Action | Allowances for emergency drugs by EMS agencies |
Stage | Emergency/NOIRA |
Comment Period | Ended on 10/9/2024 |
The transition away from hospital-supplied sealed drug kits (and especially sealed narcotics kits) is a great challenge but also may have some benefits going forward. My own experience has been that sealing all the controlled medications in one catch-all bag has had some unintended negative consequences due to the inevitable out of sight/out of mind effect. Clinicians were not able to handle and inspect the vials, and there were measurable decreases in pain medication use based on the less accessible nature (and increased restocking time) of the multiple-medicine kits.
18VAC110-20-591 section 6H refers to keeping Schedules II-V drugs in "sealed, secured kit or device" but does not provide further detail and the terms are not in the Definitions section. Our goal is to track at the individual vial level, and also make sure the medications are easy to account for (to identify any problems as soon as possible). Under the old system when we carried all our controlled meds in a single sealed bag provided by the hospital, it prevented us from tracking except at the bag level, and also made close examination of each vial difficult if not impossible.
We consulted a DEA Diversion Investigator and a pharmacist and proposed storing all medications in a single box, with each Sched II-V drug vial separately sealed in its own individual bar-coded tamper-evident bag (clear so we can monitor each vial), with the entire drug box locked in our access-controlled compartment in the EMS vehicle? We were trying to set up functional controlled medication kits, i.e. seizure kit, sedation kit, pain kit, to help our clinicians and increase medication accountability, and for regulatory purposes each kit would be both sealed and secured. Both the DEA Investigator and the pharmacist agreed these were compliant and secure solutions (although not the same as the traditional all-in-one solution). Our goal was to keep the controlled medications secure but easier to visually access, inspect, and verify/account for by sealing and storing them individually, which would also coincidentally reduce barriers to use to benefit patients, and reduce medication error potential by separating the often very similar vials. Could the language in the regulations be revised to provide more clarity on this aspect of storage?