All News

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.

A new biologic, ranibizumab (Lucentis, Genentech), has just been cleared for age-related macular degeneration (AMD). A study of Medicare patients 65 years of age and older found that AMD increased substantially-from 5% to 27%-between 1991 and 1999. The American Academy of Ophthalmology estimates that more than 1.75 million Americans have AMD, with seven million more having earlier stages of the disease.

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.

Despite the accelerating rate of HIV and AIDS on every continent, "only 12% of people in need of antiretroviral therapies in low- and middle-income countries are receiving them," said United Nations Secretary-General Kofi Annan in an opening address at a high-level conference on AIDS, held recently in New York. Thus, with treatment and prevention efforts being dubbed by Annan as "insufficient," Prezista (darunavir, Tibotec Therapeutics), the new protease inhibitor (PI), is being launched into an HIV market fraught with problems such as drug accessibility shortfalls and drug-resistant HIV.

According to a new report from the Institute of Medicine, medication errors harm at least 1.5 million people every year.

New antifungal therapies may help tame this growing problem and improve patient outcomes

The Florida Supreme Court recently added another brick to the increasingly solid legal wall of opinion that pharmacists have a duty to warn. The high court decision sent a lawsuit involving a drug overdose death against two pharmacies and a physician back to a lower court for trial.

Just a few years ago switching to a generic drug without consulting a physician or discussing it with the patient was a rare thing for a pharmacist to do. But the times are a-changin'.

Women with recurrent ovarian cancer will now have a new therapy option. Gemcitabine (Gemzar, Lilly) has been approved for use in combination with carboplatin for advanced ovarian cancer that has relapsed at least six months after initial therapy.

The law firm Hagens Berman Sobol Shapiro has filed a proposed class-action suit in the U.S. District Court of Arizona, alleging that CareMark Rx intentionally concealed revenue in order to avoid paying certain commissions owed to consultants who marketed and sold its services.

The FDA has approved Anthelio SX, a sunscreen from L'Oreal to be sold over-the-counter for the prevention of sunburn and for protection against ultraviolet B (UVB) and ultraviolet A (UVA) rays. It has a sun protection factor (SPF) of 15.

Abbott is reminding users of its FreeStyle and FreeStyle Flash blood glucose meters to check to make sure their meter is displaying the correct unit of measure (milligrams per deciliter, mg/dL) and strip calibration code each time they use their device. Abbott previously communicated that, in some cases, FreeStyle and FreeStyle Flash users could inadvertently change the units of measure on their meters when in setup mode