 This is FDA Patient Safety News. In this edition, a new test to help rule out heart attacks, new warnings on counterfeit procreate, the dangers of IV infusions of free water, and an FDA proposal to require barcodes on drugs. 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 Rayner. Let's start with our new products bulletin board and tell you about some medical products FDA recently cleared for marketing. You can find information on all FDA cleared medical products on FDA's website. FDA has recently cleared for marketing a new laboratory blood test that will increase the ability to roll out a possible heart attack in patients' complaining of chest pain. The test is called the Albumin Cobalt Binding, or ACB test, and it's manufactured by Ischemia Technologies Incorporated. This is the first new blood test to evaluate heart attacks since 1994 when the blood test for troponin was introduced. The test relies on the fact that serum albumin normally is able to easily bind to metals such as cobalt. Before an MI, there are structural changes in the albumin that make it less able to bind metals. During the test, cobalt is added to a blood sample, and the free cobalt, that is the amount that isn't bound to the albumin, is measured. If the test is negative, that is if it shows that the patient does not have a high level of free cobalt, this may indicate that the patient has not had an MI. But Mark, I'm assuming this isn't a standalone test for MI. Not at all, it's not a standalone test. It has to be used in conjunction with other tests to rule out an MI in a patient who's having chest pain. The ACB test can be viewed as a third component in a trio of tests for MI, the other two being the ECG and the troponin test. Given that we already have the ECG and troponin test, what does this new test actually add? It adds accuracy. Only about a quarter of patients who present in the emergency room with heart attack symptoms are actually having an MI. In a study conducted by the manufacturer, physicians using the ECG and the troponin test together were about 50% accurate in ruling out an MI. When they added the ACB test, their accuracy rose to about 65%. In a previous broadcast, we told you about the counterfeiting of the drug Procrit, which is marketed by Orthobiotec Products LP. Procrit is used to stimulate the production of red blood cells in patients with severe anemia. In a significant new development, Orthobiotec and FDA have now alerted healthcare providers and consumers that three more lots of counterfeit Procrit have been identified. They're labeled as 40,000 units per milliliter. I understand there's a new hazard this time. That's right. Our concern with the prior lots of counterfeit Procrit was focused on the active ingredient. That is, whether the strength of the counterfeit product might have been lower than what was stated on the label. This time, counterfeit Procrit was found to be contaminated with bacteria and that could pose a significant hazard to patients. FDA testing has also shown that some of the counterfeit product contains no active ingredient. The three affected lot numbers and expiration dates appear on your screen and can also be found on our website. It's important to note that authentic Procrit was also distributed under these lot numbers. If I'm a user of Procrit and eat it, can I tell the difference between the counterfeit and the real thing? Well, there are things to look for. In a March 2003 letter to healthcare professionals, Orthobiotek points out that there are several differences between the features of this counterfeit product and authentic Procrit. For example, one difference is with the carton closure seal. The seal on authentic Procrit leaves a visible mark on the package when it's removed and the authentic seal has the letters OB PLP void printed in random sequence on its underside, which you can see when the seal is removed. When counterfeit product seals are removed, they leave no visible mark and they have no printing on the underside of the seal. Ortho's website also points out other differences to look for. FDA is urging healthcare providers and patients to check the packaging and vials very carefully before using this product. If you receive any product that you suspect is counterfeit, don't use it. Store it properly and promptly contact the FDA and Orthobiotek. And if you know of patients who could have the counterfeit product, contact them and provide them with this information. Be sure to go to our website for instructions on how to contact FDA and Orthobiotek and for more details about this counterfeit product. Roche Diagnostics Corporation has issued an alert to healthcare providers about some of the company's blood glucose test strips. Some lots of Roche's Advantage 2 test strips that were intended only for distribution outside the United States have been repackaged and re-imported into the US as AccuCheck Comfort Curve test strips. In some cases, the expiration date on these test strips has been altered and extended beyond the original expiration date and that may affect the accuracy of the results. And since these test strips were manufactured for non-US markets, they're calibrated differently. The performance of these products could also be adversely affected if the persons who altered the expiration dates didn't store or handle the strips properly. The affected product lot numbers are shown on the screen and you can also find them on our website. If you have AccuCheck Comfort Curve test strips from any of these lot numbers, you should stop using them and either return the product to the place of purchase or contact Roche Diagnostics at 1-800-858-8072 for further instructions. Roche Diagnostics is also asking that you call this number if you notice any unusual appearance in the packaging, lot numbers or expiration dating on any of the company's blood glucose test strips. Although abbreviations and acronyms can save time, they can also cause medication errors. Abbreviations aren't always read the same way and they can be interpreted differently by different practitioners. That's why the National Coordinating Council for Medication Error Reporting and Prevention is encouraging practitioners to avoid using abbreviations when prescribing medications. Medication errors often happen when the reader misinterprets a poorly written abbreviation or acronym. For example, 10-fold insulin overdoses have occurred when the abbreviation U for units is read as a zero. That's likely to happen when the U is written too closely after the number. A patient died when 20 units of insulin was misinterpreted as 200 units. Likewise, if they're not written clearly, the abbreviations for microgram and milligram can easily be mistaken, causing a thousand-fold error. Latin abbreviations can cause trouble either because they're written poorly and thus misinterpreted or because people don't understand their meaning. The term QID has sometimes been interpreted as QD and vice versa and that leads to a four-fold dose error. In one case, a patient died when a prescription for furosimide 40 milligrams QD was misinterpreted as QID. And sometimes mistakes occur because two abbreviations sound alike. For example, an investigational drug used to treat cystic fibrosis called CPX sounds similar to CTX, which is the abbreviation for the chemotherapy drug Cytoxin. You'll find other examples of confusing abbreviations on our website. The Institute for Safe Medication Practices recently issued an alert that warned physicians, nurses and pharmacists about the danger of giving patients intravenous infusions of free water. That is water that doesn't contain any dissolved ions. The case they cited was an elderly diabetic patient who was admitted to the ICU with pneumonia, congestive heart failure, respiratory failure and severe hypernatremia. Because of the patient's hypernatremia, the physician didn't want him to receive any more sodium and because of the patient's diabetes, the physician didn't want to infuse dextrose solution. So we ordered that sterile water for injection be administered by IV infusion. This was presumably intended to alleviate water loss in the patient and thus correct the hypernatremia. The patient experienced a hemolytic reaction and acute renal failure and died. Mark, this was presumably because of receiving the sterile water for injection. That's right. ISMP's basic safety message is that free water such as sterile water for injection should never be administered through IV infusion because hypotonic solutions can result in hemolysis. But sterile water for injection usually isn't available as an IV solution. No, in fact, it's not. It's used in the pharmacy to prepare various IV solutions and it's not intended to be used alone as an IV infusion. In this case, the physician ordered a large bag from the pharmacy. They complied and the nurse administered the IV infusion. Isn't there a warning on the bags of sterile water for injection saying that it shouldn't be used as an IV infusion? Yes, that's a good point. Usually there is a warning but sometimes it doesn't stand out and in fact, in this particular case, the warning label was on the opposite side of the bag. What's ISMP recommending to prevent this kind of problem? Well, here's some of what they're recommending. First of all, they're saying that practitioners should understand the danger of infusing sterile water without any additives. They should be aware that in severe hypernatremia sodium levels should be brought down slowly with infusions that contain some sodium. Sterile water for injection should never appear in order entry systems for prescribers and if an order for sterile water is received, this should trigger an immediate call to the physician. What about safeguards in the pharmacy? Well, they are recommending some in the pharmacy. They're recommending that pharmacists never allow the ingredients used to compound IV solutions to leave the sterile compounding area and of course that would include sterile water for injection and they're saying that warning labels should be placed on the front of bags containing sterile water for injection. Everyone's seen the barcodes found on food and other consumer goods. Now, FDA has issued a proposal to require barcoding on almost all drugs and blood products. Under this proposal, barcoding would be required in all prescription drug products except for physician samples on most OTC drugs that are commonly used in hospitals and on vaccines. The barcode would contain at a minimum the drug's NDC or national drug code number. This number identifies each drug, its manufacturer, its dosage form, strength and package size. Blood and blood components for transfusion are also included in the proposal. Under the proposal, these products must have machine readable information which could be a barcode that includes blood and RH type, the facility that prepared the unit and codes that can trace back to the donor if necessary. In hospitals with barcode scanners and computerized patient information systems, the barcoding of drugs and blood products can prevent many medication errors such as giving a patient the wrong drug or unit of blood or the wrong dose or the right drug in dose at the wrong time. When the drug's barcode is scanned, a computer would compare the scanned information against the patient's drug regimen before the drug is given to the patient. So for example, barcoding could prevent a child from receiving an adult dosage of a drug or keep a patient from receiving a duplicate dose of a drug he's already been given. A barcode system could also allow the computer to record the time the patient receives a drug ensuring more accurate medical records. FDA estimates that when this barcode rule is implemented, 50% more medical errors could be caught before the drugs are dispensed or administered. That translates to 413,000 fewer adverse events over the next 20 years. And there's evidence from some hospitals that already have barcode systems in place that they can reduce even more errors. You can find complete information on FDA's barcode proposal on our website. All of us know by this time about the overprescribing of antibiotics and how this promotes the development of drug-resistant bacterial strains. And yet the problem persists. According to the CDC, about half of the 100 million antibiotic prescriptions written each year in physicians' offices in the US are unnecessary because they're prescribed for the common cold and other viral infections. Unnecessary use of antibiotics in hospitals is also common. In an effort to reduce this problem, FDA is going to require changes in the labeling for all systemic antibiotics. By early next year, healthcare providers will see new statements in the labeling advising that these drugs should be used only to treat infections that are believed to be caused by bacteria. But there's also a role for the patient. That's right. When patients fail to complete the full course of treatment, that also promotes drug resistance. And so part of the labeling will encourage physicians to counsel their patients about the proper use of these drugs and the importance of taking them exactly as directed. In other words, to complete the full course of therapy and not to skip doses even if they feel better. You'll find more information on this new labeling on our website. 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 US Food and Drug Administration, I'm Anita Reiner. And I'm Mark Barnett. I'll see you next time.