 This is FDA Patient Safety News. In this edition, stronger requirements to prevent birth defects from isotretinoin or accutane, a recall of injectable products that may not be sterile, and answering patient questions about flu vaccine. 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 a story on new requirements for prescribing and dispensing accutane or isotretinoin. In a previous story, we told you that FDA was developing stronger requirements to prevent fetal exposure to the drug accutane or isotretinoin, along with its generic equivalents such as amnestym, sotret, and clarivus. Isotretinoin is used to treat severe recalcitrant nodular acne, but it can cause serious birth defects if taken by pregnant women. These requirements are now going into effect in a new program called iPledge. Under this program, wholesalers, prescribers, pharmacies, and patients, both men and women, must register. Also, women who are capable of becoming pregnant must have two negative pregnancy tests before isotretinoin can be dispensed to them, and they also must have a negative pregnancy test each month while they're taking the drug. Now this isn't the first attempt by FDA to keep pregnant women from taking the drug. What's the difference between this iPledge program and earlier efforts? Well, the basic difference is that isotretinoin is now a restricted distribution drug. That means that unless they register, wholesalers are not going to be able to distribute the drug, pharmacists are not going to be able to dispense it, physicians are not going to be able to prescribe it, and patients are not going to be able to receive it. Well, what's the overall timetable for this? Doctors and patients have to be registered in the program by December 31st, 2005, and again the drug is going to be available only from pharmacies that have registered, and pharmacies have to register by October 31st, 2005 in order to obtain the drug from a registered wholesaler. Now, if I'm a prescriber or a pharmacy or for that matter a patient, how do I sign up? Sign up either on the phone or online, and those addresses are on our website. Now if you're a patient, then you've got to see your doctor about how to register. Now isotretinoin has also been associated with psychiatric symptoms. There's been an association between taking the drug and symptoms of depression, suicidality and psychosis, and for that reason FDA has strengthened the labeling to help practitioners and patients identify and manage these risks. If I'm a practitioner, what should I watch for, and what should I tell my patients to watch for? Any patient being treated with this drug should be carefully monitored for symptoms of depression, or suicidality, or psychosis. Patients should be told to stop the drug and contact their health professional if they experience any of these symptoms. But it's important to know that stopping the drug by itself may not be sufficient. Drug evaluation and intervention may be needed to prevent patients from harming themselves. Go to our website for more complete information on the I Pledge program. Now we want to tell you about a recall of certain injectable drug products because they may not be sterile. Of course using non-sterile injectables could lead to life-threatening patient injury or even death. The recall covers all injectable products made by Central Admixture Pharmacy Services, or CAPS, at the company's Lanham, Maryland location. They include cardioplegia solutions, oxytocin injectables, dialysate solutions, TPN products, magnesium-containing injectable products, injectable promethazine, bupivocaine, diltiasm, norepinephrine, and sephaziline products, and heparin replacement solutions. Go to our website for a complete list of the recalled products. The company distributed the affected products to hospitals in Maryland, Delaware, Washington, D.C., and Virginia. At this time, only injectables made at the CAPS Lanham site are included in this recall. CAPS has directly notified known hospital customers about the recall, but FDA is urging hospitals, physicians, and healthcare workers to examine their supplies for any CAPS injectable products made at the Lanham, Maryland facility. If you have these products, stop using them immediately and quarantine them. Also, please notify FDA of any complaints or problems with these products. You can find out how to do that on our website. FDA has issued a public health notification about the Gambo Prisma continuous renal replacement system, which is used for hemodialysis in critically ill patients. Several serious injuries and deaths have occurred when healthcare personnel did not adequately respond to one of the system's three alarms that indicate incorrect weight change detected. This resulted in excessive ultrafiltration where too much fluid was removed from the patient's body. These alarms are intended to alert the user when a potential fluid imbalances occurred during therapy, and both the FDA and the manufacturer are warning that you should never ignore or override the alarms without first identifying and removing the cause of the alarm. If you're using one of these devices, refer to the operator's manual for detailed instructions on what each of the alarms means and how to respond to it. You can get more information on our website. Custom RX compound and pharmacy of Richfield, Minnesota is recalling TriPan Blue 0.06% alphalmic solution, which is used in cataract surgery. This solution may be contaminated with Pseudomonas aeruginosa. If applied to the eye, the product could cause serious infection and possible blindness. This dark blue solution is packaged in 1CC sterile tuberculin syringes and was distributed to hospitals and clinics in Maryland, Minnesota, Illinois, Nebraska, North Dakota, Michigan, Pennsylvania, and D.C. If you have this product, you should stop using it immediately and return all unused syringes to the company for destruction. Vacuum-assisted wound closure, also known as negative pressure wound therapy, can help heal certain non-healing wounds by removing fluids and infectious material from the site. The therapy is applied to a special foam dressing packed in the wound cavity or over a flap or graft. A recent FDA article in Nursing 2005 highlights the importance of carefully selecting and monitoring patients being treated with this therapy. The article describes a patient who had his leg amputated after being seriously injured in the fall. During his recovery, he was prescribed anticoagulants to prevent venous thromalemilism. Two weeks after the amputation, he began treatment with vacuum-assisted wound closure to promote healing. But during a dressing change while undergoing the therapy, he experienced serious bleeding from several areas in the wound. He later died reportedly from severe hemorrhage and possible acute MI. Further follow-up revealed that complications associated with bleeding had begun at the time of surgery before vacuum-assisted closure therapy was started. The article lists several precautions to help prevent this kind of bleeding in patients undergoing vacuum-assisted wound closure therapy. For example, certain patients should be closely monitored for overt and occult bleeding. This includes those who are actively bleeding on anticoagulants or who have weakened, irradiated, or sutured blood vessels or organs that are close to the wound. Use protective barriers, such as gauze impregnated with petrolatum, to protect vulnerable blood vessels or organs. And follow the device manufacturer's instructions for use, including selecting the correct negative pressure that's recommended for that type of wound. Genentech is notifying health care professionals about updated proteotoxicity information related to Herceptin or Trastuzumab. Herceptin is used to treat patients with metastatic breast cancer, whose tumors over express the HER2 protein. The labeling for Herceptin already contained a boxed warning that the use of the drug can result in ventricular dysfunction and conjective heart failure in some patients. Genentech's letter now provides additional information about that risk based on a preliminary analysis of data from the National Surgical Adjuvant Breast and Bowel Project. The new information includes how often these adverse events occur and when they occur in relation to starting treatment. In a recent medication safety alert, ISMP warns about inadvertently administering nemotapine or nematop intravenously. This has resulted in patient deaths and serious injuries. Nemotapine is a calcium channel blocker that's used to prevent vasospasm in patients with subarachnoid hemorrhage. You said the problem arises when the drug is given IV, but this is a capsule supposed to be given by mouse. That's right, but for patients who can't swallow, you can extract the contents of the oral capsule and put it in a syringe and then inject it into a nasogastric tube. But putting it in a nasogastric tube is still not the same as giving it IV. That's right, but once it's in a parenteral syringe, that's when accidents can occur. ISMP notes that several incidents have occurred where a patient's been injected IV and then suffered severe hypotension, cardiac arrest, and death. ISMP recommends that pharmacists warn patient care personnel about the danger of IV administration each time that nemotapine is dispensed. ISMP also notes that some pharmacies are trying to prevent this kind of problem by preparing nemotapine in advance for patients who can't swallow rather than having it prepared in the patient care area. They're packaging the drug in amber-oral syringes and labeling them for oral NG use only. Novo Nordisk recently notified pharmacists about a packaging change that's designed to help prevent mix-ups when dispensing two of the company's insulin products. Novolog, a rapid-acting insulin analog, and Novolog Mix 7030, a premixed insulin analog. Until recently, the packaging for Novolog and Novolog Mix 7030 looked very similar. Both boxes were white with a blue band. The current packaging for Novolog Mix 7030 looks similar to the previous packaging, and it remains white with a blue band. But the packaging for Novolog has been changed to white with an orange band. The company's letter also makes several recommendations to help pharmacists avoid dispensing errors. For example, if you remove the insulin from the box for any reason, be sure to put it back in the exact same box. Store medications with similar names separately from one another. Ensure that patients know the insulin name and type that was prescribed for them, and then have patients check the name and type when they're picking up their prescriptions. Here are some of the questions about FDA and the flu vaccine that some of your patients may be asking this time of year. For example, people often ask about what kinds of flu vaccines are available. The answer is that there are two types, the traditional flu shot, given intramuscularly, which contains killed or inactivated virus, and a nasal spray, which contains attenuated live virus. The injection is approved for various ages and population groups, but the nasal spray is approved only for healthy people between the ages of five and 49. People often ask why the supply of vaccine during each year's flu season seems so unpredictable and why shortages sometimes arise. Part of the answer is that because the virus mutates, each year's vaccine is different from preceding years, and that means that a batch of vaccine can't be kept and used the following year. Early each year, a public health committee has to decide which three strains of the virus are gonna be included in that year's vaccine. The goal is to be sure that the strains in the vaccine are similar to the ones that are gonna be in circulation for that particular flu season. To complicate the picture, it takes at least six months to produce a flu vaccine using the present method, which involves using millions of live eggs to grow the virus. In the future, we hope that new methods using cell cultures or recombinant protein or DNA-based vaccines will make the process shorter, but it will be years before those technologies can be used to mass produce a flu vaccine. While it's still too early to predict how much vaccine is gonna be available for the upcoming flu season, FDA recently approved a new inactivated vaccine called Flurix for immunizing adults 18 and older. This is gonna offer an additional vaccine supplier for the upcoming flu season and help increase the number of doses that are available. You can find a projection of the number of doses that each manufacturer expects to produce and distribute on the CDC website, which you can get to from our website. 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 Reiner. And I'm Mark Barnett. See you next time.