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]

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]

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]

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!

This is on our CII safe. And no, this is not what I looked like when I was kid, thanks. ;)

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]

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.

Back in May of last year, I wrote about disposing of old medications. I drew my conclusion from an EPA suggestion that stated the best method of disposing of old medication was to simply flush it down the toilet.

Last month, the White House Office of National Drug Control Policy advised people to “take unused, unneeded or expired prescription drugs out of their original containers and throw them in the trash.” They also advise mixing the meds with kitty litter or used coffee grounds and putting them in “impermeable, nondescript containers, such as empty cans or sealable bags”

Now Harvard Med has taken this advice one step further:

1. Ask your pharmacist if he or she can take back medications.
2. Call your city or state to ask about disposal programs like those mentioned above.
3. If you need to put your medications in the trash, keep them in their original childproof and watertight containers. Leave the label on, but scratch out your name to protect privacy. Add some water to pills, and put some flour in liquids. Conceal the vials by putting them in empty margarine tubs or paper bags before throwing them out.

Like I said last year, we do take back old meds, but they just go in our PHI trash to be destroyed back at the home office — or wherever that stuff goes. I think I like the third suggestion the best, though. Good common sense seems to apply pretty well in this case if you’re paranoid.

Incidentally, I don’t think press releases and suggestions like these are a waste of time and money. With our increasingly medication-happy culture, I think they’re timely and poignant. You don’t get taught in pharmacy school how to dispose of medication. Not at my school, anyway.

[tags]Medicine, pharmacy, prescription drugs, pollution[/tags]

I’ve seen a lot of hesitation on the part of community pharmacists over the last couple of years to interface with doctors, and to suggest therapy changes. When asked why, many of them have responded that they feel that it’s not their place to do so.

I think this is bollocks. I think they’re afraid.

It IS in your purview to make therapy recommendations. This is especially true for elderly people on Medicare Part D. For the first time (ever?) we have a system that indirectly rewards a large segment of the patient population for using fewer healthcare resources. (You don’t hit the donut hole, so you save money.)

But what about those people who legitimately consume large amounts of healthcare dollars? They need an advocate. And that’s YOU. The community pharmacist. When situations like this arise, you’re the one that should go to bat for the person on the other side of the counter, because no one else can.

Interfacing with a doctor

Some pharmacists are hesitant to interface with a doctor’s office. Maybe they’re worried that they’ll get stuck on the phone all day trying to make a change to a less expensive drug. But there are ways around this.

It’s called asynchronous communication. And it’s more efficient and less demanding on both your time and the doctor’s time because it allows the both of you to communicate when you each have time rather than employing The Interrupter — AKA the telephone. This is the difference between urgency and importance. What you have to say is not usually urgent in this context. But it is important.

Last November and December, I made 25-30 suggestions for drug therapy change during the course of my Medicare consulting — all of them via fax — and all of them were accepted. This saved my patients an average of $500/year. This is serious money for someone on a fixed income.

Speak their language

Not all of these changes are silly little things like switching from one drug in a class to another. Or trying an ACEi instead of an ARB. Some of these changes were broad, tackling a given medical problem (or even multiple co-morbidities) from a different angle. Many of your elderly patients — particularly those with chronic illness — see multiple doctors, and lots of times there’s no communication going on. In these instances you are the FOCAL POINT for their drug therapy. You are the gatekeeper, you see everything they take on your little computer screen. (Unless they’re one of the relatively few people who enjoy playing Musical Pharmacies.)

In these cases you’ve got to speak their language. Don’t even bother making a suggestion unless you are familiar with the latest treatment paradigms. If you want to change someone’s insulin from a hojillion-dollar version to something more reasonable, be sure you’re aware of the pharmacokinetic differences between the two. In your note to their endocrinologist, mention that you ARE aware of these differences but that you’ve spoken to Mrs. X and she is willing to try something new, and that this something new will save her $2000/year if it works.

Doctors listen, and they’re usually willing to experiment if the patient is.

There are two types of “best drug”

You bring knowledge to the table that doctors don’t have: how much things really cost. Most doctors have access to formularies if they want them, and they can relatively easily found out what kind of copay a patient will have if they prescribe X.

That used to be enough, but not anymore.

For Medicare Part D patients, the backend cost that the doctor does not have access to is a significant factor. Something might be a $28 copay, but UHC might be kicking in $250 behind the scenes that will quickly eat through someone’s drug benefit.

There are two types of “best drug”: the drug that is best from a therapeutic standpoint, and the drug that is best from a hybrid therapeutic-financial standpoint. This is the most pertinent concept of “best drug” for the person reaching for their wallet. Why reach for the Norvasc when you haven’t tried felodipine?

Make it easy for yourself

You’re a pharmacist. You’re busy. You’re machine-gunning prescriptions as fast as you can. The phone’s ringing and one of your techs called out. Today is not the day to be making therapy suggestions. (If you find yourself in this situation often, you need to attend the RJS School of Pharmacy Management.)

But even bad pharmacies have good days. Make a template with your pharmacy name, fax and telephone numbers, with a section for the patient’s information, and your notes. Personalize it with your name and titles. If you’ve got a system where you can type a note to the doctor, great. If not, don’t insult insult them with bad handwriting, even though they may not return the favor. Be the bigger person and have someone else write it if you have to — bad handwriting does nobody any favors.

Take out as much of the repetition as you can. You have better things to spend your time on than redundancy.

Battles

There’s this misconception that many pharmacists have that they’re going to have to have a battle with the doctor to make XYZ changes. First of all, this rarely happens. Second of all, if YOU are battling THE DOCTOR, there is a problem, and it’s not with you, if you are speaking on behalf of the patient as their advocate. No battles should occur; it should be a discussion. You know something the doctor doesn’t, and maybe he knows something you don’t about why s/he chose X drug instead of Y drug.

If you do end up having a battle, stick to your guns, but only if you know for a certainty that the patient will benefit if you do. Compliance issues due to money, dosing, etc. These are legitimate. Having a pet drug that you prefer is not. Conflict is not necessarily bad. Good relationships and mutual respect have been known to grow out of past conflicts.

Closing thoughts

These are the basics in effecting change as a community pharmacist. It is possible to take many of these ideas further, if you choose. Stepping on toes is never wise: step in when you see a patient is having difficulty with money, or if you can see they’re otherwise unhappy. Many patients will come right out and ask if there’s something else they can use. Some are unhappy with their doctor for any number of reasons, even though they’ve been seeing him for years. You may have an opportunity to save this patient-doctor relationship, and we all know how important good relationships are when it comes to healthcare, and how long they can take to build from scratch. They’re not something to be thrown away lightly.

[tags]Medicine, pharmacy, MTM, community pharmacy, pharmacy practice[/tags]

Here’s me being a nerd.

[Props if you can identify the compound on my shirt.]