BREAKING NEWS

September 27, 2004

CMS revises ASP calculation for Medicare Part B

DEA limits personal Rx importation

DEA plans to limit the personal importation of controlled substances for legitimate medical use to a total of 50 dosage units by a person returning from travel abroad. The administration also emphasized that the law does not allow U.S. residents to travel to Mexico or Canada and return with up to 50 dosage units on a no-questions-asked basis. They must still meet several requirements and declare the medications at the border. Likewise, the dosage-unit limit does not apply to controlled substances lawfully obtained here by a U.S. resident who carries the drugs while traveling abroad. The new final rule will take effect Oct. 14.

CMS revises ASP calculation for Medicare Part B

CMS has come out with a revised method for manufacturers to calculate their average sales price (ASP) for Medicare Part B drugs and biologics. The agency explained that its previous method of calculation, laid out in an interim final rule published in the April 6 Federal Register, could result in excessive quarter-to-quarter variability in the reported ASPs. So CMS is moving to a new method based on a rolling average percentage of price concessions divided by total sales in dollars. For more information, check out the Sept. 16 Federal Register.

New thrombosis guidelines released

The American College of Chest Physicians (ACCP) released updated guidelines for the prevention and treatment of deep vein thrombosis (DVT). For the first time, the guidelines offer specific recommendations for the prevention of thrombosis during long-distance travel. The guidelines also provide recommendations for the prevention of DVT in those who are critically ill and/ or undergoing surgery.

The Seventh ACCP Confer-ence on Antithrombotic and Antithrombolytic Therapy: Evidence-based Guidelines were published in the September supplement to the journal Chest. The Coalition to Prevent Deep-Vein Thrombosis announced its support of the revised ACCP guidelines and of the recently released therapeutic position statement from ASHP regarding the prevention and treatment of DVT.

Prasco ships generic Cyclessa

Prasco Laboratories announced that it has begun shipping its oral contraceptive desogestrel/ethinyl estradiol (Cesia) tablets. Cesia is AB-rated and therapeutically equivalent to the brand Cyclessa (Organon). Cesia tablets are presented in a hard, compact case and are packaged three units to a box.

FDA green-lights new desloratadine formulation

Desloratadine (Clarinex, Schering-Plough) syrup has been approved for the relief of symptoms associated with seasonal allergic rhinitis in children two years old and older and perennial allergic rhinitis and chronic idiopathic urticaria in children as young as six months of age. The ap-proval of the urticaria and perennial allergic rhinitis indications makes desloratadine syrup the only prescription nonsedating antihistamine syrup on the market for a patient population as young as six months. The new desloratadine syrup is expected to be available in U.S. pharmacies during the first half of 2005. Desloratadine was previously approved in 5-mg tablet form.

FDA urges stronger warning on antidepressants

Based on the recommendations recently received from a joint meeting of the psychopharmacologic drugs and pediatric advisory committees regarding reports of an increased risk of suicidality associated with the use of certain antidepressants in pediatric patients, the FDA has begun to work on adopting new stronger warning labels on all antidepressants. The advisory committees agreed with an FDA analysis, which concluded that the finding of a 2%-3% increased risk of suicidality in pediatric patients applied to all the drugs studied (Prozac, Zoloft, Remeron, Paxil, Effexor, Celexa, Wellbutrin, Luvox, and Serzone) in clinical trials. In their recommendations, the committees reached a split decision (15-Yes, 8-No) regarding adding a black-box warning to the labeling of all antidepressants, endorsed a patient information sheet, and did not recommend these products be contraindicated in pediatrics since some patients may benefit from their use.

New delivery system approved for ReFacto

The FDA has approved Wyeth's ReFacto Antihemophilic Factor (Recombinant) R2 Kit, the first needle-less reconstitution device with a prefilled diluent syringe for hemophilia. Compared with the previous method for reconstituting ReFacto, the R2 Kit is expected to provide a faster and simpler infusion process. The kit contains a prefilled diluent syringe, a vial adapter, and a single-use vial of ReFacto containing 250, 500, 1,000, or 2,000 IUs. The adapter is placed on the vial of ReFacto, and the adapter and prefilled syringe allow ReFacto to be reconstituted without the risk of needle exposure. Wyeth expects the ReFacto R2 Kit to be available in the fourth quarter.

Guarantee program covers pay for alfuzosin

Sanofi-Synthelabo recently introduced the UroXatral Money-Back Guarantee Program. The program provides patients with up to 30-day reimbursement of their out-of-pocket prescription cost of alfuzosin (UroXatral) extended-release tablets if their urologist determines that treatment with the drug was inappropriate.

Prevnar four-dose schedule restored

CDC has announced that the recommendation for use of pneumococcal 7-valent conjugate vaccine (diphtheria CRM197 protein) (Prevnar, Wyeth Pharmaceuticals) has been updated, reinstating the full, four-dose vaccination schedule. A shortage of the vaccine earlier this year prompted CDC to modify its recommendations for administration to healthy children. A notice in the Sept. 17 issue of Morbidity and Mortality Weekly Report announced the end of the vaccine shortage and reinstatement of the routine administration schedule.

Albertsons sued over Rx practices

Privacy Rights Clearinghouse, a consumer advocacy group, has sued Albertsons Inc., alleging the supermarket chain sold prescription information to drug companies without telling customers. The clearinghouse has accused Albertsons and its pharmacy units, Sav-on Drug Stores, Osco Drug, and Jewel Osco, of sharing customer names, addresses, phone numbers, and information on prescribed medications. That information is allegedly used to solicit customers by mail or telephone. The suit, which was filed in May in San Diego Superior Court and announced only recently, asks that Albertsons end the alleged practice and seeks unspecified monetary damages for unfair business practices and deceptive advertising. Albertsons has denied the allegations. The company stated, "We highly value and respect the privacy of our pharmacy customers and do not sell, or have we ever sold, their private information. We consider the allegations in this complaint to be false and totally without merit, and we will vigorously defend ourselves."

GMDC to retailers: Focus on Rx drug buyers

Only 56% of shoppers who fill a prescription actually buy something else in the store on the same visit, according to a recent study conducted by the General Merchandise Distributors Council (GMDC) Educational Foundation. The finding underscores the major opportunities for retailers, wholesalers, and manufacturers to better connect with their customers to increase total store sales. The study, "Leveraging the Connection of Pharmacy and the Whole Store," was researched and authored by Information Resources and WSL Strategic Retail. It contends that a new consumer-centric approach, combined with a holistic view of the "whole store," is essential to generating notable growth

Caution: Reminyl Rxs being filled with Amaryl

Several instances in which the antidiabetic agent glimepiride (Amaryl, Aventis) was dispensed to geriatric patients instead of the Alzheimer's agent galantamine (Reminyl, Janssen) have been reported to the USP-ISMP Medication Errors Reporting Program and the FDA MedWatch Program. Both products are available as 4-mg tablets, and these events are most likely due to poor prescriber handwriting and a sound-alike, look-alike situation between the two names. Patients receiving glimepiride in error would not be provided with blood glucose monitoring, which could result in severe hypoglycemia requiring hospitalization. Pharmacists are urged to confirm that their patients have diabetes prior to dispensing or administering any antidiabetic medication to them.

Vioxx approved to treat juvenile RA

Rofecoxib (Vioxx, Merck) has been approved for the once-daily treatment of juvenile rheumatoid arthritis (JRA) in children two years and older who weigh at least 22 lb. The new indication is only for patients with pauciarticular or polyarticular JRA. Rofecoxib was previously approved for the treatment of osteoarthritis, rheumatoid arthritis, primary dysmenorrhea, the management of acute pain in adults, and for the acute treatment of adult migraine.

Medicine-On-Time-QS/1 improve interface

Medicine-On-Time has launched a real-time software interface connecting its medication therapy management system with QS/1 Data System's pharmacy software products. The Medicine-On-Time Gateway interface cuts data entry time by 50%, according to the firms. Community pharmacies using Medicine-On-Time and QS/1's RxCare Plus or PrimeCare Release 17.8 or higher can use the interface.

NABP to verify wholesalers

As part of its Verified-Accredited Wholesale Distributors (VAWD) program, NABP has enlisted BuzzeoPDMA to handle the wholesaler inspection, accreditation, and audit process. Founded by pharmacist Ronald W. Buzzeo, the firm specializes in helping companies comply with regulations of the FDA, DEA, and the states, as well as the Prescription Drug Marketing Act. The VAWD is part of NABP's anticounterfeit drug campaign, which also includes revisions of its model rules on wholesaler licensure and creation of a clearinghouse for wholesalers.

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