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Massachusetts Department of Public HealthTraining Module

Vaccine Management, Storage, and Handling

Presented by:

Bob Morrison

Vaccine Manager

Massachusetts Department of Public Health

November 16, 2010

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Learning Objectives

Summarize principles of vaccine management

Describe current vaccine storage and handling recommendations

Describe preventative measures to maintain refrigerator and freezer temperatures

List steps to protect vaccine in the event of a power outage or emergency

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Vaccine Management

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Importance of Vaccine Protection

Vaccines are fragile-keep at recommended temperatures at all times to maintain potency

Mishandled vaccines increase the risk that recipients will not be protected

Vaccines are expensive Vaccine Restitution Policy, effective 1/1/11

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Vaccine Management Guidelines

Develop and maintain detailed written protocols and emergency planSee www.mass.gov/dph/imm for sample templates

Assign responsibilities to one person Designate a back-up person Provide staff training on vaccine management Obtain proper equipment and materials

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Order vaccine and oversee inventory Receive vaccine and refrigerate/freeze

immediately Provide proper storage and handling Handle damaged, wasted and expired vaccine Respond when vaccine is out of required

temperature rangeContact MDPH Vaccine Unit to determine if vaccine

has been damaged (617-983-6828)

LA DPH

Vaccine Manager Responsibilities

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Vaccine Inventory Management

Limit access to authorized personnel Order vaccines regularly, do not stockpile Organize vaccine with shortest shelf life

in front Conduct and log vaccine inventory

monthly Rotate vaccines and monitor expiration

dates

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Vaccine Inventory Management

Separate by lot numbers and formulations Keep vaccines in original packaging to protect

from light Never use expired vaccine or diluent Report vaccine usage if required Return unused, expired vaccine and diluent if

required

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Receiving Vaccine

Examine shipment immediately upon arrival Report problems to MDPH within two hours Check contents against packing slip Check vaccine expiration dates Examine contents for damage Check temperature monitor Immediately place in appropriate storage Keep a shipping box on hand to use when

returning any damaged or expired vaccine

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CDC

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3 Components of the Cold Chain

Proper transport and storage equipment

Trained personnel Current vaccine management

policies and procedures

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Maintain the Cold Chain

Transport vaccine from refrigerator to clinic site in cooler with cold packs (not frozen packs) and thermometer

Refrigerate cold packs for at least 24 hours before use in transport

Keep vaccine on cold packs, but provide a barrier to protect from direct contact with cold pack

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Vaccinator Responsibilities at Station

Maintain the cold chain at vaccinator station Injectable vaccine: max 30 minutes at room

temperature Intranasal vaccine: kept at 2 - 8° C (35 - 46°F)

Any vaccine drawn up must be used by end of clinic or be disposed of

Protect from exposure to light Label opened unused vials with date and your

initials

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Vaccine Storage and Handling

CDC

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General Vaccine Storage Requirements

Have unit large enough to store your maximum vaccine inventory

Dedicate unit to vaccines/medications only Monitor refrigerator/freezer temps for at least 3

days prior to storing vaccine Maintain required temperature range year-

round Make arrangements for vaccine storage,

monitoring temperatures and receipt of vaccine during vacations or other lengthy absences

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Vaccine Storage Units CDC recommends separate refrigerator and

freezer units for vaccine storage For combination units, make sure there are

separate doors and controls for refrigerator and freezer

It is recommended that units used to store vaccines be less than 10 years old

Have a certified calibrated thermometer inside both the refrigerator and freezer in a central area

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Maintain Proper Temperatures

HANDLE WITH CARE!

Maintain refrigerator temps between

2°-8°C or 35°-46°F

Maintain freezertemps at

-15 °C or 5°F or colderProtect from light

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Vaccine Storage & Handling Tips

Do not store vaccine on unit doors Do not store biologics with food or drink Place thermometer and vaccine in central area of the unit Organize and label vaccine in baskets that allow air circulation Refer to package insert for specific guidelines

regarding the storage and handling of different formulations

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Acceptable Vaccine Storage

CDC

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Unacceptable Vaccine Storage

CDC

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Unacceptable Vaccine Storage

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Certified Calibrated Thermometers

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Monitor Temperatures

Record temperatures twice daily First thing in the morning End of the work day Temperature logs must be retained for at

least 3 years Monitor for out-of-range temperatures

Place temperature logs on front of unit Submit temperature logs as required

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Out of Range Temperatures

All out of range temperatures require immediate reporting to MDPH Vaccine Unit617-983-6828 or

617-983-6800 (24 x 7)

1-888-658-2850 Actions and results of these actions must be

documented on the temperature logs

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Emergency Plan for loss of power

Develop an emergency plan Share the emergency plan Post the emergency planUpdate and practice your plan

annually

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Power Failure

If you lose power for extended period, follow your emergency plan:

pack vaccine transport to prearranged site notify MDPH Vaccine Unit

When power returns: do not adjust the temperature control in unit allow unit to return to proper temperature range return vaccine to unit

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Temperature Adjustment

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Temperature Adjustment

Never adjust the refrigerator temperature control with vaccine in unit

Consult with MDPH Vaccine Unit Remove vaccine to another refrigerator/freezer Adjust temperature of unit Wait until you have 3 successive readings one

hour apart within range before returning vaccine to the unit

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Safeguard Power Supply

Use a plug guard or safety-lock plugPlace “Do Not Unplug” sign on

storage unit, outlet and “Do Not Disconnect” on circuit breakers

Consider installing a temperature alarm

Do not use extension cords

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Safeguard Power Supply

CA DPH

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Safeguard Power Supply

CA DPH

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The Effect of “Thermotrauma” on Vaccines

Live vaccine: Tolerates freezing (Call MDPH Vaccine

Management Unit if this occurs: 617-983-6828)

Deteriorates rapidly after removal from refrigeration

Inactivated vaccine: Damaged by freezing Tolerates short time out of refrigeration

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Vaccine Shelf Life Multi-dose vials of vaccine contain a bacteriostatic agent.

After opening, can be used until the date of expiration as specified by the manufacturer and package insert, unless visibly contaminated.

Date and initial multi-dose vials after opening and use first. In the event the refrigerator/freezer temperatures are out-of-

range, this is important in determining the viability of the remaining doses in the vial.

Always check the package insert for shelf life guidelines when opening multi-dose vials.

Single-dose vials do not contain a bacteriostatic agent. Once opened, they must either be used or discarded at the end

of the day.

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Storing Diluents

Diluents packaged separately from their corresponding vaccines can be stored at room temperature or in the refrigerator.

Diluents packaged with their vaccines should be stored in the refrigerator.

Once vaccines are reconstituted with a diluent, their shelf life is limited.

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Take-Home Messages

Colder is NOT better for inactivated vaccines It is estimated that >$100 million worth of

vaccine is exposed to freezing temperatures each year in the United States

Out of range temperature readings require IMMEDIATE action

Remove expired vaccine from refrigerator Report vaccine usage to MDPH Vaccine Unit:

617-983-6828

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Vaccine Storage & Handling Questions

MDPH Vaccine Management Unit (617) 983-6828

MDPH Immunization/Epidemiology Division(888) 658-2850 (617) 983-6800 (24x7)

Always consult with MDPH Immunization Program before removing improperly stored vaccine from the storage unit If the temperature of the vaccine goes out of

range, either too high or too low, call the MDPH Vaccine Management Unit immediately!

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Please take a look at the other training modules!

Vaccine and Medication Preparation and Administration

Planning a Clinic/EDS/POD All-Staff Briefing & Just-In-Time Training

Available at: http://sph.bu.edu/otlt/alliance/training_publichealthnursing.php

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Online Resources MDPH Guidelines for Compliance with Federal and State

Vaccine Administration Requirements http://www.mass.gov/Eeohhs2/docs/dph/cdc/immunization/guidelines_vaccine_compliance.pdf

MDPH General Protocols for Vaccine Storage, Administration, Standing Orders, and Mass Immunization Clinics, Sept 2009 http://www.mass.gov/Eeohhs2/docs/dph/cdc/immunization/mso_protocols_general.pdf

MMWR: General Recommendations on Immunization, Recommendations of the Advisory Committee on Immunization Practices (ACIP), December 2006

http://www.cdc.gov/mmwr/pdf/rr/rr5515.pdf MDPH Vaccine Management Guidelines for Vaccine Provider

http://www.mass.gov/Eeohhs2/docs/dph/cdc/immunization/vaccine_management_checklist.pdf

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Online Resources

MDPH Immunization Program http://www.mass.gov/dph/imm

Immunization Action Coalition www.immunize.org

Epidemiology and Prevention of Vaccine-Preventable Diseases, The Pink Book: Course Textbook (11th Edition), May2009 http://www.cdc.gov/vaccines/pubs/pinkbook/default.htm#download

World Health Organization http://www.who.int/en

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Online Resources

MDPH Sample Vaccine Management-Standards Operating Procedures (SOP) http://www.mass.gov/Eeohhs2/docs/dph/cdc/immunization/vaccine_management_sop_sample.pdf

Emergency Response Worksheet for vaccine storage http://immunize.org/catg.d/p3051.pdf

Pediatrics “Standards for Child and Adolescent Immunization Practices” National Vaccine Advisory Committee, Pediatrics 2003: 112: 958-963 http://www.pediatrics.org/cgi/content/full/112/4/958

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Online Resources CDC: Vaccine Storage and Handling Toolkit http://www2a.cdc.gov/vaccines/ed/shtoolkit/default.htm CDC: Vaccine Management Business Improvement Project

(VMBIP); New Centralized Vaccine Ordering and Storage Requirements

http://www.cdc.gov/vaccines/programs/vmbip/default.htm MDPH: Vaccine Management Business Improvement Plan: Basic

Guidelines http://mass.gov/EOHHS2/docs/dph/cdc/immunization/vmbip_basic_gu idelines.pdf

Los Angeles County Immunization Program, Vaccine Storage and Handling presentation http://www.lapublichealth.org/ip/trainconf/Vaccine%20Storage%20Handling.pdf

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QUESTIONS?

Thank You !