Distributors of diverted drugs indicted
New Gammagard formulation needs no reconstitution The FDA has approved Immune Globulin Intravenous [Human] (Gammagard) Liquid 10% Solution from Baxter Healthcare for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. The company plans to launch the product in the fourth quarter of this year. The ready-to-use, sterile preparation of Gammagard eliminates the need for reconstitution. In addition, its 10% concentration, compared with 5% concentrations, allows for a reduction in infusion time and volume. Baxter will continue to supply its current Gammagard S/D to those patients who require a low Immunoglobulin A therapy.
Once-daily regimen of Kaletra approved A once-daily dosing regimen of lopinavir/ritonavir (Kaletra, Abbott Laboratories) has been granted approval by the FDA. It is indicated for use in combination with other antiretroviral medications for the first-line treatment of human immunodeficiency virus infection. This new dosing option is available in both liquid and soft gel capsule formulations. Kaletra was previously approved as a twice-daily dosing regimen.
New indication for Requip calms restless legs Ropinirole (Requip, GlaxoSmithKline) has been approved for the treatment of moderate to severe primary restless legs syndrome in adults. Ropinirole is the first and only treatment approved by the FDA for this indication. The drug was previously approved for the treatment of Parkinson's disease. More information about restless legs syndrome is available at: http://www.restlesslegs.com/.
New law to weed out bad apples Hospitals, pharmacies, and nursing homes in New Jersey must share information on disciplinary actions taken against their former employees with their prospective employers under a new state law. The law was prompted by "angel of death" nurse Charles Cullen, who admitted to killing scores of patients in New Jersey and Pennsylvania. Cullen had jumped from hospital to hospital to escape detection. The law also requires health facilities to conduct a criminal background check of healthcare workers.
DEA finalizes rules on reverse distributors Under a final rule that was published in the May 2 Federal Register, DEA established standards under which reverse distributors may handle unwanted controlled substances acquired from other DEA registrants. The new rule finalizes an interim rule published July 11, 2003. The DEA said that the new rule prevents diversion of controlled substances by companies that dispose of return goods.
JCAHO creates patient safety position JCAHO is seeking qualified pharmacy candidates for a newly created position for patient safety. The pharmacist specialist would provide leadership and content expertise for the Joint Commission International Center for Patient Safety (JCICPS). Based in the Chicago area, the pharmacist would concentrate on safe medication management and disseminate information to U.S. and international healthcare organizations. Candidates must have a Pharm.D. and at least 10 years of clinical and administrative pharmacy experience, seven years of it in senior healthcare management or quality/performance improvement.
NACDS issues standards on pseudoephedrine NACDS suggests the following national standards for selling pseudoephedrine- containing products: preempting retailer requirements in state laws; keeping the sale of pseudoephedrine products available without an Rx; requiring sales of single-entity products from behind the pharmacy counter and by licensed R.Ph.s or pharmacy personnel; requiring sales of combination products from behind the pharmacy counter by Jan. 1, 2007, and by licensed R.Ph.s or pharmacy personnel; maintaining a written or electronic log of pseudoephedrine purchases to assist law enforcement efforts; limiting purchases to nine grams within a 30-day period; and limiting distribution center storage requirements.
Pharmacies to help Medicare enrollment NCPA, CMS, and the Social Security Administration will help identify and enroll low-income Medicare beneficiaries in the Medicare Rx drug benefit. CVS and Wal-Mart will also help in reaching the estimated eight million beneficiaries eligible for the Rx subsidy.
CDC adopts new repellent guidelines CDC, which has promoted the use of the chemical DEET in the battle against West Nile virus-bearing mosquitoes, has issued new repellent guidelines. It recommends the use of repellents containing the chemical picaridin and the plant-based oil of lemon eucalyptus. Repellents with DEET remain on CDC's recommendation list.
CVS partners with MinuteClinic CVS Corp. will open three MinuteClinic locations in CVS stores. Two stores in Minneapolis and one in Annapolis, Md., are slated to open in June. MinuteClinic health centers, staffed by certified family nurse practitioners and physician assistants, offer diagnosis and treatment of common family illnesses, such as strep throat and ear, sinus, bladder, and eye infections. MinuteClinic also offers screenings for cholesterol, glucose, thyroid and early memory loss, as well as common vaccinations. In a separate but related development, WellnessExpress Clinic has opened its doors in a Longs Drugs store located in Davis, Calif.
ASHP slams CMS for cutting residency funding In a strongly worded statement, ASHP expressed outrage that CMS decided not to restore funding for residency programs that provide postgraduate training for R.Ph.s in specialized areas. ASHP charged CMS with failing to reinstate reasonable-cost, pass-through funding for these programs despite evidence that the residencies meet the conditions for funding set by the agency two years ago. Henri R. Manasse Jr., Sc.D., Ph.D., ASHP executive VP and CEO, said, "Inexplicably, CMS has chosen to continue a scenario that may seriously jeopardize the health of more than 40 million Medicare beneficiaries."