Drug Topics - October 22, 2007 - (Page 6)

6 DRUG TOPICS OCTOBER 22, 2007 www.drugtopics.com Latebreakers Associations have mixed reactions to behind-the-counter drugs APhA applauded the FDA’s recent decision to consider the development of a behind-the-counter (BTC) class of drugs that would include medications available without a prescription and would also require the intervention of a pharmacist before dispensing. John A. Gans, Pharm.D., APhA CEO, said, “This new class could translate into increased access for patients, while providing additional safeguards through pharmacist interventions that would better ensure appropriate medication use.” A spokeswoman for the Consumer Healthcare Products Association stated, “CHPA and its member companies believe that the current two-class system is the best system for the American consumer and are open to discussions about expanding access.” An NACDS spokesman said, “This is an issue that the association’s governance will be considering. The FDA is in the developmental stages on the issue, so it is not possible at this time to react to a specific proposal. We look forward to contributing to the discussion as it moves forward, pending the establishment of an NACDS position. This issue has highlighted the important role of the pharmacist in the healthcare system, which is positive.” The FDA announced a Nov. 12 hearing to discuss its proposal. The announcement was published in the Oct. 4 Federal Register. NABP restarts NAPLEX After a two-month layoff, NABP is once again offering the North American Pharmacist Licensure Exam (NAPLEX) to graduating pharmacy students. In August, NABP announced that it had temporarily stopped offering NAPLEX and the Georgia Multistate Pharmacy Jurisprudence Examination (MPJE) following allegations that a University of Georgia professor may have improperly shared test questions. NABP is continuing to pursue litigation against the University of Georgia School of Pharmacy and professor Flynn Warren Jr., M.S., although a gag order has been issued in the case. According to NABP, the Georgia MPJE may not be reinstated until late November or early December. and the decision of the state Board of Medical Examiners that he practiced medicine without a license. In May, the board ruled that Larry Rawdon, R.Ph., owner of Osa’s Garden, a health food store in Hohenwald, Tenn., had improperly provided care to more than 10,000 patients since 1995. While some pharmacists have worried the ruling would have a chilling effect on pharmacy consultations, Baeteena M. Black, D.Ph., executive director of the Tennessee Pharmacists Association, cautioned that the case is very unique. “The fact that he is a pharmacist is incidental,” she insisted. “His store was very different from most pharmacies in Tennessee.” R.Ph.s’ power at stake over biogeneric approval Pharmacists should closely watch the debate now going on in Congress over what kind of a regulatory pathway should be set up to allow the approval of biogenerics. So warns Roger Williams, M.D., president and CEO of the United States Pharmacopeia. The reason is that two approaches are being considered—one of biosimilars, the other of interchangeability. “Interchangeable” means the generic product has the same labeling as the innovator product and can be substituted by the pharmacist. “Biosimilars” uses a lesser standard of comparability, which puts the decision of whether to substitute in the hands of the prescriber. So pharmacists won’t have the power to substitute biosimilars, warned Williams. “Personally, I think the comparability category is a little goofy,” he added. The USP leader was speaking at the annual Schuss lecture at the Arnold & Marie Schwartz College of Pharmacy & Health Sciences in Brooklyn, N.Y., this month. DT A Tennessee pharmacist is challenging in court a $1 million fine Photo: Jim Shive Tenn. medical board fines R.Ph. $1 million http://www.drugtopics.com

Table of Contents Feed for the Digital Edition of Drug Topics - October 22, 2007

Drug Topics - October 22, 2007 Contents Latebreakers Legislative Victory Builds Momentum for Pharmacy Month Letters Health-System Edition R.Ph.s Brace for Payment Denial for Hospital-Acquired Conditions Topical Human Thrombin Helps Arrest Bleeding FDA Panels Fail to Set Target Levels for Renal Patients’ Hemoglobin Warning Letters Raise Patient Safety Concerns for Fentora Ending/Reversing Weight Gain Man Given Fatal Drug Overdose at Staten Island Hospital Pharmacists Playing More Important Role in Dialysis Treatment AHA President R.Ph.'s Here's How You Can Increase Your Value Premier Launches Comprehensive Quality Improvement Project FDA Approves Dexrazoxane for Treatment of Extravasation New Federal, State Reforms to Ease Disaster Relief Kinks 150 Years of American Pharmacy Ten Tips for MTM Success Independent Superstars: The Ones to Watch The New Dynamic Duo A Parkinson's Disease Primer Classified New Products Advertisers Index Viewpoint

Drug Topics - October 22, 2007

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