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October 9, 2014

From Production to Patient: Vaccines for Patients

Written by SmartSense | Pharmacy Safety

Today we’ll illustrate how vaccines are kept and highlight the most important aspects of long-term vaccine storage. We’ll be examining these all-important regulations in the advent of the recent Ebola outbreak spreading through Nigeria, Guinea, and other West African countries. Because of similar symptoms, more individuals are susceptible to illnesses like malaria than ever, and death tolls continue to rise. Luckily, promising new vaccine trials could stem the influx of victims in these disease-ravaged countries.

Once vaccines have been created, and then carefully packaged; they’ll be shipped to countries such as Sierra Leone, which is known for having the world’s highest rate of child and maternal mortality rates –often from preventable diseases. This stock of vaccines need to be kept at the appropriate temperatures and safely sealed until the moment they’re needed. Using the correct freezer and/or refrigerator can help prevent costly vaccine losses and the inadvertent administra­tion of compromised vaccines. Freezers and refrigerators come in a variety of sizes, types (standalone vs. combination), and grades (household, commercial, and pharmaceutical). The CDC strongly recommends stand-alone freezers and refrigerators because they have shown to maintain stable temperatures better than combination units.

Any freezer or refrigerator used for vaccine storage should have its own exterior door that seals tightly and properly, as well as thermostat controls and temperature monitoring devices. Good air circulation around the vaccine storage unit is essential for proper heat exchange and cooling functions, and the unit should be in a well-ventilated room with space around the sides and top and at least 4 inches between the unit and a wall.

Because of high temperatures in most regions of Africa, vaccine storage equipment should be selected carefully, used properly, maintained regularly (including professional service when needed), and monitored consistently to ensure that recommended temperatures are maintained.

A variety of techniques can be used to retain the appropriate temperature inside storage units. Such as using bottles of water labeled “Do Not Drink” can be placed on fridge doors to improve circulation. Buffer vials are especially important in maintaining proper monitoring data, because the sand/glycol solution assists with more accurate temperature readings and prevents false alerts.

Prior to storing vaccines in a unit, determine where the most reliable and consistent temperature readings are and store your vaccines there. The probe should be placed amongst where the vaccines are being stored. This should be in the main body of the storage unit, away from walls, ceiling, cooling vents, doors, floor, and back of the unit.

Many vaccines also need to be diluted before administration, and mistreatment of diluents can make vaccines not administrable to patients. Diluents must be clearly labeled so that they are not confused with other additives or vaccine, and all pharmaceutical products should be 2-3 inches from the walls or door of the fridge.

When budgeting for vaccine fridges, freezers, and monitoring equipment, remember that sensors used to monitor temperature must be calibrated and NIST-certified in order to meet CDC and/or VFC compliances.  This is to ensure temperature readings are always accurate and vaccine is never wasted. While NIST is now a requirement, coping with the hassle of sending sensors back and all the necessary paperwork doesn’t have to be. SmartSense's NIST Management Program has an option to provide you with new sensors when it’s time to replace the old ones, and all the active certificates are stored online for you.

While deaths are still steadily increasing, every vaccination draws us a bit closer to stamping out dangerous, rampant diseases like malaria. New vaccine trials could severely hinder transmission of diseases on multiple levels, and gives hope for a solution. But results require many complex moving parts -of which temperature monitoring is a vital component. That solution is still a ways away but until then: keep hoping, keep inquiring, and keep monitoring.

Topics: Pharmacy Safety

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