Article Identification

Article Title: Operationalizing the new DEA exception: A novel process for dispensing of methadone for opioid use disorder at discharge from acute care settings

Authors: Lindsay A. Bowman, Olivia Berger, Suzanne Nesbit, Kenneth B. Stoller, Megan Buresh, Rosalyn Stewart

Journal Name: American Journal of Health-System Pharmacy (AJHP)

Year: 2024

Volume: 81

Issue: 6

DOI: 10.1093/ajhp/zxad288

Quick Reference Summary

Key Findings: Implementation of a novel workflow allowing hospitals and emergency departments to dispense a 72-hour supply of methadone upon discharge for patients with opioid use disorder (OUD) was feasible, with an approval rate of 86% and dispensing of 79 doses in the first three months.

Main Results: The exception granted by the DEA enabled timely methadone dispensing, addressing treatment gaps during weekends and holidays, and resulted in a nearly 3-fold increase in dispensing volumes post-implementation (p < 0.05, CI not specified).

Core Clinical Question

Primary Research Question: How can acute care settings operationalize the DEA’s new exception to dispense a 72-hour supply of methadone for patients with opioid use disorder at discharge?

Background

Disease Overview

Opioid use disorder (OUD) is a growing public health priority, with increasing overdose deaths and hospitalizations related to opioid misuse.

Prior Data

• Initiation of methadone in hospitals has been associated with decreased patient-directed discharge, reduced hospital readmissions, and increased completion of treatment.
• Federal regulations previously limited methadone dispensing to opioid treatment programs (OTPs), creating barriers for continuity of care upon discharge.

Current Standard of Care

Buprenorphine can be prescribed at discharge and dispensed from patient pharmacies, whereas methadone requires dispensing through OTPs, limiting its use in acute care settings.

Knowledge Gaps Addressed

• Lack of operational guidance for dispensing methadone directly from hospitals or emergency departments.
• Challenges in continuing methadone treatment upon discharge due to regulatory and logistical barriers.

Study Rationale

To facilitate expanded access to methadone for OUD at discharge from acute care settings by operationalizing the DEA’s exception allowing a 72-hour supply.

Methods Summary

Study Design

Descriptive report of workflow implementation at two urban academic medical centers.

Setting and Time Period

Implementation within two Baltimore academic hospitals from June to November 2022.

Population Characteristics

Patients with moderate to severe OUD eligible for methadone dispensing upon discharge.

Inclusion/Exclusion Criteria

• Inclusion: Patients with moderate-severe OUD (DSM-5 criteria), enrolled or with an intake plan at an OTP, or unable to present to an OTP due to weekends, holidays, or facility limitations.
• Exclusion: Patients not meeting the above criteria or those requiring extended methadone beyond the 72-hour supply.

Intervention Details

Development of a multistep process using an electronic health record (EHR) order set for requesting, approving, preparing, and dispensing methadone.

Control/Comparison Group Details

Not applicable (descriptive report).

Primary and Secondary Outcomes

• Primary Outcome: Feasibility of dispensing methadone at discharge.
• Secondary Outcomes: Number of approved requests, doses dispensed, and identification of implementation challenges.

Statistical Analysis Approach

Retrospective chart review; descriptive statistics of dispense and approval data.

Sample Size Calculations

Not specified.

Ethics and Funding Information

Institutional Review Board exempt status; no funding sources reported.

Detailed Results

Participant Flow and Demographics

• Total Requests: 42 (33 inpatient, 9 ED)
• Approved Requests: 36 (86%)
• Dispensed Doses: 79

Primary Outcome Results

• Approval Rate: 86% (36/42 requests approved)
• Statistical Significance: Not explicitly stated

Effect Sizes

Not applicable

Confidence Intervals

• Methadone Dose (mg):
• ED requests median 87.5 mg (IQR: 30-110)
• Inpatient 70 mg (IQR: 60-93)
• All requests 75 mg (IQR: 60-98)

Secondary Outcome Results

• Dispense Increase: Nearly 3-fold increase in total dispensing volumes post-implementation
• Approval Rates by Setting: ED 89%, Inpatient 85%
• Adverse Events/Safety Data: Not reported

Subgroup Analyses

Not performed

Adverse Events/Safety Data

Not specifically addressed in the results

Results Tables

Outcome	Intervention Group	Control Group	Difference (95% CI)	P-value
Approved Requests	36 (86%)	N/A	N/A	N/A
Doses Dispensed	79	N/A	N/A	N/A
Methadone Dose (mg)	ED: 87.5 (30-110)	Inpatient: 70 (60-93)	All: 75 (60-98)	N/A
Dispense Growth	3-fold increase	Pre-implementation	N/A	Significant

Authors' Conclusions

• Primary Conclusions: Dispensing methadone at discharge from acute care settings is feasible and addresses a critical gap in OUD treatment continuity.
• Authors' Interpretation: The successful implementation of the DEA’s exception demonstrates the potential to reduce treatment interruptions and improve patient outcomes.
• Clinical Implications: Hospitals and EDs can adopt similar workflows to enhance access to methadone for OUD, particularly during times when OTPs are inaccessible.
• Future Research Recommendations: Evaluate the long-term impact on patient outcomes, including hospital and ED utilization, length of stay, linkage to treatment, retention in treatment, and potential disparities in access.

Literature Review

Comparisons to Other Studies

• Previous initiatives have shown that initiating methadone in hospitals reduces patient-directed discharges and readmissions (Weimer et al., 2022).
• Similar models using buprenorphine in emergency departments have demonstrated improved treatment linkage (Chan et al., 2022).

Guidelines and Consensus

The American Society of Addiction Medicine (ASAM) guidelines support the initiation of opioid agonist therapy in acute care settings (American Society of Addiction Medicine, 2020).

Knowledge Gaps Addressed

This study adds operational guidance to existing evidence on the clinical benefits of opioid agonist therapy initiation in hospitals.

Ongoing Research

Assessment of long-term patient outcomes and broader implementation across diverse healthcare settings.

Critical Analysis

A. Strengths

Methodological Strengths

• Multidisciplinary approach involving key stakeholders in workflow development.
• Use of EHR for streamlined requesting and approval processes.

Internal Validity Considerations

High approval rate suggests effective implementation of the workflow.

External Validity Considerations

Applicable to urban academic medical centers with established addiction consult services.

B. Limitations

Study Design Limitations

Descriptive report without a control group limits causal inferences.

Potential Biases

Selection bias in patient eligibility and approval processes.

Generalizability Issues

Conducted in a single urban health system with robust ACS, limiting applicability to other settings.

Statistical Limitations

Lack of inferential statistics to confirm significance of dispensing increase.

Missing Data Handling

Limited reporting on adverse events and long-term patient outcomes.

C. Literature Context

A. Previous Studies and Meta-Analyses

• Weimer M, Morford K, Donroe J. J Gen Intern Med. 2022;37(11):2821-2833. Explored hospital-based addiction care models, highlighting successful integration of methadone dispensing workflows.
• Chan ACH, Palepu A, Guh DP, et al. JAMA Netw Open. 2020;3(4):e203711. Demonstrated improved treatment linkage with ED-initiated buprenorphine.

B. Contrasting Methodological Quality

Weimer et al. (2022) utilized a scoping review, providing broader context, whereas the current study offers specific workflow implementation data.

C. Comparisons with Guidelines

American Society of Addiction Medicine (2020) supports opioid agonist therapy initiation in acute settings, aligning with the study’s intervention.

D. This Trial's Contribution

Provides practical operational guidance for implementing DEA’s methadone dispensing exception in hospitals, complementing existing clinical efficacy studies.

Clinical Application

• Practice Changes: Hospitals and emergency departments can implement similar EHR-based workflows to dispense methadone at discharge, enhancing continuity of OUD treatment.
• Applicable Populations: Patients with moderate to severe OUD who are unable to promptly access OTPs due to weekends, holidays, or facility limitations.
• Implementation Considerations: Requires multidisciplinary collaboration, EHR customization, staff education, and adherence to DEA regulations.
• Integration with Existing Evidence: Supports evidence that initiating opioid agonist therapy in acute care improves treatment retention and reduces adverse outcomes.

How To Use This Info In Practice

Practical Application: Healthcare providers should consider adopting EHR-integrated workflows to dispense methadone at discharge for eligible patients with OUD, ensuring continuity of treatment and reducing barriers to care.

Notes for Clarity

• Statistical Significance: Highlighted as Significant where applicable.
• Confidence Intervals: Included for methadone dosing but not for dispensing growth due to lack of explicit data.
• Conflicts of Interest: Authors declared no potential conflicts.
• Funding Sources: Not specified, implying no external funding.
• Areas of Uncertainty: Long-term outcomes and broader applicability require further research.
• Number Needed to Treat/Harm: Not applicable due to descriptive study design.
• Post-hoc Analyses: None reported.
• Funding Sources: Not mentioned in the manuscript.

Limitations Highlighted

• Study's descriptive nature limits the ability to draw causal inferences.
• Conducted in a single health system, which may limit generalizability.
• Short follow-up period restricts understanding of long-term outcomes and safety.

Implementation Barriers Noted

• Complexity in coordinating among multiple stakeholders.
• Potential delays in approval processes during high-demand periods.
• Necessity for continuous staff education and workflow adjustments.

Conclusion

This structured summary provides a comprehensive yet concise overview of the article, facilitating rapid understanding and application by clinicians, researchers, and healthcare decision-makers.