Drug diversion is a tremendous challenge for hospitals and pharmacies, creating risk for patients, clinicians, and the entire health care system. Most diversion goes undetected and/or unreported due to its covert nature and the unreliability of traditional reporting like monthly usage reports. This makes it difficult to obtain precise data, but a wide range of investigations and studies have found that approximately 10% of US health care workers are abusing controlled substances.
In addition, poor recordkeeping and failure to notify the DEA of any issues can contribute to the misuse of controlled substances as well as overdoses or other damages to hospitals, pharmacies, and patients.
The American Society of Health-Systems Pharmacists recommends a framework for preventing drug diversion driven by four key principles. These four principles center around creating a collaborative approach, clear processes for accountability and responsibility, implementation of standard processes, and an overall culture of continuous readiness and quality improvement.
A recent drug diversion settlement at the Department of Justice highlights the importance of adhering to the Controlled Substance Act (CSA). A failure to maintain accurate records of controlled substances resulted in Northeast Hospital Corporation, a part of Beth Israel Lahey Health, agreeing to pay $1.9 million in civil penalties.
The allegations centered around non-compliance in recordkeeping, wherein Northeast placed orders of controlled substances under Beverly Hospital’s registration, but the drugs were sent to their affiliated locations without notifying the DEA of the inter-registrant transfers.
With the availability and easy access to medication in health care organizations as well as the risk of non-compliance with the CSA, a comprehensive controlled substances diversion prevention program (CSDPP) is crucial.
What is Drug Diversion?
Drug diversion is the removal of controlled substances by an individual who intends to use it for a purpose other than what it is prescribed for. This may be a pharmacist, physician or nurse who steals it for their own use, a delivery driver who skims drugs from the inventory to sell, or a patient who uses deception to try and get a particular prescription.
Drug diversion occurs when any staff member within the health system or anyone involved in the process takes a controlled substance from the institution for personal sale, use, or distribution to others.
Signs of Drug Diversion
Abnormal behavior from staff or team members
- Are staff members in areas where they shouldn’t be?
- Are they asking questions about medications or procedures that they have no reason to be asking about?
- When asked, are they saying they haven’t found any diversion issues?
Abnormal behavior from patients
- Is the patient reluctant to cooperate with an exam or give a full history?
- Do they give reasons for needing to get the medication quickly, like having to catch a plane or get to an appointment?
Complaints from patients
- Sometimes a patient’s complaint – like a pain medication not working – may indicate that the drug (i.e., opioid) was tampered with or has been replaced.
Inconsistent data and analytics
- Are there any notable patterns in how and when the drugs are moved?
- Is one person withdrawing a larger amount than others?
- Are counts of controlled substances off?
- Do vials look dirty or used or like the labels are worn?
Steps to Prevent Drug Diversion
The American Society of Health-Systems Pharmacists recommends a framework for preventing drug diversion that is driven by four key principles:
- a collaborative approach
- clear processes for accountability and responsibility
- implementation of standard processes
- and an overall culture of continuous readiness and quality improvement
With that in mind, here are nine steps that health care systems can implement to help prevent drug diversion.
- Establish a Defined Process with Clear Policies and Procedures
Prevent drug diversion by implementing policies and practices designed to deter, detect, and respond to issues. Address core administrative elements like legal and regulatory requirements, organization oversight, and accountability.
Set up system-level controls to create checks and balances so that one person does not control the entire process. Utilize automation and technology, set up monitoring and surveillance, ensure appropriate procedures for reporting, lay out a clear process of investigation, and communicate the outcome/consequences of diversion for providers and staff members.
Create individual-level controls around chain of custody, storage and security, internal pharmacy controls, prescribing and administration, returns, waste and disposal.
The process you put in place can change and adapt as you grow.
- Bring in Fresh Eyes for a New Perspective
Even with excellent policies and procedures in place, it’s easy to grow complacent and not be accountable to the processes. Bringing in an outside third party for auditing will provide an added level of oversight and accountability.
Form a diversion committee to report to so that there is oversight, then send the report up the chain. Pharmacy can be a black box, so accountability is key.
- Incorporate Automation and Technology
Automated dispensing technology and diversion monitoring software have become standard of care within healthcare organizations to assist with the prevention of drug diversion. This can be implemented at every touchpoint, including inventory control, monitoring and security, tracking chain of custody, prescribing and administration, preparation and dispensing, documentation of waste and removal, auditing, and reporting
Automated dispensing cabinets (ADC) are ideal for high-risk areas (i.e., the main pharmacy with a controlled substance vault, anesthesia and procedural areas, emergency departments, and surgery centers). But even with the extra level of security it provides, automated dispensing and its technologies still require diligent monitoring and review, including records, integrated solutions, competency, etc.
- Implement Protocols to Track Procurement and Inventory
Procurement is a vulnerable step in the process where there is high risk of drug diversion. Checks and balances between ordering and receiving inventory are imperative, and setting up procurement controls is key.
Purchasing safeguards should be put in place to ensure only authorized individuals are ordering controlled substances. An electronic ordering system should be used to minimize the risk. If a paper DEA Form 222 is used, the form should be locked in a secure location and recorded in an inventory log.
Separate individuals should be responsible for the ordering and receipt of medications, and two authorized individuals should count and check in controlled substances to ensure invoices and documentation match.
Procedures should exist to ensure chain of custody within the organization, and all paperwork should be reviewed and filed according to applicable laws and regulations.
Access to inventory should be limited. Controls should be used to identify who accesses the inventory, when they access it, and what changes are made so that an audit trail will be easily available. Inventory should also be inspected for alteration or tampering, and any discrepancies should be investigated.
- Create Standards for Prescribing, Dispensing, and Administration
Safety and security lapses can happen when prescribing, dispensing, and administering medications. Healthcare organizations should develop and implement clear standards and protocols to help prevent drug diversion. Key elements of these protocols should include the following:
- Medication should only be administered by licensed providers within their scope of practice.
- There is a process – either electronic or manual – in place to identify and verify authorized prescribers.
- Controlled substances are required to be retrieved from the storage area as close to the administration time as possible.
- Packaged medications should be dispensed in the exact amount as the dose ordered, or as close to that amount as possible and in packaging where any tampering will be clearly evident.
- The packaging will be inspected for integrity during inventory, before dispensing, and when being administered.
- Labeling standards for syringes will be established, and syringes will be kept under direct control of the person administering it.
- Multiple providers must witness the removal, destruction, or waste of controlled substances.
- Develop Methods for Drug Waste, Removal, and Destruction
Inventory, dispensing, and administration should be routinely evaluated for opportunities to reduce waste and improve the normal protocols. Medication should be stocked in as ready-to-use of a form as possible and in the lowest commercially available units that are frequently prescribed. (Example: avoid the use of vials with multiple doses.)
Similarly, controlled substances should be disposed of immediately or as close to the time of administration as possible, following established timeframes. All disposal requires an independent witness and clear documentation with waste receptacles being installed in the line of sight in order to ensure chain-of-custody controls.
Waste receptacles should ensure that the medication can not be retrieved or reused. Potentially reusable products that are issued from an ADC should have a secure and auditable verification and inspection protocol when being returned. Additionally, empty containers are to be discarded in a way that they can not be retrieved.
Identify expired medications and store them separately so they can be properly accounted for and returned or destroyed as required. All quantities should be recorded and reconciled before any expired or unused medication leaves the pharmacy.
- Storage and Security
Storage and security of medication require a coordinated approach that includes camera surveillance, physical controls to limit access, and frequent audits.
Automated dispensing cabinets should be used in areas with a high volume of controlled substances, including the pharmacy, anesthesia, and surgery locations. ADCs should keep medications locked and secure, maintaining chain-of-custody controls at all times with witnesses and verification protocols.
A clear and defined process (including password use, key controls, etc.) ensures that only authorized personnel have access to controlled substances. Individuals with access privileges are assessed every six months to ensure that only those who are permitted can have access. Access privileges should be removed immediately if anything changes in their authorization (i.e., no longer employed).
Use camera surveillance in storage areas where there is a high risk for diversion, in locations where electronic access is not available, and in remote locations. Verify that video files are archived and retrievable for investigations.
Create controls around monitoring inventory for discrepancies. Conduct both routine audits as well as random audits for verification of inventory count, including expired or unusable controlled substances that are scheduled for disposal. Documentation used to procure or prescribe controlled substances should also be secured and maintained per legal requirements.
- Consistent Monitoring and Surveillance
Monitoring and surveillance processes touch every aspect of the drug diversion prevention system, from procurement to waste and disposal, relying on the availability and use of data and information. Data reports should be created and audited on a regular basis to identify potential signs of diversion.
Diversion monitoring software can be implemented to gather this data and support surveillance activities, like monitoring the ADC reports, tracking unusual patterns in prescribing, or identifying variations or changes in the volume or pattern of drug purchasing. Track any noticeable activities related to medication inventories, cancellations, and returns.
Patient response to their medication should also be evaluated to identify any indications that the medication has been altered at administration. For example, evaluate whether pain is adequately controlled and nursing assessment notes match both the medication administration record (MAR) and the patient’s reports.
All variances should signal an opportunity for improvement and require investigation. Any discrepancies should be investigated and resolved when they are discovered.
Drug diversion is often due to opportunity. So, be visible. Round and speak regularly with everyone who may be involved (i.e., nursing, pharmacy, anesthesia, PAs). Conduct random unannounced audits throughout the system because the visibility shows people you’re watching.
- Audit Continually
Drug diversion can often be a slow leak, and the process of auditing allows health care organizations to discover it and stop it in a timely manner. Frequent audits minimize the time window for discovery and help to prevent discrepancies.
Be vigilant. If you see anything that seems off, take it seriously. Keep looking until you find out what’s going on. Being proactive with audits allows you to discover the problem before it gets worse.
The more eyes that are on the auditing process, the better. Create drug diversion committees that the auditors will report to. This should be done in every department so that there is more oversight.
Perform routine audits of the processes and practices to ensure they are operating as intended. Bottom line: Audit for problems. Fix the problems. Make continuous improvements to the process.
Provider Responsibilities in Preventing Diversion
Drug diversion can lead to serious patient safety issues, harm to the person diverting, and significant risk to the health care organization. Providers must implement an effective CSDPP to protect patients, health care workers, the organization, and the community at large. This includes:
- compliance with both state and federal laws and regulations
- prevention through secure physical barriers as well as the implementation of robust policies and procedures
- monitoring using diligent surveillance as well as routine reviews to strengthen controls
- detecting thefts and reporting and rectifying the situation immediately.
Providers have an obligation to find and report errors, to take action immediately, and to be active and not passive in order to address drug diversion before it happens or gets worse.