Predictions of an impending H1N1 influenza pandemic this fall, coupled with forecast shortages in H1N1 vaccine, means laboratories and healthcare facilities across the land must check and recheck safe storage and handling procedures.  Laxity in following these procedures can occur across the entire supply chain from manufacturing to administering and has been responsible for the loss of millions of dollars worth of vaccine each year, reports the CDC.

Proper refrigeration procedures including monitoring are critical to protecting vaccines.  For example H1N1 vaccine manufacturers Baxter Healthcare and GlaxoSmithKline recommend storage at between 2^o and 6^o C (35.6^o and 42.8^o F).   This “cold chain” extends across the supply chain.  According to a CDC report, an estimated 17% to 37% of providers expose vaccines to improper storage temperatures. Oddly enough refrigerator temperatures are more commonly kept too cold rather than too warm. One study involving site visits showed that 15% of refrigeration units had temperatures of 34°F (1°C) or lower. Out-of-range temperatures require immediate attention.

Vaccine manufacturers and healthcare facilities should not put their faith in automatic alarms that signal out-of-spec temperatures in vaccine refrigerators –or freezers when colder storage is required.  The CDC strongly suggests that refrigerators and freezers be checked by lab technicians at the beginning and at the end of the day and that the temperatures are recorded on a log posted on the storage door.  Most important, if the temperature falls outside of the recommended range action must be taken immediately.

Malfunctions in refrigeration or freezer units, or a power outage can quickly compromise the quality of vaccines.  In such instances health officials will want to know the temperature of the room in which the cold storage units are kept so they can make correct decisions.  Organizations responsible for manufacturing, shipping, storing and administering vaccines should have a procedure in place to protect them by moving them to a properly functioning storage facility.

An excellent checklist for safe vaccine handling and storage, reviewed by the CDC, is available from the Immunization Action Coalition.  It can be downloaded at www.immunize.org/catg.d/p3035.pdf

———————-

Have you experienced an incident related to proper vaccine storage?  Please share it with us.

Tags: norlake

This entry was posted on Wednesday, September 9th, 2009 at 7:12 pm and is filed under Refrigeration. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.