 This is FDA Patient Safety News. In this edition, a recall of certain defibrillators made by Access Cardio Systems, new warnings on the drug Miphaprex, more on what practitioners can do to prevent transfusion-related deaths, and a warning for consumers about treating sexual problems with certain dietary supplements. These stories and more on this edition of FDA Patient Safety News. Welcome to the program. For the U.S. Food and Drug Administration, I'm Mark Barnett. And I'm Anita Reiner. Let's start with a recent recall. Access Cardio Systems Incorporated 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 the defibrillator can't deliver a shock. Units that could 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 it can't be turned off. Units that could be subject to this kind of failure have serial numbers from 075180 to 084760. So is the company going to repair or replace these recall devices? They can't do that because they're out of business. They can't repair them. They can't replace them. They can't supply replacement parts. So what are users supposed to do then? Well, 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. What about other defibrillators made by this company, the ones that have serial numbers outside those ranges? Well, they say two things about that. First of all, as soon as your supply of disposable parts for those defibrillators is used up, remove the units from service. The company is no longer going to be able to service any of the defibrillators or supply batteries and electrodes, but they also advise customers to consider replacing the defibrillators as soon as possible. And that could mean before the supply of disposable parts is used up. FDA and Danko laboratories have notified healthcare professionals about important new safety changes in the labeling for mithoprex or mitheparastone, also known as RU-486. Mithoprex was approved in 2000 for the termination of early pregnancy. That's 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. Now while these risks are rare and they 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 healthcare 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. Mitheparastone is not effective for terminating these pregnancies. The patient medication guide instructs patients who've received mitheparastone to contact their healthcare 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 of ectopic pregnancy or infection and that heavy bleeding may require surgery. Also, if patients having problems seek help from an emergency room, their advice to take their medication guide with them, this alerts the practitioner that the patient's undergoing a termination of pregnancy so she can be appropriately assessed. FDA is going to continue to monitor the use of mitheparastone, may take further action. In previous broadcasts, we've talked about many cases of medication error 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. Jaco 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. Jaco has also posted a list of the most problematic drug name pairs for specific health care settings and facilities must include at least ten of these drug combinations on their own lists. Many of the name pairs on Jaco's list come with specific safety strategies for that particular name combination. But Jaco also has a number of general recommendations for preventing drug name mix-ups. Let's take a look at just a few of those recommendations. Prescribers should write both the brand and generic name on prescriptions for drugs 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 it's truly necessary and encourage staff to read back all orders, spell the product's name, and state the 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 pre-printed 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. In a previous program we warned about dangerous and sometimes fatal overdoses that occurred when the drug Methotrexate was accidentally taken daily rather than weekly as intended. In a recent article the Institute for Safe Medication Practices points out a similar hazard with the chemotherapeutic drug CNU or LeMustine which is used to treat brain cancer and Hodgkin's disease. A single dose of oral LeMustine should only be taken once every six weeks. But like Methotrexate, LeMustine 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 LeMustine overdose. A physician had written a poorly legible prescription for LeMustine 190 milligrams every six weeks. The pharmacist misunderstood the direction, says daily for six weeks and dispensed a six-week supply of capsules with directions to take 190 milligrams daily. The patient's physician hadn't explained how to take the medication so the patient followed the label directions and took 190 milligrams daily for 21 days. She was hospitalized with severe bone marrow suppression and acute bleeding and she died a month later. ISMP says that Bristol Myers Squibb has enhanced the labeling in the packaging of CNU. Single dose only is now printed in red on the label and dispensed 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 milligrams or less for each prescription or order. Use unit of use dose packs that are available for the manufacturer. Each 300 milligram dose pack contains two 100 milligram capsules, two 40 milligram capsules and two 10 milligram capsules with instructions for the pharmacist to select the correct patient dose within 10 milligrams, 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 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 verbal 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 the caregiver. In a previous program, we told you about the importance of recognizing and promptly treating a potentially fatal condition called trally or transfusion related acute lung injury in patients who have recently received a transfusion. Now we want to talk about an older but still persistent cause of patient deaths from transfusions, ABO incompatibility. Why are patients still dying of ABO incompatibility? We know that the blood is pretested for blood type and then it's matched to the patient. The problem is that most deaths from ABO incompatibility don't occur because the blood isn't tested properly. These accidents happen because the patient is misidentified. In other words, they happen when the hospital staff fails to use established procedures to identify the patient when drawing the pretransfusion blood samples. So what's the FDA recommending? Well, the key here is having and using standard operating procedures. That goes for pretransfusion testing and for the transfusion itself. And it includes procedures to accurately identify the patient before drawing the pretransfusion blood sample, procedures to ensure that the proper unit of blood is released by the blood bank, and procedures to identify the patient again just before the transfusion. You're talking about identifying the patient right before the transfusion. Now the FDA has a new barcode regulation that will require a barcode on blood products. How is that going to affect that? It should help healthcare personnel make sure that the right unit of blood gets to the right patient. FDA is now going to require that blood products be labeled with a barcode similar to the ones used in supermarkets. The barcode on the container can be read with a scanner at the patient's bedside to be sure that it's the correct unit of blood for that patient. 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. They cite the case of a 16-year-old boy who received four milliliters of undiluted, one-in-a-thousand epinephrine solution intracavernously to treat priopism. A one-in-a-million 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 one to a thousand, meant that the epinephrine had already been diluted with a thousand milliliters of fluid. To prevent this kind of error, ISMP recommends that you not stock the large 30-milliliter vials of one-in-a-thousand epinephrine. If you need this strength, stock only the small one-milliliter ampules. That way, a massive overdose can only be administered by using a large number of ampules, and that should alert the practitioner that something's wrong. The FDA has issued a warning to consumers not to use a product sold on websites for treating erectile dysfunction and enhancing sexual performance. It's called ACTRRX, or Yilishin, and it's promoted as a dietary supplement. The problem is that it contains prescription strength quantities of sildenafil, which is the active ingredient in Viagra. Well, aside from the legal aspects of selling sildenafil without a prescription, where's the harm to patients? We do know that sildenafil is effective in treating erectile dysfunction. Well, there are two potential hazards here. The first one has to do with simply potency and purity. The consumer can't really be 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 that contain nitrates. Now, these nitrate-containing prescription drugs are commonly taken by patients with diabetes, hypertension, hypercholesteroemia, and heart disease, and unfortunately, these same patients often have erectile dysfunction, and those people might be especially susceptible to ads for these so-called dietary supplements, and of course, that would put them at risk for serious adverse events. Now, how widespread is this problem? Is it limited to just this product that you mentioned? It's not just this product, and even if we didn't have this product, the problem wouldn't go away. It is a long-standing problem. Last year, the FDA issued warnings on several other so-called dietary supplements that contained either a sildenafil or a tidalafil, which is 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 pop up on the internet. So what should health professionals be telling their patients? Basically, the message is that if you have erectile dysfunction, you should see a doctor rather than trying to treat it over the internet. Well, that's all for this edition of FDA Patient Safety News. Remember, you can get more information on all the stories you've seen here today by visiting our website. We also urge you to use the website to report problems you've encountered with medical products. That's how we learn about problems so we can alert others. We'll be back next month with another edition, so watch for us. Until then, for the U.S. Food and Drug Administration, I'm Anita Rayner. And I'm Mark Barnett. See you next time.