Drug Topics - November 5, 2007 - (Page 6)

6 DRUG TOPICS NOVEMBER 5, 2007 www.drugtopics.com Latebreakers AACP opposes residencies as prerequisite to direct patient care CCP is for it. So is ASHP. But AACP’s board has just come out against it. At issue is whether pharmacists should complete a residency before they can provide direct patient care. In an interview at Drug Topics headquarters, Lucinda Maine, executive VP of the association for pharmacy schools, explained that AACP already states in its mission that pharmacy education prepares “graduates who Lucinda Maine beprovide patient-centered care that ensures optimal lieves graduates medication therapy outcomes.” So a pharmacy stucan provide good dent who graduates should be able to provide patient care. quality care. She hastened to add that this position doesn’t mean that AACP doesn’t support residency programs. In fact, the association supports both general and specialized residency programs across all practice settings. is no evidence that these products work in children. Following the meeting, Linda Suydam, president of the Consumer Healthcare Products Association (CHPA), stated that “the split vote to make singleactive ingredients no longer available for use in children under six years old—if adopted by FDA— would unduly limit parents’ access to medicines that work and are safe when taken as directed.… We are already planning pharmacokinetic studies in children, which are the first step toward confirming correct dosing, and we will work with the FDA to design appropriate pediatric clinical efficacy studies.” A No real surprise to Exubera discontinuation, R.Ph.s say Pharmacists were not too surprised this month when Pfizer announced it was discontinuing sales of Exubera, the company’s inhaled insulin, given the problems the product had from the beginning and the lack of acceptance among physicians and patients alike. Patients may have been expecting a device the size of an asthma inhaler, but instead they got something resembling a large flashlight that was difficult to hide even in a purse, one pharmacist said. Other complaints from patients included difficulty in dosing, with a 1-mg dose equivalent to three units of regular insulin, but 3 mg corresponding to eight units. It made calculating an appropriate dose difficult for patients, according to some pharmacists who dispensed Exubera. Sales were also thought to be low due to the high cost and poor reimbursement. chronic kidney disease (CKD) who are on dialysis. Renvela (sevelamer carbonate) differs from its predecessor Renagel (sevelamer HCl) in that it offers the added benefit of a carbonate buffer, according to manufacturer Genzyme Corp. Both products are calciumfree and are not systemically absorbed; however, in clinical trials comparing the two agents, Renvela (see www.renvela. com) was more likely to maintain bicarbonate levels within the recommended National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative, or KDOQI, ranges in addition to controlling serum phosphorus levels. It also had a lower incidence of GI adverse effects. Genzyme expects to launch Renvela during the first quarter of 2008 in 800-mg tablets. First topical NSAID for osteoarthritis Novartis has announced regulatory approval for its diclofenac sodium topical gel (Voltaren Gel 1%) for the topical treatment of pain associated with osteoarthritis. The NSAID can be applied directly to joints amenable to topical treatment such as the knees and hands. The efficacy and safety of the new formulation were tested in more than 900 patients. In two different No cough, cold OTCs for kids two to under six Following a recent two-day meeting, an FDA advisory panel voted 13 to 9 to recommend that OTC cough and cold products should not be used in children two years to less than six years and said there The FDA has approved a new form of sevelamer, a phosphatebinder used to treat patients with Photo (at top): Reid Paul Renvela OK’d for CKD patients on dialysis studies of six- and 12-week duration, use of the gel led to a reduction in pain level by 46% and 51%, respectively. Although the company said the systemic absorption of the gel is 94% less than that of comparable oral diclofenac treatment, the gel is still not recommended for use in combination with other oral NSAIDs or aspirin due to the potential for increased adverse effects. For more information on Voltaren, go to www.voltarengel.com. DT http://www.drugtopics.com http://www.renvela.com http://www.voltarengel.com

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Drug Topics - November 5, 2007 Contents Latebreakers Latebreakers in Depth Letters Rx Care Community Practice 150 Years of American Pharmacy Hospital Practice Pharmacists at Risk Government and Law High-Density Lipoprotein New Products Advertisers Index Classified Viewpoint

Drug Topics - November 5, 2007

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