In Asthma vs. Ozone Layer, Ozone Layer Wins.

 

 

I have a confession to make, it pains me to write this post, about the removal of over-the-counter epinephrine (a.k.a. primatene) inhalers, the only inhaler available to asthmatics without a prescription. I mean, it literally causes me a visceral pain. But it’s not for the reason you might think. It has nothing to do with all the hoopla concerning the politics of right vs. left . Neither is it necessarily the strange notion of telling people that they have to breathe worse, so we can save the ozone layer, so they can breathe better (though you must admit that does sound weird).
No, it has more to do with the simple fact that I (and undoubtedly other physicians as well) hate this inhaler. It is a dangerous, possibly addictive, unforgivably poor substitute for a real asthma regimen, and should have been banned from the market long ago.
And so for me, here’s the painful part; I don’t think that simply removing it from the market is the right thing to do.

Unlike most inhalers used to treat airway constriction, epinephrine has been the only such inhaler available over the counter without a prescription.  Until a few years ago, most inhalers were made with an ozone blasting C.F.C. based propellant. By law, they were changed to a C.F.C.-free formulation, known as H.F.A. Most C.F.C. based substances (remember Freon?) were banned many years ago after the U.S. signed onto the Montreal Protocol, an agreement to reduce the use of ozone depleting substances. However the continued manufacture of inhalers containing C.F.C’s, including primatene continued under an “essential-use” exemption. That exemption ended for most prescription metered dose inhalers (M.D.I.) containing albuterol at the end of 2008.  If you were using or prescribed an albuterol inhaler around that time, you probably noticed a precipitous climb in the price of those inhalers. Inhaled epinephrine (primatene) however continued to be available under the essential-use exemption, which continued until 12/31/11 (you’re next, combivent and maxair!). However, unlike the phase-out of albuterol inhalers,  there have been no measures taken to make sure that HFA formulations of primatene are being produced to ensure its continued availability, therefore this drug is no longer available as of New Year’s day 2012.
Is that necessarily a bad thing? As I eluded to above, the use of inhaled epinephrine is not condoned by any medical society guidelines that I know of. Using it raises concerns over the potential of abnormal cardiac rhythms. To my knowledge the drug has not been widely studied, and may never be due to safety concerns. Any patient of mine that is on it is asked to discard it and never use it again. But what about those people that are not patients of mine, or patients of anybody, because they have no insurance? I doubt that anybody with mild or even moderate asthma may benefit from its regular use. Might it be beneficial for people with a severe asthma attack who do not have a prescription for albuterol? Take a look at  this google search of “primatene saved my life”.  What the takeaway is from these individual anecdotal experiences is debatable, but certainly there at  is the at least the impression that several people are using this medication in emergency situations in lieu of proper medical care, and they feel that it is a vital safety net.
What are they going to do now?
Here’s what the FDA recommends that patients that have been using primatene do after it is no available, on their website (along with what I imagine would be the likely response from the target audience):

  • Talk to your health care professional about programs that help patients get medicines they need. (What health care professional, I don’t have insurance, dumbass!)
  • Contact the company that makes the drug that your health care professional prescribes. The company may have a patient-assistance program that makes medicines available to patients at low or no cost. (I called them, they said I’m not poor enough to qualify!)
  • Visit free local clinics and public hospitals for additional assistance with your medications (Good idea! Except my  local free clinic just closed!)

In reality, these are reasonable recommendations to be sure, particularly for the person with occasional symptoms. But people are unlikely to seek medical assistance from free medical clinics unless they are actively ill, and even at that point, it would be unlikely that they could be seen quickly enough to address their needs.
This leads me to the obvious question. If a medication as potentially dangerous as inhaled epinephrine has been available for so long over the counter, why do you need a prescription to get a much safer albuterol inhaler? One could even argue that the requirement that one has to have a prescription to use a relatively safe albuterol inhaler has driven people to use a much more dangerous option which has been much more readily available. I think it would have been the right thing to do to make available a non-prescription albuterol inhaler before pulling a vital, albeit dangerous safety net away from uninsured asthmatics.

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  • “Might it be beneficial for people with a severe asthma attack who do not have a prescription for albuterol? ”
    The “pain” you feel writing this post has to do with your knowledge that Primatene is a horrible drug, but concern for the patients who, mostly due to lack of health care insurance, have relied on this medication. As a physician, I too share this concern, but urge you to reconsider your position.

    “there have been no measures taken to make sure that HFA formulations of primatene are being produced to ensure its continued availability.”
    This was a business decision made by the manufacturer of Primatene. All the other companies that made inhalers converted to HFA. The company that makes Primatene also made generic albuterol CFC so they knew the rules and chose not to play by them.

    “Several people are using this medication in emergency situations in lieu of proper medical care, and they feel that it is a vital safety net.”
    Primatene in an emergency situation is very dangerous. Though they may feel it is a vital safety net, it is actually a huge risk. If someone, especially one that is not likely on an inhaled steroid, is having an asthma attack, they need immediate medical attention. Use of an epinephrine inhaler may delay an ER visit, and lead to very bad outcomes including death. Bronchodilators should be used as “reliever” medications, not “rescue” medications. If an asthmatic needs to be “rescued” from an attack, then they are really in trouble an need prompt medical attention by experts, not self diagnosis and treatment. Imagine if patients just took a baby aspirin every time they had chest pain. Sure, many of them would feel better soon, but a lot would die.

    “If a medication as potentially dangerous as inhaled epinephrine has been available for so long over the counter, why do you need a prescription to get a much safer albuterol inhaler?”
    Primatene mist’s OTC status is historical. Because it was approved so long ago, it was grandfathered, and does not need to meet any newer standards. Primatene mist would like never be approved today as a prescription medication let alone an OTC. The reason it remained on the market is because it is much harder to pull a drug from the shelves than it is to put one on the shelves. In essence, you have to have strong documentation that it is killing people before the FDA will take action. For example, infant cold medication was recently pulled from the shelves because of increased reports of infant deaths. Documenting that Primatene, and not asthma itself, is killing people is a little trickier.

    The bottom line is that our health care system has many problems. We have too many patients who are uninsured or under insured. However, two wrongs do not make a right. Free clinics do exist, and every drug company that makes an HFA albuterol will give it away for free to those that document that they can not afford it. Is this as easy as going to CVS? Of course not. However, in my opinion, the CFC ban has led to a dangerous medication no longer being available. It should stay that way.

  • Deep

    Well my friend, I’m afraid we’re just gonna have to disagree on this issue. I am not really arguing for continued primatene, but rather that albuterol in some manner should be made available to people without insurance. Having some form of access to a basic inhaler in some form or another would, to my mind, certainly be safer than the alternative. The alternative is waiting a month for a free clinic visit, only to find that the controller medications that they were prescribed are not affordable and the pharma assistance programs do not apply. Thus all pathways lead to the same point for the poor and uninsured; using primatene or their kids albuterol as their regular medication. Which leads to the question, if we know most are going to do without, and thus are going to do worse, what are we accomplishing by denying them a relatively safe medication?

  • Primatene user for 52 years

    BRAVO, TO THIS COMMENT/ BLOG!!!!!!

  • Michaela Stewart

    such an awesome blog..ozone layer is too bad that is why its important to take care of it..

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