Latelines for March 4, 2002
DrugMax Inc. has created a program to extend business credit lines to independent pharmacy owners. Qualified independents can tap into unsecured lines of credit, ranging from $5,000 to $100,000. Loan applications can be completed by fax, mail, or on-line. The average percentage rates charged depend on the credit profile of the business and the co-obligor, according to the Largo, Fla., wholesaler.
Novartis' Zometa (zoledronic acid for injection) has received approval for treating patients with multiple myeloma as well as those with documented bone metastases from solid tumors along with antineoplastic drugs. Solid tumors refer to prostate cancer, lung cancer, and breast cancer, among others. The bisphosphonate was previously approved for treating hypercalcemia of malignancy. Zometa should not be dosed at more than 4 mg, and the infusion should last no less than 15 minutes. Since patients taking Zometa have reported renal insufficiency, their serum creatinine should be monitored before the drug is administered.
A coalition of governors, employers, and labor leaders held a press conference in Washington, D.C., late last month to urge Congress to reform the Drug Price Competition & Patent Term Restoration Act (Waxman-Hatch Act) so that generic drugs could come to market more quickly. The Business for Affordable Medicine coalition claims that, while the law is designed to encourage consumer access to generic drugs, many brand-name manufacturers have exploited loopholes in the act to hamper the introduction of these low-cost products. The coalition reported that Medicaid paid more than $1.2 billion in 2001 for 17 drugs whose patents are supposed to expire by 2005. This amount could be cut by half or more if brand companies don't thwart generic competition. Disputing the coalition's charges, PhRMA held its own press conference in Washington, D.C. PhRMA said that before the Waxman-Hatch act was passed, the generic industry accounted for about 18% of the pharmaceutical market. Today, it's responsible for almost 50%. This is proof that the law is working, the association contended.
A federal jury convicted two Alabama residents of offering Rx drugs over the Internet without a valid prescription, but a physician was acquitted. The drugs were offered through a Web site called Norfolk Men's clinic in Clanton, Ala. The president of All International Co., a Miami drug wholesaler, pleaded guilty last November to dispensing misbranded Rx drugs and obstruction of justice. The four defendants had been charged with conspiring to sell Rx drugs without valid scripts and to collect fees for nonexistent medical consultations.
NABP has joined PTCB on the national certification program for pharmacy technicians as of Jan. 2, 2002. NABP will work with state pharmacy boards to encourage acceptance of PTCB's program as an assessment tool for techs. The move grew out of an NABP resolution adopted in May 2000 seeking to determine whether NABP should work cooperatively to develop a technician competence assessment program. PTCB will also create a 12-member stakeholders policy council to guide its Board of Governors.
In a surprise move, William H. Nixon resigned his post as president and CEO of the Generic Pharmaceutical Association. In a prepared statement, GPhA board chair Carole Ben-Maimon said the board was grateful for Nixon's dedication and contributions to the generic pharmaceutical industry. The GPhA board named Robert S. Milanese, former president of the National Association of Pharmaceutical Manufacturers, as the acting executive director. An executive search is being conducted to fill Nixon's position, which he has held since November 2000.
Physicians might not always treat hypertension aggressively because they may be uncertain about the importance of elevated systolic blood pressure in some patients, according to an article in the Feb. 25 issue of the Archives of Internal Medicine. In examining 270 patient visits, researchers found that medication was prescribed or changed at only 38% of visits, despite documented high blood pressure for at least six months before the most recent visit.
CMS has proposed a three-year demonstration project for disease management of chronically ill Medicare patients that includes Rx drugs. In a notice posted in the Federal Register, the agency is seeking proposals for patients with advanced-stage congestive heart failure, diabetes, or coronary heart disease. The disease management organizations will be paid a monthly premium for coordinating care and for the cost of the drugs.
National Poison Prevention Week will be observed March 17-23. Pharmacists who want to participate can check out the information kits and materials available at www.poisonprevention.org. ASHP also has fact sheets on safe medication available through the "Public Relations and Media" section of its Web site at www.ashp.org. Orders can be placed through the Web site shopping cart or by phoning ASHP at (301) 657-4383.
Without admitting any wrongdoing, American Home Products agreed to settle federal charges that it conspired with Schering-Plough to keep generic K-Dur 20 off the market. Under the agreement, AHP is prohibited from making similar deals and must notify the government before making certain agreements with other drug companies. FTC asserted that various deals resulted in delays that cost consumers more than $100 million, charges the companies deny. The proposed settlement is subject to public comment. If approved, it would expire in 10 years.
A nationwide coalition of 125 consumer and senior groups, Stop Patient Abuse Now, voiced support for a U.S. District Court decision to continue to allow access to generic versions of BuSpar. The judge for the Southern District of New York upheld Mylan Laboratories' position that Bristol-Myers Squibb's new patent for the antianxiety drug was invalid. The judge ruled that Mylan could sue Bristol-Myers for antitrust actions. Bristol-Myers had filed the new patent the same day its original BuSpar patent was to expire. The consumer coalition has also lobbied the FDA to prevent drugmakers from filing patents just to thwart generic competition.
Infants who get 20 immunizations by age two do not have a higher risk of developing Type 1 diabetes or certain infections, according to an independent panel of the Institute of Medicine. However, the panel's report said that the jury is still out on whether immunizations raise the risk of asthma. Despite growing concerns among parents that vaccines may harm an infant's immune system, the authors said there is no reason to change the federal immunization schedule.
A two-hour continuing education program on strep A screening is now on-line at www.ncpanet.org for $10. Completion of the CE is a prerequisite for pharmacists who want to participate in the strep-screening program developed by NCPA in collaboration with US Wellness Inc. (Drug Topics, Jan. 7). Qualified R.Ph.s can offer the screening service through US Wellness, which will reimburse them in cash for testing and counseling.
Eisai and Janssen Pharmaceutica have received FDA approval for the expanded use of Aciphex (rabeprazole sodium) to include the treatment of daytime and nighttime heartburn and other symptoms associated with GERD. In addition to this new indication, Aciphex is approved for healing of erosive GERD, which is caused when the lining of the esophagus is damaged by long-term acid exposure; maintenance of healed erosive GERD; healing of duodenal ulcers; and treatment of symptoms related to these conditions. Aciphex is also indicated for the treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
Schering-Plough Corp. is recalling specific lots of its allergy medication Claritin-D 12 Hour (5 mg loratadine/120 mg pseudoephedrine sulfate, USP) extended-release tablets that are still within their labeled expiration date. These products were manufactured between August 1999 and June 2001. The company said this recall does not extend to the patient level and that it believes these products are clinically safe and effective and pose no medical risk to patients. Schering said standard quality control tests uncovered problems in some Claritin tablets. In the designated batches, some tablets showed delays in releasing pseudoephedrine, the drug's decongestant ingredient.
Using reverse auction technology, a new on-line service promises to help consumers find the best deals on Rx drugs. The service, 1-800PrescriptonDrugs.com, matches patients seeking a particular prescribed drug with vendors willing to state their best price. The buyers then compare the offers and select the vendor of choice. The service is the latest addition to the stable of consumer-oriented Web sites developed by Nexan Networks, based in Philadelphia.
The Olympic Games are over, but not before Amgen's new darbepoetin (Aranesp) complicated the situation. The drug, not yet listed as a banned substance in Olympic rule books because it is so new, was found in the drug tests of three athletes. They were expelled from the games and stripped of their medals. Darbepoetin, a new and improved version of EPO (erythropoietin), which is banned, boosts oxygen in the blood and is indicated to treat anemia in patients with chronic renal failure.
Metrika Inc., Sunnyvale, Calif., is launching AlcNow diabetes monitor, the first single-use device for measuring hemoglobin A1c (HbA1c). Using the simple finger-stick test, healthcare professionals can obtain immediate, quantitative A1c results in their office and can offer their patients the ability to monitor this key health indicator at home. The AlcNow monitor provides laboratory-quality results in eight minutes from a single drop of blood.
Funded by Aventis Pharmaceuticals, the Council for Leadership On Thrombosis (CLOT) Awareness & Management has been formed to improve public consciousness of the dangers of deep vein thrombosis. The group will set up a national free DVT screening program involving 7,500 patients and more than 200 hospitals as well as establish a ClotAlert Resource Center to provide educational tools to health professionals and the public. For more information, call 1-(800) CLOT-FREE.
AdvancePCS plans to open a new customer care center in Knoxville, Tenn., on June 1 to support its rapidly growing PBM business, including the 58 new clients signed up in January. The Knoxville center will employ about 400 workers who will be able to handle 350,000 calls per day when it reaches full capacity. The independent PBM has similar centers in Arizona, California, and Texas.
New labeling for GlaxoSmithKline's inhaled corticosteroids will no longer carry a black box reminding physicians to use caution when switching patients from systemic corticosteroids (such as oral prednisone) to the inhaled form. The company had petitioned the FDA to remove the black box on grounds that physicians are cognizant of this already and that a black box could slow adoption of inhaled corticosteroids, the drugs of choice for many asthma patients. The FDA agreed after noting no adverse event reports associated with this issue.
Walgreen Co. has agreed to change its practices as part of a settlement with 40 states seeking to curb the sale of cigarettes to minors. The change in policy follows an undercover sting operation in New York to determine whether retailers complied with state law prohibiting the sale of tobacco products to people under 18. Of nearly a dozen stores targeted, Walgreens had the worst record, failing to ask for proper identification from minors who tried to buy cigarettes 11 out of 12 times. As part of the settlement, Walgreens will pay $320,000 to 40 states to cover the cost of the investigation. The chain also agreed to implement a training program for employees and to use checkout registers that will prompt cashiers to check identification.
Serono has launched SeroJet, which delivers the company's recombinant human growth hormone Serostim (somatropin for injection) in a needle-free format. Serono claims it's the only firm that offers this drug in a needle-free delivery system in this country. SeroJet purveys Serostim through an injection five times smaller than that from a standard 28-gauge needle. Serono will train health professionals on how to use the device through free workshops and has set up a hotline, 1-(866) SEROJET, to handle questions.
Latelines. Drug Topics 2002;5:9.