More than 28 million Americans suffer from migraine headaches, often beginning during adolescence, continuing throughout adulthood, and affecting three times as many women as men. The prescription drug market for the treatment of migraines is about $2 billion annually in this country. Vying for a piece of the pie are several new companies-some utilizing new combinations or new formulations of old drugs and a few developing new drug entities. Here's a heads-up on what's coming our way.
The Food & Drug Administration recently granted marketing approval to oxymorphone immediate-release and oxymorphone extended-release tablets (Opana/Opana ER, Endo Pharmaceuticals).
The Generic Pharmaceutical Association (GPhA) praised four of the nation's Governors for filing a citizen petition with the FDA seeking immediate release of agency guidance that would pave the way for the introduction of more affordable generic versions of insulin and human growth hormone (HGH). The citizen petition was filed by Govs. Kathleen Sebelius (D, Kan.), Tim Pawlenty (R, Minn.), James H. Douglas (R, Vt.), and Jim Doyle (D, Wis.).
Albemarle Corp., Richmond, Va., a leading producer of bulk ibuprofen, announced that it will increase the price of its bulk ibuprofen by a minimum of 20% in Western Europe and in the United States for spot purchases, effective Sept. 1 and as contracts allow. The company stated that the price increase is to help offset significant raw material and energy cost increases experienced over the past several years.
Teva Pharmaceuticals USA has received FDA approval for the first generic version of Effexor (venlafaxine). The tablets will be available in 25, 37.5, 50, 75, and 100 mg and will be eligible for 180 days of generic drug exclusivity before the agency can approve other generic applications for the drug.
Pfizer is offering free samples of its cholesterol-lowering drug Lipitor (atorvastatin) via mobile coupons. Working with mobile technology firm ipsh!, patients can redeem a 30-day free -rial size of Lipitor through text-message mobile coupons.
In a trial to be held in the Circuit Court of Cook County, Ill., beginning Sept. 7, Walgreens is being sued for allegedly mislabeling and misfilling a prescription that led to the death of a patient,Leonard Kulisek. In the papers filed during the lawsuit, Walgreens admitted that a pharmacy manager negligently misfilled the prescription.
The FDA is seeking public comment for the next 90 days on how the use of a unique identifier system for medical devices could improve patient safety. Among other things, the agency is hoping that a unique device identification (UDI) could have broad applications in reducing medical errors, improving the reporting of adverse events, facilitating device recalls, and improving delivery and supply chain efficiency for medical devices.
A new article in Consumer Reports Best Buy Drugs is reporting that pharmacists filled 43 million prescriptions for sleep drugs in 2005, a number that is up 32% from 2001. The report also notes that direct-to-consumer advertising contributes to increased use of sleep aids.
A revision to the 1998 ACC/AHA practice guidelines for the management of valvular heart disease has been issued. Included are indications for anticoagulation in patients with prosthetic heart valves.
The Food & Drug Administration recently granted accelerated approval to dasatinib (Sprycel, Bristol-Myers Squibb) for the treatment of adults in all phases of chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy-including imatinib (Gleevec, Novartis). The FDA also granted full approval to dasatinib for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib, considered an orphan drug for each of these indications, is currently available in retail pharmacies.
The FDA is announcing a call for safety and effectiveness data on the OTC drug product diethylhexyl butamido triazone, up to 3%, as a sunscreen single active ingredient and in combination with other sunscreen active ingredients. Submit electronic comments at www.regulations.gov by Oct. 24.
Longs Drug Stores announced the opening of its new 800,000-sq. ft. distribution facility in Patterson, Calif. With the opening of the new facility, Longs is self-distributing about 57% of front-end merchandise to all of the mainland Longs stores.
Durham, N.C.-based Parata Systems will bring 75 new manufacturing, engineering, and customer support jobs to its Durham headquarters from Louisiana, as the company begins to integrate the McKesson Automated Prescription System (APS) products that it acquired this past spring. Parata markets robotic drug dispensing systems for the retail and institutional pharmacy markets.
The FDA announced it is proceeding to work with Duramed, a subsidiary of Barr Pharmaceuticals, to resolve the remaining policy issues associated with the marketing of Plan B as an OTC contraceptive option. The agency and the sponsor will discuss the sponsor's proposed restricted distribution and risk management plan as part of the framework for potential approvability as a nonprescription product for women aged 18 and older.
Oregon's Gov. Ted Kulongoski (D) announced that Oregon will join with Washington State to form a prescription drug purchasing consortium to obtain larger discounts on medications for uninsured residents. The Northwest Prescription Drug Consortium, which will likely begin to purchase medications this year, will combine an Oregon prescription drug program that provides low-income residents older than age 55 with access to discounted medications and a similar Washington State program.
NCPA has launched an interactive on-line program designed to provide information about the Medicare Part D prescription drug coverage gap, or "doughnut hole." The program is geared toward pharmacists but also can provide information to Medicare beneficiaries and their families.
Walgreen stores in Detroit have decided not to accept the Midwest Health Plan. The decision follows a recent announcement by CVS stores in Detroit that they would no longer deal with the Midwest Health Plan, which administers Medicaid coverage for 55,000 beneficiaries, and M-Care, a University of Michigan managed care plan.
Walgreens has joined forces with the National Urban League (NUL) to launch the NUL/Walgreens Wellness Tour. The tour features a customized traveling education and health-screening vehicle, which will appear at select NUL affiliates in key urban markets as part of a 12-month national campaign.
The FDA and the Mentholatum Co. have notified consumers and healthcare professionals about a nationwide recall of WellPatch Cough & Cold Soothing Vapor Pads due to potential serious adverse health effects that could result if the product is ingested or chewed on by a child. This product contains camphor, eucalyptus oil, and menthol.
Products marketed as "35% food-grade hydrogen peroxide" are among several being targeted by the FDA in a recently issued warning. The agency said the companies selling the potent peroxide are doing so illegally, as the products have never been approved by the FDA in the high concentrations for any purpose.
CVS/pharmacy announced that its CVS Photo Center is offering consumers the option of on-line photo processing with one-hour, in-store pickup. Features of the photo center at www.cvsphotocenter.com include: free on-line storage and sharing options, editing techniques and color-correction options, images that can be uploaded from any Internet-connected computer, and personalized photo gifts.
Arcadia Resources, a national provider of home care services and products, including respiratory and durable medical equipment, announced it has leased space within a Wal-Mart store in St. Petersburg, Fla., to expand its direct-to-consumer sales channels.
In-store clinics, which are proliferating in many chains, drew a mixed bag of reactions from respondents who voted in an instant poll posted on Drug Topics' Web site in July. Some 44% of respondents think these retail clinics provide only a limited scope of clinical practice, so they should set up a referral system to doctors or other health facilities for appropriate treatment.
Pennsylvania authorities are cracking down on on-line pharmacies that sell prescription drugs for no medically necessary reason. The latest cyber pharmacy to run afoul of the law is Rx Medical One.
Pharmacy is on the verge of graduating to a new level of the profession, and it's time for pharmacists to become full partners in the delivery of health care. This was the rallying cry of Cynthia Brennan, newly elected president of ASHP during her inaugural address at the ASHP 2006 Summer Meeting, held in late June in Orlando.
Nursing home residents are one group requiring extra attention from Medicare Part D plans and providers. The average nursing home resident has seven distinct diagnoses and uses eight or more different medications. Among the 2.2 million persons residing in nursing homes, 70% are cognitively impaired and 70% are dual-eligibles.
Is technician training pharmacy's next divisive battle? It could be, if major retail employers and state pharmacy boards hold to their present courses.
