Factors leading to PPI overuse Despite FDA alerts/concerns of PPI

Impact of phamacist intervention in minimizing inappropriate use of Proton Pump Inhibitors in the elderly
Laqui, Aileen, PharmD Candidate ; Nomura, Stanley, PharmD ; Ip, Tina, PharmD Candidate ; Schwartz, Miriam, M.D.
1
2
Western University of Health Sciences Veterans Home of California, West Los Angeles
1
NOCTURNAL GERD
YES
NO
YES
Resume previous dose
Decrease PPI dose to alternate PPI (MF) and
ranitidine 300 mg qhs/ other days
x 1 week
Resume previous dose
Decrease PPI dose to alternate PPI (MF) and
ranitidine 150 mg bid/ other days
x 1 week
Did the patient tolerate
lower dose?
YES
NO
Resume previous dose
D/C PPI; Initiate ranitidine
300 mg qhs
x 1 week
Resume previous dose
Objectives: How do we unlock
the problem
• Identify unnecessary use of PPI and discontinue PPI
treatment if possible
• Determine whether an approach such as tapering off of
PPI therapy is more successful than discontinuing abruptly
in those who have been on long-term PPI therapy (> 1 year)
Adverse effects from PPI misuse are those that the elderly may associate
with old age so the connection is not obvious. Getting the message out on
the long-term side effects to patients is lacking so education is imperative—
something a pharmacist is trained to do.
YES
D/C PPI; Initiate ranitidine
150 mg bid
x 1 week
Resume previous dose
Decrease PPI dose to
1 pill daily
x 1 week
3. Patients feel the PPI is needed or the burning will return
The key is pharmacist monitoring of PPI taper progress
Did the patient tolerate
lower dose?
NO
YES
NO
Resume previous dose
Decrease ranitidine to
150 mg qhs
x 1-2 weeks
Resume previous dose
Decrease ranitidine to
150 mg qhs
x 1-2 weeks
Resume previous dose
Did the patient tolerate
lower dose?
NO
YES
NO
YES
Resume previous dose
D/C routine ranitidine
Use antacid or ranitidine PRN
Resume previous dose
D/C routine ranitidine
Use antacid or ranitidine PRN
PPI discon'nua'on pa2ern in 2013 vs. 2014 60 N=42
70% N=50
50 19 60% 50% N=50
40% 67% 30% 38% 20% 40 8 successful
20 10
10 0 0% Pharmacist & MD Baseline data from 2013 showed that in the
normal course of events, PPI use in the facility was
discontinued in 19 of 50 residents (a rate of 38%). During the first four months of 2014, with the addition
of pharmacist intervention, PPI use was discontinued
in 28 of 42 residents (a rate of 67%), a statistically
significant difference (p<0.05).
% PPI pills reduc.on post-­‐interven.on 2014 31 14 2013 2014 Unsuccessful 2 unsuccessful
Successful Of 31 residents who were still on PPIs in 2013 going
into 2014, 22 were discontinued with pharmacist
intervention in 2014 (71%). Among those 31 that
continued into 2014, 10 residents had failed abrupt
PPI discontinuation in 2013 and of those 10, 8 were
successfully tapered off in 2014 with pharmacist
intervention. Some subjects who discontinued PPIs
were transitioned to H2RA and/or pancrelipase to
prevent or treat breakthrough symptoms.
60% PPI tapering vs abrupt discon'nua'on 50% 30 40% 25 30% 53.0% # of pa'ents 20% 10% N=42
28 30 10% MD Patients may complain of pill burden but continue to take a PPI, because
it removes the burning sensation. Abrupt withdrawal may lead to an acid
rebound effect, so a gradual reduction may be required. A pharmacist can
play key role in monitoring the progress of a controlled, gradual tapering off
of PPIs. In cases where abrupt discontinuation failed, tapering was proven to
be 80% effective in our study.
YES
Initiate nocturnal GERD or
GERD all day taper
% PPI discon+nued post-­‐interven+on And CMS requires evaluation of
appropriate PPI use
Proper digestion of food allows appropriate stomach emptying leading to a
decrease risk of gastritis and GERD
NO
YES
Did the patient tolerate
lower dose?
80% 2) Adverse effects of long-term PPI use are insidious
The key is pharmacist education on PPI potential harm
Alternate 2 pills/day (MF) and
1 pill/ other days
x 1 week
YES
• Increased risk of hypomagnesemia → cramps, arrhythmias
• Acidic environment of stomach is needed for proper
digestion
• Paradoxically, sufficient stomach acid helps prevent GERD!
YES
NO
(problematic in the elderly due to an already diminished immune system)
Prioritization and limited time are often the reason that PPI misuse is
overlooked. Through the drug regimen review, the pharmacist can bring
attention to this, but that alone is not enough.
Did the patient tolerate
lower dose?
Did the patient tolerate
lower dose?
Did the patient tolerate
lower dose?
(problematic in the elderly due to an already limited intake and absorption)
• On 4/30/14, Public Citizen filed a lawsuit against the FDA demanding that the
long term side effects of PPIs be upgraded to a black box warning – the issue
will not go away
NO
Resume previous dose
Did the patient tolerate
lower dose?
NO
1) The problem is easily overlooked
The key is pharmacist drug regimen reviews
Did the patient tolerate
lower dose?
Did the patient tolerate
lower dose?
NO
• Increased risk of Clostridium difficile-associated diarrhea
Three main reasons for PPI misuse
Decrease PPI dose to alternate 2 pills/day (SMWF) and
1 pill/other days
x 1 week
Decrease PPI dose to alternate PPI (SMWF) and
ranitidine 150mg bid/ other days
x 1 week
Did the patient tolerate
lower dose?
(problematic in the elderly due to an already increased risk for falls)
YES
GERD all day
Decrease PPI dose to alternate PPI (SMWF) and
ranitidine 300 mg qhs/ other days
x 1 week
• Increased risk of fractures – hip, wrist, spine
The effects of PPI therapy on the gastric mucosa, hypergastrinemia, parietal
cell protrusion, ECL-cell hyperplasia, progression of H. pylori gastritis and
the development of atrophy may predispose to the formation of gastric
polyps
Does Patient’s Daily Dose exceed the following?
Omeprazole, esomeprazole, rabeprazole > 20mg
pantoprazole > 40 mg
lansoprazole > 15 mg
NO
Despite FDA alerts/concerns of
PPI long-term use
• High acidity poses as a barrier to infections
• Lack of acid is associated with gastric polyps
Your team may have the key and a pharmacist may be holding it!
PPI Taper Algorithm
• Very effective for reducing stomach acid
• Relatively benign when used as recommended
• Usual maximum course of therapy is 4 to 8 weeks
• Marketing and OTC status has made it readily available
• Commonly used for almost any type of gastric acid ailment
• Actual GERD prevalence in the U.S. ranges from 18% - 27.8%
• Often continued after hospitalization regardless of need
Stomach acid is a necessary bodily
function!
2
How to unlock the problem?
Factors leading to PPI overuse
• CMS included PPIs in F-tag 329, Unnecessary Drugs
• CMS expects PPI prescribing to meet one of the FDA
approved indications and dosing options
• CMS expects justifying documentation if used for more than
12 weeks
• F-tag 329 citations are among the most prevalent assessed
• CMS also warned about adverse reactions and risks with
long-term use of PPIs
1
# of pa'ents Problem: What is all the
fuss about PPI use?
2
13.8% 0% MD Pharmacist 20 12
abrupt
15 10 5 In 2014, some residents in the pharmacy intervention
group were able to decrease their PPI dosage.
Looking at the results in another way, the number
of PPI pills taken by the residents was reduced 53%
with pharmacist intervention versus 13.8% without
pharmacist intervention, also statistically significant
(p<0.05).
N=28
16
taper
0 PPI discon/nued in 2014 There was no significant difference in number of PPI
discontinuations comparing tapering vs abrupt.
However, many of the abrupt discontinuations were
successful because residents were already not taking
the PPI. But as mentioned in the previous graph,
80% of residents that did not tolerate an abrupt
discontinuation did so when tapered off.
Alternative treatments in place of PPIs
1. H2RA (Histamine2 Receptor Antagonist)
PPIs irreversibly inhibit proton pumps to stop the production of acid, which
contributes to its long-term adverse effects. H2RAs only temporarily block
gastric acid secretion and do not affect pepsin secretion making this
class of drug a safer choice.
2. Antacids
Antacids provide quick, temporary relief from “burning” by directly
neutralizing the acid in the stomach.
2. Other supplementary aids
Lack of sufficient amount of digestive enzymes can be the cause of
improper digestion. When food stays undigested, stomach emptying is
delayed & more acid is produced, increasing chance of burning & GERD.
Benefits
1) Minimizing of potential negative health effects from PPIs
2) Cost savings from discontinuance of unnecessary
medications and avoidance of associated health problems
3) Greater compliance with CMS F-tag 329
4) Likely improved digestive process for the resident
5) Enhanced utilization of resources, namely the pharmacist
Acknowledgements/References
Much thanks to Mira Cantrell, M.D., Malwinder Multani, M.D., Keiko Mimura,
N.P., Anna Kim, PharmD, Jennifer Tan, PharmD, Larry Tran, PharmD, and Rika
Galias, CPhT.
1) Ament, Paul W., et al. Reducing adverse effects of proton pump inhibitors. Am Fam Physician. 2012; 86(1): 66-70.
2) Atkins, Richard, and Smith, Lori. Impact of pharmacy intervention on
the use of proton-pump inhibitors in the hospital setting. The Consultant
Pharmacist. Dec 2013; 28(12): 786-792.
3) Center for Medicare & Medicaid Services. Proton pump inhibitors: use in
adults. August 2013. http://www.cms.gov/Medicare-Medicaid-Coordination/
Fraud-Prevention/Medicaid-Integrity-Education/Pharmacy-EducationMaterials/Downloads/ppi-adult-factsheet.pdf. Accessed 2/28/2014.
4) FDA Proton pump inhibitor information. Current safety information.
Updated 2/9/2012. http://www.fda.gov/Drugs/DrugSafety/
InformationbyDrugClass/ucm213259.htm. Accessed 2/28/2014.