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

e-News

FormularyJournal.com

August 12, 2011

Formulary
Home Medication Safety FDA Actions Latest News Policy Watch Drug Watch
In This Issue
FDA warns fluconazole
in early pregnancy may cause birth defects
American Regent recalls Vasopressin Injection, USP
FDA, international counterparts report progress on drug inspection collaboration
Office of Generics Drugs reorganizes for greater efficiency
Foundation for Managed Care Pharmacy appoints 4 new trustees

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.

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Digital Edition

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FDA warns fluconazole in early pregnancy may cause birth defects

FDA issued a warning last week that chronic high doses (400 mg/day to 800 mg/day) of fluconazole (Diflucan) during the first trimester of pregnancy may be associated with specific birth defects in infants. However, the risk does not appear to be associated with a single, low dose of fluconazole (150 mg), which is used to treat vaginal yeast infection (candidiasis), according to the safety alert released August 3. Read full article.

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American Regent recalls Vasopressin Injection, USP

American Regent, Inc. is conducting a nationwide voluntary recall of multiple lots of Vasopressin Injection, USP to the retail/hospital level. The company initiated the product recall because some vials may not maintain potency throughout their shelf-life. Read full article.

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FDA, international counterparts report progress on drug inspection collaboration

Progress has been made on increasing international regulatory collaboration among the agencies that aim to enhance drug quality and safety globally, according to the results of 2 pilot programs by FDA and its European and Australian counterparts. Read full article.

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Office of Generics Drugs reorganizes for greater efficiency

The Office of Generics Drugs (OGD) has been reorganized to improve coordination, communication, efficiency, and to enhance the Office's ability to assure that all generic drugs are safe, effective, high quality, and interchangeable to the brand name drug product/reference listed drugs, according to The Center for Drug Evaluation and Research (CDER), part of FDA. Read full article.

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Foundation for Managed Care Pharmacy appoints 4 new trustees

The Board of Trustees of the Foundation for Managed Care Pharmacy (FMCP), the educational and philanthropic arm of the Academy of Managed Care Pharmacy (AMCP), has announced the appointment of 4 new FMCP Trustees. Read full article.

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