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U.S. Department of Health and Human Services

Show #35, January 2005

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Show #35, January 2005

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 Recalls and Safety Alerts

January2005FDA Patient Safety News Homepage
Recall of Access Cardiosystems Defibrillators (Video, print, and e-mail functions)
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Access Cardiosystems, Inc. has recalled some of its automated external defibrillators because of two potentially serious problems. In some of the units, the shock delivery circuit can fail, so that the defibrillator can’t deliver a shock. Units that may be subject to this kind of failure have serial numbers from 075690 to 077140.

In other units, the defibrillator can unexpectedly turn itself on and then can’t be turned off. Units that may be subject to this kind of failure have serial numbers from 075180 to 084760.

Access Cardiosystems can’t repair or replace the recalled devices, or supply replacement parts, because they’re out of business.

The company says that if you have one of the defibrillators whose serial numbers are in the two batches we just mentioned, you should immediately take them out of service.

They also say that if you have other defibrillators made by Access Cardiosystems, that is, those with other serial numbers, you should remove these units from service as soon as your supply of disposable parts is used up. That’s because the company is no longer able to service any of its defibrillators or supply batteries and electrodes.

But they’re also advising customers to consider replacing the defibrillators as soon as possible, which could mean before the supply of disposable parts is used up.

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January2005FDA Patient Safety News Homepage
New Warnings for Mifepristone (Video, print, and e-mail functions)
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FDA and Danco Laboratories have notified healthcare professionals about important new safety changes in the labeling for Mifeprex (mifepristone), also known as RU- 486. Mifeprex was approved in 2000 for the termination of early pregnancy --- 49 days or less.

These labeling changes were prompted by reports of serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death. The black box warning on the label has been updated to add information about these risks. While these risks are rare and can occur following any termination of pregnancy, including miscarriage, the new warnings and an updated patient Medication Guide provide the latest available information to both practitioners and patients.

The warnings point out that serious bacterial infection and sepsis may occur without the usual signs of infection, such as fever and tenderness on examination. The warnings also caution providers that prolonged, heavy bleeding may warrant surgical intervention.

The label also warns that health care providers should be vigilant for patients with undiagnosed ectopic pregnancies, which can be missed by physical examination and ultrasound. Some of the symptoms of an ectopic pregnancy can mimic the expected symptoms of a medical termination of pregnancy. Mifepristone is not effective for terminating these pregnancies.

The patient Medication Guide instructs patients who’ve received mifepristone to contact their health care provider right away if they experience any one of the following: severe abdominal pain, a temperature of 100.4 degrees or higher for at least four hours, or heavy bleeding that soaks through two full size sanitary pads per hour for two consecutive hours. Patients should understand that severe abdominal pain or fever can be signs ectopic pregnancy or infection, and that heavy bleeding may require surgery.

Also, if patients having problems seek help from an emergency room, they’re advised to take their Medication Guide with them. This alerts the practitioner that the patient is undergoing a termination of pregnancy, so she can be appropriately assessed.

FDA will continue to monitor the use of Mifeprex and may take further action.

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 Preventing Medical Errors

January2005FDA Patient Safety News Homepage
JCAHO on Drug Name Mix-ups (Video, print, and e-mail functions)
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Many cases of medication error are caused by mixing up drugs whose names looked alike or sounded alike. These kinds of mistakes are more likely to happen when poor handwriting or poor oral communication are involved.

JCAHO has now made look-alike/sound-alike drugs part of its National Patient Safety Goals for 2005. That means that organizations are required, at a minimum, to annually review a list of look-alike and sound-alike drugs used in their facility and take action to prevent mix-ups. JCAHO has also posted a list of the most problematic drug name pairs for specific health care settings, and facilities must include at least 10 of these drug combinations on their lists.

Many of the name pairs on JCAHO's list come with specific safety strategies for that particular name combination. But JCAHO also has a number of general recommendations for preventing drug name mix-ups. Let’s take look at just a few of those recommendations.

Prescribers should write both the brand and generic name on prescriptions for drug whose names are known to be problematic. They should also include the intended purpose of the medication, since in most cases, drugs that look or sound alike are used for different purposes. And they should give verbal or telephone orders only when truly necessary, and encourage staff to read back all orders, spell the product name, and state its indication.

Facilities and practitioners should be aware of look-alike and sound-alike drug names and regularly provide this information to professional staff. They could computerize prescribing for these drugs, using preprinted orders or prescriptions. And when possible, they should list both the brand and generic names on medication administration records and automated dispensing cabinet computer screens.

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January2005FDA Patient Safety News Homepage
Warning about CeeNU Overdoses (Video, print, and e-mail functions)
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In a recent article, the Institute for Safe Medication Practices describes a potentially fatal dosing error with the chemotherapeutic drug CeeNU (lomustine), which is used to treat brain cancer and Hodgkin’s disease. A single dose of oral lomustine should only be taken once every 6 weeks. However, lomustine has sometimes been dispensed and administered daily, often with tragic results.

In one case, a 24-year-old woman with brain cancer died as a result of a lomustine overdose. A physician had written a poorly legible prescription for lomustine 190 mg every 6 weeks. The pharmacist misunderstood the directions as “daily for 6 weeks,” and dispensed a 6-week supply of capsules with directions to take 190 mg daily. The patient’s physician hadn’t explained how to take the medication, so the patient followed the label directions and took 190 mg daily for 21 days. She was hospitalized with severe bone marrow suppression and acute bleeding, and died a month later.

ISMP says that Bristol-Myers Squibb has enhanced the labeling and the packaging of CeeNU. “Single Dose Only” is now printed in red on the label, and “Dispense Single Dose Only” is embossed on the cap of stock bottles.

However, even these warnings can be overlooked. So here are some of the other safeguards ISMP recommends.

First, program warning messages such as “single dose only” into order entry systems. Also configure the system to limit the quantity prescribed or dispensed to 300 mg or less for each prescription or order.

Use unit-of-use Dose Packs that are available from the manufacturer. Each 300 mg Dose Pack contains two 100 mg capsules, two 40 mg capsules, and two 10 mg capsules, with instructions for the pharmacist to select the correct patient dose (within 10 mg), place the capsules in a single vial, and attach the special patient label that’s provided.

When possible, use bold font or all capital letters (e.g., CAUTION: SINGLE DOSE ONLY) when presenting dosing frequency directions on patient labels, and on nursing medication administration records. And use large print to help elderly patients with poor eyesight.

Prescribers should counsel patients directly so they understand that taking extra doses is dangerous. They should also ask the patient for confirmation to ensure that the patient understands the dosing schedule. Finally, follow up by giving patients written information that contains clear advice about the “single dose only” dosing schedule. Pharmacists should also review the prescription label with the patient or caregiver.

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January2005FDA Patient Safety News Homepage
More on Avoiding Deaths from Blood Transfusions (Video, print, and e-mail functions)
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Despite the fact that blood for transfusion is routinely pre-tested for blood type and then matched with the patient, people receiving transfusions continue to die from ABO incompatibility. These accidents generally don’t happen because the blood isn’t tested properly, but rather because the patient is mis-identified. In other words, they happen when the hospital staff fails to use established procedures to identify the patient when drawing the pre-transfusion blood samples.

To reduce the possibility of errors, FDA recommends having and using standard operating procedures. That goes for pre-transfusion testing and for the transfusion itself. And it includes procedures to accurately identify the patient before drawing the pre-transfusion blood sample, procedures to insure that the proper unit of blood is released by the blood bank, and procedures to identify the patient again just before the transfusion.

FDA has a new regulation that will require a bar code on blood products, similar to the code that’s used on supermarket merchandise. The bar code on the blood container can be read with a scanner at the patient's bedside to be sure it's the correct unit of blood for that patient. This should help health care personnel to make sure that the right patient is getting the right unit of blood.

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January2005FDA Patient Safety News Homepage
Caution on Fatal Dosing Errors with Epinephrine (Video, print, and e-mail functions)
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The Institute for Safe Medication Practices cautions that it’s easy to make potentially fatal dosing errors when administering epinephrine injections because the terminology on the label can be confusing.

ISMP cites the case of a 16-year old boy who received 4 mL of undiluted 1:1000 epinephrine solution intracavernously to treat priapism. A 1:1,000,000 solution should have been used, so the boy received a massive overdose. He arrested and couldn’t be resuscitated.

The physician who administered the drug mistakenly thought that the label on the vial, which read “1:1,000,” meant that the epinephrine had already been diluted with 1,000 mL of fluid.

To prevent this kind of error, ISMP recommends that you not stock the large, 30 mL vials of 1:1,000 epinephrine. If you need this strength, stock only the small, 1 mL ampuls. That way, a massive overdose can only be administered by using a large number of ampuls, and this should alert the practitioner that something’s wrong.

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 Advice for Patients

January2005FDA Patient Safety News Homepage
Warning on Supplements for Sexual Enhancement (Video, print, and e-mail functions)
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FDA has issued a warning to consumers not to use a product sold on Web sites for treating erectile dysfunction and enhancing sexual performance. It is called “Actra-Rx” or “Yilishen,” and it’s promoted as a “dietary supplement.” The problem is that it contains prescription-strength quantities of sildenafil, the active ingredient in Viagra.

There are two potential hazards here. The first one has to do with simple potency and purity: the consumer can’t be really certain of exactly what’s in this product, or how much of each ingredient it contains. But the most immediate risk is that sildenafil can cause a significant and sometimes life-threatening drop in blood pressure if it’s taken in conjunction with prescription drugs containing nitrates.

These nitrate-containing prescription drugs are commonly taken by patients with diabetes, hypertension, hypercholesteremia and heart disease. Unfortunately, these same patients often have erectile dysfunction, and so they might be especially susceptible to ads for these so-called dietary supplements that contain sildenafil, and of course that would put them at risk for serious adverse events.

This is a widespread and long-standing problem, and it’s not confined to just this one product. Last year the FDA issued warnings on several other so-called dietary supplements that contained either sildenafil or tadalafil, the active ingredient in Cialis. Some of these products were also promoted for sexual enhancement in women. And so products like this are likely to continue to show up on the Internet.

The basic message for patients is this: if you have erectile dysfunction, you should see a doctor rather than trying to treat it over the Internet.

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FDA Patient Safety News is a product of the US Federal Government, and as such is NOT copyrighted or restricted in any way. We encourage the further use and distribution of the video or text of the program by anyone – either in its entirety or as individual stories.

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