Drug Topics - February 2009 - (Page H8)

HSE I Clinical OFF-LABEL PRESCRIBING according to principal investigator Ran- are these areas where patients and phydall Stafford, MD, associate professor sicians are naturally interested in trying of medicine at the Stanford Prevention off-label therapies, but areas targeted Research Center. The group identiﬁed for expansion by the makers of these 14 drugs most in need of additional drugs.” The study, published in the Decemclinical research to support common ber 2008 issue of Pharoff-label uses. macotherapy (Walton SM Seroquel (quetiapine; et al. 2008;28[12]:1443AstraZeneca) topped the 52) found that a total of list of drugs used off-label POWER POINTS 76 percent of quetiapine with inadequate evidence. Quetiapine topped scripts are written for offThe agent was approved the list of drugs label uses. Stafford said for schizophrenia in 1997, used off-label with inadequate with quetiapine, off-label but is commonly used to evidence. use is even more problemtreat bipolar disorder. atic than it is with other Bipolar disorder is the Bipolar disorder is products, as indicated by most common off-label the most common its black-box warning for use found in the study, acoff-label use found dementia and suicidality in counting for 6 of the top in the study. some populations, its high 14 agents. Other mental cost, and heavy marketing disorders and cardiovascular disease were the second most-com- efforts by AstraZeneca. “Off-label prescribing means that mon off-label uses, accounting for two agents each. Fibromatosis, COPD, sleep, we’re venturing into uncharted territory, where we lack the usual level of and anemia round out the list. “Many of the drugs and conditions evidence presented to the FDA that tells on the list represent situations where us these drugs are safe and effective,” inadequate response to treatment is he said. “When the volume of off-label common and where drug side effects use of any drug reaches the magnitude are frequent,” Stafford said. “Not only that we’re documenting, it suggests a role of the pharmaceutical industry in facilitating these types of uses.” Pharmaceutical manufacturers are generally barred from promoting offlabel use of approved products, but they are allowed to distribute published research that deals with off-label use. Stafford told Drug Topics that recent lawsuits have revealed systematic plans by some drugmakers to market their products for off-label use. How, or whether, regulation of offlabel use might change is not clear. In the past, patients and private third-party payers covered most of the cost for off-label drug use. With the Medicare Part D Rx drug benefit, government and taxpayers are picking up a growing part of the bill. That could spur efforts to limit off-label prescribing, at least in government-sponsored programs. “There is clearly room for off-label use of approved drugs,” Walton said. “That is clear, and we are mindful of those issues. But I would like to see a great[er] effort made toward evidencebased drug use. Once drugs are put out there by the FDA, physicians are pretty much free to use them for anything, proven or not.” Clinical Indications Associated with On-Label and Off-Label Uses for Top 14 Drugs Drug Most Common On-Label Use Most Common Off-Label Use Bipolar, maintenence Hypertensive heart disease Bipolar Bipolar, maintenence COPD Bipolar Bipolar Bipolar Fibromatosis Coronary artery Anxiety Sleep disturbance Depression Anemia of chronic disease Quetiapine (Seroquel, AstraZeneca) Warfarin (Coumadin, Bristol-Myers Squibb) Escitalopram (Lexapro, Forest Laboratories) Risperidone (Risperdal, Janssen) Montelukast (Singulair, Merck) Bupropion (Wellbutrin, GlaxoSmithKline) Sertaline (Zoloft, P zer) Venlafaxine (Effexor, Wyeth) Celecoxib (Celebrex, P zer) Lisinopril (Prinivil, Merck) Duloxetine (Cymbalta, Lilly) Trazodone (Desyrel, Apothecon) Olanzapine (Zyprexa, Lilly) Epoetin Alfa, Procrit, Ortho Biotech) Schizophrenia Atrial brillation Depression Schizophrenia Asthma Depression Depression Depression Joint sprain /stain Hypertension Depression Depression Schizophrenia Cronic renal failure Created for Drug Topics by author; adapted from source: Stanford University H8 DRUG TOPICS Februar y 2009 W W W.D R U GTO P I C S .C O M http://WWW.DRUGTOPICS.COM

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Drug Topics - February 2009 Contents Health-System Edition Group Attempts to Resurrect Pain Care Act HSE Business Management HSE Clinical Letters Up Front Up Front in Depth Community Practice Niche Pharmacies Serve Special Populations Special Report Oral Oncology Drugs New Drugs Update 2008 Approvals OTC New Products Viewpoint

Drug Topics - February 2009

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