PHARMACY

PharmaSmart, Rexall enter deal to integrate kiosk data, electronic patient records

BY Alaric DeArment

ROCHESTER, N.Y. — Health kiosk maker PharmaSmart International and Canadian retail pharmacy chain Rexall will combine PharmaSmart’s biometric screening technology with Rexall’s dispensing system, under a new partnership announced Monday.

Pharmacists at Rexall will be presented with alerts within the electronic patient record that will inform them of a patient’s biometric screening status, with an icon appearing based on average readings and, in most severe cases, urgent alerts to trigger immediate intervention and referral to follow-up care when indicated. For the partnership, PharmaSmart is also working with Rexall’s pharmacy software division, Propharm. The kiosk maker announced a similar deal last month with Astrup Drug, a chain that operates stores in Minnesota and Iowa.

"This program can help close the systemic gaps in chronic disease management, which place a huge economic burden on the Canadian healthcare system," PharmaSmart COO Ashton Maaraba said. "Rexall has shown strong industry leadership with this deployment, and we are confident this program will help drive improved medication adherence, patient outcomes and the overall health of Canadians nationwide."

Pharmacists will also have access to an advanced clinical portal allowing an in-depth overview of the patient’s biometric history. The data are integrated into standardized medication review sessions, and comprehensive program data are available to assess risk stratification and biometric trending geographically and across the full patient population.

"This new tool leverages our community pharmacists and advanced Health IT to drive improved management of chronic disease," Rexall VP pharmacy services Tracey Phillips said. "This new technology enables pharmacists to practice to their full scope, make the necessary interventions and provide a more complete level of care to the patient."

 

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PHARMACY

Calif. bill to restrict biosimilars gets governor’s veto

BY Alaric DeArment

NEW YORK — The governor of California has vetoed a bill that critics said would have limited patients’ access to knock-off versions of biotech drugs.

On Saturday, Gov. Jerry Brown vetoed S.B. 598, which had passed the state legislature in September with promotion from such biotech companies as Amgen and Genentech. The bill would require pharmacists to notify prescribers and patients if they had substituted a biosimilar for a branded biotech drug and prohibit them from dispensing a biosimilar if prescribers indicated "Do not substitute" on prescriptions. The bill contained a "sunset clause," meaning that it would only apply to prescriptions written before 2017.

Early on, the bill attracted opposition from such groups as the Generic Pharmaceutical Association, a Washington-based industry organization, as well as the board of the California Public Employees Retirement System, Walgreens, CVS Caremark, Kaiser Permanente, Express Scripts, the California Pharmacists Association, the California Retailers Association and others.

The GPhA heralded Brown’s decision.

"This Amgen- and Genentech-promoted bill was designed to drive their profits and thwart competition from biosimilars, newer versions of biotech drugs that offer patients the promise of cutting-edge medicines without the hefty price tag," GPhA president and CEO Ralph Neas said. "But with one stroke of his pen, the governor has preserved access for millions of patients and will save California taxpayers billions of dollars."

But the Biotechnology Industry Organization, a trade group representing the companies that develop biotech drugs, said it was "disappointed" by Brown’s decision.

"Biosimilars are not generics," BIO said in a statement. "Even slight changes to a biologic drug can change its properties entirely. Unlike conventional generic medicines, biosimilars are not the same as the drugs they seek to substitute. In fact, two biologics made using different cell lines and differing manufacturing processes will rarely, if ever, be exactly the same, hence the name ‘biosimilar.’"

Another company that represents biotech companies, the California Healthcare Institute, was similarly disappointed.

"S.B. 598 would have established a responsible pathway for increased patient access to biologic medicines for life-threatening illnesses as soon as they were available in the U.S.," CHI VP government affairs Eve Bukowski said. "The governor recognized that physicians want notification on the use of biologics, but he failed to recognize that the FDA cannot affect whether physicians in California will be notified of the biologic medicines their patients receive at a pharmacy."

The Patient Protection and Affordable Care Act of 2010 contained amendments that authorize the FDA to create an abbreviated regulatory pathway for biosimilars, though the agency is still in the process of drafting regulations. Unlike generic pharmaceutical drugs, which the agency approves if their manufacturers can prove they are equivalent to the branded drugs they’re based on, it has long been understood that biosimilars would have to undergo a brief clinical trial program before winning approval.

 

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FDA approves easy-to-use injectable methotrexate for RA, psoriasis, juvenile arthritis

BY Alaric DeArment

EWING, N.J. — The Food and Drug Administration has approved a new drug made by Antares Pharma for treating rheumatoid arthritis and psoriasis, the drug maker said Monday.

Antares announced the approval of Otrexup, a version of the common arthritis drug methotrexate — commonly referred to as MTX — that is designed for once-weekly injection underneath the skin by the patient and marketed in an easy-to-use, disposable automatic injection device. The drug is meant for adults with severe RA who have had inadequate responses to full-dose non-steroidal anti-inflammatory drugs, children with polyarticular juvenile idiopathic arthritis, or pJIA, and adults with psoriasis.

"This new delivery system for methotrexate provides a welcome option for physicians and their patients to continue effective use of methotrexate," University of Colorado School of Medicine medical professor Michael Schiff said. "Otrexup can be used when a response is inadequate or there are tolerability issues with oral methotrexate, before adding or switching to costlier therapies."

 

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