CONTROLLED SUBSTANCES DIVERSION PREVENTION

To enhance awareness by the pharmacy workforce, other healthcare workers, and the public of the potential threats to the public and patient care and safety presented by diversion of controlled substances; further,

To encourage healthcare organizations to develop controlled substances diversion prevention programs (CSDPPs) and supporting policies that delineate the core administrative elements and system- and provider-level controls needed to deter diversion of controlled substances at all stages of medication use; further,

To encourage healthcare organizations to address in their CSDPPs the roles, responsibilities, and oversight of all workers who may have access to controlled substances to ensure compliance with applicable laws and scopes of practice; further,

To encourage healthcare organizations to ensure that all healthcare workers are appropriately screened for substance abuse prior to initial employment and that surveillance, auditing, and monitoring are conducted on an ongoing basis to support a safe patient-care environment, protect co-workers, and discourage controlled substances diversion; further,

To advocate that pharmacists take principal roles in collaborative, interdisciplinary efforts by organizations of healthcare professionals, patient advocacy organizations, and regulatory authorities to develop and promote best practices for preventing drug diversion and appropriately using controlled substances to optimize and ensure patient access and therapeutic outcomes; further,

To advocate that the Drug Enforcement Administration and other regulatory authorities interpret and enforce laws, rules, and regulations to support patient access to appropriate therapies, minimize burdens on pharmacy practice, and provide reasonable safeguards against fraud, misuse, abuse, and diversion of controlled substances.

Rationale

Pharmacy managers and pharmacists-in-charge have increasing responsibility for ensuring controlled substance management and storage across large healthcare organizations. This responsibility has increased as acquisition of physician office practices, clinics, and other non-hospital business units continue. According to the Drug Enforcement Administration (DEA) 2024 National Drug Threat Assessment Summary, the DEA Theft and Loss Reporting Database reveals that the number of unaccounted-for narcotic prescription drugs (opioids) in 2022 was at its lowest in 12 years and continued decline into 2023. Controlled substances are lost through employee theft (or suspected), disaster (e.g., fire, weather, etc.), hijacking of transport vehicles, accidental breakage and spillage, robberies, break-ins and burglaries, as well as other causes. Traffickers continue to manufacture and distribute counterfeit controlled substances and illicit drugs in attempts to expand their customer base and increase profits. Fentanyl and other synthetic drugs, like methamphetamine, are responsible for nearly all of the fatal drug overdoses and poisonings in the United States.

All pharmacies and healthcare organizations that handle controlled substances are required to have storage and distribution systems in place that prevent diversion. Due to the numerous medication access points embedded within hospital distribution systems, diversion can be difficult to detect. Overall, diversion incidents continue to decline; however, controlled substances lost in transit or diverted by medical professionals remain a prevalent threat across the U.S. that can lead to patient harm. Drug addiction among healthcare workers is well documented. One survey suggested that nurses who reported a perception of easier availability of controlled substances were almost twice as likely as others to divert and use a controlled substance. In another survey published in AJHP, 19% of pharmacists reported use of a controlled substance without a prescription during the preceding 12 months. Even the most conservative estimates are that 8–12% of physicians will develop a substance abuse problem at some point during their career, although the exact rate of substance abuse among physicians is uncertain. To ensure compliance with applicable laws and scopes of practice, ASHP advocates that healthcare organizations develop controlled substances diversion prevention programs and policies to describe the roles, responsibilities, and oversight of all personnel who have access to controlled substances throughout the organization. The ASHP Guidelines on Preventing Diversion of Controlled Substances offer detailed suggestions on implementation guidance for pharmacists to employ proactive measures and mitigate diversion in their institutions and communities. ASHP also supports pre-employment screening and ongoing surveillance, auditing, and monitoring of all healthcare workers to reduce the risk of controlled substances diversion.

Healthcare institutions face many challenges in managing controlled substances. New laws and regulations, including DEA quotas and controlled substances monitoring requirements at community outpatient dispensing facilities, are meant to decrease diversion and illegal activity but are also impacting patients and pharmacists. In addition, the DEA has allowed hospitals and clinics with an onsite pharmacy and status as an authorized collector to maintain collection receptacles onsite and administer mail-back programs for controlled substances, adding another layer of complexity to controlled substance disposal. Pharmacists in healthcare organizations are required to meet standards and comply with laws and regulations from a variety of sources, including the DEA, The Joint Commission, Det Norske Veritas, other accreditation organizations, and state and federal governments. The ASHP Statement on the Pharmacist’s Role in Substance Abuse Prevention, Education, and Assistance offers detailed suggestions for pharmacists in addressing substance abuse in their institutions and communities and pending ASHP policy, Recovery and Assistance Programs for Healthcare Workers with Substance Use Disorder, supports non-punitive monitoring programs that allow healthcare workers to return to work after receiving treatment for a substance use disorder.