Controlled Substance Diversion Prevention Policy

1. Policy Statement

It is the policy of this organization that all controlled substances shall be managed through a comprehensive Controlled Substance Diversion Prevention (CSDP) program that maintains secure chain of custody from procurement through administration and waste, supported by an organizational culture of safety that promotes prompt, confidential, and nonpunitive reporting of suspected diversion. Each controlled substance administration shall be accompanied by a valid order from an authorized prescriber. All healthcare team members with access to controlled substances shall receive role-specific training and demonstrate competency in controlled substance handling processes.

2. Purpose

This policy exists to:

• Protect patients from harm caused by diversion of controlled substances intended for their care.
• Establish clear expectations for professional behavior, chain of custody, access controls, and waste processes throughout the controlled substance lifecycle.
• Define a comprehensive CSDP program that empowers healthcare workers and leadership to create a safe, healthy work environment.
• Establish detection, investigation, and reporting processes for suspected or confirmed diversion.
• Support the recovery and safe return to practice of healthcare workers experiencing substance use disorders, treating addiction as a chronic illness requiring treatment rather than solely punitive response.

3. Scope

This policy applies to:

• All employees, contractors, agency staff, students, and volunteers with access to controlled substances in any organizational setting.
• All controlled substances throughout the medication pathway: procurement, storage, dispensing, transportation, preparation, administration, and waste.
• Pharmacy, nursing, physician, advanced practice, and allied health personnel who prescribe, dispense, prepare, administer, or witness waste of controlled substances.
• All clinical settings within the organization, including inpatient units, emergency departments, perioperative areas, ambulatory infusion centers, home health, and hospice settings.

4. Policy Requirements

4.1 Organizational Framework and Culture

4.1.1 Policies and Procedures. Organizational policies and procedures shall accurately reflect local and regional regulatory requirements in all aspects of controlled substance management. Policies shall be reviewed at minimum annually and updated immediately when regulatory changes occur.

4.1.2 Stakeholder Collaboration. The CSDP program shall be developed and maintained through collaboration with key stakeholders including: Pharmacy, Providers, Nursing, Law Enforcement (as applicable), Vendors, Healthcare Leadership, Infection Prevention, Contracted Services, Risk Management, Human Resources, and Biomedical Engineering.

4.1.3 Cultural Expectations. The organization shall establish and communicate clear expectations for professional behaviors that discourage abuse of controlled substances. These expectations shall be reinforced during orientation and regularly through education and leadership modeling.

4.1.4 Reporting Culture. The organization shall communicate each employee’s obligation to recognize and promptly, anonymously report behaviors that may be associated with diversion. Reporting shall be confidential and nonpunitive. Retaliation against an individual who reports suspected diversion in good faith is a policy violation subject to disciplinary action.

4.2 Chain of Custody

4.2.1 A secure chain of custody shall be maintained for controlled substances at every point in the medication pathway. This includes: locked transport containers from pharmacy to unit-based storage, secured automated dispensing cabinets (ADCs) accessible only to authorized staff, and locked devices when controlled substances are transported from storage to the point of administration.

4.2.2 Automated Dispensing Cabinets. ADCs and medication-related automated systems shall require: initial and ongoing staff training and competency verification, regular validation of proper user access levels, regular review of override lists, ongoing system maintenance, and established downtime procedures. Organizations should consider establishing interoperability between ADCs and the electronic health record to improve surveillance and detection capabilities.

4.2.3 Access Control. Access to controlled substances shall be restricted through: keys, biometrics, or badge access systems. High-risk, high-volume areas shall be identified for enhanced surveillance and medication pathway controls. Camera surveillance should be considered for high-risk areas. Authorized staff shall not delegate their individual access credentials or share access to controlled substances in ways that alter chain of custody.

4.2.4 Patient-Supplied and Transferred Substances. The organization shall maintain processes to secure controlled substances that patients bring into facilities and substances that arrive with patients transferred from other facilities.

4.3 Prevention Strategies

4.3.1 Opioid Stewardship. The organization shall implement an opioid stewardship program to optimize dosing, support multimodal pain relief, and educate patients and caregivers on diversion prevention. The program shall address home care and hospice settings with specific procedures for controlled substance waste and shall include screening of patients and caregivers for history of addiction or risk of misuse where controlled substances are in active use. The organization shall investigate abuse-deterrent formulation preparations of oral opioids to reduce diversion potential.

4.3.2 Pre-Employment Screening. Background checks shall be conducted for all healthcare workers with access to controlled substances, consistent with applicable law and organizational policy.

4.3.3 Order Review. Clinical staff shall review controlled substance orders carefully for accuracy and appropriateness for individual patients. Electronic prescribing of controlled substances shall be used whenever possible. Paper prescription pads shall be secured so that only authorized individuals have access.

4.3.4 Administration Process Compliance. Controlled substances shall be stocked in ready-to-administer form in the lowest available units typically prescribed to minimize waste volume. Preparation shall occur as close to administration time as possible. Dose preparation shall be limited to single doses when possible. When delays occur between preparation and administration, chain of custody shall be maintained by the preparing clinician. Syringes containing controlled substances shall be labeled per organizational policy if not immediately administered, and control of the medication maintained at all times. Continuous infusions or patient-controlled controlled substances shall be administered through secure devices that prevent unauthorized access or tampering.

4.3.5 Education and Training. Controlled substance diversion education shall be provided to all personnel with access to these medications—including unlicensed and contracted personnel—at initial orientation and regularly thereafter. Training shall cover:

• Professional responsibility to protect public safety.
• Risk factors for substance use disorder, addiction, and diversion.
• Signs, symptoms, and behavioral patterns that may indicate diversion.
• Medications at high risk for diversion.
• Preventive measures in place within the organization.
• Proper documentation for all controlled substance transactions.
• Diversion investigation processes.
• Civil, criminal, and disciplinary consequences of confirmed diversion.
• Professional obligation to report suspected diversion.

4.4 Waste Management

4.4.1 Proper adherence to controlled substance waste processes is mandatory. Waste shall occur at medication removal or promptly after administration within an organizationally established timeframe.

4.4.2 An independent witness shall physically observe and validate the accuracy of volume or dose of medication to be wasted. The witness shall not be the same individual who removed the medication.

4.4.3 All waste receptacles shall be secured and tracked. Controlled substances shall be disposed of in a manner that renders them irretrievable and unusable. The organization should utilize waste products that convert controlled substances to non-retrievable states allowable for landfill disposal.

4.4.4 The organization shall maintain processes for controlled substance tracking with prompt resolution of medications that are expired, unusable, returned, or subject to loss of chain of custody.

4.5 Recognition and Detection

4.5.1 Drug Testing. The organization shall implement drug testing as appropriate to detect potential diversion and impaired practice in accordance with local jurisdiction and governing board requirements.

4.5.2 Waste Testing. Waste-testing technology may be implemented to detect saline replacement of controlled substances as a diversion tactic.

4.5.3 Discrepancy Investigation. Controlled substance discrepancies shall be investigated and resolved promptly. Routine audits of the medication pathway shall be conducted to detect potential diversion. Audits shall review: prescribing patterns for anomalies, system-generated reports for patterns and trends in medication retrieval, documentation for accuracy and unusual patterns, and patient pain management trends to identify deviations in actual medication delivery compared to documented administration.

4.5.4 Immediate Response to Impairment. When a healthcare worker is suspected of being impaired, organizational processes shall be activated immediately to: remove the individual from patient care delivery, prevent access to controlled substances while investigation is conducted, and initiate the organization’s impaired provider protocol.

4.5.5 Regulatory Reporting. Confirmed diversion and unaccounted loss of controlled substances shall be reported to proper entities in accordance with licensing, local laws, and regulations. The organization shall maintain systems to rapidly identify and manage infectious outbreaks attributable to controlled substance diversion.

4.6 Recovery and Return to Practice

4.6.1 The organization shall establish and communicate processes to support the confidentiality and recovery of healthcare workers experiencing substance use disorders. Substance use and addiction shall be regarded as chronic illnesses, with organizational goals of retention, rehabilitation, and reentry into practice when appropriate and safe.

4.6.2 Alternative-to-discipline programs implementing evidence-based recovery strategies shall be utilized when permitted by the applicable licensing board and when consistent with patient safety. These programs are associated with increased success in supporting recovery and enabling safe return to practice.

4.6.3 The organization shall establish monitoring processes for healthcare workers returning to clinical practice after recovery to ensure patient safety is protected during the reintegration period.

5. Compliance

5.1 Monitoring. Compliance shall be monitored through: regular audits of ADC access logs, override rates, and discrepancy patterns; waste witnessing compliance rates; annual controlled substance education completion rates; tracking of reported discrepancies and investigation resolution times; and regulatory audit outcomes.

5.2 Key Performance Indicators.

• Controlled substance discrepancy rate and resolution time (target: all discrepancies resolved within organizationally defined timeframe).
• Waste witnessing compliance rate (target: 100%).
• Controlled substance education completion rate (target: 100%).
• ADC override rate (target: year-over-year reduction).

5.3 Enforcement. Confirmed controlled substance diversion shall result in immediate suspension of access, investigation through the organization’s interprofessional diversion review process, reporting to applicable regulatory and law enforcement agencies, and disciplinary action up to and including termination. Failure to report known or strongly suspected diversion is itself a policy violation subject to disciplinary action.

6. Exceptions

6.1 In emergent resuscitation situations where controlled substance administration occurs without a pre-existing order, a verbal order shall be obtained from the responsible physician and documented in the patient’s health record within the organizationally defined timeframe, and waste shall be witnessed as soon as the emergency has stabilized.

6.2 No exception shall be granted to the requirement for witnessed waste or the prohibition on sharing access credentials.

7. Related Documents

• ASHP Guidelines on Preventing Diversion of Controlled Substances
• ASHP Guidelines on the Safe Use of Automated Dispensing Cabinets
• DEA Regulations on Controlled Substance Management
• Organizational Impaired Provider Policy
• Organizational Progressive Corrective Action Policy
• Organizational Alternative-to-Discipline Program Policy
• POL-009: Patient Education in Infusion Therapy
• POL-012: Documentation in the Health Record for Vascular Access
• Controlled Substance Diversion Reporting Form
• Impaired Provider Response Protocol

8. Revision History