Disclaimer: none of the stores I’ve worked in have ever been held up. I’ve never had anyone shove any weapons into my face and demand XYZ controlled substance. Those of you who have experienced this may think differently.

All of the pharmacies I work in, save my home store, have mandatory 24 hour OxyContin waiting periods. I used to be envious of these stores, but the more I learn think about it, and about pain management in general, the more I think maybe it’s a stupid rule. Why was I envious of those other stores at first?

Well people that bring in scripts for CIIs — especially OxyContin — seem to bring in 2 or 3 at a time. And they usually come in packs of 2-3 people at a time. Almost like they’re all friends or something. (“Hey guys let’s hang out and take some Oxies tonight!” “Yeah, OK!”) I have no idea why. Maybe it’s just my area. Anyway, that means you’ve got anywhere between 6 and 9 OxyContin scripts to fill. These people often choose to wait. Filling 9 prescriptions for CIIs really gums up the works. Most retail pharmacies keep their CIIs in a safe, and only a pharmacist has access to them for theft reasons. This means that the pharmacist is tied up for about 15-20 minutes doing nothing but working on these prescriptions. That’s a royal pain in the ass for everyone else. Those of you familiar with retail pharmacy understand that ours is an interrupt-driven business. You just don’t have time to concentrate exclusively on one task for 15 or 20 minutes to the exlusion of all else. The rest of the place falls apart because the pharmacist is the bottleneck through which all prescriptions must pass.

It’s easier if there are two pharmacists on, because one can pick up the slack, but at most smaller retail pharmacies, there is no pharmacist overlap.

Anyway, as I said, my attitudes have changed. While I don’t think it’s often necessary for these people who wait for their Oxy scripts to do so, I do think retail pharmacies should re-think the “mandatory” 24 hour wait period so that (ostensibly) we can order OxyContin for the next day.

Random aside: Ordering OxyContin for the next day is complete and utter BS anyway, as you pharmacists will know. It takes at least two days for the requisite 222 form to make it to the supplier. In fact, there’s just one pharmacist per pharmacy allowed to sign off on a CII order, and s/he doesn’t work 7 days a week, usually. So next-day ordering is out most of the time. The idea is that this policy will trick people into thinking that your retail store doesn’t actually have any OxyContin on the premises for safety reasons.

Back on topic: people who are on maintenance doses of OxyContin don’t usually need to wait. In stores where there’s a 24-hour wait policy, these people happily drop off their prescriptions and pick them up the next day.

Last night we had a person who had been in a serious accident involving a tractor trailer get released from the hospital. She had 3 prescriptions, one of which was for OxyContin. I had to turn her away — which made me mad because we had it in stock, and I sent her up the street to my home store where we don’t have any waiting rules — for what amounted to no reason. I guess this “rule” is in place for “safety” reasons. Though any criminal is going to know — not guess — that this rule is complete BS, which isn’t going to prevent him from holding you up in the first place.

If you’re at one of these 24-hour wait stores, are you really going to try to convince some dude sticking a .44 magnum in your face that you really don’t have any OxyContin in the safe? Somehow I doubt it. It’s just not worth the risk.

So we’ve created a rule that merely offers the illusion of protection. It keeps the honest opioid users honest, won’t deter those bent on breaking the law, and prevents those who may legitimately need a prescription for OxyContin today (first-time fillers) from getting their medication.

What a wonderful, pointless system we’ve created. I think it would be more effective if we simply advertised the fact that we keep less than 100 tablets of OxyContin in the store at all times. That, at least, sounds somewhat believable.

While this post was more introspective and rant-ish, I have lots more to say about the clinical aspects of pain management in the near future, especially about the castigation of opioid users by pharmacy staff, and the backwards attitudes of (usually older) pharmacists when it comes to pain management.

[tags]Medicine, pharmacy, OxyContin[/tags]

So it looks like at the end of next week, we’re going to run out of generic Plavix. I’ve not followed the business drama of Big Pharma in a little while because I find it dull, so I have no commentary on the outcome of the lawsuit, which I presume has been settled in S-A and BMS’s favor. Apotex had a good run while it lasted. I mentioned in September that we were warned that this might happen.

In any event, it looks like it’s for real. As far as I know, this is the only time in recent history where a generic has been withdrawn. I think I recall similar things happening for Lanoxin (digoxin) and Synthroid (levothyroxine), but generics for those drugs were withdrawn because of problems with bioequivalence rather than as a result of litigation.

It’s going to suck explaining the reasons why clopidogrel is temporarily going the way of the Dodo. People don’t take too kindly to the idea of their copayments doubling (or more). I’m thinking I should write a little handout for people explaining what happened so we don’t have to have the same conversation 500 times. After telling something a dozen or so times, you’ve heard all the wisecracks and complaints that such a topic engenders, and it just gets redundant and tiresome.

I also think the idea of jerking patients/consumers around like this is ethically wrong, patents and the justice system be damned. But then morality is entirely dependent on one’s point of view, now isn’t it?

[tags]Medicine, pharmacy, big pharma, plavix, clopidogrel, ethics[/tags]

As I mentioned about six weeks ago, I ended up going to the hospital while I was on vacation in California. Of course one of the hospitals lost my insurance info so they sent me an itemized bill instead. I’ve posted it here so we can all laugh together at how much they’ve charged me for a few things. I’ve not included a couple of things because they didn’t seem terribly unreasonable to me.

Promethazine 25AMP: $37.88
Sublimaze (fentanyl) 100mcg injection: $47.50
1000mL Normal Saline: $99.01
Contrast with Exam: $412.00

CT scan/body:
CT W/W/O Contrast: $2629.69
CT Pelvis W/W/O Contrast: $2355.70

Emergency Room
Level 3 w/ MD/Nurse procedure: $699.43
Admin of IV Injection: $184.71

——————————

Self-pay adjustment: -$1321.54

Continue reading On the absurdity of not having health insurance →

I’ve got a soft spot in my heart for GI disorders since I suffer from one myself. They suck. So when I read this the other day I was a bit surprised.

“For people with active ulcerative colitis who do not respond to corticosteroids or immunosuppressive agents, infliximab is effective in inducing clinical remission, inducing clinical response, promoting mucosal healing and reducing the need for colectomy, at least in the short term,” said review co-author Dr. Anthony Kwaku Akobeng.

[…]

“Infliximab is another option if steroids fail,” said Peter Higgins, M.D., an assistant professor in gastroenterology at the University of Michigan Medical Center in Ann Arbor.

And here I was, thinking this was common knowledge. In fact I during my hospitalization a few weeks ago whilst on vacation I had a discussion about UC with the tech doing my CT scan. She was telling me one of her friends had severe UC, and that he was on steroids. I distinctly remember suggesting Remicade or Humira instead of prednisone through my drug-induced stupor. She was telling me he hated the side effects. What a surprise. Then I think I started rambling about monoclonals and the lack of a generic approval pathway for biologics in general. She stopped talking to me after that.

She was cute, too. Really cute.

But hey, more studies are always good. Too bad Remicade is WAY more expensive than prednisone…

[tags]Medicine, pharmacy, Remicade, infliximab, ulcerative colitis[/tags]

Hat tip to MRSA Notes for this one. An study published in JAMA suggests that by telling parents to wait 48 hours to fill scripts for ear infection, physicians can help curb antibiotic overuse in children. It’s not a bad idea, and it’s something that I’ve often thought about myself. As a child I had chronic ear infections until the age of 10 when I stopped consuming dairy products. I had tubes six times. Throughout that time in my life I was averaging around one ear infection per month. In my case, waiting a day or two didn’t do anything except make things worse.

Ironically, I’m sitting here now and I’ve got an ear infection in my left ear that I’m currently taking antibiotics for. Even more messed up is that I got the infection while on a 7 day regiment of Levaquin and Flagyl. (That’s whack, eh?) Anyway, when I was a kid I wondered what people did before antibiotics. Did they go deaf? Did they walk around with chronic ear pain? Did their eardrums burst? None of my infections ever went away on their own, so I thought they stuck around until you made them go away with drugs.

Of course I know better now, and it warms the concerned medical professional and microbiology enthusiast in me to see experts pushing for moderation in antibiotic use.

Out of 238 patients aged 6 months to 12 years brought to a hospital emergency room complaining of ear infections, two-thirds of the parents who were told to wait ultimately did not fill their prescriptions.

The group that did not fill the prescriptions recovered at the same rate as children who had prescriptions filled right away, an indication the condition often clears up on its own.

Those are some impressive findings. But it doesn’t get past the sense of entitlement that patients have when then visit a doctor’s office. People often want antibiotics now because germs are bad, mmkay? Why else would we have all these alcohol-based antibiotic cleansers on the market that we see so heavily advertised on TV? Surely it’s more than marketing…

[tags]Medicine, pharmacy, antibiotics, ear infections[/tags]

I’m a firm believer that one of the most important aspects of democracy is not a given outcome of a political debate, but is instead the constant push and pull of the ideas behind a decision. The decision to make Plan B available without a prescription was a long time in coming, and I support it fully.

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]

Looks like Gardasil may be effective against more than just the four most-prevalent HPV strains (16, 18, 6, and 11): it’s showing promise against strains 31 and 45 as well.

HPV types 16 and 18, which are directly targeted by Gardasil, are responsible for 75 percent of all cervical cancer. But scientists found the vaccine also induces an antibody response capable of neutralising strains 31 and 45, which together account for another 8 to 9 percent of cases.

It makes me wonder how much mindshare (and possibly marketshare) Cervarix — the GSK competitor to Gardasil — will garner when it’s approved by the FDA. GSK is going to have to work hard to differentiate its vaccine against Gardasil. They’ll certainly have their work cut out for them, because you can bet Merck will be testing Gardasil against the remaining 34 strains of HPV (which makes up only a tiny percentage of cases) to see if it has any success there as well. If I were GSK, I’d be thinking about getting some more clinical trials going on strains that Merck isn’t playing with yet.

[tags]Medicine, pharmacy, Cervarix, Gardasil, HPV, cancer, oncology[/tags]

Medpundit’s got a good post on the marketing of Lipitor. It stands alone so I won’t quote anything here, except to re-post the comment that I left there:

Interesting post. Thanks for the analysis. It mirrors what I had suspected recently with regards to the “80mg Lipitor” reduces the risk of stroke. Emphasis on the 80mg part.

AstraZeneca did something similar with their marketing of Nexium, btw. You’ll recall that Prilosec is typically prescribed as 20mg QD. Nexium is most common as 40mg QD. A drug rep (no longer with AZ) told me that they compared the two together — only Nexium was at 40mg and Prilosec was at 20mg. Naturally that part wasn’t emphasized, and a lot of doctors were snowed by it. Hence Nexium’s evergreened, un-deserved, excessively-costly popularity.

In the case of Lipitor, I think marketing will only work for so long. It’s in the government’s interest to conduct head-to-head studies comparing the generic statins to Lipitor because it can save them money. It’s only a matter of time before this is done — and I think the results are not going to be in Pfizer’s favor, which is why I think Lipitor will largely be irrelevant by the time it loses protection in 2010.

And another comment I left on PharmaGossip about a week or so ago:

It seems likely, to me, that this study was conducted with an eye toward generic competition in the form of simvastatin. Pfizer knew Merck was their largest competitor in the statin market, and conducted this study in the hopes of finding this correlation at around this time.

Why?

In the last month, I’ve seen Express Scripts (one of the largest pharmacy PBMs) move toward making Lipitor available only with a Prior Authorization where before it was the preferred statin of choice. Several other PBMs have done the same thing.

The only exception in the case of Express? 80mg Lipitor. I think that’s why Pfizer is emphasizing the “80mg” part as much as the “Lipitor” part: the strength is just as significant (for them) as the drug itself.

My experience is anecdotal in this case — and should be taken as such — but there it is nonetheless.

I should add an addendum that I have since seen Express Scripts cover lower doses of Lipitor, and that different plans probably have different formularies. (Or doctors simply bothered to call in a PA before the patient filled the script which is equally possible.)

Yay marketing!

[tags]Medicine, pharmacy, marketing, Pfizer, Lipitor, cholesterol, statins[/tags]

My first post on bacteriophages was all a build-up to this piece of news that I found while perusing MRSA Notes.

A mix of bacteria-killing viruses may be sprayed on cold cuts, wieners and sausages to combat common microbes that kill hundreds of people a year, federal health officials ruled Friday.

The ruling, by the Food and Drug Administration, is the first approval of viruses as a food additive, said Andrew Zajac of the Office of Food Additive Safety at the agency.

[…]

The viruses, called bacteriophages, are meant to kill strains of the Listeria monocytogenes bacterium, the food agency said.

The bacterium can cause a serious infection called listeriosis, primarily in pregnant women, newborns and adults with weakened immune systems. In the United States, an estimated 2,500 people become seriously ill with listeriosis each year, according to the federal Centers for Disease Control and Prevention. Of those, 500 die.

Being bacteriophages, they don’t attack humans. I say bring ’em on.

[tags]Medicine, food, phage therapy, bacteriophages, listeria[/tags]