Drug Distribution and Control–Guideline 77 ASHP Guidelines on Preventing Diversion of Controlled Substances Purpose The purpose of these guidelines is to provide guid- ance to health systems on planning for and implementing Controlled substances (CS) diversion in health systems can best practices when establishing a comprehensive CSDPP. lead to serious patient safety issues, harm to the diverter, Establishing a comprehensive CSDPP will require engaged and significant liability risk to the organization. Diversion leadership oversight that promotes a culture of organiza- driven by addiction puts patients at risk of harm, including tional awareness, implements and evaluates the effective- inadequate relief of pain, inaccurate documentation of their ness of systems and processes, and works toward continuous care in the medical record, exposure to infectious diseases improvement. The guidelines provide recommendations on from contaminated needles and drugs, and impaired health- developing CS diversion prevention strategies and a frame- care worker (HCW) performance.1,2 In addition to patient work for integrating those strategies into a comprehensive harm, there are regulatory and legal risks to the organization, organizational program that ensures successful implementa- including fraudulent billing and liability for resulting dam- tion. The recommendations outline a collaborative, interdis- ages, and decreased community confidence in the healthcare ciplinary approach to and accountability for CS diversion system. These guidelines provide a detailed and comprehen- prevention and response within the organization. Some sive framework to support organizations in developing their topics outlined in these guidelines are the subjects of other CS diversion prevention program (CSDPP) in order to pro- ASHP Best Practices documents, which should be referred tect patients, employees, the organization, and the commu- to for additional information and guidance. Pharmacy lead- nity at-large. Ultimately, each organization is responsible for ership and other key stakeholders within healthcare organi- developing a CSDPP that complies with applicable federal zations should use their professional judgment when deter- and state laws and regulations but also one that applies tech- mining applicability to their own needs and circumstances. nology and diligent surveillance to routinely review process compliance and effectiveness, strengthen controls, and seek Scope to proactively prevent diversion.3,4 Diversion of CS is common, but it is rarely discussed These guidelines address all settings in which health-system openly. Some recent high-profile events are raising new pharmacies typically have responsibility for purchasing, awareness to the prevalence of this issue and its implica- procuring, and distributing CS, including, but not limited tions. It is estimated that 10–15% of HCWs misuse alcohol to, inpatient settings, outpatient and community pharma- or drugs at some point in their careers, which is similar to 5 cies, organization-owned clinics, and physician practices. the general population. With the role HCWs have in taking The broad range of CS diversion prevention strategies rec- care of patients and the accessibility of CS in the work en- ommended in this document supports a culture of safety for vironment, organizations must routinely evaluate their em- 6,7 patients and HCWs and includes a suggestion that healthcare ployees, systems, and patient care environments. It is im- organizations define how to address impaired HCWs. To en- perative that healthcare organizations develop CSDPPs that courage dissemination and adoption of the strategies and include support systems for the work force (e.g., employee recommendations outlined in this document, Appendix A assistance programs, professional monitoring programs), provides a list of definitions of terms used in this document methods to monitor effectiveness of diversion prevention and in diversion prevention generally. Appendix B provides efforts, and patient safety considerations. Education on the additional guidance regarding implementation strategies, signs and symptoms of impaired HCWs—supported by rig- examples of best practices, and key action steps described orous monitoring and surveillance, human resources man- within the guidelines that can assist in self-assessment. agement, awareness of state and national diversion reporting Some of these approaches are relatively straightforward and requirements, and substance abuse treatment programs—is can be implemented within the pharmacy. Other approaches paramount for healthcare organizations. In addition, health- are more complex and require collaboration throughout the care organizations are not immune to the larger societal is- organization and, in some cases, with vendors. Successful sues associated with substance abuse, including the recent diversion prevention requires systematic attention to and in- exponential rise in accidental overdoses, and should there- tegration of both types of approaches. When selecting and fore ensure that there are systems in place to positively influ- implementing these strategies, it is essential that the organi- ence prescribing, procurement, dispensing, administration, zation remains mindful of patient safety and the quality of and proper disposal and wasting of CS.8-15 patient care; patients must still be ensured access to timely There are many points where diversion may occur and care and effective pain management. many methods of diversion (Figure 1). CSDPPs that build in tight control through process checks and balances, diligent surveillance, and prompt interventions are required to pre- Core Elements of a CSDPP vent, promptly identify, and investigate suspected diversion. Such programs require a rapid response by key stakeholders, A comprehensive CSDPP includes core administrative ele- using established processes and time frames as defined by the ments (e.g., legal and regulatory requirements, organization organization. Clear policies, procedures, and lines of account- oversight and accountability), system-level controls (e.g., hu- ability should be in place for dealing with such investigations man resources management, automation and technology, mon- and reporting in a timely and thorough manner. itoring and surveillance, and investigation and reporting), and 78 Drug Distribution and Control–Guideline Figure 1. Examples of common risk points and methods of diversion. CS = controlled substances, DEA = Drug Enforcement Administration, ADD = automated distribution device. ● Purchase order and packing slip removed from records Procurement ● Unauthorized individual orders for CS on stolen DEA Form 222 ● Product container is compromised ● CS are replaced by product of similar appearance when prepackaging Preparation and ● Removing volume from pre-mixed infusion Dispensing ● Multi-dose vial overfill diverted ● Prepared syringe contents are replaced with saline solution ● Prescription pads are diverted and forged to obtain CS ● Prescriber self-prescribes CS Prescribing ● Verbal orders for CS created but not verified by prescriber ● Written prescriptions altered by patients ● CS are withdrawn from an ADD on discharged or transferred patient ● Medication documented as given, but not administered to patient Administration ● Waste is not adequately witnessed and subsequently diverted ● Substitute drug is removed and administered while CS is diverted ● CS waste is removed from unsecure waste container Waste and Removal ● CS waste in syringe is replaced with saline ● Expired CS are diverted from holding area provider-level controls (e.g., chain of custody; storage and Billing and Fraud Implications. CS diversion also has security; internal pharmacy controls; prescribing and admin- billing fraud implications. When there are diversions with istration; returns, waste, and disposal) (Figure 2). This frame- known documentation or processes that have impacted the work is driven by key principles that include a collaborative integrity of the billing process, additional actions may be approach, setting clear lines of accountability and responsi- required. Organizations, with input from pharmacy, should bility, implementation of standard processes, and a culture take the initiative to self-monitor practices to prevent, iden- of continuous readiness and quality improvement. When an tify, and correct potential fraud, waste, or abuse in collabora- organization has multiple Drug Enforcement Administration tion with relevant departments (i.e., corporate compliance, (DEA) licenses, all organization policies and procedures re- finance, and internal audit).18 lated to the CSDPP should be applied consistently. DEA Registrations. The organization should be aware of Legal and Regulatory Requirements applicable DEA registrations under its control and appoint a registrant who will be accountable for enforcement of re- The procurement, prescribing, administration, and transfer quirements. Powers of attorney issued by a DEA registrant of CS are highly regulated by federal and state laws and reg- should be current and reevaluated on a regular basis (i.e., ulations, as well as compliance standards (e.g., those of the at least annually). There should be procedures in place for Joint Commission and Centers for Medicare and Medicaid reporting suspected or known diversion to DEA and other Services), and these requirements must serve as the foun- appropriate local authorities, with the appropriate person dation for the organization’s policies