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About P&T Journal
Editorial: Sonja Sherritze, Editor
Advertising: Maureen Dwyer Liberti,
    Vice President, Group Publisher

Production: Mary Ellen Curry,
    Director of Production Services

Circulation: Jackie Ott, Circulation Manager

Statement of Purpose
Guidelines for Authors
Editorial Board

Recent Issues

May 2013


FDA Strategies to Prevent and Respond to Drug Shortages

Finding a Better Way to Predict and Prevent Company Closures

To stave off a shortage of doxorubicin in 2011 and 2012, the FDA expedited the approval of a company’s unapproved manufacturing process. Paying companies sufficiently so that they can invest in their facilities when needed is just one of many steps that could be taken to rectify future shortages.
Stephen Barlas


Part 1: Proposed Regulatory Criteria for FDA Approval

Biosimilars, although not identical to their originator product, are expected to become essential in reducing health care costs and improving access to lifesaving drugs. The FDA must find a way to balance rigorous testing to ensure quality, as is done for generic chemical drugs, with providing a cost-efficient way to expedite approvals of these products.
C. Lee Ventola, MS

Comparison of Adverse Events and Hospital Length of Stay Associated With Various Amphotericin B Formulations

Sequential Conventional Amphotericin B/Lipid Versus Lipid-Only Therapy for the Treatment of Invasive Fungal Infections in Hospitalized Patients

Clinicians who prescribe amphotericin B should keep in mind the potential for nephrotoxicity. Lipid-based formulations can be less toxic than the conventional form but may also be more expensive. Patient outcomes and cost-effectiveness of the various formulations are discussed.
Rolin L. Wade, RPh, MS; Paresh Chaudhari, PharmD, MPH; Jaime L. Natoli, MS, MPH; Robert J. Taylor, AS; Brian H. Nathanson, PhD; and David Horn, MD

Meeting Highlights

American Academy of Dermatology
Cardiovascular Research Technologies 2013
American College of Cardiology

Dermatology topics include agents for psoriasis, urticaria, and infantile hemangiomas. The pros and cons of antiplatelet drugs prasugrel (Effient) and ticagrelor (Brilinta) are discussed, and an investigational agent, cangrelor, shows promise in reducing ischemic events when compared with clopidogrel (Plavix).
Walter Alexander


Prescription: Washington

FDA Pushes Plans for Drug Compounding

More Scrutiny for Hospital Pharmacies

Stephen Barlas

Medication Errors

Improved Safety Needed in Handling Elastomeric Reservoir Balls Used for Pain Relief

Potential problems with pain pumps
Matthew Grissinger, RPh, FASCP

Pharmaceutical Approval Update

Dimethyl fumarate capsules (Tecfidera) for multiple sclerosis, ado-trastuzumab emtansine injection (Kadcyla) for HER-2–positive breast cancer, and ospemifene tablets (Osphena) for painful intercourse in postmenopausal women
Marvin M. Goldenberg, PhD, RPh, MS

New Drugs/Drug News/New Medical Devices

FDA approvals, drug indications, and updates