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U.S. Department of Health and Human Services

Show #29, July 2004

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Show #29, July 2004

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 New Medical Products

July2004FDA Patient Safety News Homepage
New Drug Approved for Parkinson's Hypomobility Episodes (Video, print, and e-mail functions)
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FDA recently approved the drug Apokyn to treat Parkinson's patients during episodes of hypomobility. These are the so-called "off periods" when a patient becomes immobile or unable to perform activities of daily living. These hypomobility episodes can occur toward the end of a dosing interval with standard background medications, or at unpredictable times. Apokyn is apomorphine, and it's distributed by Bertek Pharmaceuticals.

There are other drugs used to help decrease the amount of time that Parkinson's patients spend in these "off" periods, but they're taken orally, on a long-term basis. The difference is that Apokyn, which is injected subcutaneously, is for acute treatment of these episodes.

Apomorphine is an emetic, so it should be given with an antiemetic drug. Otherwise it causes severe nausea and vomiting. But it shouldn't be taken with one class of antiemetics, 5HT3 antagonists, which includes ondansetron and similar drugs. Combining Apokyn with these drugs can lead to hypotension and loss of consciousness. Apokyn can also cause a variety of other side effects, including hallucinations and excessive sleepiness.

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 Recalls and Safety Alerts

July2004FDA Patient Safety News Homepage
Certain Medtronic MiniMed Insulin Infusion Sets Recalled (Video, print, and e-mail functions)
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Medtronic MiniMed is recalling the company's Paradigm Quick-set Plus insulin infusion sets because of problems that can interrupt insulin flow to diabetic patients who use them. These problems have included bent cannulas, occlusions in the tubing, leaking at the insertion site, and accidental dislodging of the infusion set while removing the insertion device. A number of serious injuries have occurred as a result, including some hospitalizations.

This recall covers all Paradigm Quick-set Plus models (MMT-359S6, MMT-359S9, MMT-359L6 and MMT-359L9) and lot numbers. Patients who have any of these sets should contact the company at (800) MINIMED to get free replacements by overnight delivery. They should stop using the recalled sets as soon as they get the replacements.

If patients need to continue to use the Quick-set Plus sets while waiting for replacements, Medtronic is recommending that they monitor their blood glucose levels frequently, and be prepared to inject insulin if necessary. Patients should also contact their healthcare provider if they experience excessively high or low glucose levels.

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July2004FDA Patient Safety News Homepage
Warning on Using Cordis Biliary Stent in the Vascular System (Video, print, and e-mail functions)
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Cordis Corporation is cautioning health care professionals about the use of the company's biliary stent, the PRECISE® RX Nitinol Stent Transhepatic Biliary System. The PRECISE RX stents are intended to treat obstructions in the bile duct due to malignancies. FDA has not cleared these stents for use outside the biliary tract. In fact, the stent's current labeling contains a warning that the device's safety and effectiveness in the vascular system have not been established.

Nonetheless, some physicians have used these devices in the vascular system. When used this way, air can be introduced into the patient by the stent system, and this can cause serious problems, including coma, seizure and stroke. In fact, we've had several reports of malfunction, and also of patient injuries due to air embolism, when this system is used outside the biliary tract.

On May 4, Cordis sent a notification to their customers describing these severe adverse events and advising them to limit the use of this device to the FDA-cleared uses only.

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July2004FDA Patient Safety News Homepage
Alert on Certain Children's Motrin Grape Chewable Tablets (Video, print, and e-mail functions)
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McNeil Consumer & Specialty Pharmaceuticals has issued an alert about a possible mix-up with some bottles of Children's Motrin Grape Chewable Tablets. Instead of containing children's ibuprofen tablets, the bottles might mistakenly contain Tylenol 8-Hour® Geltabs, which provide an adult dose of acetaminophen. Children who take the Tylenol 8-hour product could receive an overdose of acetaminophen, although no injuries have been reported to date.

McNeil says that one manufacturing lot (Lot # JAM108, exp 1/06) is currently affected. This lot was distributed nationwide to wholesale and retail customers between February 5 and April 1, 2004.

Children's Motrin Grape Chewable Tablets are round, purple, scored tablets with a non-glossy finish and a grape smell. The Tylenol 8-Hour Geltabs are white on one side, red on the other, with "8 Hour" printed in blue on either the red or the white side.

Consumers can identify the lot number by looking on the carton end flap and on the bottle label. Anyone identifying one of the affected bottles should contact McNeil's Consumer Relationship Center at 1-800-962-5357. And parents who think their children may have taken Tylenol 8-Hour Geltabs, believing them to be Children's Motrin tablets, should contact their health care provider or a poison control center immediately.

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 Preventing Medical Errors

July2004FDA Patient Safety News Homepage
New Risk Information on Zelnorm (Video, print, and e-mail functions)
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New risk information will now appear in the labeling for the drug Zelnorm, or tegaserod maleate. This medication is used for the short-term treatment of women with irritable bowel syndrome whose primary bowel symptom is constipation.

The new labeling will contain a warning about the serious consequences of diarrhea in these patients, including hypovolemia, hypotension and syncope. The labeling also warns that patients on Zelnorm who develop hypotension or syncope should stop taking the drug. And patients who have or frequently experience diarrhea should not be started on Zelnorm.

The labeling will also contain a new precaution on ischemic colitis in patients receiving Zelnorm. Although a causal relationship has not been established, the drug should be discontinued immediately if the patient develops symptoms of ischemic colitis. These include rectal bleeding, bloody diarrhea, or new or worsening abdominal pain.

The new information will also be incorporated in a revised leaflet for patients.

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July2004FDA Patient Safety News Homepage
Mix-ups between Brethine and Methergine (Video, print, and e-mail functions)
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In previous programs, we've talked about several examples of mix-ups between drugs whose names look or sound alike. But here's an example of dangerous mix-ups between two drugs whose packaging looks similar. In a recent article, the Institute for Safe Medication Practices warns about confusing Brethine (terbutaline sulfate) and Methergine (methylergonovine maleate).

These two drugs are pharmacologic opposites, with very different actions. Methergine stimulates contraction of smooth muscle, and Brethine relaxes it. They're frequently used in labor and delivery settings, but for very different clinical reasons. Brethine is used off-label to treat preterm labor, and Methergine is primarily used after delivery of the placenta to treat uterine atony, subinvolution, or hemorrhage. Methergine should not be used in pregnancy except after the delivery of a newborn. It would be especially dangerous to a patient in preterm labor.

If one of these drugs is mistakenly used instead of the other, this can be especially serious for the mother and baby. In one reported case, four doses of Methergine were administered to a patient in preterm labor, which was believed to contribute to the death of the fetus.

The packaging for these products is remarkably similar, and that could account for the mixups. Both are packaged as 1 mL ampuls in an amber plastic tube. The tube is covered by a foil label with the product name in tiny print, making them difficult to tell apart. Both ampuls also have similar colored "rings" around the ampul necks, and that adds to their similarity.

The ISMP says that it's important to keep the staff informed about the potential for errors, and to store these products separately. Methergine is stored in the refrigerator, so this can help to keep them apart. But errors are still possible, so ISMP suggests using reminder labels on the ampuls to prevent mix-ups.

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July2004FDA Patient Safety News Homepage
More About Hazards in Patient-Controlled Analgesia (Video, print, and e-mail functions)
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We've reported before about the dangerous overdoses that can occur with patient-controlled analgesia, or PCA, when the drug is administered by people other than the patient. This hazardous practice is called "PCA by proxy." Those who might push the patient's PCA button and cause an overdose include well-meaning family members, visitors, and sometimes even the clinical staff.

The problem continues to occur, as pointed out by a recent FDA article in Nursing 2004. It describes a case where a nurse awakened a patient to assess pain and, based on the patient's response, pushed the PCA button. The patient eventually became unresponsive and died.

The article points out that although PCA pumps include dose and time limits to prevent overmedication, patient participation is crucial to maintain safety. If the patient is sleeping or over-sedated, he or she won't push the button, so additional medication isn't delivered. But in this case, the nurse over-rode the patient's control of the medication by pushing the button herself and administering more of the analgesic.

The article offers several suggestions to prevent these kinds of occurrences. For example, place warning labels that say "For Patient Use Only" on PCA buttons or equipment. And remind patients and visitors that the PCA button is to be used only by the patient. Tell visitors that they shouldn't push the button even if the patient asks. And tell them to notify a nurse if the patient seems overly sleepy.

Our original story on PCA has more recommendations on how to use PCA safely. And several articles by the Institute for Safe Medication Practices go into greater detail on patient selection, patient monitoring, selecting a PCA pump, programming the pump, preventing PCA prescription errors, and other aspects of the problem.

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July2004FDA Patient Safety News Homepage
Burns in MRI Patients Wearing Transdermal Patches (Video, print, and e-mail functions)
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In a recent article, the Institute for Safe Medication Practices talks about a hazard that many people may not know about. Transdermal medication patches, like those that deliver nicotine, testosterone and nitroglycerin, can cause burns if a patient wears one during an MRI procedure. That's because some transdermal patches have an aluminized backing. The backing isn't ferromagnetic and so it's not attracted to the magnetic field of an MRI system. However, this metallic component conducts heat, and so it can cause burns.

We've recently received reports of patients wearing nicotine transdermal patches who were burned during an MRI exam. In one case, a patient entered an MRI scanner wearing a Habitrol 21 mg patch. He started thrashing when the third scanning cycle started, and the test was stopped immediately. The patient reported that his arm was burning and there was a small, denuded blister where the patch had been. In another report, a patient had a short MRI of the lumbar spine while wearing a nicotine transdermal patch. Later, the patient complained of burn lines on his upper arms.

Here's ISMP's recommendation. Before MRI exams, ask all patients whether they use any medication patch. Unless you're sure the patch doesn't contain metal, tell the patient to remove it temporarily, in order to avoid possible burns.

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July2004FDA Patient Safety News Homepage
Avoiding Errors with Oncolytic Drugs (Video, print, and e-mail functions)
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In a recent issue of its monthly publication, "CAPSLink," the USP Center for the Advancement of Patient Safety cautions that it's especially important to avoid errors when using oncolytic drugs. Most of these drugs have a narrow therapeutic index and are toxic even at the recommended dosage, so that serious patient harm can occur as a result of medication errors.

The USP analyzed nearly 4,000 reports of errors with oncolytic drugs reported through its MEDMARX program. They found that the most common types of errors were giving the wrong dose, mistakes in prescribing the drug, giving the drug at the wrong time or not at all, and using unauthorized drugs.

The USP cites a case in which paclitaxel was ordered at a dose of 375 mg/m2 to treat metastatic breast cancer. Although the correct dose is 175 mg/m2, neither the pharmacist nor the nurse questioned the dosage. The patient developed neutropenia, fever and sepsis. This is a good example of the narrow therapeutic index with these drugs. Hematological toxicity from paclitaxel begins to increase at doses above 190 mg/m2, which is only about 10 percent higher than the correct dose.

The USP lists a number of recommendations to decrease the likelihood of errors with oncolytic drugs. Here are just a few of them.

First, include oncolytics on your list of high-risk, high-alert medications.

Use standardized, preprinted order forms for commonly used chemotherapy regimens, or computerized prescriber order entry systems. Don't permit verbal orders for these drugs.

Don't use abbreviations, acronyms or "nicknames" when prescribing these drugs, and establish a list of required elements on the medication order, including specific information about the patient. And review the oncolytic drugs in your formulary to assess the possibility of errors due to look-alike products.

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