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Proper storage of vaccines is needed to maintain effectiveness

Appropriate storage and handling of vaccines is necessary to ensure adequate protection.

[Rule #1] [Rule #2]
[Rule #3] [Rule #4]
[Rule #5] [Rule #6]

[Your turn]

September 1998

LANSING, Mich. - Giving immunizations is an integral part of a pediatrician's practice, but the storage facilities for the vaccines should not be neglected.

Maintaining proper temperatures and lighting conditions are necessary for the vaccines' shelf life. If the vaccines are not stored in the appropriate conditions, a child may not receive the proper protection needed for immunity.

According to the Michigan Department of Community Health and the Centers for Disease Control and Prevention, there are six basic rules for proper vaccine storage. However, the vaccine manufacturer should be contacted if additional questions arise regarding the vaccines.

Rule #1

Keeping the refrigerator between 36° F and 46° F and the freezer below 32° F for oral poliovirus vaccine (OPV) and below 5° F for varicella vaccine is important. To ensure the temperature remains constant, a log of refrigerator and freezer temperatures should be kept and checked twice daily.

Containers of water and packs of ice should be stored in the refrigerator and freezer to help stabilize the temperature in case of an incidental loss of power. Also, using freezer packs is an important consideration when transferring supplies, said Dean Mason, chief of the Program Support Branch of the National Immunization Program.

Warning signs should be posted at the electric outlet and at the circuit breaker so everyone in the office, including the janitorial staff, is aware that the power supply must not be interrupted.

Don't store vaccines in the door of the refrigerator or freezer because of varying temperatures from opening and closing the door. Food should never be stored in the same refrigerator with vaccines.

"When food is stored in the same refrigerator as vaccines, that usually means the door is opened more frequently and the temperature can vary," Mason said. "Often when food is stored in the same refrigerator, the vaccines are pushed to the more undesirable places in the refrigerator like the refrigerator door."

Mason also mentioned that storing food with vaccines lowers the image of vaccines and their importance.

Rule #2

Ensuring the vaccine is kept cold is the second rule for vaccine storage and handling. The vaccines should be refrigerated immediately after arriving in the office - except for OPV and varicella which should be put into the freezer.

Vaccines that require refrigeration - and cannot be frozen - include diphtheria-tetanus-pertussis (DTP) and diphtheria-tetanus-acellular pertussis (DTaP), DTP/Haemophilus influenzae type b (Hib), inactivated poliovirus vaccine, hepatitis B, hepatitis A, pneumococcal and influenza. Measles-mumps-rubella (MMR) vaccine remains viable if frozen, but is normally kept in the refrigerator.

Rule #3

MMR should be kept cold and away from bright light after reconstitution. In addition, only the diluent supplied with each dose should be used when reconstituting MMR vaccine; old or left-over diluent should not be used. The vaccine should be discarded if not used within eight hours after reconstitution.

Rule #4

OPV is kept in the freezer. It can be thawed and refrozen up to 10 times. However, if the cumulative duration of thaw exceeds 24 hours, the vaccine must be used within 30 days and must be stored in the refrigerator rather than the freezer. If the temperature exceeds 46° F, the vaccine cannot be used.

The normal color of OPV is pink but can sometimes appear yellow; the color of the vaccine has no effect on efficacy of vaccine. Because OPV contains sorbitol, it may also appear slushy even if not stored at freezing temperatures. This also has no effect on efficacy.

Rule #5

Varicella vaccine must be kept frozen (5° F or colder) and away from light. Only the diluent provided with each dose should be used for reconstitution, and varicella should be administered immediately after reconstitution. If not used within 30 minutes the reconstituted vaccine must be discarded.

Rule #6

Rotation of vaccine stock should be done frequently to prevent expiration. Someone in the office or clinic should always be aware of all vaccine lot numbers and equate them to different expiration dates and ensure those with the shortest shelf life be used first.

"This usually means that all new vaccine shipments should automatically - but not always - be rotated to the back and the back inventory be brought forward." Mason said. "Considering the cost of vaccines, there is no excuse for vaccines expiring whether it be in the private or public sector."

The expiration dates should be checked monthly at a minimum. Ordering of supplies should be sensible to prevent over-ordering which could result in wasted stock - and wasted money.

"Other than expiring vaccines, the worst excuse an immunization program/clinic can have is to run out of vaccine because it did not have good inventory management. Every clinic should evaluate the threshold at which it should reorder vaccine," he said.

The peak times for vaccine administration are around the start of school: August, September and October.

The Vaccines for Children (VFC) program for the first time has allowed for the provision of public-purchased vaccine to private providers in every state. Before the VFC program began, 12 states routinely supplied vaccine to private doctors. VFC has allowed for the expansion of that service nationwide.

"Now more than ever before, we are able to keep children in a medical home for the completion of their vaccination series as well as comprehensive health care instead of fragmenting their health care by providing the well-child visits in the office of their primary care provider but referring children to the health department for their vaccinations," Mason explained.

However, the expansion brings new responsibility and recognition. These vaccines are expensive and return privilege for public purchased vaccine is not offered. Therefore, it is incumbent on the physicians' office to properly handle the inventory, and keep in mind the cost of vaccine and ensure the vaccine is not wasted through expiration or carelessness.

For your information:

Michigan Department of Community Health. Vaccine storage and handling. Immunization Update 1998;2:18-19.

CDC. Vaccine management recommendations for handling and storage of selected biologics. May 1996.

CDC. Guidelines for vaccine storage and handling. February 1998.

Vaccine	Arrival condition	Storage requirements	Special instructions
Vaccine Storage and Handling Requirements
DTP, DTaP, DT, Td, DTP/Hib, Hib, IPV, Hepatitis A & B, Influenza, and Pneumococcal	Packed with refrigerant. Vaccine should NOT have been frozen.*	Refrigerate immediately upon arrival at 36°F to 46°F (2 to 8 C). Do not freeze.
Measles, mumps and/or rubella (MMR)	Packed with refrigerant. During shipment vaccine must be maintained at 50°F (10°C) or less. May be frozen.*	Vaccine: Refrigerate or freeze immediately upon arrival at 36°F to 46°F (2°C to 8°C) or less. Diluent: Store separately at room temperature or in the refrigerator. Protect vaccine from light at all times.	Use only the diluent supplied to reconstitute the vaccine.
Oral poliovirus vaccine (OPV)	Packed with dry ice. Vaccine should be frozen.*	Maintain continuously in the frozen state (below 32°F or 0°C). Ice cubes that remain frozen continuously when stored in the same freezer compartment will confirm that the temperature is appropriate for storage of OPV. However, since the vaccine contains sorbitol, it may remain fluid at temperatures above 7°F (-14°C).	Color change: OPV contains phenol red as a pH indicator. The usual color of the vaccine is pink; however, some containers of vaccine shipped or stored in dry ice may look yellow. The color of the vaccine prior to use (red-pink-yellow) has no effect on the efficacy of the vaccine.
Varicella	Packed with dry ice. During shipment vaccine must be maintained at -4°F (-20°C) or colder. There must be evidence of dry ice in the package.*	Vaccine: Maintain continuously in the frozen state at an average temperature of 5°F (-15°C) or colder. Diluent: Store separately at room temperature or in the refrigerator. Protect from light before reconstitution.	Use only the diluent supplied to reconstitute the vaccine.
* If you have any questions about the condition of the vaccine at the time of delivery, you should immediately place the vaccine in recommended storage and notify the manufacturer. Please note: These recommendations are not a substitute for the package insert included with each biologic. Source: Michigan Department of Community Health

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