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U.S. District Court rules in favor of patent protecting Pfizer’s Sutent

BY Michael Johnsen

NEW YORK — Pfizer on Thursday announced that the U.S. District Court for the District of Delaware upheld its basic patent and the L-malate salt patent covering Sutent (sunitinib malate) capsules. This decision, which is subject to appeal, affirms Pfizer’s right to exclusively provide sunitinib malate as Sutent to patients through the term of the patent, which expires in 2021.
 
“The Court’s decision acknowledges the validity and infringement of our patents and affirms the value of Sutent, a standard of care in the treatment of advanced renal cell carcinoma,” said Douglas Lankler, EVP and general counsel for Pfizer. “Defending our intellectual property is crucial to our ability to discover and develop innovative new medicines, which is at the very core of what we do.”
 
Pfizer filed suit in June 2010 after Mylan Pharmaceuticals applied to the Food and Drug Administration to market a generic version of Sutent prior to the expiration of the patents covering sunitinib malate and its uses. After a four-day trial, the Court agreed that Mylan infringed the valid patents covering Sutent.
 
The patents at issue are U.S. Patent Nos.6,573,293 and 7,125,905.
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New McKesson solution guards against data breaches

BY Michael Johnsen

AUSTIN, Texas — McKesson Pharmacy Systems and Automation on Thursday announced the launch of its new SecureHIPAA solution this week at the National Community Pharmacists Association’s 116th Annual Convention and Trade Exposition. The new solution helps pharmacies reduce their risk of experiencing a data security breach and helps them learn how to be HIPAA compliant. McKesson developed the solution with security and compliance company, ANXeBusiness Corp.
 
“Security breaches are occurring more frequently and protecting patient’s health information is more important than ever,” stated Joe Ross, business services product manager, MPS&A. “SecureHIPAA equips pharmacy owners with information and tools on how they can lessen their chance of experiencing a data security breach.”
 
SecureHIPAA helps pharmacies identify potential security gaps and provides information on how owners can alleviate those gaps. This aspect of the new program allows pharmacy owners to be proactive in helping to prevent data breaches from occurring in their pharmacies. It also provides up to $100,000 of HIPAA data breach protection services in the event a breach does occur.
 
There were significant updates to HIPAA in 2013, including changes to the definitions of terms, privacy, security, breach notification and enforcement rules. The new changes are documented in over 500 pages that explain new standards pharmacies must make to their HIPAA forms, agreements and documents.
 
“SecureHIPAA helps pharmacies navigate through the new requirements by providing online training, HIPAA compliance assessments and templates that help pharmacies create HIPAA compliant forms and documents,” Ross said.
 
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NEHI white paper tackles nonadherence problem

BY Michael Johnsen

BOSTON — The U.S. healthcare system must address the problem of patients not picking up newly-prescribed medicines if national goals for improved health and reduced costs of medical care will be realized, according to a NEHI white paper issued Thursday
 
The paper, “Ready for Pick Up: Reducing Primary Medication Non-Adherence — A New Prescription for Health Care Improvement,” outlines the problem of prescriptions for newly initiated therapy that are not picked up for the first time and, thus, never taken, leading to the possibility of worse health and increased stress on the healthcare system. 
 
The rate of primary nonadherence, that is, the percentage of first-time prescriptions abandoned by patients (and thus not picked up at pharmacies), can range as high as 30% among some classes of medication, according to recent research. 
 
“In recent years, our healthcare system has begun to take action to improve patient medication adherence, and yet primary medication nonadherence — the failure to commence newly initiated therapy — remains a major but largely unacknowledged problem,” said Tom Hubbard, NEHI VP policy research, who authored the paper. “The good news is that potential strategies for reducing primary medication nonadherence are emerging as electronic prescribing becomes common. This paper is a call to accelerate action that will reduce the failure to pick-up newly initiated medication therapy.” 
 
A May 2014 working group convened by the NACDS Foundation, the Pharmacy Quality Alliance and NEHI framed the issues outlined in the paper. The paper addresses key issues in the adoption and utilization of a new pharmacy quality metric on primary medication nonadherence endorsed by the Pharmacy Quality Alliance in November 2013. Prior to the advent of e-prescribing, tracking PMN rates was not feasible. 
 
“The PQA PMN measure introduces a consensus-based, scientifically tested, nationally endorsed metric to the market,” said Laura Cranston, PQA executive director. “This metric brings much-needed consistency in defining PMN, which will help us to identify, test and compare results for PMN interventions across healthcare settings.” 
 
Current adherence policy focuses on patients who have received their therapies at least once — because these patients trigger payment claims processing that allows medication adherence to be tracked. 
 
“Obviously this leaves out patients who never get their newly-prescribed therapy at all,” Hubbard said. “Community pharmacies that receive e-prescriptions can now track primary medication non-adherence by comparing the e-prescriptions they receive to the records of the prescriptions that are actually picked up. This paper outlines the issues pharmacies face in using this data to create effective interventions with patients that will increase the first-fill of new prescriptions.” 
 
NEHI makes eight recommendations that stakeholders, from physicians and pharmacists to insurers and health plans, could do to understand and attack the problem, including pharmacist interventions with nonadherent patients. 
 
High on the list: more dialogue among healthcare payers, the physician community and the pharmacy industry to establish common ground for action. 
 
“Collaboration is key in the face of the challenges that result from patients not taking their medications as prescribed. And to that end, pharmacy works in close partnership with hospitals, physicians, nurses and other healthcare providers in helping patients understand the importance of taking their medications as prescribed,” said Kathleen Jaeger, NACDS Foundation president. “We are pleased that NEHI has raised awareness of primary medication non-adherence — a critical public health gap.” 
 
“As the late Surgeon General C. Everett Koop said, ‘Drugs don’t work in patients who don’t take them,’" Hubbard said. "He might have continued, ‘Drugs never work in patients who don’t take them for the very first time.’” 
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