8 Must-Haves for a DEA Controlled Substance Management and Destruction Program

Organizations that handle and eliminate expired or unwanted controlled substances must have a full understanding of the essential components this kind of program requires.

Above all, managers must ensure they are conducting the program according to Drug Enforcement Administration (DEA)-approved guidelines—as well as any state or regional rules. And there can be no deviations from such a system. Any execution gaps or errors in these operations could result in serious consequences. Shrinkage—by theft or error—can have major reputational and legal repercussions.

We know that the professional handling of controlled substances is a major challenge. The overall United States market for these drugs, according to one research firm, hit some $50 billion at 2023’s close—and it will grow to $74.3 billion by 2031. That is a lot of controlled substances for organizations to track, manage, and dispose of legally and efficiently.

From experience, we know the essential components involved in a successful DEA-compliant system. Are you a manager at an organization that handles drugs that require management and elimination? Perhaps you are looking to expand (or launch) such a program, either in-house, with a partner, or in a hybrid mode?

If so, you must be sure that your program has the following capabilities or enabling platforms to support successful compliance and operations.

One: Accountability

The entire management and disposal system must be based on extremely restricted access. Only those who are authorized to do so should be handling any controlled substance. This includes anyone involved in any step of the drug management and disposal process, such as:

• Internal collection and sorting
• Packaging and labeling
• Loading and transportation
• Movement to final destination
• Destruction and attestation

In each transaction, there must be a clear, documented chain of custody—with only authorized professionals interacting with the drugs.

Two: Traceability and Documentation

To fully support accountability, there must also be a complete record of the entire management and disposal process—with traceability to any precise moment. This necessitates a system of record, preferably cloud and data-based, that can document compliance at every step. This is especially important when there is a DEA audit. 

Additionally, traceability requires managers to regularly review the program operations—and confirm that all personnel involved are adhering to even the smallest requirements, without any protocol lapses. This is crucially important at the very end of the process (during witnessed destruction or return) to guarantee that no drugs escape the protocol.

Three: Physical and Virtual Security

Controlled substances must never be vulnerable to theft, loss, or any other type of shrinkage—ever! A strong security system is key to ensuring that only approved team members (with impeccable records and outstanding reputations) have access to the substances. The security system typically includes the protection of collection receptacles and the surveillance or tracking of the drugs.

It also means that the procedures are fully transparent to all relevant stakeholders—including law enforcement, as needed. Electronic solutions with rich data capabilities can make this easier, allowing managers to pinpoint the location of any controlled substance in the chain, in real-time, and confirm it is fully secure. It also should be paired with industry standard cybersecurity tools like encryption, password management, and so on.

Four: Guaranteed Reliability, Frequency, and Repeatability

The drug management and disposal system must work like clockwork 24/7/365—ideally, without any significant variations. All participants must know, for example, collection times—by day, week, or month. All team members, regardless of their role, must rigidly observe and enforce regular protocols, on deadline, to ensure efficiency and streamlined traceability through the process.

The stakeholders should also know the program routine and be capable of addressing any potential issues. This will ensure the smooth flow of all controlled substances through every checkpoint. All team members must be ready to perform their roles and make their deadlines—from drug pickup to mailing (or whatever form of disposal is used). Such a tight, regular operation helps avoid surprises and achieve a smooth and predictable flow of controlled substances through the network.

Five: Allowances for Size and Scale

No one single approach will fit all scenarios. An efficient DEA controlled substances management and destruction program must make allowances for all varied drug volumes. These may shrink or grow depending on a variety of circumstances—including market conditions. And obviously, the system must match the type of operation it supports.

For instance, a manager at a pharmacy or clinic will regularly be coping with relatively small amounts of controlled substances, usually with regular customers. On the other hand, an administrator at a large corrections facility or hospital will be dealing with exponentially greater amounts of drugs. This will require a more robust and scalable system. Also, some programs may consolidate individual facilities in a large network, which will require enterprise-level planning for collections, labeling, packaging, and transportation.

Regardless, no matter how large a network is, it must have the same accountability, visibility, and regularity as a small and more easily controlled one. Success here requires careful planning and, ideally, robust electronic tracking and documentation solutions.

Six: Efficiency and Cost Control

As with any system that must collect and dispose of unwanted materials (like hazardous and non-hazardous waste), cost is a key factor. Managers can’t afford to sacrifice performance just to save money—as mistakes and shrinkage can be catastrophic to the organization. That is why regularity and repeatability are so important. Packages, labels, and the like must be standardized and purchased in bulk (to realize discounts or economies of scale) and not as one-offs. When the transporter arrives to take the drugs to destruction or back to a reverse distributor, the expected amounts must be ready to go—without delays or extra trips. This avoids unplanned and potentially expensive custom pickups and drops.

Seven: Performance Metrics

Any system involving logistics, organization, collection, and disposal expenses should have fixed baseline performance goals. Managers must closely monitor these to ensure there is progress towards these objectives. All stakeholders should always seek to make improvements, such as increased load consolidation—or to refine the controls to be more granular. Realistic key performance indicators (KPIs) and other metrics can help guide operational improvement, and ensure the team is meeting baseline goals.

Metrics should include: how often pickups are on time; how quickly the drugs are sorted; and the like. Team members should collect data at regular intervals, so efficient and exhaustive reports can be easily and regularly shared. This will give the stakeholders visibility into exactly how the system is performing. It also will help them pinpoint areas that are doing well—and those that need improvement.

Eight: Flexibility for Improvement and Development

Every major program that touches multiple facilities, stakeholders, and organizations requires periodic review and potential overhaul. Over time, organizations, facilities, and workgroups will grow or shrink. Laws over controlled substances will also often change at the federal, state, and local levels. So, managers must regularly—be it monthly, annually or at some other reasonable interval—perform an audit of the program and match it against KPIs, corporate performance goals, legislative requirements, and so on. They must address any gaps in the operations, as well. This ensures program relevance and prevents the growth of substandard or noncompliant practices. 

Partner for DEA Controlled Substances 

A robust and rigid management program requires time, effort, and financial obligation. For some organizations, it makes sense to use a trusted partner for part (or all) of the program, from collection to attested destruction. This can simplify life for administrators who would rather just focus on core competencies—without the worry of running their own compliant and efficient DEA controlled substances program.

Triumvirate Environmental is one such partner. DEA-approved, we have decades of experience in handling controlled substances, as well as hazardous and non-hazardous waste. We can oversee or supplement a gamut of programs, large or small, supporting:

• Hospitals or clinics
• Research labs
• Pharmacies
• Manufacturers
• Wholesalers

Talk to us today to learn more about how we can help you stay fully compliant with DEA controlled substances management and disposal.