The Food and Drug Administration approved a record 45 new drugs in 2015, the most the agency has cleared for the market since 1996. But overlooked in the sheer number of drug approvals is the kinds of drugs that are getting the regulatory nod. The FDA also approved the first biosimilar, Zarxio, which is a copy the Amgen’s biological drug Neupogen. Drugs made from biological products need to be stored at cool and constant temperatures – even if they are administered to patients at room temperature. Zarxio’s approval opens the door for other biosimilar products to likewise seek the regulatory nod to enter the market. As more biological and biosimilar drugs enter the market, hospitals, pharmacies, and other health care facilities will need to make sure that they have proper medical chillers to store these medicines at the appropriate temperatures.
Temperature sensitivity of biological drugs
Blood-based therapies, vaccines, and other biological products typically have shorter shelf lives and must be kept within strict temperature ranges; many products that must be kept cold require temperatures between 35 to 46 degrees, according to Inbound Logistics. With a few exceptions, vaccines should never be frozen, cautions the Centers for Disease Control and Prevention. The agency’s guidelines state that the ideal temperature for vaccine storage is 40 degrees Fahrenheit. As a precaution, the CDC suggests twice-a-day temperature checks of medical chillers.
Some facilities use “dormitory style” refrigerators for temporary storage of medications, an option that runs the risk of either being too cold or not cold enough. It’s not enough to keep vaccines and biological drugs cold. The cool temperature must be constant. Dorm fridges typically have a cooling coil inside an ice maker unit within the fridge, a setup brings severe temperature control and stability issues, according to the Immunization Action Coalition. Consequently, temperatures inside the refrigerator can vary widely, being too cold, bordering on freezing in some places, but not cold enough in other parts of the unit.
The risks of improper medical chilling
When medications are found to be stored outside of the safe temperature range, the drug’s manufacturer, or the state or local health department may need to be consulted to determine whether the product can still be used. If the manufacturer or health officials deem the temperatures unsafe, the product must be discarded – an expensive but necessary step to ensure patient safety.
The best way to ensure that vaccines and other biological drugs are kept at safe temperatures is to use chilling equipment designed specifically for medication storage. Medical chillers are available for purchase, but buying this equipment represents a hefty investment. Inventory levels of medications can rise and fall. A pharmacy or medical clinic may need some time to assess the medical demand and the inventory needs of their site. Leasing a chilling unit can provide health care professionals more flexibility to make that determination.
Your medical chiller options
Renting a chilling unit gives a health care facility the chance to make sure that it’s not adding more chilling capacity than it needs. If the patient levels increase, and demand for vaccines and other biological products likewise rises, a leasing arrangement gives health care providers the flexibility to move up to a bigger medical chiller accordingly.
At J.C. Younger, we bring chilling expertise to our customers. In addition to serving the food and plastics industry, we have a long history of supplying chilling equipment to medical professionals. That means that we know how to work with medical customers to assess, and then address, their medication chilling requirements. Biological drugs are taking up a greater share of the medication market. Make sure that your facility has the capacity for them. Please contact us for help with your medical chilling needs.