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P&T June 2014


A New List of 503B Outsourcing Facilities Offers No Guarantee of Anything
Compounders who prepare nonpatient-specific prescriptions have been slow to sign up for a new FDA program meant to serve as a de facto “Good Housekeeping” seal of approval. Meanwhile, inspectors are turning up problems wherever they go.

For patients with low back pain, skeletal muscle relaxants are often initiated after failure of first-line analgesics. However, these medications (reviewed in this article) are controversial alternatives that carry risks of adverse effects and increased cost.

An array of natural substances purported to possess disease-modifying qualities for osteoarthritis are designated as “dietary supplements” and thus avoid rigorous FDA regulation. Substantial scientific evidence for the efficacy of these agents is elusive.

An integrated health care system used an online database that captured pharmacists’ reports of medication errors and an algorithm that helped classify and prioritize the information to identify patterns and improve safety outcomes.


Medication Errors
Conservative prescribing can improve medication safety.
Prescription: Washington

FDA starts light-touch inspections for some imports.

FDA approvals, drug indications, and updates

Apremilast (Otezla) for active psoriatic arthritis, omalizumab (Xolair) for chronic idiopathic urticaria, and grass pollen allergen extract (Oralair) for grass pollen-induced allergic rhinitis with or without conjunctivitis

Meeting Highlights

The American Association for Cancer Research meeting included reports on new agents for breast cancer and melanoma.

Meeting Highlights

The American Psychiatric Association meeting offered updates on treatments for bipolar depression, autism, and depression.