EMS: Prep for New DEA Controlled Substance Regulations

  • Posted on September 17, 2019

After decades of blurred lines and state-driven interpretation of the Controlled Substance Act, the United States Drug Enforcement Administration (DEA) is refining and clarifying its requirements specific to EMS agencies that must administrate, store, track, and dispose of these controlled substances.

Building off momentum from the Protecting Patient Access to Emergency Medications Act (PPAEMA) passed in 2017 – which itself was established to help ensure EMS agencies were able to distribute controlled substances in the appropriate settings – the DEA will be releasing more specific guidelines for EMS agencies in 2019. The goal is to create more consistent usage and tracking across the country when it comes to controlled substances such as opioids and benzodiazepines that EMS agencies often use for advanced life support patient care.

A History of Ambiguity

When the CSA was originally passed in 1970, it lacked instructions for the maintenance and use of these substances by EMS. Subsequently, various states established their own controlled substances requirements for EMS, causing a fair degree of confusion and varied regulations depending on location.

At the time, the CSA required physicians, pharmacists, manufacturers, and researchers to register with the DEA before making, distributing, administering, or studying substances on the national list of controlled substances. Since the CSA did not specifically mention EMS, EMS agencies often interpreted the rule to allow them to administer controlled substances under the DEA registration of the medical director or the hospital overseeing the agency’s patient care.

Other states permitted the use of “standing orders” or written protocols – pre-approved by a medical director – to administer controlled substances in certain situations. When the DEA raised concerns about the use of standing orders, the discussion escalated into a larger, much-needed conversation that would eventually result in the PPAEMA.

Clarifying Guidelines and Regulations

The DEA recently released its list of proposed regulatory changes, including a modification of regulations related to the registration requirements of DEA registrants to allow EMS registrants to transport controlled substances for the purpose of dispensing under certain circumstances. Additionally, it plans to provide the EMS community with specific requirements for handling controlled substances, including security, ordering, and record-keeping requirements.

Today, EMS agencies are still waiting to see exactly what the specific regulations and requirements the DEA will be releasing, but proactive agencies are already preparing for more scrutiny and accountability in tracking the use of controlled substances, from procurement to use or waste. While controlled substances are an vital tool in the arsenal of an EMS crew, they do create a unique set of circumstances and challenges. For example, it’s important to maintain an accurate account of available stock, along with very detailed information with each administration. Agencies must also carefully track how they dispose of expired stock, and abide by specific requirements and facilities that have the capabilities of proper disposal.

An additional area of concern is also fighting “diversion,” or the intentional diverting of a controlled substance away from its intended purpose. This can occur at the time of administration or at the time of waste; ensuring that all team members are held accountable for their interaction with this substances helps protect the team and the agency as a whole.

Smart Tools for Controlled Substances

Knowing that added scrutiny is on its way, some EMS agencies are looking into more advanced tools that simplify their maintenance and tracking of controlled substances. One tool gaining popularity is a high-tech security system that helps trace an agency’s total controlled substance inventory through all phases. The box itself appears to be a simple, secure box that is plugged into a wall outlet or car adaptor, and is opened with a secure PIN code, with all controlled substances stored inside.

However, the technology involved in this product delivers a wide range of reporting for the agency, including inventory levels, usage, restocking, and medication temperature throughout the entire system. Individual medications can be tracked by a unique identifier for precise location tracking, and automatic reporting can be schedule by location, personnel, or medication administered. Perhaps most useful, Electronic Patient Care Reports (EPCR numbers), CAD numbers, or dispatch numbers can be associated with any medication administration to link that event to the patient.

The data received from each product within the system is store in the Cloud and can be accessed by personal computers and handheld devices at any time. Using this collection of information with an ePCR system such as EHR reporting fast and simple, helping ensure EMS agencies are prepared to account for any details required by the DEA. This data can also help agencies make community outreach plans based on trends in administration in the communities, or improve team education by being aware of any outliers who may not be following best practices consistently.

Additionally, administrators can instantly lock down or open any box remotely, and can be notified as soon as an unauthorized person opens that box. Not only do tools like this product help agencies stay in compliance, but they do, in fact, help battle the opioid crisis in the nation by adding an additional level of security to ensure that these controlled substances are used correctly and kept in the hands of qualified professionals only.

Other Ways to Prepare

EMS agencies can also work to stay prepared and up to date on the new DEA regulations by ensuring they are aware of the most current news, and have their own data in order as much as possible. EMS agencies can:

  1. Stay one step ahead of the regulations.
    Rules and regulations around opioids, data collection, and other controlled substances can change rapidly. Consider setting up Google Alerts on those keywords so you’ll have the most recent information delivered straight to your inbox. It is anticipated the new DEA proposed rules will be available for public comment in early spring 2019.
  2. Make data tracking easier and more actionable.
    Find tools that ensure you accurately collect and sort needed data, such as ESO Electronic Health Record(EHR). By documenting required data in advance, you’ll be prepared to understand and identify the right needs for controlled substance response in your area. Read the article, Spokane Valley Fire Officials Map Opioid Hot Spots, from Spokane Public Radio for an example of how opioid documentation can turn into actionable data.

By proactively collecting and reviewing data on your agency’s opioid administration practices, you can not only reduce your own instances of diversion, but be prepared to easily respond and comply with new requirements from the DEA.