1. Effective Risk Management Strategies in Outpatient Methadone Treatment: Clinical Guidelines and Liability Prevention Curriculum MODULE 5 Take-Home Medication

2. Medical Director responsibility Federal Regulation (42 CFR, Part 8 § 12(i)): 1.Absence of recent drug and alcohol abuse 2.Regular OTP attendance 3.Absence of behavioral problems at the OTP 4.Absence of recent criminal activity 5.Stable home environment and social relationships 6.Acceptable length of time in treatment 7.Assurance of safe storage 8.Rehabilitative benefits outweigh potential diversion risk Clinical Pharmacology, Chapter 5, (TIP) Treatment Improvement Protocol #43. http://www.ncbi.nlm.nih.gov/books/NBK25944/

3. Federal Guideline Take-Home Medication: Restrictions Length of TimeMonths Dose First 90 days1-31 dose per week Second 90 days4-62 doses per week Third 90 days7-93 doses per week Fourth 90 days10-126 days’ supply per week 1 year (continuous treatment) 13-242 weeks’ supply 2 years (continuous treatment) 25-36 1 months’ supply, but monthly OTP visit required Clinical Pharmacology, Chapter 5, (TIP) Treatment Improvement Protocol #43. http://www.ncbi.nlm.nih.gov/books/NBK25944/

4. 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/

5. 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. 6 Take-Home Medication: Legal Federal regulation permits THs for patients; however, it does not absolve the OTP of their legal responsibility.

7. 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/

8. 8 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/

9. 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/

10. In Summary Criteria for eligibility ▫State and federal criteria ▫Clinical judgment Medical Director responsibility and accountability Monitor, reassess and document