Establishing a Controlled Substance Compliance Program

July 2017 - Vol. 14 No. 7 - Page #2

Recent events, including the nationwide opioid addiction crisis and accounts of DEA-imposed monetary penalties on hospitals that are noncompliant with the Controlled Substances Act, have increased awareness of diversion in the hospital setting. Although reliable statistics on the prevalence of diversion in hospitals are not available, diversion is common and can occur at any institution. Diversion of controlled substances by health care workers is a clear threat to patient safety.1

A review of Centers for Disease Control and Prevention (CDC) data and medical literature searches documented six infection outbreaks related to health care worker diversion of controlled substances in the hospital setting within a 10-year period.2 Two of these outbreaks involved gram-negative bacteremia in 34 patients from potentially contaminated patient-controlled analgesia (PCA) pumps, and four outbreaks involved hepatitis C virus infection in 84 patients resulting from tampered syringes and vials of fentanyl. Nearly 30,000 patients were potentially exposed to blood-borne pathogens.

The gravity of these patient-safety events, as well as the pressures of imminent, unannounced DEA visits, are motivating pharmacy leaders to act quickly and decisively to mitigate risks. Establishing a comprehensive controlled substance compliance program, including preparing for a DEA audit, conducting a biennial controlled substances inventory, developing an interdisciplinary team, introducing automated anesthesia cabinets to the ORs, establishing proper monitoring processes, and developing policies and procedures (P&Ps) can significantly improve an organization’s controlled substance management.

Start With the Basics

Many US hospital pharmacy leaders are preparing for the inevitable DEA audit. Just the thought of an audit can be daunting, and may fuel hospital-wide anxiety. As with any other problem that requires a solution, it is best to start with the basics.

Begin by ensuring that all of the hospital’s DEA licenses and applicable state licensures and certificates are up-to-date. Establish a contact person, who has a reminder set to renew licensure at least 3 months prior to expiration, to prevent a lapse in coverage. Moreover, it is important to ensure that all power of attorney (POA) documents are up-to-date. Typically, the president or CEO of the hospital is the registrant of the DEA license. The president or CEO would then give POA to the pharmacy chief/director and any other pharmacy managers that may sign DEA 222 order forms. It is a best practice to review all POAs on an annual basis in the event of personnel changes within the institution.

Another basic DEA requirement that often is overlooked is the performance of a biennial inventory of all Schedule II-IV controlled substances. This requires a physical count of all inventories in all locations of the institution, not simply within the confines of the pharmacy. Generating reports that show the current inventory quantities in automated dispensing cabinets (ADCs) or electronic inventory software is not sufficient to perform a full and accurate biennial inventory. The elements of an appropriate inventory include3:

  • Must be performed at least every 2 years
  • The final inventory report must state “biennial inventory” with the institution’s name, date, and time
  • The inventory must be done at the start or close of business
  • Controlled substances that expired or that have not yet been destroyed must be included
  • The inventory must include the medication name and dosage form, the number of units or volume in each container, and the number of containers of each finished form

Interdisciplinary Teamwork

It is important to note that ensuring compliance with the DEA and local regulatory bodies should not be the sole responsibility of the pharmacy department; engage nursing and physician leadership when devising the initial compliance plan and oversight. It is critical to form an interdisciplinary committee, including representation from the following departments: pharmacy, nursing, anesthesiology, compliance, human resources, risk management, and security.

Establishing an interdisciplinary committee helps support the business case for additional staff or equipment needed to bring the institution into compliance. It is best to be transparent with senior leadership; referencing other hospitals nationwide that have received hefty monetary fines for non-adherence to DEA requirements can be an effective tool for gaining buy-in. Investing in necessary equipment or staff support in the short run may help mitigate millions of dollars in fines in the long run.4

Introducing Automation in the Operating Room (OR)

One of the key targets of diversion control and controlled substance monitoring is the OR environment. In a highly acute, emergent area, it can be difficult to maintain the chain of custody of controlled substances. Best practices to support appropriate transactions in the OR include installing automated anesthesia cabinets, adopting disposal and destruction systems to dispose of controlled substance waste, and implementing equipment to test the validity of controlled substances prior to destruction.

  • Automated Anesthesia Cabinets. The use of automated anesthesia cabinets in the ORs facilitates access to controlled substances while maintaining safe, secure storage. These cabinets also support the documentation of controlled substances used, wasted, and can document a witness when required.
  • Disposal and Destruction Systems. Hospitals may define the requirement to render controlled substances irretrievable in multiple ways. The use of disposal systems, such as smart sinks, which facilitate safe disposal of controlled substances by deactivating the active component of the substance, bring standardization to this practice.
  • Refractometry or Spectroscopy. Refractometry or spectroscopy can be used to test the pedigree of controlled substances that were drawn up into a syringe or container but not used. If it is not feasible for all waste to be tested, developing a randomized method to test substances can be used as a diversion deterrent.

Controlled Substance Monitoring

Monitoring and auditing controlled substance use can be an overwhelming challenge, especially if technology is not in place to support the process. Important mechanisms that help ensure controlled substances are being utilized appropriately include the capacity to adjudicate all transactions and the availability of an electronic medical record that can be easily audited.

Software is available to assist nursing, pharmacy, and anesthesia leadership in identifying anomalous ADC usage. These programs can compare one user’s dispensing and administration activity to other users’ transactions. Ideally, the software should have the capability to interface with the ADC software and the electronic health record. Having an automated mechanism to generate reports of specific transactions can significantly increase the efficiency and accuracy of auditing compared with a manual process.

Policy and Procedures

All basic DEA requirements, as well as those more detailed measures to deter and prevent diversion, should be outlined in an institution’s policies and procedures (P&Ps). Developing and implementing a hospital- or health system-wide controlled substance policy is a best practice. P&Ps should encompass procurement, purchase order acknowledgements, inventory, waste, reporting, and monitoring. All P&Ps involving controlled substance management should be reviewed on an annual basis to ensure they reflect current hospital practices.


Controlled substance diversion from the hospital setting impacts addiction rates and can help fuel the US opioid epidemic. Hospitals are responsible for ensuring controlled substance security to prevent diversion for non-medical purposes. Developing a comprehensive P&P for controlled substance management, adopting the use of automation and technologies that track and identify anomalous use of controlled substances, conducting biennial controlled substance audits, and properly preparing for a DEA audit are effective methods of preventing unauthorized use.


  1. Brummond PW, Chen DF, Churchill WW, et al. ASHP guidelines on preventing diversion of controlled substances. Am J Health Syst Pharm. 2017;74(5):325-348.
  2. Schaefer MK, Perz JF. Outbreaks of infections associated with drug diversion by US health care personnel. Mayo Clin Proc. 2014;89(7):878-887.
  3. CFR 21 1304.11 Inventory Requirements.
    2014-20926/disposal-of-controlled-substances. Accessed May 19, 2017.
  4. United States Department of Justice. The United States Attorney’s Office, District of
    Massachusetts. September 28, 2015. Accessed May 19, 2017.

Caryn Belisle, RPh, MBA, is the director of pharmacy regulatory compliance, quality, and safety at Brigham and Women’s Hospital in Boston, Massachusetts. She received her BS in pharmacy from the Massachusetts College of Pharmacy and her MBA from the University of Massachusetts. Caryn is the current president of the Massachusetts Society of Health-System Pharmacists. Her areas of expertise include USP <797>, sterile product robotic and workflow technology, regulatory compliance, patient safety, and pharmacy operations.


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