How utterly snooze-worthy. Now you Europeans can waste your tax dollars money on the drug, too! Hooray!

Bonus Tekturna story:

Doctor writes a prescription for Tekturna for one of his patients. (One of our drug delivery guys, actually.) Gives him a free sample card, even though he doesn't have insurance and thinks he's doing him a favor. He gets 30 Tekturna for free, and the next month rolls around. That'll be $100, please, even with the employee discount I gave him because he amuses me.

He almost shit a brick.

Remember, folks: giving patients a FREE SAMPLE is great, but it's a complete WASTE OF EVERYONE'S TIME if they are without insurance or if their insurance doesn't cover it.

Mr. Delivery Guy comes back a week later with a prescription for lisinopril, after I write him a note to give to his bonehead physician.

Sometimes I wonder…

[tags]Tekturna, aliskiren, Rasilez[/tags]

I think it's somewhat sad that it's been overly politicized, but I guess that's the price of doing something controversial in a country where the "religious right" has a lot more clout than is warranted. Politicians on both sides think the FDA has gone too far or hasn't gone far enough. I'd say that the agency has done a good job with their Plan B policy so far, if for no other reason than the fact that no one's completely happy with it.

Some of the nonsense on both sides is actually pretty funny, particularly when viewed with an eye towards history — especially the stuff from the right:

Coburn and other social conservatives said that the high doses of hormones in the pills carry risks, and that making them more easily available will encourage sexual activity and result in more unwanted pregnancies and sexually transmitted diseases.

That, my friends, is Grade A political BS. Opponents of oral contraception said the same stuff about "The Pill" when it first came out. It was then, and still is, a complete load of crap.

First of all, Plan B will prevent unwanted pregnancies. That's why it exists, and it does its job quite well. That whole STD thing… is anyone else having 1960s flashbacks here? Hello, these arguments were made when the pill first came out. They were unsubstantiated then, how is today any different?

"This is a bad decision for women, for girls, for parents and for public health," said Wendy Wright of Concerned Women for America, which led a campaign to block the decision. "The FDA's decision today will only make things worse for American women."

I'd love to hear the logic behind that one, backed up with some numbers. But wait, that'll never happen because the numbers won't be there, and the only thing the right will be able to come up with will be anecdotes here and there. And I'd put some serious money on that.

What does concern me is the current administration's emphasis on teaching abstinence. I think a rigorous sexual education program would go a long way in preventing STD transmission — but that, of course, is a bad idea because it will encourage teenagers to have sex. (Insert a humongous roll-eyes emoticon here.) Nevermind that the US has the highest rates of teen pregnancy and STD transmission of any first world country. Clearly the abstinence emphasis isn't working.

But the left isn't entirely reasonable either.

Plan B's backers, meanwhile, criticized the agency for not allowing the drug to be sold to everyone.

"We urge the FDA to revisit placing age restrictions on the sale of Plan B," said Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.). But because the decision represents "real progress" and an "important step in restoring the American people's faith in the FDA," the senators said, they were lifting a hold they had imposed on von Eschenbach's confirmation as FDA commissioner.

I don't think it's a good idea for it to be sold willy-nilly to anyone that wants it. Ideally it'd be only sold to the person who is going to use it so its use can be more closely monitored, and the procedure for using it — and how it works — can be made clear to the woman who needs it.

So we've got Plan B available OTC. Now it'd be nice if the lay public got on the "Plan B is not abortion" bandwagon. Because it's not.

[tags]Medicine, pharmacy, Plan B, abortion, politics, healthcare policy[/tags]

Anyway, the whole point of yesterday's post was to mention baby steps towards creating a legitimate market for organs. A Jerusalem district court ruled that Israeli HMOs must pay kidney donors NIS 63,000 (~$14,300) to cover their expenses, but it stopped short of saying whether they're allowed to pay for a kidney:

The Western world generally forbids organ trade. In Israel the ban came in a directive by the CEO of the Health Ministry. But Jewish law (halakha) does allow payment for organs and even considers selling one to be a mitzvah.

In a precedent-setting ruling on Monday by the Jerusalem District Court, Judge Joseph Shapira instructed HMOs to pay 31 kidney donors NIS 63,000 each to cover expenses. Shapira stipulated that the ruling is not on the more fundamental issue of whether payment should be allowed for the kidney itself.

An interesting ruling. But since most kidneys are donated by living relatives, it would almost seem a little odd for an HMO to be giving money to the donor outside of expenses. It would seem like it would be the responsibility of the private parties to handle that sort of thing.

I believe Levitt is wrong in his blog post on the topic when he says that these people are getting an extra $13,000 in their pockets. It reads to me that the Israeli HMO's are merely covering the expenses of the second party involved rather than allowing them to take home some extra pocket cash. How do you all read it?

[tags]Medicine, organ donation, economics, healthcare, Israel, ethics[/tags]

The authors of Freakonomics (an excellent book, by the way) have covered the economics of organ donation in a New York Times article from July 9, 2006. ("Flesh Trade: Why Not Let People Sell Their Organs") All jokes about people selling kidneys on eBay aside — which has been tried — there doesn't seem to be anything inherently unethical about doing so. While I wouldn't sell one of my kidneys (though I might give one away) I don't see anything wrong with the practice for those interested in doing so. Levitt and Dubner agree, noting that the practice could help alleviate the organ shortage:

One case of repugnance is far from settled: the dispute over how human organs for transplantation should be allocated — and, perhaps, even sold. If you happen to have a failing heart or liver or kidneys, you will almost certainly die without a transplant, but if you aren't lucky enough to get an organ through an official registry, you can't legally purchase one at any price. So instead of a free market in organs, we have a volunteer market. Some people agree to give up their usable organs once they die. In the case of a living donor, someone sacrifices a kidney or a portion of a liver to a recipient, most likely a family member.

In the space of just a few decades, transplant surgery has become safe and reliable (to say nothing of miraculous). But success breeds demand: as more patients get new organs, more patients want them. In 2005, more than 16,000 kidney transplants were performed in the U.S., an increase of 45 percent over 10 years. But during that time, the number of people on a kidney waiting list rose by 119 percent. More than 3,500 people now die each year waiting for a kidney transplant.

To an economist, this is a basic supply-and-demand gap with tragic consequences.

The kneejerk reaction for many is "No way should that be allowed!" but when you really get right down to it… why not? Besides offending sensibilities — the human body is sacred and shouldn't be sold at any price — are there any real moral or ethical arguments that can be made against saving lives and making a buck on the side? There aren't any that spring readily to this health professional's mind.

Saving lives and making a buck on the side is how medicine works. Altruism is wonderful, but it doesn't pay the bills and put food on the table. Naturally, that doesn't mean that Americans will be embracing the idea anytime soon, so Alvin Roth, the economist who has studied the problem, came up with a way around the repugnance factor: The New England Program for Kidney Exchange. The program doesn't buy or sell organs, but it's the next best thing: a kidney swap program.

NEPKE uses a computer program to find cases where the donor in an incompatible pair can be matched to a recipient in another pair. By exchanging donors, a compatible match for both recipients may be found. You can learn more about the program here.

It's nice to see business and economics providing unique solutions for real medical problems. While I don't expect we'll see an eBay for organs anytime soon, I wouldn't be surprised to see legislation regulating the "market" — for lack of a better word — on human organs to change sometime in the next decade as the demand for organ transplants increases while the supply remains largely unchanged.

[tags]Medicine, organ donation, economics[/tags]

I have a special place in my heart for microbiology in general, and superbugs in particular. Ever since microbiology lab, I've loved playing with bacteria. In fact, I still have a urea agar slant vial that's a lovely shade of flourescent pink — thanks to proteus vulgaris — that I stoletook from lab. (They were just going to throw it away!) It was hanging from my rearview mirror in my car for a while, and now it sits on my desk, an old friend from a favorite class. It looks something like this, only the agar is translucent rather than opaque, and is quite pretty when it catches the sun just right. Maybe I'll take a picture of it one of these days. I'm surprised it's as vibrant pink as it is — it's quite old.

Alas, I'm showing my nerdy side. On with the real news…

MRSA is turning into a real problem in prisons. Not only for prisoners, but for guards as well. I've been watching this blog for a while, and following the comments therein. There's some scary stuff going on:

K Schacht Says:

Until recently I was employed as an part-time instructor in two of our local jails. I had been working just a few months when suddenly I began to not feel well, and then the symptons developed… which were misdiagnoised for several months. Finally, I was correctly diagnoised with MRSA, but six months later I’m still ill and the antibiotics are not working.

Yes, I’m mad and yes I do feel the jails have a culpability of informing and educating not only outside and inside staff, but the inmates as well.

I had no idea of this risk and was not informed at each jail orientations. The choice of exposure was not an option and the lack of information has prolonged and perhaps worsened my health.

State Corrections Officer Says:

I have been infected with the MRSA infection and I appeal to all of the other concerned staff and health-care employees to write your poltical parties and voice your concerns about the lack of information distributed by the institutions and unwillingness to allow and/or approve sick leave benefits.

Cindi Goreham Says:

My mother passed Jan 26,2006 with this disease. She was incarcerated before she passed and had sores on her face and arms. She began getting them while she was incarcerated and when she went to medical nobody could tell her anything and she continued to get sicker and sicker. My mother had her faults but she didn’t deserve to die. If anyone can give me any information on inmate lawsuits I would appreciate it.

Yes, these are anecdotes, and should be taken as such. However the story is the same for all of them: a lack of disclosure of the risks. Prisoners shouldn't be subjected to these conditions, to say nothing of the employees that work for the institutions. This is a first-world country, not the PRC. Human rights actually means something here, and these rights should be universal inasmuch as they can be.

I hope conditions improve, and there is some hope on the horizon through a new rapid MRSA test. Here are some random MRSA-related links. I could find dozens more relating to jail lawsuits alone without much effort, so these are just the tip of the iceberg.

• Staph infection complaints lead to probe at jail
• $15,000 neck abscesses — treatment for one inmate could run as high as $15,000
• Soap, water, and probiotics — battling drug-resistant bacteria by suppression with probiotics in the OR

As a taxpayer, I'd like to see prisons be safer for inmates and employees alike. Ignoring the problem is only going to make it worse: more infections, more lawsuits, and more unnecessary suffering. And I surely hate to see my tax dollars going to pay for treatments of inmates and employees when prevention is far more effective in the first place. In the case of prison guards, they should be made aware of these risks before day 1 on the job. They have it rough enough without having to worry about staph infections.

I've said before that I think that drug-resistant bacteria are going to become one of the nastiest medical problems in first world countries in the next 10-15 years.

[tags]Medicine, pharmacy, microbiology, bacteria, MRSA, prison, human rights[/tags]

An editorial by someone published in the NYT this past week questions whether the vaccine should be mandatory. Of course, there are some vaccines that are required for anyone entering a public school, for instance. Gardasil could be among these required vaccines (MMR, etc.) for girls aged 9-26. (So that means college students as well.)

I don't see the problem with making the vaccine mandatory. While there are some reasons that this might not be necessary — cancer-causing HPV can only be contracted through sexual contact — there aren't any reasons listed that are compelling safety issues.

So we have a sexually-transmitted disease, and a vaccine to prevent it. Should the vaccine be mandatory?

I present to you two brief arguments for why I believe it should.

First off, someone who has HPV doesn't always know they have it. I have a friend, for instance, who contracted it from a partner who didn't know she was infected it. While he can't get cervical cancer because he's, well, a guy — she can. And she didn't know she had it. From WebMD:

Most people infected with the HPV viruses have no symptoms and may not know they are infected.

Oops. A mandatory HPV vaccine several years ago would mean that she would never have contracted it, and as a result, wouldn't have passed it to my friend.

Secondly, not all sexual contact is voluntary. Rape happens. It's an unfortunate fact of life, but there it is. A woman (or man, for that matter) can contract the human papilloma virus through unwanted sexual contact just as easily as a consenting partner can. STDs don't differentiate between the willing and the unwilling. And there is no cure for HPV once it's contracted.

So why again shouldn't this vaccine be mandatory? If there are no unhealthy downsides, where's the problem? Is it money? I don't think so. How much does it cost to treat cervical cancer? Quite a bit more than it costs for a vaccine. For that matter, the costs of treating repeated outbreaks will add up to be more than the cost of the vaccine which runs around $360 for 3 shots. An ounce of prevention compared to a pound of cure works when comparing the dollars and sense involved with a compulsory vaccine. The cost of a single tube of Aldara cream, for example, is over $100.

In short, I see smoke in mirrors, and not much substance.

DB has got some commentary on the issue as well.

[tags]Medicine, pharmacy, cancer, oncology, gardasil, vaccines, vaccination, hpv[/tags]

This article is pretty long, so you may wish to get a cup of coffee or something before you read it, but I do think it's very relevant to healthcare today. The sections:

• The retail misconception
• Healthcare as a collaboration
• A problem of medical records?
• Making a diagnosis vs determining treatment options
• Pharmacists are already prescribing today
• Who's more qualified?
• Random talking points
• Conclusions

There was quite a bit of excited discussion in the thread, and I wanted to address some of those things here. Some were legitimate concerns, and some were just plain wrong. I have mixed feelings about being able to prescribe someone medication. On the one hand, it would be terribly convenient to alter drug therapy when the prescriber can't be reached, but on the other hand, that's quite a bit of additional responsibility. (Not from a "getting work done" point of view, but rather being directly responsible for therapeutic outcomes.)

In my experience dealing with most pharmacists and most pharmacy students, most of them chose the path because it paid well, was relatively stress-free,* and while it was challenging to make it through, the financial and personal rewards at the end made it worth it. Not because they're necessarily passionate about being a pharmacist. Naturally, there are exceptions to these rules — such as yours truly; I truly love medicine in general and pharmacy in particular — and this phenomenon isn't even a bad thing. There's nothing wrong with not being passionate about what you do. (Though I do think that actively disliking one's job is a recipe for disaster, particularly if you are a pharmacist.)

One of the reasons for this lack of passion is that being a pharmacist is largely a passive role in healthcare. The most exciting and interesting parts of my day are the discussions I have with patients about XYZ. Those are the moments that make what I do truly worthwhile. I think a more active role in healthcare would cause a lot of pharmacists to be happier about their jobs. Not that I think that job satisfaction should be a reason to involve pharmacists more actively — rather, I think that involving pharmacists more would results in more positive therapeutic outcomes if for no other reason than they are more accessible than any other provider.

* Where stress-free is defined as work stays at work when you leave, not that working in a retail environment is without stress, because this is most certainly not the case.

The retail misconception

First off, not all pharmacists are retail pharmacists. That is, of course, what everyone thinks of when they think of a pharmacist, but the majority of RPhs out there don't stand behind a counter all day and count pills. They do other things. When we're talking about pharmacists prescribing meds, we're not necessarily talking about your neighborhood pharmacist. That's probably the biggest misconception out there — even among other healthcare providers.

Discussion-based healthcare

Medicine is slowly but surely moving towards a more collaborative style of managing outcomes. This stems from the fact that breakthroughs occur faster than any one person can keep up with, which in turn results in specialization. Everyone in healthcare knows this intuitively, even if they perhaps haven't sat down and thought about it in such explicit terms.

In many cases, pharmacists — especially clinical pharmacists specializing in something, e.g. geriatrics — knows more than your average GP when it comes to dosing and drug interactions in general in their field of study. This is often why you'll find pharmacists supervising physicians in managed care settings like nursing homes. In their field, they're quite simply better at making the right decision because they know more about that particular aspect of patient care. I can think of two different clinical pharmacists who regularly sit down and work out the pharmacokinetics for drug regimens for specific trouble patients. These two people are incredibly well respected, and when they make a treatment suggestion, it is always followed. (And I'm not aware of a single case where they've been wrong.)

This is the collaboration I'm talking about. Mostly it applies to difficult patients: those on lots of meds or who have idiopathic symptoms — which are often the result of drug therapies unsuitable for those with impaired liver and renal function. Being able to tweak these meds without having to call for a doctor's authorization would be wonderful (and is wonderful in the settings where it occurs).

Ever tried to call a doc's office and get a response within a reasonable amount of time (20-30 minutes)? Hah! It rarely happens. Naturally this is because docs are incredibly strapped for time, and I sympathize, but it does make getting an approval immensely frustrating. It's also frustrating for the patient, which is why pharmacists are consistently considered the most accessible healthcare experts in the field. These are all problems the medical profession knows about, and I think it will eventually get better.

And pharmacists are going to keep medical records where? And how are they going to prevent duplications?

There are three problems with this argument.

1) More than 50% of our patients (especially the elderly) see more than one doctor. You think they're sharing medical records in perfect accord? Well, I can assure you they probably aren't. I've seen quite a few drug interactions because Doc A doesn't know what Doc B is doing. Trusting a patient to facilitate conversation between the two providers is nothing short of laughable in most cases.

2) The other problem with this argument is that most patients go to the same pharmacy all the time, regardless of who the doc writing the script is, which puts the pharmacist in a unique position. I don't know what is meant by duplication, but if that person is referring to getting the same drug twice, the insurer simply won't allow it. Ironically, this means that insurers are helpful in tracking down therapeutic duplications, even if a patient doesn't go to the same pharmacy all the time. Insurance rejections are, of course, an imperfect solution, but most people have some form of third-party coverage, whether it's a discount or actual insurance.

3) Because of point #2, pharmacists are better able to see the overall picture from a therapeutic standpoint than Doc A or Doc B alone. If they can't see it directly, they can respond indirectly to an insurance rejection, for instance, and dig deeper to see what's going on.

I've written extensively on universal access to healthcare records before (not on this site), and this would solve a lot of these problems. However, this is years away. As universal access improves, we'll be seeing more of this active collaboration, rather than providers all working in their own little vacuums.

Making a diagnosis vs determining treatment options

I wouldn't trust a pharmacist to know the difference between peritonsillar abscess, viral URI and Lemierre's syndrome. These would all be treated the same by the pharmacist (no disrespect to them). If someone isn't trained to do something, why would they want to perform that task?

In most cases, pharmacists don't want to make diagnoses, so this point is completely irrelevant, and demonstrates a misunderstanding of the difference between the roles of doctor and pharmacist. Every pharmacist I've talked to knows they're not well-equipped to make complicated diagnoses. We simply haven't taken the necessary courses to make a determination beyond "basic" problems that are easily testable. (Hypertension, blood sugar levels, etc.)

Once a diagnosis is made, it's not unreasonable for a pharmacist to make therapy suggestions, especially when there are adverse events. This is particularly true today with the PharmDs that are graduating, and who have more clinical experience in making complex decisions than most people think. You won't find pharmacists making diagnoses very often; you're more apt to find them making alterations to existing therapy. Tweaking for optimal performance, as it were.

Pharmacists are already prescribing today

The discussion at Kevin, MD seemed to completely ignore the fact that pharmacists regularly prescribe medications here in the United States already.

You'll find this phenomenon in mostly in VA hospitals and in the Indian Health Services. That is, federal agencies. There are many reasons for this, but they're not particularly relevant to this discussion. Suffice it to say that many of the pharmacists in these two areas of study are quite good at what they do — an acquaintance of mine teaches pieces of Disease State Management (the capstone pharmacy course for fifth year students before they do their clinical rotations) and pieces of clinical pharmacology — and they are well-respected in their specific fields.

You won't usually find pharmacists making diagnoses, but you do see them monitoring patient progress and adjusting medications based on what they see.

In the case of VA pharmacists, they are under the supervision of an MD in much the same way that a nurse practitioner is.

Who's more qualified?

Some people suck, no matter what the letters after their name say. In every field some are better than others; some are downright awful, and others are unbelievably fantastic, and most are somewhere in the middle. It's certainly true that MDs tend to be better qualified to make diagnoses than pharmacists. I don't know of any pharmacists that would argue that point.

But are MDs more qualified to make drug therapy decisions? Ignoring the traditional healthcare provider roles and the kneejerk reaction to say "yes!", I am not aware of any studies that have looked at this, and if they have, what the outcome has been. It would probably be a mixed bag, but I would guess that the number of positive outcomes between the two providers would probably be pretty even.

That's a bold statement, of course, but I expect to see research in this area in the next five to ten years, so we'll have to wait and see. By and large, I would trust a PharmD to make a better drug therapy decision than an NP or PA, though, because a pharmacist's drug knowledge is much wider than a PA's, NP's, and even an MD's.*

All of this boils down to the question of which body of knowledge is best when it comes to making drug therapy decisions: broad and deep knowledge of physiology and pathophysiology or broad and deep drug knowledge?*

Obviously the answer is both, and this is why we'll see a continuing progression towards healthcare as a discussion among colleagues rather than a "dictatorshipship." (For lack of a better word.)

A fun little related anecdote… just two days ago, there was a nurse practitioner who wrote a script for Suprax. Suprax isn't particularly common any longer, the pharmacist on duty wanted to change it. He talked to the nurse, and all she knew was that she wanted a cephalosporin. The problem was, she didn't know of any other cephalosporins besides Suprax.

…

That's not exactly confidence-inspiring, and it happens more than you probably think.

* A pharmacist’s education overlaps with a physician’s quite a bit, and even moreso vice versa. A physician probably knows more than a pharmacist does about physiology and making diagnoses. But in general, pharmacists know more about drugs than physicians do — for a reason: they went to school for it.

Random talking points

everybody and their brother wants to script meds these days….. and dont you dare tell me they want to do it for the public good, they want to do it for one reason only: $$$$

I'm not intimately familiar with the Canadian healthcare system, so maybe the motivation for pharmacists up there is different. In the United States, however, you might see a slight bump in pharmacists' salaries, but not much more than that. The days of the independent pharmacy are largely over due to economies of scale. Retail pharmacists working for big chains don't have any incentive to prescribe more meds, but they do have incentive to take patients off meds. (Less work.)

Basically, a doctor has about as much motivation to prescribe medications as a pharmacist does. This argument is a straw man.

where the evidence that pharmacists w/ script rights are just as good as medical doctors?

In specialized fields, the evidence is there. I touched on it above. Beyond that, there hasn't been any research done simply because pharmacists don't have script rights.

If Canada has a problem with script providers, train more NPs, PAs, and MDs. Thats 3 different pathways to scripting meds. There is no reason to add yet another pathway.

Canada is a free country. It's not simply a matter of "training more" as though people are cattle to be herded one way or the other.

The United States is the same way.

1. What are "basic medications" (that is the ones, that the pharmacists think they should be able to prescribe)? Antihypertensives? Insulin? Steroids? Last time I checked, there are plenty of medication errors and injuries to patients caused by physicians who prescribe these meds.

That statement relies on the faulty assumption that a physician is always the most qualified person to make a therapeutic decision. There is no data that I am aware of to support your claim — or mine. So it's impossible to defend one side or another in any meaningful way.

3. What is the malpractice coverage for a pharmacist?

A lot less than for an MD. The cost will go up when pharmacists begin "prescribing," I can guarantee you that. I use the term prescribing lightly, because I think we'll see more "tweaking" than outright prescribing.

4. And when Wal-Mart comes rolling through Canada (which probably has already happened), and your "neighborhood pharmacist" is transformed into another generic low-paid FTE (full-time equivalent) behind the counter, how exactly is that better than your regular physician?

Just because a pharmacist works for Wal-Mart, doesn't mean they suck. And so long as there's a shortage of pharmacists, they will never be "transformed" into a "low-paid" anything. In fact, Wal-Mart has some of the best salaries for pharmacists, and treats them very well (from what I've been told). They've brought their business acumen to inventory management and apparently made it quite easy to run a Wal-Mart pharmacy.

But they also have the Wal-Mart stigma to deal with, which is one of the reasons their pharmacists are paid more. This is conjecture on my part, but most pharmacists think "Wal-Mart? Why would I want to work there?" so they've got to sweeten the pot somehow.

Beyond this, one's employer doesn't diminish one's education and (ultimately) that one knew enough to get licensed.

Conclusions

Would I trust every pharmacist to make a good therapy decision? No, I absolutely wouldn't. Before I could reach that comfort level, I'd have to see pharmacists taking more CE credits, and not just CEs where you show up, have a nice dinner or what have you, and then automatically get credit for it, as is the case with most of these CEs today. There needs to be a better way of making sure a pharmacist is up on current therapies and best practices.

That said, I would trust a pharmacist over a PA or an NP when it comes to managing complicated drug therapy. There is no question in my mind about that.

There would also need to be a better way to keep (and share!) medical records with other providers. It would be awesome if everyone could be on the same page, but this hasn't happened and won't happen for a while. As we move towards healthcare as a collaboration and discussion, we'll gradually see this occur as a positive feedback loop wherein one fuels the other. I can't tell you the number of times I've wished that I could see a patient's medical records when answering the question "Why am I on this medication?" Pharmacists can make educated guesses, but if the medication can be used for a million and one different things, and so long as they are kept mostly in the dark, that's all they are: educated guesses.

[tags]Medicine, pharmacy, prescriptions, law, pharmacy law, PharmD[/tags]

Furfaro, a disabled heart-transplant patient, hit the doughnut hole last month when he tried to fill a prescription for two medications. Instead of two $25 co-pays, the pharmacist charged him $661 and $329 for the prescriptions.

"I threw a fit," he said. "What am I supposed to do? I don’t have $661 in my pocket."

Stuff like this comes down to personal responsibility. As the person in charge of Medicare consultation at my place of employment, we killed ourselves educating people about the plan. We did everything humanly possible to 1) educate people and 2) help them pick the plan that was right for them based on their current drug therapy. From the perspective of my pharmacy, there was nothing more that we could have done to educate people and help them make the right decision. Nothing.

Millions of people and millions more family members are going to be experiencing this shocking and crushing problem,” Hayes said.

The Medicare doughnut hole is a strange compromise between lawmakers who wanted to limit the cost of the program and those who wanted it to cover as many people as possible.

While it is an "advocacy" group's job to push for more, more, more — there are limits, and these limits were advertised, and most importantly, there were and are plans which do not have a doughnut hole. A pharmacist cannot help it if someone didn't pick a plan that would suit their needs better. At some point, it must be the patient's responsibility to take care of themselves. It is not that pharmacist's issue that this patient happened to be on Prograf and that Prograf costs a lot of money, however that pharmacist does end up looking like the bad guy, even though he or she was just bearing the bad news.

The fact that plans exist without a doughnut hole is conveniently conflated with the basic plan that the federal government outlined about a year and a half ago, before the private sector finalized their plans. Perhaps it is because the journalist doesn't know, but more probably, it is because leaving this fact out tugs on the heartstrings that much more.

If his health deteriorates further, Furfaro said, he’ll just get admitted to a hospital and receive his medicine that way, as Medicare will pay all bills if he is hospitalized.

In Mr. Furfaro's shoes, I would do the same thing, and it is something that will be addressed as in a year or two. With the doughnut hole, some people will always run out of coverage through poor planning, catastrophic occurrences, or what have you, and they will go to the hospital to continue getting their medications. However it is in the government's best interest to keep people out of the hospital when they are picking up the tab, because it is more expensive to keep someone in a hospital bed than it is to pay for their medications at a retail pharmacy.

In the meantime, the current Part D plan has worked out astoundingly well, and it is certainly off to a very good start. Where the money will come from in the future to continue its funding is anyone's guess, though.

Update 12.26am: I forgot to mention that Part D providers are required to send monthly notices to their subscribers telling them how much of their benefit they have used up, so if Mr. Furfaro had been doing his due diligence, he wouldn't have been blindsided by the doughnut hole.

[tags]Medicine, pharmacy, Part D, doughnut hole, Medicare Part D[/tags]

In the United States when a drug goes OTC, you typically see a huge price drop because people are unwilling to pay what it actually cost their insurers when a drug is prescription-only. I've touched on this briefly in the past — people have no concept of the costs associated with medicine. You see medications go OTC like this when their patent protection is about to run out: mandatory generic substitution robs Big Pharma of revenues if a drug stays behind the counter. In the case of a relatively safe, proven drug like Imigran/Imitrex, making it available OTC can only mean more money for the manufacturer. People know the brand name, not the generic one, so that's what they seek out. This is the same reason that Tylenol and Motrin outsell their generic counterparts.

The cost for the consumer will increase from a £6.65 flat fee for X number of tablets (whatever is allowed) to £7.99 for two tablets of unspecified strength. The convenience of not needing a prescription will almost certainly outweigh the increased price. Profit per unit sold will be lower, but the higher volume should more than compensate for this. Because of the different pricing structure of UK prescription drugs, it is unclear what the third party (in this case, the NHS) has been kicking in up behind the scenes. One thing is certain: GSK had to raise the price for consumers because if they had they not, you can bet the government would have been pretty unhappy — governments always get the most preferred pricing. GSK is certain that this move will increase their profits, otherwise they wouldn't have lobbied for it to go OTC.

Eventually, we will see more drugs going OTC like this in the US as the number of PharmDs slowly surpasses the number of RPhs. Dispensing of Imigran will still be monitored by the pharmacists dispensing the medication.

[tags]Imigran, Imitrex, GSK, sumatriptan, migraines, medicine[/tags]

Chantix joins another smoking-cessation drug that's not very popular at all: Zyban. Zyban never really made it big because insurance companies refused to pay for it, and there was another drug on the market that had the same active ingredient — the perennially popular Wellbutrin.

For Pfizer's sake, I hope they find a second clinical use for Chantix before someone else does, otherwise I suspect they will have wasted a boatload of money. Rarely are brand-name medications priced low enough to appeal to the masses who have to pay out-of-pocket.

On a completely unrelated note, I saw Thank You for Smoking yesterday and it was excellent.

[tags]Chantix, Pfizer, smoking cessation, Wellbutrin, Zyban[/tags]

Unfortunately, I can't seem to find which drugs' patents will expire without a generic equivalent to take its place — I suspect that none of them are massively profitable by themselves — but all told, the market value of these 800 drugs is a whopping $78 billion per year for their manufacturers. For comparison, the entire generic drug industry is only worth just over $22 billion — even though it accounts for over half the prescriptions dispensed each year in the United States. Broken down, that's almost $100 million per drug, ceteris paribus. Regardless of the specifics of each case, the aggregate dollars involved are huge.

If a creative generic manufacturer like Teva can squeak a few generic approvals by, they will effectively have a six-month monopoly on those drugs. The Hatch-Waxman Act allows the first generic manufacturer to produce and sell their generic equivalent with no competition — save from its brand equivalent. These first six months are crucial. During this time, a generic drug usually undercuts the brand-name competition by about 6%. This is a hugely profitable time, because once other generic manufacturers are allowed to start selling their own equivalents, the price drops to some 80% less than the brand-name drug, so in theory, that first-to-market manufacturer can make more in those first six months than they could in the 4-5 years after their monopoly ends.

Big Pharma sometimes combats this by paying off the first generic manufacturer to continue their monopoly for another 180 days — which in the case of a huge drug like Zoloft or Zocor could be in the billions of dollars of additional revenue. And sometimes they roll out a lower priced "generic" version themselves, which is really just the name-brand med without the name. (One of these days I'll give you an example of how convoluted — and silly — the whole brand-generic wars can be. It's actually kind of funny, but with billions of dollars in revenue at stake, it's a game well-worth playing.)

[tags]patent protection, FDA, generic drugs, pharmacy[/tags]