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DrugTopics.com

August 18, 2011

Drug Topics
Home CE DT Blog JP at Large Viewpoints Regulatory and Legal Archives
In This Issue
Drug shortages and
the gray market
Do PPIs interact
with aspirin?
Joint Commission cites med prep, storage issues
ISMP warns about insulin administration errors
Antibiotics in preemies
FDA approves 1-tablet
HIV regimen
FDA posts label changes for 32 products
Peginesatide NDA gets PDUFA action date
Continuing Education
Newest: Interprofessional Communication
For pharmacists, from Drug Topics: Continuing education for pharmacists and pharmacy technicians. Go to CE site here
Meetings

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Senators call for FDA hearing on drug shortages and gray-market markups

Soon after a report revealed an average 650% markup on "gray-market" drugs, which are used when there is a shortage of other drugs, U.S. senators called for an FDA hearing. Read full article.

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Drug Topics Staff

Anticoagulation update

Leeann Hakobyan

A monthly review of the
peer-reviewed literature by
Drug Topics' Editorial Advisor
Anna D. Garrett, PharmD, BCPS.
Anna Garrett is manager, Outpatient Clinical Pharmacy Programs, Mission Hospital, Asheville, N.C.

Do PPIs interact with aspirin? Read full article.

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Joint Commission's 2010 report targets medication preparation, storage, security

Medication storage was one of the biggest problems that The Joint Commission found in hospitals in 2010, according to its new survey. Read full article.

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ISMP warns about insulin administration errors

The Institute for Safe Medication Practices (ISMP) is warning pharmacists, physicians, and nurses against misadministration of insulin through inappropriate dosing and treatment of hyperkalemia. Read full article.

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Prolonged empirical antibiotics in preemies linked to adverse outcomes

Premature infants who get empirical antibiotic therapy for five days or more are at higher risk for late-onset sepsis, necrotizing enterocolitis, and death, according to a new report. Read full article.

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FDA approves single-tablet regimen
for HIV-1 infection in treatment-naive adults

FDA has approved emtricitabine/rilpivirine/tenofovir disoproxil fumarate (Complera, Gilead Sciences), a complete single-tablet regimen for the treatment of HIV-1 infection in treatment-naive adults. Read full article.

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FDA posts safety label changes
for 32 products

FDA has announced changes to the boxed warnings, contraindications, and warnings sections of the labels
for 32 products. Read full article.

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FDA assigns PDUFA action date
for peginesatide NDA

FDA has assigned a Prescription Drug User Fee Act action date of March 27, 2012, for the review of the New Drug Application for the investigational agent peginesatide (formerly known as Hematide). If approved, peginesatide will be the first once-monthly erythropoiesis stimulating agent available for the treatment of anemia associated with chronic kidney disease in patients on dialysis in the United States. Read full article.

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Career Opportunities

Cross Country
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Meetings and Events

August 27-30, 2011 NACDS Pharmacy & Technology Conference
Boston
Contact:
P.O. Box 34814
Alexandria, VA 22334-0814
703-683-5678

September 26-27, 2011 2nd Annual Pharmaceutical Labeling Summit
Washington, D.C.
Contact:
Jeff Grizzel, Conference Director
FDA News
300 N. Washington St., #200
Falls Church, VA 22046-3431
703-538-7668
jgrizzel@fdanews.com
www.fdanews.com/PharmaLabeling

October 6-7, 2011 NCPA Diabetes Accreditation
Standards-Practical Applications (DASPA)
Nashville, TN
Contact:
100 Daingerfield Road
Alexandria, VA 22314
800-544-7447

October 8-12 2011 NCPA Annual Convention
Nashville, TN
Contact:
100 Daingerfield Road
Alexandria, VA 22314
800-544-7447

November 29, 2011 NACDS Foundation 13th Annual Dinner
New York, NY
Contact:
Jennifer Sargeant, Manager, Foundation Programs and Education, NACDS
703-837-4224

CEC

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