Latelines for Aug. 6, 2001



Black-box warning added to OxyContin labeling

Purdue Pharma worked closely with the FDA to significantly revise the labeling for OxyContin Tablets (controlled-release oxycodone HCl) amid increasing reports of illegal misuse, abuse, and diversion. The changes, which are detailed in a "Dear Healthcare Professional" letter sent out to physicians and pharmacists, include a new black-box warning, which highlights the abuse liability of OxyContin, and a revised indication and usage section, which reinforces the appropriate patient population for whom the product is intended. OxyContin is indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. It is not to be used as a p.r.n. analgesic or for pain in the immediate postoperative period (the first 12-24 hours following surgery).

FDA OKs Rebetol split from Rebetron

Schering-Plough received FDA clearance to market Rebetol (ribavirin) capsules for use only in combination with Intron-A (interferon alfa-2b, recombinant). It is indicated for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with alpha interferon or patients who have relapsed following alpha interferon therapy. According to Schering, Rebetol, previously approved for the same indication as a component of Rebetron Combination Therapy, will be used "if patients need a dose modification" supplementing the combination therapy with more ribavirin. The stand-alone product is expected to be available this fall.

Aciphex gets a makeover

Eisai Inc. and Janssen Pharmaceutica have announced a new look for their proton pump inhibitor, Aciphex (rabeprazole sodium). The 20-mg tablet will now be imprinted with Aciphex 20 and packaged in larger unit-of-use bottles to accommodate Rx labels. In order to distinguish between the 30- and 90-count-size containers, the new bottles will feature color-coded blue or red Aciphex brand labels, respectively.

Quality group identifies errors that shouldn't happen

Call it a hospital's "Don't Do" list—27 adverse events that the National Quality Forum (NQF) says should never or rarely happen in health care. The events include operating on the wrong person or body part, using contaminated drugs or devices, and discharging a baby to the wrong family. "The errors on our list represent health care's crashes," said Kenneth W. Kizer, president of NQF, which is made up of some 120 consumer groups, insurers, government agencies, and professional organizations.

FDA OKs new indication for Genotropin

The FDA has approved Pharmacia Corp.'s growth hormone Genotropin Lyophilized Powder (somatropin [rDNA origin] for injection) for the long-term treatment of growth failure in children who were born small for gestational age (SGA) and do not have catch-up growth by age two. Genotropin, which received orphan status for SGA, has orphan status for use in children suffering from growth failure due to Prader-Willi Syndrome. It is also approved for long-term therapy for children who have growth failure due to growth hormone deficiency (GHD) and as replacement therapy in adults with a diagnosis of GHD.

Wisconsin R.Ph.s optimistic about Rx aid plan ...

Lawmakers in Wisconsin and the governor are near a deal that would provide Rx aid for low-income seniors. Community pharmacists are pretty satisfied with the deal. A stiff hike in the cigarette tax will fund the SeniorCare program, which calls for pharmacy reimbursement at AWP minus 6.25% plus a $4.38 dispensing fee. There are additional payments for special packaging, compounding, and pharmacist care services. The program is closely linked to Medicaid, under which product reimbursement is being trimmed from AWP minus 10% to AWP minus 11.2%.

... while R.Ph.s in Indiana fight Medicaid cuts

The scenario is not as rosy in Indiana. There, state officials are pushing a plan to cut Medicaid reimbursement from AWP minus 10% plus $4 to AWP minus 13% and $3. Major chains, including Walgreens, have said they'll be forced to reduce hours at stores with heavy Medicaid business to pare their losses. When Medicaid cuts were made in adjoining Illinois earlier this year, Walgreens made a similar pronouncement, and the ensuing outcry forced the state to restore some funding.

VA wants to hike Rx co-pays to $7

Veterans Affairs is proposing that co-pays for some one million veterans rise from $2 to $7 for each 30-day outpatient Rx supply. The co-pay was last increased in 1990. From 1990 to 2000, the VA's Rx bill climbed from $715 million to $2.1 billion. A number of veterans, such as those with severe service-related disabilities, are exempt from co-pays.

Conn. bars schools from recommending psychotropics

Connecticut has enacted a first-in-the nation law that bars teachers, counselors, and other school officials from recommending that a child be placed on a psychiatric medication. They can suggest only that a physician evaluate the child. The law's intent is to ensure that the first recommendation for possible Rx treatment for attention deficit hyperactivity disorder comes from a doctor, not an educator.

Rx bar-coding should be mandated, ASHP contends

ASHP has urged HHS to require manufacturers to place standardized machine-readable bar codes on all Rx product containers, including single-dose medication packages used in hospitals. "It's shameful that drug manufacturers are not universally employing bar codes to protect the safety of patients," said ASHP CEO Henri R. Manasse Jr. He predicted that hospitals will quickly deploy scanners to bedsides if bar-coding becomes mandatory.

Poll finds support for Rx plan erodes as more is learned

A national poll for NACDS suggests that consumers strongly support President Bush's Medicare Rx discount card plan—until they learn the details. Wirthlin Worldwide found that 88% of those polled supported the plan, NACDS said. But when told the plan had been developed in secret meetings, 81% said they would be less likely to support it. Some 66% said they would be less likely to support the plan when told it would encourage the use of mail order.

Walgreens unlikely to accept Rx discount cards

The Walgreen Co. is unlikely to participate in Medicare Rx discount card networks offered by PBMs, according to David Bernauer, president. The framework for plans proposed since the Bush Administration's announcement is "not fair to community pharmacies," he said, adding that any Medicare Rx plan lacking input from seniors or R.Ph.s won't provide a real solution or be acceptable to Walgreens.

Bisphosphonates advised for bone loss from steroids

In its new treatment guidelines, the American College of Rheumatology (ACR) recommends that bisphosphonates be used as first-line therapy together with calcium, vitamin D, and lifestyle modifications for preventing and treating glucocorticoid-induced osteoporosis (GIO). The guidelines state that therapy with a bisphosphonate should be considered for patients starting on a glucocorticoid (prednisone equivalent of 5 mg/day), with plans for treatment duration of three months; already receiving long-term glucocorticoid therapy; or already experiencing GIO. Currently, Aventis Pharmaceutical's Actonel (risedronate sodium) 5 mg is approved for the prevention and treatment of GIO in men and women on chronic glucocorticoid therapy (>/= 7.5 mg prednisone/day), while Merck's Fosamax (alendronate sodium) has approval for the treatment of GIO in this same patient group.

Ten pharmacy firms unite for Rx data mining

Albertson's, CVS, Wal-Mart, and Kmart joined six other chains and Cardinal Health Inc. to launch ArcLight Systems, a real-time data mining firm to identify Rx drug industry trends at Internet speed. RxealTime provides drug manufacturers with nonpatient-specific data in minutes, instead of weeks, according to company officials. Duane Reade, Happy Harry's, Kerr Drug, Lewis Drug, and Mays Drug Stores are also founding partners of the venture based in Dublin, Ohio, and Paradise Valley, Calif.


Marina Marketos. Latelines. Drug Topics 2001;15:5.

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