PHARMACY

APhA Foundation appoints five new board members

BY Alaric DeArment

WASHINGTON — The American Pharmacists Association’s philanthropic wing has appointed five new members to its board of directors, the group said Monday.

The APhA Foundation announced in September the official installment of Stuart Haines, professor of and vice chairman for clinical services in the Unviersity of Maryland School of Pharmacy’s Department of Pharmacy Practice and Science in Baltimore, as well as a clinical pharmacy specialist in primary care at the West Palm Beach, Fla., VA Medical Center.

The other members will be installed during the APhA2014 Annual Meeting in Orlando, Fla., in March. They are Timothy Canning, who has worked in the healthcare field in positions ranging from operations to marketing, primarily related to retail pharmacy, including positions at McKesson and Health Mart; Jerry Moore is the director of state government affairs for Teva Pharmaceuticals; Megan Tucker is SVP at Edelman’s Healthcare Practice in Washington; and commander Kelly Valente became a regional pharmacist for the Centers for Medicare and Medicaid Services in Boston this year, with previous experience working in the Federal Bureau of Prisons.

 

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Plan to reorganize FDA’s Office of Generic Drugs receives approval

BY Alaric DeArment

WASHINGTON — The Food and Drug Administration’s Office of Generic Drugs will be elevated to a "super office," a top official in the agency told staff members in a memo Monday.

Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, of which the OGD is a part, said the elevation of the office meant it would house subordinate offices within its organizational structure and would report directly to her, with acting director Kathleen Uhl continuing in that role. Woodcock said the reorganization, plans for which were originally announced in September 2012, would strengthen the OGD’s operations and allow it to "meet the evolving needs of generic drug review."

"Transforming OGD into a super office is a critical and necessary step in recognizing the importance of generic drugs to public health and our national economy," Woodcock wrote. "As a super office, OGD will coordinate and manage the abbreviated new drug application review process, provide safety, surveillance, clinical and bioequivalence reviews for generic products, as well as contain new offices to develop policy and regulatory science for generic drugs."

The new structure of the OGD will include an Office of Research and Standards, an Office of Bioequivalence, an Office of Generic Drug Policy and an Office of Regulatory Operations, each of which will have multiple divisions under it. Members of a transition team will lead the offices.

 

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Generic drug prices spike, but PBMs’ reimbursement rates don’t keep up, NCPA study finds

BY Alaric DeArment

ALEXANDRIA, Va. — A survey of more than 1,000 independent pharmacists finds that acquisition costs for generic drugs have spiked by as much as 1,000% this year.

The survey, conducted by the National Community Pharmacists Association, said that patients were paying more for drugs and often going without them, particularly Medicare and Medicaid patients, and many patients are declining medications due to increased co-pays. Higher co-pays and larger charges to drug plans also are pushing seniors into the "donut hole" coverage gap of Medicare.

"Once generic drugs become available, lower costs typically follow, and community pharmacists are leading the way to maximize the savings for patients and health plans from the proper use of generics," NCPA CEO B. Douglas Hoey said. "However, pharmacy acquisition costs for more and more generic drugs are rising in rapid, breathtaking fashion. This is having a negative impact on a number of patients, particularly Medicare beneficiaries. Meanwhile, reimbursement from pharmacy benefit managers is not keeping up, leaving pharmacists out in the cold and putting patient access to pharmacist care on unsustainable footing."

According to the survey, 77% of pharmacists reported 26 or more instances of a large upswing in a generic drug’s acquisition price over the past six months, while 86% said it took the PBM or another third-party payer from two to six months to update its reimbursement rate, but it was not done retroactively. In addition, 84% said the acquisition price spike and lagging reimbursement trend has a "very significant" effect on their ability to remain in business to continue serving patients. In some cases, pharmacists were faced with having to refrain from filling prescriptions that would have caused them to lose up to $100 or more per prescription.

Generic drugs most frequently cited included the blood pressure drug benazepril; the antidepressant clomipramine; the heart rate drug digoxin; the psychiatric drug divalproex; the asthma drug budesonide; the pain drug morphine and many others. The report noted that the causes of the price increase are uncertain.

"In an era of instant communication, it is indefensible for PBMs to wait weeks or even months before updating their payment benchmarks in the wake of these price spikes without ever reimbursing pharmacies retroactively," Hoey said. "Pharmacists’ appeals to PBMs to update payment rates are consistently denied or ignored. This situation is untenable for small business community pharmacies, and we urge PBMs to update their reimbursements."

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