The healthcare landscape is constantly evolving, with each change bringing its own set of challenges and adjustments. For Emergency Medical Services (EMS) and fire agencies in Virginia, a significant shift is on the horizon regarding the drug box exchange program. This blog aims to distill essential information from the Virginia Department of Health’s Office of Emergency Medical Services (OEMS) about upcoming federal regulatory changes affecting this program.
Overview of Changes
Due to the implementation of the Drug Supply Chain Security Act (DSCSA) and the anticipated final rule for the Protecting Patient Access to Emergency Medications Act (PPAEMA) of 2017 by the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA), respectively, the current Virginia EMS agency hospital drug box exchange program is slated to end possibly by November 27, 2024. These changes are primarily driven by compliance requirements under the DSCSA, which does not provide the same allowances for hospitals as it does for EMS agencies, thereby impacting the traditional drug box exchange process.
Key Recommendations
In response to these changes, a workgroup comprising representatives from various EMS and healthcare organizations has developed recommendations to guide EMS agencies through the transition. Here are the critical recommendations:
Controlled Substances Registration Certificate
EMS agencies planning to store drugs at their stations will need to obtain a Virginia Board of Pharmacy Controlled Substances Registration Certificate (CSRC) for Schedule II through VI medications. Additionally, a registration with the DEA might be necessary. The Board of Pharmacy is in the process of amending requirements for obtaining a CSRC, with final requirements expected to be adopted soon.
DEA Registration
Agencies intending to carry federal schedule II-V medications must obtain a registration under the Controlled Substances Act (CSA) with the DEA. A single registered location for an EMS agency is allowed, with other locations within the agency listed as non-registered locations.
Schedule VI Medication Exchange Program
Regional EMS Councils are encouraged to explore the feasibility of a 1:1 Schedule VI medication exchange program with hospitals, compliant with FDA DSCSA regulations.
Developing Processes for Medication Purchase
EMS agencies should create processes for purchasing Schedule II-VI medications, allowing them to replace medications when needed.
Frequently Asked Questions
Can my organization keep medications in our building without a Controlled Substance Registration (CSR)?
No, housing medications in your organization’s premises without securing them on an ambulance may lead to possible citations for deficiencies by the Board of Pharmacy.
Should my organization buy or keep medications before obtaining a CSR?
No. Before an EMS organization purchases medications from an authorized pharmaceutical manufacturer, wholesale distributor, or third-party logistics provider, it should acquire a CSR from the Board of Pharmacy and registration from the DEA. An inspection of the medication storage area within the building will be conducted before issuing the CSR. Any identified deficiencies during the inspection must be rectified before issuance.
Can I store Regional Drug Kits in my facility when not secured in an ambulance?
No. The drug kit must always remain secured in the ambulance at appropriate temperatures. These kits are not meant to be stored within the EMS facility.
Does my organization require a CSR?
Yes. If you intend to store regional drug kits or stock additional medications and IV fluids within your facility.
Does my organization need a CSR for each facility?
No. A Controlled Substances Registration (CSR) is not necessary for every facility in your organization. If your organization operates multiple facilities and designates specific ones for restocking drugs or storing regional drug kits, a CSR is only required for those designated locations. However, if drugs or drug kits are stored at each facility, then a CSR is required for each one.
If I have out-of-box drugs, do I need a CSR?
Yes. If you will be storing and restocking drugs that are not part of a regional med kit, then you will need a CSR.
The enforcement of these new federal regulations presents undeniable challenges for EMS agencies across the Commonwealth of Virginia. However, with proactive planning, collaboration, and the utilization of available resources and assistance, agencies can successfully adapt to these changes. OEMS encourages all EMS agencies to stay engaged, seek technical assistance when needed, and work closely with regional EMS councils and healthcare coalitions to ensure a smooth transition.
For more information and updates, please visit the Virginia Office of Emergency Medical Services website.
The landscape for EMS drug management in Virginia is rapidly evolving, with new regulations poised to redefine traditional practices. Our range of MedixSafe and IntelliView products are specifically designed to address these changes, providing EMS agencies with the tools needed to ensure compliance with controlled substance tracking and secure storage requirements in this new regulatory environment.
For more information on how our MedixSafe and IntelliView products can help your EMS agency adapt to these legislative changes, please contact us. Together, we can pave the way for a seamless transition into the future of EMS drug management.
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