ASHP Guidelines on Preventing Diversion of Controlled Substances

Abstract

Controlled substances (CS) diversion in health systems can lead to serious patient safety issues, harm to the diverter, and significant liability risk to the organization. Diversion puts patients at risk of harm, directly or indirectly, including inadequate relief of pain, inaccurate documentation of their care in the medical record, exposure to infectious diseases from contaminated needles and drugs, and impaired healthcare worker (HCW) performance.1,2 In addition to patient harm, there are regulatory and legal risks to the organization, including fraudulent billing and liability for resulting damages, and decreased community confidence in the healthcare system. These guidelines provide a detailed and comprehensive framework to support organizations in developing their CS diversion prevention program (CSDPP) in order to protect patients, HCWs, the organization, and the community at-large. Ultimately, each organization is responsible for developing a CSDPP that complies with applicable federal and state laws and regulations, but also one that applies technology and diligent surveillance to routinely review process compliance and effectiveness, strengthen controls, and seek to proactively prevent or detect diversion.3,4 Although rarely discussed openly, diversion of CS is common, and serious events have highlighted the prevalence of this issue and its implications. It is estimated that 10% to 15% of HCWs misuse alcohol or drugs at some point in their careers, which is similar to the general population.5 HCWs may also divert for sale or for use by someone else. With the role HCWs have in taking care of patients and the accessibility of CS in their work environment, organizations must routinely evaluate their employees, systems, and patient care environments for opportunities to prevent diversion.6,7 It is imperative that healthcare organizations develop CSDPPs that include support systems for the workforce (eg, employee assistance programs, professional monitoring programs), methods to monitor the effectiveness of diversion prevention efforts, and patient safety considerations. Education on the signs and symptoms of impaired HCWs—supported by rigorous monitoring and surveillance, human resources management, awareness of state and national diversion reporting requirements, and substance abuse treatment programs—is paramount for healthcare organizations. In addition, healthcare organizations are not immune to the larger societal issues associated with substance abuse, including the recent exponential rise in accidental overdoses, and should therefore ensure that there are systems in place to positively influence procurement and storage, prescribing, preparation and dispensing, administration, and proper disposal and wasting of CS.8-15 There are many points in the medication management process where diversion may occur (Figure 1). CSDPPs that build in tight control through process checks and balances, diligent surveillance, and prompt interventions are required to prevent, promptly identify, and investigate suspected diversion. Such programs require proactive surveillance and a rapid response by key stakeholders, using established processes and time frames as defined by the organization. Clear policies, procedures, and lines of accountability must be in place for conducting such investigations, reporting findings, and implementing corrective action plans in a timely and thorough manner. The purpose of these guidelines is to provide guidance to health systems on planning for and implementing best practices a comprehensive a comprehensive CSDPP a require that a of awareness and and the effectiveness of systems and and The guidelines provide on developing CS diversion prevention and a framework for a comprehensive program that the organization, of The a to and accountability for CS diversion prevention and response the organization. in these guidelines are the of which should be to for and and key healthcare organizations should use their professional to their and of risk points and methods of diversion. These guidelines in which have for and of but not care and community care and and The of CS diversion prevention in this a of safety for patients and HCWs and to impaired and of these and in this and in diversion prevention guidance of best and key action the guidelines that can in of these are and can be the are and require the organization in some with diversion prevention to and of of and implementing these is that the organization of patient safety and the of patient patients must be to timely care and comprehensive CSDPP (eg, legal and regulatory requirements, organization and (eg, human resources management, and monitoring and surveillance, and and and (eg, of and and and (Figure framework is by key that include a lines of accountability and of and a of and organization with and to the CSDPP should be Controlled substances diversion prevention The and of from procurement and to prescribing, dispensing, administration, and is by federal and state laws and as as compliance (eg, of organizations and the for These must as the for the and or through the use of and must legal and regulatory requirements, but not to and and procurement and of including and and reporting (eg, monitoring surveillance, and reporting of CS diversion or to CS to or and documentation of and the CSDPP of CSDPPs and procedures, such as required by professional CS diversion also billing implications. there are with documentation or processes that have the of the billing may be with from should the to practices to prevent, identify, and or abuse in with (eg, and The organization should be of applicable its control and a be for of and of by a should be and on a at There should be in place for reporting suspected or diversion to and required with the in with and may in their and for and to suspected diversion or in their for may and for and of and for assistance responsible for their CSDPP should be with and state and work to risk to the organization and ensure should ensure and of required required in and of documentation procurement and and surveillance and investigations, and to and such documentation should be for the established by and as required by the organization. organizations should develop for the of medical and substances a and should of the and to substance abuse programs patients substances the organization, as required by of HCWs, and the should work with the legal to and and these as as the of patients, in developing the It should be in the of medical and and laws from state to It is imperative that organizations a CSDPP that diversion and suspected diversion and to or suspected diversion and to organization with and a accountability a framework for a should support the CSDPP by including human controls, and The role is for the be for a for organization and accountability include the for The organization CS management program in compliance with and regulatory and with systems that diversion and and points of a of where there are processes for diversion and ensure that the of and accountability are and at are at and there is a in the or (eg, or to ensure that are applicable best practices and are the organization. HCWs to or CS are and in established policies, procedures, and regulatory of its organization a that and organization with to and of the The organization CSDPP to provide and for developing and and for the The CSDPP is proactive in its prevention and prevention diversion reporting procedures, and The CSDPP is by a diversion of the The of this are with compliance management programs, and the at directly to the of the organization. are and have with defined from the human risk management, administration, and employee must have a role on the CSDPP diversion response should be established to to suspected and to the should be and on the and of the It is that healthcare organizations CS diversion prevention with the to to patient safety and a of awareness that comprehensive human resources to support the CSDPP should at a include a employee and substance abuse and and awareness a employee and assistance support and systems (eg, for including a for and for and for and diversion should in or to the of substance abuse prevention and assistance programs healthcare and organizations must to protect patients from harm to substance abuse and diversion and have a process to suspected of impaired from patient care and to prevent to CS or a diversion or should ensure compliance with federal and state laws to and applicable The should the or for or and should ensure that or are and should the is or substance use that of or there of CS for sale and The substance abuse should in which is to support a substance use Such diversion should be to applicable and the should be to a substance abuse The substance abuse should also to a from the the of or not with substance abuse program or requirements, and guidance on the organization should and the There are signs that CS and HCWs to their role in diversion. The should the that HCWs of or issue to CS diversion and should ensure that HCWs be from a suspected issue to CS diversion. The organization should therefore and for HCWs to (eg, compliance or to a The organization should such as and to protect the of the and the of the the HCWs should and in diversion prevention and substance abuse and diversion awareness and and symptoms of and reporting and at on medication diversion and CS and should be required or to to HCWs should be that compliance checks occur and that HCWs be for compliance with policies, and the should HCWs that have the to suspected diversion and that the such as The organization should the of reporting the signs of a impaired or suspected CS diversion and the on patient including for to should also and to is in and their should of a or suspected diversion. The organization should a process to support for HCWs are CS for substance abuse employee assistance program which may include program reporting to the state or professional assistance and a for the to for should be as required for or by or organizations should and and for The organization should have to the of to to patient care there a the organization should have a that to there may be on patient such as control and should for (eg, human are should ensure that HCWs CS and that the the organization there is action or is of for HCWs, the should or provide processes and accountability for and reporting suspected and there should be with to and to and to and support (eg, employee assistance diversion in or in the These require of the and of suspected but also require that be which to be to be and and the of be for including and diversion monitoring have to with the management of including documentation of administration, and of and The use of the of care for the process in healthcare systems are to provide patient provide of and ensure of the process in healthcare and surveillance that support surveillance, and processes should be at in to be risk include the CS and and their of and and surveillance require in the of and of and and review of the of in the and in the organization should with work to develop and and plans for their technology of and technology to support a CSDPP include the for that in the and of systems (eg, surveillance and technology (eg, and to ensure support diversion surveillance, and of CS and and role in the and or to technology are by key stakeholders, including to the on systems of surveillance, and and the are and to ensure that and of this and with the and a for are in a and by the CSDPP CS management and technology with healthcare organizations to provide that support surveillance, and that the of to and including to the and have the to and from technology systems but not of that diversion and of and to CS is to and is to one and at a time should not be from technology are and required to and is to ensure that are and that are technology (eg, diversion monitoring medical and are for dispensing, and HCWs are their and in the use of and including surveillance and their is is a or there is a to is to including and management, and to ensure that are in place to to CS in by the of with as as the to or and that and are established in the of or The organization, through its CSDPP should and that CS diversion and ensure that and are on in a timely and that corrective action plans are (Figure should for and require CS monitoring and surveillance on the and use of and including timely to that support surveillance and system. the CSDPP should the and of documentation and response to suspected diversion events and compliance with established and systems and diversion monitoring are to support surveillance, for or The CSDPP with from the diversion and compliance should the monitoring and surveillance efforts, including required and compliance surveillance for for and of and conducting established of diversion monitoring and documentation of suspected diversion The organization, through the CSDPP should and at surveillance requirements, including the of monitoring and surveillance of that require reporting and surveillance The organization, through the CSDPP should ensure that are in a timely and as program and (Figure should be for compliance on a (eg, at The CSDPP should provide to ensure that established for diversion monitoring are and The use of diversion monitoring with to support monitoring and surveillance is and surveillance processes should be and of the CS management from management, administration, and to documentation through process should be and at for CS should be on a as by processes in a such as patient care care and the on risk points (Figure and should be as as by to the The organization should compliance with diversion controls, including human resources for to CS (eg, of required documentation of and for HCWs, compliance with for for requirements, and compliance with program of surveillance practices include the for of The healthcare organization a with support and time for surveillance is for the and of and diversion monitoring reporting (eg, are in surveillance monitoring and and with of and for procurement surveillance are by that CS their (eg, (eg, of is The healthcare organization through to diversion through or in or CS are with CS and the the may be with CS also are to or to detect process is in place to in or of CS and to of the of CS from the to patient care with documentation patient care of a should be on a with the with the to the time for It is to in a timely the for the can be CS through have each time a CS is by CS in are CS are at each by CS in the CS is at of CS is and state requirements, is the of CS the organization is and are (eg, CS with the with of practices and are and significant from should be are at by and patient care as defined by the organization, and the of the review and are with medication response to medication is also medication documentation of and patient The medication is for the and and with HCWs on there is in patient management and surveillance or including signs of symptoms of substance abuse, and review of and wasting and monitoring of for and and reporting of suspected diversion in with organization management patient to that patients the CS and the response (eg, that the medication and also to patient and medication on patient or patients of medication may point to diversion at the time of medication is with in the medication in which patient response is not as and are similar of medication are to the for of there are of CS the and these a medication process is in place to CS and the time in which must be It is that CS be to the in and as as the of the work and that to be are by the to ensure the of the that be are to and are by and patient care with to is of and the is and a is responsible for the of the a with these are for documentation (eg, to in the CS or and of and are of documentation practices by HCWs is for diversion. in with CS at in by the with the as and the as may occur through surveillance may be in that are not or by surveillance The organization CS that are and include of from or (eg, and as by and in with state and federal and The organization should (eg, care and include of risk for diversion (eg, diversion of (eg, of and controls, state of awareness of and of harm (eg, to the of and technology should be in to and of monitoring and surveillance should be defined by the organization but include where the is prescribing, and the such as and and are also where of CS are and the The is a and are for which organizations should of in the health should be routinely with documentation of and as as The should be responsible for drugs and CS and in these the of the be many of the for these as by state and federal there is a should be in each and should be a to the and should be the and are the is not a may be to The and should to the drugs and required for this including of the and and the accountability to be should be and resources the for and timely monitoring of CS and of diversion. to drugs as and monitor should be The on provide guidance on best practices to CS management for these patient care and It is imperative that there is a detailed and thorough to and reporting suspected diversion. and can have serious patient and compliance implications. should be a diversion and to with to occur as defined in the should be in place to the and and the of required Although the in the where diversion is suspected in conducting the to the should be to ensure that not influence the The or or and diversion should be of suspected diversion the organization and in and reporting should include the for is by the CSDPP with to the review including the and organization legal documentation of the and of and are as and as at a reporting is that the is or that there a or diversion. the there is and of in the and defined by the HCWs are in with the and with the organization of of for use of the organization of the to diversion The organization to or the or action (eg, to or the The organization to CS diversion is suspected the is and a of diversion or risks to patient care is The organization guidelines for such as and is with to review processes to is required to be to is responsible for the and for the The organization reporting for diversion or of CS in with laws and The organization in with the a should be for that There are for of for a or significant is to be and the be to the of the diversion must be significant a review should be by the CSDPP including a and to prevent from the where there is a suspected diversion should be in the and of prevention the CSDPP should a proactive diversion risk such as by conducting a and of there are and are technology or technology are and systems are of the risk review should be to as of the The organization should have a and process to to patients and are by CS diversion. The organization should also have guidelines for the and of the and processes should to the are and is responsible for the and to also and protect and diversion control systems on implementing that the of is at and at points the of CS or to the (eg, to use of systems, to medical or from on the to the of point the of should be and to detect and The organization should and a that HCWs with to CS may not their to in a that the for the of (eg, not medical record, or not key and to this of The of CS to a and by may not the of the of In addition, should be in is (eg, a to ensure that the CS is and as by should be in place to ensure the and of the of and the safety of and (eg, or should be to The should not the (eg, should be and should be and (eg, with The of must also to or to or as of or In in which CS or drugs are directly to patients (eg, in and must ensure that the of is and CS are to medical (eg, the organization should ensure that are in place that with and federal and ensure that the of is and the of CS is and for and of CS require a that (eg, (eg, or and checks and surveillance to to be in a timely manner. of CS and include the for CS are in a and (eg, at in the control of implementing or and controls, the and safety of HCWs are CS in or is such or the for storage, and as and are not and are in a to not in use or for on (eg, medication or CS are to the of time that is for the There is a defined process to ensure that have to to CS is and to There is a of HCWs with to ensure that to employees, or with have and of There are and CS including through key controls, and the use of should be at and (eg, or with a is CS and that are not are with that a or is and for are (eg, and are to the and there is a to and their of and are to have to or CS be to provide surveillance should be in where there is risk for diversion (eg, community in where or is not in and to with diversion should be and for a to for It is to work with the and human resources to review state laws and that the use of such surveillance, as as the and technology should be in CS including the and and CS to or from the there should be a or process in the and are in place to monitor for In of the at one of conducting the is with management, CS are by or (eg, or are to prevent or and the time for of the management, a is at but one of conducting the is a The or CS disposal or to a CS by or are by a each time a CS or is technology is is for CS by by HCWs a not CS not through are by HCWs at the and of the is for CS are in a and to these are and as with and to or CS (eg, are and with the as CS to prevent or are established to to ensure are in place to CS and prevent diversion of CS the organization by should be to their to a or patients or their may be with to to their or to a for in with and state a for disposal of CS by patients or their CS should be are to be to the patient to a medication on of the and with their These should be and in a a patient is not to of their to of or or are documentation of the and of HCWs should be in the medical of the and as as for The organization should the of time to be and in such should of the as by or their Diversion for guidance on proper disposal CS should be in a and of (eg, the patient or signs to of the medication and its patients substances the organization, should of the as required by include to and of These processes to Diversion can occur at points these and is to key to opportunities for diversion. include the of to order of and of HCWs through the and for in It is that these processes be by the review at a of and for CS are from the or are to there are checks and established to ensure the and are the organization. There are in place that of CS by not by the organization. CS may be by and for with of CS is or use of are are in a on a and to to order are to to ensure that are by of the and of and in CS and that the and documentation one of the is The process is by a There is a process to investigate and CS are in the from the or There are processes to and CS where preparation is to and from a that ensure the of is for or of CS (eg, from a the and required documentation CS are CS procurement is for and to applicable laws and are in place for patient care of the organization that are control that support the to provide and to ensure proper procurement are is and a process is or CS from a to is with to the the and to the provide a diversion through or are for or and is for diversion. diversion CS are and in Diversion are in place CS are and are routinely to ensure and of CS in patient care and require of and from the patient care and (eg, a have of are for CS may be by are in with the and to and or required by CS and are and by systems with in are there are in place to and these and to the and and guidelines that include CS should be in with are by and with the to and diversion should not patient treatment or patient of and diversion include the for order from for CS and the of CS is There is a process to and or a system. There is also a process to and and by medical or are to CS the (eg, use of a for which the or order is with to or of the or and the monitoring program to with and dispensing, or required by and for CS are and CS are the a patient to a of The medical in and with and for CS there is not a time or of CS are from the and to patients by a or of and such is in the medical is the can be to the patient (eg, established to for a patient is at CS are from by the responsible for the medication to the patient and as to the time of as as defined by organization and to the care for in or are and these are for The CS for a patient is the or the the to be CS (eg, systems, of is for dispensing, and of and in patient care CS are not in and is that these processes may be in some and are not to The in these are as required by and the control of the the are required from a (eg, there is a in place to the and the documentation of CS but and there is a process to the CS to should be in a and not to the in the These should not be for and should be and of to prevent CS are in (eg, the use of or and in the for for may include for but not to the patient (eg, a order or a patient or a is from its (eg, or may also include in and in The practices should of to the risk for CS diversion. CS should be or as to the time of as The wasting of CS and at but of the should be should and timely documentation of CS wasting should the that the or the that the the in the and that the wasting for disposal and in a that the CS defined by the The process of and wasting should be the can be that the CS and not a or is methods and for and disposal of CS are as defined in and laws and of and of CS include for but CS that may be are to the or to a to the and using a require that the of be and that of is In patient care where is through the the is by the and the medication to the in the from which the medication In patient care for the and CS including are and by organization are established that ensure the of is is to the for conducting or are not to the for for of The of wasting and the documentation of CS are by the and the of in which this may not be include wasting a CS in

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