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Recent Issues
July 2011
Features
Pharmacogenomics in Clinical Practice
Reality and Expectations
The cost of DNA sequencing has dropped dramatically since the completion of the Human Genome Project in 2003. However, many barriers need to be overcome in order to translate pharmacogenomic research findings into clinical practice.
C. Lee Ventola, MS
Regulatory Compliance
The ESA APPRISE Oncology Program
A History of REMS Requirements, a Review of the Data, and an Approach to Compliance in the Hospital
Risk Evaluation and Mitigation Strategy (REMS) programs now accompany more than 150 drug products. The ESA APPRISE Oncology Program was implemented to ensure the safe use of erythropoiesis-stimulating agents (ESAs). One hospital’s response to the challenge of meeting compliance criteria involved the creation of a specific medication order set.
David J. Reeves, PharmD, BCOP; Amanda K. Quebe, PharmD; and Ranita Patel, PharmD
Perspective
The Value of Branded Proton Pump Inhibitors
Formulary Considerations
Newer-generation branded proton pump inhibitors (PPIs) have shown some advantages over generic PPIs in the treatment of gastroesophageal reflux disease. These differences are discussed along with ways of incorporating the newer PPIs into formularies.
David A. Peura, MD; Rosemary R. Berardi, PharmD; Javier Gonzalez, PharmD; and Louis Brunetti, MD, JD
Meeting Highlights
American Society of Hypertension and European Congress of Rheumatology/European League Against Rheumatism
Sessions on hypertension focus on four fixed-dose clinical trials and the effects of coffee and caffeine. The EULAR meeting includes news about pegloticase (Krystexxa) for gout; tofacitinib, an investigational oral biologic for rheumatoid arthritis; and anti–tumor necrosis factor therapy for arthritis.
Walter Alexander
Departments
Medication Errors
A Fatal Zinc Overdose in a Neonate
Confusion of Micrograms With Milligrams
A fatal zinc overdose in a newborn caused by confusion of micrograms versus milligrams
Matthew Grissinger, RPh, FASCP
Prescription: Washington
Critics Assail FDA Medical Device Approval Process
Slow Review Time and Safety Are at Issue
Stephen Barlas
New Drugs/Drug News/New Medical Devices
FDA approvals, drug indications, and updates
Pharmaceutical Approval Update
Fidaxomicin (Dificid) for fecal incontinence, rilpivirine (Edurant) for HIV-1 infection, and boceprevir (Victrelis) for patients with chronic hepatitis C virus genotype 1 infection
Marvin M. Goldenberg, PhD, RPh, MS
