PHARMACY

Pharmacy OneSource releases new version of Simplifi 797 pharmacy compounding software

BY Alaric DeArment

BELLEVUE, Wash. — A division of Wolters Kluwer Health has released a new version of a Web-based quality-assurance software for pharmacy compounding.

Pharmacy OneSource announced the release of a new version of Simplifi 797, used for ensuring compliance with USP chapter 797 regulations, which call for proper training of staff who prepare sterile compounded products.

The software includes a redesigned dashboard that allows for tracking of competencies by separating them for each staff member. This allows assignments for the entire clean-room staff to be created or modified with just a few clicks, the company said.

The release of the new software comes amid a nationwide outbreak of meningitis that authorities say stemmed from compounded injectable steroids that were contaminated with a rare fungus from a New England-based compounding pharmacy. The outbreak so far has resulted in 257 cases and 20 deaths as of Friday, according to the Centers for Disease Control and Prevention’s daily update.


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FDA gives tentative approval to Cipla combo pill for HIV

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to a new drug for HIV made by an Indian company.

FDA records show that the agency gave tentative approval tablets and oral suspension that combine lamivudine, nevirapine and zidovudine in the 30-mg/50-mg/60-mg strength.

The drug doesn’t currently carry a brand name, and all three active ingredients are available as generics; Apotex and Aurobindo market generic versions of lamivudine, a generic version of ViiV Healthcare’s Epivir, while versions made by several other companies have tentative FDA approval.

A Cipla tablet that combines the three ingredients in the 150-mg, 200-mg and 300-mg strengths, respectively, received tentative approval from the FDA in 2007 and is marketed outside the United States as Duovir N.

Tentative approval means that a drug meets the FDA’s requirements for approval, but the agency can’t allow the manufacturer to launch because of the branded drug’s patent or the market exclusivity period of another company making a generic version hasn’t expired.


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McKesson Patient Relationship Solutions honored for Lap-Band campaign

BY Michael Johnsen

SCOTTSDALE, Ariz. — McKesson Patient Relationship Solutions earned top honors for patient compliance and adherence programs in both the 2012 Medical Marketing and Media Awards and the PM360 Trailblazer Awards, the company announced Thursday. 

MPRS was honored with a Medical Marketing and Media Award for the company’s Lap-Band Behavioral Call Campaign on behalf of Ogilvy Healthworld. The MM&M Awards are a premier industry event that annually recognizes creativity and marketing effectiveness in health care.  

The Lap-Band Behavioral Call Campaign also recently won the PM360 Trailblazer Award for the Best Direct Marketing to Patient Campaign. McKesson’s LEO Quality Care Program was selected as a finalist for the Best Persistence Campaign Award. Selected by the PM360 editorial board from more than 800 award applications, finalists represent the most forward-thinking leadership of their fields, McKesson noted. 

“We are very pleased that the Lap-Band program was recognized for its creative innovation and proven results by both PM360 and MM&M,” stated Peggy Yelinek, VP and general manager, MPRS. “This continues to validate the importance of personalized conversations that result in meaningful patient interactions to help patients be more engaged with their health.” 

The Lap-Band campaign focused on consumers who had requested initial information about the weight-loss procedure, but had not responded to invitations to attend an informational seminar. Taking the leads generated through DTC efforts, McKesson developed an outreach solution designed to maximize conversion opportunities through live behavioral calls to help guide the consumer through the decision process.

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