PHARMACY

PTCB’s CREST Summit emphasized pharmacy’s role in health care

BY Alaric DeArment

WASHINGTON — By 2015, “pharmacists will be the healthcare professionals responsible for providing patient care that ensures optimal medication therapy outcomes.” That was the consensus reached in the Joint Commission of Pharmacy Practitioners’ vision statement at the Pharmacy Technician Certification Board’s Consumer Awareness, Resources, Education, State Policy and Testing Summit last month.

The CREST Summit brought together pharmacists, pharmacy technicians, employers, pharmacy associations and state boards of pharmacy. The PTCB has certified pharmacy technicians since its founding in 1995.

“Pharmacy technicians play an integral role in supporting pharmacy practitioners in virtually all practice settings,” PTCB executive director and CEO Melissa Murer Corrigan said. “Feedback from the summit, survey and social media show that significant steps are being taken to support innovation in the roles and responsibilities of pharmacy technicians through education, training and PTCB certification.”

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NCPA responds to congressional members’ concerns over short-term cycle dispensing rule

BY Allison Cerra

ALEXANDRIA, Va. — Ten members of Congress expressed concerns over a provision in the Patient Protection and Affordable Care Act that is said to reduce Medicare program costs, according to the Centers for Medicare and Medicaid Services.

In a letter sent to CMS administrator Donald Berwick on Friday, the congressional members — Reps. Peter Roskam, R-Ill.; Aaron Schock, R-Ill.; John Barrow, D-Ga.; Adam Kinzinger, R-Ill.; Lloyd Doggett, D-Texas; Paul Gosar, R-Ariz.; Shelley Capito, R-W.Va.; Geoff Davis, R-Ky.; Sam Graves, R-Mo.; and Nan Hayworth, R-N.Y. — said they were unsure what was motivating CMS’ plan to move ahead with the Notice of Proposed Rulemaking provision, which would limit short-cycle dispensing of brand-name drugs for long-term care facilities. The representatives addressed the lack of evidence that could support the idea that shorter dispensing cycles would save money. In the letter, the representatives urged CMS to delay the implementation.

In response, the National Community Pharmacists Association’s EVP and CEO, Kathleen Jaeger, said she appreciated the representatives speaking up on behalf of pharmacists and patients in long-term care facilities. “While we all share the goal of eliminating waste in programs like Medicare Part D, there is scant evidence substantiating that a move to shorter dispensing cycles would actually reduce costs," Jaeger said. “More importantly, the requirement is very burdensome for pharmacies, which may have to invest significant resources in order to comply with the regulation."

"Before CMS moves forward with implementation, we hope it will conduct a thorough, fact-finding study to determine what is the wisest course of action," Jaeger continued. "Plowing ahead without that data could have unintended consequences, such as higher costs to Medicare or fewer pharmacies providing LTC services. Those are outcomes nobody should want."

The NCPA operates a division that focuses on LTCs, Jaeger pointed out, and said that, “[our] association’s staff and membership will continue working with like-minded organizations to engage Congress, CMS and others on this issue for a positive resolution that benefits patients, payers and pharmacists.”

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Biodel discloses accelerated development plan for diabetes drugs

BY Allison Cerra

DANBURY, Conn. — A drug maker focused on development and commercialization of diabetes treatments unveiled its accelerating clinical development plans of two drug candidates.

Biodel said BIOD-105 and BIOD-107, known as ultra rapid-acting insulins, are designed to result in more rapid insulin action, compared with currently marketed mealtime insulin analogs.

The company said it is initiating a phase-1 trial in third quarter 2011, which will examine the efficacy of the drugs in Type 1 diabetes patients, and will be followed by a phase-2 trial in fourth quarter 2011 if the initial phase is successful. The phase-2 study is intended to follow the same overall design that would be implemented in phase-3 studies, which would commence in 2012 and include two separate pivotal trials — one in patients with Type 1 diabetes and the other in patients with Type 2 diabetes.

Biodel said it recently received initial guidance from the Food and Drug Administration on the design of two pivotal phase-3 clinical trials. "We have identified two new formulations with commercial target product profiles that appear to be superior to any of our previous ultra rapid-acting human insulin drug candidates," said Errol De Souza, president and CEO of Biodel. "We have accelerated the clinical development program of these formulations and plan to initiate phase-1 clinical testing this month and could initiate phase-3 testing before the end of 2012."

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