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Statement of Purpose
Guidelines for Authors
FDA Plans New National Standards, Pharmacies Tread with Trepidation
The government will be setting standards to prevent counterfeit products from getting into pharmacies. Implementing the requirements for applying an electronic pedigree to all drug packages will be a huge task for manufacturers and hospitals.
Results From a Large Inpatient Database
In a study to evaluate the economic impact of the alvimopan after bowel surgery, the authors found that patients receiving alvimopan capsules had faster recoveries, lower hospital costs, and shorter stays than matched controls.
Sara Poston, PharmD; Michael S. Broder, MD, MSHS; Melinda Maggard Gibbons, MD; Robert MacLaren, PharmD; Eunice Chang, PhD; Christine J. VandePol, MD; Suzanne F. Cook, PhD; and Lee Techner, DPM
Current and Potential Therapies
Rapid air flights over two or more time zones can cause symptoms of jet lag (circadian desynchrony) in many travelers. Selected medications for sleep disorders, caffeine, central nervous system stimulants, and light therapy may help travelers alleviate fatigue and malaise in the new time zone.
Mary Choy, PharmD; and Rebecca L. Salbu, PharmD, CGP
Three Leading Candidates
Serine–threonone protein kinase B (Akt) leads to cell growth and proliferation. Three investigative Akt pathway inhibitors—perifosine (KRX-0401), MK-2206, and GSK-2141795—represent potential targeted therapies for various tumors.
Topics include human Factor XIII concentrate (Corifact) to treat Factor XIII deficiency, a form of hemophilia; hydroxyprogesterone caproate (Makena) to reduce the risk of preterm births; and azilsartan medoxomil (Edarbi) for hypertension.
Marvin M. Goldenberg, PhD, RPh, MS
P&T committees will be facing tough decisions as they debate whether to approve expensive new drugs such as sipuleucel-T (Provenge), a new prostate cancer vaccine with a price tag of $93,000 over the course of therapy.
David B. Nash, MD, MBA
Strategies for preventing mixups with heparin and insulin are discussed.
Matthew Grissinger, RPh, FASCP
Will the FDA Quickly Define an Abbreviated Pathway for Biosimilars?
The President’s goal of reducing 12 years of patent exclusivity for biologics to seven years could result in some short-term savings but might end up costing the government more money in the long run.
FDA approvals, drug indications, and updates
The First Immunotherapy Agent (Vaccine) For Hormone-Refractory Prostate Cancer
Sipuleucel-T (Provenge), a vaccine for prostate cancer
Enock Anassi, MD, PharmD; and Uche Anadu Ndefo, PharmD, BCPS