Pharmacy directors are required to balance many different operational factors in order to protect inventory, serve patients, manage staffing, and reduce expenses. So when the question of cold storage comes up, it can be tempting to jump straight to the cheapest viable option.
However, it’s important to understand the regulations at play and the potential ramifications of your decision. Let’s look at what regulations and other factors that bear consideration when planning for cold storage in a hospital pharmacy.
What Do the Regulations Say?
Note: Specific products may have storage and handling requirements that are more stringent than general storage regulations. Follow manufacturer specifications for storage of all products.
Currently, there are technically no regulations requiring a hospital pharmacy in the United States to use medical-grade refrigeration. There are, however, a few relevant regulations and standards as well as some basic performance requirements.
One resource is the CDC Vaccine Storage and Handling Toolkit, which outlines the minimum recommendations for transportation, staff training, storage, and temperature monitoring for vaccines.
The CDC Vaccine Storage and Handling Toolkit requires refrigerators maintain a temperature between 2-8° C and devices should be monitored by a temperature monitoring device. Specifically, the CDC recommends using a digital data logger to track and store information about temperature fluctuations.
The CDC does not require purpose-built or medical-grade refrigerators, but the Toolkit does include a best practice of placing water bottles on the top shelf, floor, and door racks of non-medical-grade units to help maintain temperature uniformity.
The other major standard in the pharmacy refrigeration space is the NSF/ANSI 456 Vaccine Storage Standard, which lays out a series of performance criteria cold-storage equipment should meet in order to be used to store vaccines.
These standards include self-closing doors, audible and visual alarms for temperature excursions, display presenting the interior temperature of the unit, and the ability to pass cables into the unit without breaking the door seal, along with several temperature performance benchmarks.
While neither of these resources technically require purpose-built cold-storage equipment, there are several benefits to making the investment in pharmaceutical-grade refrigeration.
Benefits of Purpose-Built Pharmacy Refrigerators
While non-pharmaceutical-grade refrigerators generally boast a lower price-point, there are several other factors to consider when choosing refrigerators for a hospital pharmacy:
- Performance: Non-pharmaceutical-grade refrigerators may be able to reach the appropriate temperature range, but unable to maintain, resulting in large temperature swings throughout the daily use of the unit.
- Easier Monitoring: It is possible to adapt non-medical-grade refrigerators to meet the monitoring requirements from the CDC and NSF/ANSI 456, but you can lose usable storage space. Many purpose-built pharmacy refrigerators come standard with monitoring capability.
- Cost: The value of product stored in a single pharmacy refrigerator can be thousands of dollars, making temperature excursions (periods of time when the temperature of the refrigerator is outside the acceptable storage range) and equipment failures potentially catastrophic financial events.
- Peace of Mind: Here’s what the pharmacy manager of a large research hospital said about replacing 85 pieces of non-medical-grade cold storage equipment with Helmer refrigerators:
“Switching to Helmer refrigerators has been a night and day difference. Since switching, we have not experienced temperature excursions, and the units maintain their set point. They are reliable and consistent, which is a huge relief for me and my team, as the previous units were a big point of stress and difficult to manage.”
Are Medical-Grade Refrigerators Required for Hospital Pharmacy?
No, but given the performance and temperature requirements as well as the high value of inventory that will be stored, purpose-built pharmacy refrigerators are worth the investment.
Helmer Scientific GX Solutions Pharmacy Refrigerators are powered by OptiCool™ technology. GX Solutions are the first medical-grade pharmacy refrigerators to deliver optimized control in temperature management, noise, and energy usage.
Helmer’s medical-grade refrigerators provide superior temperature uniformity, recovery, and stability to prevent temperature excursions and safely store medications and vaccines. They also are certified to the NSF/ANSI 456 Vaccine Storage Standard to support safe and effective storage of temperature-sensitive vaccines.
OTHER BLOGS YOU MAY BE INTERESTED IN...
- Demystifying Medical-Grade Cold Storage: Part 1
- NSF/ANSI 456: How it Works and Why It’s Important
- Survey: Pharmacists Continue to Trust and Rely on Helmer Equipment
- Choosing Vaccine Refrigerators, Freezers to Meet NSF/ANSI 456 Standard
To read more from a pharmacy manager and how upgrading to medical-grade refrigeration helped the hospital, read our testimonial.
