Scope-of-practice question for pharmacists

[wolfie]

Just curious, but what happens when you run across a prescription that would be extremely dangerous to dispense as written, you contact the doctor to point this out, and the doctor's reply is to dispense as written?

Hypothetical example: A certain narcotic is available in dosages of X, 2X, and 4X milligrams per tablet. Each tablet also contains approximately 300 milligrams of acetaminophen, regardless of the narcotic dosage. A prescription comes in for this narcotic in dosage X, to be taken as 4 tablets 4 times per day. This would result in the patient taking FAR more than the safe daily dosage of acetaminophen per day.

Since this pill would be prescribed for the narcotic content (as the other active ingredient is OTC), the doctor might not be aware of the danger. Pharmacist calls the doctor, informs them of the problem, and suggests that the prescription be changed to dosage 4X of the narcotic to be taken as 1 tablet 4 times per day. This would give the same narcotic dosage, but 1/4 the acetaminophen. Doctor refuses to make the change.

Obviously, a pharmacist can't make the change on their own. Do you dispense as written, even though this would result in a (probably) lethal dose of the acetaminophen? Do you simply return the prescription to the patient unfilled, explaining the problem, and hope the next pharmacist also catches the problem, or do you, before returning the unfilled prescription, write on it "(pharmacy name) refused to fill - as written, has unsafe dosage of acetaminophen"? Note that you're not questioning the dosage of the narcotic.

As an aside, I can see TWO reasons (neither is valid) for the doctor to insist on dispensing as written:
1) Trying to kill the patient.
2) Doctor knows (or suspects) the patient is reselling the pills. By having dosage X instead of 4X, the patient/pusher has more flexibility in selling to their clients.

[mathnerd]

I can see another reason.

My old insurance charged the same copay for a prescription regardless of the number of pills. So my cost for a prescription of X drug four times a day would be the exact same as my cost for the same drug twice a day. I might or might not have had a doctor who wrote out prescriptions for more times a day than I actually needed so I could get a larger supply at a lower cost.

[wolfie]

That one is dicey for a couple reasons: insurance fraud (sounds like the co-pay is for a month's supply, so disguising a 2-month supply as a 1-month supply to cut out a month's co-pay is fraud), and the instructions on the bottle would be WRONG.

AFAIK, the only information the pharmacist has is from the prescription itself, so he's justified in assuming the dosage is actually what the doctor intended, not a supply to be "stretched".

Also, in the example I gave, it would be a BAD IDEA for the doctor to do what you mentioned. Since this would be one of the more highly controlled medications, if it was a multi-month supply disguised as a high dose single-month supply, to the DEA it would be VERY suspicious for a doctor to prescribe a high dosage on alternate months (or every 4th month) and none on the other months on a routine basis. Considering (not a pharmacist, but based on what I've seen here and elsewhere) C2 prescriptions can only be for 1 month, with no refills, the doctor would be breaking federal law to write what's essentially a 2 (or 4) month prescription.

[mathnerd]

I didn't say it was ethical, but just another reason they might do it. And actually, in the one and only case where a doctor did that, it wasn't a controlled substance, it was a medication I take for an ongoing condition and I was broke, homeless and living in my car at the time.

[Sapphire Silk]

Hypothetical example: A certain narcotic is available in dosages of X, 2X, and 4X milligrams per tablet. Each tablet also contains approximately 300 milligrams of acetaminophen, regardless of the narcotic dosage. A prescription comes in for this narcotic in dosage X, to be taken as 4 tablets 4 times per day. This would result in the patient taking FAR more than the safe daily dosage of acetaminophen per day.

Based on your example, I see another problem: the patient is getting an overdose with each DOSE, not just per day. I'm not sure if you're in the US, but the acetaminophen content is usually either 325mg or 500mg, not 300mg.

So 4 tabs would be (using your dose) 1200mg of acetaminophen per dose, for a total of 4800mg per day if the patient took all four doses in a 24 hour period.

The maximum safe dose is 1000mg per dose, and 4000mg (4gms) per 24 hour period. The liver can't process any more; acetaminophen is actually fairly toxic to the liver.

Now, I'm not a pharmacist. As a nurse, I would refuse to administer such a dose in a hospital or clinic based setting. I would teach a patient NOT to take this drug using these instructions, to consult with the physician as to why he would ask the patient to take an overdose of acetaminophen. I'd not only not have a problem telling a patient this, it is my legal and ethical DUTY to do so. I might go up my chain of command for help as well. This hypothetical (which doesn't sound so hypothetical, otherwise why would you ask) is very dangerous.

I'm hoping Shalom will come along and tell us what a pharmacist would actually do. I'm guessing one of two things: to either refuse to dispense, or to contact the Pharmacy Board for guidance on how to handle the matter.

As an aside, I can see TWO reasons (neither is valid) for the doctor to insist on dispensing as written:
1) Trying to kill the patient.
2) Doctor knows (or suspects) the patient is reselling the pills. By having dosage X instead of 4X, the patient/pusher has more flexibility in selling to their clients.

Some doctors just don't pay attention to the acetaminophen dose, and think a "few" milligrams over the limit won't cause any harm. He's wrong.

Some doctors are just arrogant and don't think about the acetaminophen; they're thinking about the narcotic ingredient. But they don't like to be questioned.

Some doctors are involved in pill mills, so your 2nd possibility could happen. The DEA and the Medical Boards are cracking down on that kind of prescriptive behavior.

[jedimaster91]

Imaging tech here, but medical personnel in general have every right to question and even refuse to do something they reasonably think will harm the patient. In fact, it's our responsibility to do so.

I actually ran into something similar recently where we felt it was not in the patient's best interest to run a scan. We attempted to contact the ordering physician and when that didn't work, we got our supervisor involved. She reached out to other physicians who told us not to do the exam. So if the hypothetical doctor won't change the dosage knowing now that it's a dangerous amount of acetaminophen and without a medically sound reason to do it anyway* go above and/or around him. Because it would be the pharmacist's license that got yanked if/when bad things happened to that patient because his name is on the label and he didn't question it. And as always, document, document, document.

*Everything in medicine is a balance between risk and benefit. Sometimes the benefits really do outweigh the risks.

[wolfie]

Based on your example, I see another problem: the patient is getting an overdose with each DOSE, not just per day. I'm not sure if you're in the US, but the acetaminophen content is usually either 325mg or 500mg, not 300mg.

Not in the medical field, and didn't know the exact number (read it once, quite a while back), so "ballparked" it at 300.

I'm hoping Shalom will come along and tell us what a pharmacist would actually do. I'm guessing one of two things: to either refuse to dispense, or to contact the Pharmacy Board for guidance on how to handle the matter.

Some doctors just don't pay attention to the acetaminophen dose, and think a "few" milligrams over the limit won't cause any harm. He's wrong.

Some doctors are just arrogant and don't think about the acetaminophen; they're thinking about the narcotic ingredient. But they don't like to be questioned.

One of my (unstated) assumptions was that the doctor prescribing it was thinking ONLY about the narcotic content, and either didn't realize (or ignored) the fact that it also contained acetaminophen.

From what people have replied, it seems that "dispense as written" is a no-go for ethical reasons (I thought this would be the case, since it would involve KNOWINGLY supplying a dangerously high dosage of a drug). My understanding is that when a pharmacist refuses to dispense, unless it's obviously a forged prescription (I believe someone on the Student Doctor forums once mentioned a prescription for "1 pound mofine"), the pharmacist is required to return the prescription to the patient (otherwise they're "unprescribing" what the doctor had originally prescribed, which would be going outside their scope of practice). In this hypothetical case, the doctor had confirmed the dosage (when called to question the acetaminophen content), so it's clearly NOT a forged prescription.

Is this a case where the prescription would be returned "as-is" (my second option), hoping the next pharmacist would also spot the problem, or with a note added (my third option) to alert subsequent pharmacists (although this would involve marking-up the prescription, which may be a questionable practice)?

[Sapphire Silk]

There are situations where "dispense as written" is appropriate.

Technically generic drugs are the same as the brand name. But they sometimes contain different fillers that affect how the drug works in minor ways; usually it doesn't work as well or has a side effect that the brand name doesn't. Dyes used to color the tablets are an example of what I mean. In that case, the doctor will write dispense as written so the insurance company will pay for it, and so the pharmacy gives the right drug.

[Shalom]

Based on your example, I see another problem: the patient is getting an overdose with each DOSE, not just per day. I'm not sure if you're in the US, but the acetaminophen content is usually either 325mg or 500mg, not 300mg.

As it happens, they just reformulated brand-name Vicodin®, reducing the acetaminophen content from 500 mg to 300 mg per tablet. The excuse given is the new guideline which has reduced the maximum recommended dose of APAP to 3000 mg/24 hours.

They also jacked up the wholesale price from 3c/tablet to $1.13/tablet. Just a coincidence, I'm sure . . . You can still get generic old-formula Vicodin at the old price (for now, anyway), but see, the thing is, if the doctor just writes "Vicodin" without any qualifiers, you now have to dispense the 5/300 and charge the new price. I'll generally call the doctor on these and remind him that generic Norco (5/325) is still around, just as safe, and 1/10 as expensive. Never had one refuse to make that change: I'll bet most doctors who aren't pain-management specialists aren't even aware of the reformulation in the first place.

There's a really excellent rant about this here, by the way. Read the comments too. They've done this a few times, most recently with Poly-Vi-Flor, the kids' vitamin and fluoride supplement, which has been around for donkey's years and runs about $7.00 wholesale for the generic. Now they've tweaked the formula just a tad, and raised the price to $182.67. Wholesale price. I shit you not.

So 4 tabs would be (using your dose) 1200mg of acetaminophen per dose, for a total of 4800mg per day if the patient took all four doses in a 24 hour period.

The maximum safe dose is 1000mg per dose, and 4000mg (4gms) per 24 hour period. The liver can't process any more; acetaminophen is actually fairly toxic to the liver.

They've actually reduced that. See above.

Now, I'm not a pharmacist. As a nurse, I would refuse to administer such a dose in a hospital or clinic based setting. I would teach a patient NOT to take this drug using these instructions, to consult with the physician as to why he would ask the patient to take an overdose of acetaminophen. I'd not only not have a problem telling a patient this, it is my legal and ethical DUTY to do so. I might go up my chain of command for help as well. This hypothetical (which doesn't sound so hypothetical, otherwise why would you ask) is very dangerous.

I'm hoping Shalom will come along and tell us what a pharmacist would actually do. I'm guessing one of two things: to either refuse to dispense, or to contact the Pharmacy Board for guidance on how to handle the matter.

Definitely refuse to dispense. It's ultimately my responsibility, and my license. If a prescriber utters a prescription that's patently unsafe to fill, and refuses to alter it even when called on it, there's no law that says I have to fill it anyway. If he's enough of an asshole about it, and if it's a controlled substance, I might just make a phone call to the guys at the state Bureau of CS (which stands for something different in pharmacy than it does here) and ask if this guy's kosher. State Board of Pharmacy might also be an option, though I don't know if they have any authority over doctors.

Some doctors just don't pay attention to the acetaminophen dose, and think a "few" milligrams over the limit won't cause any harm. He's wrong.

Had one patient giving me a whole argument when I was trying to explain why I wasn't filling her Vic ES. I finally told her outright, "Look, my malpractice insurance isn't paying for your liver transplant!" That settled her down a bit.

Some doctors are just arrogant and don't think about the acetaminophen; they're thinking about the narcotic ingredient. But they don't like to be questioned.

Difference between G_d and a doctor: G_d doesn't think He's a doctor.

Some doctors are involved in pill mills, so your 2nd possibility could happen. The DEA and the Medical Boards are cracking down on that kind of prescriptive behavior.

Not in the medical field, and didn't know the exact number (read it once, quite a while back), so "ballparked" it at 300.

Actually hit a home run while trying to bunt. Not bad, that.

One of my (unstated) assumptions was that the doctor prescribing it was thinking ONLY about the narcotic content, and either didn't realize (or ignored) the fact that it also contained acetaminophen.

This, basically. I've seen prescribers (often dentists, for some reason) write for Vicodin ES (7.5/750), which under the old 4000mg guideline had a max daily dose of 5, and put down "1-2 tabs Q4-6h prn" (one to two tablets every four to six hours as needed). If you count it up, that comes up as a potential total of 12 tablets per day, or more than double the maximum. That WILL cause liver damage, no ifs ands or buts. I've called them on it and had them tell me "Oh, he'd never take that many!" Well maybe no, and maybe so. The fact is that the signatura on the label tells him that he can take that many.

From what people have replied, it seems that "dispense as written" is a no-go for ethical reasons (I thought this would be the case, since it would involve KNOWINGLY supplying a dangerously high dosage of a drug). My understanding is that when a pharmacist refuses to dispense, unless it's obviously a forged prescription (I believe someone on the Student Doctor forums once mentioned a prescription for "1 pound mofine"), the pharmacist is required to return the prescription to the patient (otherwise they're "unprescribing" what the doctor had originally prescribed, which would be going outside their scope of practice). In this hypothetical case, the doctor had confirmed the dosage (when called to question the acetaminophen content), so it's clearly NOT a forged prescription.

We learned in pharmacy law class (circa 1994, but I don't think it's changed) that the patient retains ownership of the physical prescription until the medication is dispensed, at which time the pharmacy becomes the owner. This is true even if it's a forgery; theoretically if I refuse to return a bogus script, I could get arrested for theft, although I'd make damned sure I had company on the way to the jailhouse. (It's called "uttering and publishing a forged instrument" or something similar.)

Is this a case where the prescription would be returned "as-is" (my second option), hoping the next pharmacist would also spot the problem, or with a note added (my third option) to alert subsequent pharmacists (although this would involve marking-up the prescription, which may be a questionable practice)?

Third option would be my choice.

There are situations where "dispense as written" is appropriate.

Technically generic drugs are the same as the brand name. But they sometimes contain different fillers that affect how the drug works in minor ways; usually it doesn't work as well or has a side effect that the brand name doesn't. Dyes used to color the tablets are an example of what I mean. In that case, the doctor will write dispense as written so the insurance company will pay for it, and so the pharmacy gives the right drug.

That's a whole different kettle of fish. "DAW" refers to the generic substitution law, which does not allow pharmacists to substitute a different chemical entity, different dosage form, or different dose. Doctors don't always understand this; I've called to ask a doctor to change a non-formulary drug to one that the insurance would pay for, and had the prescriber say "But I checked 'Substitution Permissible', why do you even have to call me?" Um, no, Doc, that's not how that works.

There are a few drugs where the generic chosen does make a difference. Mostly these are in the neuro/psych fields (Wellbutrin XL is notorious for this; there are several different generics and from what I've read in the lay blogosphere they might as well be different drugs, and each one has its champions. Antiepileptics also have their partisans, and I've had many patients over the years swear that if their Fioricet wasn't blue/Darvocet wasn't pink it wouldn't work, regardless of which manufacturer actually made the tablet. I personally found that one particular generic of atenolol just plain did not work for me, but it might just have been from a defective lot.) You can theoretically write "DAW" on a generic, but unless you put a specific manufacturer's name down, all that will happen is that the pharmacist will laugh at you and dispense what s/he would have done anyway.

That one is dicey for a couple reasons: insurance fraud (sounds like the co-pay is for a month's supply, so disguising a 2-month supply as a 1-month supply to cut out a month's co-pay is fraud), and the instructions on the bottle would be WRONG.

I've discussed this with one neurologist, as it happens. He likes to write for 6 ml daily of Quillivant (basically Ritalin-LA in a liquid form) and then tell the patient to take only 4ml. This means a theoretical 30 day supply will last 45, or more if you don't take it on non-school days. He says it's to allow for increasing the dose if warranted, but thus far the patient's been doing OK on the 4ml.

AFAIK, the only information the pharmacist has is from the prescription itself, so he's justified in assuming the dosage is actually what the doctor intended, not a supply to be "stretched".

Also, in the example I gave, it would be a BAD IDEA for the doctor to do what you mentioned. Since this would be one of the more highly controlled medications, if it was a multi-month supply disguised as a high dose single-month supply, to the DEA it would be VERY suspicious for a doctor to prescribe a high dosage on alternate months (or every 4th month) and none on the other months on a routine basis. Considering (not a pharmacist, but based on what I've seen here and elsewhere) C2 prescriptions can only be for 1 month, with no refills, the doctor would be breaking federal law to write what's essentially a 2 (or 4) month prescription.

Depends what state you're in. Federal law allows for up to a 3 month supply on controlled substances, including C-II, for any of five medical conditions, and up to 6 months for anabolic steroids, provided that a diagnosis is written on the face of the prescription. It is also acceptable to write "CODE A" through "CODE F" in lieu of a diagnosis. The list is here if you'd like to look.

State law can override this, though. Whereas New York State allows 90-day prescribing, Jersey does not, no way no how. 30 days or nothing. Also, if your insurance only allows you to get 30 days at a shot, then you're screwed, because C-II's can't be refilled, so you need a new script for the last 60 days worth.

Sorry, that got longer than I expected. I gotta go to bed now, driving carpool in (looks at clock) 5-1/2 hours. Holy crap.

[Sapphire Silk]

Thanks for the clarification, Shalom. That helps a lot.

The "1 lb mofine" story is mine. I posted it here quite awhile ago; it happened to a doctor I knew in California. A woman stole his prescription pad and wrote a script for "1 pound mofine stat."

The pharmacy called the police and she was arrested. The prescription went into evidence, and the prescription pad was recovered.