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Recent Issues
May 2013
Features
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
Biosimilars
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
Departments
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
