Latelines for Jan. 15, 2000
Despite protests from APhA, NACDS, and NCPA, HCFA has issued final rules that offer a limited role for most R.Ph.s in providing diabetes education and self-management services for Medicare beneficiaries. To receive coverage for up to 10 hours of training, beneficiaries must go to a team that includes at a minimum a certified diabetes educator (or an R.N. with training as a diabetes educator) and a registered dietitian. The teams' services must meet HCFA-approved quality standards, and the teams must currently be eligible to bill Medicare for other services, such as DME. The new rule was little changed from the 1999 proposed version strongly opposed by the three pharmacy groups.
The FDA approved 27 new molecular entities last yearthe fewest since 1994 , when 22 Rxs were sent to the nation's medicine chest. In 1999, 35 Rxs won approval. The record was 53 in 1996. The average approval time in 2000 was 17.2 months, compared with 12.9 months in 1999. The agency also cleared six new biologics last year, up from five in 1999.
Pregnant women may be at increased risk of fatal lactic acidosis when prescribed the combination of the HIV Rxs stavudine (Zerit) and didanosine (Videx or Videx EC) with other antiretroviral agents, the FDA and Bristol-Myers Squibb warned health-care professionals Jan. 5. BMS recommended that the combination be prescribed to pregnant women only when the potential benefit clearly outweighs the potential risk, such as when the woman has exhausted all other treatment options. The black box section of the official labeling is being strengthened to include the new prescribing information.
With Congress in general agreement there should be tax cuts of some size and shape, NCPA is planning to lobby lawmakers to carve out Rx expenses as an itemized deduction. Currently, Rx costs are part of the general medical and dental expense deduction that kicks in only after they exceed 7.5% of a filer's adjusted gross income. NCPA wants out-of-pocket costs for OTCs and pharmacist services, Rx co-pays, and premiums for Rx-only insurance coverage made first-dollar deductible, too. There also should be some refund feature for those who do not itemize or who do not have to file because of low income. NCPA believes the uninsured would be the biggest beneficiaries, gaining some relief from high Rx prices without involving PBMs, HCFA, or the states.
The FTC is allowing Cardinal Health's $2.1 billion acquisition of Bindley Western Industries to go ahead. Bindley Western shareholders are scheduled to vote on the stock-for-stock transaction Feb. 14. The deal will put the Cardinal/Bindley combination in a virtual dead heat with McKesson as the top Rx wholesaler. Bergen Brunswig, Cardinal's proposed merger partner in 1997, will hold the third spot in the marketplace, with AmeriSource at No. 4. In 1998, the FTC scuttled a Cardinal/Bergen deal and a planned McKesson/AmeriSource merger on the grounds that they would have significantly reduced competition. A federal court upheld the FTC ruling. There now is speculation in the financial community that AmeriSource and Bergen may start merger talks.
The New Jersey Attorney General's office sued two on-line pharmacies for illegally selling Rx drugs on the Internet. For the first time, state officials also cited a national network of doctors and pharmacists who allegedly authorized the Rxs. The civil lawsuits were filed against Rx Leader and RB Drugstores for illegally selling mostly lifestyle drugs, such as Viagra, Xenical, and Propecia.
Phyne Pharmaceuticals of Scottsdale, Ariz., has issued a recall of a number of injectable products due to a lack of assurance of sterility and a mislabeling of colchicine as .5 mg/ml when it is actually a superpotent 5 mg/ml. The products may be labeled with the Phyne name or that of the contract facility that produced them, Amram Inc. of Rathdrum, Idaho, said the FDA. A complete product list with lot numbers/codes and expiration dates is available from the FDA at www.fda.gov/medwatch and from Phyne at 1-(800) 345-3301.
CDC has issued a warning that healthy workers inadvertently stuck by needles should not receive nevirapine (Viramune, Roxane Laboratories) as prophylaxis. The reason is the HIV drug has been associated with liver damage severe enough to require liver transplants. The drug can, however, still be used to treat HIV patients and to prevent HIV transmission from mothers to babies during childbirth.
George F. Archambault, widely honored as the "founding father" of consultant pharmacy, died Jan. 1 in Bethesda, Md. He was 91. As the chief pharmacy officer in what was then the Department of Health, Education & Welfare, Archambault promoted the concept of R.Ph. involvement in nursing home patients' Rx regimens in the 1950s and advocated their role in the Medicaid and Medicare programs in the 1960s. A past president of APhA and ASHP, he was awarded the U.S. Surgeon General's Medal for his "creativity, imagination, and dedication" during a 20-year career in the Public Health Service. ASCP honors one of its members annually with the George F. Archambault Award.
In tapping Wisconsin's Tommy Thompson to head HHS, President-elect George W. Bush has turned to a longtime governor whose administration began paying R.Ph.s for some pharmaceutical care services under Medicaid while repeatedly seeking deep cuts in product reimbursement under the federal-state program he'll now oversee. Bush also has named political veteran Mitch Daniels, for the past decade a senior executive at Lilly, to run the White House Office of Management & Budget. Daniels headed the GOP Senate campaign committee and later was political director in the Reagan White House before joining Lilly, where he helped steer the purchase of PCS through the FTC. Sally Canfield, a former Congressional aide and Washington lobbyist, was selected to serve as White House deputy assistant on health-care policy.
JCAHO has approved new patient safety/medical error reduction standards. The criteria include creation by hospital leaders of an environment that encourages nonpunitive error identification and remediation; hospitals must proactively assess high-risk activities and undertake improvements, and they must undertake information management to identify patient risks, reduce those risks, and improve professional performance. Hospitals will also be required to inform the patient and family members about the results of care, including unexpected outcomes. The standard is slated to be implemented in July.
RxTechSchool.com has been launched as an on-line preparation course to help pharmacy technicians pass the Pharmacy Technician Certification Board examination. Sponsored by Pharmacy Choice, a Denver-based Web-services firm, the course is self-paced and available at all times on the Net. The price is $175, but there's a 30% discount for users who register with Pharmacy Choice.
Oral contraceptives and intrauterine devices not approved by the FDA are easily available without prescription via the Internet. This finding was revealed in the January issue of Obstetrics and Gynecology. Investigators from the University of Washington in Seattle posed as consumers and ordered various contraceptive devices from Web sites located with commonly used search engines. The team found that male and female condoms, vaginal sponges, and diaphragms were widely available, although delivery often took up to 12 days.
Novartis Pharmaceuticals has received FDA approval for its Type 2 diabetes drug Starlix (nateglinide). Starlix is a D-phenylalanine derivative that restores early-phase insulin release, thus halting the increases in postprandial blood glucose levels, or "mealtime glucose spikes" often experienced by Type 2 diabetes patients. The new drug is indicated for use alone or in combination with metformin, the active ingredient in Bristol-Myers Squibb's diabetes drugs Glucophage and Glucovance, in patients whose blood glucose is not controlled by diet and exercise.
You can expect Toronto-based Biovail Corp. to assume a bigger presence in the United States. That's because Biovail has acquired the North American rights to Aventis' Cardizem (diltiazem) family of products, including Cardizem CD, Cardizem SR, and Cardizem injectable products. To ensure a smooth transition, Aventis will continue to manufacture the cardiovascular products for four years. Biovail plans to introduce a once-daily diltiazem product, called Cardizem XL, in the first half of 2002.
Roche's Cellcept (mycophenolate mofetil) has received FDA clearance for preventing rejection in youngsters receiving kidney transplants. The compound was first approved in 1995 for preventing kidney transplant rejection in adults. Since then, it has added several other indications, including as a prophylactic for heart and liver transplant patients. The latest approval covers three oral formulationsa 250-mg capsule, 500-mg tablet, and solution in 200-mg/ml strength.
SmithKline Beecham and Roche have swapped drugs. Roche has bought SmithKline Beecham's Kytril (granisetron), which prevents chemotherapy-induced nausea and vomiting. SmithKline Beecham has acquired Roche's antihypertensive drug Coreg (carvedilol). The deal grew out of the merger of SmithKline Beecham and Glaxo Wellcome.
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