Drug Alteration Policy
Position on Storage of Medications on Ambulances
Ambulance services carry multiple medications and other preparations on their ambulances on a routine basis. They do this so that medics can treat patients exhibiting various medical conditions with state of the art medical care wherever it is needed. Whether it is in the home, work or in public settings medics respond to treat our patients with the best pharmacological interventions available today. Medications that are normally stored in the controlled environments of pharmacies and clinical settings are routinely carried in the less controlled environment of the ambulance. In addition, these medications are routinely transported outside of the ambulance as the medics take medical equipment and these medications to the patient’s side. Emergency Medical Services medications are sometimes exposed to environmental extremes that theoretically might impact the effectiveness of the medication over prolonged exposure times.
The American Ambulance Association advocates the creation of policy and procedures for the storage of medications. It is the position of the American Ambulance Association that all ambulance services use the approach outlined in the Commission on Accreditation of Ambulance Services standard 203.03.04 which states:
“The agency shall have a policy/procedure for the storage of medications and IV fluids that allows for the protection from extreme temperature changes. The policy shall also include a procedure for what to do if medications or IV fluids do get exposed to extreme temperatures.” Practical measures to consider in these procedures could include regular stock rotation from the ambulance to temperature controlled storage rooms, parking ambulances in shaded areas and garages with temperature control, insulated portable bags and storage compartments, and some form of temperature/time monitoring.
In October 2004, the USP issued an informational chapter 1070 (Emergency Medical Services and Ambulances—Storage of Preparations). The chapter describes recommendations similar to the ones listed above. It also calls for more data and research on the stability of the specific medications ambulances carry. The AAA supports this call for more research so that any further recommendations or standards that are developed are based on conclusive scientific peer reviewed research. The AAA does not support more prescriptive standards until the scientific basis is well established specific to the medications ambulances carry.
In the 1990’s the issue of the impact of temperature extremes on the medications ambulances carry became widely discussed in the ambulance service community. Limited research was completed and as a result a few states developed, or attempted to develop, regulations in response. Manufacturers were promoting expensive technologies to “control medication temperatures” in ambulances based upon this non-scientific evidence. The AAA evaluated the issue and issued a Clinical Advisory on October 9, 1998 that reminded members that most medications we carry have manufacturer recommended storage at room temperature (59-86°F). We responded and urged regulators to base any new guidance on good science and refrain from issuing needless and potentially non-effective regulatory controls.
In early 2000, the AAA urged that USP develop ambulance specific recommendations rather than include ambulances services in the regulations being developed for the shipping and transport industries. USP agreed and embarked in discussions with the AAA and other EMS stakeholders. A research project was launched jointly to understand the specific environment medications experience in the EMS setting. The research was designed in two phases: 1) a national study of the actual storage temperatures found in ambulance services and 2) based on that data, an assessment of the impact those conditions had on the stability of the specific medications carried in ambulances today.
In a collaboration with USP, the AAA and SUNY Upstate Medical University, the first research project was designed, conducted and published in 2002 under the title
“Medication Storage on U.S. Ambulances: a prospective multi-center observational study.” The lead investigator was Lawrence Brown from the Department of Emergency Medicine, SUNY Upstate Medical University. It concluded: “Exposure to excessive heat and cold is a consistent problem for EMS medication storage, regardless of the time of year or duration of exposure. It is unlikely that any single strategy will effectively mitigate the problem in every location.”
The AAA urged USP to proceed with the next phase of the research project which was to study the impact of temperature in the ambulance environment as it relates to the specific medications carried in ambulances. We also recommended that various mitigation strategies be examined as well for effectiveness. Instead, USP moved forward with writing an informational chapter on the issue and called for more research. This chapter was released in October 2004. Throughout the process, the USP was open to comment and much consideration was given to the AAA’s comments.
The USP has now released informational chapter 1070 and the recommendations generally correspond appropriately with the CAAS standard and AAA recommendations. Therefore, the AAA encourages ambulance services to review this material and institute appropriate policies and procedures that work for their specific environmental circumstances.
Committee Action: Approved by Professional Standards Committee on January 7, 2005.
Board Action: Approved by Board of Directors on January 14, 2005.