The Safety of Appropriate Use of Over-the-Counter Proton Pump Inhibitors: An Evidence-Based Review and Delphi Consensus
File(s)Johnson 2017 Drugs p 547.pdf (872.63 KB)
Published version
Author(s)
Type
Journal Article
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.
Date Issued
2017-02-23
Online Publication Date
2017-02-23
2017-06-27T12:49:38Z
Date Acceptance
2017-02-01
ISSN
0012-6667
Publisher
Springer
Start Page
547
End Page
561
Journal / Book Title
DRUGS
Volume
77
Issue
5
Copyright Statement
© 2017 The Author(s). Open Access. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
Source Database
pubmed
Identifier
http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000398035200005&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
Subjects
Science & Technology
Life Sciences & Biomedicine
Pharmacology & Pharmacy
Toxicology
GASTROESOPHAGEAL-REFLUX DISEASE
SPONTANEOUS BACTERIAL PERITONITIS
COMMUNITY-ACQUIRED PNEUMONIA
ACID-SUPPRESSIVE DRUGS
QUALITY-OF-LIFE
BONE-MINERAL DENSITY
UPPER GASTROINTESTINAL MALIGNANCY
CLOSTRIDIUM-DIFFICILE INFECTION
CUTANEOUS LUPUS-ERYTHEMATOSUS
STEADY-STATE PHARMACOKINETICS
Delphi Technique
Evidence-Based Medicine
Gastroesophageal Reflux
Humans
Nonprescription Drugs
Proton Pump Inhibitors
Risk Assessment
1115 Pharmacology And Pharmaceutical Sciences
Publication Status
Published