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Formulary, A peer-reviewed drug management journal for managed care and hospital decision-makers
Part of the Modern Medicine Network

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FormularyJournal.com

August 19, 2011

Formulary
Home Medication Safety FDA Actions Latest News Policy Watch Drug Watch
In This Issue
FDA warns unapproved emergency birth control may be ineffective, unsafe
FDA posts safety labeling changes for 32 products
Statins may reduce risk of recurrent vascular events in young stroke patients
New guidelines for COPD diagnosis, management
FDA approves first antivenom for Centruroides scorpion stings
Results of biologics and specialty pharmacy research confirm knowledge gap
FDA approves Zelboraf and companion diagnostic test for late-stage skin cancer
FDA approves 2 new strengths of leuprolide acetate for treatment of children with central precocious puberty

Survey

This month we would like to know...

With the evolution of the medical home and ACO models of healthcare delivery, what do you see as the most essential means by which pharmacy departments can support the success of such models?

a) More active direct patient outreach, education, and consultation.

b) Enhanced provider education and drug info support.

c) Improved ability to deliver more timely and actionable patient-specific drug alerts to PCPs/care managers.

d) Enhanced mechanisms to monitor and improve patient compliance.

e) More advanced analytics to better risk stratify patients for intervention need.

f) More timely and robust reporting to measure pharmacy-specific quality performance metrics.

Click Here to Vote

Digital Edition

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FDA warns unapproved emergency birth control may be ineffective, unsafe

FDA is warning consumers in the United States not to use an emergency birth control medication labeled as Evital. According to a recent press release from the agency, Evital has not been approved by FDA, and the product may be a counterfeit version of the morning-after pill. It may not be safe or effective in preventing pregnancy. Read full article.

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Formulary Staff

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FDA posts safety labeling changes
for 32 products

Thirty-two products recently have had label changes to the boxed warnings, contraindications, and warnings sections, according to FDA. Read full article.

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Statins may reduce risk of recurrent vascular events in young stroke patients

Young adults treated with a statin after a first ischemic stroke of undetermined cause were 77% less likely to suffer subsequent vascular events, according to a recent study published in Neurology. Read full article.

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New guidelines for COPD diagnosis, management

The American College of Physicians (ACP), American College of Chest Physicians (ACCP), American Thoracic Society (ACT), and the European Respiratory Society (ERS) have issued updated recommendations to the 2007 ACP clinical practice guideline on diagnosis and management of stable chronic obstructive pulmonary disease (COPD). The new recommendations were published in Annals of Internal Medicine. Read full article.

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FDA approves first antivenom
for Centruroides scorpion stings

FDA has approved the first antivenom treatment specifically for stings from Centruroides scorpions in the United States. The new biologic treatment called Anascorp was designated an orphan drug and given priority review because adequate treatment did not exist in the United States, according to a consumer update and corresponding news release issued by the agency. Read full article.

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Results of biologics and specialty pharmacy research confirm knowledge gap

How much do employers know regarding biologics and specialty pharmacy? A recent survey indicates that while approximately half of employers had a moderate understanding related to biologics and specialty pharmacy, about one-third did not know how much their claim costs had increased over the last few years. Read full article.

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FDA approves Zelboraf and companion diagnostic test for late-stage skin cancer

FDA has approved vemurafenib (Zelboraf, Genentech), the second melanoma drug this year to improve overall survival. Zelboraf is indicated for the treatment of patients with late-stage (metastatic) or unresectable melanoma, the most dangerous type of skin cancer. Read full article.

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FDA approves 2 new strengths of leuprolide acetate for treatment of children with central precocious puberty

FDA has approved 2 new strengths (11.25 mg and 30 mg) for 3-month administration of leuprolide acetate for depot suspension (Lupron Depot-PED, Abbott) for the treatment of children with central precocious puberty (CPP). Read full article.

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