The DATA 2000 act requires prescribers to complete an eight-hour training course, which will allow them to prescribe buprenorphine to a limited number of patients. The DATA 2000 waiver also requires prescribers to give patients regular urine drug tests and maintain records to track that patients are taking the medication as directed. This includes checking to make sure that patients are not sharing the medication, overusing it, or mixing it with other opioids, marijuana, alcohol, or other medications. 

In some cases, poor prescribing practices or failure to adhere to the DATA 2000 requirements have resulted in buprenorphine misuse or diversion.

Setting clear expectations for patients and requiring them to read and sign an informed consent and treatment agreement can be part of an effective strategy to reduce diversion and misuse of buprenorphine.

The form should define or provide examples of misuse and diversion. It should explain how buprenorphine works and the phases of treatment, along with patient responsibilities that include agreeing to take the prescription only as prescribed and to not sell, share, or give the medication to another person.

The informed consent and treatment agreement should also require the patient to:

• Comply with required film/pill counts and urine drug screens
• Notify the agency immediately if medication is lost or stolen
• Keep the agency informed of current phone number
• Manage the prescription safely, by storing it in a locked safe
• Discuss use of other medications or opioids with the agency physician
• Notify the agency immediately in case of relapse
• Attend all treatment sessions

See sample agreement from the Addiction Resource Center at Mid Coast Hospital in Maine.

Patients who fail to show for required intensive outpatient therapy sessions may be misusing or diverting their medication. Inform patients that their medication will be discontinued if they fail to appear for therapy sessions.

The Addiction Resource Center (ARC) in Maine uses the following system to determine whether to continue medication after no-shows:

Requiring patients to take their medication in front of the prescribing physician or other qualified medical professional can be an effective strategy for preventing diversion or misuse.

Pill/film counts

Ask patients to bring in their prescriptions for unannounced pill or film counts.  With this procedure, the treatment agency notifies a patient that they must appear at the agency with their unused medication within a specified time period.  A failure to show could indicate that the patient is misusing or diverting the medication.

Ask patients to bring in their prescriptions for unannounced pill or film counts.  With this procedure, the treatment agency notifies a patient that they must appear at the agency with their unused medication within a specified time period.  A failure to show could indicate that the patient is misusing or diverting the medication.

Buprenorphine will be present in the urine of a patient who has taken the medication. It will not show in the urine of patients who are not using the medication properly.  To prevent falsified urine collections, some treatment agencies have all urine tests observed by a same-sex staff member.

Prescription Drug Monitoring Programs (PDMPS) collect data on prescriptions that have been prescribed and dispensed by pharmacies and dispensing practitioners.  States use the data from PDMPs to support their efforts to prevent abuse and enforce safe use of prescription medications.  PDMPs are currently active in 49 states.

The Prescription Drug Monitoring Program Training and Technical Assistance Center  (PDMP TTAC) provides:

• Links to each state’s PDMP
• Case studies documenting the effectiveness of PDMPs.

The case study, Keeping Patients Safe: A Case Study on Using Prescription Monitoring Program Data in an Outpatient Addictions Treatment Setting found that at one outpatient opioid addiction treatment program, “unknown to clinical medical staff, approximately 23% of patients were being prescribed significant quantitates of opiates, benzodiazepines, and other controlled substances from providers outside the clinic.”

PDMPs can be particularly useful to physicians who prescribe buprenorphine and help them identify patients who might be misusing or diverting their medication.