The Safety of Appropriate Use of Over-the-Counter Proton Pump Inhibitors

An Evidence-Based Review and Delphi Consensus

David A. Johnson, Philip O. Katz, David Armstrong, Henry Cohen, Brendan C. Delaney, Colin Howden, Peter Katelaris, Radu I. Tutuian, Donald O. Castell

Research output: Contribution to journalReview article

11 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)547-561
Number of pages15
JournalDrugs
Volume77
Issue number5
DOIs
StatePublished - Apr 1 2017

Fingerprint

Proton Pump Inhibitors
Safety
Consensus
Politics
Clostridium Infections
Heartburn
Clostridium difficile
Micronutrients
Expert Testimony
Esophageal Neoplasms
Self Care
Masks
Gastroesophageal Reflux
Peritonitis
Natural History
Terminology
Bone Density
Stomach Neoplasms
Prescriptions
Diarrhea

All Science Journal Classification (ASJC) codes

  • Pharmacology (medical)

Cite this

Johnson, D. A., Katz, P. O., Armstrong, D., Cohen, H., Delaney, B. C., Howden, C., ... Castell, D. O. (2017). The Safety of Appropriate Use of Over-the-Counter Proton Pump Inhibitors: An Evidence-Based Review and Delphi Consensus. Drugs, 77(5), 547-561. https://doi.org/10.1007/s40265-017-0712-6

The Safety of Appropriate Use of Over-the-Counter Proton Pump Inhibitors : An Evidence-Based Review and Delphi Consensus. / Johnson, David A.; Katz, Philip O.; Armstrong, David; Cohen, Henry; Delaney, Brendan C.; Howden, Colin; Katelaris, Peter; Tutuian, Radu I.; Castell, Donald O.

In: Drugs, Vol. 77, No. 5, 01.04.2017, p. 547-561.

Research output: Contribution to journalReview article

Johnson, DA, Katz, PO, Armstrong, D, Cohen, H, Delaney, BC, Howden, C, Katelaris, P, Tutuian, RI & Castell, DO 2017, 'The Safety of Appropriate Use of Over-the-Counter Proton Pump Inhibitors: An Evidence-Based Review and Delphi Consensus', Drugs, vol. 77, no. 5, pp. 547-561. https://doi.org/10.1007/s40265-017-0712-6
Johnson, David A. ; Katz, Philip O. ; Armstrong, David ; Cohen, Henry ; Delaney, Brendan C. ; Howden, Colin ; Katelaris, Peter ; Tutuian, Radu I. ; Castell, Donald O. / The Safety of Appropriate Use of Over-the-Counter Proton Pump Inhibitors : An Evidence-Based Review and Delphi Consensus. In: Drugs. 2017 ; Vol. 77, No. 5. pp. 547-561.
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