Study: Xgeva reduces chances of bone metastasis among prostate cancer patients
THOUSAND OAKS, Calif. — A cancer drug made by Amgen reduced the chances of prostate cancer spreading to the bones, according to results of a late-stage clinical trial presented at the American Urological Association’s annual meeting in Washington.
The phase-3 “Study ‘147” of Xgeva (denosumab) showed that men taking the drug survived for four months longer without the cancer spreading to their bones, compared with those taking placebo.
The study enrolled 1,432 men with prostate cancer that persisted despite castration but had not spread to the bones — known as bone metastasis — who were administered Xgeva or placebo. Study data showed that Xgeva reduced the risk of bone metastases by 15%, compared with placebo.
Chain pharmacy lauds efforts for safe use of pediatric acetaminophen products
ALEXANDRIA, Va. — The National Association of Chain Drug Stores delivered on Tuesday testimony on the safe usage of pediatric acetaminophen products before a joint meeting of the Food and Drug Administration Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee.
"As [the] FDA has recognized in the past, acetaminophen is an extremely safe medication when used at recommended doses. In addition, it is one of the most commonly used medications in the United States. With this in mind, it is important to ensure that any new policies or regulations affecting availability of acetaminophen products are workable considering the great consumer need for, and widespread use of, these products," stated Kevin Nicholson, VP pharmacy adviser, government affairs and public policy with NACDS.
In the testimony, NACDS also expressed its support for the recent announcement that all single-ingredient pediatric acetaminophen products will be converted to one concentration.
"We are pleased that the makers of single-ingredient pediatric acetaminophen products have announced that they are converting all pediatric liquid acetaminophen formulations to one concentration. This, as well as other improvements and initiatives they have announced, will help patients and caregivers accurately dose pediatric acetaminophen products and help prevent medication errors," Nicholson added.
NACDS also highlighted its support for weight-based dosing instructions for all children’s single-ingredient liquid acetaminophen medicines.
"We believe that it will allow for more accurate dosing and help to reduce adverse incidents," Nicholson stated.
NACDS has been engaged in review of pediatric liquid acetaminophen formulations. In 2009, NACDS testified before an FDA advisory group detailing its recommendation to include dosing instructions for children younger than 2 years of age on labels of over-the-counter single-ingredient acetaminophen products intended for children.
The association also is a member of the Acetaminophen Awareness Coalition, spearheaded by the Consumer Healthcare Products Association and the American Pharmacists Association to address acetaminophen-related issues and educational needs. The coalition will soon be launching a campaign to educate consumers about the importance of following directions on labels and how to properly use products containing acetaminophen.
NCPA expresses support of Community Pharmacy Fairness Act of 2011
ALEXANDRIA, Va. — The National Community Pharmacists Association on Tuesday endorsed the Community Pharmacy Fairness Act of 2011 (H.R. 1839), legislation recently introduced in the House of Representatives by Rep. Anthony Weiner, D-N.Y.
If passed, the bill will create a more competitive marketplace for the delivery of pharmacy services by enhancing the ability of independent community pharmacies to negotiate with pharmacy benefit managers, the association stated.
“For years, the major insurance companies and pharmacy benefit managers, or PBMs, have benefitted from an antitrust exemption and have opposed efforts to grant the same status to independent pharmacists,” stated Douglas Hoey, NCPA EVP and CEO. “This dynamic produces one-sided, take-it-or-leave-it contracts that can disadvantage community pharmacists with onerous contract terms while impeding true competition for consumers.”
The end result means more prescriptions for the PBM-owned mail-order pharmacies. “This inherent conflict of interest creates an even greater incentive for benefit managers to impose unfair audit and reimbursement practices [on community pharmacists],” Hoey added.