1070 EMERGENCY MEDICAL SERVICES VEHICLES AND AMBULANCESSTORAGE OF PREPARATIONS
The storage and handling of pharmaceuticals in emergency vehicles and ambulances should be done so that the attributes of the official articles are preserved. There are a number of practices that need consideration when an effective plan is formulated, evaluated, put in place, and periodically re-evaluated. Those practices are listed here.
Monitoring devices should be in place to record weekly temperatures, and allow the calculation of mean kinetic temperature (MKT) for conformance to controlled room temperature storage for those vehicles utilized continuously. Measurement should also be made during a typical challenging 24-hour period, and the derived temperature should be used for the calculation of MKT and storage temperature of the sample.
PHARMACEUTICAL STORAGE CABINET MONITORING; LOCATION OF PARKED VEHICLES
Ambulances and other emergency medical response vehicles that routinely carry Pharmacopeial articles should be monitored to verify that temperature profiles and onboard pharmaceutical storage cabinets or cold chests are within established limits. Suitable monitoring devices are to be placed in the pharmaceutical cabinet of each vehicle that records highest and lowest temperatures, at the least, of each hot summer and cold winter day. To avoid temperature extremes, ambulance personnel should consider parking in the shade or in air-conditioned garages in the summer or in heated garages in the winter.
A program of regular stock rotation should be in place for articles with low rates of turnover. Rotation is understood as transfer of the articles with suitable marking of stock items to an appropriate climate controlled facility or storage cabinet such as in an ambulance bay. Off-vehicle storage of each article is subject to the storage requirement in the approved labeling or the pertinent USP monograph.
PORTABLE CARRYING CASE STORAGE AND MONITORING
The portable bag or carrying case in which drugs are kept is to be insulated, and when not in use, should be kept in a pharmaceutical storage cabinet or at controlled room temperature within facilities. Storage in portable bags or cases only, rather than in onboard cabinets, should be considered to facilitate stock rotation where indicated. The use of timetemperature indicators is recommended to monitor cumulative insult to the contents of all compartments.
ADDITIONAL REQUIREMENTS FOR SOME ARTICLES
All articles are to be protected from excessive heat (40). If the article requires storage in a cold or dry place or at controlled room temperature, then suitable measures are to be taken to maintain it within the defined limits (see Preservation, Packaging, Storage, and Labeling under General Notices and Requirements.) Articles that have the most stringent storage requirements determine the storage of mixed loads.
STORAGE AND HANDLING OF SENSITIVE PREPARATIONS
Environmentally sensitive preparations are not to be stored in emergency response vehicles unless the onboard cabinet in which the medications is stored is climate controlled or a timetemperature indicator is attached to each package. If environmentally sensitive preparations must be kept in the emergency medical services vehicle, then the supply of medications should be rotated with reserve stock on a schedule based on local climate, but not longer than every 3 days.
USE OF TIMETEMPERATURE INDICATORS
Attach timetemperature indicators to individual thermally sensitive preparations where time outside of the onboard cabinet can exceed 4 days total. Onboard cabinets must be insulated and while medications are inside, active heating and cooling devices should be used in accord with the local climate and as specified for the preparations.