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Federal Retail Pharmacy Program Partners Must Prioritize Medical Refrigeration

  • by Lauren Levy
  • Sep 20, 2021, 09:37 AM

Gaining remarkable momentum since it launched on February 11, the Federal Retail Pharmacy Program for COVID-19 vaccination now has 40,000 pharmacies and other partner stores nationwide. This collaboration of federal, states, and territories with retail pharmacies is now one vital component of the national vaccination strategy to fight the pandemic.

The Program has scaled up rapidly by creating and distributing more of the vaccines and enlisting as national pharmacy partners some of America's largest chains of pharmacies as well as independent pharmacies and other stores. All stores must qualify under the program by having the right equipment for storage of the vaccines, the right personnel to deliver the doses, and willingness to provide the service free of cost to the patient.

How the program works

The program leverages the existing strengths and expertise of pharmacists, their direct contact with their local customers, their marketing resources, and widespread trust of individuals in the pharmacists they know personally. On average, Americans live within less than five miles of a pharmacy, but even with 40,000 partners in the Program access is not the same everywhere.

For one thing, the Program includes an element of "equity," as gauged by a "social vulnerability index" (SVI), so that pharmacies and other outlets in the hardest-hit areas of the country--and pharmacies serving hard-hit population categories--have gotten priority. As the program grows, however, access will keep improving and widening. At this time anyone aged 12 or older is eligible to be vaccinated.

The roster of partners in the Program, now lists the leading retail pharmacy chains in America such as (to take but a few examples) Albertsons Companies, Costco, CVS, Rite Aide Corp., The Kroger Co., Walmart's, and Walgreen.

Since many of these retail-chain pharmacies have similar equipment, standards, and services, their stores were able to qualify relatively quickly for becoming a Program partner.  Some COVID-19 vaccines, of course, must be kept within low temperature ranges to maintain their effectiveness up to the moment of delivery to the patient. For that reason, rushing the vaccines directly from the federal government to the frontline stores has been a challenge. The Pfizer-BioNTech vaccine must be kept at subzero temperatures creating a logistical puzzle of dry ice and specialized freezers. The Moderna vaccine is slightly less demanding of low temperature, but it also has to be kept frozen during shipping and storage.

 

Why adequate, consistent refrigeration is vital

The essential component of the vaccine is messenger (mRNA). The mRNA is the genetic material that "teaches" our immune cells how to make the spike protein found on the virus that causes COVID-19. By doing that, the mRNA causes our immune system to respond by creating antibodies against the specific spike protein, thus preparing to protect our body against the virus in the future.

The pivotal storage issue arises because mRNA molecules are unstable and rapidly degrade. One result could be that the mRNA could deliver harmful levels of proteins to our cells. Another problem is that enzymes in the environment also break down mRNA. To help counter the effects of these enzymes, vaccine manufacturers coat the mRNA with a protective surface of fat bubbles.

For all that, however, the ultimate protection is very cold temperatures at which the enzymes that break down mRNA simply can't function at all.

The bottom line is that there must be an unbroken "cold chain" to protect the vaccines from creation to injection into the patient. The ranges are -13 degrees Fahrenheit and 5 degrees Fahrenheit for the Moderna vaccine and a truly polar -112 degrees Fahrenheit to -76 degrees Fahrenheit for the one from Pfizer. But the drug manufacturers keep secret the exact formulas used for the protective coatings on mRNA and those formulas dictate how cold the vaccines must be kept--and thus the differing storage requirements.

Because the Pfizer vaccine must be stored at temperatures well below what is achievable in the standard freezer, a pharmacy's partnership in the Program could turn on just the issue of obtaining a professional pharmacy refrigerator, freezer, or combination unit. Authorities emphasize that vaccines are required to be monitored daily using a "digital data logger" attached to a probe that goes into the storage unit so that the temperature of the vaccine is accurately known at all times.

Some physicians are urging their patients to check personally that the vaccine they are given has been kept cold enough to remain viable. This could involve no more than asking the pharmacy for those temperature logs, which pharmacy managers must in any case maintain for state inspectors. "This is a patient-centric model and patients need to feel confident in the process and safety of the vaccine," says Timothy Lise, PharmD, executive director of pharmacy services for New Jersey's Atlantic Health System. "If a patient asks us, we can provide all of that temperature data. I'd print it out for them." But it is clear that most patients put their trust in the doctors and pharmacies administering the vaccine as long as it is known that they have the equipment and quality controls in place to follow requirements of the vaccine manufacturers.

 

The American Biotech Supply medical refrigeration standards

At American Biotech Supply, all storage units for laboratory samples, pharmacy supplies, and other perishable items are equipped with temperature controls to achieve and consistently maintain required ranges. Units also have warning and alarm systems to signal if temperature in a unit no longer is within the required range. Interior fan-driven, forced air pumps safeguard samples and supplies when doors are opened frequently. The units are compliant with CDC vaccine storage and handling toolkit guidelines for storing COVID-19 vaccines and ABS will have products that will meet the new NSF 456 standard for construction and performance. This will ensure consistent safety of COVID-19 vaccine supplies.

If your pharmacy or pharmaceutical unit is reviewing its storage requirements and equipment to meet COVID19 vaccine standards, an important step could be to reach out to our storage technology experts to discuss your specific needs and timing.

Be sure to check back here regularly for information, insights, and updates on refrigeration storage technology. Although all units meet the highest standards for performance, they offer as well the special features you may need such as under-counter or countertop placement, glass or stainless-steel doors, high security, accommodation of flammable materials, and much more.

 

 

 

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