National Vaccine Storage and Handling Guidelines for Immunization Providers (2007)

Section 8 Vaccine Management

Contents

8.1 Vaccine Management
8.2 Expiration Dates
8.3 Inventory Management

8.1 Vaccine Management

Limit access to the vaccine supply to authorized personnel only. This will help protect the vaccine supply by avoiding inappropriate removal of vaccine or inappropriate handling of vaccine and vaccine storage units by untrained personnel.

8.2 Expiration Dates

Interpreting Expiration Dates

All vaccines and diluents have expiration dates. The expiration date is the date by which the vaccine or diluent should be used. This date is labeled on all vaccine and diluent containers (e.g. vials, syringes, ampoules) and their package boxes.

Expiration dates vary by the type of vaccine or diluent, and by the lot number. The vaccine or diluent may be used up to and including this date. When the expiration date is marked with only a month and year, the vaccine or diluent may be used up to and including the last day of the month indicated on the vial.

What to Do with Expired and Mishandled Vaccine or Diluent

Expired vaccine and diluent, even if they are only one day past the expiration date, should never be administered. Likewise, vaccines that have been mishandled should not be administered. If expired vaccine is inadvertently given, contact your local public health office or immunization program* for advice. Record the lot number and expiry date of the immunizing agent. Promptly remove expired or mishandled vaccine and diluent from the refrigerator or freezer and place in a container marked “DO NOT USE.” Return it or dispose of it according to public health guidelines or policies. Consult your local public health office or immunization program* for specific policies regarding the disposition of mishandled or expired vaccine.

Expired vaccine and diluent, even if they are only one day past the expiration date, should never be administered.

Exceptions to the Expiration Date

The expiration date labeling each vial or box is valid only if proper storage and handling conditions are observed at all times. If vaccine has been inappropriately exposed to excessive heat, cold, or light, its potency may be reduced before the expiration date is reached.

The only way to determine if proper transport and storage conditions have been maintained is to monitor vaccine and diluent temperatures during every link in the cold chain and to safeguard light sensitive vaccines from exposure to light. The manufacturer-labeled expiration date may also be invalidated after the vial is opened or reconstituted. (See “Expiration of multidose, single dose, and select vaccine products” later in this section for details.)

Transferring Vaccine or Diluent that Cannot Be Used Before Expiration

If you determine that a product cannot be used prior to expiry date, contact your local public health office or immunization program* for guidance. You may be able to transfer the product under appropriate cold chain conditions to another facility where it can be used before it expires.

Expiration of Multidose, Single Dose, and Select Vaccine Products

Some multidose premixed vaccine vials contain bacteriostatic agents that prevent the growth of bacteria. Once punctured, multidose vials should be marked with the date of puncture, maintained under appropriate storage conditions, and should be used within the timeframe specified by the manufacturer.

Single-dose vials are meant for one-time use only. To avoid needless waste of vaccine, always check the vial or syringe before removing the cap to make sure you have the correct vaccine type, and remove the cap only when you are ready to draw up and administer the vaccine. Single-dose vials without their protective caps should be discarded at the end of the clinic day even if there is residual volume.

Following reconstitution of vaccines, consult the package insert for the most up-to-date information about expiration times and dates. Unused reconstituted vaccines kept beyond recommended limits should not be administered. The best way to avoid such waste is to reconstitute and draw up vaccines immediately before administration.

Once punctured, multidose vials should be marked with the date of puncture and should be used within the timeframe specified by the manufacturer.

8.3 Inventory Management

General Recommendations

Inventory management is important for vaccine quality management. Proper inventory management means knowing the following:

• Quantities of vaccines and diluents that have been received
• Quantities of vaccines and diluents that have been administered, wasted, or spoiled
• Vaccines and diluents, and the quantities that are currently in stock and are available for administration
• Vaccines and diluents, and the quantities that are currently in quarantine awaiting follow-up directions
• Vaccine and diluent vials that should be used first
• Vaccine and diluent vials that are expired and that must not be administered
• Vaccines and diluents that need to be ordered

The vaccine coordinator should arrange the vaccine and diluent supplies according to the expiration dates on a weekly basis and each time a vaccine shipment arrives. The vials and boxes with the earliest expiration dates should be placed in front of other vials and boxes of the same type with later expiration dates. This practice avoids waste by ensuring that short-dated vaccine and diluent are easily accessible and will be used first, thereby limiting the amount of unused vaccine that has passed its expiration date.

The vaccine coordinator should arrange the vaccine and diluent supplies according to the expiration dates on a weekly basis and each time a vaccine shipment arrives.

Vaccine Inventory Calculations and Vaccine Ordering

In general, there are three main principles to keep in mind when calculating the amount of vaccine supplies needed and when placing vaccine orders.

• Order and stock enough vaccine to ensure that there is an adequate supply to meet the needs of the population served. An adequate supply for most practices would normally be enough vaccine to last 30 days. Consult your local public health office or immunization program* for recommendations on different supply levels, depending on local use.
• Do not over order vaccines. This practice leads to vaccine waste if unused vaccine expires. It also results in unnecessarily large volumes of vaccine being stored, which increases the risk of losing a large quantity of vaccine should there be a cold chain break.
• Alert office staff that an order has been placed. The designated vaccine coordinator should be notified immediately upon arrival of a vaccine shipment so that the vaccine is stored under appropriate conditions and the cold chain is maintained. (See Receiving and Unpacking Vaccine Shipments in Section 9—Vaccine Shipments for more details.) Vaccine shipments must also be documented in the appropriate inventory record.

Use the Monthly Vaccine Inventory and Refrigerator and Thermometer Maintenance in the Resources Section.

The three main principles to keep in mind when calculating the amount of vaccine supplies needed and when placing vaccine orders are: Order and stock enough vaccine to ensure that there is adequate supply to meet the needs of the population served Do not over order vaccines Alert office staff that an order has been placed.

Inventory Records

Maintaining complete and accurate inventory records is a critical component of inventory management to prevent over- or under-stocking of supplies and disruption to the immunization program. This also contributes to planning for seasonal fluctuations in inventory, such as during an influenza program or school-based program. The balance of doses remaining in stock as indicated on the inventory records should be updated weekly, using a tally of doses administered, wasted, spoiled, or expired that week.

Quantities of vaccine and corresponding diluent must be equal at all times.

Each inventory record should contain the following:

• Date each shipment arrived at the facility
  
  
• Initials of the person who unpacked and checked the shipment upon arrival (This person should also record the shipment on the inventory record.)
  
  
• Condition of the shipment upon arrival (i.e. Did the vaccine arrive in good condition at the proper temperature or was there a reason to question its integrity?)
  
  
• For each vaccine and diluent:
  
  • Manufacturer and lot number
  • Quantity of units received per lot number (or the balance of doses carried forward)
  • Expiration date for each lot (including the new expiration dates for punctured multi-dose vials and times for vaccines that have been reconstituted)
  • Type of container (i.e. single-dose vial, multidose vial, or manufacturer-filled syringe)
  • Number of doses used (i.e. administered, wasted, spoiled, or expired)
  • Balance remaining (in doses) after subtracting the amount used (i.e. administered, wasted, spoiled or expired)

If you receive multiple vials of the same vaccine in the same type of container (i.e. single-dose vial, multidose vial, or manufacturer-filled syringe) from the same lot with the same expiration date, these doses may be recorded as one entry on the inventory record. Simply indicate the total number of doses of that particular vaccine (regardless of the number of vials or syringes those doses came in).

Use the Monthly Vaccine Inventory and Refrigerator and Thermometer Maintenance sheet that can be found in the Resources Section. It shows the components that you may include on your own inventory record.

Maintaining complete and accurate inventory records is a critical component of inventory management to prevent over- or under-stocking of supplies and disruption to the immunization program.

Tally Sheets

A running tally sheet must be used to record vaccine doses and diluent that were removed from or returned to the vaccine storage unit. These include doses that were administered, wasted, spoiled, or expired. Each time a dose of vaccine is removed or returned, it should be marked on a tally sheet that is placed on the outside of the storage unit door or in some other convenient location. Tick marks can be used to record doses that have been removed from the storage unit. Alternatively, the initials of the person removing the dose may be used.

The tally sheet(s) can be used to keep inventory records updated. For example, place a tally sheet on the storage unit door and record the doses removed from the unit during the week. At the end of the week, the vaccine coordinator or a designated person should add up the number of doses of each vaccine used and update the inventory records accordingly to determine the new inventory balance at the end of the week. Store used tally sheets in a file for future reference for the length of time determined by your jurisdiction.

Use the Vaccine Tally Sheet in the Resources Section. It shows the components that you may include on your own tally sheet.

A running tally sheet must be used to record vaccine doses and diluent that were removed from or returned to the vaccine storage unit. The tally sheet(s) can be used to keep inventory records updated.

Recording New Shipments

See Receiving and Unpacking Vaccine Shipments in Section 9—Vaccine Shipments for details.

Recording Administered, Wasted, Spoiled and Expired Doses

Consult pertinent local policy for vaccine inventory management requirements for recording and reporting of vaccine use or reasons for not using the vaccine. Maintaining a tally sheet where each dose of vaccine is accounted for will help with inventory management.

Counting Inventory

An actual count of the number of doses of vaccine and diluent in inventory is an important component of inventory management and is the responsibility of the designated vaccine coordinator.

• At the end of every month, make a summary of the amount of each vaccine and diluent used during that month and the amount of inventory still available at the end of that month. This information is useful in determining how much vaccine to order and can be used to monitor the seasonality of vaccine use.
• At the end of every year, total the amount of each vaccine and diluent received and the amount used. This information is useful for determining the annual vaccine needs of the practice.

*Including local, regional, provincial, territorial, or federal health departments, or other jurisdictional immunization programs.