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

Today’s Agenda                                                                                  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.  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

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 REPEAT THIS AS A FINAL SLIDE Contact Fiona Roberts froberts@macoalition.org

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

Overview of antibiotic stewardship and the long term care opportunity Shira Doron, MD Assistant Professor of Medicine Division of Geographic Medicine and Infectious Diseases Tufts 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

The importance of prudent use of antibiotics

Bad Bugs No Drugs

The drug development pipeline for antibacterials

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

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

Antimicrobial Therapy Unnecessary Antibiotics, adverse patient outcomes and increased cost Appropriate initial antibiotic while improving patient outcomes and healthcare A Balancing Act Antibiotic treatment of nosocomial pneumonia is a balancing act. Clinicians need to treat patients with these potentially life-threatening infections with an appropriate initial antimicrobial regimen while also trying to minimize the emergence of resistant pathogens.

What is Antimicrobial Stewardship? Antimicrobial stewardship involves the optimal selection, dose and duration of an antibiotic resulting in the cure or prevention of infection with minimal unintended consequences to the patient including emergence of resistance, adverse drug events, and cost. Ultimate goal is improved patient care and healthcare outcomes Dellit TH, et al. CID 2007;44:159-77, Hand K, et al. Hospital Pharmacist 2004;11:459-64 Paskovaty A, et al IJAA 2005;25:1-10 Simonsen GS, et al Bull WHO 2004;82:928-34

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

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

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

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

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.

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 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.

The Iceberg Effect Infected Colonized This iceberg graphically represents colonization versus infection. Those patients that are infected with an organism represent just the “tip of the iceberg” of patients that are colonized or infected. Just because a patient is not infected, or showing signs of infection, does not mean that they do not carry organisms that could be transferred to another patient if proper hand hygiene and other infection control precautions are not taken.

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;49:375-390 4. Kelly CP, et al. Annu Rev Med. 1998;49:375-390. 5. McCusker ME, et al. Emerg Infect Dis. 2003;9:730-733..

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

C. Diff rates in the US Courtesy CDC

Colonic mucosal injury and inflammation Pathogenesis of CDAD Antibiotic therapy Alteration of colonic microflora C. difficile exposure and colonization Antibiotics cause a disruption of the bacteria that normally predominate in the colon. After the bowel has been made susceptible to C. difficile by antibiotic therapy, colonization occurs by the oral-fecal route. Pathogenic strains of C. difficile produce two potent toxins: toxin A (an enterotoxin) and toxin B (a cytotoxin). Some strains are now recognized to also release a binary toxin, and this has been shown to be associated with more severe disease, although the significance is not completely understood. Both toxins bind to and damage colonic epithelial cells. The toxins also cause a severe inflammatory reaction in the lamina propria and the formation of microulcerations of the colonic mucosa, which are covered by an inflammatory pseudomembrane. Infection may be asymptomatic, cause mild diarrhea, or result in severe pseudomembranous colitis. C. difficile also forms heat-resistant spores that can persist in the environment for years. It can contaminate hospital surfaces and be transmitted by health care workers. Release of toxin A and toxin B (and in some strains, binary toxin) Colonic mucosal injury and inflammation Reprinted from Kelly CP, et al. Annu Rev Med. 1998;49:375-390.

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.

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.

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

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

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 Control

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

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

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

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.

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.

Proton-pump inhibitors in the Acute Care Setting Erica Tenholder, PharmD, BCPS Clinical pharmacy specialist, antimicrobial stewardship Baystate Medical Center April, 2012

Objectives 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

Adverse Effects: proton-pump inhibitors Increased risk C. difficile-associated diarrhea Health-care associated Community acquired Recurrence Pneumonia Decreased absorption Calcium Osteoporosis Magnesium Annualized cost of the inpatient and outpatient costs of inappropriate stress ulcer prophylaxis estimated at $111,7911

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

Risk of C. difficile 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

New study assessing risk factors for C 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

And if that doesn’t convince you…

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

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)

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

Discontinuation in acute care Stop PPI or H2RA once extubated (or other indications have resolved) Taper duration > 28 days present at admission

Steps taken at Baystate Multi-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

*Risk of C. difficile Infection: details Community2 Nosocomial3 Recurrent4 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

References Heidelbaugh JJ, Inadomi JM. Am J Gastroenterol. 2006;101:2200-2205. Dial, et al. JAMA. 2005; 294 (23): 2989. Howell M, et al. Arch Int Med. 2010 May; 170 (9): 784. Linsky, et al. Arch Intern Med. 2010; 170 (9): 772. Loo VG, et al. N Engl J Med. 2011; 365(18):1693-1703. Herzig S, et al. JAMA. 2009 May; 301 (20): 2120. Lahelj, et al. JAMA. 2004 Oct; 292 (16): 1955. Spirit M, Stanley S. Crit Care Nurse. 2006 Feb; 26(1): 18-28. Lin P, et al. Crit Care Med. 2010; 38(4): 1197-1205. Lachman L, Howden C. Am J Gastroenterol. 2000 Jan; 95(1): 57-61. Cook D, et al. N Eng J Med. 1994 Feb; 330(6): 377-381. Spirit M. Clinical Therapeutics. 2004; 26(2): 197-213. Cash B. Crit Care Med. 2002; 30(suppl 6): S373-S378. Estruch R, et al. Scand J Gastroenterol. 1991; 26:819-26. Grube R, May D. Am J Hosp Pharm. 2007 Jul; 64: 1396- 1400.

Proton Pump Inhibitors (PPIs) Reduction Strategies David B. Goldwater R.Ph Clinical Consultant Pharmacist Partners Pharmacy Massachusetts

GOALS To clearly identify which indications to target for reduction or discontinuance of PPI therapy. 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. Review the best strategy for tapering PPI’s, while minimizing rebound symptoms.

Appropriate Chronic PPI Use GERD with ongoing symptoms. GERD with Barrett’s Esophagus. SEVERE Peptic Ulcer Disease. Zollinger –Ellison Syndrome To heal ulcers caused by NSAIDS

Inappropriate PPI Use for 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.

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.

H. Pylori Detection and Elimination H. 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: 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

Discontinuation of Proton Pump Inhibitors in Patients on Long-Term therapy: A Double-Blind, Placebo-Controlled Trial. PURPOSE: To determine the proportion of patients on long-term PPI therapy who are able to discontinue PPIs without developing symptoms 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

Many pts will safely tolerate PPI tapering 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

How to Taper PPI “Dependent” Patients to Reduce Rebound Symptoms FOR RESIDENTS ON HIGH DOSE PPI (e.g. Pantoprazole 40mg) REDUCE DOSE BY HALF for 2 weeks e.g. Pantoprazole 20mg 62

PPI 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 63

Action Steps that can Impact appropriate utilization Who 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.

Action Steps that can Impact appropriate utilization How 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

Use the A.R.M.O.R Approach to Apply the PPI REDUCTION PROTOCOL A ASSESS PPI use in each resident R REVIEW - Documented indications for use - Nature and intensity of any GI symptoms M MINIMIZE - Medication use according to functional status rather than evidence-based medicine O OPTIMIZE By selecting appropriate PPI dosage forms By timing the PPI appropriately R 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.

Available Academic Detailing Resources Independent Drug Information services iDiS www.Rxfacts.org iDiS is a state initiative, sponsored by the PACE Program of the Pennsylvania Department of Aging. Their Academic detailing materials on “Acid Suppressant therapy” available for public access at www.Rxfacts.com

Design an effective Auto text Recommendation Use Pharmacy recommendations and staff and Physician education to drive through a PPI REDUCTION PROGRAM

Background Information for Auto text creation Some patients treated with 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. (1) According to a study, over 50% of patients can be successfully tapered off of PPIs, with particularly good success rates in elderly patients.(2) References: 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

How to Taper PPI “Dependent” Patients to Reduce Rebound Symptoms FOR RESIDENTS ON HIGH DOSE PPI (e.g. Pantoprazole 40mg) REDUCE DOSE BY HALF for 2 weeks e.g. Pantoprazole 20mg 71

Sample Recommendation # 1 RECENT 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: This resident continues to receive (PPI) XXX Please review continued need for PPI therapy, and consider switching over to Ranitidine 150 MG BID to prevent REBOUND GERD off PPI therapy. After a period of evaluation subsequent reduction of Ranitidine to 150mg HS can then be considered with eventual PRN Ranitidine only. If therapy remains warranted, then please clarify the treatment plan with a supporting diagnosis. 72

Sample Recommendation #2 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. 73

Sample Recommendation #3 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. If after 30 - 60 day review of PRN Zantac use, results in frequent use then consider resuming the previously scheduled PPI agent.

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

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?

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?

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

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)

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

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

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

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  

Contacts                                                                                  sss@hcqi.com froberts@macoalition.org hmagliozzi@maseniorcare.org eileen.mchale@state.ma.us Susanne Salem-Schatz Fiona Roberts, MA Coalition for Prevention of Medical Errors Helen Magliozzi, MA Senior Care Eileen McHale, Department of Public Health