Pharmacy schools must meet new stringent standards
April 2nd 2007ACPE will be more rigorous in reviewing Pharmacy schools for accreditation. The change is spurred in part by the Department of Education, which surveys ACPE. Thanks to a more demanding DOE, ACPE put two pharmacy schools on probation recently.
New report covers how to advance personalized medicine
April 2nd 2007HHS has released a 128-page report on realizing the promise of pharmacogenomics (PGx). The report discusses, among other issues, the educational needs of pharmacists, physicians, and other health professionals; PGx tests sold over the counter in drugstores; and the liability to M.D.s and R.Ph.s from off-label use of PGx.
FDA issues final rule for OTC laxative drug products
April 2nd 2007FDA is issuing a final rule establishing that over the counter laxative drug products in granular dosage form containing the bulk-forming ingredients psyllium (hemicellulose), psyllium hydrophilic mucilloid, psyllium seed, psyllium seed (blond), psyllium seed husks, plantago ovata husks, and plantago seed are not generally recognized as safe and effective and are misbranded.
Latebreakers: Breast cancer agent gets green light
April 2nd 2007Patients with HER2-positive advanced or metastatic breast cancer whose disease has progressed following treatment with an anthracycline, a taxane, and trastuzumab (Herceptin, Genentech) will now have a new therapeutic option. Lapatinib (Tykerb, GlaxoSmithKline) has been approved by the FDA for use in combination with capecitabine (Xeloda, Roche) following a priority review.
FDA Safety Page: Helping patients understand OTC labeling
April 2nd 2007The FDA recommends that you counsel patients on the importance of reading product labels carefully to determine the active ingredients and dosing instructions of each product and to discourage them from making assumptions about use based on product names or appearance. The use of similar trade names (so-called "brand-name families") is common practice for OTC products. The products with the trade names "Sudafed" and "Sudafed PE" illustrate specific concerns.
Is phenylephrine an effective decongestant?
April 2nd 2007A group of researchers at the University of Florida College of Pharmacy recently submitted a citizen's petition asking the Food & Drug Administration to increase the maximum allowable dose of phenylephrine (PE) from 10 mg to 25 mg and to withdraw approval of phenylephrine for children under 12 years of age. The petition also called for additional research to validate the safety and effectiveness of the higher recommended dose.
Caution: Heparin errors can have fatal results
April 2nd 2007Last September, the Institute for Safe Medication Practices (ISMP) reported an incident that occurred at a Midwestern hospital. A pharmacy technician had stocked an automated dispensing cabinet with heparin 10,000 units/ml vials in a drawer reserved for heparin 10 units/ml. The nurses retrieving the vials did not notice the discrepancy in strength and used the 10,000 units/ml heparin for umbilical line flushes of six premature infants. Three of the babies died of heparin overdose.
Who's for and against negotiated prices?
April 2nd 2007The shift from Republican to Democratic control of Congress ensures ongoing debates about requiring Medicare officials to negotiate directly with pharmaceutical firms for lower drug prices. The Medicare Modernization Act (MMA) expressly forbids interference from the HHS secretary in negotiations between manufacturers and pharmacies or PDP sponsors, and prohibits the establishment of a formulary or price structure for reimbursement under Part D.
New bill on pharmacy compounding stirs concern
April 2nd 2007Pharmacy industry critics are "gravely concerned" that the Safe Drug Compounding Act of 2007, a draft Senate bill, would sharply curtail the practice of compounding by giving the Food & Drug Administration authority to regulate compounding. A coalition of nine pharmacy organizations drafted a letter to the bill's expected sponsors-Senators Edward Kennedy (D, Mass.), Pat Roberts (R, Kan.), and Richard Burr (R, N.C.)-insisting that the bill "would negatively impact patient access to necessary compounded prescription medications and create onerous, new requirements for prescribers and pharmacists."
American Heart Association revision stresses stepped care for pain
April 2nd 2007The new guide recommends that physicians start with nonpharmacologic treatments such as exercise, physical therapy, weight loss, and heat or cold therapy. If there is no relief of pain, physicians should consider acetaminophen, aspirin, and even short-term use of narcotic analgesics as a first step, taking the patient's medical history into account.
Less abuse potential for new ADHD drug
April 2nd 2007For the 4.4 million American children who have attention deficit hyperactivity disorder (ADHD), there will soon be another option for treatment. The Food & Drug Administration recently approved the first prodrug to treat the condition: lisdexamfetamine dimesylate (Vyvanse).
Manufacturers extraordinaire: The top 10 drug firms of 2006
April 2nd 2007When measured by retail dollars, nine out of the top 10 companies were brand-name firms, with Teva Pharmaceuticals being the only generic representative that made the list. When measured by number of prescriptions, three out of the top 10 companies were generic drugmakers, including Teva, Mylan, and Watson Pharma.
Medicaid generics reimbursement outlook deemed bleak
April 2nd 2007The Deficit Reduction Act is the federal government's attempt to slow the pace of spending growth in Medicare and Medicaid. Under the act's provisions, the basis for state Medicaid programs' prescription reimbursement to pharmacists changes from average wholesale price (AWP) to average manufacturer price (AMP).
Biogeneric substitution: Time for an approval pathway from Congress
April 2nd 2007The terms being used to describe these generics-biogenerics, generic biologics, biological follow-on products, biosimilar drugs, generic biopharmaceuticals-are interchangeable, but the question of how to determine whether these generics are safely interchangeable with the branded products is only now starting to be answered.