Transcript Role of the Executive Sponsor - Massachusetts Coalition for the

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
2
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.
3
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 Roberts
[email protected]
4
Continuing Education Disclosures

The speakers on today’s call have no
financial interests or relationships to
disclose.
5
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 longterm 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
7
The importance of prudent use of
antibiotics
8
Bad Bugs No Drugs
9
The drug development pipeline for
antibacterials
10
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. 674679
11
12
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
13
14
15
Antimicrobial Therapy
Appropriate initial
antibiotic while improving
patient outcomes and
healthcare
Unnecessary
Antibiotics, adverse
patient outcomes and
increased cost
A Balancing Act
16
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
18
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
19
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
20
Case 1
• The nurse notes that an 82-year-old longterm 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
21
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.
22
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
23
The Iceberg Effect
Infected
Colonized
24
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
25
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
26
C. Diff rates in the US
Courtesy CDC
27
Pathogenesis of CDAD
Antibiotic therapy
Alteration of colonic microflora
C. difficile exposure and colonization
Release of toxin A and toxin B
(and in some strains, binary toxin)
Colonic mucosal injury and inflammation
28
Reprinted from Kelly CP, et al. Annu Rev Med. 1998;49:375-390.
29
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
30
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.
31
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 piperacillintazobactam 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 piperacillintazobactam
32
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
33
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
34
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
36
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
37
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
38
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.
39
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
41
Adverse Effects: proton-pump inhibitors

Increased risk
C. difficile-associated
diarrhea




Health-care associated
Community acquired
Recurrence

Decreased absorption
Calcium


Osteoporosis
Magnesium
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
43
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
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
45
And if that doesn’t convince
you…
46
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
47
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 nonhemorrhagic 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)
48
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






Severe Burns
Myocardial Infarction
Multiple Organ Failure
Ileus
High Dose Corticosteroids
Major Surgery
• Bleeding significantly lower with prophylaxis only if ≥ 2 RF
• Major non-ICU risk of GI bleed is anticoagulation
– Not affected by SUP
49
Discontinuation in acute care
• Stop PPI or H2RA once extubated (or
other indications have resolved)
• Taper
– duration > 28 days
– present at admission
50
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
51
*Risk of C. difficile Infection: details
Community2
Nosocomial3
Recurrent4
Case-control study
Prospective cohort study
Retrospective cohort study
Adjusted relative risk:
2.9 (95% CI, 2.4-3.4)
defined as PPI use
within the past 90
days
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 community
acquired CDAD risk
Conclusion: PPI use
increases risk of nosocomial
CDAD
Adjusted hazards ratio:
1.42 (95% CI, 1.111.83)
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
52
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
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.
53
Proton Pump Inhibitors (PPIs)
Reduction Strategies
David B. Goldwater R.Ph
Clinical Consultant Pharmacist
Partners Pharmacy
Massachusetts
GOALS
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.
55
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
56
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.
57
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.
58
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
59
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
60
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
61
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.
64
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
65
Use the A.R.M.O.R Approach to Apply the
PPI REDUCTION PROTOCOL
A
R
-
ASSESS
PPI use in each resident
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.
66
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
67
68
Design an effective Auto text
Recommendation
• Use Pharmacy recommendations and staff and
Physician education to drive through a PPI REDUCTION
PROGRAM
69
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
70
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:
1.
This resident continues to receive (PPI) XXX
2.
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.
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
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.
74
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?
77
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?
78
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
79
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)
80
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
81
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
82
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/hospitaldischarge?source=search_result&search=discharge&selectedTitle=1%7E150TBD
83
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 [email protected]
ALL programs grant CME / CEUs for physicians, nurses, pharmacists and long term care
administrators
84
Contacts
Susanne Salem-Schatz
[email protected]
Fiona Roberts, MA Coalition for
Prevention of Medical Errors
[email protected]
Helen Magliozzi, MA Senior Care
[email protected]
Eileen McHale, Department of
Public Health
[email protected]
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