On 10/28/2016 the American Society if Health-System Pharmacists (ASHP) announced the publishing of the first set of national guidelines designed to help healthcare organizations devise and implement strategies to prevent the diversion of controlled substances. The guidelines include a framework for creating a collaborative, comprehensive controlled substances diversion prevention program (CSDPP) to protect patients, employees, organizations, and the community1. The guidelines in their entirety can be found by our readers in the second listed below2 as well as clicking the link: http://www.ashp.org/DocLibrary/BestPractices/MgmtGdlCSDiversion.aspx. (Please note this link is to a prepress version of guidelines that will appear in final form in AJHP at a future date in 2017).
The purpose for ASHP publishing these new guidelines regarding controlled substances (CS) diversion in health systems is because it can lead to serious patient safety issues, harm to the diverter, and significant liability risk to the organization. Diversion driven by addiction puts patients at risk of harm, including inadequate relief of pain and inaccurate documentation of their care in the medical record, exposure to infectious disease from contaminated needles and drugs, and impaired healthcare worker (HCW) performance. In addition to patient harm, there is regulatory and legal risk to the organization, including fraudulent billing and liability for resulting damages, and decreased community confidence with 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, employees, 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 diversion2.
These guidelines address all settings in which health-system pharmacies typically have responsibility for purchasing, procuring, and distributing CS, including, but not limited to, inpatient settings, outpatient/community pharmacies, organization-owned clinics, and physician practices. The broad range of CS diversion prevention strategies recommended in this document supports a culture of safety for patients and HCWs and includes a suggestion that healthcare organizations define how to address impaired HCWs2. The guidelines encourage healthcare organizations to develop a CSDPP that complies with applicable federal and state laws and regulations; supports rigorous monitoring and surveillance, human resource management, and substance abuse treatment programs; and establishes systems to positively influence prescribing, procurement, dispensing, administration, and proper disposal and wasting of controlled substances. Other elements of an effective CSDPP include use of technology to routinely review process compliance and effectiveness, strengthen controls, and proactively prevent diversion as well as staff education on the signs and symptoms of impaired healthcare workers. Notably, the new guidelines also feature two appendices that provide definitions of commonly used terms and specific guidance regarding implementation strategies, examples of best practices, and key action steps to assist in self-assessment1, 2.
The publication of these national guidelines is an important step to address the issue of CS diversion and prevention. According to the 2015 National Drug Threat Assessment (NDTA), abuse of controlled prescription drugs is more common than that of cocaine, methamphetamine, heroin, MDMA, and PCP combined. Pharmacists face increasing pressure to ensure the security of controlled substances across large healthcare organizations, even as those organizations seek to identify and prevent diversion and abuse of prescription drugs by healthcare workers1. Additionally, the expert guidelines committee notes that healthcare organizations should develop procedures for the disposition of patient’s CS, medical cannabis, marijuana, and illicit substances brought into a facility. Procedures should address notification of the local authorities when patients bring illicit substances into the organization, as required by law. Pharmacy leaders, representatives of other affected HCWs, and the security department should work closely with the organization’s legal counsel to interpret and weigh legal, regulatory, and accreditation requirements regarding these substances, as well as the rights of individual patients, in developing the organization’s policies. It should be noted that, especially in the case of medical cannabis and marijuana, possession and prescription laws vary from state to state2.
The ASHP Expert Guidelines Committee was comprised of experts from the ASHP Section of Pharmacy Practice Managers. Amongst the notable experts serving on this panel was Pharmacy Consulting International (PCI) senior consultant Toni Fera, Pharm.D, a nationally recognized expert in the practice of pharmacy.
As always, readers of this blog are highly encouraged to completely review and familiarize themselves with the information provided in the links below as well as many of the cited references within these documents. Additionally, interested parties seeking professional consulting guidance and support on the topic of controlled substance diversion prevention and how their pharmacy practice or institution can achieve the objectives of these expert guidelines should call Pharmacy Consulting International (PCI) at 321-622-8448.