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 As of December 2008, all MDIs with CFCs must be withdrawn from the market, as per the FDA.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.]

If you do a Google search for "Tylenol #3", the second hit on the page is this link. Looking closely at the page, you’ll note that we’re talking about "Tylenol #3" specifically. Why then, is the Common Name listed as "acetaminophen – codeine – caffeine"?

There is no caffeine in Tylenol #3. There’s just acetaminophen and codeine.

What form(s) does this medication come in?

Tylenol NO. 3 with Codeine®: Each round, hard, white, flat-faced tablet, bevelled-edged, engraved with "3" on one side and "McNEIL" on the other, contains acetaminophen 300 mg and caffeine 15 mg, in combination with codeine phosphate 30 mg. Nonmedicinal ingredients: cellulose, cornstarch, and magnesium stearate. This medication does not contain gluten, lactose, sodium metabisulfite, or tartrazine.

Who should NOT take this medication?

Anyone allergic to acetaminophen, caffeine, or codeine should not take this medication.

In the United States, when a doctor writes "T3" or "Tylenol #3" you’re getting 300mg of acetaminophen and 30mg of codeine. No caffeine.

However if you go to the Janssen-Ortho website and hit up their product information PDF for their Tylenol products, it indicates there’s caffeine in T2 and T3, but not T4. But the Ortho-McNeil website’s prescribing information (PDF), for T3 indicates that it’s 300mg APAP and 30mg of codeine. No caffeine.

So WTF is going on here? I called Ortho-McNeil (US makers of T3) and I also called Janssen-Ortho (Canadian counterpart). The US office told me what their website did: no caffeine. I have yet to hear back from the Canadians — they say they’ll return your call in one business day. I’m wondering if there’s a difference between Canadian T3s and US T3s? Maybe in Canada, they have 15mg of caffeine, whereas in the US, they don’t? If this is indeed the case, talk about a nightmare trying to track down accurate consumer information. Yikes.

Update: I just got off the phone with Janssen-Ortho of Canada, and Tylenol #3 in Canada has caffeine in it, which means that it is different than the US formulation of Tylenol #3. If I had trouble figuring this out, how much moreso would your average consumer struggle?

[tags]Medicine, pharmacy, drug information, T3, Tylenol #3[/tags]

According to a Reuter’s report, CVS plans to open 300 new Minute Clinics in 2007.

Is this going to change the way doctor’s offices fundamentally do business? In the long-term, I think so, because right now they can’t compete with retail convenience. In multi-doc office, I expect to see doctor/NP/PA scheduling altering to have a more or less constant presence in the office. This will be particularly true with NPs and PAs who can handle more immediate issues — the things that will be diagnosed at Minute Clinics.

There’s been lots of talk in the medical blogging community about how Minute Clinics are “bad” in the sense that a patient’s medical history will be spread out over multiple locations. That the treatment prescribed by the NP at the Minute Clinic will be sub-par, or not what one’s PCP would have chosen. These are valid complaints, so I expect to see doctors respond in the areas where Minute Clinic density is higher.

You don’t need a large medical practice to cover a lot of hours. Lots of hours = lots of availability. Sure it’s not as nice as a 7-7 medical practice, but it IS more convenient for the patients/customers. And it has unexpected benefits as well — 3 days weekends once a month and the like are not uncommon for pharmacists.

Realistically, a moderately-sized medical practice (3 docs, say) could easily cover 72 hours of availability per week. 8am-8pm Monday through Friday, and 9am-3pm on Saturday and Sunday. Start with one doctor in the morning, have the second come in later in the day, say around 11am or noon, and doctor #1 goes home around 4-5pm while his/her colleague stays until late. This is what retail pharmacists do, and I expect you’ll see variations on this theme for doctors once they start feeling the pressure from retail clinician availability. Get an NP or a PA to see the urgent cases, and I think you could probably cut down on ER overuse in your area.

Are there problems? Yes. Are the insurmountable? No. Will it happen in the next five years? Probably. Think about it. 300 Minute Clinics in 2007 alone. If they become big hits, expect to see that number grow yearly. That’s a lot of Minute Clinics. That’s a lot of lost, easy revenue.*

*I think it was Flea(?) who said that these types of visits are the bread and butter of pediatricians because they’re fast and easy. These are the types of visitors the Minute Clinics are catering to.

[tags]Medicine, pharmacy, CVS, Minute Clinic, retail medicine[/tags]

The University of Maryland School of Medicine has essentially come up with a spit test for lung cancer:

In the January 15 issue of Clinical Cancer Research, the researchers report that their fledgling test, designed to check whether two genes believed to be tumor suppressors are deleted in cells found in sputum, identified 76 percent of stage I lung cancer patients whose tumors also showed the same genetic loss. Existing sputum “cytology” tests, which look for changes in cell structure, identified only 47 percent of the patients, they say.

While no other simple sputum analysis has found such a high correlation with lung cancer, it is not yet good enough for the clinic, researchers say, and so they are now expanding their test to screen for up to eight genes.

This is pretty cool, and while it may not be good enough for the clinic, it does appear to have greater potential than say, the controversial PSA test for prostate cancer which misses 82% of tumors in men younger than 60, and 65% of cancers in men over 60. While you can’t yet make a direct comparison between the two, this spit test does seem like it will end up being more accurate than the PSA test.

The researchers are hoping to drill down to the genes that are specific only to cancer. Current cytology tests show the extend of cell damage, but this doesn’t correlate to lung cancer rates because most heavy smokers do not develop cancer. Looking for only the genes involved is a more precise approach to calculating lung cancer risk.

[tags]Medicine, cancer, lung cancer, oncology, genetics[/tags]