Emergency Preparedness: Vaccine Storage and Handling

Emergencies can happen at any time. Whether it’s a severe weather condition, natural disaster, power outage, or unexpected closure due to a pandemic, the end result could compromise vaccine storage conditions. Practices should have standard operative procedures (SOPs) in place for such emergencies.

What if your office needed to close for an extended period of time? In that case, you may need a system for monitoring temperatures remotely. Consider purchasing a phone-enabled or internet-aware alarm to alert you of temperature excursions. Multiple staff members should be on the notification list to ensure appropriate action can be taken, if needed. In addition, your data logger should have enough memory to store at least one month of data, and the data recording should loop when memory is full. This FAQ document from the AAP contains detailed information on data loggers and vaccine monitoring.

Emergencies can happen anytime, including after hours. Work with your facility’s building manager to ensure emergency access. Your storage and handling SOPs should include instructions and a map/diagram for accessing vaccine storage units and the locations of flashlights, keys, circuit breakers, and other useful items.

In a situation where a storage unit is no longer functioning or during a power outage, vaccines may remain inside the unit as long as appropriate temperatures are maintained. It is important to not open the storage unit door unless power is restored or you need to pack the vaccines for transport. Monitor your digital data logger to determine when you need to take additional steps.

If you cannot monitor temperature inside the unit without opening the door, wait until power is restored to record the temperature. At that point, record the room temperature and the temperature inside the unit. Follow your procedure for a temperature excursion and be sure to mark effected vaccines “Do NOT Use” until a decision can be made about whether or not to use them.

If you have external temperature monitoring, record the room temperature and unit temperature as soon as the power goes out. Also record the minimum and maximum temperatures reached. If a temperature excursion should occur, follow your SOPs.

If you have a generator or backup battery power source, this can prevent the need to move vaccines to another location. Both generators and back up battery power sources must be tested quarterly and serviced annually. In addition, ensure you have enough fuel on hand to run your generator for 72 hours.

Even if your practice has a backup power source, you need to establish an alternative storage facility. Establish a working agreement with at least on alternative storage facility such as a hospital, long-term care facility, the Red Cross, or a commercial pharmacy. Ensure that you have 24-hour access to your alternative facility. You can also have a back up storage unit at your facility to use as an alternate.

The CDC’s Vaccine Storage and Handling Toolkit includes a section for establishing SOPs and emergency management. These can be found on pages 25-26 and 30-34.

The Immunization Action Coalition produced a useful Emergency Response Worksheet. It includes instructions, a table for recording vaccines, and helpful numbers. If your practice is in the state of Ohio, the Ohio AAP has a Vaccine Emergency Management Plan with Ohio specific information.

Coming next: what to do in a situation where your vaccines must be transported.

New Discount Opportunity for CPP Members

One of the most important elements of vaccine storage is utilizing an accurate temperature monitoring device that has been properly maintained.

According to the CDC Vaccine Storage & Handling Toolkit:

Calibration testing should be done every one to two years or according to the manufacturer’s suggested timeline. TMDs can experience a “drift” over time, affecting their accuracy. This testing ensures the accuracy of the device continues to conform to nationally-accepted standards.

If you need to replace the temperature monitoring device at your practice or if the cost of calibration testing outweighs the cost of purchasing a new device, CPP members can access a discount on LogTag Vaccine Temperature Monitoring Kits.  Simply contact the CPP office at mailto:cpp@nationwidechildrens.org for more information.

Handling Vaccine Temperature Anomalies and Refrigerator Repairs

Effective refrigeration is an important part of managing your vaccine program. Does your practice know what to do in the case of a temperature anomaly? What about when your vaccine refrigerator needs to be repaired?

Here are 6 tips for when vaccine temperatures go outside of normal limits:

  • Investigate and determine how long the vaccine temperatures have been out of range
  • Check to see if the refrigerator door is ajar or making an unusual noise
  • Inventory the vaccine affected currently in the refrigerator
  • Move vaccines to a temporary refrigerator that is working appropriately 
  • Contact the vaccine manufactures to determine the status of the vaccines
  • Document the entire incident, results and actions taken to prevent another temperature excursion

The Immunization Action Committee created a helpful form to complete after an unacceptable vaccine storage event. This handout and other storage and handling tools can be found here: https://www.immunize.org/clinic/storage-handling.asp

If you determine that a refrigerator needs to be repaired after a temperature anomaly, here some sources of good refrigerator repair information:

  • Refrigerator manufacturer
  • Your medical supplies and equipment provider
  • Commercial appliance repair company
  • Other medical practices or hospitals in your area
  • Restaurant equipment repair companies

CPP Buying Group has a robust collection of Vaccine Storage and Handling resources. In addition, we can help with the purchase of a new vaccine refrigerator or freezer. Our Vaccine Storage Equipment Educational Program (VSEEP) provides grants of up to $750 to offset the cost of vaccine storage equipment. Contact our office for more information.

Merck’s Pediatric Recombivax HB Available March 9, 2020

As announced at the ACIP meeting last week, supply of the pediatric formulation of Merck’s Recombivax HB will be returning to the private sector.  The following vaccine presentations will be available for purchase beginning March 9, 2020:   

CPP members can purchase Merck vaccines directly from Merck or through a Merck Vaccines Prime Distributor to receive the CPP member discounts.        

At this time, the adult formulations of Recombivax HB are still unavailable.  You can keep up on supply updates by visiting the Merck Supply Status website.  Remember, CPP members can access a discount on Dynavax’s Heplisav-B, a 2-dose hepatitis B vaccine series for adult patients.  To participate in this discount opportunity, contact the CPP office to request an opt-in form.  Once your practice is linked to the CPP member discount, doses can be purchased through an authorized distributor of Heplisav-B.   

If you have any questions or would like additional information, please contact the CPP Office at 614-722-2145 or your Merck representative.

Shared Clinical Decision-Making: Understanding the Recommendations from the CDC

The immunization schedules for 2020 recently published by the Center for Disease Control (CDC) four recommendations for vaccination based on shared clinical decision-making. These vaccines are:

  • Meningococcal B (MenB) vaccination for adolescents and young adults aged 16–23 years
  • Human papillomavirus (HPV) vaccination for adults aged 27–45 years
  • Pneumococcal conjugate vaccination (PCV13) for adults aged 65 years and older who do not have an immunocompromising condition, cerebrospinal fluid leak, or cochlear implant
  • Hepatitis B (HepB) vaccination for adults age 60 years and older with diabetes mellitus

But what is a shared clinical decision-making recommendation? According to the CDC, an immunization is given this designation when it is not indicated for all members of a population. The vaccination may benefit some members of the age or risk group, but broad vaccination of people in that group is unlikely to have population-level impacts. For shared clinical decision-making immunizations, patients and providers should discuss the potential benefits of vaccination and come to a personalized decision together.

Over the next month, we will examine the individual immunizations that the ACIP recommends for shared clinical decision-making.

HPV

The HPV vaccination is routinely recommended for ages 11 or 12 with catch-up recommendations for those not vaccinated on time.

In June 2019, the ACIP recommended shared clinical decision-making for HPV vaccination of adults aged 27–45 years. According to the ACIP Shared Clinical Decision-Making Recommendations, HPV acquisition generally occurs soon after first sexual activity. Vaccine effectiveness is lower in older age groups because of prior infections and lower risk of exposure (for example, among persons who are in a long-term, mutually monogamous sexual partnership). The ACIP recommended shared clinical decision-making rather than catch-up vaccination because most adults in this age group would have no or minimal benefits from vaccination. However, some individuals who are not already immune to HPV through vaccination or natural infection (e.g., a previously unvaccinated person who has never had sex) and who might be at risk for acquiring a new HPV infection in the future (e.g., plans to have sex with a new partner in the future) might benefit from vaccination.

A detailed explanation of the ACIP’s recommendation and considerations for shared clinical decision making regarding HPV vaccination of adults aged 27 through 45 years can be found on the HPV Updated Recommendations webpage.