Drug Topics - June 16, 2008 - (Page 30)

30 DRUG TOPICS JUNE 16, 2008 www.drugtopics.com Cover Story HAS THE TIME COME FOR A If a behind-the-counter category of drugs is approved, pharmacists can reap professional and financial benefits from serving as the gatekeepers. Sandra Levy I magine this scenario. You hold a cholesterol screening clinic at your pharmacy. In walks a middle-aged woman who couldn’t go to a physician because she doesn’t have insurance. You perform a blood test and find that her cholesterol level is dangerously high. You explain the benefits of taking cholesterol-lowering medication and making lifestyle changes. You prescribe a behindthe-counter (BTC) cholesterol-lowering drug, advise the patient how to take it, and discuss potential side effects and drug interactions. You charge the patient for the screening, consultation, and the medicine. After the consult, the patient makes an appointment to return for a follow-up so that you can monitor her drug therapy. This scenario may be played out in pharmacies nationwide if the Food & Drug Administration approves a third, or behind-the-counter (BTC), class of drugs. Once opposed, the FDA is now exploring the idea of making certain drugs available BTC at the pharmacy without a prescription, but only after intervention of a pharmacist before dispensing. FDA posted an announcement in the October 4, 2007, Federal Register; then held a public meeting on November 14, 2007, to elicit comments. Elevating the role of the R.Ph. Steve Giroux, the National Community Pharmacists Association president, envisions that a BTC class would increase patient access to prescription medications and improve patient safety. “If the category creates an opportunity for drugs that are currently restricted to Rxonly sales and if we can get consumers more access and quicker access to potentially better products, it makes a lot of sense,” said Giroux. Michael D. Hogue, Pharm.D., assistant professor of pharmacy practice at the McWhorter School of Pharmacy Samford University, echoed Giroux’s sentiments about the benefit to patients of increased access. “There are far too many people who are uninsured or underinsured who simply can’t afford to seek care from a physi- cian on a regular basis. I don’t think a BTC category exempts a patient from having to see their physician, but it offers us an opportunity to reduce the number of physician office visits that are necessary and hopefully to remove that access barrier to the pharmaceuticals.” William Zellmer, deputy executive VP of the American Society of Health-System Pharmacists (ASHP), anticipates that a BTC class would elevate pharmacists’ clinical role and improve patients’ health. He argued that by making certain prescription medications more widely accessible, public health issues such as hypertension and hypercholesterolemia may improve. “Because these drugs are available by prescription only from a physician, there seems to be a certain segment of the population who are not using these medications, and yet there are some safety concerns surrounding the medication which makes us hesitant to make them OTC. The idea would be to create an intermediate class of medications, where the prospect for making them OTC could be evaluated, and while this evaluation is going on, these medications would be available from pharmacists,” Zellmer explained. ASHP has recommended to FDA that the agency launch some demonstration projects around the country to assess a couple of models, including payment for pharmacist services. “If that were done, we would strongly advocate that outpatient pharmacy departments in hospitals be part of those experiments, because in many respects pharmacies in an institutional environment are used to practicing in this environment,” said Zellmer. BTC ruffles some feathers While many associations applaud the FDA’s desire to study the public health implications of making certain drugs available BTC, several groups are adamantly opposed or have some serious concerns about it. In a statement to FDA, Joseph W. Cranston, Ph.D., the American Medical Association’s director of science, George Doyle / Getty Images http://www.drugtopics.com

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Drug Topics - June 16, 2008 Contents Latebreakers Letters Latebreakers in Depth Pharmacists Lose in Final ESRD Rule New Drug Helps Palliative Patients on Opioids Take Care of Business Oral Treatment Reduces Multiple Sclerosis Flare-ups Beware of Inflammatory Masses From Implantable Infusion Systems Safer Therapeutic Options Emerging for Atrial Fibrillation Congressional Committee Chair Calls for Action Against Hospital Infections This Software System Helps Hospitals Manage Anticoagulation Therapy Rx Care Community Practice JP at Large Self-Care Cover Story Long-Term Care Chains and Business Technology Technology Update Continuing Education New Products Advertisers Index Classified Viewpoint

Drug Topics - June 16, 2008

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