The Good, The Bad and Drug Shortages.

It doesn’t take a rocket scientist to know that when you don’t have enough of a good thing, bad things can happen. This is the case with the on-going drug shortages and the resulting potential issues that affect the care we provide and patient safety concerns. The ISMP (Institute for Safe Medication Practices) recently released…

Epogen and Procrit: Voluntary Recall

Certain lots of Epogen and Procrit (Epoetin alfa) vials are being recalled as a precaution, because the vials may contain extremely thin glass flakes (lamellae) that are barely visible. The potential serious adverse events resulting from the use of a sterile injectable product with particulates by the intravenous route include embolic, thrombotic and other vascular…

FDA Safety Alert on Nimodipine: Not for IV use

Nimodipine is a medication intended to be given in a critical care setting to treat neurologic complications from subarachnoid hemorrhage and is only available as a capsule. The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals that nimodipine capsules should be given ONLY by mouth or through a feeding tube (nasogastric tube). This…

FDA Requires Baxter to recall Colleague Infusion Pump

On July 13, 2010, the U.S. Food and Drug Administration required Baxter Healthcare Corp. to take specific steps to carry out the April 2010 recall of all Colleague Volumetric Infusion Pumps (CVIP) and to provide customers with a refund, a replacement pump, or lease termination. According to the FDA, it is requiring Baxter to provide…

Epinephrine – Warning Risk for Serious or Fatal Medication Errors

Please note this urgent message from the National Alert Network (NAN) for Serious Medication Errors.   The National Council for Medication Error Reporting and Prevention (NCCMERP) is distributing a NAN alert to warn practitioners about the potential for serious or fatal errors with epinephrine, caused by the current shortage of epinephrine emergency syringes. EPINEPHrine emergency syringes…

FDA Alert on certain IV medications

The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals not to use certain intravenous (IV) bags of metronidazole, ondansetron, and ciprofloxacin because of potential contamination. FDA has received reports of floating matter in IV bags manufactured by Claris Lifesciences Limited, in Ahmedabad, India. Microbiological analysis identified the matter in one of the bags…

Informed consent for Infusions of Biologics

A common question I get asked by nurses is…..do I need to obtained an  informed consent from a patient who is receiving infusions of biologic agents such as  Remicade (Infliximab)? An informed consent, according to the American Medical Association (AMA), is the communication process between a patient and his or her physician that results in…

Infusions of Monoclonal Antibodies in New York State

In the past 12 years, we have seen an increase in new monoclonal antibodies approved by the FDA for numerous indications as treatment options for cancer, neurologic disorders, immunologic,  and autoimmune diseases, to name a few. These monoclonal antibodies are administered either subcutaneously, usually self administered by patients or administered intravenously by a registered nurse…

Recall: IV Extension Sets with BD Q-Syte™ Luer Access Device

An FDA press release stated that Acacia Inc. voluntarily executed a product recall of certain lots of IV Extension Sets with BD Q-Syte™ Luer Access Device.   The BD Q-Syte™ Luer Access Device is a Needleless Valve manufactured by BD (Becton, Dickinson and Company). The IV Extension Set with BD Q-Syte™ Luer Access device is intended…