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Show #72, February 2008

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Show #72, February 2008

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 Preventing Medical Errors

February2008FDA Patient Safety News Homepage
Helping Patients Avoid Counterfeit Drugs over the Internet (September 2007) (Video, print, and e-mail functions)
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This story originally aired in September 2007. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern.

FDA has previously warned about the risks of buying drugs and other medical products over the Internet. Products bought on the Internet could be fake, sub-potent, or not approved by the FDA. They could also be counterfeit.

FDA recently discovered two different web sites selling a counterfeit version of the weight-loss drug Xenical. In one case, it actually contained another drug, and other samples contained just starch and talc. And that is just one example of the risks people take if they buy drugs over the internet.

An article in a recent issue of "Family Practice Management" gives several tips that practitioners can give to patients to help avoid counterfeit products. One is to advise patients to use only U.S. sites that are licensed by a State board of pharmacy. Some of these sites display the VIPPS seal, which stands for Verified Internet Pharmacy Practice Site. The National Association of Boards of Pharmacy (NABP) gives the seal to Internet pharmacies that meet State licensure and other criteria.

The article also suggests advising patients to carefully compare the appearance and packaging of the medicines they buy online with the same medicine they may have gotten in the past from a conventional pharmacy. If the Internet product does not match up exactly, the patient should not use it. The suspected counterfeiting should be reported to the drug manufacturer, and to the FDA through the Medwatch system.

The article lists some of the drugs that are most susceptible to counterfeiting and points outs that counterfeiters tend to favor expensive drugs that are sold in large volume, e.g., anti-cholesterol medications. The article notes that so-called "embarrassment drugs" are widely counterfeited i.e., drugs for conditions that patients may be reluctant to discuss with their doctors. This would include drug such as Viagra, Cialis and Propecia.

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Safe Use of Pneumatic Tourniquet Cuffs (April 2007) (Video, print, and e-mail functions)
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This story originally aired in April 2007. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern.

Pneumatic tourniquet systems are used to compress the patient's blood vessels during a surgical procedure, which helps to ensure a bloodless operative field. But their effectiveness can be compromised if the tourniquet cuffs become crinkled, folded or bent. This can cause insufficient or inconsistent pressure, resulting in poor control of blood flow to the affected area.

Here are several precautions you can take to prevent this from happening:

• Be sure to select a cuff that will overlap between 3-6 inches when used on the patient. Too much overlap causes increased pressure and wrinkling of the underlying soft tissues.

• Before applying the cuff to the patient, inspect it for rips or holes, and be sure that the tubing connecting the cuff to the system is not kinked or occluded.

• When applying the cuff, be sure it is smooth because wrinkles or tunneling in the cuff could damage the underlying skin and soft tissue. If the manufacturer's instructions suggest it, use a soft, wrinkle-free padding between the cuff and the skin for added protection.

• If the patient experiences uncontrolled bleeding at the site, increasing the pressure may not be effective if the cuff is not allowing the pressure to be applied properly. Before increasing the pressure, check the cuff to be sure that it is inflated properly, is not damaged, and does not have wrinkles or crinkling.

• If the location or position of the cuff needs to be adjusted, remove the cuff and reapply it. Never pull the cuff up or down while it is on the limb.

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Avoiding Accidental Overdoses when Methadone is Prescribed for Pain (February 2007) (Video, print, and e-mail functions)
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This story originally aired in February 2007. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern.

FDA has issued a Public Health Advisory cautioning practitioners about avoiding overdoses when they are prescribing methadone or managing patients taking this drug. Since the 1970s, methadone has been primarily used in treating drug abuse, but now it’s also being used increasingly for the treatment of pain.

FDA issued the Advisory because of reports of life-threatening adverse events and death in patients receiving methadone for pain control. Part of the reason is that physicians prescribing methadone for pain relief may not fully understand the drug’s pharmacology and potential adverse effects. For example, methadone, like other opioids, causes respiratory depression. But in addition, it can also have effects on cardiac conduction, leading to prolonged QT intervals and serious arrhythmias. Methadone also interacts with many other drugs, some of which can slow methadone’s elimination from the body and thus increase the likelihood of overdose and adverse effects related to either respiratory depression or cardiac arrhythmias.

Overdoses can also occur because methadone remains in the body much longer than the drug's analgesic effect lasts. So if a patient takes more methadone to extend the duration of pain relief, he or she may be at serious risk of respiratory depression.

The Advisory lists several recommendations for health care professionals, including closely monitoring patients on this drug, especially when starting treatment or adjusting the dose. This should be done even for patients who are opioid-tolerant.

Because many patients will be taking the methadone at home without medical supervision, much of the responsibility for avoiding overdoses rests with patients and caregivers. Because of this, FDA is working on a Medication Guide for patients, to be distributed when prescriptions for methadone are dispensed.

In the meantime, health care professionals should refer patients to the Patient Package Insert for advice on how to use the drug safely. Here’s what patients should know if they take methadone for pain relief:

• First, don’t take more of the drug than prescribed. If pain isn’t relieved at the prescribed dose, call your doctor.

• Be aware that pain relief may take a few days after you start the drug.

• Get medical attention right away if you experience palpitations, dizziness, lightheadedness or fainting.

• And be sure to tell your doctor about other medications you’re taking because they may interact with the methadone.

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Avoiding Burns from Electrodes and Cables during MRI Exams (February 2007) (Video, print, and e-mail functions)
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This story originally aired in February 2007. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern.

A recent FDA article in Nursing2006 describes second and third degree burns in patients undergoing MRI exams while they were wearing ECG electrodes and cables. Many of these burns were discovered only after the exam was over and some were severe enough to require plastic surgery.

The problem is that the radiofrequency fields created during an MRI exam can heat ECG cables and electrodes, seriously burning the underlying skin. This hazard is likely to increase as the number of MRI exams goes up, and as more patients need ECG monitoring during their MRI procedures.

The article recommends a number of ways to reduce the risk of these kinds of burns. Here are some of them:

• Remove any electrodes and cables that are no longer being actively used for monitoring. Search the patient for any electrodes and cables that may have been inadvertently left behind in clothing or sheets, or on the patient.

• If the patient needs ECG monitoring during the MRI procedure, check beforehand with the MRI staff to be sure that the cables and electrodes have been cleared for use in the MRI environment. If still in doubt, check with the manufacturer of these devices.

• Be sure that there is complete contact between the electrode surface and the patient's skin. If contact is poor - for example, if excess hair hasn't been removed or there's an air gap between the electrode and the skin - a serious burn can occur even if you are using electrodes and cables that are approved for MRI. Inadequate contact can also occur if the gel layer on the electrode has dried out, so avoid using electrodes that are past their expiration date and inspect each electrode before using it.

• Avoid looping and crossing the cables, because this can create excessive heat from resistance in the cable, which can burn the patient. Keep cables off the patient's skin by placing padding, such as a blanket, between the cable and the skin.

• After completing the MRI study, examine the patient for possible burns or reddening of the skin under the electrodes. This is especially important for patients who can't express themselves, or those who have impaired sensation. If the patient has a burn, administer appropriate treatment.

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Severe Tissue Injury with IV Promethazine (December 2006) (Video, print, and e-mail functions)
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This story originally aired in December 2006. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern.

The Institute for Safe Medication Practices recently warned that administering promethazine parenterally may cause more severe tissue injuries than previously recognized. Promethazine, which is commonly sold under the trade name Phenergan, has many uses including as an antihistamine, a sedative and an antiemetic.

ISMP points that out promethazine is a known vesicant which is highly caustic to the intima of blood vessels and surrounding tissue. Deep intramuscular injection into a large muscle is the preferred parenteral route of administration, and is least likely to cause damage. But promethazine is also given by slow IV push in many hospitals. The IV route, along with inadvertent intra-arterial or subcutaneous administration is most likely to result in significant complications, ranging from burning and pain to paralysis, tissue necrosis, and gangrene. Sometimes surgical intervention such as fasciotomy, skin graft or even amputation is needed.

ISMP describes several recent cases where severe tissue damage occurred following IV administration of promethazine. For example, in one case a 19-year-old woman who went to the emergency department with flu-like symptoms was given Phenergan IV. During the injection, she cried out in pain, and after the injection she told the nurse that her arm was still in significant pain and that she felt “something was wrong.” The nurse reassured her and then left the room. The patient’s arm and fingers became purple and blotchy and then over the next several weeks eventually turned black and shriveled. Her thumb, index finger, and top of her middle finger eventually had to be amputated.

ISMP points out that the product labeling makes several recommendations to reduce the risk of these adverse events. They include giving the drug in concentrations no greater than 25 mg/mL, administering the drug at a rate no greater than 25 mg/minute, injecting the drug through the tubing of an infusion set that’s running and known to be working satisfactorily, and stopping the injection immediately if the patient reports burning in order to investigate whether there might be intra-arterial placement or perivascular extravasation.

In addition to the manufacturer’s recommendations, ISMP lists about a dozen other strategies to prevent or minimize tissue damage when giving IV promethazine. Here are several suggestions.

• Stock promethazine only in the 25 mg/mL concentration (not the 50 mg/ml) since this is the highest concentration of promethazine that can be given IV.

• Consider 6.25 to 12.5 mg of promethazine as the starting IV dose, especially for elderly patients.

• Give the medication only through a large-bore vein and check the patency of the access site before administering.

• Administer IV promethazine through a running IV line at the port furthest from the patient’s vein.

• Consider administering IV promethazine over 10-15 minutes.

• Before administering the drug, tell patients to let you know immediately if burning or pain occurs during or after the injection.

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