PHARMACY

FDA revisits label changes with public meeting

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration on Friday is hosting a public meeting on supplemental applications proposing labeling changes for approved drugs and biological products, the agency noted. The purpose of the meeting is to provide a public forum for the FDA to listen to comments on the proposed rule on “changes being effected” supplements that was published in the Federal Register of Nov. 13, 2013, and alternatives offered to this proposed rule.
 
"The Generic Pharmaceutical Association applauds the FDA for today's public meeting in response to comments from dozens of health care stakeholders, minority providers and legislative membership organizations, supply chain participants, and many others troubled about the FDA Proposed Rule on generic drug labeling," said Ralph Neas, GPhA president and CEO. "These groups continue to voice concerns about how the Proposed Rule would allow generic companies to unilaterally update labels without prior FDA approval, elevating patient safety risk, raising costs and causing confusion among prescribers and providers."
 
GPhA advocates the Expedited Agency Review, an alternative proposal that's also supported by the Pharmaceutical Research and Manufacturers of America that meets the FDA objective to strengthen and expedite the labeling process but does so without provisions that could have unintended safety consequences for patients, providers, taxpayers, payors or others.
 
"The EAR would establish defined time parameters for FDA to take action on a label change made:
1) following FDA’s receipt and review of 'new safety information' from a multi-source application holder; or 2) following review of data received through the Sentinel System and/or other databases including global sources that are suggestive of a need for a label change," Neas said. "Moreover, the EAR calls for the adoption of e-labeling technology to make new information available in real time. The Proposed Rule relies on updates to paper labels that can take months or even years to be incorporated."
 
The FDA is also reopening the comment period for the proposed rule until April 27, 2015, to receive submissions of additional written comments on the proposed rule as well as alternative proposals presented during the public meeting.
 
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Cardinal Health blog: Value of MTM isn’t being realized

BY Michael Johnsen

DUBLIN, Ohio, — When a new solution benefits everyone in the healthcare system, yet still is not being widely adopted, it's appropriate to start asking why. Such is the case with medication therapy management — which has been established as mutually beneficial for payers, patients and pharmacies — yet has experienced a slower-than-expected adoption rate.  
 
In a new blog post on Cardinal Health's thought leadership site, Essential Insights, Brad Tice, medication therapy management product leader at Cardinal Health, reported that a main reason underlying the relatively slow adoption of MTM is that it can be difficult to measure and understand the total return on investment that these services deliver. He also shares his perspective on what's needed to understand the full value and benefits of MTM.
 
"I believe that one explanation for slow MTM adoption is that the complexity of the healthcare system can obscure MTM's proven value," he wrote. "Timing issues, cost allocations and financial incentives are a few obstacles that impact how MTM programs are measured. Failing to measure the full impact of MTM programs is difficult to do, yet doing so is a fatal analytical error."
 
Tice explains that health plans that focus on MTM's return on investment will gain an essential competitive advantage in the marketplace. He contends that although MTM services can generate immediate cost savings and health benefits for patients, these services can generate an even greater return in the later years, as patients remain healthy. Furthermore, most MTM savings appear outside the pharmacy benefit via fewer hospital readmissions, drops in emergency room visits, improvements in how physicians are utilized, etc. — all cost savings that can be difficult to fully measure.
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NACDS awards first-ever NACDS RxIMPACT Key Contact Award

BY Antoinette Alexander

Image credit: NACDSmedia

WASHINGTON — As the National Association of Chain Drug Stores raised the curtain on this year’s NACDS RxIMPACT Day on Capitol Hill on Wednesday, it presented Shopko’s Ryan Swensen with the first-ever NACDS RxIMPACT Key Contact of the Year Award.

Presented during Wednesday evening’s Welcome Dinner, the award recognizes a rank-and-file pharmacist who actively engages on behalf of pharmacy with his or her local member of Congress.

Highly-motivated in engaging with his member of Congress, Swensen hosted an NACDS RxIMPACT pharmacy tour, inviting then-Rep. Jim Matheson, D-Utah, to see first-hand the value of highly accessible healthcare services in the local pharmacy. During the NACDS RxIMPACT Day on Capitol Hill event this week, Swensen will meet with his new member of Congress, Rep. Mia Love, R-Utah, to discuss key issues impacting pharmacy.  

The NACDS RxIMPACT Key Contact Program fosters one-to-one engagement of pharmacy leaders advocating on behalf of pharmacy with their members of Congress and their offices. This engagement can take various forms, including pharmacy tours and congressional district activities, attending the NACDS RxIMPACT Day on Capitol Hill meetings, and possible political engagement.

“Ryan’s engagement on behalf of pharmacy is exemplary,” said NACDS president and CEO Steve Anderson. “His efforts to showcase the value of pharmacy surpass the standard of pharmacy advocacy, and is therefore rightfully deserving of the new NACDS RxIMPACT Key Contact Award.”

Earlier Wednesday, NACDS also recognized Jonathan Lee, a pharmacy student at the University of Connecticut School of Pharmacy, as the 2015 NACDS RxIMPACT Ambassador, for his mentorship and serving as a role model in encouraging pharmacy students from across the country to participate in this year’s NACDS RxIMPACT Day on Capitol Hill.

Following Lee’s participation in last year’s NACDS RxIMPACT Day on Capitol Hill, he became an advocate for the event, publishing an article about the importance of student engagement and urging other pharmacy students to participate this year. Lee also addressed fellow pharmacy students at the “U” Academy event today, which was held earlier today in conjunction with the NACDS RxIMPACT Day on Capitol Hill events.

The NACDS RxIMPACT “U” Academy is an interactive advocacy education and training program for selected pharmacy students in lead-up to their meetings with lawmakers on Capitol Hill.

“As the future of their profession, students play a pivotal role in pharmacy advocacy,” Anderson said.  “Jonathan is truly an ambassador for pharmacy and a role model for pharmacy students in how to become engaged in the policymaking process. We applaud his efforts to stand up for pharmacy.”

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