2005N-0374 Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
FDA Comment Number : EC1
Submitter : Dr. Timothy Op't Holt Date & Time: 12/19/2005 01:12:29
Organization : University of South Alabama
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I will precede my comments with personal information and my practice setting. I am a registered respiratory therapist (RRT) and certified asthma educator (AE-C). I operate an asthma and COPD education and treatment program that is part of a faith-based family practice clinic for the working uninsured in Mobile, Alabama

Who currently uses OTC epinephrine MDIs?

Patients who come to our clinic?s program are always queried as to their current medications. Of about 100 patients we have seen in the past 2? years, only 2-3 have indicated they have used OTC epinephrine. We recommend they dispose of the OTC epinephrine and we provide a prescription for a beta2 adrenergic bronchodilator, available through a drug company?s indigent care program or for about $16 at local pharmacies.

How many of these MDIs are used annually?

In our patient cohort, perhaps 1-2 total.

What are the alternatives if these products are no longer available?

There are 4-5 other beta2 adrenergic bronchodilators available by prescription. All are available as metered dose inhalers with CFC propellants. One is already formulated with HFA. Others are to be released shortly with non-CFC propellants. Even in our cohort, we anticipate no problem with providing appropriate alternatives.

From literature sources, what is the value of use of the product to the users, and why do they use it?

I am not aware of any literature source that describes the value of the product. The National Lung Health Education Program describes this product as dangerous for those with heart disease and inadequate in the treatment of COPD. Patients use it because they have no regular doctor and they heard about it from a friend or relative.

What established treatment guidelines recommend the use of OTC epinephrine?

None. As a matter of fact, they specifically tell us to avoid this product.

How many people with asthma do not have ready access to prescription medication through healthcare professionals?

None of my patients. All children in Alabama with asthma have access to appropriate medications through the All Kids program. Appropriate medications are available to Medicare and Medicaid patients.

Summary: There is no need for OTC epinephrine. Few patients use it, it is dangerous, and there are appropriate medications available to all patients who need bronchodilators.

Tim Op?t Holt, Ed.D., R.R.T., AE-C
Professor
Cardiorespiratory Care
University of South Alabama
1504 Springhill Ave.
Mobile, AL 36604
251-434-3405
toptholt@jaguar1.usouthal.edu