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Parsing FDA’s new Rx-to-OTC switch initiative

BY Jim Frederick

Heads up practicing and soon-to-be-licensed pharmacists! More than ever, the Food and Drug Administration will soon need more of your help.

The FDA is now mulling a vastly accelerated campaign to shift a slew of prescription medications like statins to over-the-counter status. If the initiative succeeds, it could spawn an explosion of Rx-to-OTC switches affecting a broad range of prescription products generating an estimated $35 billion or more in annual sales, as well as giving patients, government health agencies and health plan sponsors one more reason to turn to pharmacists for their expertise and patient access.

That’s according to a newly released study from Francesco International looking at the new Rx-to-OTC switch paradigm under consideration by the FDA. In a Feb. 8 report, Drug Store News cites the Francesco study’s prediction of a potential boom in OTC sales that could result if the agency’s plan to push many prescription drugs into non-Rx, widely-available status, goes through.

More importantly, according to the report, the FDA “has been looking at ways technology and pharmacists could be employed to ensure that patients taking drugs new to the consumer health space take them appropriately.”

Besides statins, the agency’s accelerated switch pathway could also put some meds for conditions like hypertension, COPD and benign prostate hyperplasia within easy reach of Americans, according to the Francesco report. Citing the study, DSN senior editor Michael Johnsen observes, “Enabling access to OTCs through technology or consults with retail pharmacists and clinicians could bring prescription-only medicines like statins into the mass market.” Other potential switch candidates identified by Francesco in the report include medicines for hypertension, benign prostate hyperplasia, chronic obstructive pulmonary disorder and erectile dysfunction.

Pharmacists already do a lot to counsel patients on OTC medicines. What impact do you think OTC status for some of these prescription-only drug classes would have on patients and your own practice?

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Pictured: (from left to right) Andrew Draghi, Sanofi US district sales manager; Michael Bunker, Sanofi US clinical product specialist; Cindy Borassi, CCCF director communications and operations; Dr. Thomas Weber, CCCF founder; and Rose Maione, Sanofi US executive clinical product specialist
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Sanofi named CCCF’s corporate partner of the year

BY Jason Owen

NEW YORK — Sanofi US was named corporate partner of the year by the Colon Cancer Challenge Foundation (CCCF), a nonprofit organization dedicated to reducing colorectal cancer incidence and death throughout the United States, and presented with CCCF’s annual Blue Star Corporate Award.

Sanofi is a global healthcare pharmaceutical firm that is leading innovation in cancer research and therapy. The Blue Star Corporate Award was presented to Rose Maione, executive clinical product specialist; Michael Bunker, clinical product specialist; and Andrew Draghi, district sales manager during CCCF’s 2013 kickoff and awards dinner last week.

“Finding an end to colorectal cancer really requires an immense level of collaboration between organizations,” said Dr. Thomas Weber, CCCF founder, professor of surgery at the State University of New York at Downstate and chief of surgery at the Department of Veterans Affairs New York Harbor Healthcare System, Brooklyn campus. “Sanofi US has gone above and beyond to help support CCCF and they are truly worthy of this award for the contributions they make to cancer research.”

CCCF selected Sanofi US for its promotion and support of the NY Colon Cancer Challenge, an annual event in Central Park which will celebrate its 10th anniversary on Sunday, April 7. The event offers colorectal cancer survivors and the family and friends of those affected by colorectal cancer a unique opportunity to help raise public awareness and contribute to the fight against this often fatal, yet preventable disease. Sanofi US raised more than $24,000 for CCCF in 2012 and continues to support the organization’s efforts to increase colorectal cancer awareness and prevention. In addition to sponsoring the Colon Cancer Challenge, Sanofi is dedicated to discovering, developing and distributing therapeutic solutions to improve people’s lives.

For more information about the Colon Cancer Challenge Foundation, visit www.coloncancerchallenge.org.

To register for the Colon Cancer Challenge, visit http://events.coloncancerchallenge.org


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Agenda for upcoming 2013 Retail Clinician Education Congress now available

BY Antoinette Alexander

LAS VEGAS — The agenda for the 2013 Retail Clinician Education Congress, which will be held in May in Las Vegas, is currently available, and those who register now can take advantage of a $99 registration fee.

To check out the 2013 RCEC agenda, click here.

The sixth annual RCEC conference, which is hosted by Drug Store News Group in conjunction with the Convenient Care Association, will be held May 14 to 16 at the Planet Hollywood Resort in Las Vegas.

The three-day educational and networking forum is designed to meet the needs of the growing field of convenient care practitioners. The entire program is dually accredited for nurse practitioners and physician assistants. This year’s event will, once again, feature an Executive Track, as well as a Collaborative Care Track, which is accredited for nurse practitioners, physician assistants and pharmacists.

The RCEC event also serves as a platform to honor those providers and key executive leaders whose work throughout the year has distinguished them among their peers in retail health care. The annual Clinician Awards for Retail Excellence (CARE) Awards honor the “Unsung Heroes” who work tirelessly each day to help further the cause of retail-based health care. CARE Award nominations are open until April 1.

During the event, the winner of this year’s Loretta Ford CARE Lifetime Achievement Award also will be announced. Past winners of the Lifetime Achievement Award include Loretta Ford, who helped revolutionize the nursing profession more than 40 years ago with her work in co-founding the nation’s first pediatric nurse practitioner program; Mona Counts, who opened one of the first all nurse practitioner practices in the United States; Shirley Chater, former commissioner of the U.S. Social Security Administration; and Hal Rosenbluth, co-founder of Take Care Health Systems.
 

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