Drug Topics - December 10, 2007 - (Page 6)

6 DRUG TOPICS DECEMBER 10, 2007 www.drugtopics.com Latebreakers Final DEA rule OKs multiple Schedule II Rxs B eginning Dec. 19, prescribers will be officially permitted to issue multiple Rxs for up to a 90-day supply of Schedule II drugs. While some doctors had given multiple prescriptions to patients in the past, prior to the rule it was unclear whether the practice was legal. Many patients with chronic conditions complained that it was costly and difficult to visit the doctor monthly to receive a new Rx. DEA received nearly 300 comments after the rule was proposed, with the majority in favor of the change. The final rule clarified that the Rxs must be sequentially dated and may not add up to more than a 90day supply of Schedule II narcotics. Pharmacists will not be able to fill any of the Rxs before the date on the prescription. In a related issue, DEA proposed creating a new single-page form with special security features for ordering Schedule I and Schedule II drugs. The current triplicate form is more than 30 years old. cepting comments on the rule through Jan. 15. Comments can be submitted electronically at www.cms.hhs. gov/eRulemaking. FDA OKs OTC Zyrtec McNeil Consumer Healthcare, a division of McNeil-PPC, has received approval for the allergy treatment Zyrtec (cetirizine HCl) to be used without a prescription for adults and children. Zyrtec relieves symptoms caused by perennial and seasonal allergic rhinitis, commonly referred to as indoor and outdoor upper respiratory allergies. Zyrtec also relieves itching due to hives. The approval comes one week after the FDA granted the company approval to market Zyrtec-D 12 Hour (cetirizine HCl 5 mg/pseudoephedrine HCl 120 mg), which combines Zyrtec with a decongestant. Zyrtec-D and Zyrtec will be available OTC in late January 2008 in their original prescription strength. With Zyrtec’s patent expiring this month, generic Rx versions are also expected to make their debut. USP revises compounding standards to improve patient safety USP has revised its standards and conditions for sterile compounding in order to improve patient safety. Changes to General Chapter Pharmaceutical Compounding—Sterile Preparations have been posted online on USP’s Web site (www.usp. org/USPNF/pf/generalChapter797. html) and will be published in March in the second edition of the Pharmacists’ Pharmacopeia. The revisions were posted on-line to give the compounding community time to implement changes before they take effect on June 1, 2008. Diane Cousins, USP’s VP of healthcare quality and information, called the revisions “one of the most important contributions to patient safety in decades.” class of cholesterol-lowering medicines known as statins. The application for OTC lovastatin is scheduled to be reviewed by the FDA on Dec. 13. The application seeks approval of OTC lovastatin 20 mg taken once daily to help lower cholesterol. This is Merck’s third application to take lovastatin OTC. CMS proposes Medicare e-prescribing standard In perhaps another important step toward widespread adoption of electronic prescriptions, CMS proposed new standards for e-prescribing under Medicare Part D. The proposed rule governing formulary and benefit data and medication history keeps CMS on track to have a final standard ready to be implemented by April 1, 2009, as required by the Medicare Modernization Act. The rule has drawn positive responses from e-prescription companies. Allscripts, a member of the National ePrescribing Patient Safety Initiative, issued a statement proclaiming its “strong support” for the proposed rule. Kevin Hutchinson, CEO of SureScripts, praised CMS for coordinating its work with other standards organizations like NCPDP and for greater openness and clarity in the process of creating the standards. The agency is ac- New AHRQ report compares antirheumatics Which drugs work well for rheumatoid arthritis? Some answers can be found in a new report funded by the Agency for Healthcare Research & Quality. It concluded that combining methotrexate with one of the biologic disease-modifying antirheumatic drugs (DMARDs) works better than using each alone. Also combining prednisone with hydroxychloroquine, methotrexate, or sulfasalazine works better than using only a synthetic DMARD to reduce joint swelling and improve function. The report, which also presented findings on which medications offer no improvement over others, can be found at www.effectivehealthcare. ahrq.gov/. DT If Mevacor goes OTC, Glaxo will push it In anticipation of FDA approval, GlaxoSmithKline and Merck have entered into an agreement for OTC marketing rights for lovastatin (Mevacor). Under the agreement, Glaxo will have exclusive rights to market nonprescription lovastatin in the United States. Mevacor was introduced in this country in 1987 by Merck as the first in a http://www.drugtopics.com http://www.cms.hhs.gov/eRulemaking http://www.usp.org/USPNF/pf/generalChapter797.html http://www.usp.org/USPNF/pf/generalChapter797.html http://www.usp.org/USPNF/pf/generalChapter797.html http://www.effectivehealthcare.ahrq.gov/ http://www.effectivehealthcare.ahrq.gov/

Table of Contents Feed for the Digital Edition of Drug Topics - December 10, 2007

Drug Topics - December 10, 2007 Latebreakers Latebreakers in Depth Letters Health-System Edition - Cover Story Clinical Practice Professional Practice Special Report Technology Community Practice Unraveling Medicare 150 Years of American Pharmacy Rx Care In the Pipeline Cover Story: Fair or foul? Self-Care Chains and Business Government and Law Continuing Education: Natural Medicines for Bone Health New Products Advertisers Index Classified Viewpoint

Drug Topics - December 10, 2007

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