Last Approval Date: November 2019 Policy Title: Pharmacist-Managed Stress Ulcer Prophylaxis Protocol Departments Affected: Pharmacy Page 1 of 5 Key Words: SUP, PPI, H2RA Reference #: 1835 I. PURPOSE: To ensure safe, evidence-based utilization of stress ulcer prophylaxis in the inpatient setting to prevent upper gastrointestinal bleeding while minimizing the associated adverse effects (Clostridium dificile colitis, nosocomial pneumonia, electrolyte abnormalities, vitamin deficiencies, drug interactions, thrombocytopenia, etc) through use of a standardized, pharmacist-managed protcol. II. POLICY: It is the policy of SHC to provide a process for pharmacists to discontinue or convert stress ulcer prophylaxis therapies (proton pump inhibitors to histamine-2 receptor agonists) in the inpatient setting to align with current practice guidelines and literature. Exclusions: Continuation of home therapy or PRN use in the inpatient setting Use of acid suppression therapy for treatment indications III. PROCEDURE: A. Evaluation 1. Pharmacists will screen patients receiving scheduled acid suppression therapy for indication at the time of order verification and on a daily basis thereafter. 2. If the indication for PPI or H2RA use is treatment as listed below, or the frequency is PRN (as needed), the pharmacist will not intervene. a. Zollinger-Ellison Syndrome b. Acute upper GI bleed c. Erosive esophagitis d. Helicobacter pylori treatment e. Gastric or duodenal ulcer f. Gastroesophageal Reflux Disease (GERD) g. Continuation of home therapy 3. If the indication for PPI or H2RA use is stress ulcer prophylaxis (SUP), pharmacists will perform a detailed review of the patient’s chart to determine whether the patient meets any of the following approved criteria for therapy4: a. Patients on mechanical ventilation (independent risk factor for GI bleed) Last Approval Date: November 2019 Policy Title: Pharmacist-Managed Stress Ulcer Prophylaxis Protocol Departments Affected: Pharmacy Page 2 of 5 Key Words: SUP, PPI, H2RA Reference #: 1835 b. Coagulopathy defined as platelet count <50, INR >1.5 or PTT 2x baseline (independent risk factor for GI bleed) c. Burns affecting >35% total body surface area d. Solid organ transplantation postoperatively in the ICU setting e. Use of two antiplatelet agents (i.e. clopidogrel, aspirin, cilostazol, ticagrelor, dipyridamole) f. Patients receiving enteral feeds will only qualify for SUP if they are also receiving dual antiplatelet therapy. i. They DO NOT qualify for stress ulcer prophylaxis despite the presence of any of the other approved criteria above. 4. H2RAs are the preferred therapy for SUP. a. PPIs are reserved for use in the following situations: i. Dual antiplatelet therapy ii. Continuation of home therapy iii. Patient is unable to tolerate H2RAs (e.g. history of thrombocytopenia with use) iv. Treatment indications (e.g. gastrointestinal bleed, H. pylori, etc.) B. Intervention 1. Pharmacists will discontinue PPI or H2RA therapy for SUP in patients who do not meet any of the criteria outlined in Section A.3, using the “Per protocol without co-sign” mode. 2. If SUP is indicated, pharmacists will convert PPIs to H2RAs using the “Per protocol without co-sign” mode unless the patient meets one of the criteria outlined in Section A.4.a. a. The preferred formulary H2RA is famotidine and it is dosed as follows: Renal Function* Dose CrCl > 50 ml/min Famotidine 20 mg IV/PO** BID CrCl < 50 ml/min Famotidine 20 mg IV/PO** daily *Dose SHOULD NOT be adjusted for a low CrCl in post-renal transplantation days 0-3 per Pharmacist-Managed Renal Dosing Protocol. **Famotidine oral solution should be used in patients with feeding tubes. Last Approval Date: November 2019 Policy Title: Pharmacist-Managed Stress Ulcer Prophylaxis Protocol Departments Affected: Pharmacy Page 3 of 5 Key Words: SUP, PPI, H2RA Reference #: 1835 3. Pharmacists will also perform IV to PO conversions, when appropriate, in accordance with the Pharmacist-Managed Intravenous to Oral Therapy Interchange Protocol. C. Documentation 1. Pharmacists will populate a progress note within the patient chart documenting discontinuation. 2. If the ordering provider objects to discontinuation and would like to initiate or continue stress ulcer prophylaxis outside of the criteria outlined in this protocol, the rationale for objection will be documented as an addendum to the note if a note has already been entered. I. COMPLIANCE: A. All workforce members including employees, contracted staff, students, volunteers, credentialed medical staff, and individuals representing or engaging in the practice at SHC are responsible for ensuring that individuals comply with this procedure; B. Violations of this procedure will be reported to the Department Manager and any other appropriate Department as determined by the Department Manager or in accordance with hospital policy. Violations will be investigated to determine the nature, extent, and potential risk to the hospital. Workforce members who violate this procedure will be subject to the appropriate disciplinary action up to and including termination. II. DOCUMENT INFORMATION: A. References: 1. Abraham NS, Hlatky MA, Antman EM, et al; American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents. ACCF/ACG/AHA 2010 expert consensus document on concomitant use of proton pump inhibitors and thienopyridines: a focused update of the 2008 ACCF/ACG/AHA expert consensus document on reducing the gastrointestinal risks of antiplatelet therapy and NSAID use; a report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents. Circulation. 2010;56:1051-66. 2. Alhazzani W, Guyatt G, Alshahrani M et al. Witholding pantroprazole for stress ulcer prophylaxis in critically ill patients: A pilot randomized clinical trial and meta- analysis. Crit Care Med. 2017; 45:1121-1129. 3. Allen ME, Kopp MJ, Erstad BL. Stress ulcer prophylaxis in the postoperative period. Am J Health-Syst Pharm. 2004; 61:588-96. Last Approval Date: November 2019 Policy Title: Pharmacist-Managed Stress Ulcer Prophylaxis Protocol Departments Affected: Pharmacy Page 4 of 5 Key Words: SUP, PPI, H2RA Reference #: 1835 4. Arthur Grube RR, May DB. Stress ulcer prophylaxis in hospitalized patients not in intensive care units. Am J Health-Syst Pharm. 2007; 64: 1396-400. 5. ASHP Commission on Therapeutics. ASHP therapeutic guidelines on stress ulcer prophylaxis. Am J Health-Syst Pharm. 1999; 56:347-79. 6. Bhatt DL, Cryer BL, Contant CF et al. Clopidogrel with or without omeprazole in coronary artery disease. N Engl J Med. 2010; 363:1909-17. 7. Buendgens L, Bruensing J, Matths M, et al. Administration of proton pump inhibitors in critically ill medical patients is associated with increased risk of developing Clostridium difficile-associated diarrhea. J Crit Care. 2014 Aug;29(4):696.e11-5. 8. Cook DJ, Fuller HD, Guyatt GH, et al. Risk factors for gastrointestinal bleeding in critically ill patients. N Engl J Med. 1994; 330: 337-41. 9. Daley RJ, Rebuck JA, Welage LS, et al. Prevention of stress ulceration: current trends in critical care. Crit Care Med. 2004; 32: 2008-13. 10. Eom CS, Jeon CY, Lim JW, et al. Use of acid-suppressive drugs on risk of pneumonia: a systematic review and meta-analysis. CMAJ. 2011;183:310-319. 11. Howell MD, Novak V, Grgurich P, et al. Iatrogenic gastric acid suppression and the risk of nosocomial Clostridium difficile infection. Arch Intern Med 2010; 170:784-790. 12. Huang HB, Jiang W, Wang CY et al. Stress ulcer prophylaxis in intensive care unit patients receiving enteral nutrition: a systematic review and meta-analysis. Criti Care. 2018; 22(1):20. 13. Krag M, Maker S, Perner J, et al. Pantoprazole in patients at risk for gastrointestinal bleeding in the ICU. N Engl J Med. 2018 Oct 24. 14. Lexicomp Online®, Lexi-Drugs® , Hudson, Ohio: Lexi-Comp, Inc.; May 2, 2018. 15. Marik PE, Vasu T, Hirani A, et al. Stress ulcer prophylaxis in the new millennium: a systematic review and meta-analysis. Crit Care Med. 2010;38(11):2222-2228. 16. Miano T, Reichert M, Houle T, et al. Nosocomial pneumonia risk and stress ulcer prophylaxis: a comparison of pantoprazole vs ranitidine in cardiothoracic surgery patients. Chest. 2009 Aug;136(2):440-7. 17. Qadeer MA, Richter JE, Brotman DJ. Hospital-acquired gastrointestinal bleeding outside the critical care unit: risk factors, role of acid suppression, and endoscopy findings. J Hosp Med. 2006; 1:13-20. 18. Terdiman JP, Ostroff JW. Gastrointestinal bleeding in the hospitalized patient: a case- control study to assess risk factors, causes, and outcomes. Am J Med. 1988 Apr;104(4):349-54. B. Original Document: 1. Owner: Pharmacy Department 2. Author and date: Cody Parsons, PharmD, Hangyul Chung-Esaki, MD, and Nicholas Berte, RN, BSN: 11/2014 3. Stored in: Pharmacy – Departmental Manual C. Distribution and Training Requirements: Last Approval Date: November 2019 Policy Title: Pharmacist-Managed Stress Ulcer Prophylaxis Protocol Departments Affected: Pharmacy Page 5 of 5 Key Words: SUP, PPI, H2RA Reference #: 1835 1. New documents or any revised documents will be distributed to Department Manual holders. The department/unit/clinic manager will be responsible for communicating this information to the applicable workforce members. D. Review and Rewnewal Requirements: 1. This policy will be reviewed and/or revised every three years or as required by change of law or practice. E. Review and Revision History: 1. Ann Weinacker, MD; Norman Rizk, MD: 11/2014 2. Cody Parsons, PharmD: 01/2018 3. Janjri Desai, PharmD, MBA, BCPS: 10/2019 F. Approvals: 1. ICU Continuous Quality Improvement Committee: 11/2014 2. Pharmacy and Therapeutics Committee: 02/2015 3. Pharmacy and Therapeutics Committee: 01/2018 4. Pharmacy and Therapeutics Committee: 11/2019 “This document is intended for use by staff of Stanford Health Care. No representations or warranties are made for outside use. Not for outside reproduction or publication without permission.” .