Proper vaccine storage in ltc LTC Advisory Meeting May 7, 2019 Gregory Gahm, MD

Resources for presentation CDC Vaccine Storage and Handling Document / Toolkit Provides information, recommendations, and resources to assist in proper storage and handling of vaccine supplies Brings together best practices from the Advisory Committee on Immunization Practices (ACIP) General Best Practice Guidelines for Immunization, product information from vaccine manufacturers, and results of scientific studies

Problems with improper storage Vaccines exposed to storage temperatures outside the recommended ranges may have reduced potency, creating limited protection and resulting in the revaccination of patients and enormous expenses for wasted vaccine Must be maintained at a proper, cold temperature from manufacture through delivery / administration to the patient Frozen / thawed vaccines typically have NO potency

Staff and training Should include: Facilities should have clear, detailed policies about storage and handling Should include: Guidance for emergencies such as equipment or power failures Contact information for vaccine manufacturer or distributor Contact information for equipment service providers Identify which staff are responsible for vaccine management Steps to take if / when equipment fails or the power goes out Keep easily understood guidelines in an obvious place near vaccine Document which staff have been trained / when

Staff and training Designate primary and secondary vaccine coordinators to oversee: Ordering Receipt / Handling of deliveries Setting up temperature monitoring devices and tracking Regular (weekly) review of temperature logs Rotating stock to use oldest vaccine first Removing expired or damaged vaccine (eg, frozen, overheated) Staff training

Storage and Temperature Monitoring Purpose-built or pharmaceutical grade units are more expensive, but have chip-based temperature controls and fans that better insure uniform temperatures throughout the unit Amazon: 4.3 Cu Ft: $709; 10 Cu Ft: $1000 - $1700 Glycol Thermometer with Alarm: $40 Household-grade units are acceptable, but the freezer compartments are not recommended for storing frozen vaccines and areas of the rest of the unit may be unevenly cooled Separate freezers should be used if you have frozen vaccine Do not store vaccine near the freezer portion of dorm refrigerators or in vegetable / fruit drawers or in door shelves of larger refrigerators (decreased air flow)

Storage and Temperature Monitoring Before using a new unit, check temperature logs twice daily for 2-7 days to assure compliance (preferably with a digital thermometer) Refrigerators should maintain temperatures from 36o – 46o F Freezers should maintain temperatures from –58o to 5o F Each vaccine storage unit must have a Temperature Monitoring Device CDC recommends a “digital data logger (DDL)” [Amazon: $150] Includes data on when it is operating outside the recommended temperature range (“excursions”) Should have an alarm for out-of-range temps and a low-battery indicator Require current / valid Certificates of Calibration Testing See Guidelines for DDL Certification details

Temperature Monitoring Devices (TMDs) TMDs NOT recommended by the CDC: Alcohol or mercury thermometers Bimetal stem Those used for food Infrared

Protecting the power supply Plug in only 1 storage unit per electrical outlet Use a safety-lock plug or outlet cover to prevent the unit from accidentally being unplugged Post ”DO NOT UPLUG” Warning Signs Label fuses and circuit breakers with alerts not to shut off Don’t use outlets operated by wall switches Don’t use in a multioutlet power strip

Organizing and storing vaccine Store in original packaging (avoid excess light) Check / record minimum and maximum temps each day Note actions taken if a temperature excursion occurred Avoid storing anything but vaccine, diluent and water bottles in these storage units Leave space between vaccines to allow for air circulation

Organizing and storing vaccine Store water bottles above, below and in the door of large refrigeration units to help maintain stable temperatures (unless contraindicated by the unit’s manufacturer)

temperature excursions Immediately involve the facility’s vaccine coordinator Place exposed vaccines in a separate container marked “DO NOT USE”, but do not discard Document: Date, time and room temperature during event How long the vaccine may have been affected General description of event Problems with storage unit

temperature excursions Adjust temp to appropriate range Make sure TMD is placed in center of vaccines Contact manufacturer or distributor with information to determine if vaccine can be used Document information received and who provided it

Routine maintenance Check seals and door hinges Clean coils and defrost freezer units regularly Keep unit interior clean to prevent microorganism growth Adjust temps seasonally depending on room temp

Vaccine management Schedule deliveries so they aren’t accidentally left sitting out Unpack units immediately before storing, ie, don’t store in the shipping box with cool packs that can affect vaccine temps once placed in a refrigeration unit Look for damage to shipment Make sure you don’t receive expired vaccine Track all doses used Immediately remove expired dosages to avoid using them

Vaccine preparation Only prepare vaccine when it is ready for immediate use Double-check expiration dates and type of vaccine For vaccines that are lyophilized (freeze-dried) and need to be mixed with a liquid (diluent), always recheck the package insert to confirm volume of diluent to use If a reconstituted vaccine is not used within 30 minutes, check manufacturer’s guidelines to determine how long it may be stored at what temperature before it must be discarded

Vaccine transport Do not transport vaccines from one facility to another without appropriate coolant use that maintains a constant temperature in the appropriate range

Emergency Vaccine storage Know in advance where to move vaccine if the power or refrigeration unit fails and post this information where it can easily be found in an emergency Document the time to transport and follow transport guidelines During a power outage to a facility, make sure the vaccine storage areas are covered by the emergency generator and that there is someone who knows to check them quickly if the generator fails

Closing comments The CDC Guideline contains several pages of checklists and documents that may be useful at the end of the document It also contains some sample warning labels that can be used When vaccinating, take only a few vaccines at a time from the refrigerator and use them quickly. Do not leave vaccines out for more than a few minutes (5-10?) before using to avoid having them warm to room temperature and lose potency