FDA picks acting director for Office of Generic Drugs
SILVER SPRING, Md. — The Food and Drug Administration has picked Kathleen Uhl to serve as acting director of the Office of Generic Drugs, the agency said Tuesday.
In a memo sent out to staff of the Center for Drug Evaluation and Research, the section of the agency that oversees the OGD, CDER director Janet Woodcock wrote that Uhl most recently served as senior adviser to director Greg Geba, who announced his resignation Thursday.
"Dr. Uhl brings a wealth of regulatory and medical policy, scientific, and management experience to the position," Woodcock wrote. "In her fifteen years with [the] FDA, Dr. Uhl has become widely-regarded both inside and outside of the agency as a compassionate, committed, and dedicated leader. Because of her strong management skills and extensive expertise in clinical pharmacology, I am confident in her abilities to lead OGD during a time of transition as we work to evolve quality throughout the Center and implement the Generic Drug User Fee Amendments of 2012."
The agency has started a nationwide search to find a new director to replace Geba, Woodcock wrote.
CVS Caremark research: Rx adherence can spell cost savings for coronary artery disease patients
WOONSOCKET, R.I. — Patients with coronary artery disease who are adherent to their prescribed medications can save the healthcare system up to $868 per patient per year, according the findings of a recent study conducted by researchers at Brigham and Women’s Hospital and CVS Caremark.
The research was published in the April issue of the American Journal of Medicine.
Heart disease costs the United States $108.9 billion each year, according to the Centers for Disease Control, but there are ways those costs can be controlled. The study found a consistent trend toward improvement in coronary artery-related events, mortality, re-admissions and costs among those patients who most adhered to their medication regimens.
"Managing rising healthcare costs is the most pressing issue facing our health care system today," stated Troyen Brennan, EVP and chief medical officer of CVS Caremark. "This study affirms a consistent trend we have seen in research regarding the positive effect of improving medication adherence. Patients with chronic conditions are healthier when they adhere to their prescribed medication regimens, and as a result, the costs associated with their care are reduced."
In the study, titled "The Impact of Medication Adherence on Coronary Artery Disease Costs and Outcomes: A Systematic Review," the researchers reviewed more than 2,500 studies published between 1966 and 2011, analyzing the 25 studies that met the inclusion criteria related to adherence and coronary artery disease outcomes. A subset of the studies measured the impact of medication adherence on primary prevention of CAD, and the remainder focused on the relationship between medication adherence and costs and outcomes related to secondary prevention of the disease. All of the studies reviewed found that adherence significantly improves health outcomes, and those that analyzed costs found reduced total annual CAD costs (consistently between $294 and $868 per patient).
While the study found consistent outcomes in cost reductions and health improvements related to better medication adherence, the researchers also identified an opportunity for greater standardization and improved research methods across medication adherence studies. The authors pointed out that many of the studies they reviewed did not account for what they refer to as the "healthy adherer" effect, noting that few of the studies they analyzed controlled for predisposed healthy behaviors in the patients that were followed.
"The research community has long believed that those patients who adhere to their medications may also be more likely to pursue a healthier lifestyle," stated Asaf Bitton, lead author of the study affiliated with the Brigham and Women’s Hospital Division of General Medicine and the Harvard Medical School Center for Primary Care. "The next step from a research perspective would be to find a consistent way to control for the effect of these ‘healthy adherers’ to provide a more accurate picture of adherence for future studies and to further advance the research science in this field."
CVS Caremark has been working in a multiyear collaboration with Harvard University and Brigham and Women’s Hospital to research pharmacy claims data in order to better understand patient behavior, particularly around medication adherence. Annual excess healthcare costs due to medication nonadherence in the United States have been estimated to be as much as $290 billion annually.
MTM message breaks through in Congress
Last week, I wrote about medication therapy management and a new bill in the House of Representatives to expand the pool of patients who qualify for MTM programs through Medicare. This week, I’m writing about — wait for it — medication therapy management.
Why? Because MTM is important, vitally important, to the future of community pharmacy, and is one of the key health and prevention services that will define the profession in the era of health reform and evidence-based health care.
I also am revisiting MTM because the Senate has now taken up similar legislation. As reported by Drug Store News senior editor Michael Johnsen, the Medication Therapy Management Empowerment Act, introduced in the Senate on March 14, would “allow seniors with any high-cost chronic illness to review all their medication and develop a plan of action with a pharmacist.”
One of the bill’s sponsors, Sen. Kay Hagan, D-N.C., called MTM “a commonsense, fiscally responsible way to improve seniors’ health and reduce preventable trips to the hospital.” And Hagan has seen its value up close in her home state, where statewide health programs like ChecKmeds NC “save lives and have already saved tens of millions of dollars in North Carolina alone,” thanks in large part to interventions by pharmacists in the chronic care of seniors through MTM and prescription drug adherence efforts.
The Senate bill’s co-sponsor, Republican Pat Roberts of Kansas, sees MTM as “an important tool in the pharmacist’s tool box for many patients…which can be critical for those suffering from chronic conditions.” What’s more, he voiced the realization that pharmacists “can sometimes be the only health provider in our rural towns.”
The moves in Congress to more effectively enlist pharmacists in the urgent search for solutions to the nation’s health crisis was timely: It came as hundreds of pharmacists, pharmacy executives and pharmacy faculty and students descended on Washington for the 5th Annual NACDS RxImpact Day last week. Drug Store News senior editor Antoinette Alexander reported that this yearly exercise in mass grass-roots lobbying spawned 400 direct meetings between chain pharmacy advocates and the federal lawmakers representing their home districts.
What’s more, Alexander reports, “The RxImpact Day event continues to grow in popularity,” with participation up 29% in 2013 and 70% of the chain pharmacy industry represented. If you were among those RxImpact participants, please share your experience with your fellow readers. Were the senators, congressional representatives and staff members you met with on the Hill receptive to pharmacy’s message? Did they understand the need for MTM and other pharmacist-provided health services? And did they understand community pharmacy’s huge cost-saving potential?