or enemies of the state Janelle Jones Dev Jayaraman Todd C Lee Outline PPI overprescription PPI adverse effects PPI indications The PPI project and how you can help Heres the problem ID: 921387
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Slide1
The PPI dilemma: miracle pills or enemies of the state?
Janelle
Jones, Dev Jayaraman, Todd C. Lee
Slide2Outline PPI over-prescriptionPPI adverse effectsPPI indications
The PPI project and how you can help!
Slide3Here’s the problem…Gastrointestinal complaints are incredibly commonHeartburn
Reflux
“Indigestion”
Bloating
Slide4And the solution?Marketed direct to consumer and physician alike
The proton pump inhibitor!
Slide5PPI Overprescription
Slide6PPI OverprescriptionNaunton
(2000) Retrospective study. 200
pts
on PPI- approved indications 37%. Median duration of PPI use 450 days.
Zink (2005) Retrospective. 60% on PPI without indication during hospitalization. 34% discharged on PPI. Longer length of stay predictive. At 3 months- 80% and 6 months – 50% still on PPI inappropriately.
Pham (2006) Retrospective. 29% on acid suppressive, 33% PPIs. During Admission – increased to 84% PP1. Only 10% had indication.
Slide7Adverse effects – random PPI monograph
1
% to 10%:
CNS:
Headache (7%), dizziness (2%)
Derm
:
Rash (2%)
GI:
Abdominal pain (5%), diarrhea (4%), nausea (4%), vomiting (3%), flatulence (3%), acid regurgitation (2%), constipation (2%)
Resp
:
Upper respiratory infection (2%), cough (1%)
≤1%
(Limited to important or life-threatening; adverse event occurrence may vary based on formulation): Abdominal swelling, abnormal dreams, aggression, agitation,
agranulocytosis
, alkaline phosphatase increased, allergic reactions, alopecia, ALT increased, anaphylaxis, anemia, angina, angioedema, anorexia, anxiety, apathy, AST increased, atrophic gastritis, benign gastric polyps, bilirubin increased, blurred vision,
bradycardia
, bronchospasm, chest pain,
cholestatic
hepatitis, confusion,
creatinine
increased, depression, double vision, dry skin, epistaxis, erythema
multiforme
, esophageal candidiasis, fatigue, fecal discoloration, fever, fracture,
gastroduodenal
carcinoids, GGT increased, glycosuria,
gynecomastia
, hallucinations, hematuria, hemolytic anemia, hepatic encephalopathy, hepatic failure, hepatic necrosis, hepatitis, hepatocellular hepatitis, hyperhidrosis, hypersensitivity, hypertension, hypoglycemia,
hypomagnesemia
,
hyponatremia
, insomnia, interstitial nephritis, irritable colon, jaundice, joint pain, leg pain, leukocytosis, leukopenia, liver disease (hepatocellular,
cholestatic
, mixed), malaise, microscopic colitis, microscopic
pyuria
, mucosal atrophy (tongue), muscle cramps, muscle weakness, myalgia, nervousness, neutropenia, ocular irritation, optic atrophy, optic neuritis, optic neuropathy (anterior ischemic), osteoporosis-related fracture, pain, palpitation, pancreatitis, pancytopenia,
paresthesia
, peripheral edema,
petechiae
, pharyngeal pain, photosensitivity, proteinuria, pruritus, psychiatric disturbance,
purpura
, skin inflammation, sleep disturbance, somnolence, Stevens-Johnson syndrome, stomatitis, tachycardia, taste perversion, testicular pain, thrombocytopenia, tinnitus, toxic epidermal
necrolysis
, tremor, urinary frequency, urinary tract infection,
urticaria
, vertigo, weight gain,
xerophthalmia
,
xerostomia
Slide8Adverse effects – the “special problems”
Dial et al. (2006) – CMAJ – cohort/case-control study- use of PPI was associated with C. diff diarrhea OR 2.7 (95%CI 1.4-5.2).
Aseeri
et al. (2008) – AJG –retrospective case control – CDAD was associated with use of PPI OR 3.6 (95%CI 1.7-8.3
)
Slide9Continued.Chun Shing Kwok et al. (2011) – AJG – meta-analysis of 42 observational studies including 313000 patients. Association between PPI and risk of CDAD – OR 1.74 (95% CI 1.47-2.85). Concomitant PPI and
Abx
CI 1.96 (95%CI 1.03-3.70).
Slide10Other “special problems”: fracturesFracture risk-
Yu et al. (2011) – Am J med – meta-analysis of 11 international studies including 1,084 560 patients.
Hip # RR 1.30 (95%CI 1.19-1.43)
No increase with H2 blockers
Slide11Other harmful associations in literature?PneumoniaHospital Acquired Pneumonia
Functional decline in elderly
Falls in elderly
All cause mortality post-discharge
B12 deficiency
There are more…
Slide12Are PPIs all bad?Of course not
One needs to balance the therapeutic benefit with the potential risks
For certain indications the evidence is in favor of using these medications
Slide13IndicationsUlcer
with documented bleed or symptoms within 3 months
Pathological
secretatory
conditions (i.e.
Zollinger
-Ellison)
GERD or severe indigestion with exacerbation within 3 months and non-responsive to H2 blocker
Erosive esophagitis
Helicobacter therapyDual Antiplatelet therapyAntiplatelet and Anticoagultion
Antiplatelet and previous complicated ulcer
Antiplatelet/NSAID and more than one of: Age >60, Corticosteroids, Previous Uncomplicated Ulcer,
Concomittant
NSAID/Antiplatelet
Slide14PPI AuditWhat can YOU do to help this project?
Find out if your patient is on a PPI and ask them WHY.
Discuss the reasons why stopping the PPI is important if there is no
ongoing indication.
Enter the patient in the web tool (the link was given to them here)
Ensure the patient receives a copy of the letter
to community MD
if you stop the therapy
Slide15Our success story so far- the data.This slide would be updated monthly during the intervention
Slide16Thank you!
Slide17References.M.
Naunton
, G. M. Peterson, M. D.
Bleasel
(2000) Overuse of proton pump inhibitors. J
Clin
Pharm
Ther
. 2000 October; 25(5): 333–340
.Zink D.A., Pohlman M., Barnes M., Cannon M.E. (2005) Long-term use of acid suppression started inappropriately during hospitalization. Aliment
Pharmacol
Ther
21: 1203–1209
.
Pham C.Q.D., Regal R.E.,
Bostwick
T.R.,
Knauf
K.S. (2006) Acid suppressive therapy use on an inpatient internal medicine service. Ann
Pharmacother
40: 1261–1266
.
Dial S., Delaney J.A.C.,
Barkun
A.N.,
Suissa
S. (2005) Use of gastric acid-suppressive agents and the risk of community-acquired
Clostridium
difficile
-associated disease. JAMA 294:
2989–2995.
Aseeri
M., Schroeder T., Kramer J.,
Zackula
R. (2008) Gastric acid suppression by proton pump inhibitors as a risk factor for
Clostridium-
difficile
-associated diarrhea in hospitalized patients. Am J
Gastroenterol
103: 2308–2313
.
Chun
Shing Kwok et al
. (2011)
Risk
of Clostridium
difficile
Infection With Acid Suppressing Drugs and Antibiotics:
Meta-Analysis.
The American Journal of
Gastroenterology
107 (7), 2012,
p.1011
Yu EW, Bauer SR, Bain PA, Bauer DC
.(2011)
Proton pump inhibitors and risk of fractures: a meta-analysis of 11 international
studies
Am J Med. 2011 Jun;124(6):519-26
.