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FDA Tries to Stem Drug Mix-Ups

By LAURAN NEERGAARD

..c The Associated Press

WASHINGTON (AP) - The epilepsy drug Lamictal looks and sounds too much like

the antifungal pill Lamisil. How much? At least 22 times, pharmacies have

confused the names and dispensed the wrong drug - causing three people to

suffer seizures, says the government's third warning in as many years about

the problem pair.

Mix-ups with look-alike or sound-alike drug names are a major source of

medication-caused injuries and deaths. Now the Food and Drug Administration

is pushing some eye-catching changes to try to stem confusion.

Expect the labels of more than 30 medications soon to list their names in a

mix of upper- and lowercase and different-colored letters. The hope is that

putting, for example, the ``-ictal'' part of Lamictal in red italics will

get pharmacists' attention so they don't grab the wrong bottle.

For the first time, FDA workers also are literally testing potential

confusion about a new drug name before it hits the market. They scribble out

fake prescriptions for 120 volunteer doctors, nurses and pharmacists to

read. So far, confusion has caused about a third of the brand names

manufacturers want to use to be rejected.

The changes are long overdue, say excited drug-safety experts.

``They're getting away from blaming pharmacists, nurses, doctors and

patients from not reading the names properly and making it easier for them

to read it properly,'' says Cohen of the nonprofit Institute for

Safe Medication Practices.

Yet consumers still must protect themselves, he cautions, by checking their

own prescriptions carefully and questioning the pharmacist.

More than 1,000 U.S. drugs have names so similar that health workers can get

them confused. It's easy to mistake a doctor's scribble or blurry faxed

prescription for the wrong drug, or for a hurried pharmacist faced with

alphabetized bottles on a shelf to simply grab the wrong one.

An estimated 1.3 million Americans are injured each year from medication

errors, such as administering the wrong dose or wrong drug. Nobody knows how

many injuries are caused by drug name mix-ups, although some studies suggest

name confusion is to blame for 30 percent.

A new FDA study of 400 deaths caused by medication errors found 16 percent

were due to name mix-ups; only the wrong dose was a bigger culprit.

The FDA's pre-Christmas warning about Lamictal and Lamisil is just the

latest example of a problem pair. Some others getting attention: Sarafem -

the alias used to market Prozac for severe premenstrual symptoms - and

Serophene, an infertility drug. The schizophrenia drug Zyprexa and the

antihistamine Zyrtec. The anti-depressant Serzone and anti-psychotic

Seroquel.

One of the worst mix-ups came about a year ago, when a diabetic died after

getting the tranquilizer chlorpromazine instead of the diabetes medicine

chlorpropamide.

That death was a final straw, says Jerry , FDA's chief of medication

error prevention.

FDA had long issued warnings about drug mix-ups, and only very rarely forced

a company to rename an already sold drug.

Now the agency tried a novel approach, issuing 142 letters to makers of more

than 30 medications ordering label changes to highlight confusing names.

Pharmacists soon should see ``ChlorproMAZINE'' and ``ChlorproPAMIDE'' on

bottles, for example. Special shading and different-colored letters also

will help distinguish look-alikes.

That's in addition to pre-marketing simulations to weed out confusing brand

names before they begin selling.

Will such steps work? It's too soon to know, although Lamictal may be a good

test case, says.

Lamictal maker GlaxoKline even took an extra step, issuing pharmacies

an attention-grabbing card called a ``shelf-shouter'' that Cohen says may

also stop pharmacists from grabbing the wrong bottle.

Regardless of those actions, there are critical steps consumers should take

to guard themselves against mix-ups, Cohen says:

Ask the doctor to write the reason for the medicine right on your

prescription. A pharmacist who reads ``for epilepsy'' is less likely to

interpret the doctor's scribble as Lamisil instead of Lamictal.

Always talk to the pharmacist about a new prescription - don't simply sign

those clipboards store clerks hand over that waive your right to counseling.

``If you know what the medicine is for and the pharmacist tells you

something different, that's a red flag he may have misread the

prescription,'' Cohen says.

And never hesitate to question if pills look different than you remember

them.

EDITOR'S NOTE - n Neergaard covers health and medicine for The

Associated Press in Washington.

On the Net:

FDA drug errors information:

http://www.fda.gov/cder/drug/MedErrors/default.htm

Institute for Safe Medication Practices: http://www.ismp.org