“Should I add a PPI?” A review of inpatient GI prophylaxis Lenny Noronha, MD Associate Professor, Hospitalist Section 2/5/10

Case 1 Mrs. Lowdee 78yf POD 2 s/p L hip ORIF Consult for opiate-rel delirium Changed to toradol 15mg IV q8h Nurse calls for am lab drop in H/H. “I did that to her.” ‘Maybe I should have put her on a PPI…’

Case 2 Dr. Coldfeet - 35ym a couple years out of residency - Notices housestaff, colleagues use PPI’s left and right for inpatient GI prophylaxis. - Not sure whether to adopt practice Doesn’t want partners to notice omission and gossip about incompetence.

Thanks to Rush Pierce, MD Jim Little, RN David Hedberg Kendall Rogers, MD Sanjeev Arora, MD

Objectives Review current appropriate use of GI prophylaxis Discuss literature of risk Display UNM IM use, concerns

Underlying Concepts Efficacy:Harm, Perceived Safety, Cost, Estrogen, Bb, Bisphosphonates, Statins (Taylor) Extrapolation (ICU -> SAC/ward) Dangers of templates, following patterns of supervisors/peers

Risk Factors for Gastrointestinal Bleeding in Critically Ill Patients Volume 330:377-381 February 10, 1994 Number 6                        Risk Factors for Gastrointestinal Bleeding in Critically Ill Patients Deborah J. Cook, Hugh D. Fuller, Gordon H. Guyatt, John C. Marshall, David Leasa, Richard Hall, Timothy L 2252 patients > 16 yo adm to med/surg ICU’s in 4 academic medical centers Risk of “clinically important” bleeding in “critically ill”

Risk Factors for Clinically Important Bleeding among 2252 Patients Admitted to an Intensive Care Unit Table 4. Risk Factors for Clinically Important Bleeding among 2252 Patients Admitted to an Intensive Care Unit. Conclusion: You don’t have to prophylax critically ill patients unless they have coagulopathy or require mechanical ventilation.

Risk Factors for ICU UGIB* Mechanical ventilation > 48 hours Coagulopathy INR > 1.5 Platelets < 50K UGIB within past year Chronic Liver, Kidney Disease +/- Steroids * Multiple meta-analyses

Outside the ICU Quadeer MA, “Hospital-Acquired Gastrointestinal Bleeding Outside the Critical Care Unit Risk Factors, Role of Acid Suppression, and Endoscopy Findings”, Journal of Hospital Medicine, Jan/Feb 2006, Vol 1, Issue 1 Retrospective review of 17,701 non-GI patients admitted to medicine ward academic hospital who bled at least 24 hours after admission AND bouncebacks for UGIB within 1 month. 0.4% clinically significant bleeding rate. No benefit from PPI or other prophylaxis. Nonsignificant trend toward PPI benefit for patients on therapeutic anticoagulation or clopidogrel

PPI, H2, Sucralfate, Maalox? Efficacy over placebo for all agents established Shuman RB, “Prophylactic therapy for stress ulcer bleeding: a reprisal.” Ann Internal Med, Apr 1987; 106(4): 562-7. Cook DJ, “Stress ulcer prophylaxis in the critically ill: a meta analysis” Am J Med, Nov 1991; 91(5):519-27 Decreased incidence in clinically significant UGIB and mortality with PPI over H2, other agents. Conrad SA, et al, Critical Care Med, Apr 2005; 33(4); 760-5.

Risk of Harm Data Risk of Community-Acquired Pneumonia and Use of Gastric Acid–Suppressive Drugs, Robert J. F. Laheij; Miriam C. J. M. Sturkenboom; Robert-Jan Hassing; Jeanne Dieleman; Bruno H. C. Stricker; Jan B. M. J. Jansen, JAMA, October 27, 2004; 292: 1955 - 1960. Acid-Suppressive Medication Use and the Risk for Hospital-Acquired Pneumonia Shoshana J. Herzig, MD; Michael D. Howell, MD, MPH; Long H. Ngo, PhD; Edward R. Marcantonio, MD, SM JAMA. 2009;301(20):2120-2128. Association of Proton Pump Inhibitor Therapy With Spontaneous Bacterial Peritonitis in Cirrhotic Patients With Ascites Jasmohan S Bajaj MD, MS, Yelena Zadvornova MD, Douglas M Heuman MD, Muhammad Hafeezullah MBBS, Raymond G Hoffmann PhD, Arun J Sanyal MD and Kia Saeian MD, MS, Am J Gastroenterol 104: 1130-1134; March 31, 2009; doi:10.1038/ajg.2009.80 HAP: 63, 878 non-ICU admissions over 3 days in an academic medical center. “pharmacoepidemiologic cohort study” Thank sub-I John Kennedy HAP: 63, 878 non-ICU admissions over 3 days in an academic medical center. “pharmacoepidemiologic cohort study” SBP: retrospective case-control study: chart review of 1193 pts with cirrhosis adm to hospital on PPI as outpt. 70 sbp patients age/severity/comorbidity matched to 70 without sbp or UGIB who had paracentesis. Of sbp pt’s 69% on PPI, 31%

Authors’ comments: 33,000 preventable US deaths! Rates of Hospital-Acquired Pneumonia According to Acid-Suppressive Medication Status Herzig, S. J. et al. JAMA 2009;301:2120-2128. Half of patients on acid-suppressing medicine (83% PPI) 30% higher risk of HAP with PPI. Headline: highest risk in first 48hrs, seemed to decr with time. NNH 111 180,000 HAP, 18% mortality Authors’ comments: 33,000 preventable US deaths! Copyright restrictions may apply.

Other suggested risks… C. diff Enteric infections (salmonella, campylobacter) Hip fracture B12 deficiency Decreased absorption of B12, iron and calcium Gastric, colon polyps Long-term Safety Concerns with Proton Pump Inhibitors, Ali T, Roberts DN, The American Journal of Medicine, Oct 2009 (Vol. 122, Issue 10, 896-903) Long-term Proton Pump Inhibitor Therapy and Risk of Hip Fracture Yu-Xiao Yang, MD, MSCE; James D. Lewis, MD, MSCE; Solomon Epstein, MD; David C. Metz, MD JAMA. 2006;296:2947-2953.

Cost (per dose) Nexium PO $6.19 $14.90 Protonix PO $4.79 $12.12 Drug Cost to UNM Patient Charge Nexium PO $6.19 $14.90 Protonix PO $4.79 $12.12 Protonix IV $28.20 $67.60

2009 Q3 UNMH PPI Use

ICU vs SAC/Wards 2009 PPI Use 72% of ICU pts on PPI Cardiology excluded - 72% of ICU pts on PPI - Cardiology excluded

Appropriate GI Prophylaxis with PPI Ventilated, coagulapathic or therapeutically anticoagulated critically ill patients Continue PPI on outpatient users Consider potential absorption effects (Ca, Fe, etc) What about Plavix patients? Stay tuned for guidelines updates, quality marker implementation

Plan of Attack This talk Change Inpatient Provider Progress Note Remove “Nutrition/GI prophylaxis” prompt Empower Clinical Pharmacists Report 2010 Q1 IM use at May business meeting

Thank you