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P&T May 2018
FDA Implementation Slow, Industry Criticism Significant
The FDA is making progress but is still laboring to address safety concerns about compounded drugs, an issue taken up by the Drug Quality and Security Act in 2013.
The clinical manifestations of Gaucher disease, a rare genetic lysosomal storage disorder, are debilitating, and the neuronopathic forms of the disease are fatal. The authors describe the current and investigational therapies for treatment.
Health Care & Law
Sterile Compounding Needs Risk Management: Access, Reconstitution Or Preparation, and Administration
Appropriate risk management strategies must be employed for compounding and administering sterile products. We review the new credentialing, regulatory, and related legal aspects of gaining and maintaining compliance for these processes.
Evaluation of Physician Prescribing Patterns For Antibiotics in the Treatment of Nonnecrotizing Skin and Soft Tissue Infections
Through a retrospective chart review, researchers found a substantial opportunity for clinical pharmacists to guide appropriate treatment of skin and soft tissue infections.
A Saudi group describes their universally applicable tool developed to prioritize and optimize formulary considerations at their large institution.
Key sessions reported on findings in noncardiac surgery, pharmacological agents in the setting of acute coronary syndromes, and cardiotoxicity of cancer therapy.
Errors with flecainide suspension in children
White House report on drug prices is a detailed road map
Approvals, new indications, regulatory activities, and more
Vancomycin hydrochloride for oral solution (Firvanq) for C. difficile-associated diarrhea and enterocolitis caused by S. aureus; dexamethasone intraocular suspension 9% (Dexycu) for the treatment of inflammation after eye surgery; and apalutamide (Erleada) for prostate cancer
Olaratumab (Lartruvo): an innovative treatment for soft tissue sarcoma