Latelines for June 18, 2001
Pfizer has become the first drug company to endorse patient access to providers and payment for pharmacist care services. A joint statement with NCPA issued June 11 reads in part:
"We favor comprehensive reform of Medicare overall, which includes drug coverage. Because structural reform of the Medicare program is likely to entail a long and complex process, we also support drug coverage that can be provided in the near term. Any drug benefits at the federal and state level should include:
Amgen has discovered more counterfeit Neupogen. That's the third time this year bogus filgrastim has been found. The latest involves lot number P000992. Legitimate vials have a 06/02 expiration date. The fake ones carry 06/03. The company also suspects lot number P000905 may contain counterfeits. Legitimate vials bear an expiration of 02/02; counterfeit ones show 08/02. Any vials with lot numbers P000889 and P000819 are not genuine.
Just weeks after lightening its look by washing away its Clairol unit, Bristol-Myers Squibb is buying the DuPont Pharmaceuticals Co. for $7.8 billion. BMS sold the Clairol hair products business to Procter & Gamble in May for $4.95 billion. The DuPont purchase is subject to FTC review.
Two state-based Rx-discount plans for low-income senior citizens have run into legal roadblocks. In a Vermont case, a U.S. appeals court reversed a lower court ruling and found that HHS did not have the authority to expand Medicaid coverage and require manufacturer rebates. PhRMA had opposed the expansion. HHS is reviewing a similar plan proposed by Florida.
In Washington, a state court overturned a state-approved expansion of a Merck-Medco-run PPO for state employees that promised discounts of up to 30% off retail prices and more for mail order. The Washington State Pharmacists Association, Washington Retail Association, and Washington Food Industry opposed the plan because their pharmacies were expected to give enrollees the discounts without reimbursement from the state.
Cortisone injections contaminated by a noncontagious strain of meningitis killed at least one man and infected three others in Walnut Creek, Calif. Twenty patients had received cortisone injections in their spinal cords at Sierra SurgiCenter on May 29 or May 31. One man died, and three of seven patients hospitalized were diagnosed with meningitis. However, another death has not been definitely linked to the injections. The suspect cortisone solution, compounded at a Walnut Creek pharmacy, has been recalled by local health officials.
Barr Laboratories expects to launch generic Prozac (fluoxetine) in 20-mg capsules on Aug. 3, when Eli Lilly's six months of pediatric exclusivity expires. On May 30, a three-judge federal appeals panel in Washington, D.C., reaffirmed its earlier decision invalidating a patent that would give Lilly exclusivity until June 2004. Lilly is likely to appeal for a hearing by the entire 12-judge appellate court or to the U.S. Supreme Court, either of which could delay generic competition for the antidepressant, which accounts for $2.6 billion in sales per year.
A Boston-based consumer group has filed a class action lawsuit against Schering-Plough, American Home Products, and Upsher-Smith Laboratories. The suit alleges the firms entered into an illegal agreement that is keeping a generic form of Schering's K-DUR 20 (potassium chloride) off the market. The companies denied the charge. The FTC has filed a similar suit. The consumer group, the Prescription Access Litigation project, earlier this year sued Bristol-Myers Squibb for blocking a generic version of BuSpar (buspirone) and AstraZeneca and Barr Laboratories over the pricing of tamoxifen. All of the group's suits have been filed in both federal and state courts.
Florida has a new law that removes digoxin, phenytoin, quinidine gluconate, and sodium warfarin from the state's negative drug formulary that bars substitution. R.Ph.s now must dispense generic versions of the four drugs unless the M.D. writes "medically necessary" on the prescription. Supporters of the change estimated Rx costs would decline by about $20 million annually.
GlaxoSmithKline is appealing a federal jury verdict in Cheyenne, Wyo., that blames M.D.-dispensed Paxil (paroxetine HCl) in the case of a man who shot and killed his wife, daughter, and granddaughter and then turned the gun on himself. The jury awarded the family survivors $6.4 million based on testimony that suggested SSRIs like Paxil can cause some individuals to commit homicide and/or suicide. GSK argued that there was no reliable scientific evidence to support that finding.
Utah officials have released a report examining 90,000 medical errors among hospital patients over the past five years. The most common mistakes involved complications during surgery or other procedures, and nearly half of all problems involved adverse reactions to medications. The mistakes were reported voluntarily by hospitals. The state health department is proposing that hospitals be required to report certain incidents, including adverse drug reactions. The rules are expected to become effective in October.
In response to reports of dispensing errors, GlaxoSmithKline has dramatically changed the container labeling for its antiepilepsy drug Lamictal (lamotrigine) Tablets. The packaging changes include different-colored labels for each strength available; addition of the following message to the label: Caution: Verify Product Dispensed; use of a yellow bottle cap; and visual modification of the Lamictal proprietary name.
The most common dispensing errors have been between Novartis' antifungal agent Lamisil (terbinafine HCl) and Lamictal, but GSK has also received reports of errors involving other medications, including its own lamivudine (Epivir), Ludiomil (maprotiline HCl, Novartis), labetalol (Normodyne, Schering), and Lomotil (diphenoxylate/ atropine, Searle).
Wyeth-Ayerst has modified the labeling for its antiarrhythmic drug Cordarone IV (amiodarone). The changes reflect the company's recognition that amiodarone IV is used off-label to treat arrhythmias in pediatric patients despite the lack of safety and efficacy data supporting this use. The first addition to the labeling warns of the product's propensity to leach out plastics, which may adversely affect male reproductive tract development during fetal, infant, and toddler stages. The second addition concerns reports of fatal "gasping syndrome" in neonates following the administration of IV solutions containing the preservative benzyl alcohol, which is used in amiodarone IV.
HMG-CoA reductase inhibitors top the list of drugs most affected by three-tier co-pays, according to 79% of HMOs and 75% of PBMs surveyed by Scott-Levin. Proton pump inhibitors and antihistamines placed second and third on the list. Three-tier benefit plans are used by about 80% of managed care firms in an effort to steer beneficiaries away from costly drugs toward less expensive generics or preferred brands with rebates.
The Lake Erie College of Osteopathic Medicine received a provisional go-ahead from Pennsylvania's department of education to establish a pharmacy school. The green light puts the Erie school on track for a September 2002 opening, with 78 students enrolled in an accelerated Pharm.D. program. An ACPE evaluation team will visit the college later this summer as part of the accreditation process.
Eckerd Corp. reached a settlement in a class action lawsuit alleging that the drugstore chain had failed to pay 1,062 pharmacists for overtime hours. The settlement is confidential, but Clayton Davis, the Lake Charles, La., attorney representing the pharmacists, said he's pleased with its terms. The R.Ph. plaintiffs in the suit will share in the award on the basis of the number of overtime hours they had worked.
Pharmacists should begin now to communicate with their high-risk patients most in need of influenza immunizations next fall, according to APhA. High-risk patients include those over 50 years of age, nursing home residents, those with chronic conditions, pregnant women, and healthcare workers and caregivers. Such patients should ask their R.Ph. to inform them when the vaccine supply becomes available.
U.S. inspectors are being overwhelmed by the Internet-spurred volume of Rx drugs mailed from overseas, and the only practical solution is to turn away almost all of them, the FDA has suggested. William Hubbard, a senior associate commissioner, told a Congressional panel that an estimated two million packages with drugs come into U.S. international mail facilities each year, many containing products that may be "counterfeit or worse." Most packages are sent on without review. Hubbard said Congress should make it illegal to accept drug shipments except in "compassionate use" cases when a treatment for a serious disease is unavailable in the United States.
Marina Marketos. Latelines. Drug Topics 2001;11:7.