title: The Safety of Appropriate Use of Over-the-Counter Proton Pump Inhibitors: An Evidence-Based Review and Delphi Consensus.
abstract: The availability of over-the-counter (OTC) proton pump inhibitors (PPIs) for the short-term (2 weeks) management of frequent heartburn (≥2 days/week) has increased markedly, yet evidence-based recommendations have not been developed. A panel of nine international experts in gastroesophageal reflux disease developed consensus statements regarding the risks and benefits of OTC PPIs using a modified Delphi process. Consensus (based on ≥80% approval) was reached through multiple rounds of remote voting and a final round of live voting. To identify relevant data, the available literature was searched and summarized. Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system terminology was used to rate the quality of evidence and strength of recommendations; consensus was based on ≥2/3 agreement. After 4 rounds of review, consensus was achieved for 18 statements. Notably, the available data did not directly reflect OTC use, but instead, prescription use; therefore, extrapolations to the OTC setting were often necessary. This limitation is regrettable, but it justifies performing this exercise to provide evidence-based expert opinion on a widely used class of drugs. The panel determined that using OTC PPIs according to label instructions is unlikely to mask the symptoms of esophageal or gastric cancer or adversely impact the natural history of related precursor conditions. OTC PPIs are not expected to substantially affect micronutrient absorption or bone mineral density or cause community-acquired pneumonia, Clostridium difficile infection, or cardiovascular adverse events. However, OTC PPI use may be associated with slightly increased risks for infectious diarrhea, certain idiosyncratic reactions, and cirrhosis-related spontaneous bacterial peritonitis. The available evidence does not suggest that OTC PPI use consistent with label instructions is associated with substantial health risks. To minimize potential risks, healthcare professionals and consumers must actively participate in decision making when managing reflux-related symptoms in the self-care setting.
authors.affiliation: Department of Gastroenterology, Eastern Virginia Medical School, 885 Kempsville Rd, Suite 114, Norfolk, VA, 23505, USA. dajevms@aol.com.
authors.forename: David A
authors.initials: DA
authors.lastname: Johnson
authors.affiliation: Division of Gastroenterology, Einstein Medical Center, 5401 Old York Rd, Suite 363 Klein Building, Philadelphia, PA, 19141, USA. philipokatz@gmail.com.
authors.forename: Philip O
authors.initials: PO
authors.lastname: Katz
authors.affiliation: Division of Gastroenterology, McMaster University, HSC-3V3, 1280 Main St W, Hamilton, ON, L8S 4L8, Canada.
authors.forename: David
authors.initials: D
authors.lastname: Armstrong
authors.affiliation: Department of Gastroenterology, National University of Uruguay, Av. Italia 2370, 11600, Montevideo, Uruguay.
authors.forename: Henry
authors.initials: H
authors.lastname: Cohen
authors.affiliation: Department of Surgery and Cancer, Imperial College, Kensington, London, SW7 2AZ, UK.
authors.forename: Brendan C
authors.initials: BC
authors.lastname: Delaney
authors.affiliation: Division of Gastroenterology, University of Tennessee Health Science Center, 956 Court Avenue, Suite H210, Memphis, TN, 38163, USA.
authors.forename: Colin W
authors.initials: CW
authors.lastname: Howden
authors.affiliation: Department of Gastroenterology, University of Sydney, Concord, Sydney, 2139, Australia.
authors.forename: Peter
authors.initials: P
authors.lastname: Katelaris
authors.affiliation: Department of Gastroenterology, University of Bern School of Medicine, Freiburgerstr 10, Bern, Switzerland.
authors.forename: Radu I
authors.initials: RI
authors.lastname: Tutuian
authors.affiliation: Division of Gastroenterology and Hepatology, Medical University of South Carolina, 11 Harleston Place, Charleston, SC, 29401, USA.
authors.forename: Donald O
authors.initials: DO
authors.lastname: Castell
mesh_terms: D003697:Delphi Technique; D019317:Evidence-Based Medicine; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006801:Humans; D004366:Nonprescription Drugs / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D054328:Proton Pump Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D018570:Risk Assessment
chemical_list: D004366:Nonprescription Drugs; D054328:Proton Pump Inhibitors