FDA medication guides
Fairlight
fairlite at fairlite.com
Mon Dec 12 09:54:05 PST 2005
On Mon, Dec 12, 2005 at 12:03:06PM -0500, Don Coleman, the prominent pundit,
witicized:
> Bob:
>
> The guide for each med in each class will be identical except for the
> limited patient & drug info to be shown at the top. FDA is requiring each
> patient to receive a separate guide for each of the appropriate drugs. So
> if the patient is taking three med's which qualify in a particular class
> that patient must receive three copies (one for each med) each time that
> prescription is filled. The unfortunate thing is that 99.9% of these sheets
> will be thrown away as soon as the shipment is opened. The only reason for
> doing this is FDA rules and liability issues.
First, it's about damned time the FDA mandated this. They -need- to
mandate -more-. You have -no- idea how many people are entirely unaware
of contraindications of even the simplest things--like taking SSRI's with
decongestants. Having been on that roller coaster myself once (you have no
idea just how bad that reaction can be unless you've done it), I can say I
wish they'd give out the -full- monograms with the prescriptions, not some
watered down pablum that they've likely derived. You can -never- be too
educated about what you're taking. They're mandating it for the reasons
you say, but if there's any saving grace, they -might- stem some of the
mass ignorance that has plagued the patient community for decades.
And, as I say, whatever watered down pablum they've cooked up is exactly
what people will get, based on your description. I -know- they're not
providing even close to the full monogram. We hand-transcribed about
twelve of those back in '94-2000 for a web site I ran, and they took hours
each to transcribe, even at 114wpm speeds. So I know they're not even
coming close. Let's just hope they include the important stuff.
Now if they'd start mandating it for dietary supplements. There's
something intrinsically wrong with people taking SSRI's while concurrently
taking a dietary supplement out of desperation that acts both as an SSRI
-and- as an MAOI to begin with--but it's definitely insane whle taking
another SSRI. I'm still wondering when someone's going to get themselves
killed trying something that stupid. They need to do more for OTC's as
well.
Sorry, hot-button subject with me. I've -seen- the ignorance of tens of
thousands of patients, combined with the desperation of many of those
patients, over the course of six years of my life spent trying to help a
community. The combination of ignorance and desperation couldn't have
-enough- information fired at it to stem an accident waiting to happen.
For someone to say it's basically a load of beaurocratic nonsense that
shouldn't be enacted goes against pretty much everything I believe about
being an educated patient. What they're doing actually falls far short of
being enough, IMNSHO.
Now then...
As for how to do it programmatically, if it were a full monogram, I'd do it
externally for sure--they're too damned long. If it's just a single page
summary as you say, I'd probably do it in fP as a form and just have done.
mark->
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