Who is responsible manufacturer or pharmacist for wrong concentration of carbamazepine?

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WP Fan - 19 Mar 2004 16:46 GMT

Who is responsible manufacturer or pharmacist for wrong concentration
of carbamazepine, the manufacturer or pharmacy?

Background: Elderly lady takes carbamezapine / tegretol in liquid
form to prevent siezures after a stroke. Lab report shows that
concentration was 353 ml/ 5 ml (teaspoon). Correct concentration
should be 100 ml/5 ml.. Overdosage causes coma.

Pharmacy says that it received the medication in ?stock bottles?from
manufacturer (Taro) with which it filled the prescription.

Does anyone know what the procedures that a pharmacy must follow after
it receives the carbamaepine from the manufacturer in stock bottle?
(Does pharmacy merely add a specified amount of water to the
medication that is in the bottle? Or does pharmacy have other
responsibilities? What exactly is a ?stock bottle??

Does anyone know if FDA has taken any action regarding carbamezapine /
tegretol (warnings or instructions to consumers, labeling,
manufacture, marketing, or dispensation)?

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CJ - 20 Mar 2004 08:13 GMT

Tegretol suspension is premixed so the pharmacist probably had nothing to do
with this error in terms of reconstituting at the wrong concentration.
Something doesn't seem right to me though--A drug company doesn't just send
out a batch that is 4 times too potent.
cjrph

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rxempress - 22 Mar 2004 17:11 GMT

Because Carbamazepine is a suspension it must be shook well before each use.
If not ... the concentration at the bottom of the bottle is going to be
much higher than the concentration at the top of the bottle.

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P T - 22 Mar 2004 19:08 GMT

Suspensions (especially pre-mixed as opposed to reconstituted) are a
pain in the a.s. I floated a lot for Wag, and now work in a hospital
with many techs, so I usually don't know the skill of the techs. About 5
years ago, early in my career, I had an experience that confirmed the
old maxim that if something CAN go wrong, something WILL go wrong.

We had a prescription that required dispensing about a L of Carafate
suspension. The tech poured two or more of the manufacturer's bottles
into our pharmacy bottles. I asked it they shook it, and they said Yes.
Just for fun, I checked the stock bottles, now in the trash. At the
bottom of each bottle was a fat layer of sucralfate, a half inch to an
inch.

Of course, Carafate is an especially nasty suspension, but I fear that
techs frequently do not shake enough.

And how do you shake the first pour in a new bottle of Bactrim
suspension? Maybe pharmacy is half part science and half part art.

Pete
"Whole lot of shaking goin' on"

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Jonathan Smith - 23 Mar 2004 01:30 GMT

> Tegretol suspension is premixed so the pharmacist probably had nothing to do
> with this error in terms of reconstituting at the wrong concentration.
> Something doesn't seem right to me though--A drug company doesn't just send
> out a batch that is 4 times too potent.
> cjrph

The OP listed Taro Pharmaceuticals as the manufacturer. This is a
generic manufacturer of an "equivalent" of Tegretol made by Novartis.

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CJ - 23 Mar 2004 03:17 GMT

That doesn't make a bit of difference as both are available the same way and
ab rated. Rxempress's theory is a good one and would probably be my guess
as well.
cj

> > Tegretol suspension is premixed so the pharmacist probably had nothing to do
> > with this error in terms of reconstituting at the wrong concentration.
[quoted text clipped - 4 lines]
> The OP listed Taro Pharmaceuticals as the manufacturer. This is a
> generic manufacturer of an "equivalent" of Tegretol made by Novartis.

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