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Archive for September, 2009

Could More Medication Guides and Package Inserts Be on FDA’s Wish List?

Wednesday, September 30th, 2009

FDA has issued draft guidance for industry on Risk Evaluation and Mitigation Strategies (REMS), which are required for certain drugs or biologics. Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), FDA gained authority to require the submission and implementation of a REMS if the agency decides a ...

Matching Dispensing Instructions to the Dispenser

Thursday, September 24th, 2009

FDA has received reports that administration errors involving Tamiflu oral suspensions have occurred when dosing instructions for the patient have not matched the dosing dispenser provided with the prescription. The mistakes seem to have been made because "U.S. health care providers usually write prescriptions for liquid medicines in milliliters (mL) ...

How Far Should Warnings Go?

Wednesday, September 16th, 2009

Today FDA asked manufacturers of promethazine to include a boxed warning in the drug's labeling regarding the injectable form of the drug. Promethazine was previously sold under the brand name Phenergan. The drug was at the center of the Supreme Court case Wyeth v. Levine, decided in favor of Diana ...

Who Caught Their Breath from the Fear of Using Stolen Albuterol?

Tuesday, September 15th, 2009

On September 11, Dey L.P. issued an advisory regarding the theft of a tractor-trailer in Florida containing two different types of its respiratory medications, Ipratropium Bromide Inhalation Solution, 0.02%, and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials. It appears that before the theft, portions of the lots that were later stolen ...

Death of Child Painful Reminder of Human Error

Wednesday, September 9th, 2009

There's a sad, sad story recounted in the latest issue of the ISMP Medication Safety Alert Acute Care newsletter. Two-year-old Emily Jerry died after receiving too much sodium chloride during chemotherapy, and the hospital pharmacist who oversaw preparation of that sodium chloride solution, Eric Cropp, has been stripped of his ...

How Are You Handling Supplier Consolidations? Interchangeability or Redundancy? Or Both?

Wednesday, September 2nd, 2009

Alcan Packaging is a very large company--14,000 employees at 80 locations in 28 countries--so chances are you may use some of its materials, or have at least considered it. So Amcor's pending acquisition of the global giant may affect you. The deal could take a while to close, and then plant ...