Pharmacy & Therapeutics- August 2008 - (Page 444) NEW DRUGS of Congress for voting to override the President’s veto of the Medicare Improvements for Patients and Providers Act of 2008 (H.R. 6331). This legislation delays physician payment cuts in Medicare and includes critical provisions to help ensure patient access to pharmacist services. The bill became Public Law No: 110-275 on July 15, 2008 and amends titles XVIII and XIX of the Social Security Act. Among other stipulations, the bill requires prompt payment of Medicare Part D claims and weekly updating of Medicare prescription drug pricing and postpones implementing the first round of Medicare’s competitive bidding program on durable medical equipment, prosthetics, orthotics, and supplies. (Sources: American Pharmacists Association, July 16, 2008; www.govtrack. us/congress/bill.xpd?bill=h110-6331.) DRUG NEWS includes two single-use laser radial firing tips (EndoTips), about two to three times the width of a human hair. The laser energy is emitted in a radial pattern, allowing the dentist to disinfect the root cavity while preserving tooth structure. Purpose: Root canal procedures are performed to save decayed teeth. The nerve and pulp are removed, and the inside of the tooth is cleaned, disinfected, and sealed. Benefit: The laser system eliminates bacteria better than chemical methods, minimizing the chance of a root canal failure. With conventional methods, 4% to 6% of root canals fail, often causing the need for re-treatment. Sometimes the tooth cannot be saved, and other restorations (e.g., dental implants) are required. Disinfection is completed quickly, in 2 to 3 minutes, in contrast to the 20 to 30 minutes needed in traditional treatments using sodium hypochlorite (bleach) that have been performed since the 1920s. Source: www.biolase.com Skin Product Recall Sage Products is voluntarily recalling some lots of its 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation product because the lots tested positive for Burkholderia cepacia. This organism poses little medical risk to healthy people, but people who have a weakened immune system or chronic lung disease, particularly cystic fibrosis, might be more susceptible to infections with B. cepacia. This organism can cause infections in hospitalized patients. Effects can range from no symptoms to serious respiratory infections. The following products are involved: Product Code No. 9705 (lots 10722 and 10729); No. 9706 (lot 10718); and No. 9707 (lots 10357, 10365, 10641, 10672, 10753, 10755, and 10944). Sage has received no reports of injuries to patients. (Source: FDA, June 27, 2008.) I NEW MEDICAL DEVICES Marvin M. Goldenberg, PhD, RPh, MS Name: Eon Mini Neurostimulator Manufacturer: St. Jude Medical, Inc., Minneapolis, Minn. Approval Date: April 14, 2008 Use Classification: This small rechargeable neurostimulator is used to treat chronic pain of the trunk or limbs and pain from failed back surgery. Description: Slightly larger than the circumference of a U.S. silver dollar, the Eon Mini weighs about 10 ounces. Its fully portable charging system allows patients the freedom to recharge the battery while walking or doing other activities. This device can be placed discreetly, making it less noticeable. Purpose: The neurostimulator is used to treat pain. Benefit: The small size of the device allows for a smaller incision, giving physicians more flexibility in selecting the implant location; it also helps to make the site less visible and more comfortable for patients. The device provides highpower output and long periods between recharges. Even with its small size, batter y life is the longest-lasting of any rechargeable device in its class; the battery is FDA-approved for 10 years. This longevity means that fewer surgical procedures might be necessary to replace the batteries. Sources: www.pharmacyonesource. com; www.sjm.com; www.reuters.com Name: Endolase RFT Root Canal Therapy System for Waterlase MD Laser System Manufacturer: Biolase Technology, Inc., Irvine, Calif. Approval Date: April 10, 2008 Use Classification: The advanced laser technology is designed for root canal disinfection after endodontic procedures. Description: The Endolase system How Do Osteoporosis Drugs Compare with Each Other? Is one osteoporosis medication better than another? To find out, researchers from Brigham and Women’s Hospital, Harvard University, and Boston University studied data on 43,135 new recipients of oral bisphosphonates, nasal calcitonin, and raloxifene (Evista, Eli Lilly). Over a period of 12 months, no large differences in fracture risk were observed between risedronate (Actonel, Procter & Gamble), raloxifene, and alendronate (Fosamax, Merck). However, among patients with a history of fracture, the raloxifene patients had more nonvertebral fractures than those taking alendronate. Patients using calcitonin had a 40% higher risk for nonvertebral fractures than those taking alendronate. The researchers concluded that there is probably “no single clearly superior” drug therapy for osteoporosis. (Source: Ann Intern Med 2008;148: 637–646.) 444 P&T® • August 2008 • Vol. 33 No. 8 http://www.govtrack.us/congress/bill.xpd?bill=h110-6331 http://www.govtrack.us/congress/bill.xpd?bill=h110-6331 http://www.biolase.com http://www.pharmacyonesource http://www.sjm.com http://www.reuters.com
For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.