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PHARMACY

At the scene of NACDS RxIMPACT Day

BY DSN STAFF

Images courtesy of NACDS

WASHINGTON — More than 350 pharmacy advocates headed to Capitol Hill for the seventh annual NACDS RxIMPACT Day to further reinforce the recognition by lawmakers of the evolving role of pharmacy in patient care and educate members of Congress about pro-patient, pro-pharmacy policy.

During this year’s event, held Wednesday and Thursday, pharmacy advocates conducted more than 450 meetings with members of Congress, meeting with every member of Congress who serves on a Congressional healthcare committee, and with every member of Congress who was newly elected in November 2014.

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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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