The NEJM on HFA inhalers
As a followup to my post the other day…
The NEJM concludes — along with the rest of the world — that HFA albuterol formulations are more expensive than their CFC counterparts. The article (subscription required) delves into some of the differences between the various HFA formulations as well as the differences between CFC and HFA albuterol.
The article doesn't talk much about ProAir HFA, which I find a bit strange, especially as it has captured 60% of the HFA albuterol market. Unrelatedly, it seems that concentrations of albuterol are slightly higher with HFA than the CFC versions, despite the smaller plume.
Here're some semi-relevant differences between Ventolin HFA and Proventil HFA, emphasis mine:
The excipients added to the propellant formulation differ according to the brand of HFA inhaler. For instance, each puff of Proventil HFA releases 4 μl of ethanol. This small amount of ethanol will not have a discernible clinical effect, but it may be of concern for patients who for religious or other reasons abstain from alcohol. Breathalcohol levels of up to 35 μg per 100 ml may be detected for up to 5 minutes after two puffs of Proventil HFA. Unlike CFC propellants, HFA propellants may cause false positive readings in anesthetic gas–monitoring systems. The infrared spectrums of HFA overlap with commonly used anesthetic gases in the range of 8 to 12 μm. One albuterol product, Ventolin HFA, contains no excipients other than the propellant, a characteristic that may improve tolerability for some patients. However, Ventolin HFA comes packaged in a moisture-resistant protective pouch containing a dessicant and has a limited shelf life once it has been removed from the pouch. Ventolin HFAs have a greater affinity for moisture than do CFCs, which means that water vapor is more likely to enter the canister around the meteringvalve gaskets. The other approved HFA inhalers are less susceptible to moisture permeation and do not require a protective pouch.
Shelf life for Ventolin HFA is 2 months after opening, so it's a mixed bag.
A breakdown:
[tags]Medicine, pharmacy, albuterol, HFA, CFC[/tags]
A visit to a Nicaraguan pharmacy
In August of 2004, I went to Costa Rica on vacation, and we made a day trip into Nicaragua. One the whole, Nicaragua was probably my most favorite place on the whole trip. While we were in the country, we stopped into a Nicaraguan pharmacy. I couldn't resist taking pictures, which frightened the pharmacist after a while.
I must have spent 20 minutes in this place, examining everything. It's set up a like a deli: everything in glass cases, and you simply pick out what you want. No prescription necessary. It turns out that the pharmacist thought we were from the government — though I don't think we could have looked more tourist-y if we tried). Perhaps she couldn't fathom foreigners being so interested in a pharmacy? I don't know. I didn't notice this, but my girlfriend did (also a pharmacy student), and I said "farmacia estudiante" and she got very excited.
She got very excited about this, and started asking me questions about pharmacy in the United States. Alas, I don't speak Spanish, so I was unable to answer her. That made me a little sad — this probably would have been the highlight of my trip if I had.
I asked about a couple of CIIs: Percocet, Adderall, Ritalin, etc. She didn't have any stimulants, but she did have Percocet, which you needed a prescription for. I don't recall if you could buy Vicodin with a script or not. I do remember seeing Tylenol with codeine, though I don't know what the formulation was.
I ended up buying 60 tablets of alprazolam 0.5mg made by Merck, just because I could. In the US, these tablets would be under the Greenstone moniker. AKA, The Real Thing — you pharmacists know exactly what I'm talking about. This was back in 2004, and I paid about $12. The pharmacist was so happy, she gave me a student discount. (LOL) The sticker price was 234.30 Nicaraguan Cordobas, but she sold it to me for 199.50 Cordobas — about $12USD at the time. (I still have the receipt.) I took a picture of that this morning, and it's at the bottom of this entry.
Anyway, the pharmacy was situated next to an open-air market. It was dusty, and most of the light came from the sun outside the building, which made it shaded inside, and mostly unsuitable for good pictures, and since the items were encased in glass, a flash would have reflected. These are the images that turned out satisfactorily. I wish I'd had a better camera like I do now.
[tags]Pharmacy, Nicaragua, drugs[/tags]
"If you become infected, you will die."
Trolling through the medical press releases today, I was reminded of the only time I ever told someone that they would die if they didn't do something. He was about 25 years old, and he'd been bitten by an animal earlier in the day. He didn't want to get his rabies series, so he decided he'd ask in the pharmacy while he was picking up his prescriptions if it would be okay if he didn't get the vaccine. He just didn't want to make the effort, and he wanted someone to help him feel better about his decision.
My words were, "If you have been bitten by an animal, and it has rabies, and you do not get the rabies vaccine, and you become infected, you will die."
(If you've been bitten by an animal, and it has rabies, then it follows that you've now got it, too. But I suppose there's always the off chance that infection didn't occur…)
It was very strange to hear those words come out of my mouth. Very strange. I remember turning the conversation over in my mind for a few hours afterward, examining it from every conceivable angle. Was I wrong? Had I been too emphatic? Perhaps over-dramatic? Is it possible to be over-dramatic when you're trying to drive the gravity of a situation home? Perhaps it felt wrong because you can't be emphatic about much of anything in medicine, so being emphatic feels out-of-place — even when it's warranted — because the profession itself deals mostly in shades of gray?
People survive being shot in the head with bullets and other objects on a semi-regular basis. But so far, not rabies. (Then again, gunshot wounds are more common than rabies infections, so maybe if n for rabies were a little larger…)
In any event, he ended up getting the vaccine.
[tags]Medicine, pharmacy, rabies[/tags]
Albuterol HFA, and Proventil/Ventolin substitutions
A recent entry by #1 Dinosaur on albuterol HFA formulations got me thinking. We've been substituting Ventolin HFA and Proventil HFA for Ivax's ProAir HFA.
Unfortunately ProAir HFA isn't substitutable… up until about a year ago, ProAir HFA was called Albuterol HFA — a clever marketing trick meant to confuse pharmacists into thinking that it's a generic drug rather than a trademarked trade name. (Note the capital A!) The name change to ProAir (same NDC, btw) hasn't done much to change the perception. Pharmacy people are a wily bunch — names get changed for pointless reasons quite often, so changing a product's name effectively means nil.
This has created a beneficial situation for Teva/Ivax: because — fairly or unfairly — ProAir is now associated with "generic" albuterol HFA, pharmacists and technicians will reach for the ProAir before they reach for anything else. If a doc writes "albuterol HFA," I'm going to reach for the ProAir HFA, even though Ventolin HFA might be the same price, because the two are inextricably linked in my mind now, and until I have a reason to change this — taste or whatever — it's going to be the preferred drug by default.
I've surveyed about half a dozen pharmacists over the last week, and only one of them knew that ProAir HFA cannot be substituted for Ventolin or Proventil. So here's my PSA to you pharmacy types who, like me, didn't know until recently. You can't substitute ProAir HFA for Proventil HFA or Ventolin HFA. Nor would you necessarily want to, as copayments are typically Tier 2.
I'm fairly apathetic about the environmental issues involved with CFCs; I'm more concerned about the impact on copayments, and doing the right thing. As of December 2008, all MDIs with CFCs must be withdrawn from the market, as per the FDA.
Copayments and NDAs
Teva/Ivax IS a generic drugmaker, you're right. However, when they created their Albuterol HFA formulation — notice the capital A, here — they didn't file an Abbreviated NDA (ANDA) which is required for generic drugs. They filed a full-blown NDA. NDA are used for brand-name drugs. So why did they do it?
I'm speculating here, but I suspect that Ivax saw their time running out on CFC albuterol and decided to work on an HFA-based version in the meantime. However, both Ventolin HFA and Proventil HFA are new drugs. As, of course, is ProAir HFA — which now controls about 60% of the non-CFC ALH market. I wonder how much of this is due to incorrectly substituting ProAir HFA?
- Ventolin HFA: April 19, 2001
- Proventil HFA: August 15, 1996
- ProAir HFA: October 29, 2004
This means that the soonest you'll see a generic albuterol HFA — no capital a! — is, I believe, sometime in 2010. (If anyone wants to clarify that for me, I would appreciate it.)
Unfortunately, it looks like there's going to be about two years where patients will have to pay brand-name copays for their MDIs, because ProAir is a brand-name drug on every insurance plan I've tried it on. (Yes, I was wrong in my comments on Dr. Dino's entry.)
When Proventil HFA's patent expires, I wonder if Teva/Ivax will have a generic form of their albuterol HFA inhaler already lined up? Will it cannibalize their profits in the short-term but create a long-term win? I do know that they've certainly captured mindshare with their clever early naming and then the name-change.
For doctors
If you're a physician, and you want to prescribe an albuterol MDI, don't specify which brand name you want. Let the patient's insurer decide. This will save you phonecalls that go something like "Mrs Jones's insurer will only cover Ventolin HFA or ProAir HFA, but you've written Proventil HFA. Can we switch?"
What a pointless waste of time that is for everyone involved, but unfortunately it's necessary for legal purposes. Unless you get a pharmacist who's tired of the bologna and simply does the switch automatically because they couldn't be arsed to waste 30 minutes of their time on the phone to be told what they already know is going to happen.
Tired of all the "HFA"? Technically "HFA" is part of the trade name. Sort of like "OTC" is a necessary part of the "Prilosec OTC" name because it's not the same as Prilosec for legal purposes. Gah!
Our poster child…
This is on our CII safe. And no, this is not what I looked like when I was kid, thanks. 
Can you read these prescriptions?
These three prescriptions were handed to me two days ago. Can you read them? (Click each for a larger image.)
Answers will be posted tomorrow night. Reply in the comments! (Directions, too!)
Exhibit A:
Exhibit B:
Exhibit C:
I should remind you, however, that electronic prescriptions are not a magic bullet, either, though they certainly mitigate problems like these.
[tags]Medicine, pharmacy, prescriptions, bad handwriting, doctor's handwriting[/tags]
Anecdotally: demographics, adult ADHD, and atypical psychotics
I worked in a pharmacy in a very wealthy community last night. First time. It was a huge change from both other pharmacies that I spend most of my time in. (One very poor, and one very middle class.) The thing I noticed most was the sheer number of adults (mostly men) filling prescriptions for Adderall XR and Concerta. I must have had maybe 7 or 8 in one hour. No Strattera or Cymbalta, interestingly enough. And most of the scripts were accompanied by other scripts for benzos, mostly for bedtime use. No surprise there.
Contrast this to my "home" pharmacy where we get maybe one or two adults filling these types of scripts per day. Then there's the other pharmacy in the poor section of town: I've never seen a prescription for an adult ADD med. Ever.
The correlation between wealth and adult ADD diagnosis is very interesting to me. I could draw some other conclusions about the relative intelligence of the people coming into each pharmacy, but I haven't worked at the wealthy pharmacy enough yet.
This is in contrast to the number of atypical antipsychotics used in children in the poor area. Lots of children on Zyprexa, Seroquel, and Risperdal. Almost none in the wealthy pharmacy. Again, the middle ground in my home store.