Me and my meds

UPDATED August 30, 2008: I'm getting a lot of hits on this post from people looking for info about the hyoscyamine/Levsin shortage. The best I can offer (aside from my rambling story time post below which does actually have some useful information) is a more recently updated but still not very heartening bulletin from "The American Society of Health-System Pharmacists", full text at link & excerpt immediately below. If you have any more elucidating information about what's going on with this drug, please pass it along in a comment!
Hyoscyamine Tablet
25 August 2008
Products Affected - Description
Hyoscyamine sulfate, Alaven
Levsin 0.125 mg sublingual tablet, package of 100 (NDC 68220-0113-10)
Levsin 0.125 mg sublingual tablet, package of 500 (NDC 68220-0113-50)
Levbid 0.375 mg extended-release tablet, package of 100 (NDC 00091-3538-01)
Levbid 0.375 mg extended-release tablet, package of 500 (NDC 00091-3538-05)

Hyoscyamine sulfate, Capellon
Symax Fastabs 0.125 mg orally disintegrating tablet (NDC 64543-0114-01)
Symax SR 0.375 mg extended-release tablet (NDC 64543-0112-01)
Symax SL 0.125 mg sublingual tablet (NDC 64543-0111-01)

Hyoscyamine sulfate, Ethex
0.125 mg orally-disintegrating tablet (NDC 58177-0423-04)
0.125 mg tablet (NDC 58177-0274-04)
0.125 mg sublingual tablet (NDC 58177-0255-04) - discontinued
0.375 mg extended-release tablet (NDC 58177-0237-04)

Reason for the Shortage
* Multiple manufacturers (Actavis, Major, Ascher, Alphagen, Qualitest, Teva, Kremers Urban, Excellium, UCB Pharma) have discontinued their hyoscyamine products. All hyoscyamine products are unapproved.
* The manufacturer of Ethex brand hyoscyamine products (KV Pharmaceuticals) had multiple unapproved products, including hyoscyamine, seized and destroyed by FDA on July 30, 2008.



Some weeks ago, I had an appointment at my GI doc's office. My gut had been more or less stable for over a year - as measured by weight and nutritional status as well as quality of life issues like number of bowel movements a day and level and frequency of pain. For me, I use the latter two as predictors of likely impact on the former. There's a very tight and strong correlation if you map the symptoms and signs out over time (greater than a month I'd say). A few months ago, the gut cramps started getting routinely worse. My toilet time was increasing as well. I put off making an appointment, hoping this was just a bump. But when the pain and frequency got bad enough that they were affecting my job attendance (tardy because I kept having to return to the bathroom in the AM) and performance (alternately spaced and cranky from pain), I made the appointment.

I told the GI nurse practitioner I saw that I had already increased my hyoscyamine and was taking about 4 pills a day. I made sure to communicate that I can take more and am OK with taking more but I'd need a script written for more since my primary screwed it up last time they called it in. Also, I was very clear with the GI nurse that I thought this change in severity and frequency of my symptoms was something to attend to not simply for relief of these symptoms but for reassessment. This is something I've had a hard time communicating to doctors, particularly GI doctors, in the past. Maybe there's something I don't know, like maybe it's normal (as in common, innocuous, and expected) for people with hyperactive guts (for lack of a better term) to become desensitized to their meds and require periodic increases or changes. But so far, no one has sat me down and explained that. Also, if anyone were to try, they'd have to do a lot of explaining because quality of life issues aside, I simply won't accept that it's innocuous for someone whose appetite and activity level are relatively stable to become clinically malnourished every 18 months.

GI nurse was agreeable. She's up for a reassessment, starting unfortunately with a colonscopy, of course. This office has wanted to do one since last Fall and I put them off once already*. I agreed to one this August but with the understanding that if it's negative, we at least consider looking at the small bowel and discuss vasculitis as well (steroids made my gut feel mmm-mmm good).

In the meantime, she told me she'd write me a script for something other than hyoscyamine, partly to give me something stronger for the worsening symptoms and partly because her patients were reporting problems with hyoscyamine distribution. Indeed, I had just been told at my pharmacy that I couldn't have my script refilled. I find if somewhat disheartening that the pharmacist didn't know (or seem to care at all) why there was no hyoscyamine to be gotten.

A bit of research has turned up the following information about the hyoscyamine shortage:
From the Cleveland Clinic Pharmacotherapy Update (full text is on the last page of this PDF document)
In June 2006, the Food and Drug Administration (FDA) made their Unapproved Drug Initiative a top priority (See Pharmacotherapy Update newsletter May/June 2007). This initiative was established to emphasize the FDA’s commitment to providing consumers with safe and effective medications.

All hyoscyamine (Levsin®, Levbid®) products are considered to be unapproved by the FDA. These products were on the market prior to the FDA’s approval process that establishes safety and efficacy. Although the FDA has not taken action against any of the manufacturers of hyoscyamine, many manufacturers have voluntarily withdrawn their product(s) from the market to avoid a potential review by the FDA. This has resulted in an unexpected increase in demand on some companies, and thereby creates a shortage for the remaining products.

And so I left my GI doctor's office with a script for some good old fashioned donnatal . Ever had donnatal? If you're a doctor who prescribes it or who believes the donnatal cocktail is a suitable substitute for the more simple but similar drug hyoscyamine/Levsin, you should try it. Seriously. I suggest this because apparently doctors think ingesting belladonna with a side of barbiturate is as innocuous as sniffing a daisy on a summer day but woah mama, let me tell you, it's not. Why do I call it a cocktail? Because here's what's in it: A pinch of Hyoscyamine sulfate, a dash of atropine sulfate, a whisper of scopolamine hydrobromide, and a liberal splash of phenobarbital. I do believe it's the last one which does me in, taking a toll on my ability to do things like walk and talk. I've had it before, once, in college. It is not a functional medication for me. That is, it leaves me stuporous and trippy, which is not exactly the goal in medicating my pain and frequency since both non-treatment and treatment with donnatal have the same outcome of lost productivity.

For the past few weeks, I let the Donnatal script sit in my drawer unfilled while I whittled down the plain ol'hyoscyamine-sl tablets left in my bottle. And while I was counting them (6 left), I discovered a nasty little bit of information. My script is for one pill three times a day, as needed. This is not exactly right, and the reason for it is the result of my new (as of this year) primary care doctor's office having communication problems. What I had been on was 1-2 tablets 3 to 4 times a day. I hadn't been taking it that much when my new primary refilled it with the scanty 1 tab TID order so although I noticed they called it in short, I didn't make a fuss about it at the time. Now that I was in greater need and looking over the information on the bottle, I realized that by my reckoning, 1 tab TID should equal 90 pills for a month's prescription. On my bottle it said "60 pills". WTF?

I took out my other pill bottles and noticed similar shortcomings. Ok, it must be the PRN aspect, I figured. I took out even more pill bottles (I have a lot of pill bottles folks), finally getting to the Donnatal which was written for 1 tablet four times a day. Note that this is not a PRN order. How many pills should I have for a month's supply then? 120, right? Not 80? No, definitely not 80. So why does the bottle say 80? Again I say, WTF?

I called the pharmacy today and asked them to look up how many pills they recorded the order being for. In each case, the number the pharmacy said my doctors' wrote for was less than what you'd get if you did some math. Here's what the doctors apparently wrote for.
Celebrex 1 tablet BID (PRN) = 30 tablets (not 60).
Hyoscyamine 1 tablet TID (PRN) = 60 tablets (not 90).
And lastly, Donnatal 1 tablet QID = 80 tablets (not 120).

I called the docs to ask "How do you guys calculate how many pills to write for on a script?" and referenced the particular script. Here's what they had to say:
- PCP: Er, I'm not sure. I guess I can ask someone.
- PCP call back: Um, we don't know. It depends on how long the patient needs to take it for and how long the patient's been taking it for...(I've been taking this med for years, I tell them). Also, uh, it depends on the patient. It's not that important though. (I explain that actually it is because I got a scant refill and then they ran out and now I'm taking a drug that is addictive and unpleasant - I believe in feedback).
- GYN: Hang on, let me get your chart. Ok, written on July 07, no number of pills recorded. Sorry, sometimes we just don't put down that much information. Here's the refill in January...by...oh, by me. I called it in for 30 pills with six refills, sorry about that - if you need anything at all, let me know, alright?
- GI: still waiting. The message I left actually was regarding wanting off the Donnatal. I mentioned Bentyl, and said the Donnatal was too sedating and I can't take it on a routine basis. I'll hit them with the "how many pills do you write for when you write a script" question when they call back.

Why do I care? This isn't just nitpicking folks. There's a real practical side to my asking about this for the PRNs and not. But for the sake of argument, consider a PRN med, like the Celebrex. I take on average one pill every two or so days. But if the weather's bad and my joints are killing, I take more. If I have a higher than normal activity week, I take more. If I have a bad period, I take more. If one of the ovarian cysts rears up and hits me with weeks long pain, I take more. If some combination of these factors occurs in a given month, I will be taking it BID most days, and 30 pills 15 days worth at that dose. So in sum, I have to plan to have as much on hand as I might need because I can't predict when I will need to take the BID every day dose and when I might be able to skip it. Therefore, if I need to make a point of saying "hey can you write that for Y pills please?" (where Y = daily maximum x 30 days), I will. But I need to know that I have to ask.

And why am I blogging about it? Aside from letting you know that Donnatal is not a mild drug, my point in writing this today is to share my experiences in a subtle little bit of patient advocacy/communication with you. If you're a provider, you might want to consider it a caution in assumption. Write for what your patient takes. If you really do know the patient well, sure, you can assume more or less safely that you know what the patient's needs are. But if you don't know the patient that well, why not ask? If you're a patient, look at the script carefully. Do the math. Ask for clarification and correction of even what seems like a small error or discrepancy in your meds and med orders. These little things can add up. For me, they add up to less than ideally managed symptoms. There's a financial consequence as well in terms of more frequent refills.

* = I'm thinking there should be some kind of frequent flier program for scopes. Maybe like those cards they have at coffee shops, where you get it stamped or punched each time you go and eventually you get a free coffee or a coffee upgrade. If I'd been stamping since my first ever endoscopy, I'm fairly certain I'd have a free angiogram by now.