By Robin Warner, MD

Credited for saving millions of lives, vaccines are one of the most significant public health achievements in recent history. But vaccine potency is dependent on proper handling and storage; even slight fluctuations in storage temperature can render these life-saving vaccines ineffective.

Additionally, federal guidelines on storage and inventory management, such as compliance with the federal Vaccines for Children (VFC) program and those from private suppliers, carry indirect, un-reimbursable costs and require considerable staff time, which could be otherwise spent on patient care.

Maintaining the ‘Cold Chain’ 24×7

Almost all vaccines must be kept within a narrow temperature range to maintain potency. Vaccines must be refrigerated or frozen upon manufacture and kept at a consistent temperature from the time they are shipped from the warehouse, delivered to and stored at the physician’s office and ultimately administered to the patient. This is called the “cold chain.”

Unfortunately, nearly one-quarter of the immunization errors reported from 2000-2013 were related to storage and dispensing errors, such as administering expired vaccine or improper temperature maintenance.

Considering the environment of healthcare practices, this is not surprising. Even a brief break in the cold chain can make vaccines ineffective and a visual inspection is not indicative of whether or not a vaccine has maintained its potency. While nurses may be aware that temperature fluctuations are an issue with vaccine storage, there are gaps when it comes to recording the temperature changes and then appropriately assessing the inventory and properly disposing of expired or ineffective vaccines.

Complex Storage and Inventory Protocols

Ensuring vaccines stay at the right temperature requires a complex initial setup and compliance with strict maintenance protocols outlined by the Centers for Disease Control and Prevention (CDC). Complying with these recommendations requires a significant amount of planning and staff time to ensure each dose is stored at the correct temperature, prevent temperature variations, and detect any temperature fluctuations that may occur.

In a real-world setting, though, this high standard is often not met. Expired vaccines must be discarded or returned to the manufacturer, leading to significant waste of valuable vaccines and staff time. One CDC study found vaccine providers wasted on average 2.6% of their stock annually, with expiration and cold chain lapses as the primary causes of waste.

In pediatric and family practices, staff is faced with the burden of inventory control to track which vaccines are from private suppliers and which are provided by the government through public vaccine programs. Clinics often need to store up to 17 different types of vaccines and managing inventories is a time-consuming task that is ripe for error.

A review of 45 healthcare facilities participating in the VFC program, which included approximately 45,000 sites:

  • Three out of four facilities had exposed vaccines to inappropriate temperatures for at least five cumulative hours.
  • Thirteen facilities stored expired vaccines, along with non-expired ones.
  • All facilities failed to fully meet vaccine management, oversight, and documentation requirements.

The Need for Innovative Vaccine Storage and Tracking

So where do we go from here?

The challenges of proper vaccine storage and handling have led many practices and thought leaders to look beyond standard refrigerators—opened and closed by staff countless times a day and potentially exposing vaccines to fluctuating ambient temperatures—to push for the use of pharmaceutical-grade storage systems.

The good news is technology is evolving quickly. One such system, dubbed the AccuVax Vaccine Management System, even goes a step further on storing and managing vaccine. In addition to temperature control to protect vaccine potency, this doorless system fully automates many time-intensive storage, handling, and documentation tasks, and is freeing clinicians to focus more on patient care.

Moreover, AccuVax underwent rigorous testing and refinement during a two-year pilot program, and the product developers met with clinics across the country to gaininsight into the real-world challenges that practices face. The system helps simplifies compliance with many CDC guidelines, as well as requirements for public vaccine programs.

Perhaps most importantly, this type of an automated system can help eliminate many common medical errors by preventing the dispensing and use of incorrect or expired vaccines. Medical errors happen; taking advantage of innovative automated vaccine storage systems like the AccuVax may greatly reduce these errors and is a move that will benefit both patients and practices alike.

References

  • Hibbs, BF, et al. 2015. Vaccination errors reported to the vaccine adverse event reporting system, United States, 2000-2013. Vaccine, pii: S0264-41 OX(15)00620-9.
  • Vaccine Storage and Handling Toolkit. CDC, Updated May 2014.
  • Setia, S. et al. 2002. Frequency and causes of vaccine wastage. Vaccine, doi:10.1016/S0264-410X(01)00433-9 (http://www.sciencedirect.com/science/article/pii/S0264410X01004339?via%3Dihub)
  • Vaccines for Children Program: Vulnerabilities in Vaccine Management. 2012. Office of the Inspector General, U.S. Department of Health and Human Services. ReportOEI-04-1 0-00430.

Robin Warner, MD, has served on the Childhood Immunization Support Program Project Advisory Committee for the American Academy of Pediatrics for the past three years, where she advocates for innovations in safe vaccine storage.