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Recently amended NABP Model State Pharmacy Act and Model Rules now available

BY Michael Johnsen

MOUNT PROSPECT, Ill. — The recently amended NABP Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy are now available to assist the state boards of pharmacy in developing state laws or board rules in their efforts to protect the public health, NABP posted on its website Wednesday. 
 
The Model Act was revised to add clarifying information on resident and nonresident pharmacy licensure standards and pharmacy inspections, and to recommend that boards should be provided with a report of any inspection of their licensees. 
 
In recognition of the fact that many pharmacy benefit managers design the clinical programs for their associated mail-order and/or network pharmacies, direction and design of clinical pharmacies was added to the list of activities that may constitute the practice of pharmacy by PBMs. 
 
Language also was revised to address 5% rules to avoid conflict with Drug Enforcement Administration controlled substance regulations. The Committee on Law Enforcement/Legislation noted that previous Model Act language limited the amount of product that a pharmacy can transfer to another pharmacy to 5% of its total sales volume. DEA regulations limit the transfer of controlled substances between DEA registrants to 5% of dosage units dispensed. Accordingly, the Model Act reliant on sales volume was amended stating, "providing that such transfers are compliant with federal law."
 
A full summary of the changes can be found in the September 2014 issue of the NABP Newsletter
 
The Model Act is available for download from the members section of the NABP website
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Allscripts launches patient engagement tool designed to improve outcomes

BY Michael Johnsen

CHICAGO — Allscripts on Thursday announced the market launch and general availability of Allscripts FollowMyHealth Achieve, a consumer-friendly, patient engagement innovation intended to mobilize and empower patients as active partners in the management of their care.
 
Achieve is now generally available for Allscripts TouchWorks EHR and Allscripts Sunrise EHR users, and will soon be available for use with Allscripts Professional EHR. 
 
Allscripts FollowMyHealth Achieve, first introduced at HIMSS14 in Orlando, Fla., helps enable providers and patients to stay connected between formal visits or encounters. Clinicians can use Achieve to monitor patient compliance with care plans remotely and initiate interventions in a timely manner to influence behavior and impact outcomes.
 
With Achieve, providers can enter care management instructions for four conditions — congestive heart failure, diabetes, hypertension and obesity — and make those care plans available to patients through their Allscripts FollowMyHealth accounts.
 
Achieve functionality enables users to potentially leverage savings associated with remote monitoring and the use of consumer technologies. Patients can use Achieve to carry out orders at home, using such wireless devices as scales, glucose meters and blood-pressure monitors that those patients have integrated with FollowMyHealth. Readings and results are forwarded to the applicable Allscripts EHR and incorporated within the patients' medical record.
 
"Creating an environment where patients are active partners in their health is critical," said Robert Davidson, chief information officer, Hutchinson Clinic, a beta-user of Achieve. "Allscripts FollowMyHealth Achieve is an important tool to help patients and the care team stay connected, and allow us to more closely monitor patient status. Patients tell us they like the convenience Achieve offers and, because they are more engaged, we're finding patients are following care plans more closely and paying better attention to factors that impact their health."
 
"Providers are increasingly looking for ways to improve patient engagement, specifically as it relates to chronic diseases such as diabetes," said Peter McClennen, president for Population Health Management at Allscripts. "Achieve represents a critical step forward, as it is a consumer-oriented solution that optimizes the involvement, connection and coordination of the care team as well as the patient. It is a powerful tool that we believe will have a tremendous impact on the quality of care our clients can deliver."
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Endo International to acquire Auxilium Pharmaceuticals

BY Michael Johnsen

DUBLIN — Endo International and Auxilium Pharmaceuticals on Thursday announced that they have entered into a definitive agreement under which Endo will acquire all of the outstanding shares of common stock of Auxilium for a per share consideration of $33.25 in a cash and stock transaction. The boards of directors of both companies have unanimously approved the transaction, which is valued at $2.6 billion, including the repayment and assumption of debt. 
 
"We are pleased to have reached this agreement with Auxilium, which we believe will create value for both Endo and Auxilium shareholders, as well as for patients, customers and employees," said Rajiv De Silva, president and CEO Endo. "By adding Auxilium's complementary commercial portfolio, we believe this transaction is aligned with our strategy of pursuing accretive, value creating growth opportunities. We intend to leverage Auxilium's leading presence in men's health, as well as our R&D capabilities and financial resources to accelerate the growth of Xiaflex and Auxilium's other products. We look forward to working with the Auxilium team to achieve the growth and synergy potential of this compelling strategic combination."
 
Upon completion of the transaction, Endo's pharmaceutical portfolio will have a broader offering of urology and orthopedic products that are natural complements to its current men's health and pain products. Endo expects to drive increased adoption and enhance the performance of Auxilium's Xiaflex and accelerate development of the product in potential new indications. Endo also intends to leverage its resources to optimize Auxilium's other products, including Testopel and Stendra. Endo believes the combined company will be well positioned to drive organic growth across its portfolio and to capitalize on additional future strategic M&A opportunities.
 
Immediately prior to the entering into the merger agreement with Endo, Auxilium terminated its proposed merger agreement with QLT, in accordance with the terms of the QLT merger agreement.
 
The transaction is expected to close in the first half of 2015 and is subject to the approval of Auxilium's stockholders, regulatory approval in the United States and certain other jurisdictions, and other customary closing conditions. 
 
The per share consideration represents a premium of 55% to Auxilium's closing price on Sept. 16, the day Endo made public its proposal for Auxilium. Subject to aggregate cash and equity consideration limits, Auxilium stockholders may elect one of three options with respect to transaction consideration: 100% equity which equates to 0.488 Endo shares per Auxilium share, 100% cash which equates to $33.25 per Auxilium share or a standard election of an equal mix of $16.625 in cash and 0.244 Endo shares per Auxilium share. The total cash consideration will not exceed 50% of the total equity value and the equity consideration will not exceed 75% of the total equity value.
 
Citi served as financial advisor to Endo, Lazard provided an independent fairness opinion and Sullivan & Cromwell served as legal advisor. Deutsche Bank served as lead financial advisor, Morgan Stanley served as financial advisor and Willkie Farr & Gallagher and Morgan, Lewis & Bockius served as legal advisors to Auxilium.
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