SAFE USE OF CONTROLLED SUBSTANCES THROUGH REGULATORY REFORM

To advocate for the reform of the Controlled Substances Act (CSA) to align with contemporary healthcare practice standards, with input from pharmacists and other stakeholders; further,

To urge the Drug Enforcement Administration (DEA) to issue transparent and practical guidance when interpreting and applying laws and regulations related to the CSA and other drug laws that affect patient care; further,

To encourage the DEA and other regulatory agencies to balance regulatory requirements with patient access to medically necessary controlled substances when developing regulations and interpreting and enforcing laws and regulations; further,

To promote collaboration among the DEA, professional associations, and regulatory agencies to identify and reduce: 1) barriers to patient care; 2) burdens on healthcare workers; and 3) cost of healthcare delivery in the establishment and enforcement of controlled substance laws and regulations.

Rationale

The Drug Enforcement Administration (DEA) and Department of Justice (DOJ) routinely update regulations and measures to counter substance abuse in the US. Two major implications of these changes include: (1) increasing regulatory burden on pharmacy operations and (2) a lack of standardized education and resources to support pharmacies in adequately responding to DEA inspections.

The mission of the DEA is to enforce U.S. controlled substance laws and regulations. The DEA has the authority to enter the controlled premises of a registered location and conduct administrative inspections both routinely and as circumstances warrant (21 U.S.C. 880 and 21 CFR 1316.03). The primary purpose of an inspection is to ensure compliance with the Controlled Substances Act (CSA) of 1970 regarding record-keeping, inventory, security, access controls, training records, and reports. Inspections can be conducted with voluntary consent of the DEA registrant or by an administrative inspection warrant by any judge of the United States or of a state court of record (21 U.S.C 880). Upon notice of CSA violations, pharmacies may face criminal investigations, civil and administrative actions, letters of admonishment, or even revocation of registration, which can be detrimental to both the organization and individual pharmacists. To mitigate or prevent avoidable CSA violations, transparency and uniformity in DEA interpretation and application of laws and regulations is essential. DEA should provide transparent and practical guidance that clearly communicates expectations, explains enforcement rationale, and maintains publicly accessible, up-to-date information about how it interprets and enforces laws and regulations under the CSA and related drug policies.

Since the original authorship of the CSA in 1970, health-system pharmacy practice has evolved significantly, yet the laws governing controlled substances have remained largely unchanged. Dissonance between practice and law presents ongoing challenges for compliance and vulnerabilities within health systems. Pharmacists and pharmacy technicians responsible for overseeing and monitoring controlled substances often face challenging situations, including how to respond to specific patient care scenarios (e.g., the handling and disposition of controlled substances brought into hospitals by patients) that conflict with the CSA or involve product-specific nuances that are not addressed by the CSA. Modernization of the CSA would provide an opportunity for the DEA to collaborate with key stakeholders, including health-system pharmacists, to achieve greater alignment with practice, improve regulatory compliance, and reduce the overall regulatory burden. Some examples to consider for the modernization of the CSA include expansion and formalization of telemedicine authority for CS prescribing; creation of a national telemedicine registration that would eliminate the need for a state-by-state DEA registration requirement; establishment of risk-based flexibility for patients with chronic conditions who need to maintain continuity of therapy during emergencies; and shifting from weight-based production quotas to dosage-form based quotas to mitigate drug shortages for clinically appropriate care.