For fire and rescue operations, everything comes down to ensuring the best patient outcomes. Having well-trained staff as well as current technology and equipment is critical to doing that, of course. Keeping medication in the proper temperature range – both in storage and on-board EMS vehicles – is just as important. That’s because many medications lose their potency or efficacy if they get too warm or too cold.
Knowing the proper temperature ranges for medication and continually monitoring temperatures is the only way to give crews in the field confidence that they are administering effective and stable life-saving medication.
Understanding Temperature Ranges for EMS Medication
Manufacturers typically include a recommended temperature range in package inserts. For instance, some of the more common medication carried by EMS providers include epinephrine and morphine, both of which manufacturers recommend be kept between 15º and 30ºC (59º to 86ºF). Lorazepam, on the other hand, needs to be refrigerated and kept at between 2o and 8oC (36 and 46oF). Other manufacturers might only provide guidance that says ‘controlled room temperature,’ which is where US Pharmacopeia (USP) can be helpful.
USP maps out standards for best practices around shipping and storing pharmaceuticals. In particular, USP Chapter 659 Packaging and Storing Requirements provides temperature definitions.
Temperature Ranges According to USP Chapter 659*
Between -25o and -10oC (-13o and 14oF), and in some instances below -20oC
|Refrigerated||Between 2o and 8oC (36o and 46oF)|
|Controlled Room Temperature||Between 20o and 25oC (68o and 77oF), with certain excursions allowed if mean kinetic temperature does not exceed 25oC|
Temperature-sensitive medications labeled by the manufacturer as controlled room temperature have extended stability and USP 659 provides guidance on allowable temperature excursions. The standards indicate that these medications can safely reach 2º to 30ºC or even as high as 40ºC for brief periods, unless otherwise stated by the manufacturer. In addition to this, USP 659 also provides information on how best to measure and track temperature, all geared toward protecting the integrity of medication. More recently, USP updated their guidelines to include Chapter 1079 Good Storage and Distribution Practices for Drug Products. The goal of this revision was to provide guidance to any organization involved in storing and distributing drug products, including Emergency Medical Services.
Monitoring Temperature Medication for Accreditation
While not required, many EMS providers look to earn accreditation from various agencies such as the Commission on Accreditation of Medical Transport Systems (CAMTS) and/or the Commission on Accreditation of Ambulance Services (CAAS). Both require that some sort of procedures be in place for monitoring the temperature of medication in storage and in vehicles – and both base their standards on USP Chapter 1079.
CAMTS includes air transportation in its standards in addition to ambulances, vans and other ground EMS vehicles. Their standards cover proper storage and temperature monitoring of medication as well as blood products in addition to cabin temperature on emergency aircraft. CAAS standards also say there should be a procedure in place to protect medication, IV fluids and devices from extreme temperatures.
Even certain states such as Iowa, South Carolina and Virginia have put regulations in place around keeping medication within the proper range. In Texas, EMS providers are required to be accredited by a formal accreditation agency like CAAS and CAMTS in order to bid on capitated contracts.
How to Monitor Temperatures
Historically, EMS providers have tracked temperatures in their vehicles manually. As Shaun Curtis, Support Services Manager for MedStar Mobile Health in Fort Worth, Texas, explains, “In the past, we had thermometers installed on the trucks and staff would manually record temperatures. There were multiple failure points in this process—and we ended up disposing of medications that might not have been exposed to a temperature excursion.”
Not only does disposing of medication that might still be viable impact the bottom line, the manual processes are prone to human error and take up valuable time, especially in emergency situations. Plus, manually recording temperatures is typically not enough for either CAMTS or CAAS accreditation. That’s why MedStar, who was working toward CAAS certification, ultimately decided on wireless temperature sensors and gateways.
Using wireless monitoring devices, the temperature is recorded continuously. Sensors can be put in containers onboard EMS vehicles or mounted to the interior of cabinets, vehicles or refrigerators. Real-time alerts tells users if ambulance or cold storage temperatures fall above or below a pre-defined threshold. In some cases, a mobile app is available for setting alarms, datalogging interval times, time and temperature units and more. In cases where the gateway is installed in the garage bay, a mobile app can also allow users and supervisors to spot check temperatures while ambulances are in the field. When these digital sensors come in range of the wireless gateway, data is downloaded from the device, stored in the cloud and can be accessed via a web portal on-demand. This information can be used to create reports that illustrate compliance with either CAMTS or CAAS standards as well as city and state regulations. Wireless sensors are also useful in monitoring cabin temperature, as required for CAMTS accreditation.
In addition to complying with various regulations, temperature monitoring with sophisticated wireless dataloggers like these can also lead to critical process improvements. That’s what happened for Clemson University Fire & EMS in South Carolina. According to Captain William Shivar, the state regulations require that controlled room temperature medications be monitored and stored in a temperature range that doesn’t fall below 20ºF (-7ºC) and doesn’t exceed 100ºF (38ºC). If temperatures fall outside these extremes, the medication must be discarded. “What we realized is that when the mini-refrigerators weren’t being powered by an inverter the temperatures were not stable,” Captain Shivar says. They also tested coolers with reusable ice packs to see if that worked better, but the result was the same – temperatures did not remain in a stable range for a full 24-hour period. As a result of the temperature monitoring, Clemson Fire & EMS decided to purchase coolers that could be plugged into an AC or DC power source for regulating temperatures and those are now used instead of on-board mini-refrigerators. “The stability of our environment is so important not just from a compliance standpoint, but also in our ability to deliver safe drug products to our patients,” says Captain Shivar.
*Source: USP Chapter 659 Packaging and Storage Requirements