IMPROVING DRUG USE TO ENHANCE INFECTION

PREVENTION: ANTIBIOTIC STEWARDSHIP AND BEYOND

CDI Prevention Partnership Collaborative

Audio Conference Call

April 25, 2012

www.macoalition.org

      

  

                 

          

                              

           

Program Overview

Conference call:  April 25th noon-1:30PM   Overview of antibiotic stewardship and steps you can take in your facility Appropriate use of PPIs in acute and long term care: who needs to be on them,

who doesn’t? Morning workshop: April 30th 8AM-Noon Newton MA (repeated May 16 in

Sturbridge) Appropriate diagnosis and treatment of UTI in acute and long term care Communication about antibiotic treatment inside and across facilities:

working with with residents/ families, colleagues, and transferring facilities 

ALL programs grant CME / CEUs for physicians, nurses, pharmacists and long term care administrators

 

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Today’s Agenda 

                                                                              

 Overview of antibiotic stewardship and the long term care opportunity

Appropriate use of Proton pump inhibitors (PPIs)

In the acute care setting PPI reduction strategies PPIs across a transition of care

Shira Doron, MD Assistant Professor of Medicine Division of Geographic Medicine and Infectious

Diseases Tufts Medical Center

Erica Tenholder, PharmD, BCPS Clinical pharmacy specialist, antimicrobial

stewardship, Baystate Medical Center

David B. Goldwater R.Ph Clinical Consultant Pharmacist Partners Pharmacy Massachusetts

Terrence A. O’Malley, MD, CMD Medical Director, Non-Acute Care Services Partners HealthCare System, Inc.

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Upcoming Events

April 30th or May 16 Morning Workshops register now! April 30th 8AM-Noon, Newton MA Repeated May 16 8AM-Noon, Sturbridge MA

Ask the expert Focus on Diagnosis and Treating UTI Communication strategies to promote appropriate medication use

June 22nd C. Difficile Prevention Partnership Collaborative Learning and Sharing Workshop

Learn additional strategies for C. diff prevention from local and national experts, and your Massachusetts colleagues

Contact Fiona Robertsfroberts@macoalition.org 4

Continuing Education Disclosures

The speakers on today’s call have no financial interests or relationships to disclose.

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Overview of antibiotic stewardship and the long term

care opportunity

Shira Doron, MDAssistant Professor of Medicine

Division of Geographic Medicine and Infectious DiseasesTufts Medical Center

Boston, MA

Antibiotics in Long Term Care:why do we care?

• Antibiotics are among the most commonly prescribed classes of medications in long-term care facilities

• Up to 70% of residents in long-term care facilities per year receive an antibiotic

• It is estimated that between $38 million and $137 million are spent each year on antibiotics for long-term care residents

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The importance of prudent use of antibiotics

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Bad Bugs No Drugs

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The drug development pipeline for antibacterials

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The burden of infection in long term care

• 12 studies in North America:– 1.8-13.5 infections per 1000 resident-care

days– Rate of death from infection 0.04-0.71 per

1000 resident-care days

Strausbaugh et al. Infection Control and Hospital Epidemiology 2000, 21(10), p. 674-679

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The burden of resistance in long term care

• Rogers et al:– Over 3000 LTCFs– One year (2003)– Incidence of new infection caused by an

antibiotic-resistant organism was 12.7 per 1000 patients

Rogers et al. Journal of Infection Control 2008, Volume 36, Issue 7, Pages 472-475

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A Balancing ActA Balancing Act

Appropriate initial antibiotic while improving patient

outcomes and healthcare

Appropriate initial antibiotic while improving patient

outcomes and healthcare

Antimicrobial Therapy

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Unnecessary Antibiotics, adverse

patient outcomes and increased cost

Unnecessary Antibiotics, adverse

patient outcomes and increased cost

Why focus on long term care?

• Many long-term care residents are colonized with bacteria that live in an on the patient without causing harm

• Protocols are not readily available or consistently used to distinguish between colonization and true infection

• So, patients are regularly treated for infection when they have none– 30-50% of elderly long-term care residents have a

positive urine culture in the absence of infection

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Why focus on long term care?

• When patients are transferred from acute to long-term care, potential for miscommunication can lead to inappropriate antibiotic use

• Elderly or debilitated long-term care residents are at particularly high risk for complications due to the adverse effects of antibiotics, including Clostridium difficile infection

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Common long-term care scenarios in which antibiotics are not needed

• Positive urine culture in the absence of symptoms (cloudy or smelly urine should not be considered symptoms)

• Upper respiratory infection (common cold with or without fever, bronchitis, sinusitis not meeting clinical criteria for antibiotics)

• Abnormal chest x-ray without signs/symptoms of respiratory infection

• Positive wound culture in the absence of cellulitis, abscess or necrosis

• Diarrhea in the absence of positive C. diff toxin assay

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Case 1

• The nurse notes that an 82-year-old long-term care resident has cloudy urine

• She sends a culture which grows >100,000 CFU of E. coli

• The patient is started on ciprofloxacin and given a 2-week course

• By the end of treatment the patient has diarrhea and C. diff toxin assay is positive

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What could have been done differently?

• Urine changes have many causes• In the absence of symptoms of UTI, no need to

culture urine• A urinalysis should be sent with the urine culture• If the urinalysis doesn’t have white blood cells,

there is no inflammation in the bladder and therefore NO UTI (regardless of symptoms)

• Ciprofloxacin and the other quinolone antibiotics (levofloxacin, moxifloxacin) are known to promote the development of C. diff.

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Colonized or Infected:What is the Difference?

• People who carry bacteria without evidence of infection are colonized

• If an infection develops, it is usually from bacteria that colonize patients

• Bacteria that colonize patients can be transmitted from one patient to another by the hands of healthcare workers

• There is no need to treat for colonization

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The Iceberg Effect

Infected

Colonized

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Clostridium difficile–Associated Disease (CDAD)

• Most common cause of nosocomial infectious diarrhea in adults1

• Significant associated morbidity2

• Antibiotic use is strongly associated with CDAD1,3

• Highest association with clindamycin, penicillins, cephalosporins, quinolones4,5

• Judicious antibiotic use decreases incidence of CDAD3

1. Settle CD, et al. Aliment Pharmacol Ther. 1998;12:1217-1223.

2. Anand A, et al. Am J Gastroenterol. 1994;89:519-523.

3. Kelly CP, et al. Annu Rev Med. 1998;49:375-3904. Kelly CP, et al. Annu Rev Med. 1998;49:375-390.

5. McCusker ME, et al. Emerg Infect Dis. 2003;9:730-733..

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Clostridium difficile: New Issues

• INCREASING INCIDENCE– Estimated >400,000 hospital cases annually in US

• EPIDEMIC STRAIN– A common resistant epidemic C. difficile strain called

NAP-1 has been found in the US, Canada, and Europe.

• MORE SEVERE– Higher mortality and higher rates of colectomy

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Courtesy CDC

C. Diff rates in the US

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Pathogenesis of CDAD

Antibiotic therapy

Colonic mucosal injury and inflammation

Release of toxin A and toxin B (and in some strains, binary toxin)

C. difficile exposure and colonization

Alteration of colonic microflora

Reprinted from Kelly CP, et al. Annu Rev Med. 1998;49:375-390.28

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Case 2

• A 72 year old man is sent back to his long-term care facility after a brief stay at an acute care hospital

• On transfer, he is on intravenous vancomycin for “bloodstream infection”

• This is continued for 4 weeks, at which point the patient develops a brain bleed

• When his labs are checked he is found to have severely low platelets, presumably a side effect of the vancomycin

• The blood culture results had been incomplete at the acute care hospital at the time of transfer. As it turned out, when the organism was finally identified, it was one typically associated with blood culture contamination rather than infection, and the patient did not need any antibiotics. 30

What could have been done differently?

• Improve communication and coordination– Acute care hospital could have

communicated to long-term care facility the plan re duration of antibiotics and the pending lab result

– A system could be in place for the hospital to follow up on the culture results of a longer in their care and communicate with the long term care facility.

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Case 3

• A 49 year old long term care resident develops respiratory symptoms, and chest xray is consistent with pneumonia, so he is started on the broad-spectrum antibiotic piperacillin-tazobactam to cover resistant organisms

• 2 days later the sputum culture grows Strep pneumoniae

• No one narrows the antibiotic, and the patient gets better quickly, completing a 10-day course

• One month later the patient develops urosepsis with Pseudomonas highly resistant to all antibiotics tested including piperacillin-tazobactam

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What could have been done differently?

• Use of a narrower agent rather than a broad-spectrum antibiotic

• Shorter, appropriate course of treatment

• Adjust antibiotic based on culture results

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Long term facilities can*• Establish multidisciplinary teams to address

antibiotic stewardship and optimal drug use• Have protocols that outline the appropriate

circumstances for use of antibiotics• Review antibiotic culture data for trends suggesting

a worsening resistance problem• Have protocols ensuring that cultures are checked

and antibiotics adjusted according to culture results• Establish programs for periodic review of antibiotic

utilization

*Centers for Disease Control34

Long term facility providers should*

• Obtain cultures whenever available when starting antibiotics, and check results, adjusting antibiotics appropriately to the narrowest spectrum agent possible

• Avoid the use of antibiotics for colonization or viral infections, and keep the duration as short as possible

• Take care to effectively communicate with the transferring facility re pending lab results and plan for antibiotics and follow-up

*Centers for Disease Control 35

Nurses Can

• Be familiar with current protocols for testing and treatment of urinary tract infection

• Educate families and residents that many respiratory infections are caused by viruses and do not require antibiotics

• Identify advanced directives for limited treatment• Follow up with referring facility regarding

pending lab results

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Physicians / NPs can• Obtain cultures whenever available when starting antibiotics, and

check results, adjusting antibiotics appropriately to the narrowest spectrum agent possible

• Avoid the use of antibiotics for colonization or viral infections, and keep the duration as short as possible

• Encourage use of screening tools and protocols to decrease the use of unnecessary antibiotics.

• Educate fellow clinicians, staff and family members on appropriate use of antibiotics

• Implement measures to reduce the need for treating with antibiotics (avoidance of indwelling urinary catheters, maximizing immunization levels, decubitus ulcers, etc.

• Take care to effectively communicate with the transferring facility re pending lab results and plan for antibiotics and follow-up

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Pharmacists can• Get more involved with infection control issues in each facility

serviced, particularly antibiotic treatment of symptomatic versus asymptomatic UTIs.

• Review antibiotic utilization and, where possible, appropriateness; identify opportunities for improved prescribing to discuss at quarterly QI meetings.

• Educate physicians and nursing staff about targeted antibiotic use, using a narrow spectrum antibiotic based on culture results.

• Prepare updated and easily accessible protocols for certain antibiotics; monitor vancomycin trough levels and focus on monitoring for appropriate vancomycin doses, dosing intervals and duration of therapy

• Avoid simultaneous administration of “heavy metal” drugs (containing Fe, Ca, Zn, Mg, etc) with Quinolones. Either temporarily hold or administer these drugs AT LEAST Six (6) hours BEFORE or Two (2) hours AFTER the Quinolones. 38

What facilities can do together

• Develop communication tools to share critical information between acute and long term facilities when patients are transferred– Culture results

– Pending results

– Treatments initiated (what, when, indication, stop date)

– Precautions

– Immunizations

– History of C. difficile

• Ensure contact information is provided for follow up on patient history and pending test results.

• Establish cross-facility teams to address infection prevention and antibiotic stewardship.

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Proton-pump inhibitors in the Acute Care Setting

Erica Tenholder, PharmD, BCPSClinical pharmacy specialist, antimicrobial stewardship

Baystate Medical CenterApril, 2012

ObjectivesObjectives• Summarize adverse effects associated with acid suppression

medications• Evaluate appropriate indications for the use of proton-pump

inhibitors• Discuss practical approaches to decrease unnecessary use

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Adverse Effects: proton-pump inhibitorsAdverse Effects: proton-pump inhibitors

Decreased absorption Calcium

Osteoporosis Magnesium

Increased risk C. difficile-associated

diarrhea Health-care associated Community acquired Recurrence

Pneumonia

Annualized cost of the inpatient and outpatient costs of

inappropriate stress ulcer prophylaxis estimated at

$111,7911 42

How do PPIs increase risk?

• Non-antibiotic disruption of normal flora

• Mechanism not completely understood– ↓ gastric acidity

• Allows survival of vegetative cells• Associated with colonization of upper GI tract –

alters normal flora

– Effects on host immune function– Effects on organism toxin production

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Risk of Risk of C. difficileC. difficile Infection (CDI)* Infection (CDI)*

Proton-pump inhibitors are associated with

• Community-Acquired CDI2

– 3-fold ↑ risk

• Hospital-Acquired CDI3

– 1.7-fold ↑ if taken daily– 2.4-fold ↑ if taken > daily

• Recurrence of CDI4

– 1.7-fold ↑ after antibiotics – 1.3-fold ↑ w/o antibiotics

H2 receptor antagonists are associated with– 2-fold ↑ risk of Community-Acquired CDI2

*Detailed slides with evidence and references at end of presentation 44

New study assessing risk factors for C. difficile infection or colonization5

• Increased risk of C. diff infection– Antibiotic– PPI

• Increased risk of colonization– Antibiotic– PPI– H2RA

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And if that doesn’t convince you…

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Appropriate Indications in Acute Care

• Patient has active GERD– Try to limit use to 4 weeks

• H. pylori eradication – Recommended duration: 10-14 days

• High dose NSAIDs• Stress Ulcer Prophylaxis

– Mechanical Ventilation/ ICU– Coagulopathy– INR > 1.5– Platelets < 50,000– 2+ Risk Factors

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Stress Ulcer Prophylaxis• Incidence of clinically significant gastrointestinal bleeding

ranges <1% to 6% in ICU patients– Variability due to definition of clinical significance

• Increased mortality– 57% in patients with endoscopic evidence of ulcers, bleeding, or

both within 18 hours of ICU admission– 24% in patients with either a normal mucosa, only non-

hemorrhagic erosions, or petechial changes

• Conflicting data regarding superiority of PPIs – PPIs are at least as effective as H2RAs for SUP

– H2RAs may cause development of tolerance within 5 days (some patients within 24 hours)

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Risk Factors for Stress Ulcers• Risk factors independently predictive of clinically significant

bleeding:– Mechanical ventilation >48 hours– Coagulopathy (plt <50,000 or INR >1.5)

• Other risk factors Sepsis Renal Failure Hepatic Failure Hypotension Trauma

• Bleeding significantly lower with prophylaxis only if ≥ 2 RF• Major non-ICU risk of GI bleed is anticoagulation

– Not affected by SUP

Severe Burns Myocardial Infarction Multiple Organ Failure Ileus High Dose Corticosteroids Major Surgery

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Discontinuation in acute care

• Stop PPI or H2RA once extubated (or other indications have resolved)

• Taper – duration > 28 days– present at admission

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Steps taken at BaystateMulti-factorial approach • Didactic sessions to educate prescribers on the clinical indications

– Internal medicine attending physicians, third year medical residents, first year medical interns, and fourth year medical students

– Repeated quarterly• Pharmacy students are trained to intervene on PPI orders when rounding

– Appropriate indications– Patient was taking PPI prior to admission

• Validate GERD history• ID pharmacist reviews all patient profiles if positive C. difficile

– Reviews indication for PPI – Contacts prescribers directly

• A computerized alert was designed to fire a message to the prescriber to prevent discharge on a PPI for stress ulcer prophylaxis

– Medication reconciliation is performed both at admission and discharge. – If a patient is being discharged on a PPI and was not on a PPI at admission, an

automated message will alert the physician that the patient is newly on a PPI– This message also outlines the indications and adverse effects of PPIs – At that point, the prescriber may choose to continue with the order or cancel the

PPI

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*Risk of *Risk of C. difficileC. difficile Infection: details Infection: details

CommunityCommunity22 NosocomialNosocomial33 RecurrentRecurrent44

Case-control study

Adjusted relative risk:2.9 (95% CI, 2.4-3.4) defined as PPI use within the past 90 days

Conclusion: PPI use increases community acquired CDAD risk

Prospective cohort study

Adjusted odds ratio for developing C. diff

Daily PPI: 1.74 (95% CI, 1.39-2.18)

Greater than daily PPI: 2.36 (95% CI, 1.79-3.11)

Conclusion: PPI use increases risk of nosocomial CDAD

Retrospective cohort study

Adjusted hazards ratio:1.42 (95% CI, 1.11-1.83)

Unadjusted HR for risk after antibiotics:

1.71 (1.11-2.64)Unadjusted HR for risk w/o antibiotics:

1.30 (0.94-1.79)

Conclusion: PPIs increase the risk for recurrent CDAD; risk is amplified by concurrent PPI + antibiotic use

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References1. Heidelbaugh JJ, Inadomi JM. Am J Gastroenterol. 2006;101:2200-2205.2. Dial, et al. JAMA. 2005; 294 (23): 2989.3. Howell M, et al. Arch Int Med. 2010 May; 170 (9): 784. 4. Linsky, et al. Arch Intern Med. 2010; 170 (9): 772.5. Loo VG, et al. N Engl J Med. 2011; 365(18):1693-1703.6. Herzig S, et al. JAMA. 2009 May; 301 (20): 2120.7. Lahelj, et al. JAMA. 2004 Oct; 292 (16): 1955.8. Spirit M, Stanley S. Crit Care Nurse. 2006 Feb; 26(1): 18-28.9. Lin P, et al. Crit Care Med. 2010; 38(4): 1197-1205.10. Lachman L, Howden C. Am J Gastroenterol. 2000 Jan; 95(1): 57-61. 11. Cook D, et al. N Eng J Med. 1994 Feb; 330(6): 377-381.12. Spirit M. Clinical Therapeutics. 2004; 26(2): 197-213.13. Cash B. Crit Care Med. 2002; 30(suppl 6): S373-S378.14. Estruch R, et al. Scand J Gastroenterol. 1991; 26:819-26.15. Grube R, May D. Am J Hosp Pharm. 2007 Jul; 64: 1396- 1400.

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Proton Pump Inhibitors (PPIs)Proton Pump Inhibitors (PPIs)Reduction StrategiesReduction Strategies

David B. Goldwater R.PhDavid B. Goldwater R.Ph

Clinical Consultant PharmacistClinical Consultant Pharmacist

Partners Pharmacy Partners Pharmacy MassachusettsMassachusetts

GOALSGOALS

1. To clearly identify which indications to target for reduction or discontinuance of PPI therapy.

2. To communicate this message with prescribers using the most recent FDA report on studies demonstrating the strong association of C.Diff with prolonged PPI use.

3. Review the best strategy for tapering PPI’s, while minimizing rebound symptoms.

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Appropriate Chronic PPI UseAppropriate Chronic PPI Use

• GERD with ongoing symptoms.

• GERD with Barrett’s Esophagus.

• SEVERE Peptic Ulcer Disease.

• Zollinger –Ellison Syndrome

• To heal ulcers caused by NSAIDS56

Inappropriate PPI Use Inappropriate PPI Use for Stress Ulcer Prophylaxisfor Stress Ulcer Prophylaxis

• It is now evident that NON-ICU patients, are ALSO receiving acid suppression, with the explicit indication of reducing stress ulcer complications.

• Stress ulcer prophylaxis has never been shown to be helpful in NON-ICU patients.

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Non-Ulcer Dyspepsia (NUD)Non-Ulcer Dyspepsia (NUD)

• Most frequent complaint after UGI endoscopy

• Not related to acid production

• Recent Clinical trials indicate that Reglan (motility enhancing drug) is more effective than PPIs or H2 Blockers.

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H. Pylori Detection and EliminationH. Pylori Detection and Elimination

H. pylori eradicationH. pylori eradication• Identifying and treating H. pylori infection can achieve a

cure in patients with peptic ulcer disease and may eliminate the need for lifelong drug therapy.27

Whom to test:Whom to test:• All patients with clinical evidence of a gastric or duodenal

ulcer, history of an ulcer, or gastric (MALT*) lymphoma should be tested for H. pylori.

• Testing in patients with functional dyspepsia is controversial, and studies evaluating its efficacy have reported mixed results. 28-30

* MALT = mucosa-associated lymphoid tissue

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Discontinuation of Proton Pump Inhibitors in Patients on Long-Term

therapy: A Double-Blind, Placebo-Controlled Trial.

PURPOSE:PURPOSE:

• To determine the proportion of patients on long-term PPI therapy who are able to discontinue PPIs without developing symptoms

CONCLUSIONS:CONCLUSIONS:• Discontinuation of PPI was successful in 27% of

long-term PPI users. • GERD patients had more difficulty discontinuing PPIs

than non-GERD patients. Reference: E. BjÖrnsson et al. Discontinuation of Proton Pump Inhibitors in Patients

on Long-Term Therapy: A Double-Blind, Placebo-Controlled Trial. Aliment Pharmacol Ther.  2006;24(6):945-954

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Many pts will safely tolerate PPI tapering Many pts will safely tolerate PPI tapering when indicated*when indicated*

• > 50% can be successfully tapered off of PPIs

• Those previously on long term PPI may have rebound hypersecretion of acid when PPIs are stopped

• Not always symptomatic• Symptoms generally brief

• Best chance of success-if H2 blockers are used

• Some pts can be successfully managed with PRN doses of H2 blockers or antacids.

Independent Drug Information Service (IDS) January 2006. www.Rxfacts.org

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How to Taper PPI How to Taper PPI “Dependent”“Dependent” Patients to Patients to

ReduceReduce Rebound Symptoms Rebound Symptoms

• FOR RESIDENTS ON HIGH DOSE PPIFOR RESIDENTS ON HIGH DOSE PPI (e.g. Pantoprazole 40mg)

• REDUCE DOSE BY HALF for 2 weeksREDUCE DOSE BY HALF for 2 weeks

e.g. Pantoprazole 20mg

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PPI TAPER PROTOCOLPPI TAPER PROTOCOL

• AFTER 2 WEEKS…….. STOP PPI

• PRESCRIBE RESCUE THERAPY as follows:– H-2 Blockers (e.g. Ranitidine 150mg BID or

Famotidine 20MG BID) and– PRN antacids

Action Steps that can Impact appropriate Action Steps that can Impact appropriate utilizationutilization

WhoWho • Identify all residents on PPIs

• Determine which ones should NOT be tapered

• Identify those with non-ulcer dyspepsia

• Identify those residents who could be screened for H Pylori.

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Action Steps that can Impact appropriate Action Steps that can Impact appropriate utilizationutilization

HowHow• Review discharge hospital summaries

• Identify if the PPI was started in the hospital for stress ulcer prophylaxis; then address the Prescriber

• FOCUS the nursing staff and physicians on the most recent FDA report on the studies….. demonstrating the strong association of C.Diff with prolonged PPI use

• Consultant pharmacist should then design and write recommendations

• Nurse will facilitate MD response and observe and document for any rebound GI symptoms

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AA ASSESSASSESS- PPI use in each residentRR REVIEWREVIEW- Documented indications for use- Nature and intensity of any GI symptoms

MM MINIMIZEMINIMIZE- Medication use according to functional status rather than evidence-based

medicine

OO OPTIMIZEOPTIMIZE- By selecting appropriate PPI dosage forms- By timing the PPI appropriately

RR REASSESS for PPI Taper in the following situations:REASSESS for PPI Taper in the following situations:

• In GERD residents who are symptom free, after 4 weeks of PPI therapy.• In PUD after 8 weeks of therapy and after H. Pylori eradication.• In Non-Ulcer Dyspepsia who are symptom free for 2 weeks on PPI therapy.

Use the A.R.M.O.R Approach to Apply the Use the A.R.M.O.R Approach to Apply the PPI REDUCTION PROTOCOL PPI REDUCTION PROTOCOL

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Available Academic Detailing ResourcesAvailable Academic Detailing Resources

Independent Drug Information services iDiSIndependent Drug Information services iDiS www.Rxfacts.org

• iDiSiDiS is a state initiative, sponsored by the PACE Program of the Pennsylvania Department of Aging.

• TTheir Academic detailing materials on “Acid Suppressant therapy” available for public access at www.Rxfacts.com

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Design an effective Auto text Design an effective Auto text RecommendationRecommendation

• Use Pharmacy recommendations and staff and Physician education to drive through a PPI REDUCTION PROGRAM

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• Some patients treated with long-term with PPIs may have rebound hypersecretionrebound hypersecretion of acid when PPIs are stopped, but this is not always symptomatic; even when symptoms occur, their duration is generally brief. (1)

• According to a study, over 50%over 50% of patients can be successfully tapered off of PPIs, with particularly good success rates in elderly patients.(2)

ReferencesReferences::1. Qvigstad G, Waldum H. rebound hypersecretion after inhibition of gastric acid

secretion. Basic & Clinical Pharmacology & Toxicology. 2004;94202-8. 2. Inadomi JM, McIntyre L, Bernard L, Fendrick AM. Step-down from multiple- to single-

dose proton pump inhibitors (PPIs): a prospective study of patients with heartburn or acid regurgitation completely relieved with PPIs. American Journal of Gastroenterology. 2003;98:1940-4

Background Information for Auto text creationBackground Information for Auto text creation

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How to Taper PPI How to Taper PPI “Dependent”“Dependent” Patients to Patients to

ReduceReduce Rebound Symptoms Rebound Symptoms

• FOR RESIDENTS ON HIGH DOSE PPIFOR RESIDENTS ON HIGH DOSE PPI (e.g. Pantoprazole 40mg)

• REDUCE DOSE BY HALF for 2 weeksREDUCE DOSE BY HALF for 2 weeks

e.g. Pantoprazole 20mg

Sample Recommendation # 1Sample Recommendation # 1RECENT CONFIRMATION OF HIGH RISK OF C. DIFF INFECTION ASSOCIATED

WITH PPI EXPOSURE: According to the 2-8-12 FDA Safety Announcement, the agency reviewed a total of

28 observational studies. Twenty-three of the studies showed a higher risk of C. difficile infection or disease, including C.D.A.D., associated with PPI exposure compared to no PPI exposure. (1)

According to a separate study, over 50% of patients can be successfully tapered off of PPIs, with particularly good success rates in elderly patients.(2) Some patients treated long-term with PPIs may have rebound hypersecretion of acid when PPIs are stopped, but this is not always symptomatic; even when symptoms occur, their duration is generally brief. (3)

 RECOMMENDATION: 1. This resident continues to receive (PPI) XXX2. Please review continued need for PPI therapy, and consider switching over to

Ranitidine 150 MG BID to prevent REBOUND GERD off PPI therapy.3. After a period of evaluation subsequent reduction of Ranitidine to 150mg HS

can then be considered with eventual PRN Ranitidine only.4. If therapy remains warranted, then please clarify the treatment plan with a

supporting diagnosis.

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The pharmacy and therapeutics committee of this facility has decided to focus on residents receiving routine long term PPIs.

The goal is to assess these residents for a POTENTIAL TRIAL of discontinuance of the PPI agent in the following situations:

• Residents with GERD who are symptom free for some time• Residents with Peptic Ulcer disease, after 8 weeks of therapy and H. pylori

eradication.• Residents with NUD, (Non-Ulcer Dyspepsia) when patient is symptom-free.

PPIs can lead to hypergastrinemia, which can result in hyper-secretion of acid when the PPI is stopped. This can make it difficult for some patients to discontinue use. (1)

FOR THIS REASON, THE FOLLOWING TAPERING REGIMEN IS PRESENTED

TO YOU FOR CONSIDERATION:1. Reduce PPI dose by half the first two weeks, Reduce by half again if the patient

was taking high-dose PPI.2. Stop PPI and prescribe rescue therapy for the next two weeks: H2 blockers (e.g.

Ranitidine 150mg BID) & PRN antacids. 3. LONG TERM: Slowly decrease dose and frequency of H2 blockers and antacids

as symptoms improve.

Sample Recommendation #2Sample Recommendation #2

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Sample Recommendation #3Sample Recommendation #3

1. Please reevaluate GI / GERD status and consider TRIAL D/C of XXX mg PO daily, and ADD ZANTAC 150mg PO BID X 2 weeks and then change to PRN for C/O heart burn or GI upset.

2. If after 30 - 60 day review of PRN Zantac use, results in frequent use then consider resuming the previously scheduled PPI agent.

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PPIs across a Transition of Care

Terrence A. O’Malley, MD, CMD

Medical Director, Non-Acute Care Services

Partners HealthCare System, Inc.

Objectives

• Identify the medication related data elements that “sending clinicians” should include in their transfer packets

• Identify patients whose PPIs can be stopped in Post Acute Care (PAC) settings

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What “Receivers” Want to Know

• They need the following for all meds, PPIs in particular:– indication–     dose–     date and time of last dose–     heads-up re potential adverse effects–     pre-admission med list–     current active med list

• Why do they need all this?

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Because They have These Questions

• What do we do if there is no indication?

• Which PPIs should we stop?

• Which categories of PPI use can we safely stop without a taper?

• Which categories of PPI use can we stop with a taper?

• What are the risks of stopping PPIs?

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No Indication

• An approach– Check the D/C Summary. Does the patient have a

diagnosis that requires a PPI?• Yes- continue• No- consider D/C

– Check with the referring clinician– Check with the patient– Check the Pre-admission Med List

• A complete transfer data set answers these questions

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Which PPIs are Safe to Stop?

• Immediately: Short term use– No indication, started during hospitalization,

duration less than four weeks

• With taper: Greater than 4 wks of use– No indication– Taken improperly– Safer alternatives available (H2 blockers)

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Risks of Stopping PPIs

• The risks accrue only to patients with a valid indication:– H pylori treatment– Zollinger Ellison – Recent UGIB/Peptic Ulcer Disease– Barrett’s Esophagus

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Objectives

• Identify the medication related data elements that “sending clinicians” should include in their transfer packets

• Identify patients whose PPIs can be stopped in Post Acute Care (PAC) settings

• In conclusion: – If you’re a “sender”, send the necessary information– If you’re a “receiver”, review all PPIs and stop all you

can

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References

• Gandara E, Moniz T.T, Ungar J; Lee J, Chan-Macrae M, O’Malley T,Schnipper J. L Deficits in Discharge Documentation in Patients Transferred to Rehabilitation Facilities on Anticoagulation: Results of a Systemwide Evaluation. The Joint Commission Journal on Quality and Patient Safety, August 2008 Volume 34 Number 8 460-463

• Gandara E, Moniz TT, Ungar,J, Lee,J, Chan-Macrae M, O’Malley T, Schnipper JL. Communication and information deficits in patients discharged to rehabilitation facilities: An evaluation of five acute care hospitals. J Hosp Med. 2009;4:E28-E33

• Gandara E, Ungar J, Lee J, Chan-Macrae M, O'Malley T, Schnipper JL. Discharge documentation of patients discharged to subacute facilities: a three-year quality improvement process across an integrated health care system. Jt Comm J Qual Patient Saf. 2010 Jun;36(6):243-51

• Kelly NA, Mahoney DF, Bonner A, O'Malley TA Use of a Transitional Minimum Data Set (TMDS) to Improve Communication Between Nursing Home and Emergency Department Providers doi:10.1016/j.jamda.2011.02.007 

• Alper, E, O’Malley, TA, Greenwald, J Hospital Discharge. Up To Date http://www.uptodate.com/contents/hospital-discharge?source=search_result&search=discharge&selectedTitle=1%7E150TBD

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Workshop Registration April 30th 8AM-Noon, Newton MA

REGISTER FOR NEWTON WORKSHOP HERE http://www.regonline.com/Register/Checkin.aspx?EventID=1078870

May 16th 8AM-Noon, Sturbridge MA

REGISTER FOR STURBRIDGE WORKSHOP HERE http://www.regonline.com/Register/Checkin.aspx?EventID=1078941

Questions or help with registration: Fiona Roberts, 781-262-6080 or froberts@macoalition.org

ALL programs grant CME / CEUs for physicians, nurses, pharmacists and long term care administrators

 

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Contacts

 

                                                                              

Susanne Salem-Schatz

Fiona Roberts, MA Coalition for Prevention of Medical Errors

Helen Magliozzi, MA Senior Care

Eileen McHale, Department of Public Health

sss@hcqi.com

froberts@macoalition.org

hmagliozzi@maseniorcare.org

eileen.mchale@state.ma.us

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