1.       
              
               
Improving drug use to enhance infection prevention: antibiotic stewardship and beyond
                           
             
CDI Prevention Partnership Collaborative
Audio Conference Call
April 25, 2012

2. 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

3. 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

4. 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

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

6. 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

7. 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

8. The importance of prudent use of antibiotics

9. Bad Bugs No Drugs

10. The drug development pipeline for antibacterials

11. The burden of infection in long term care
12 studies in North America:
infections per 1000 resident-care days
Rate of death from infection per 1000 resident-care days
Strausbaugh et al. Infection Control and Hospital Epidemiology 2000, 21(10), p

13. 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

16. 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.

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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.

23. 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.

24. 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.

25. 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:
2. Anand A, et al. Am J Gastroenterol. 1994;89:
3. Kelly CP, et al. Annu Rev Med. 1998;49:
4. Kelly CP, et al. Annu Rev Med. 1998;49:
5. McCusker ME, et al. Emerg Infect Dis. 2003;9:

26. 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

27. C. Diff rates in the US
Courtesy CDC

28. 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:

30. 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.

31. 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.

32. 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

33. 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

34. 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

35. 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

36. 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

37. 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

38. 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.

39. 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.

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

41. 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

42. 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

43. 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

44. 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

45. 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

46. And if that doesn’t convince you…

47. Appropriate Indications in Acute Care
Patient has active GERD
Try to limit use to 4 weeks
H. pylori eradication
Recommended duration: days
High dose NSAIDs
Stress Ulcer Prophylaxis
Mechanical Ventilation/ ICU
Coagulopathy
INR > 1.5
Platelets < 50,000
2+ Risk Factors

48. 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)

49. 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

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

51. 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

52. *Risk of C. difficile Infection: details
Community2
Nosocomial3
Recurrent4
Case-control study
Adjusted relative risk:
2.9 (95% CI, )
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, )
Greater than daily PPI:
2.36 (95% CI, )
Conclusion: PPI use increases risk of nosocomial CDAD
Retrospective cohort study
Adjusted hazards ratio:
1.42 (95% CI, )
Unadjusted HR for risk after antibiotics:
1.71 ( )
Unadjusted HR for risk w/o antibiotics:
1.30 ( )
Conclusion: PPIs increase the risk for recurrent CDAD; risk is amplified by concurrent PPI + antibiotic use

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

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

55. 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.

56. 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

57. 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.

58. 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.

59. 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
* MALT = mucosa-associated lymphoid tissue

60. 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):

61. 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

62. 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

63. 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

64. 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.

65. 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

66. 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.

67. Available Academic Detailing Resources
Independent Drug Information services iDiS
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

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

70. 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;
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

71. 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

72. Sample Recommendation # 1
RECENT CONFIRMATION OF HIGH RISK OF C. DIFF INFECTION ASSOCIATED WITH PPI EXPOSURE:
According to the 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

73. 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

74. 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 day review of PRN Zantac use, results in frequent use then consider resuming the previously scheduled PPI agent.

75. PPIs across a Transition of Care
Terrence A. O’Malley, MD, CMD
Medical Director, Non-Acute Care Services
Partners HealthCare System, Inc.

76. 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

77. 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?

78. 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?

79. 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

80. 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)

81. 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

82. 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

83. 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
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 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: /j.jamda  
Alper, E, O’Malley, TA, Greenwald, J Hospital Discharge. Up To Date

84. Workshop Registration
April 30th 8AM-Noon, Newton MA
Register for Newton workshop here
May 16th 8AM-Noon, Sturbridge MA
Register for Sturbridge workshop here
Questions or help with registration: Fiona Roberts, or
ALL programs grant CME / CEUs for physicians, nurses, pharmacists and long term care administrators

85. Contacts
                                                                              
Susanne Salem-Schatz Fiona Roberts, MA Coalition for Prevention of Medical Errors Helen Magliozzi, MA Senior Care Eileen McHale, Department of Public Health