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Helping People Live Better

Lives. 1

Dr. Maureen Tierney, MD, MSc • Director of the Healthcare Associated Infections

Program in the Epidemiology and Informatics Unit of the Nebraska Division of Public Health

Peg Gilbert, MS, RN, CIC, FAPIC • Quality IC, LLC, Owner, Safe Injections Grant

Coordinator, Nebraska DHHS

Give “Just” the Vaccine

Upon completion of the WebEx, participants will be able to:

• Relate the principles of injection safety

• Describe the process to prepare vaccines for administration

• Identify safe handling and storage of vaccines to maximize effectiveness

Objectives

How Do Vaccines Work?

• Activates innate immunity (immediate)

• Activates adaptive immunity (T and B cells)

• Process takes days to weeks

• Adjuvant increases immediate immune response • Increase enhances T and B cells

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Types of Vaccines

• Live Attenuated Vaccine

• Inactivated

• Subunit

• Conjugate

• Recombinant

Live Attenuated Vaccines

• Weakened version of microbe

• Stronger immune response

• Require refrigeration

• Risk to those with weakened immune systems

• MMR, Varicella, Zoster, Yellow fever, Smallpox

• Inhaled flu

Inactivated Vaccine

• Heat or irradiated of entire microbe

• Weaker response

• Multiple doses

• IPV, Hepatitis A, Rabies

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Inactivated Subunit

• Not the whole microbe, only the antigens with the most significant immune response

• Less adverse reactions

• Tetanus toxoid, diphtheria, pertussis

• Hepatitis B (older), Influenza

• Some recombinants-newer Hep B, HPV

Conjugate

• Some bacteria have a polysaccharide coat “disguise”

• Immature immune system of infants cannot respond

• Conjugate with the antigen an immature immune system can respond to

• HIB-Haemophilus Influenza B

• Whole Cell Pertussis

• Pneumococcus

• Meningococcus

Timing of Live Virus Vaccines

• Any vaccines can be given together

• If not together, live virus vaccines need to be separated by 4 weeks

• Killed vaccines can be given in any sequence or time interval;

• Post immunoglobulin products: • Hep A,B, Tetanus IgG 3-4 months

• Varicella, measles IgG 5-6 months

• Packed RBCs 6 months

• IVIG >8 months

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Immunocompromised and

Pregnant Hosts

• Avoid oral typhoid, MMR, Rotavirus and Varicella

• Exceptions in HIV patients • In children<5, if CD4>15% can get usual schedule

• In anyone>5, if CD4>200 can receive

• If immune reconstituted with HAART to above #s

• Follow levels

Controversies/New items

• MMR-measles and mumps outbreaks

• Meningococcal B vaccines

• Zoster vaccines to come

• Pneumococcal schedules

• Influenza vaccine • Reduced efficacy for LAIV last year

• Newer formulations

Pneumococcal Vaccine Schedules

• https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/pneumo.html

• PPSV23-Polysaccharide Vaccine-only • Over age 19 who smoke, have chronic lung or heart

disease, DM, chronic liver disease

• PCV 13-conjugate only (similar to diphtheria toxin) allows for response in those less that 2, induces mucosal immunity so reduces carriage

• Under age 2 -4 doses

• Can start as early as 2 months.

• If incompletely vaccinated , complete 24-59 months

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Pneumococcal Vaccine Schedules

• Both-Over age 2 with certain conditions (immunosuppression, CSF leak, cochlear implant, SCD, asplenia) and over age 65

• Start with PCV 13

• Follow by PPSV23

• Interval 8 weeks for the very young

• Interval 1 year for over 65

• ? revaccination every 5 yrs

• Over 65 schedules (see MMWR-www.cdc.gov/preview/mmwr/mm6337a4.htm)

Trivalent Influenza Vaccines

• Standard-dose trivalent shots (IIV3) that are manufactured using virus grown in eggs. Different flu shots are approved for different age groups. Most flu shots are given in the arm (muscle) with a needle. One trivalent vaccine formulation can be given with a jet injector, for persons aged 18 through 64 years.

• A high-dose trivalent shot, approved for people 65 and older.

• A recombinant trivalent shot that is egg-free, approved for people 18 years and older.

• A trivalent flu shot made with adjuvant (an ingredient of a vaccine that helps create a stronger immune response in the patient’s body), approved for people 65 years of age and older (new 2016 season).

Quadrivalent Influenza Vaccines

• Standard Quadrivalent flu shots

• No high dose Quadrivalent

• An intradermal quadrivalent flu shot, uses a

much smaller needle than the regular flu shot.

• It is approved for people 18 through 64 years of age

• A quadrivalent flu shot containing virus grown in

cell culture

• Approved for people 4 years of age and older (new

this season)

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2017-2018 Influenza Viruses

• an A/Michigan/45/2015 (H1N1)pdm09-like virus

• an A/Hong Kong/4801/2014 (H3N2)-like virus

• a B/Brisbane/60/2008-like (B/Victoria lineage) virus

• Four-component vaccines, which protect against a second lineage of B viruses, will add a B/Phuket/3073/2013-like (B/Yamagata lineage) virus.

• No LAIV again

• Any vaccine, except LAIV, can be given to pregnant women

Vaccine Cold Chain • The temperature-controlled

environment used to maintain and distribute vaccines in optimal condition.

• Begins with the cold storage unit at the manufacturing plant, extends through transport of vaccines to the distributor and delivery to and storage at the provider facility, and ends with administration of vaccine to the patient.

• Appropriate storage and handling conditions must be maintained at every link in the cold chain

Source: CDC

Too much exposure to heat/cold /light at any step in the cold

chain can damage vaccines, resulting in loss of potency.

Potency cannot be restored.

Each time vaccines are exposed to improper conditions,

potency is reduced further.

Eventually, vaccines will be useless resulting in

inadequate immune response in patients and poor protection

against disease.

A single exposure to freezing temperatures (0° C [32° F] or

colder) will destroy some.

Liquid vaccines that contain an aluminum adjuvant can

permanently lose potency when exposed to freezing

temperatures

Vaccine Cold Chain

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Notify vaccine coordinator or alternate coordinator when arrive

Avoid having people accept deliveries who may not understand

the importance of storage at appropriate temperatures

• Examine vaccine deliveries

• Container

• Contents

• Shipping temperature monitors/indicators

If there are concerns, label vaccines “Do NOT Use,” store under

appropriate conditions, separate from other vaccines

Consult immunization program, distributor, and/or vaccine

manufacturer for guidance

Policy on Vaccine Deliveries

Refrigerated vaccines should be stored at temperatures between 2° C

and 8° C (36° F and 46° F)*.

The thermostat should be set at midrange to achieve a temperature of

about 5° C (40° F), which will decrease the likelihood of temperature

excursions.

Vaccines stored in the freezer should maintain temperatures between -

50° C and -15° C (-58° F and +5° F).

The thermostat should be at the factory-set or midpoint temperature

setting to assure appropriate temperatures.

Vaccine Storage Temperatures

*New with 2016 Guide

All vaccines EXCEPT varicella-containing vaccines (varicella, zoster,

and MMRV) should be stored in a refrigerator between

2° C and 8° C (36° F and 46° F), with a desired target temperature of 5°

C (40° F).

Measles, mumps, and rubella (MMR) vaccine may be stored in either a

refrigerator or freezer.

Some diluents must be refrigerated, while others may be stored in the

refrigerator or at room temperature (no warmer than 25° C [77° F]).

Vaccine Storage Temperatures

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Pharmaceutical grade units and are designed specifically

for storage of biologics.

These units often have:

• Microprocessor-based temperature control with a digital temperature sensor (thermocouple, resistance temperature detector [RTD], or thermistor).

• Fan-forced air circulation, with powerful fans or multiple cool air vents inside the unit that promote uniform temperature and fast temperature recovery.

Storage Equipment

Household-grade Combination

• If a purpose-built unit is not available, use a stand-alone household unit.

• Only use the refrigerator compartment for storing vaccines.

• These units have cold spots and temperature fluctuations, and air circulating from the freezer could expose refrigerated vaccines to freezing temperatures.

• Use a separate stand-alone freezer to store frozen vaccines.

Dormitory style or Bar-style Combined Refrigerator/Freezer

• Do not store any vaccine in a unit under any circumstances.

• These units have a single exterior door and an evaporator plate/cooling coil, usually located in an icemaker/freezer compartment.

• These units have been shown to pose a significant risk of freezing vaccines, even when used for temporary storage.

• Not all small storage units are dormitory-or bar-style units. Compact purpose-built units for biologics can be used to store vaccines.

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Storage

• Large enough to store the inventory at the busiest point in the year (e.g., flu season) without crowding.

• Remove any deli, fruit, and vegetable drawers from refrigerator units.

• Provides extra space for water bottles to help maintain stable temperatures and prevents use of the drawers for storing food, beverages, or vaccines.

• Use safeguards to ensure the doors of the unit remain closed (for example, self-closing door hinges, door alarms, door locks, etc.)

Storage

• May take 2 to 7 days to stabilize the temperature in a newly installed or repaired refrigerator or 2 to 3 days for a freezer.

• Before using a unit to store vaccines, check and record temperatures a minimum of 2 times each workday for 2 to 7 days.

CDC recommends the use of a continuous monitoring and recording

digital data logger (DDL) with a current and valid Certificate of

Calibration Testing (also known as a Report of Calibration), set at a

minimum recording interval of at least every 30 minutes.

CDC recommends DDLs with the following characteristics:

• Detachable probe in a thermal buffered material (e.g., glycol, glass beads, sand, Teflon®).

• Alarm for out-of-range temperatures.

• Low-battery indicator.

• Current, minimum, and maximum temperature indicator.

• Recommended uncertainty of +/-0.5° C (+/-1° F).

• Logging interval (or reading rate) that can be programmed by the user.

Monitoring devices

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Some temperature monitoring devices have significant limitations

• Should not be used to measure temperatures in a vaccine storage unit.

• Only show the temperature at the exact time they are read, may fail to detect temperatures outside the recommended range.

• These type of devices are designed for household food storage

Monitoring devices

Digital Data Logger (DDL)

• Place the buffered probe in the center of the unit with the vaccines surrounding it.

• A device placed near the walls, floor, vent, ceiling, or door may indicate temperatures that are colder or warmer than the actual vaccine temperature.

• This may not be true for pharmaceutical units because air flow and temperature are better regulated. Refer to your owner’s manual for instructions on temperature monitoring device placement.

• Place the DDL’s active digital display outside the unit so temperatures can be read without opening the door and disturbing the probe.

• The DDL should be set to measure temperatures at least every 30 minutes.

Store in original packaging with lids closed until ready for administration.

• Protects from light and provides additional thermal protection/ stability.

Never store loose vials or manufacturer-filled syringes outside of their packaging.

• Increases risk of administration errors, exposes to light, increases difficulty to track expiration dates.

Place water bottles on the top shelf and floor and in the door racks. • Helps maintain stable temperatures caused by opening doors

or a power failure. • Prevents from being stored in areas where there greater risk of

out-of-range temperatures (such as the top shelf, floor, and door).

• Place water bottles carefully so they don’t prevent the door from closing securely

• Label all water bottles, “DO NOT DRINK.”

Best Practices for Storing Vaccine & Diluent

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Store diluent with the corresponding refrigerated vaccine.

Store each type of vaccine or diluent in a separate container.

Attach labels to shelves and containers to clearly identify where each

type of vaccine and diluent is stored.

Store vaccines and diluents with similar packaging or names or with

both pediatric and adult formulations on different shelves.

• Make sure to label the formulation “pediatric” or “adult,” if applicable.

Place vaccines and diluents in the center of the unit, 2 to 3 inches away

from walls, ceiling, floor, and door with space for air circulation.

Avoid storing vaccines and diluents in any part of the unit that may not

provide stable temperatures or sufficient air flow, such as directly under

cooling vents, in drawers, or in shelves on the door.

Best practices for Storing Vaccine and Diluent in a Refrigerated Unit

Best Practices for Storing Vaccine and Diluent in a Freezer Unit

• No additional items stored in the units

• Never store any diluent in the freezer.

• If medications must be stored in the same unit as vaccines, use

separate containers.

• Store them below vaccines and on a different shelf to prevent

contamination and reduces medication errors.

• Food and beverages should never be stored in the unit with vaccines.

• This leads to frequent opening of the door to access food, causing

temperature fluctuations and excessive light exposure.

• It can also result in spills and contamination.

Out-of-range Storage Temperature

• Any temperature reading outside ranges recommended in the manufacturers’ package inserts is considered a temperature excursion.

• Manufacturers analyze information about the magnitude of the temperature excursion and the total amount of time that temperatures were out of range, as well as information about the vaccine in question, to determine whether a vaccine is likely to be viable.

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Actions to Take

• CDC recommends the following steps: • Any staff member who hears an alarm or notices a

temperature excursion on the DDL should notify the vaccine coordinator immediately or report the problem to their supervisor.

• Label exposed vaccines, “DO NOT USE,” and place them in a separate container apart from other vaccines in the storage unit (do not discard these vaccines).

Vaccine Coordinator Role • Document the event:

• Date and time of the temperature excursion

• Storage unit temperature and room temperature, if available (including minimum/maximum temperatures during the time of the event, if available)

• Name of the person completing the report

• Description of the event: • General description of what happened,

• Length of time vaccine may have been affected

• Inventory of affected vaccines

• Items in the unit (including water bottles) other than vaccines

• Any problems with the storage unit and/or affected vaccines before the event, and other relevant information.

Vaccine Coordinator Role

• Contact your immunization program and/or vaccine manufacturer(s) for further guidance on whether to use affected vaccines and for information about whether patients will need to be recalled for revaccination.

• Implement your facility plan to adjust unit temperature to the appropriate range.

• At a minimum, check the temperature monitoring device to make sure it is appropriately placed in the center of the vaccines.

• Complete your documentation of the event, including:

• Action taken (what you did with vaccine and the time, whom you have contacted and instructions received, and what you have done to prevent a similar future event).

• Results (what happened to affected vaccines and other comments).

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Adjusting the Temperature

• Thermostat adjustments should only be made by the primary or alternate vaccine coordinator, based on information from digital data loggers and temperature monitoring logs.

• Post a warning sign on all storage units stating, “Do NOT adjust temperature controls. Notify (name of vaccine coordinator) if adjustments are necessary.”

• Temperature adjustments should not be done during a busy clinic day when the unit door is being frequently opened

Before making any adjustment:

• Confirm the unit is securely plugged into a power source.

• Check the temperature inside the storage unit.

• Wait 30 minutes, without opening the door, and check it again. Use your backup device f you think there might be a problem with your monitoring device.

If an adjustment is needed:

• Refer to the owner’s manual for detailed instructions.

• Turn the thermostat knob slowly to avoid going outside the correct temperature range, and make a small adjustment as necessary.

• Allow the temperature inside the unit to stabilize for 30 minutes without opening the door.

Adjusting the Temperature

Recheck the temperature. Repeat these steps as needed.

Consider placing additional water bottles in the unit to help

improve temperature stability.

Please note: with a combination storage unit, adjustments

to the freezer temperature can adversely affect the

refrigerator compartment temperature, possibly resulting in

frozen refrigerated vaccines.

Adjusting the Temperature

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Check storage unit door seals regularly for signs of wear and tear. If seals need

to be replaced, contact a repair technician immediately.

Check door hinges and adjust so that the door opens and closes smoothly and

fits squarely against the body of the unit.

Clean unit coils and motor. Dust and dirt buildup can prevent the unit from

working efficiently.

Clean inside of units to discourage bacterial and fungal growth. Cleaning must

be done quickly to minimize the risk of the temperature going out of range.

Defrost manual-defrost freezers when the frost exceeds either 1 cm or the

manufacturer’s suggested limit. Follow the manufacturer’s instructions. While

defrosting, store vaccines temporarily in another unit with appropriate freezer

temperatures

Equipment Maintenance

Expiration Dates

• Vaccine and diluent expiration dates indicate when the product must be discarded if it has not been used.

• Dates are printed on vials, manufacturer-filled syringes, and packages.

• When the expiration date has only a month and year, the product may be used up to and including the last day of that month.

• If a day is included with the month and year, the product may only be used through the end of that day.

Deliver directly to that facility.

If that is not possible, vaccines should transported using a portable

vaccine refrigerator with a temperature monitoring device.

If this is not available, qualified containers and pack-outs can be used

with a temperature monitoring device.

If you must transport vaccines:

• Transport only what is needed for the workday.

• The total time for transport and workday should be a maximum of 8

hours.

• If you must transport vaccines in non-commercial vehicles, use the

passenger compartment—not the trunk.

Do not use dry ice, even for temporary storage. Dry ice might expose

the vaccines to temperatures colder than -50° C (-58° F).

Off-site use of Vaccines

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Store in an appropriate storage unit with a temperature monitoring

device, and temperatures should be read and recorded a minimum of 2

times during the workday.

If vaccines cannot be stored in an on-site storage unit, they should be

kept in the portable vaccine refrigerator during an off-site clinic:

• Place a temperature monitoring device (preferably with a probe in a

thermal buffer) as close as possible to the vaccines, and read and

record temperatures at least hourly.

• Keep the container closed as much as possible.

• Remove only 1 multidose vial or 10 doses at a time for preparation

and administration by each person administering vaccines.

On Arrival

Checklist for Off site Clinics • https://www.izsummitpartners.org/naiis-workgroups/influenza-workgroup/off-

site-clinic-resources/

Transport of Multidose Vials (MDVs)

• If absolutely necessary, a partially used vial may be transported to or from an off-site/satellite facility operated by the same provider, as long as the cold chain is properly maintained.

• A partially used vial cannot be transferred from one provider to another or across state lines.

Off-site use of Vaccines

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Collier County, FL (2009): 77 students given seasonal flu instead of

Swine flu (H1N1) shot.

Montgomery County, TX (2015): $70,000 worth of revaccinations

required after vaccines were stored at the wrong temperature.

Wellesley, MA (2010): School staff given insulin in flu vaccine error.

Some staffers had to be hospitalized, but all recovered.

Off site Clinic Outbreaks

Prepare in a designated area away from any space where

potentially contaminated items are placed.

Only prepare vaccines when you are ready to administer them,

checking expiration dates and the correct vaccine.

Only administer vaccines you have prepared at the time of

administration

• Once inside syringes, it is difficult to tell them apart, which can

lead to administration errors.

• Predrawing can result in vaccine waste if more is drawn up

than is needed.

Injection Safety

• General use syringes are designed for immediate administration—not

for storage. Contamination and growth of microorganisms can occur

in syringes with predrawn vaccine that does not contain a

preservative.

• Vaccine components may interact with polymers in a plastic syringe

over time, potentially reducing vaccine potency.

• Vaccine manufacturers do not recommend predrawing vaccines in

advance of influenza vaccination clinics because no data exist on the

stability of vaccines stored in general-use syringes that have been

filled by providers.

• As an alternative to predrawing vaccines, CDC recommends using

manufacturer-filled syringes for large immunization clinics.

Injection Safety

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Single-dose Vial (SDV) contains ONE dose, used ONE time for ONE

patient.

• Do not combine leftover vaccine from one SDV with another to obtain a dose.

Multi-dose Vials (MDV): Only the number of doses in the manufacturer’s

package insert should be withdrawn from the vial. After the maximum

number of doses has been withdrawn, discard the vial

• MDVs can be used until the expiration date on the vial or there is a beyond use

date (BUD) noted in the package insert.

• Never use partial doses from two or more vials to obtain a dose of vaccine

Manufacturer-filled syringe (MFS) is prepared and sealed under sterile

conditions by the manufacturer and are single use

• Do not activate an MFS until ready to use

• Do not contain a preservative

• Once the sterile seal has been broken, the vaccine should be used or

discarded at the end of the workday.

Injection Safety

Set up a separate administration station for each vaccine type to prevent

medication errors.

Do not draw up vaccines before arriving at the clinic site.

Each person administering vaccines should draw up no more than one MDV, or

10 doses, at one time.

Monitor patient flow to avoid drawing up unnecessary doses.

Discard any remaining vaccine in predrawn syringes at the end of the workday.

Do not predraw reconstituted vaccine into a syringe until you are ready to

administer it. If not used within 30 minutes of being reconstituted, follow

manufacturer guidance for storage conditions and time limits.

Never transfer predrawn reconstituted vaccine back into a vial for storage.

If Vaccine must be Pre-drawn

Lyophilized (freeze-dried) vaccines may be in the form of a powder or

pellet that must be mixed with a liquid (diluent) in a process known as

“reconstitution” before being administered.

Diluents are not interchangeable unless specified by the manufacturer.

Use only the diluent supplied with the vaccine to reconstitute it.

Never use a stock vial of sterile water or normal saline to reconstitute

vaccines.

Liquid diluents vary in volume and composition, and are specifically

designed to meet the requirements of their corresponding vaccine.

Some diluents contain antigen.

Diluents

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Vaccine Adverse Event Reporting System (VAERS)

• Jointly administered by CDC and FDA

• National reporting system

• Receives ~30,000 reports per year

• Passive - depends on healthcare providers and others to report

https://vaers.hhs.gov/index.htm, Download 7/22/2017

Detect new, unusual, or rare vaccine adverse events;

Monitor increases in known adverse events;

Identify potential patient risk factors for particular types of adverse events;

Assess the safety of newly licensed vaccines;

Determine and address possible reporting clusters (e.g., suspected localized

[temporally or geographically] or product-/batch-/lot-specific adverse event

reporting);

Recognize persistent safe-use problems and administration errors;

Provide a national safety monitoring system that extends to the entire general

population for response to public health emergencies, such as a large-scale

pandemic influenza vaccination program.

Primary Objectives of VAERS

Form and instructions on how to report at website:

https://vaers.hhs.gov/reportevent.html

VAERS Reporting Form

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Understand the type of vaccine to be given

Store vaccines in the appropriate equipment

Maintain a safe temperature

Prepare vaccines according to safe injection guidelines

Report any adverse events

Summary

Give “Just the Vaccine”

Checklist for Safe Vaccine Storage:

http://www.immunize.org/catg.d/p3035.pdf

Temperature Log for Freezers:

http://www.immunize.org/catg.d/p3038f.pdf

Temperature Log for Refrigerators:

http://www.immunize.org/catg.d/p3037f.pdf

Vaccine Storage and Handling Toolkit:

https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/index.html

Handouts for Patients and Staff:

http://www.immunize.org/handouts/view-all.asp?s=1&d=asc

Resources

Vaccine Information Statements:

http://www.immunize.org/vis/

Seasonal Influenza Information

• https://www.cdc.gov/flu/professionals/vaccination/index.htm

• Immunization Schedules

• https://www.cdc.gov/vaccines/acip/index.html

ACIP Recommendations

https://www.cdc.gov/vaccines/acip/recs/index.html

CDC Resources on Proper Vaccine Handling

https://www.cdc.gov/vaccines/hcp/admin/storage/index.html

Resources

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Helping People Live Better

Lives. 58

Questions

Helping People Live Better

Lives. 59

Dr. Maureen Tierney, MD, MSc

• Nebraska Department of Health and Human Services

• OFFICE: 402-471-6549 |CELL: 402-309-3471 |FAX: 402-471-3601

• E-mail: maureen.tierney@nebraska.gov

Peg Gilbert, MS, RN, CIC, FAPIC

• E-mail: peggilbert@qualityic-llc.com

Contact Information