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This month we would like to know...

How does your health system handle new drug approvals?

1) We have a 6-month moratorium on newly FDA-approved drugs.

2) We have a 12-month moratorium on newly FDA-approved drugs.

3) If approved by the P&T committee, newly FDA-approved drugs can be added at anytime without restrictions.

4) If approved by the P&T committee, newly FDA-approved drugs can be added at anytime with step therapy or other modality to manage drug use and cost.

5) Other

Digital Edition

Drugs in short supply: Change and challenge among all stakeholders

The Preserving Access to Life-Saving Medicines Act, introduced February 7, 2011, and sponsored by US Senators Amy Klobuchar (D-Minn.) and Bob Casey (D-Pa.), would increase the authority of FDA to address and mitigate this problem affecting prescription drugs. Read full article.

FDA warns against terbutaline for preterm labor

FDA is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor because of the risk for serious maternal heart problems and death. Read full article.

TXA reduces death from bleeding in trauma patients

Tranexamic acid reduces the risk of death from bleeding without increasing the risk of vascular occlusive events or the need for surgical intervention in patients with acute traumatic injury, according to a review published in the 2011 Cochrane Database of Systematic Reviews. Read full article.

Black box warnings accelerate reduced antipsychotic use in dementia

The rate of decline in the use of atypical antipsychotics in outpatients with dementia accelerated following a black box warning by FDA, according to a multicenter study of national Veterans Affairs data. Read full article.

Two drugs show promise in advanced pancreatic neuroendocrine tumors

Sunitinib and everolimus improved progression-free survival in patients with advanced pancreatic neuroendocrine tumors, according to 2 recent studies. Read full article.

Sanofi-aventis to acquire Genzyme

The $20.1 billion acquisition of Genzyme by Sanofi-aventis will allow Sanofi-aventis to expand its footprint in biotechnology and give it an edge in the market for drugs for rare diseases, according to experts. Read full article.

FDA approves Corifact to prevent bleeding in people with rare genetic defect

FDA has approved Corifact (CSL Behring), the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency. Read full article.

THERAPY UPDATE

A review of peripherally acting
mu-opioid receptor antagonists

This article reviews the emerging class of peripherally acting mu-opioid receptor antagonists and provides insight on formulary considerations when evaluating these agents. Read full article.

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