html

Tracking/Reporting: Use and Outcomes

• Process Measures: o Completeness of clinical assessment documentation at the time of the

antibiotic prescription o Completeness of antibiotic prescribing documentation o Antibiotic selection is consistent with recommended agents for specific

indications o Point prevalence of antibiotic use o Antibiotic days of therapy (DOT) o Post-prescription review of appropriateness

• Outcome Measures:

o Track C. difficile and resistant organisms o Track adverse drug events related to antibiotic use o Antibiotic resistance o Track costs related to antibiotic use

Tools and Protocols: Antibiotic Appropriateness Assessment - G+ Infections

Tools and Protocols: Antibiotic Appropriateness Assessment- UTI

http://www.remedirx.com/site/wp-content/uploads/2016/02/2016-02-M.R.-UTI-Assess-Tool.pdf














Education

• Provide antibiotic stewardship education to clinicians, nursing staff, residents and families

• Linking education with feedback on physician prescribing practices

• Interactive academic detailing (e.g., face-to-face interactive workshops) has the strongest evidence for improving medication prescribing practices

• Providing feedback on individual physician prescribing practices and adherence to the guidelines over 12 months

Tools and Protocols: Appropriate Antibiotic Use Summary

http://www.cdc.gov/getsmart/community/materials-references/print-materials/hcp/adult-approp-summary.pdf











The First Steps:

• Ensure all orders have dose, duration, and indications

• Get cultures before starting antibiotics

• Take an “antibiotic timeout,” reassessing antibiotics after 48–72 hours

• Implement policies that encourage best practices o Establishment of minimum criteria for prescribing antibiotics

o Review of antibiotic appropriateness/resistance patterns

o Nursing protocols for monitoring patients’ status for an evolving condition if there is no specific indication for antibiotics

Small, Sustainable Changes

• Facility should not attempt to implement all of the interventions at once.

• Interventions to implement should be tailored to the areas that most need improvement at your facility

• Essential to monitor and measure

o Measurement Framework- various measures of antibiotic use to assess effectiveness of improvements

http://www.remedirx.com/news-events/news/





Changing Prescribing Behaviors Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing

Among Prescribers; Leeker et al. JAMA. 2016;315(6):562-570. doi:10.1001/jama.2016.0275

Alternative: EHR pop-up: presented electronic order sets 22% 6% suggesting non-antibiotic treatments Justification: Required clinicians to enter free-text justification 23% 5% when prescribing ABTs into EHR. “No justification” populated if left blank Comparison: Sent e-mails to prescribers that compared their ABT 20% 4% prescribing rates with those of “top performers” (those with lowest inappropriate prescribing rates)

Antibiotic Stewardship:

Are You Ready?

LTC Antibiotic Stewardship Tool Core Elements Checklist

http://www.cdc.gov/longtermcare/pdfs/core-elements-antibiotic-stewardship-checklist.pdf






References • State Operations Manual: Appendix PP - Guidance to

Surveyors for Long Term Care Facilities • (https://www.cms.gov/Regulations-and-

Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf)

• Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities • (https://www.federalregister.gov/articles/2015/07/16/2015-

17207/medicare-and-medicaid-programs-reform-of-requirements-for-long-term-care-facilities)

• Overview and Evidence to Support Stewardship • (http://www.cdc.gov/getsmart/healthcare/evidence.html)

Thank You

Questions?

Documents

Move Over Pscyhotropics Here Come the Antibiotics