Ford Research Group
The following best practices were identified that relate to the establishment of lab protocols prior to offering naltrexone injections.
A urine drug testing policy and procedure should outline (a) how the urine drug test will be conducted, (b) who will be responsible for conducting the test, (c) who will be responsible for confirming the results prior to providing the injection, (d) steps needed if the results are positive, and (e) how the results will be communicated to the patients’ prescriber. In addition, the pharmacist needs to ensure that urine drug testing equipment is in stock in the pharmacy.
A Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver is required if a pharmacy is going to administer any lab tests, including a rapid urine drug test, as part of the process to provide injectable naltrexone.
More information can be found at How to Obtain a CLIA Certificate of Waiver. Note: there may be fees associated with obtaining a CLIA certificate. Please refer to the CLIA Certificate Fee Schedule for more information.
After the pharmacy conducts the urine drug test, the results obtained in the pharmacy should be sent to an outside pharmacy for confirmation. To accomplish this goal, the pharmacy should establish a relationship with an external lab where the UDS sample could be sent to the lab to confirm the findings in the pharmacy. In doing so, it may be necessary for the patient to sign a permission for the urine drug test results to be forwarded t
A rapid urine drug test should be done to check for recent opioid use immediately prior to administering naltrexone. While some pharmacists rely on test results performed by the prescriber, this does not represent best practice since a patient could use opioids in the time between leaving the prescriber’s office and arriving at the pharmacy. It is essential to ensure that a patient is clean of opioids prior to being given the injection to avoid precipitating opioid withdrawal.
According to FDA Vivitrol prescribing information, a person must be opioid-free for a minimum of 7-10 days before starting naltrexone treatment.