HHS 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 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.
What emergency medical countermeasures should the U.S. employ against chemical, biological, radiological, and nuclear threats?
It's not official until AMA publishes its CPT Manual 2008, but APhA officials are confirming that the CPT billing codes for medication therapy management are switching from a temporary to a permanent status.
Recognizing the growing problem of prescription drug abuse among teenagers, the White House Office of National Drug Control Policy (ONDCP) is partnering with pharmacy organizations to combat the problem.
Patients six years of age and older with primary generalized tonic-clonic seizures can now use levetiracetam (Keppra, UCB) as an adjunctive therapy to treat their epilepsy.
Patients 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.
CMS has launched a durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) Competitive Bidding Implementation Contractor (CBIC) Web site.
Medicare Part D patients now have detailed instructions on how to appeal decisions.
This is the story of my bout with Lyme disease and what a harrowing experience it's been. I hope that by telling my story, I can help you learn from my experience and apply it to your practice.
What follows is a review of the biggest news of 2006 in just a few categories, along with their new product standouts.
The 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.
Pharmacists Planning Service Inc. (PPSI) honors former Surgeon General Richard Carmona, M.D., and Julie Gerberding, M.D., director of the Centers for Disease Control and Prevention.
A 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.
Generics were the big winners in the prescription drug world of 2006. While generic prescription volume was surging 11.4% last year compared with 2005, brand-name Rx volume was falling by 5.1%. Generics now account for 56.9% of all scripts and 63.8% of new scripts.
Last 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.
The 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.
Pharmacy 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."
The 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.
For 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).
Aliskiren (Tekturna, Novartis) is a new molecular entity approved for treating hypertension either as monotherapy or in conjunction with other antihypertensive agents.
When 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.
The 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).
The 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.
The National Quality Forum (NQF) is adopting many of IOM?s recommendations. NQF works with the Joint Commission and other groups to set national standards that healthcare facilities must meet.
Results of a clinical trial comparing linezolid (Zyvox, Pfizer) with vancomycin, oxacillin, or dicloxacillin show that patients treated with linezolid had a higher mortality rate compared with patients treated with other antibiotics.
Davenport, Iowa-based Kaplan University announced that it will offer its pharmacy technician certification program on-line.
Eligible members in these markets can receive up to four months of medication for free as an incentive to switch to simvastatin from brand-name statins.
The FDA has given the green light to eculizumab (Soliris) from Alexion Pharmaceuticals as the first treatment for patients with paroxysmal nocturnal hemoglobinemia (PNH) to reduce hemolysis.
A panel representing community pharmacy addressed members of the Maryland General Assembly recently, emphasizing the need for pending legislation that would force PBMs to end what they call "deceptive business practices" and provide better safeguards for patients.