Latelines for Nov. 19, 2001
HHS doesn't see the need for more federal oversight of R.Ph.s, as Sen. Christopher S. Bond (R, Mo.) had suggested. "Overall, we feel the current system has provided, and will continue to provide, adequate protections to the public health," HHS secretary Tommy Thompson wrote Bond last month. Reacting to the indictment in August of a Kansas City R.Ph. for allegedly diluting cancer drugs to increase his profits, Bond had asked HHS to determine whether a "larger federal role in policing the conduct" of R.Ph.s was warranted.
Frova (frovatriptan succinate) is a new drug for adults with migraine with or without aura from Elan Corp., which has licensed the product from the European firm Vernalis Group. Unlike other triptans, which have a half-life of up to six hours, Frova 2.5-mg tablets are effective for 26 hours to treat migraine attacks, which often last from four to 72 hours. The price of the product will be released after Elan, which is currently seeking promotional partners, finalizes its launch plans.
Pregnant or breastfeeding women who have been exposed to anthrax should first be treated with ciprofloxacin 500 mg every 12 hours. But once susceptibility testing confirms that their anthrax isolate is sensitive to penicillin, they should be switched to amoxicillin 500 mg t.i.d., and this treatment should continue for 60 days. These recommendations represent new guidelines from the American College of Obstetricians and Gynecologists. ACOG explained that the switch to amoxicillin is recommended because it has a longer record of safety during pregnancy.
Patients who are taking warfarin and the cancer drug Xeloda (capecitabine, Roche) should have their INR or prothrombin time checked frequently. This is because a study has found that there are significant increases in prothrombin time and INR among patients receiving these drugs. Postmarketing reports have also corroborated this finding. To alert health professionals of this danger, the FDA and Roche have added a black box warning and changed the Precautions section in Xeloda's label.
Discovery of anthrax at Washington, D.C.'s main postal distribution facility last month disrupted mail service at the FDA, DEA, and other government offices and delayed delivery of mail-order Rxs. R.Ph.s concerned about new or renewal applications they sent to DEA's office of diversion control registration unit should contact their local DEA office. For a list of offices, visit www.deadiversion.usdoj.gov . AdvancePCS suggested that customers submit refill orders 30 days in advance instead of two weeks. A false positive anthrax test at FDA offices in Maryland also halted mail service there for several days this month.
Indiana pharmacists and state Medicaid officials have agreed to negotiate instead of litigate. The two sides have been battling over the state's cut in Medicaid reimbursement from AWP minus 10% and $4 to AWP minus 13% and $3. A state judge blocked the cuts, but the state adopted an "emergency" rule and imposed the cuts anyway. As R.Ph.s were heading back to court, both sides agreed to talk about ways R.Ph.s could help the state pare $680 million from the $3.8 billion program, and the state lifted the cuts.
The FDA has warned 11 foreign Internet vendors to stop selling ciprofloxacin to American consumers. The agency has informed regulatory officials in the countries where the e-pharmacies operate that the companies were violating U.S. law and has asked the U.S. Customs Service to refuse entry to their shipments. But the difficulties in policing foreign companies was illustrated when the FDA noted it had found five other overseas Web sites that it had taken similar actions against were continuing to sell ciprofloxacin to U.S. residents.
Officials urging people to get flu shots to avoid confusion between influenza and inhaled anthrax symptoms has boosted demand for the flu vaccine. Delivery of the vaccine is behind schedule again this year. CDC reported that 56% of the vaccine supply was delivered in October, with 31% anticipated this month, and the remaining 13% expected in December. Some experts warn that giving flu shots to otherwise healthy people may mean more deaths if at-risk populations can't get the vaccine.
Rite Aid has agreed to pay a $150,000 fine to the state of New Jersey to settle allegations that it overcharged consumers who lacked Rx drug coverage. The retailer was cited for allowing individual R.Ph.s to arbitrarily charge higher prices to patients without Rx benefits. According to the N.J. division of consumer affairs, Rite Aid referred to this practice as a "positive override" price policy in its internal documents.
Oklahoma R.Ph.s are back giving flu and pneumococcal vaccinations after winning an injunction against an attorney general's opinion that said they couldn't legally administer drugs. Pharmacists had been giving the immunizations under physician protocols for about four years until the attorney general received a complaint from the State Board of Medical Licensure & Supervision, explained Phil Woodward, executive director of the Oklahoma Pharmacists Association (OPA). The AG ruled in June that the state board of pharmacy had exceeded its authority when it adopted rules that permitted R.Ph.s to administer certain Rxs. The R.Ph.s must have a written agreement with a physician, be certified in CPR, and pass a special course in immunizations at a pharmacy school. Last month, OPA, arguing that public health would be compromised if R.Ph.s couldn't continue to immunize, got a favorable court ruling. Woodward said OPA would seek legislation next year to put R.Ph.s' immunization authority into law.
GlaxoSmithKline's Coreg (carvedilol) has been cleared to treat severe heart failure. It was formerly approved to treat mild to moderate heart failure. With the new indication approval, Coreg is the only beta-blocker approved to treat mild, moderate, and severe heart failure, GSK said. In studies, patients with severe heart failure who took Coreg reduced their risk of death by 35% as compared with placebo.
Bristol-Myers Squibb has received the FDA's blessing to market Tequin (gatifloxacin) as a five-day treatment for acute bacterial exacerbation of chronic bronchitis (ABECB). This short-course regimen approval is another feather in the cap of the broad-spectrum fluoroquinolone, which is already approved for seven- to 10-day treatment of ABECB. Other respiratory conditions the antibiotic has had indication approval for are acute sinusitis and community-acquired pneumonia.
APhA has issued a set of guidelines for nuclear pharmacy compounding, an area left uncovered by the FDA Modernization & Accountability Act. "Since the compounding of radiopharmaceuticals was not included in FDAMA, there has been no guidance available to nuclear pharmacy practitioners," observed S. Duann Vanderslice, R.Ph., BCNP, chair of the APhA Academy of Pharmacy Practice and Management (APhA-APPM) section on nuclear pharmacy practice. "In order to help fill this need, the approval of these guidelines could not have come at a better time. Additionally, the guidelines will give nuclear pharmacy practitioners an integral tool for modeling their compounding practices and providing radiopharmaceutical care and services." The guidelines are posted on APhA's Web site at www.aphanet.org .
Marina Marketos. Latelines. Drug Topics 2001;22:6.