Latelines for Feb. 5, 2001
A lawsuit filed by a pharmacist charging she was fired in 1996 by Kmart for refusing to dispense Micronor (norethindrone, Ortho-McNeil), which is used as an emergency contraceptive, can proceed, according to a U.S. District Court judge in Ohio. While four of five claims were dismissed, the judge ruled that Karen Brauer, R.Ph., can pursue a claim under the state's freedom-of-conscience law. The suit was filed in August 1999 by the pro-life Center for Law & Justice on behalf of Brauer, who now works part-time in the Cincinnati area.
The American College of Chest Physicians has released the 2001 Consensus Statement on Antithrombotic and Thrombolytic Therapy for Ischemic Stroke. It states that the antiplatelet agent, aspirin/extended-release dipyridamole 25 mg/200 mg (Aggrenox, Boehringer Ingelheim), is more effective than aspirin alone in reducing the risk of secondary stroke in those who have already experienced a stroke or transient ischemic attack (TIA). The recommendations were supported by the results from the European Stroke Prevention Study-2, which demonstrated that aspirin/extended-release dipyridamole reduced the risk of stroke by 37% compared with placebo and by 22% compared with aspirin alone. It is recommended that all patients who have already suffered a stroke or TIA receive antiplatelet therapy.
According to researchers at the University of California-Davis School of Medicine, a routine treatment for diabetic ketoacidosis in children can trigger cerebral edema and can be fatal. The treatment involves giving an injection of sodium bicarbonate to reverse the toxic acid buildup in their blood. Children who received the bicarbonate were 4.2 times more likely than the other children to develop this rare complication. Swelling of the brain was fatal to about one-fifth of those children with ketoacidosis and left an additional one-fourth with brain damage.
Merck & Co. has received FDA approval to market its new antifungal, caspofungin acetate (Cancidas). It is the first in a new class of antifungals called echinocandins or glucan synthesis inhibitors, which work by attacking the fungal cell wall. Caspofungin acetate is indicated to treat invasive aspergillosis, a life-threatening fungal infection, in patients who have not responded to or cannot tolerate other antifungal therapies, amphotericin B, lipid formulations of amphotericin B, and/or itraconazole.
NACDS will develop a proposal for Congress and the Bush Administration to consider that looks at ways "to compensate pharmacies for the services performed by pharmacists," Craig Fuller, the association's CEO, told Drug Topics. Fuller, who has close ties to the new administration, suggested that "the role of the pharmacist and how pharmacies are compensated" could be addressed as a part of Medicare reform and the addition of a drug benefit.
Community R.Ph.s will have to give patients an FDA-mandated MedGuide with every new and refilled prescription for Accutane (isotretinoin, Roche), the agency said Jan. 23. It also is requiring new consent forms that patients must sign before an M.D. can prescribe the treatment for nodular acne. MedGuide and the forms state that possible serious side effects include mental problems and suicide in both men and women. Since birth defects are possible if a pregnant woman takes the Rx, women of child-bearing age will not be able to refill their Rxs. They will need to visit their doctors and have negative pregnancy tests before receiving another Rx.
Bayer Corp. will pay $14 million to the U.S. government and 45 states to settle allegations that it reported inflated drug prices used by Medicaid to set reimbursement rates. The German-based firm also has settled charges that it underpaid Medicaid rebates. The agreement is part of a wide-ranging federal-state investigation into several companies thought to be "marketing the spread"reporting an extremely high AWP to services such as Red Book, a sister publication of Drug Topics, that states use to calculate reimbursement rates, then selling certain IV, injectable, or inhalant products to M.D.s at dramatic discounts.
New Jersey HMOs can't limit full coverage to only one Rx for a condition if other Rxs also are available, under new state rules that take effect July 1. The price break HMOs give patients for using formulary Rxs also cannot be more than 30%.
President George W. Bush has accepted the resignation of Jane E. Henney, M.D., as FDA commissioner and begun what could be a long search for her successor. Henney, like all Clinton Administration appointees, formally offered her resignation. But given her low profile and nonconfrontational style, there was speculation she would be retained at least until a replacement was confirmed. Some Democratic senators indicated that Henney's approval of the abortion drug RU-486 might have led to her dismissal. Deputy commissioner Bernard Schwetz, Ph.D., was named acting commissioner. The Bush Administration also postponed for 60 days the effective dates of any federal regulations that had been issued but not yet taken effect. No new proposed or final regulations can be issued unless approved by a Bush-appointed cabinet or agency head.
President George W. Bush's proposal to provide $48 billion over four years for states to establish or expand Rx-aid plans for low-income seniors "is an ill-advised and ill-conceived concept"and that's from Bush's closest Democratic confidante in the Senate, John Breaux of Louisiana. Other Democrats were nearly as blunt and a number of GOP lawmakers also were cool to Bush's "immediate helping hand" idea. Some opponents believe it would take as long to get the Bush stop-gap measure up and running as it would to enact a universal Rx benefit as part of a major overhaul of Medicare, as Bush also has proposed. Senate Democratic leader Tom Daschle of South Dakota has reintroduced a Medicare Rx bill that includes payment for pharmacist services, pharmacy freedom of choice, and extra payments for R.Ph.s in rural and hard-to-serve areas.
A federal judge is allowing Vermont's expansion of Medicaid to cover some otherwise ineligible seniors to proceed while PhRMA's lawsuit against the program is pending further court action. Mainewhose own Rx discount plan passed last year is being held up by a different federal judge because of a PhRMA challengesaid that just before leaving office, the Clinton Administration gave it a waiver to copy the Vermont program. In Washington, a state judge has denied a request by a group of pharmacists to block a discount program that they argued would either put them out of business or out of networks to which many of their patients belong. Further legal action is pending. Nevada is enrolling seniors in a private insurance model plan with premium subsidies for the poorest.
Four Connecticut pharmacists pleaded not guilty in federal court to charges that they filled at least 15,000 bogus Rxs in a conspiracy to distribute narcotics such as Percocet and Valium. The Rxs were written by a 78-year-old doctor running a sham office, according to an assistant U.S. attorney. The pharmacists allegedly filled the Rxs repeatedly for the same customers, often within days, and dispensed an estimated half million doses of narcotics during the two-year investigation. If convicted on the conspiracy charge, each of the R.Ph.s and four other defendants faces a maximum sentence of 20 years in jail and a $1 million fine.
Marina Marketos. Latelines.