Non-prescription Supplemental Oxygen
Pulmonary Fibrosis Foundation Position Statement on Non-prescription Supplemental Oxygen
April 5, 2023
To members of the Pulmonary Fibrosis Community,
The PFF recommends that patients should only use FDA approved oxygen delivery devices as prescribed by their doctor and should not purchase an oxygen supply device without a prescription. Non-FDA approved oxygen delivery systems may not reliably deliver oxygen.
Long term oxygen therapy is an important element of supportive care for many patients living with pulmonary fibrosis (PF) to help relieve breathlessness due to low blood oxygen levels. Supplemental oxygen can facilitate exercise and may also reduce the risk of complications such as pulmonary hypertension. Prescribed by a health care provider such as a physician, oxygen delivery devices include stationary and portable oxygen concentrators, compressed gas tanks, and compressed liquid tanks. Portability is an important aspect of oxygen delivery for patients1, and many prefer to use portable oxygen concentrators (POC) when outside the home
for this reason. Unfortunately, existing POCs are limited by short battery life, device weight, and inadequate oxygen flow for patients needing high flow oxygen (>=3 liters per minute continuously)2. Like other medical treatments and devices,
the FDA oversees the safety and dependability of oxygen devices.
In recent years, there has been a number of non-FDA approved devices sold online without a prescription by medical supply sites and online retailers, such as Amazon. Sellers claim these devices are lightweight, high flow, with long battery
life, and priced far lower than FDA-approved POCs. A study of over the counter (OTC) POCs demonstrated that they did not reliably provide oxygen supply comparable to that from an FDA-approved POC or a compressed gas oxygen tank3. The FDA
has warned consumers against the use of these OTC oxygen devices and the use of any oxygen supply without a doctor’s order4.
It is understandable that patients desire oxygen devices that are lightweight and portable with adequate oxygen flow to meet their needs. The PFF has joined with 23 other patient, professional, and industry groups to advocate for patient-centric
legislative changes to supplemental oxygen supply and reimbursement (link).
Additionally, the National Heart Lung and Blood Institute has sponsored the Air You Wear Challenge, which seeks to stimulate innovation in the delivery of supplemental oxygen for patients with chronic lung disease5.
The PFF recommends that patients should only use FDA approved oxygen delivery devices as prescribed by their doctor and should not purchase an oxygen supply device without a prescription. Additionally, patients should speak with their pulmonologist,
ILD nurse, or respiratory therapist prior to any out of pocket purchase of a portable oxygen concentrator.
More information about supplemental oxygen can be obtained from the PFF website (pulmonaryfibrosis.org).
On behalf of the Pulmonary Fibrosis Foundation,
William T. Schmidt - President and Chief Executive Officer
Joe Lasky, MD - Chief Medical Officer
Amy Hajari Case, MD, FCCP - Senior Medical Advisor, Education and Awareness
Sonye Danoff, MD, PhD - Senior Medical Advisor, PFF Care Center Network
Kevin Flaherty, MD, MS - Steering Committee Chair, PFF Registry
Joyce Lee, MD, MS - Senior Medical Advisor, Research and Health Care Quality
Jessica Shore, PhD, RN - Vice President, Clinical Affairs and Quality
References / Bibliography
1. Dakkak J, Tang W, Smith JT, et al. Burden and Unmet Needs with Portable Oxygen in Patients on Long-Term Oxygen Therapy. Ann Am Thorac Soc. Sep 2021;18(9):1498-1505. doi:10.1513/AnnalsATS.202005-487OC
2. Jacobs SS, Krishnan JA. Patients Choose Hypoxemia over Social Isolation. Ann Am Thorac Soc. Sep 2021;18(9):1460-1461. doi:10.1513/AnnalsATS.202106-676ED
3. Casaburi R, Hess M, Porszasz J, et al. Evaluation of over-the-counter portable oxygen concentrators utilizing a metabolic simulator. Respir Care. Nov 18 2022;doi:10.4187/respcare.10495
4. Pulse oximeters and oxygen concentrators: what to know about home oxygen therapy. Accessed March 21, 2023, https://www.fda.gov/consumers/consumer-updates/pulse-oximeters-and-oxygen-concentrators-what- know-about-home-oxygen-therapy
5. NHLBI Air You Wear Challenge. Accessed March 21, 2023, https://www.nhlbi.nih.gov/grants-and-training/