Article Text
Abstract
Background and importance Emergency vehicles carry crucial medicines that face the same storage conditions required by pharmaceutical regulations. Nonetheless, it has been shown, mostly in North America, that out-of-hospital storage environments tend to exceed these requirements through exposure to extreme temperatures, sunlight or vibrations leading to possible drug alterations.
Aim and objectives Our pilot study aimed to determine whether the interior of observed emergency medical and non-medical vehicles met room temperature standards following the European Pharmacopeia (EP) and therapeutic product manufacturer requirements.
Material and methods Following European Good Distribution Practice, a temperature mapping setup in an emergency non-medical vehicle was first carried out in July 2020. Fifteen temperature recorders (Testo 184 T3, Testo, Lenzkirch, Germany) were allocated inside the vehicle following recommendations of temperature characterisation referential and monitored every minute for 48 hours. To replicate true out-of-hospital storage conditions, the vehicle was used as usual by the emergency team. During the daytime a pharmacist monitored the vehicle’s status (ie, in motion, stationary, open or closed doors) and the number of people inside. Then, six emergency non-medical vehicles, one medical vehicle and storage facilities were monitored every 10 min for 6 weeks (July–August 2020) with 22 temperature recorders.
Results The first mapping stage was characterised by a mean arithmetic temperature ± IC95% of 25.8±0.2°C and an absolute maximal recorded temperature of 35.4°C. The United States Pharmacopeia (USP) mean kinetic temperature for each measuring point of the vehicle was between 25.4°C and 26.2°C.
Temperatures exceeding 25°C were recorded onboard all vehicles and storage areas, ranging from 47.5% to 98.1% of the total exposure time. Temperatures above 30°C represented 3 to 10 days of measurements within the vehicles with the highest absolute temperature being 38.9°C.
Conclusion and relevance Medicines carried by emergency vehicles must be stored between 15°C and 25°C. In the summer of 2020, no vehicles were consistent with the EP’s and drug manufacturers’ room temperature recommendations. The mapping setup showed that temperature within the vehicles is impacted by their moving state, location and air circulation. Our results endorse the implementation of periodic stock rotation, continuous vehicle temperature monitoring and the use of controlled temperature storing boxes.
Conflict of interest No conflict of interest