Latelines for Oct. 21, 2002
Ray Burns, owner of Urgent Care Pharmacy in Spartanburg, S.C., denied that there's any direct evidence linking his compounding pharmacy to a fungal meningitis outbreak that killed an elderly woman and sickened two others in North Carolina. The victims had received methylprednisolone injections between April and July at separate North Carolina health clinics that received the drug from the pharmacy. State officials contended the drug was contaminated with the soil mold Wangiella dermatitidis, but Burns, who recalled the drug batch, said independent lab test results were negative.
In a stunning setback for the generic drug industry, a U.S. District Court Judge in New York ruled that four generic drugmakers infringed on patents held by AstraZeneca PLC for its proton pump inhibitor Prilosec. The court ruled that AstraZeneca's patents for Prilosec (omeprazole) (Nos. '505 and '230) are valid and that bioequivalent versions of the drug developed by Andrx Corp., Genpharm Inc., and Cheminor Drugs LTD infringe on the patents. The court also determined that the bioequivalent version of Prilosec developed by Kremers Urban Development Co. does not infringe the asserted claims of those patents. The court has not yet made any rulings with respect to the '281 patent, which was asserted solely against the Andrx product, and has not indicated when such a ruling is expected. At press time, Andrx officials announced that they would appeal the decision.
Members of AMCP will be able to take advantage of a free CE program on-line through a new service the association is offering beginning this month. The service, on AMCP's Web site, will also help members keep track of all the CE courses they have completed, even those offered by other sponsors. In addition, to improve relations between managed care and community pharmacy, AMCP is rolling out a CE presentation Managed Care and the Community Pharmacist. These were some developments the association announced at its educational conference in Washington, D.C., this month.
A tool to help hospitals evaluate the effectiveness of their computerized physician order entry (CPOE) system should be available soon from the Leapfrog Group and First Consulting Group. So said Suzanne DelBanco, executive director of the Leapfrog Group, at the AMCP educational conference in Washington, D.C., this month. She added that a similar evaluation tool is in development for CPOE in the outpatient setting. The Leapfrog Group, a consortium of large employers, is also expected to announce refinements to its existing three recommendations next spring. The three recommendations now call for the use of CPOE, intensivists in ICU, and evidence-based hospital referrals to improve patient safety.
Medication errors caused by prescribers indicating the wrong dosage form are on the rise, according to a new study published in the Journal of General Internal Medicine. During a five-year period, dosage form errors rose from about 0.6 per 100 patients to 1.3 per 100 patients at Albany Medical Center, Albany, N.Y. Of the 1,115 errors reported, 49 were considered to be potentially serious and three could have been fatal. The rise was attributed to the increase in available dosage forms, such as controlled-release, for both old and new drugs.
Pharmaceutical Care Network has launched a Web site that allows physicians and pharmacists to submit prior-authorization requests via the Internet rather than by fax. The Sacramento, Calif., PBM, which processes 23,000 prior authorizations monthly, touts the on-line service as a way to save time and trees by eliminating faxes.
In a final rule published in the Oct. 7 Federal Register, DEA gave notice that it has rescheduled buprenorphine from Schedule V to Schedule III. This announcement coincides with the approval of Reckitt Benckiser's Suboxone (buprenorphine/naloxone) and Subutex (buprenorphine) 2 mg and 8 mg sublingual tablets for the treatment of opiate dependence. The firm pointed out that these products would expand treatment options for the opioid-dependent from drug treatment centers, which are few and far between, to physicians' offices, which are more private and prevalent.
Eli Lilly and Bristol-Myers Squibb settled more than 300 civil lawsuits stemming from the Kansas City chemotherapy dilution case. Terms of the settlement were not revealed. The drug firms were sued for allegedly failing to stop R.Ph. Robert Courtney, who pleaded guilty in February and faces up to 30 years in prison at his sentencing set for December. Lilly and BMS have denied any wrongdoing. A spokeswoman said that under Missouri law, even if a jury found Lilly only 1% at fault, it could have been required to pay 100% of any damages.
AdvancePCS has agreed to buy Accordant Health Services, a privately held disease management firm focused on complex, chronic, and progressive conditions. Based in Greensboro, N.C., Accordant specializes in 15 high-cost niche disease states, such as hemophilia, multiple sclerosis, cystic fibrosis, and seizure disorders. Terms of the deal were not disclosed.
Sankyo Pharma has announced that in a multicenter trial, treatment with colesevelam (Welchol) significantly increased the size of low-density lipoprotein cholesterol (LDL-C) particles from baseline in patients with moderate hypercholesterolemia. In addition, study investigators found that colesevelam therapy significantly reduced levels of LDL-C and total cholesterol. Analyses of previously published studies have shown that the presence of small, dense LDL-C particles is associated with an increased risk of coronary heart disease. For patients with moderate hypercholesterolemia, treatment with colesevelam at the recommended starting dose (3.8 gm) may lead to improved particle size distribution. Results of the current study were presented recently at the European Atherosclerosis Society's 73rd Congress in Salzburg, Austria.
The popular dietary supplement Sam-e shows promise as an equivalent treatment to prescription drugs for depression and osteoarthritis and may help some chronic liver conditions. This finding comes from a new Evidence Report Summary sponsored by AHRQ and prepared by Rand Corp., which examined 102 clinical studies.
Under pressure from three drugstore chains, Massachusetts cut its Medicaid reimbursement rate by 4%, not the 11% approved by the state legislature last summer. The cutback drops the state's anticipated savings from $60 million to $10 million. The new AWP plus 6% rate is retroactive to all scripts filled on or after Aug. 3. The state also raised the dispensing fee from $3 to $3.50 for brands and from $3 to $5 for generics. Brooks, CVS, and Walgreens, which fill 60% of the state's Medicaid Rxs, had threatened to leave the program. CVS agreed to stay in Medicaid after announcement of the new rate.
Allterra Inc. and B&T Pharmaceuticals have joined in a licensing agreement to market Novitra, a homeopathic medicine to treat cold sores. The nonprescription medication is made with a zinc formulation. The firms claim Novitra shortens the duration of cold sores by half. The product, a white cream that dries clear when applied to the skin, is recommended for adults and children two years of age and older.
Drug companies participating in the Together Rx discount card for low-income Medicare recipients have agreed to provide additional data to show why the program should be exempt from Medicaid's "best price" mandate. Bristol-Myers Squibb and GlaxoSmithKline reduced their discounts after CMS notified the seven drug firms sponsoring Together Rx that they must charge Medicaid the best price and are illegally allowing Medicare patients to pay less than Medicaid patients. The firms say extending the discounts to Medicaid would be prohibitively expensive.
Marina Marketos. Latelines. Drug Topics 2002;20:5.