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U.S. Department of Health and Human Services

Show #11, January 2003

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Show #11, January 2003

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 New Medical Products

January2003FDA Patient Safety News Homepage
New Drugs to Treat Opiate Dependence in Doctor's Office (Video, print, and e-mail functions)
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FDA recently approved two new formulations of the drug buprenorphine that can be used to treat opiate addiction in physicians' offices. The products are called Subutex and Suboxone, and they're manufactured by Reckitt Benckiser Pharmaceuticals. These drugs prevent withdrawal symptoms when the patient stops taking heroin or other opiates.

Subutex and Suboxone are the first narcotic drugs available for the treatment of opiate dependence that can be prescribed in an office setting under a new law passed in the year 2000. Physicians prescribing these drugs must be specially trained.

Until recently, the narcotic drugs used to treat opiate dependence, such as methadone, could only be dispensed in a very limited number of clinics that specialize in addiction treatment. Historically, there haven't been enough of these clinics for all the patients who want withdrawal therapy. Providing this treatment in physicians' offices should provide patients with greater access to needed treatment.

Subutex, which is used at the beginning of drug abuse treatment, contains only buprenorphine. Suboxone, which is used in the maintenance stage, also contains an opiate antagonist, naloxone. The naloxone is added to discourage drug abusers from crushing and injecting the Suboxone tablets.

To help deter misuse of these drugs, a comprehensive plan has been developed that includes education, tailored drug distribution, and supervised dose induction. Active and passive surveillance are also being used to allow early detection of any problems. If it becomes clear in the future that buprenorphine is being widely diverted and misused, tighter regulations can be enacted.

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 Recalls and Safety Alerts

January2003FDA Patient Safety News Homepage
Alert on Injectable Drugs Prepared by Urgent Care Pharmacy (Video, print, and e-mail functions)
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FDA recently issued a nationwide alert about all injectable drugs prepared by Urgent Care Pharmacy of Spartanburg, South Carolina, because these products may not be sterile. FDA's inspection of Urgent Care's facility showed that the company failed to have adequate controls to ensure necessary sterility of their injectable drugs.

In September 2002, Urgent Care recalled all lots of one of its injectable drugs, methylprednisolone acetate, after four patients treated with this product developed a rare fungal meningitis.

But so far, Urgent Care has refused to voluntarily recall any other injectable products. They also refused to provide FDA with a complete list of products they distributed. And so FDA is urging consumers, physicians, and health care workers to immediately stop using all injectable products from Urgent Care. So far, we've identified 11 states in the northeast, south, and mid-west where Urgent Care distributed their injectable drugs.

FDA is working with CDC and state officials on this investigation, and will take additional action if needed. We'll update you as this situation develops. In the meantime, go to our web site for more information.

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January2003FDA Patient Safety News Homepage
Lung Injuries from Blood Transfusions (Video, print, and e-mail functions)
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The FDA recently alerted health professionals about the possibility that patients who receive blood transfusions, particularly those containing plasma, can develop Transfusion Related Acute Lung Injury, or “TRALI.” This is a serious and potentially fatal condition, and it's important to recognize and treat it promptly.

A wide variety of blood products can induce TRALI, including whole blood, packed red blood cells, fresh frozen plasma, cryoprecipitate, platelet concentrates, and, rarely, IGIV.

Unlike the allergic or anaphylactic reactions sometimes seen in transfusion recipients, the antibodies implicated in TRALI come from the blood donor, not the recipient. About 90 percent of donors whose blood has been found to induce TRALI have either anti-HLA or anti-granulocyte antibodies.

Once they're transferred to the recipient, these antibodies produce a range of symptoms including hypoxemia, hypotension, fever, and severe bilateral pulmonary edema. Depending on the severity of symptoms, patients may require respiratory support. Diuretics are not effective in treating TRALI, since the underlying pathology involves microvascular injury, not fluid overload.

FDA has several recommendations for health care professionals regarding TRALI.

* First, be alert that any respiratory distress that occurs during or following the transfusion of blood or blood components could potentially be TRALI.
* If this occurs, discontinue the transfusion immediately, and begin oxygen and supportive treatment.
* Notify the blood center that supplied the blood component and return the remaining product so it can be tested for anti-HLA and anti-granulocyte antibodies in the donor.
* And finally, report fatalities from TRALI to the FDA

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January2003FDA Patient Safety News Homepage
Hospital Bed Safety (Video, print, and e-mail functions)
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During the past several years, FDA has received hundreds of reports of deaths and injuries that occurred when hospital and nursing home patients were trapped in beds with side rails. These entrapments can occur in a number of ways - for example, through the bars of a side rail, through the space between split side rails, or between the bed rail and the mattress, headboard, or footboard. Most of these incidents occurred with patients who were frail, elderly or confused.

Although the number of reported incidents is small compared to the large number of patients who use hospital beds, most of these tragic events can be prevented by taking appropriate precautions. One of the most important precautions is doing a careful assessment of each patient to see if safe care can be provided without bed rails.

Our web site has a brochure that was put together by the Hospital Bed Safety Working Group, made up of FDA and other government agencies, the healthcare community and the medical bed industry. This brochure gives suggestions on how to help keep patients safe with or without bed rails.

When bed rails are used, the brochure advises performing an on-going assessment of the patient's physical and mental status, and closely monitoring high-risk patients. The brochure also suggests other strategies. For example, lower one or more sections of the bed rail, such as the foot rail. Use a proper size mattress or a mattress with raised foam edges to prevent patients from being trapped between the mattress and rail.

The brochure also gives suggestions on how to keep patients safe when you're not using bed rails. For example, use beds that can be raised and lowered close to the floor to meet the needs of both the patient and the health care worker, and keep the bed in the lowest position with the wheels locked.

We'll be talking about other ways to improve bed safety in future programs, including additional resources from the Hospital Bed Safety Working Group.

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 Preventing Medical Errors

January2003FDA Patient Safety News Homepage
Drug Name Confusion: Taxotere and Taxol (Video, print, and e-mail functions)
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Now for another example of confusion between drugs whose names look or sound alike. Taxol and Taxotere are both chemotherapeutic agents. But mix-ups between these two drugs can result in serious adverse outcomes because they have different dosing recommendations and different uses in various types of cancer.

In one case, a physician ordered a 260 mg preparation of Taxol. The pharmacist prepared 260 mg of Taxotere instead. The patient's nurse did not notice the mistake and started the infusion, which continued until a physician noticed that the infusion container was labeled Taxotere. The patient died several days later, although the death could not be linked to the error since he was debilitated with metastatic disease.

Here are some ways that have been suggested to help prevent these kinds of name confusion errors.

* You can use brand and generic names on the prescription orders since the generic names don't look similar.
* You can use preprinted order forms to clearly communicate the desired medication.
* You can have two pharmacists provide independent confirmation before chemotherapy is dispensed, and have two nurses ensure that the correct drug has been dispensed for the correct patient before administering the medication.
* And you can use computer systems that alert staff when doses go beyond a preset limit for each drug

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January2003FDA Patient Safety News Homepage
Anesthetic Sprays and Methemoglobinemia (Video, print, and e-mail functions)
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In a recent report, the Institute for Safe Medication Practices warned that overuse of topical anesthetic sprays can cause methemoglobinemia. This is a potentially life-threatening complication that may result in cyanosis, confusion, hemodynamic instability and coma. The report points out that these sprays, most of which contain benzocaine, are probably used millions of times each year in preparing patients for endoscopic procedures and endotracheal intubation.

The problem occurs when practitioners use multiple sprays, and sprays of longer duration than recommended. Part of the reason, according to the report, may be that clinicians don't realize that these topical anesthetics are significantly absorbed. An earlier report by ISMP notes that up to 35 percent of benzocaine applied to mucous membranes can be absorbed.

That report also cautions that in teaching hospitals, inexperienced fellows and technicians who are performing bronchoscopies may not be aware of the absorption and toxicity of topical benzocaine, and it recommends issuing reminders to new members of the house staff.

The ISMP report also points out that some of these local anesthetic products are available over the counter in the form of gargles and sprays, so that methemoglobinemia could also occur in consumers who over-use them to treat sore throats and minor injuries.

The report recommends alerting clinicians and patients about proper dosing with topical anesthetics and about the possibility of methemoglobinemia. It points out that inflamed areas absorb more of the drug. It also notes that certain patients are especially at risk, including infants under six months old, patients with cardiac problems, and those with certain hemoglobin and enzyme abnormalities.

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 Advice for Patients

January2003FDA Patient Safety News Homepage
Warning about Decorative Contact Lenses (Video, print, and e-mail functions)
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The FDA has issued a warning to consumers about the possible risks associated with wearing decorative contact lenses that are distributed without a prescription and without proper fitting by an eyecare professional. This increases the risk of permanent eye injury.

These products are being manufactured and distributed directly to consumers through flea markets, convenience stores, and beach shops.

FDA has received reports of corneal ulcers from wearing these decorative lenses too long. These ulcers can lead to infection, corneal scarring and vision impairment. In severe cases, blindness and eye loss can occur.
FDA is urging consumers to immediately stop using decorative contact lenses that were obtained without a prescription and proper fitting. And we're encouraging health care professionals to report cases of eye injury from these lenses.

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January2003FDA Patient Safety News Homepage
Advice on Buying Medical Products On Line (Video, print, and e-mail functions)
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Some of your patients may be asking about buying medicines and medical products online. They may be concerned about whether the companies are legitimate, or whether the products are safe.

FDA has set up a website that provides tips and warnings about buying medical products on line. The website warns that you could receive a contaminated or counterfeit product, the wrong product, an incorrect dose, or no product at all. It also points out that getting a prescription drug by filling out a questionnaire without seeing a health care professional poses serious health risks.

If people decide that they do want to purchase on line, the FDA web site has some tips on doing so safely. For example, be careful about web sites that sell drugs and products not approved by FDA, or those that don't list a U.S. address and phone number to contact if there's a problem. Don't purchase from foreign web sites, because in general, it's illegal to import drugs. And to find out whether a web site is a licensed pharmacy in good standing, check with the National Association of Boards of Pharmacy (NABP). You'll find their internet address on our web site.

You can help make on-line purchases of medical products as safe as possible by urging your patients to consult with a health-care provider rather than ordering a prescription drug using just an on-line questionnaire, and by reporting to the FDA any site that you suspect may be illegal.

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 Preventing Medical Errors

January2003FDA Patient Safety News Homepage
NIOSH shares “Lessons Learned” on Needlestick Prevention (Video, print, and e-mail functions)
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Before we close today, we wanted to mention a new resource to help prevent needlestick injuries to health care workers. The National Institute for Occupational Safety and Health has developed a new web site that shares first-hand experiences from health care facilities that developed needlestick prevention programs. The site discusses the steps these facilities took to establish their programs, the barriers they encountered, how these barriers were resolved, and lesson learned from the experience.

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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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