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U.S. Department of Health and Human Services

Show #14, April 2003

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Show #14, April 2003

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 New Medical Products

April2003FDA Patient Safety News Homepage
Approval of Prozac for Pediatric Use (Video, print, and e-mail functions)
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FDA recently approved the use of the antidepressant Prozac to treat children ages 7 to 17 for major depressive disorder and obsessive compulsive disorder. This is the first time that a selective serotonin reuptake inhibitor has been approved to treat this age group. Prozac had already been approved for major depressive disorder in adults.

It's estimated that depression affects up to 2.5 percent of children and 8 percent of adolescents in the U.S. Obsessive compulsive disorder affects about 2 percent of the population, generally beginning during adolescence or early childhood. At least one-third of adult cases of obsessive compulsive disorder begin in childhood.

The approval of Prozac for pediatric use was based on two placebo controlled clinical trials. The side effects of the drug in children were similar to those experienced in adults.

In one clinical trial, the pediatric patients treated with Prozac gained, on average, about ½ inch less in height and about 2 pounds less in weight after 19 weeks compared to the placebo group. The clinical significance of this finding is unknown at this time. Eli Lilly, the company that markets Prozac, has agreed to perform a postmarketing study to determine any possible effect of the drug on long-term growth in children.

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April2003FDA Patient Safety News Homepage
New Immunosuppressive Treatment for Psoriasis (Video, print, and e-mail functions)
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In a recent Talk Paper, FDA announced the approval of a new immunosuppressive treatment for moderate to severe plaque psoriasis. It's called Amevive, and it's made by Biogen, Inc. The generic name is alefacept.

Psoriasis affects between one and two percent of the U.S. population. Plaque psoriasis is the most common form of the disease, characterized by inflamed, scaling lesions, pain and itching. Some patients also experience arthritic changes in the joints.

Amevive provides a new option in managing psoriasis patients. Unlike other immunosuppressive agents used to treat this disease, Amevive targets “memory” T-cells, that enable the body to maintain immunity long after the initial challenge to the immune system. Because of this, the response to Amevive tends to be sustained.

But this also raises concerns about long-term adverse effects. That's why the labeling for Amevive stresses the need to inform patients about the importance of regular monitoring of white blood cell counts during treatment. The labeling also states that patients should be informed that Amevive suppresses their immune systems, which could increase the likelihood of developing infections or malignancies.

Because the effect of Amevive on the fetal immune system is not known, if a patient becomes pregnant while taking Amevive, the practitioner should enroll her in the manufacturer's pregnancy registry.

FDA based its approval of Amevive on the results of two randomized, double-blind, placebo-controlled studies of over a thousand patients. In both studies, a significantly higher percentage of patients receiving Amevive showed improvement compared with those receiving a placebo.

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April2003FDA Patient Safety News Homepage
Home Use Glycated Hemoglobin Test for Diabetics (Video, print, and e-mail functions)
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In another Talk Paper, FDA announced that a test for glycated hemoglobin is now available over-the-counter for home use by diabetic patients. The test, A1c Now, is manufactured by Metrika, Inc., and was previously available only by prescription.

Glycated hemoglobin is produced in the body when glucose interacts with hemoglobin. Blood levels of this substance are an indicator of long-term glucose levels in the body, and so it's important for diabetic patients to be tested for it every three to four months. In the past, patients generally had to go to a medical facility to have the test done. The new test offers the convenience of immediate results in the patient's home, which may help motivate patients to be tested on schedule.

To perform the test, the patient takes a fingerstick blood sample and places it in the single-use monitor that comes with the kit. The results are displayed in eight minutes.

FDA cleared the test for non-prescription use based on a clinical study in which nearly 300 patients used the test without supervision, and achieved test results comparable to those of medical professionals.

Additional Information:

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April2003FDA Patient Safety News Homepage
New Drug Treatment for Osteoporosis (Video, print, and e-mail functions)
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FDA recently approved the first drug for osteoporosis that stimulates new bone formation. It's called Forteo, manufactured by Eli Lilly and Company and its generic name is Teriparatide. Teriparatide is a portion of human parathyroid hormone, the primary regulator of calcium and phosphate metabolism in bones.

Forteo is indicated for the treatment of osteoporosis in those postmenopausal women who are at high risk for fracture. In men, it's indicated to increase bone mass for those with primary or hypogonadal osteoporosis who are at high risk for fracture. Forteo is administered intramuscularly, once a day, in the thigh or abdomen.

It's important to note that in laboratory studies, the drug was shown to increase the incidence of osteosarcoma in rats. Although no cases of osteosarcoma were reported in human studies, the possibility cannot be ruled out that humans treated with this drug could face a higher risk of developing this type of cancer. Forteo's label includes a black box warning about this potential risk. It's also explained in a Medication Guide provided to patients each time the drug is dispensed.

People with growing bones, like children and adolescents, and people with an increased baseline risk of osteosarcoma, such as those with Paget's disease of the bone, should not be treated with Forteo. The drug is also contraindicated in patients with hypercalcemia, women who are pregnant or nursing, and patients who have ever had bone cancers or cancers that have metastasized to bone. And patients should not be treated with Forteo for more than two years, since long-term effects are not currently known.

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 Recalls and Safety Alerts

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Caution on Reprocessing Certain Olympus America GI Endoscopes (Video, print, and e-mail functions)
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Olympus America, Inc. has learned that some health care facilities were not cleaning and disinfecting the auxiliary water channel found on certain 160 series Olympus GI endoscopes --- because either they may not have realized the auxiliary channel was there, or because they didn't use the channel during the endoscopic procedure. Failing to clean and disinfect the water channel could potentially cause cross-infection between patients.

This auxiliary water channel, or “water-jet”, is found on 5 models of Olympus's EXERATM colonoscopes and one gastroscope. The channel allows the endoscopist to wash the GI mucosa under observation during endoscopy. You can tell whether your EXERATM endoscope has an auxiliary water channel by looking for the auxiliary water inlet on the endoscope's light source connector.

In February, Olympus sent a safety notice to remind customers that their endoscopes have an auxiliary water channel, and reemphasized existing instructions on proper reprocessing. Most importantly, Olympus stressed that this channel must be cleaned and disinfected each time the endoscope is used, even if the auxiliary water feature isn't used.

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 Preventing Medical Errors

April2003FDA Patient Safety News Homepage
Incompatible Pacing Connectors (Video, print, and e-mail functions)
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Several years ago, FDA received a number of reports of patients being electrocuted when the electrode lead wires or patient cables attached to their bodies were accidentally inserted into live electrical outlets. To protect patients from these kinds of mix-ups, FDA required that lead wires and cables be protected or shrouded so they can't be inadvertently plugged into electrical outlets. But sometimes solving one problem can create the potential for a different problem.

There was a case described in a recent FDA article in the journal Nursing 2002, where a patient in the ICU had a temporary transvenous pacing catheter inserted. A problem arose when the catheter pin design was incompatible with the pacer adapter, so staff members couldn't connect it to the pulse generator and pacing was delayed for the patient. We've received other reports of equipment incompatibility or of difficulty in maintaining the connection between a temporary pacing lead and the pacing generator.

The main reason for the problem is that there are different connector designs used in temporary pacing systems. They're made by different manufacturers, and they may not be compatible. So when you assemble a temporary system with components from more than one manufacturer, they may not fit properly.

The solution is to take an inventory of your facility's temporary pacing equipment and identify the type of connector design. Make sure ahead of time that all pacing components are compatible and fit properly. Remove and replace any incompatible components. Ask the manufacturer of your pacing system if it requires adapters and be sure to get the right one if it does. By doing those things, you'll prevent delays in pacing therapy.

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April2003FDA Patient Safety News Homepage
New Fact Sheet on Preventing Medical Errors in Children (Video, print, and e-mail functions)
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The American Academy of Pediatrics and the Agency for Healthcare Research and Quality have announced a partnership to help avoid medical errors in children. They have published a new Fact Sheet for parents called 20 Tips to Help Prevent Medical Errors in Children.

The fact sheet explains that medical errors can occur in the hospital, doctors' offices and even in patients' homes, and that the kinds of errors range from diagnostic issues to surgery to medications. It urges parents to be involved in their child's health care, and to act as an advocate for their child, speaking up if there are questions or concerns. It goes on to suggest specific ways to do this.

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April2003FDA Patient Safety News Homepage
Caution on Drug Names that End in “L” (Video, print, and e-mail functions)
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The Institute for Safe Medication Practices recently cautioned about writing drug names that end in the letter “L.” ISMP reported on two overdoses that occurred because a lower case “L” was the last letter in a drug's name and it was misread as the number 1.

In the first case, an order for Tegretol 300 mg was misinterpreted as 1300 mg. The letter “L” at the end of Tegretol had been written very close to the 300 on the patient's transfer order form. When a nurse transcribed this medication onto a hospital order form, she misread the dose and wrote an order for Tegretol 1300 mg. The pharmacist who processed the order wasn't familiar with the medication and the pharmacy computer system did not alert him that the dose exceeded safe limits. The patient received only one dose in error before a clinical pharmacist caught the mistake. Fortunately, the patient's Tegretol level had been low, so the dose made him lethargic, but not seriously toxic.

In the other case, a nurse misread an order for Amaryl 2 mg as 12 mg, because, again, there wasn't enough space between the last letter in the drug name and the numerical dose. But in this case, the pharmacist caught the error before it reached the patient because the profile on the automated dispensing cabinet stated the dose correctly.

Adequate spacing between the drug name and the dose is also crucial on medication history forms, preprinted order forms, and electronic formats such as the pharmacy computer, computer-generated medication administration records, and computerized order entry systems.

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 Advice for Patients

April2003FDA Patient Safety News Homepage
Caution on Fetal Ultrasound for Non-Medical Reasons (Video, print, and e-mail functions)
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For some time now, certain firms have been offering expectant parents ultrasound videos of their unborn child. The idea is to have a video that shows your baby before it's born, and keep it alongside videos and snapshots of the child later in life. Your pregnant patients may ask you if this is a good idea. After all, it sounds like harmless fun.

But there's a problem: these procedures could carry some risk. Ultrasound is a form of energy, and even at the low levels used in imaging procedures, it can produce physical effects in tissue, such as mechanical vibrations and a slight rise in temperature. We should stress that ultrasound has been used in obstetrics for many years, and to date there's no evidence that these effects are harmful to the fetus.

So the fact that these effects exist means that we can't assume prenatal ultrasound procedures are completely innocuous. When the ultrasound procedure is performed by a qualified clinician to check for such things as fetal age, positioning or abnormalities, the medical benefit far outweighs the risk, if any. But fetuses should not be exposed to ultrasound energy simply to have a video. If your patients ask about whether they should get one of these so-called “keepsake videos,” you should advise them that it's not a wise decision.

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 Related Article

April2003FDA Patient Safety News Homepage
DEVICE SAFETY - Monitoring Temporary Pacemaker Connections (Video, print, and e-mail functions)
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By Diane Dwyer, RN, BSN
Nursing2002, Volume 32, No. 9, p. 76.

A patient with myocardial infarction and bifascicular block was admitted to the ICU, where a physician inserted a temporary transvenous pacing catheter. However, the catheter pin design was incompatible with the pacer adapter, so staff members couldn’t connect it to the pulse generator. They connected the patient to a transcutaneous pacemaker and transferred him to another facility, but he died shortly after arriving.

What went wrong?
A temporary invasive cardiac pacing system produces an electrical pulse to stimulate the heart. But pacing systems and pacing electrodes vary, and assembled temporary systems may contain equipment from one or more manufacturers. The U.S. market currently offers two different types of cardiac pacing connectors. Without a proper connection to the pulse generator, the device won’t pace properly. In this case, the staff used incompatible equipment to assemble the system, creating a faulty connection.

What precautions can you take?
To prevent delaying pacing therapy, careful planning and selection of compatible connectors is needed.

* Take an inventory of your facility’s temporary pacing equipment and identify the type of connector design.
* Make sure ahead of time that all pacing components are compatible and fit properly. Remove and replace any incompatible components.
* Ask the manufacturer of your pacing system if it requires adapters and make sure you get the correct ones if it does.
* Report all pacing connection problems to your supervisor and the manufacturer.
* Share with colleagues the FDA’s public health advisory “Unsafe Electrode Lead Wires and Patient Cables Used with Medical Devices.”

You can get a copy at http://www.fda.gov/cdrh/safety.html by scrolling down and clicking on 12/28/93.
Although you need to support the adverse event-reporting policy of your health care facility, you may voluntarily report a medical device that doesn’t perform as intended by called MedWatch at 1-800-FDA-1088 (fac:1-800-FDA-0178). The opinions and statements in this report are those of the author and may not reflect the views of the Department of Health and Human Services. Beverly Albrecht Gallauresi, RN, BS, MPH, coordinates Device Safety.

Diane Dwyer is a nurse-consultant at the Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD.

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