Prescribing drugs for off-label uses

[cool_vkb]

I read that prescribing a drug for off label use is legal and nearly 40% prescriptions are for offlabel uses and 75%-80% in peds, cancer & psychiatric patients.

How does this works and is there any authority that can challenge the judgement of the physician when he/she prescribes a drug to use its offlabel advanatges.

PS: Please respond only if you have answer. I dont want to lose my question in the midst of useless arguments.

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[PharmD/DPM]

It is legal to prescribe off-label use. The whole thing about label/off-label use is for what was a drug approved for by the FDA. This stems from what tests the drug companies did to get an indication for use for a particular drug. Most drugs will work for many disorders and help pt's with many problems, but certainly a drug company will not spend the ten's of millions of dollars to get every indication under the sun for its drug. All a LABEL usage means is that a drug went through testing for that particular problem with the FDA to get the FDA's seal of approval. Their are of course many many drugs that work safe and effectively for off-label use. Also for peds, the reason most peds drugs (~90%) are off-label is that there is NO WAY the FDA will allow drug testing and research be performed on children. It's too much of a liability and risk. That's why most peds drugs are weight based and extrapolated from adults. So, as physician we can prescribe off-labeled drugs, the big thing is if the pt's insurance will cover that drug for your indication, that's the problem that we get into, INSURANCES, NOT LEGALITIES! Also, if a pharmacist notices inappropriate off-label drug prescribing, he/she can deny a physician that drug to be prescribed (eg. Podiatrist prescribing asthma inhaler. LEGALLY he could because he has a DEA with full prescribing privileges, but ETHICALLY a pharmacist may deny the Rx because the drug is not in the physician's scope).

 

[Aznfarmerboi]

I read that prescribing a drug for off label use is legal and nearly 40% prescriptions are for offlabel uses and 75%-80% in peds, cancer & psychiatric patients.

How does this works and is there any authority that can challenge the judgement of the physician when he/she prescribes a drug to use its offlabel advanatges.

PS: Please respond only if you have answer. I dont want to lose my question in the midst of useless arguments.

A drug can legally prescribed for off label uses. However, it has to be used within a standard of care limit (ie documented with good evidence behind it based on how it was used in literature, and within guideline recommendations).

PS. It is illegal for drug companies to promote off label uses though.

 

[diabeticfootdr]

It is legal to prescribe off-label use. The whole thing about label/off-label use is for what was a drug approved for by the FDA. This stems from what tests the drug companies did to get an indication for use for a particular drug. Most drugs will work for many disorders and help pt's with many problems, but certainly a drug company will not spend the ten's of millions of dollars to get every indication under the sun for its drug. All a LABEL usage means is that a drug went through testing for that particular problem with the FDA to get the FDA's seal of approval. Their are of course many many drugs that work safe and effectively for off-label use. Also for peds, the reason most peds drugs (~90%) are off-label is that there is NO WAY the FDA will allow drug testing and research be performed on children. It's too much of a liability and risk. That's why most peds drugs are weight based and extrapolated from adults. So, as physician we can prescribe off-labeled drugs, the big thing is if the pt's insurance will cover that drug for your indication, that's the problem that we get into, INSURANCES, NOT LEGALITIES! Also, if a pharmacist notices inappropriate off-label drug prescribing, he/she can deny a physician that drug to be prescribed (eg. Podiatrist prescribing asthma inhaler. LEGALLY he could because he has a DEA with full prescribing privileges, but ETHICALLY a pharmacist may deny the Rx because the drug is not in the physician's scope).

I see you're also a PharmD and a DPM, so perhaps your responses might be more reasoned than some of the PharmDs who troll here to enact their Pharmacy Imperialism.

I have always wondered/thought .... how does a pharmacist know what is the indication of the drug that is prescribed. What if a DPM uses a drug like an albuterol MDI for a reason that might be in the scope of practice (as farfetched as that might be - but for the sake of argument)?

1. How would a pharmacist know this without calling the prescribing physician? (doctors do not, nor are they required to - write the indication on the prescription so the pharmacist can double check if they think it's a reasonable medication for the indication suggested)

2. Why do pharmacists feel like they're the "scope of practice police"? Isn't the state board of podiatry the scope of practice police and if a valid prescription is presented to a pharmacist shouldn't they FILL it, then file a complaint with the state board if they feel it is out of scope?

I commonly write discharge prescriptions for all the patients discharged from my inpatient care. Many of these include new medications from I-Med consults who write .. "begin atenolol 100 mg BID, F/U with me in 2 weeks." I write 1 month supply of any discharge medication -- as it is hospital protocol that the discharging attending manage all the discharge medications. I've never been called about one, but I wonder if the "scope of practice" police think it's out of scope (even though it was under the direction of an MD) and don't fill it without letting anyone know???

 

[PharmD/DPM]

diabeticfootdr,

You are absolutely correct about your Rx writing! I too, as a resident at a major teaching institution discharge pt's on everything from BP to migraine to GI drugs. Yes, I've never gotten either questioned nor have I heard of any of my co-residents being questioned. Here in Pennsylvania, we need to have our DEA's before residency, so we write our own Rx's out, because we need to with the huge co-morbidity population of our admitting podiatric surgical service. But, going back, when I worked as a full-time pharmacist for 1 year between pharmacy and pod medical school, not once did I call up a podiatrist or any physician for that matter and question his authority on a prescription. You just don't do that! Unless, you see something possibly dangerous for the pt. But remember, a physican is a physician and a pharmacist is a pharmacist. Big difference that we can not forget.

 

[Aznfarmerboi]

I see you're also a PharmD and a DPM, so perhaps your responses might be more reasoned than some of the PharmDs who troll here to enact their Pharmacy Imperialism.

I have always wondered/thought .... how does a pharmacist know what is the indication of the drug that is prescribed. What if a DPM uses a drug like an albuterol MDI for a reason that might be in the scope of practice (as farfetched as that might be - but for the sake of argument)?

1. How would a pharmacist know this without calling the prescribing physician? (doctors do not, nor are they required to - write the indication on the prescription so the pharmacist can double check if they think it's a reasonable medication for the indication suggested)

2. Why do pharmacists feel like they're the "scope of practice police"? Isn't the state board of podiatry the scope of practice police and if a valid prescription is presented to a pharmacist shouldn't they FILL it, then file a complaint with the state board if they feel it is out of scope?

I commonly write discharge prescriptions for all the patients discharged from my inpatient care. Many of these include new medications from I-Med consults who write .. "begin atenolol 100 mg BID, F/U with me in 2 weeks." I write 1 month supply of any discharge medication -- as it is hospital protocol that the discharging attending manage all the discharge medications. I've never been called about one, but I wonder if the "scope of practice" police think it's out of scope (even though it was under the direction of an MD) and don't fill it without letting anyone know???

I am going to try to explain it to the best of my ability without bringing up points from the other thread so that this thread wont turn into a debate.

1. A pharmacist does not know what indication the prescription is written for. Hence most pharmacists will accept a prescription without questioning you. There are exceptions such as controlled RXs.

2. Pharmacist are not the scope of practice police. That belongs to the different boards presiding over each practice.

The answer to the second part of the question is no. The reason for this is

1. Most Boards of Pharmacy would penalize the pharmacist for filling a prescription where they do not believe it was proper to fill in the first place. For example, A pharmacist filling a questionable narc script and then reporting it to the board will get into big trouble.

and 2. Even if the Board of Pharmacy is fine with it, the insurance might not be. When audited, it can result in the loss of $$$. I was at one store where they were fined closed to a million dollars. A good percentage of those scripts were lost due to invalid prescribers.

We were taught that for most scripts, verify it with the prescriber first. If it is okay, document and fill it. But....., keep in mind another thing. Most pharmacists are really busy. This means that if they believe it is way out of line, it is better for them to give the prescription back. It is better that way because calling a physcian might take 5 minutes + that they dont have. Sometimes the physician might not even be in. This pisses off the patient because they are always in a rush and will start arguing to get it, and thus disrupting my pharmacy and potentially harrassing my staff. On the other hand if we do accept it, then we dont have that documentation and worth losing a lot of money from the drug cost. Hence the best thing to do is to turn it down and tell them to go to another pharmacy. If I tell them we dont have the drug in stock, they wont argue with me and everybody goes on with their normal lives. Pharmacies do have a legal right to refuse prescriptions provided that there are other pharmacies around.

That is why a lot of times, we dont bother reporting fake narc prescriptions too. It all comes down to business. Heck, just giving you guys a phonecall can take 5 minutes that we dont get paid for. Most part D plans for example gives us a 2 dollar dispensing fee maybe. A loss considering that calling you guys would cost us 5 minutes from the pharmacist wage alone.

If pharmacists have to fill every prescription, then we do not need 6 years of training min. Pharmacy technicians can take our job. A pity that I get paid 120k just to count pills. . .