Recommended Changes in Federal and State Oversight for OTPs 


Currently, many organizations are being compelled to focus on changing policies to make take-home medication more flexible for patients, both stable and unstable, during the COVID-19 pandemic. A good deal has been written about the complexity and comprehensive nature of SAMHSA’s regulations and guidelines for OTPs, especially in the March 2015 Federal Guidelines for OTPs and the fact that it is 79 pages in length. OTPs have followed these guidelines since the SAMHSA regulations were published in 2015 and when SAMHSA released its OTP regulations during May 2001. For the most part, they provide guidance to the field, based on years of proven clinical practice standards and evidence-based care. While they are extremely detailed and should be considered for some modification, as a whole, they provide useful guidance to the field.  


The existing SAMHSA criteria in determining take-home doses should be cautiously reevaluated even though the existing requirements appear to be reasonable and based on years of clinical practice. It is also reasonable to change the current regulation paradigm, which cites that the medical director is making the determination of the patient’s ability to receive take-home medication and expanding this decision-making responsibility to program medical practitioners to make such determinations.  


SAMHSA criteria for patient take-home doses 

(i) Absence of recent abuse of drugs (opioid or nonnarcotic), including alcohol; 

(ii) Regularity of clinic attendance; 

(iii) Absence of serious behavioral problems at the clinic; 

(iv) Absence of known recent criminal activity, e.g., drug dealing; 

(v) Stability of the patient’s home environment and social relationships; 

(vi) Length of time in comprehensive maintenance treatment;  

(vii)  Assurance that take-home medication can be safely stored within the patient’s home and 

(viii) Whether the rehabilitative benefit the patient derived from decreasing the frequency of clinical attendance outweighs the potential risks of diversion. 


Some states currently require that OTPs be open seven days a week, especially in treating newly admitted or unstable patients. Once again, changes in federal regulations should be woven into the policy tapestry and aligned with state regulatory agencies and reimbursement entities.  AATOD recommends that SAMHSA work with State Alcohol and Drug Abuse Authorities in addition to the State Opioid Treatment Authorities to provide greater flexibility in how OTPs provide take-home medication based on the lessons learned during COVID-19. Current regulatory criteria with regard to time and treatment, to be eligible for take-home medication, must be carefully reevaluated.  


Additionally, a review of state regulatory policies is needed regarding staffing to patient ratios, the use of pharmacists in preparing onsite and take-home medications, and the use of lockboxes when patients do get take-home medication. The use of lockboxes creates a number of difficulties for the patient, especially since it becomes more obvious to other parties that the patient is carrying such a box. If the treatment program trusts that the patient will use such take-home medication appropriately, the use of a lockbox becomes questionable. Obviously, the circumstances are different if clinically unstable patients are being provided with take-home medication. This is why such regulatory issues need to be better resolved. 


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