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Requirements for Lock Box Use for Methadone

posted on Fri, Nov 21 2014 1:48 pm by Southeastern Region

The Network was recently contacted by a clinician in Colorado about state laws requiring the use of lock boxes for patients on methadone in licensed methadone treatment centers. She had been told that patients receiving take-home methadone from these centers are required in some circumstances to place the methadone in a locked box, even though patients receiving the same amount of methadone from a primary care clinic for pain treatment do not.

The Network researched the issue and found that there are both federal regulations and Colorado state regulations that explain the discrepancy between the requirements for dispensing methadone to patients at a licensed methadone treatment center and dispensing methadone for pain to patients in a primary care clinic. This is because these regulations only apply to opioid treatment facilities.

The most likely explanation is found in relatively recent Colorado regulations on “take-home dose privileges” for patients receiving Opioid Medication Assisted Treatment (OMAT). In these regulations, there are two separate provisions on transporting take-hone doses based on the number of take-home doses dispensed. For take-home doses numbering 12 or less, the regulations require the methadone to “be transported in a discrete and secure manner agreed upon by OMATs and individuals.” For take-home doses numbering 13 or more, the regulations require methadone to “be transported in locked containers constructed of rigid materials that resist tampering.”

These regulations also require that “take-home doses … be dispensed in medication containers that conform to state and federal poison prevention packaging requirements, including childproof lids.” Further, a label must be affixed to the container that includes the OMAT names, addresses, and telephone numbers; individual (the patient’s) name, drug types, dose amounts, and directions for use.

These state requirements are more stringent than federal regulations that apply to opioid treatment programs, which require only, in relevant part, that take-home methadone doses be “packaged in a manner that is designed to reduce the risk of accidental ingestion, including child-proof containers.”

Because these regulations only apply to opioid treatment facilities, they are not applicable when dispensing methadone in a primary care clinic to patients for pain.