Musings of a Dinosaur

A Family Doctor in solo private practice; I may be going the way of the dinosaur, but I'm not dead yet.

Monday, March 23, 2009

I Called It: The Ozone May Not Be Falling, but Something is About to Hit the Fan

It's been more than two years since I posted my screed about CFC-free inhalers under what I thought was the pretty cool title of The Ozone is Falling, The Ozone is Falling. To briefly recap, rescue inhalers for asthma deliver the drug albuterol. The CFC propellant used by the generic inhalers was deemed too dangerous for the environment, and so they were banned. The problem is that the new hydrofluoroalkane (HFA) propellant doesn't seem to work as well, and NOT just because patients aren't used to the weaker "whoosh."

I take a great deal of care explaining metered dose inhaler technique to patients, emphasizing the need to inhale the medicine slowly. As it happens, the lighter "blow" of the HFA inhaler makes this easier. Still, in spite of this, I too am hearing complaints about efficacy.

Now (two years later, but who's counting) KevinMD deigns to weigh in. *Sigh* None of this should come as any surprise. The only thing we're waiting for now is the first reports of deaths from ineffective HFA rescue inhalers. Scary times.

11 Comments:

At Mon Mar 23, 12:27:00 PM, Anonymous Adam said...

As an intern pharmacist, I am also finding that patients don't know that they have to clean the new HFA inhalers. They need to run warm water through it about once a week because the HFA causes a buildup on the mouthpiece. I don't know if it is statistically significant, but it can't hurt, either.

 
At Mon Mar 23, 01:31:00 PM, Anonymous Anonymous said...

Some folks are having some major problems with the new HFA inhalers.

The most compelling story is at consumer affairs:
http://www.consumeraffairs.com/news04/2009/02/asthma_hfa02.html

Read the thousands of complaints at this petition:
http://www.ipetitions.com/petition/saveCFCinhalers/signatures.html

More complaints:

https://www.savecfcinhalers.org/Guestbook.php

http://www.askapatient.com/viewrating.asp?drug=20503&name=PROVENTIL-HFA

http://www.opednews.com/populum/diarypage.php?did=11627

If you are unhappy with the new HFA inhalers, kindly sign the petition to save CFC inhalers.

http://www.savecfcinhalers.org

Also worth mentioning from the FDA website is the following:

http://www.fda.gov/cder/foi/nda/2001/20-983_Ventolin-HFA_medr_P1.pdf

These quotes taken directly from the new drug application for Ventolin HFA.

"In the multiple dose adolescent and adult studies, albuterol HFA showed a numerically smaller improvement in FEV1 than was seen with albuterol CFC"

"There was other evidence that the HFA formulation delivers a lower/less effective dose on a per acutation basis than the CFC product. In the single dose, dose ranging study in adults, and in the single dose methacholine challenge study in adults one and two acutations of albuterol CFC were statistically indistinguishable in terms of effect, whereas significant differences were seen between one and two acutations of albuterol HFA. Finally, the combined adolescent/adult studies showed that the HFA formulation had a longer median time to onset of effect(4.2-9.6 minutes versus 3.6-4.2 minutes), had a shorter duration of effect(1.55-3.30 hours versus 2.29 - 3.69 hours), and was associated with more albuterol 'back up' use than the CFC formulation."

"We note that in the two 12 week clinical trials in adolescents and adults, Ventolin HFA Inhalation Aerosol consistently showed a smaller effect size than Ventolin CFC Inhalation Aerosol"

"Because it is expected that many physicians will prescribe Ventolin HFA Inhalation Aerosol for patients who have previously used the CFC formulation, it would be appropriate to include some description of the relative effectiveness of these two formulations in the product label."

"Unfavorable changes in physical examinations were observed in the ears, nose, and throat category as follows: 8% placebo HFA; 13% albuterol HFA; and 5% albuterol CFC."

 
At Mon Mar 23, 03:07:00 PM, OpenID crankylitprof said...

I haven't bitched, because I haven't had to use my rescue inhaler a whole lot, but the new ones do indeed suck jumbo cocoanut donkey balls.

 
At Mon Mar 23, 04:07:00 PM, Anonymous Anonymous said...

Does it matter if patients die?? If I understand St. Albert of Gore, the polar bears and ice caps are MUCH more important than human lives. Pattie, RN

 
At Mon Mar 23, 04:35:00 PM, Blogger HugeMD said...

I'm a doc with asthma. I tried to keep an open mind. I caught a cold last year and started wheezing. I was sucking on the Albuterol HFA constantly with no relief. My mom was at my house and had an old ozone-depleting albuterol MDI, so I took 2 puffs and INSTANTLY felt better. Then I stockpiled the old inhalers until I couldn't get them anymore.

I definitely think it's a problem.

 
At Wed Mar 25, 02:10:00 PM, Anonymous Anonymous said...

I'm a pharmacist & left a note on Kevin's blog.

So much of this is just poor education - on your part (sorry Dr Dino), the pharmacist & the patients.

Some physicians don't educate the difference - cleaning the device is a major, major issue with drug delivery. Learning how to use it is hard for people who are used to the old inhalers - HugeMD. You don't suck on them like the old inhalers.

Pharmacists tell people there is no difference, when actually there is. We need to educate them in the difference. It is more like inhaling an Advair (altho not a dry powder) - I'm speaking of the physiology of the inhalation process.

Patients also need to take responsibility to learn the difference. They listen, but don't hear. Habits, particularly when learned over decades are hard to break.

They aren't going away & the old CFC inhalers aren't coming back. We need to educate all involved to improve how they work.

 
At Wed Mar 25, 07:48:00 PM, Anonymous Anonymous said...

Hello Pharmacist,

With all due respect this is not at all about education. It is about the fact that these inhalers are not working correctly. I have but one question for you. Do you have asthma? That is really all we need to know because if you answered yes, I can guarantee with 1000% certainty that you would not be talking about poor education. You would be afraid for your life.

Asthma Patients Outraged at Indifference to Problems with New Inhalers:
http://www.consumeraffairs.com/news04/2009/02/asthma_hfa02.html

Olympian Jackie Joyner-Kersee: FDA "Insensitive" to Asthma Patients' Problems:
http://www.consumeraffairs.com/news04/2009/03/asthma_hfa04.html

The number of patient complaints is skyrocketing:
http://www.consumeraffairs.com/health/hfa_inhalers.html

Read the thousands of complaints at this petition:
http://www.ipetitions.com/petition/saveCFCinhalers/signatures.html

Patients at askapatient.com are reporting HFA inhalers as "useless" with a rating of 1.2 on
a scale of 1 to 5 with 5 being the best and 1 being the worst:
http://www.askapatient.com/viewrating.asp?drug=20503&name=PROVENTIL-HFA

You can only wonder if the FDA is trying to kill asthmatics:
http://www.opednews.com/populum/diarypage.php?did=11627

Also worth mentioning from the FDA website is the fact that a manufacturer of one of the HFA inhalers admits in it's own new drug application to the FDA that it's HFA based albuterol is less safe and effective than it's CFC based albuterol:
http://www.fda.gov/cder/foi/nda/2001/20-983_Ventolin-HFA_medr_P1.pdf

These quotes taken directly from the new drug application for Ventolin HFA.

"In the multiple dose adolescent and adult studies, albuterol HFA showed a numerically smaller improvement in FEV1 than was seen with albuterol CFC"

"There was other evidence that the HFA formulation delivers a lower/less effective dose on a per acutation basis than the CFC product. In the single dose, dose ranging study in adults, and in the single dose methacholine challenge study in adults one and two acutations of albuterol CFC were statistically indistinguishable in terms of effect, whereas significant differences were seen between one and two acutations of albuterol HFA. Finally, the combined adolescent/adult studies showed that the HFA formulation had a longer median time to onset of effect(4.2-9.6 minutes versus 3.6-4.2 minutes), had a shorter duration of effect(1.55-3.30 hours versus 2.29 - 3.69 hours), and was associated with more albuterol 'back up' use than the CFC formulation."

"We note that in the two 12 week clinical trials in adolescents and adults, Ventolin HFA Inhalation Aerosol consistently showed a smaller effect size than Ventolin CFC Inhalation Aerosol"

"Because it is expected that many physicians will prescribe Ventolin HFA Inhalation Aerosol for patients who have previously used the CFC formulation, it would be appropriate to include some description of the relative effectiveness of these two formulations in the product label."

"Unfavorable changes in physical examinations were observed in the ears, nose, and throat category as follows: 8% placebo HFA; 13% albuterol HFA; and 5% albuterol CFC."

The following false advocates have hung asthmatics out to dry as they are
not responding to any of the pleas for help:
American Lung Association
Asthma and Allergy Foundation of America
Allergy and Asthma Network Mothers of Asthmatics
American Academy of Allergy, Asthma and Immunology

Contact them for yourself and see how happy they will be to "help" you!

 
At Thu Mar 26, 01:47:00 AM, Anonymous Anonymous said...

Fellow Anonymous 7:48 - yes, of course the kinetic profile is different between inhalers. That is to be expected. The kinetics are different from albuterol oral liquid, solution for nebulization and the inhaler. This comes as no surprise to any pharmacist & few physicians. Most all of us have read the comparative studies.

The issue here is the lack of of education passed on by the prescriber and pharmacists. I represent a field that has not done the best job on this transition and perhaps Dr Dino has not covered all the bases either.

When switching dosage forms, if the prescriber does not obtain the desired therapeutic endpoint in spite of education about the extensive differences in inhalers, there are alternatives - use of a spacer, increased dose (causing more side effects) or switching to Xopenex, the R- enantiomer which is the active portion of the racemic albuterol.

btw - this is not the first inhaler to switch. The first one was Atrovent, which was still under patent at the time of the switch. It was seamless & probably due to the fact the name never changed.

Since you asked - yes, I do have exercise induced asthma - well controlled by the HFA inhaler. I am not afraid for my life, particularly when it gets exacerbated by exercise in cold weather. I know what to do & do it.

Knowledge is power & control. Honestly, this will not change - its been 15+ years in the switching. Take the knowledge and take control of your disease. If your inhaler is not working, get to your pharmacist to review usage & cleaning (its also available online). I've actually replaced clogged inhalers without charge because no one told them to clean it (& they didn't read the pt information). If it still is giving you trouble, get back to your physician and discuss treatment options.

No one in healthcare wants you to suffer. We all need to do our best to work with what is available. If you can imagine - when I first started working as a pharmacist, albuterol was not available as an inhaler - only a nebulized solution. Products change and thus, treatment must change. The HFA patents expire in 2012. There is a dry powder alternative in Europe (similar to Advair) which might be approved in the US - again - its an expensive process. The advantage of the dry powder is your force of inhalation draws the drug into the bronchi. The disadvantage is most constricted airways have little force. Currently, not availabe in the US.

See your doctor & discuss the options!

 
At Thu Mar 26, 08:59:00 AM, Anonymous Anonymous said...

My Pharmacist friend-

I take all of your points kindly, but I strongly disagree with all of it. We can agree to disagree and that is ok. I know beyond a shadow of a doubt, there are people suffering because of this. Not everyone will be able to achieve the success you have with the HFA based albuterol.

All the best

 
At Thu Mar 26, 09:27:00 AM, Anonymous Anonymous said...

I don't think they work as well and they are also more expensive, which annoys me. I found a couple old inhalers that expired in 2005, and found that they worked better than this little HFA dealy.

 
At Mon Mar 30, 01:59:00 PM, Anonymous Anonymous said...

Hello Pharmacist,

It looks like your train of thought is getting some more bad press:

Ozone-friendly inhalers could face early demise
http://www.journalgazette.net/article/20090330/BIZ/303309942/1031/BIZ

Benefits vague, problems clear in inhaler ban
http://www.journalgazette.net/article/20090330/BIZ/303309941

 

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