Latelines for Sept. 17, 2001
In the wake of last month's indictment of a Kansas City R.Ph. for allegedly diluting Rxs, Sen. Christopher Bond (R, Mo.) wants HHS to determine whether "a larger federal role in policing the conduct" of R.Ph.s is warranted. "What are the generally established mechanisms used at state and federal levels to police the conduct of pharmacists, and are greater safeguards, such as spot checks, required?" Bond asked. He also wanted HHS' views on whether "it is feasible and/or appropriate to establish federal assistance" for state pharmacy boards.
A federal court at least temporarily has derailed the Bush Administration's fast-track plan to have PBMs offer senior citizens Medicare-endorsed Rx discount cards. U.S. District Court Judge Paul Friedman granted a motion by NACDS and NCPA on Sept. 6 for a preliminary injunction to halt the program. HHS planned to announce the first endorsements Sept. 21, with marketing scheduled to begin Nov. 1. The program, announced by President Bush in July and developed with the assistance of the nation's five largest PBMs, promises discounts of 10%-25% on brands and 40%-60% on generics. At press time, the government had not said whether it would appeal. Sen. William Frist (R, Tenn.) said he would introduce legislation to give HHS the legal authority to proceed with the program.
Sen. Byron Dorgan (D, N.D.) is drafting legislation that would allow R.Ph.s and consumers to import drugs from Canada. He believes that the narrow focus would stymie opponents who have raised concerns about safety and savings in broader reimportation measures. Congress passed a law last year that would have permitted the reimportation of U.S.-made drugs, but both the Clinton and Bush administrations said they could not certify that the Rxs would be safe and consumers would save money. The House passed a "personal use" amendment in July that would allow an individual to import a drug that "appears to be FDA-approved [and] does not appear to be a narcotic drug."
The FDA has approved a new treatment that combines the use of two established drugs for patients with metastatic breast cancer whose cancer has progressed after treatment with an anthracycline-containing cancer therapy. The two drugs are Xeloda (capecitabine, Roche) and Taxotere (docetaxel, Aventis).
Bristol-Myers Squibb has become the second Rx manufacturer to forge a deal with Florida to provide healthcare services for Medicaid recipients. In exchange, the drugmaker will get all its medicines placed on the state formulary without paying supplemental rebates. Bristol-Myers said its community-based disease state management initiatives would save Florida $16.3 million over two years and pledged to give the state the balance if that amount is not reached. Pfizer negotiated a similar $33 million pact in June. Both firms are active members of PhRMA, which in August sued Florida over the formulary. The suit said federal rules require that all Rx drugs be available to Medicaid enrollees.
DEA is proposing that central fill pharmacies be allowed to prepare controlled-substance prescriptions for delivery to community pharmacies. "By transferring some of the time-consuming, nonclinical duties such as prescription filling to central fill pharmacies, traditional retail pharmacies can dedicate more time to assisting patients," DEA said. The prescriptions could be transmitted to the central fill facility either electronically or by fax. The community pharmacy would be required to retain the original hard copy of the Rx. DEA said it would soon propose standards for electronic transmission of Rx information in a separate ruling.
Tap Pharmaceuticals has been granted FDA approval to market its new oral, broad-spectrum cephalosporin antibiotic Spectracef (cefditoren pivoxil). The new agent will be available in a 200-mg tablet and is indicated for the treatment of acute exacerbations of chronic bronchitis, pharyngitis/tonsillitis, and uncomplicated skin and skin structure infections.
Global Enterprises is recalling its dietary supplement T3 because it contains tiratricol. The potent thyroid hormone, also known as tri-iodothyroacetic acid, or TRIAC, may cause strokes and heart attacks, the College Station, Texas, company said.
Pharmacists who have earned credentials through the National Institute for Standards in Pharmacist Credentialing now qualify for the designation Certified Disease Manager (CDM). NISPC offers credentialing exams for pharmacists in anticoagulation, asthma, diabetes, and dyslipidemia. Since its founding in 1998, NISPC has credentialed nearly 1,000 pharmacists.
The FDA has approved Genentech's thrombolytic agent Cathflo Activase (alteplase), a tissue plasminogen activator (t-PA), for the restoration of function to central venous access devices (CVADs). Administration of medical therapies through CVADs, which include many types of catheters, can be delayed by the formation of blood clots, which then occlude the CVAD. Cathflo Activase can break down the clot and restore function to the CVAD by activating plasminogen, which dissolves the clot-forming fibrin. The company will market Cathflo Activase in a 2-mg single-patient-use vial and claims it is the only marketed thrombolytic available for this indication.
The American College of Cardiology, the American Heart Association, and the European Society of Cardiology have reached a consensus on new practice guidelines for managing atrial fibrillation (AF). The guidelines, which include algorithms for managing specific types of AF, stress individualized treatment. Antiarrhythmic agents are usually not needed to treat patients with newly diagnosed AF or patients with recurrent paroxysmal AF. But patients who present with problematic symptoms generally require suppressive antiarrhythmic therapy and need to receive therapy to prevent thromboembolism. An executive summary of the guidelines will be published in the October issue of the Journal of the American College of Cardiology.
Following reports of 21 patients hospitalized because of severe liver injury associated with a two-month treatment regimen of rifampin and pyrazinamide (RIF-PZA) for latent tuberculosis infection (LTBI), CDC and the American Thoracic Society have issued revised treatment guidelines for LTBI. Sixteen of the patients recovered, and five died. According to the guidelines, a nine-month regimen of daily isoniazid (INH) is the preferred treatment for most individuals with LTBI. RIF-PZA remains a treatment option for patients at high risk for developing active TB disease (HIV-infected, recent contact with someone with active TB, IV drug users) or for those who are unable to complete the INH regimen. Careful monitoring of liver function is important with all treatment regimens for LTBI. Any additional cases of severe liver damage should be reported to the CDC's Division of TB Elimination.
The federal government has asked the Supreme Court to review a case that overturned the FDA's restrictions on the advertising and promoting of pharmacy-compounded Rxs. Earlier this year, an appeals court found that the compounding provisions of a 1997 FDA reform law were overly broad and violated the free speech protections of the First Amendment.
The FDA has approved Ortho-McNeil's antiepileptic drug topiramate (Topamax) tablets and sprinkle capsules as an adjunctive treatment option for adults and children (aged two to 16) who suffer from Lennox-Gastaut Syndrome (LGS). LGS, a severe debilitating form of epilepsy, accounts for up to 10% of all cases of pediatric epilepsy. The approval was based on a clinical study of 98 children aged two to 16, in which topiramate in combination with one or two other antiepileptic drugs significantly reduced both the severity of seizures and the number of atonic or "drop attacks." Topiramate is also approved as adjunctive therapy to treat partial-onset seizures and generalized tonic-clonic seizures in adults and children aged two to 16.
To encourage participation in two surveys it was conducting, Drug Topics held a drawing for R.Ph.s, with a palm pilot as the prize. Bagging the palm pilots are Ken DeLor, Louisville, Ky., who took part in a readership survey, and Sandy Fishman, Jersey City, N.J., who responded to our survey on third parties.
DEA has moved dichloralphenazone to Schedule IV status. This means the substance is subject to the registration, storage, security, and record-keeping requirements of a Schedule IV controlled substance. Pharmacies possessing dichloralphenazone are required to take inventory after Sept. 17. All prescriptions for dichloralphenazone or products containing the substance issued on or before Oct. 15if authorized for refillingshall, as of that date, be limited to five refills and shall not be refilled after Feb. 12, 2002. This final rule was issued in the Aug. 16 Federal Register.
Marina Marketos. Latelines. Drug Topics 2001;18:5.