 This is FDA Patient Safety News. In this edition, a rapid test for HIV that uses oral fluids instead of blood, a warning on hyperglycemia and diabetes with certain antipsychotic drugs, and advice for patients on home pregnancy tests. 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 Rainer. Let's start with some medical products FDA recently approved. FDA recently approved the first rapid HIV diagnostic test that uses oral fluids instead of blood. The Oryquic Rapid HIV-1-2 Antibody Test provides HIV-1 antibody results with over 99% accuracy in as little as 20 minutes. The test is manufactured by Oryshire Technologies Incorporated. I thought the Oryquic Test was already approved. The original version of this rapid test was approved in 2002 to detect antibodies to HIV-1 in blood samples. Since then, it's also been approved to detect HIV-2 in blood. But this latest approval is important because now oral fluid can be used to screen for HIV-1 antibody instead of blood. The person being tested for HIV-1 takes the device which has an exposed absorbent pad at one end and places the pad above the teeth against the outer gum. The person gently swabs completely around the outer gums both upper and lower one time around. The device is then inserted into a vial containing a solution. In as little as 20 minutes, the test device will indicate if HIV-1 antibodies are present in the solution by displaying two reddish-purple lines in a small window on the device. So I'm assuming that having this test gives people who may be skittish about a finger stick another option. That's right. People who shy away from finger sticks or punctures might be less reluctant to be tested with this device. And the risk of infection to healthcare workers performing the test is greatly reduced since they won't be exposed to blood. Now, can you use this device to screen potential blood donors? The test is only approved as preliminary screening for HIV-1 antibody and it can't be used to screen for blood donors. And as with all screening tests for HIV, if the ORACWIC test gives a preliminary positive result, this must be confirmed with a more specific blood test. FDA has approved a new drug to treat secondary hyperparathyroidism in dialysis patients with chronic renal disease and also to treat hypercalcemia in patients with parathyroid cancer. The drug, called sensipar or synacalsate, is manufactured by Amgen. Sensipar is the first in a new class of compounds called calciumimetics. These compounds activate calcium receptors in the parathyroid gland and thus decrease the secretion of parathyroid hormone or PTH. If a patient with chronic kidney disease who's on dialysis develops secondary hyperparathyroidism, this can alter calcium and phosphorus metabolism and that can lead to bone pain, fractures and cardiovascular death. By reducing PTH secretion in these patients, sensipar lowers serum levels of calcium and phosphorus and the drug has a similar effect in treating parathyroid carcinoma where it reduces abnormally high levels of serum calcium. Some patients in clinical trials with sensipar experienced abnormally low serum calcium levels and so patients on the drug should be monitored frequently for serum calcium. In an earlier program, we told you that one lot of Dura-G6 75 microgram per hour transdermal patches was being recalled by Janssen Pharmaceutical. The recall has now been expanded to include four more manufacturing lots. These patches deliver the opioid fentanyl which is used to treat severe chronic pain. These lots are being recalled because of a concern that a small percentage of the patches may leak medication because of an improper seal along one edge of the patch. If the medication leaks from the patch directly onto the patient's skin, overdosing may occur. This can cause nausea, sedation, drowsiness or potentially life-threatening complications. Caregivers can also be exposed so anyone who comes in contact with a leaked medication should rinse the exposed skin thoroughly with water. Don't use soap because this could increase the drug's absorption to the skin. Patients could also be underdosed as a result of a leaking patch. In an opioid-tolerant patient, this can lead to withdrawal symptoms such as sweating, sleeplessness and abdominal discomfort. If you have any product with these lot numbers, stop using or administering or distributing it. Go to our website to find Janssen Pharmaceutical's instructions on how to return the product and on helping patients who may have the product. Or you can call Janssen directly at 1-800-JANSSEN. FDA has asked manufacturers of all atypical antipsychotic drugs to add a new warning to the drug's label about the increased risk of hyperglycemia and diabetes. Atypical antipsychotics include clozaryl, risperdol, zyprexa, seriquil, geodone and abilify. Epidemiologic studies suggest that the risk of hyperglycemia and diabetes is increased in patients taking clozaryl, risperdol, zyprexa and seriquil, although the relationship isn't completely understood. In some cases, the hyperglycemia was extreme and it was associated with ketoacidosis or hyperosmolar coma or death. Geodone and abilify weren't marketed at the time this epidemiologic study was conducted. For some patients, the hyperglycemia resolved when the drug was discontinued, but others required continuing treatment for their diabetes even after they stopped taking the drug. The warning recommends that patients with diabetes who are started on atypical antipsychotics be monitored regularly for worsening of glucose control. Patients starting on these drugs who have diabetes risk factors, such as obesity or a family history of diabetes, should have a fasting blood glucose test at the start of treatment and periodically thereafter. And all patients treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia, such as excessive thirst, excessive appetite, frequent urination or weakness. If they develop symptoms of hyperglycemia while they're on these drugs, they should have a fasting blood glucose test. Here's news to pass along to your colleagues in the clinical laboratory. It's about the recall of certain cards used for antimicrobial sensitivity testing. The product is the Vitec GPS-107 gram-positive sensitivity card manufactured by Biomaria Incorporated and used with the company's Vitec system. Two lots are currently being recalled. Those lot numbers are M83X and B28E. Some of these cards were stamped with an incorrect code and that could cause them to read and report the cards incorrectly and inaccurate test results could lead to the choice of an ineffective antibiotic and that could have potentially life-threatening consequences. FDA has asked the company to work with clinical laboratories to notify physicians who ordered this test about the problem. If you have Vitec GPS-107 cards in your facility from the recalled lots, you should stop using them and contact the company. Peredural nutrition can be a life-saving therapy, but it can also be especially vulnerable to errors. In a recent newsletter, the USP Center for the Advancement of Patient Safety describes a wide variety of ways that errors can occur when prescribing, compounding, dispensing and administering these solutions. USP points out that many healthcare facilities now have performance improvement programs to monitor the appropriate use of parenteral nutrition, the accuracy of orders and complications from the procedure. But despite these improvement programs, errors continue to occur. Let's start with prescribing errors. The USP cites examples of incomplete orders that omitted a base solution or an essential component like protein or dextrose or electrolytes or the order didn't specify a total volume or flow rate. There are other kinds of prescribing errors. In one report, a neonate was prescribed parenteral nutrition containing less than 1% protein as well as both calcium and phosphorus electrolytes. Even though the pharmacy told the prescriber that the calculated protein wasn't high enough to prevent calcium phosphate from precipitating, the physician didn't change the order. So shortly after the parenteral nutrition was hung, precipitate formed in the solution. The infusion was then stopped and the order changed. Now, the patient wasn't harmed in this case, but precipitates of calcium phosphate are one of the most dangerous incompatibilities, and they've sometimes caused fatal embolisms. Dispensing errors occur in preparing the parenteral nutrition using automated compounding devices and labeling the bag. And a significant number of errors occur when administering parenteral nutrition. For example, an IV pump can be incorrectly programmed. In the USP sites, a case where an infusion was supposed to occur at 80 milliliters per hour, but the IV pump was programmed for 802 milliliters per hour. The entire bag infuses in only 2 hours and 45 minutes. The patient experienced muscle spasms and shortness of breath as a result of this fluid overload and had to undergo additional diuresis. Sometimes parenteral nutrition can mistakenly be administered peripherally when it was ordered as a central line infusion. In one report, a central hyperalimentation IV was administered through a peripheral line and ran for 42 hours before the error was discovered. The patient developed phlebitis at the IV site. Capillary blood glucose levels weren't monitored and the patient's glucose level peaked at 331. USP's article contains a number of recommendations to prevent these kinds of errors from suggestions on standardizing order forms to visually inspecting the formulation for particulates or phase separation. It's been estimated that about a third of US women have used home pregnancy tests. They allow women direct access to highly sensitive and personal information and because they can provide results quickly, these tests can give pregnant women an earlier opportunity to get prenatal care. Patients often ask about the accuracy of home pregnancy tests and that can be a confusing issue. Some of these tests are labeled 99% accurate. Now, I'm assuming the FDA has approved that statement so that that's true. Well, yes, but FDA judges the accuracy of home pregnancy tests by comparing them to standard lab tests for pregnancy. Specifically, they look at the ability of the test to detect HCG, human corionic anatotropin, which is the standard marker for pregnancy. So what you're saying is that when a test is labeled 99% accurate, it's 99% accurate compared to the lab test. That doesn't mean that it'll necessarily detect pregnancy accurately 99% of the time. That's right. A test's ability to detect pregnancy in any particular woman could be lower than 99% depending on how much HCG sees secreting. And that can depend on the stage of pregnancy and on the woman's individual biology. And the tests vary in their ability to detect low levels of HCG. So what do we tell women about all this? Well, patients need to understand that there's a possibility that they can get both false positive and false negative results. Of course, the woman finds out about a false positive when she has a period and she finds out about a false negative when she fails to have a period or shows signs of pregnancy. So I guess the bottom line for the woman is don't jump to conclusions. That's right. And most importantly, women shouldn't jump to the conclusion that they're not pregnant just because they got a negative test result. Until they know for sure that they're not pregnant, women should avoid behaviors that could harm a fetus like smoking, drinking, poor nutrition, and taking certain medications. We've had several stories over the past few months on the growing problem of counterfeit drugs in which we've alerted healthcare professionals about specific cases of counterfeiting and how to spot the counterfeit product. But you know there's a role for the patient in this fight against counterfeiting too. A recent FDA report lists several steps that patients can take to help assure that they're not using bogus pills or medical devices. But to help identify a counterfeit drug or device, doesn't a patient first have to know what the genuine product is supposed to look like? Yeah, but you know patients who use a product over a long period of time actually get to be quite expert in recognizing how it's supposed to look, how it's supposed to taste, how it's supposed to smell. So in fact that's the key to their being able to detect a counterfeit product. So what should we be telling patients to look for? Well the FDA report lists several things. The most obvious is to tell the physician or pharmacist if the product looks or tastes or smells differently than the one they're accustomed to. But with a prescription drug that could be due just to the pharmacist changing the brand? Or it could be due to the pharmacist using a generic instead of a brand name, that's true. But it also could be due to counterfeiting and interestingly enough it also could be to a medication error. And of course that should be reported too. So what else should we be telling patients? Well there are several things. First of all they should report new or unusual side effects with a drug that they're accustomed to taking. They should report a recurrence of their original symptoms despite taking the medication. And if it's an injectable they should report unusual pain or redness at the injection site. 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.