Canadian Immunization Guide
Seventh Edition - 2006

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Part 1
General Guidelines

Storage and Handling of Immunizing Agents

Immunizing agents are biologic materials that are subject to gradual loss of potency from deterioration and denaturation. Loss of potency can be accelerated under certain conditions of transport, storage and handling, and may result in failure to stimulate an adequate immunologic response, leading to lower levels of protection against disease. Conditions that result in loss of potency vary among products.

The province or territory should follow Public Health Agency of Canada guidelines to ensure that the manufacturer monitors the cold chain during the shipment of vaccine. Also, the province or territory should have a standard for monitoring shipments to regions, public health units and private offices. Manufacturer and NACI recommendations generally specify that most products should be stored at temperatures from +2º to +8º C. Exceptions exist (e.g., yellow fever) for which the recommended storage conditions are -30º to +5º C, as outlined in the manufacturer's product leaflets.

The term "cold chain" as used in this statement refers to all equipment and procedures used to ensure that vaccines are protected from inappropriate temperatures and light, from the time of transport from the manufacturer to the time of administration.

The effects of exposure to adverse environmental conditions, such as freezing, heat and light, are cumulative. Data are available to indicate that certain products remain stable at temperatures outside of +2º to +8º C for specified periods of time, but mechanisms rarely exist for monitoring the effect of cumulative exposures. Additionally, different products are often transported and stored in the same container. Therefore, it is recommended that all biologics for immunization be maintained at +2º to +8º C at all times, unless otherwise specified in the product leaflet. Management of products that have been exposed to adverse conditions should be guided by specific instructions pertaining to the conditions from the vaccine supplier.

Monitoring of the vaccine cold chain is required to ensure that biologics are being stored and transported at recommended temperatures. Testing of product potency or seroconversion rates as indicators of cold chain integrity are rarely feasible.

Refer to the product leaflet of each immunizing agent for specific instructions related to storage and handling. The following general principles apply.

Multidose vials

Multidose vials should be removed from the refrigerator only to draw up the dose required and should be replaced immediately. Although the practice of drawing vaccines and leaving them in the refrigerator in advance of administration is strongly discouraged (see the Vaccine Administration Practices chapter), two exceptions are noted:

• Pre-loading of syringes in the hospital setting where vaccines are drawn up and labeled in the pharmacy. Strict adherence to cold chain procedure for transport of the vaccine to the ward and patient bedside is required.
• Pre-loading of syringes in an immunization clinic setting. This may be considered in order to facilitate the flow of the clinic. Proper labeling and adherence to cold chain is required

Vaccine providers should observe strict aseptic technique when using multidose vials. Multidose vials should be dated once entered and used only for the period of time specified in the manufacturer's product leaflet. If no directions are given the vaccine should not be used beyond 30 days after initial entry into the vial.

Lyophilized (freeze-dried) vaccines

For optimal potency, freeze-dried vaccines (e.g., measles, mumps rubella [MMR], varicella, Bacille Calmette-Guérin [BCG], Haemophilus influenzae type b) should be reconstituted immediately before use with the diluent provided for that purpose. Reconstituted vaccines, including yellow fever vaccine, should be used within 1 hour of reconstitution; if unused, they should be discarded. There are slight variations in the time intervals recommended by specific manufacturers, and users should refer to the product leaflet to guide timing of reconstitution.

Light exposure

MMR, varicella and BCG vaccines should be protected from light at all times by storage of the vials in the cartons provided. After reconstitution, if vaccines are not used immediately, they must be kept at +2º to +8º C, protected from light and used within the time frame recommended in the product leaflet.

Freezing

Vaccine providers are reminded that the maintenance of cold chain also requires that vaccines not be exposed to temperatures lower than those recommended. Liquid inactivated and adsorbed vaccines should not be used if they have been frozen. These include Tdap, DTaP, DT, DTaP-Polio, DT-Polio, Td, Td-Polio, hepatitis A and B vaccines, influenza, pneumococcal and meningococcal vaccines. Before use, liquid vaccines should be inspected and should not be used if the usual appearance is altered or a temperature recording device shows that the vaccine was exposed to temperatures below zero.

Expiry

Vaccines should not be used beyond their expiry date. For expiry dates specified as month/year, products are deemed to expire on the last day of the specified month. The error of administration of expired vaccine should be reported to the local public health authority.

Disposal of spoiled or expired vaccines

All vaccines that cannot be used because of expiry or adverse environmental exposure should be returned to the source for appropriate recording of returns and disposal or should be appropriately disposed of according to local or regional standards.

Refrigerators

The temperature in frost-free refrigerators may cycle widely and should be monitored to ensure that cycling is within the acceptable range. Special maximum-minimum thermometers are commercially available for purchase and are useful for most office storage. Vaccine providers should record daily current maximum and minimum refrigerator temperatures and contact the local public health unit if vaccines are exposed to temperatures outside the recommended range. More expensive, constant chart-recording thermometers with alarms are appropriate for larger vaccine storage depots. Non- frost-free refrigerators should be defrosted regularly and immunizing agents stored in a functioning refrigerator during the defrosting process. Refrigerators older than 10 years are more likely to malfunction and to have breaks in the seal around the door, leading to temperature instability. Half-size/under the counter/bar refrigerators are less reliable than full-size kitchen refrigerators. Vaccine providers in private practice will discover that the cost of replacing ageing bar refrigerators with newer and full-size equipment is offset by the savings in hydroelectric power and staff time dealing with reporting and fixing cold chain breaks.

Placement of full, plastic water bottles in the lower compartment and door shelves of the refrigerator and ice packs in the freezer compartment will help stabilize temperatures, especially in the event of a power failure.

Recommended office procedures

The following office procedures should be implemented to ensure that storage of vaccines is optimized:

• Designate and train a specific staff person to be responsible for managing vaccines.
• Post storage and handling guidelines on the refrigerator.
• Use insulated storage containers with ice packs for transport of vaccines; to avoid freezing, do not place vaccine packages in direct contact with ice packs. Practitioners transporting vaccines out of the office (e.g., to housebound seniors) should observe these cold chain precautions as well.
• When transporting vaccines, keep a log of pre- and post-transport vaccine temperatures and the specific batches transported.
• Place newly delivered vaccines into the refrigerator immediately upon delivery to the office.
• Store vaccines in the middle of the refrigerator to avoid the coldest and warmest parts of the refrigerator; do not store vaccines on the door shelves.
• Place a maximum-minimum thermometer on the middle shelf of the fridge.
• Read, record and re-set the thermometer at least once daily.
• Secure the electrical cord from the fridge to the wall outlet to prevent accidental power interruptions.
• Ensure that the fridge door does not accidentally swing open by installing a fail-safe (e.g., Velcro™) closing mechanism.
• Do not store food or biologic specimens in the same fridge as vaccines.
• Rotate stock so that vaccines with the earliest expiry date are at the front of the shelf. Place expired vaccine into a marked box in the refrigerator for appropriate disposal, based on consultation with local public health authorities.
• Vaccine should only be removed from the refrigerator immediately prior to administration.
• If refrigerator malfunction is suspected on the basis of temperature readings, obtain servicing immediately and store the vaccine in an alternative refrigerator in the meantime.
• In the event of an identified cold chain break, seek advice from your local public health authority about whether the vaccine(s) may continue to be used; while awaiting advice, keep the vaccines stored in appropriate cold chain conditions and ensure that they are not administered until a determination has been made by the public health authority.
• When a cold chain break is identified after vaccine has been administered, consult with the local health department about management of the situation. Information required to assess the circumstances will include the name of the vaccine(s), and the duration and temperatures of exposure. People immunized with vaccines whose potency is likely to have been jeopardized may need to be tested for serologic evidence of immunity or be re-vaccinated.

Ongoing cold chain monitoring should be integrated into immunization practice. Periodic cold chain surveys are worthwhile to evaluate awareness, equipment and practices as well as the frequency of breaks in the cold chain during transport from depots and storage in peripheral offices. These should be undertaken by provincial/territorial and local immunization programs.

Selected references

Carrasco P, Herrera C, Rancruel D et al. Protecting vaccines from freezing in extremely cold environments. Canada Communicable Disease Report 1995;21(11):97-101.

Cheyne J. Vaccine delivery management. Reviews of Infectious Diseases 1989;11(S3): S617-S622.

Deasy T, Deshpande R, Jaiyeola A et al. Evaluating the cold chain in Ontario: results of a province-wide study. Public Health Epidemiological Report, Ontario 1997;8(3):44-52.

Dimayuga RC, Scheifele DW, Bell A. Survey of vaccine storage practices: Is your office refrigerator satisfactory? British Columbia Medical Journal 1996;38(2):74-7.

Gold MS, Martin L, Nayda CL et al. Electronic temperature monitoring and feedback to correct adverse vaccine storage in general practice. Medical Journal of Australia 1999;171(2):83-4.

Guthridge SL, Miller NC. Cold chain in a hot climate. Australian and New Zealand Journal of Public Health 1996;20(6):657-60.

Health Canada. Guidelines for temperature control of drug products during storage and transportation. Ottawa: Health Canada, 2005. URL: <http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0069_tc-tm_e.html>. Accessed November 17, 2005.

Health Canada. National guidelines for vaccine storage and transportation. Canada Communicable Disease Report 1995;21(11):93-7.

Jeremijenko A, Kelly H, Sibthorpe B et al. Improving vaccine storage in general practice refrigerators. British Medical Journal 1996;312(7047):1651-52.

Kendal AP, Snyder R, Garrison PJ. Validation of cold chain procedures suitable for distribution of vaccines by public health programs in the USA. Vaccine 1997;15(12-13):1459-65.

Krugman RD, Meyer BC, Enterline JC et al. Impotency of live-virus vaccines as a result of improper handling in clinical practice. Journal of Pediatrics 1974;85(4):512-14.

Lerman SJ, Gold E. Measles in children previously vaccinated against measles. Journal of the American Medical Association 1971;216(8):1311-14.

Milhomme P. Cold chain study: danger of freezing vaccines. Canada Communicable Disease Report 1993;19(5):33-8.

Steinmetz N, Furesz J, Reinhold C et al. Storage conditions of live measles, mumps and rubella virus vaccines in Montreal. Canadian Medical Association Journal 1983;128(2):162-63.

Woodyard E, Woodyard L, Alto WA. Vaccine storage in the physician's office: a community study. Journal of the American Board of Family Practice 1995;8(2):91-4.

World Health Organization. Expanded programme on immunization: stability of vaccines. Weekly Epidemiological Record 1990;65(30):233-35.

World Health Organization. Report of the Technical Review Group Meeting, 7-8 June 1998: achievements and plan of activities, July 1998-June 1999. Geneva: World Health Organization, 1998 (Technical Report Series, No. 98.02).

Yuan L, Daniels S, Naus M et al. Vaccine storage and handling: knowledge and practice in primary care physicians' offices. Canadian Family Physician 1995;41:1169-76.

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