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This module focuses on the effective risk management of take-home medication in outpatient methadone treatment, covering federal regulations, monitoring practices, legal considerations, and diversion control policies. It emphasizes criteria for eligibility, clinical judgment, and the responsibility of the medical director for safe storage and administration. The curriculum provides insights into exceptions to take-home medication restrictions, monitoring procedures, and a toolkit for comprehensive patient screening and management. With a focus on liability prevention and clinical guidelines, this module equips practitioners with the knowledge and tools necessary for successful outcomes in methadone treatment programs.
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Effective Risk Management Strategies in Outpatient Methadone Treatment: Clinical Guidelines and Liability Prevention Curriculum MODULE 5 Take-Home Medication
Take-Home Medication • Medical Director responsibility • Federal Regulation (42 CFR, Part 8 § 12(i)): • Absence of recent drug and alcohol abuse • Regular OTP attendance • Absence of behavioral problems at the OTP • Absence of recent criminal activity • Stable home environment and social relationships • Acceptable length of time in treatment • Assurance of safe storage • Rehabilitative benefits outweigh potential diversion risk Clinical Pharmacology, Chapter 5, (TIP) Treatment Improvement Protocol #43. http://www.ncbi.nlm.nih.gov/books/NBK25944/
Federal Guideline Take-Home Medication: Restrictions Clinical Pharmacology, Chapter 5, (TIP) Treatment Improvement Protocol #43. http://www.ncbi.nlm.nih.gov/books/NBK25944/
Take-Home Medication: Exceptions • OTP closed and holidays • Medical conditions • Rehabilitative potential • Emergency circumstances • State & Federal requirements • State approval/coordination • SAMHSA SMA-168 form • SAMHSA • “Dear Colleague” letters • Guidelines for Accreditation Clinical Pharmacology, Chapter 5, (TIP) Treatment Improvement Protocol #43. http://www.ncbi.nlm.nih.gov/books/NBK25944/
Take-Home Medication: Monitoring • Review the rationale • Drug Testing • PDMP review • Review of all prescriptions • Attendance for counseling Clinical Pharmacology, Chapter 5, (TIP) Treatment Improvement Protocol #43. http://www.ncbi.nlm.nih.gov/books/NBK25944/
Take-Home Medication: Legal Federal regulation permits THs for patients; however, it does not absolve the OTP of their legal responsibility.
Take-Home Medication: Policies • The TIP 43 recommends the following diversion control policies: • Return empty bottles • Procedure for those who fail to return bottles • Stay open 7 days a week Clinical Pharmacology, Chapter 5, (TIP) Treatment Improvement Protocol #43. http://www.ncbi.nlm.nih.gov/books/NBK25944/
Take-Home Medication: TOOLKIT • Conduct “call-backs” • Monitor take-home medication • Home safety inspections • Case management staff • Locked containers • Not a total guarantee for safety Clinical Pharmacology, Chapter 5, (TIP) Treatment Improvement Protocol #43. http://www.ncbi.nlm.nih.gov/books/NBK25944/
Take-Home Medication: TOOLKIT • Screen for patients who: • Have children • Are using/abusing substances • Policies to address treatment interruptions: • Travel • Illnesses or disabilities • Bereavement / funerals • Emergencies • Hospitalizations Clinical Pharmacology, Chapter 5, (TIP) Treatment Improvement Protocol #43. http://www.ncbi.nlm.nih.gov/books/NBK25944/
In Summary • Criteria for eligibility • State and federal criteria • Clinical judgment • Medical Director responsibility and accountability • Monitor, reassess and document