CHPSO patient safety alert—Viaspan from Teva Pharmaceuticals

March 26, 2010

During a CDPH visit, a CHPSO member hospital identified a potential problem with the packaging and distribution of Viaspan®, from Teva Pharmaceuticals. The hospital is concerned that the product can be inadvertently given intravenously.

Viaspan, a solution for the flushing and cold storage of organs for transplantation, contains about 125 mEq/L potassium. If the solution is mistakenly used for intravenous infusion, cardiac arrest is likely.

The following concerns were identified:

Packaging:

• The labeling “Not for direct injection or IV infusion” , “Risk of cardiac arrest” along with the ingredient labeling (especially the large amount of potassium) are all in very small font in black print over plastic making it very difficult to read or capture the attention of the user.
• Despite the bag being labeled not for infusion, the delivery set port can easily accommodate regular IV tubing. Other manufacturers have rendered such a port, for a non-infusion purpose, impossible to connect with IV administration tubing.

Distribution:

• Viaspan can be purchased through non-pharmacy channels, such as materials management, without the knowledge of the pharmacy. This has reportedly happened at several hospitals. CMS states that this product should only be purchased and delivered to pharmacies and not directly to surgical services departments.

As Viaspan represents a source of concentrated KCl and presents a risk of accidental intravenous administration, appropriate safeguards should be in place.

This notice is being sent to all recipients of the CHPSO newsletter distribution list. It also is being distributed by the California Society of Health-System Pharmacists. The hospital has notified the manufacturer and the FDA.