FDA committee recommends kidney transplant drug be approved
PRINCETON, N.J. The Food and Drug Administration has recommended approval for a biotech drug for treating kidney transplant patients.
Bristol-Myers Squibb Co. announced Tuesday that the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 13-to-5 to recommend approval for belatacept, for preventing rejection of transplanted kidneys. Bristol submitted its application in September 2009 and expects a final decision in May.
The FDA takes committees’ recommendations into account when deciding whether or not to approve a drug, but is not bound by them.
“Bristol-Myers Squibb is encouraged by the committee’s recommendation,” Bristol SVP global development and medical affairs Brian Daniels said. “We will continue to work closely with the FDA to support the review of belatacept, which has the potential to provide another treatment option for kidney transplant patients.”
Turning new corner, Winn-Dixie builds store
COVINGTON, La. —Winn-Dixie Stores in early February celebrated the completion of its new store, the first ground-up store for the grocer since 2004.
“We are very proud to be able to offer this beautiful store to the neighbors and communities of Covington,” stated Winn-Dixie chairman, CEO and president Peter Lynch. “Not only does it provide a best-in-class shopping experience, but it brings 200 new jobs to the area, as well.”
The 55,000-sq.-ft. supermarket, located a little north of New Orleans, features a 24-ft. tall open entrance way highlighted by an outdoor farmer’s market. Inside are a host of “enhanced” features, including a wine department staffed with a wine steward, a peanut butter machine and a full pharmacy department and wellness center.
Winn-Dixie offers several health testing services and immunization opportunities for consumers throughout the year. As a recent enhancement to its pharmacy offering, Winn-Dixie rolled out its WD RxConnect program chainwide. WD RxConnect links all of Winn-Dixie’s more than 400 pharmacies through a centralized prescription record system and also allows patients to access their own records online. “That’s kind of unique in the food store industry,” John Fegan, Winn-Dixie VP pharmacy, told Drug Store News earlier this year. “Under the WD RxConnect program, a patient can walk in, look up their medication history online and see what they’re taking.”
E-prescribing use soars, but independents unconnected
NEW YORK —American retail pharmacy continued its slow but inexorable journey into the 21st century in 2009 as a mixture of government incentives and trends resulted in a mushrooming of prescribers and pharmacists embracing electronic prescribing and electronic health records.
According to e-prescribing network Surescripts, the volume of e-prescriptions went from 240 million in 2008 to 800 million in 2009, while the number of active e-prescribers went from 78,000—12% of all office-based prescribers—to 150,000 over the same period.
“While this is a positive development, there is much room to build on this growth,” National Community Pharmacists Association associate director of public relations John Norton told Drug Store News. NCPA helped sponsor the creation of Surescripts, along with the National Association of Chain Drug Stores and the pharmacy benefit managers CVS Caremark, Express Scripts and Medco Health Solutions.
By October 2009, 100% of pharmacies in Rhode Island were using e-prescribing, and the statewide system allowed state health authorities to track prescriptions and usage of such antiviral drugs as Roche’s Tamiflu (oseltamivir) to identify possible problems, such as shortages, over-prescribing and misuse by patients.
By the end of 2009, 85% of community pharmacies nationwide were connected for e-prescribing, Norton said, but independent pharmacies have lagged, with 40% remaining unconnected and capabilities varying “tremendously” among independents, particularly in rural areas. Also, given the relatively small number of prescribers electronically transmitting prescriptions, not all community pharmacies with e-prescribing equipment actually use it regularly.
That could change soon, however. The financial incentives for adopting e-prescribing under the Medicare Improvements for Patients and Providers Act of 2008 kicked in at the beginning of 2009, offering qualified prescribers payments of 2% of their Medicare Part B physician fee schedule, and the MIPPA incentives have been cited as a reason for the strong growth in e-prescribing in the last year. The 2% rate will continue through 2010, but will fall to 1% in 2011 and 0.5% in 2013. Starting in 2012, prescribers who have failed to adopt e-prescribing will pay 1% penalty fees, which will increase to 1.5% in 2013 and 2% in 2014.
On the electronic health records side, the American Recovery and Reinvestment Act of 2009 provides physicians with stimulus incentives of between $44,000 and $64,000 if they can demonstrate “meaningful use” of a certified EHR system, and in January, healthcare information technology firm Allscripts launched the Allscripts Stimulus Program, designed to persuade prescribers to adopt EHR. Dozens of states also have received federal matching funds for moving to electronic health records under ARRA, according to the Centers for Medicare and Medicaid Services.
General adoption of EHR and e-prescribing is well on its way to happening in the United States, but it still faces obstacles.
“Challenges include installation and transaction costs, the costs associated with training staff and challenges with physician prescriber management systems, having to call back physicians regarding incomplete information on prescriptions, the incompatibility of technology systems and enhancing two-way online communications with prescribers,” Norton said.