Pharmacy & Therapeutics - September 2008 - (Page 522)

NEW DRUGS one leg. Another delivery catheter, containing an endovascular graft, is inserted through a small skin incision on the other side of the groin. This graft connects the first graft with the arteries that go to the other leg. Purpose: The graft system is used instead of more invasive open surgery in patients with an AAA. Benefit: The device should benefit patients by preventing further growth and rupture of the AAA. Contraindications: This stent graft should not be used in patients with any condition that threatens to infect the graft, in patients with sensitivities or allergies to the device materials, or in patients who cannot undergo the necessary imaging and implantation studies. Sources: www. medtronic.com; www. fda.gov Name: HeartMate II Left Ventricular Assist System Manufacturer: Thoratec Corporation, Pleasanton, Calif. Approval Date: April 23, 2008 Use Classification: Heart-assist devices are surgically implanted mechanical pumps that help the heart’s ventricles pump blood to the rest of the body. Previous models were too large to be placed in the upper abdomen of some women and smaller men. Description: An electrical cable powers the blood pump and passes through the patient’s skin to an external controller worn on the patient’s waist. The controller either is powered by batteries or is connected to an electrical power outlet. Blood flow is determined according to the patient’s need, and the controller monitors pump performance. An alarm is sounded if a dangerous condition or a possible malfunction is detected. The system can operate on two external batteries, and patients have freedom of movement for up to three hours. DRUG NEWS as soon as possible if they suspect that the device is not working correctly. Source: www.fda.gov Purpose: This is the first device that mechanically supports the weakened heart of a small adult with heart failure who may be at risk of dying while awaiting a heart transplant. Benefit: Instead of the standard pulsatile pump that simulates the action of the heart, a continuous-flow pump constantly moves blood with a single spinning rotor. This design allows the device to be reduced to a mere three inches in length and a weight of approximately one pound. Source: www.fda.gov Recalls CentriMag Blood Pumping System. Public Health Notification Possible Malfunction of Electronic Devices during CT Scans. The FDA has issued an alert about the possibility that the x-rays used during computed tomography (CT) might cause malfunction of some implanted or external electronic medical devices, such as pacemakers, defibrillators, neurostimulators, and drug-infusion pumps. Here are recommendations to reduce the risk: 1. Before the scan begins, the operator should use scout views to determine whether the patient has a medical device. If so, the operator should assess its location in relation to the scan’s range. 2. If a device is within or next to this range, the operator should determine the type of device and try to move an external device out of the scan’s range. Patents should shut off neurostimulators during the scan. The lowest possible x-ray tube should be used, and the x-ray beam should not remain over the device for more than a few seconds. 3. If the scan lasts more than a few seconds, the staff should be ready to take emergency measures to treat any adverse reactions. 4. After the scan, patients should turn the device back on, check it for proper functioning, and contact their physician Levitronix and the FDA have notified health care professionals of a Class 1 recall of the CentriMag Extracorporeal Blood Pumping System and Primary & Backup Consoles, distributed from Januar y 2001 through March 2008. This device temporarily replaces the function of the heart and lungs and maintains the appropriate circulation of blood and oxygen levels during surger y. The company’s letter, dated July 24, 2008, recommended that physicians not use Valleylab Force FX-C or SSE2L electrosurger y devices with the CentriMag system because of the possibility that stoppage of the pump might cause serious injury or death. This recall action is an interim step while the firm further investigates the source of the problem. Source: FDA, August 1, 2008, www. fda.gov Boston Scientific NexStent Monorail, NexStent Carotid Stent, and Monorail Deliver y System. On June 6, 2008, a voluntary recall was initiated because of the possibility that the tip of the stent deliver y system might detach from the delivery system during the stenting procedure. Such an event can lead to the need for a longer procedure and can cause vessel wall injury, stroke, or emergency surgery in order to remove the detached tip. This recall does not affect stents that have already been implanted. The stents were manufactured from June 12, 2007, through May 2, 2008, and were distributed from June 19, 2007, through May 5, 2008. Source: FDA, updated August 14, 2008, www.fda.gov I 522 P&T® • September 2008 • Vol. 33 No. 9 http://www.fda.gov http://www.fda.gov http://www.medtronic.com http://www.fda.gov http://www.fda.gov http://www.fda.gov http://www.fda.gov http://www.fda.gov

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Pharmacy & Therapeutics - September 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Effect of Prescription Copays on Adherence and Treatment Failure with Oral Antidiabetic Medications Vaccine Declinations Present New Challenges for Public Health Universal Health Care in America Digestive Disease Week and American Diabetes Association Pharmaceutical Approval Update

Pharmacy & Therapeutics - September 2008

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