In the News:  Food and Drug Administration Releases

Several recent releases from the Food and Drug Administration [FDA] are of interest to home care and hospice providers.  In a recent December release and alert, the FDA issued a recall for pre-filled heparin syringes due to contamination.  These were pre-filled Lock Flush Solutions 5 ml of solution in 12-ml syringes, Lot # 070926H.  A bacteria contamination was present in these heparin IV flush syringes that can lead to serious health effects as a result of an infection.  Consumers and health providers should check lot numbers on all heparin flush syringes in patients’ homes as well as any available for use by staff.  Any products that match this lot number should be returned for refund and should not be used.  More complete information on this MedWatch Alert is available at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#HeparinLock.

A second Public Health Advisory of interest is an up-to-date version of a previously released FDA alert on the use of fentanyl transdermal system (patch) for pain management.  As a result of ongoing reports of death and life-threatening adverse events related to fentanyl overdose, the appropriate prescribing, usage, dosage and general safe use highlights released in July have been updated.  It has been demonstrated that for those unfamiliar with the potency and effects of the fentanyl patch, i.e. those who are opioid-naïve and prescribed fentanyl patches for pain management, incorrect application and usage continues to occur.  The more frequently reported errors in the use of this medication include both incorrect or misuse of the fentanyl patch.  Three of these include [1] applying more patches than prescribed, [2] exposing the patch to heat and [3] changing the patch too frequently.  These errors have led to adverse side effects, including death.  The heat exposure to the fentanyl patch leads to a more rapid release of fentanyl that results in increased fentanyl absorption through the skin with the potential to cause a fatal overdose.

In this recent MedWatch release, it was reemphasized that the fentanyl patch is indicated for persistent, moderate to severe chronic pain in cases where the patient has taken daily and regular around-the-clock narcotic pain medicine for over a week.  Another factor that should be present is that the patient should be considered opioid-tolerant.  For complete information on this recent release, go to: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fentanyl.

In other FDA patient safety related activities, there was a release of the monthly Patient Safety News Video that covers significant safety alerts, recalls, new product approvals and offers important tips on protecting patients.  The news release, as well as web location for more information on each topic is provided with each Patient Safety News Edition.  Consumers and providers can read the complete stories and watch or download the video program at http://www.fda.gov/psn.