Comments on: AMA Reaffirms The Right To Off-Label Prescribing

By: Hank

Hank — Mon, 14 Jan 2008 18:24:00 +0000

Thanks to folks re: off-label use question. Those are roughly the stats I was imagining, and with the qualifications and provisos you included.

At the (risk/certainty) of stretching a point, perhaps there is a parallel between who can contribute to discussions like this and “off-label” use. Having “official” degrees, training, and experience is obviously tremendously useful for certain aspects of certain topics. Consumers as stakeholders can also bring a variety of “off-label” expertises - political, experiential, activist-grounded knowledge, etc. - to the table.

It seems to me important on all sides (1) not to pretend to know more than one does, (2) to acknowledge fallibility (i.e., non-omniscience)_whatever_ one’s background, (3) to aim toward learning from, or appropriately correcting, each other rather than knee-jerk dissing.

Again, on all sides.

By: TOdd

TOdd — Mon, 14 Jan 2008 16:27:45 +0000

Lisa, let’s exchange education. You first….

Any college at all, HS diploma, a JUCO class or two?

By: Bob Freeman

Bob Freeman — Mon, 14 Jan 2008 15:36:42 +0000

Hank and Atlex, I agree it’s hard to get an accurate figure because diagnosis does not appear on the prescription and it’s not always clear if it’s off-label.

However, fairly reliable data I have seen suggests that oncology drugs’ off-label use is as high as 70-75%. Is that bad medicine? absolutely not in my opinion especially in advance stages (III and IV).

By: Lori

Lori — Mon, 14 Jan 2008 13:03:59 +0000

Hank -
This figure is very difficult to track at the industry level. Most of these estimates are done at the drug or class level. Some products have almost all off-label usage; others have negligible or no off-label usage. I have worked on a couple of different products where off-label use was 50-60%.
The other consideration about off-label usage is that it is not all the same in terms of risk and safety. As I am sure you are aware, some off-label prescribing causes major health concerns while other off-label use is considered standard practice.

By: Atlex

Atlex — Mon, 14 Jan 2008 12:42:17 +0000

Hank, it’s hard to know what percent of scripts are “off-label” for a couple of reasons. First, and foremost, scripts typically are not attached to diagnoses and must be linked back to diagnosis via database analysis. Most such analyses suggest off-label use of 50% or more However, that’s somewhat misleading. The vast majority of off-label use is for treatments that have been readily accepted into the medical community. Typically, these indications are in the medical literature or in medical compendia.

Strayze’s issue must be that his condition is not listed in a medical compendium; otherwise, his medication would be reimbursable by Medicare Part D.

By: Hank

Hank — Mon, 14 Jan 2008 05:40:03 +0000

Anyone know what percentage of ’scripts are off-label? It’s got to be very high.

By: Lisa Van S

Lisa Van S — Mon, 14 Jan 2008 02:36:31 +0000

Todd,

Have an R.N. behind your name? 17 Years ago an R.N. saved the life of my son who could have died from Kawasaki’s Disease, a Disease that went undiagnosed by several Physicians, who appeared quite baffled by the symptoms of this rare, but potentially life threatening Disease. What would Docs do without Nurses, who have, and will continue to save their “BUTTS”

Some times,… Some things,.. are better left unsaid!!…

By: TOdd

TOdd — Mon, 14 Jan 2008 02:08:00 +0000

strayze, your story definitely is the poster for why this is wrong. And I am with you 90% of the way. But if this is a true story, all it takes is 2 clinical trials and then there is really no way that anyone would turn down a prior auth. Also contact the manufacturer about PAP.

But I get the point, off label prescribing is the world we live in. Plain and simple.

So Ken you don’t trust someone who went to school for 11 years, but you would rather rely on your 2 year community college RN? You didn’t have to take logic at the JUCO did you? Arrogance is thinking the guy you take orders from all day knows less than you.

By: Bob Freeman

Bob Freeman — Sun, 13 Jan 2008 22:15:23 +0000

Strayze, your plight is difficult and reflects fact that private and public programs are resistant to cover “experimental” therapies. One of the problems is, of course, rare conditions are not profitable for companies to pursue. The other is due to the fact it takes time for studies to be presented and published in the medical literature–If you can cite studies that goes a long way to establish that the prescribing is appropriate, not experimental. In other words it’s not just the labeling that’s considered but the total body of knowledge surrounding the disease and the drug’s use.

By: strayze

strayze — Sun, 13 Jan 2008 20:35:55 +0000

My life depends upon off-label prescribing, for I have a
rapidly progressive rare and fatal disease. It is not
possible to test drugs for rare conditions for there is
not a statistically suitable patient base. In addn the
speed of decline leaves no room. My drug is not substi-
tutable with another drug. The kicker is that Medicare
D does not allow off-label prescribing. That means that
I’m a dead duck. There are no drug plans that are not
based upon the deadly Medicare D. That leaves me with a
$34,000 drug bill every year. All “help with drug costs”
plans, as well meaning as they are, cannot help with my
off-label drug because of Medicare regs.