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)):
1.
2.
3.
4.
5.
6.
7.
8.
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
Length of Time
Months
Dose
First 90 days
1-3
1 dose per week
Second 90 days
4-6
2 doses per week
Third 90 days
7-9
3 doses per week
Fourth 90 days
10-12
6 days’ supply per week
1 year (continuous treatment)
13-24
2 weeks’ supply
25-36
1 months’ supply, but monthly OTP
visit required
2 years (continuous treatment)
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/
6
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/
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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