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The following are excerpts from the newsletter

March 22, 2012

  • Results of our survey on drug storage, stability, compatibility, and beyond use dating
  • Safety Brief:  Too close for comfort. Hospital pharmacy’s IV admixture service recently underwent renovations for the addition of a new a clean room. Once the construction was completed, a reorganization of parenteral products began, and look-alike 10 mL vials of calcium gluconate (100 mg/mL) and cupric sulfate (4 mg/10 mL) somehow wound up next to one another. It didn’t take long before a mix-up occurred.
  • Safety Brief: FDA panel says no to eye product label change A US Food and Drug Administration (FDA) advisory committee met earlier this month to discuss labeling of anti-inflammatory eye drops used after cataract or other eye surgeries. FDA was asked to approve a larger fill size of an anti-inflammatory eye drop to allow patients undergoing two cataract extraction surgeries to treat each eye using a single bottle.
  • Safety Brief: Compounded unapproved drug leads to eye infections.  Earlier this week the US Food and Drug Administration (FDA) reported that the agency had received reports of fungal endophthalmitis in patients who had eye injections of Brilliant Blue G during eye surgery. Clinicians in several states reported the adverse events. The synthetic dye, which is not an FDA-approved drug, was supplied by a compounding pharmacy in Ocala, Florida. A recall was issued by the compounding pharmacy earlier this month for all lots of Brilliant Blue G due to suspected fungal contamination. The full FDA warning statement can be read at: www.fda.gov/Drugs/DrugSafety/ucm296410.htm.
  • Safety Brief: It’s Bio-T-Gel not T-Gel.  The US Food and Drug Administration (FDA) recently approved a testosterone replacement product known as Bio-T-Gel, which will be distributed in the US by Teva Pharmaceuticals. This prescription product is a testosterone gel for the treatment of male hypogonadism or low testosterone levels. Don’t confuse Bio-T-Gel with the over-the-counter product T-Gel, which is a medicated shampoo manufactured by Neutrogena.
  • NAN alert issued. ISMP and the American Society of Health-System Pharmacists (ASHP) activated the National Alert Network (NAN) earlier this week to address the risk of inadvertent injection of EXPAREL (bupivacaine liposome suspension injection) intravenously.
  • ISMP webinar. Join us on April 24 for a technology-focused webinar, Protecting Your Patients: Using an Active Surveillance System to Improve Quality and Safety of Medication Use.  For details, please visit: www.ismp.org/educational/webinars.asp.
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