by: Dr. Max Lebow
Nearly 2 million Americans are currently prescribed Suboxone to treat opioid addiction. Known as a MAP/Medically Assisted Pathway medication, Suboxone combines buprenorphine, a DEA Class III opioid partial agonist, and naloxone, an opioid antagonist. Suboxone use has increased because of its success in treating opioid dependence, with higher rates of opioid abstinence and lower rates of relapse. Suboxone is also prescribed for chronic pain as an alternative to pure opioid agonists.
How should FMCSA Medical Examiners make certification decisions when a driver lists Suboxone as a current medication?
The guiding principle for making certification decisions for medications that could adversely affect the driver’s ability to operate a commercial vehicle safely is 49 CFR § 391.41. Requiring drivers to have their prescribing provider complete the MCSA-5895 –391.41 CMV DRIVER MEDICATION FORM is an essential adjunct to decision-making. In addition, FMCSA through its Medical Review Boards have urged Medical Examiners to use current best practices and evidence-based medicine to make certification decisions.
Commercial Driver Medication Evaluation for Certification
Based on the information cited above, we have created a six-element medication evaluation tool that can be applied to any medication that has the potential to affect a driver’s ability to operate a commercial vehicle safely.
Evaluating Suboxone using the Medication Evaluation Tool
1. What are the direct pharmacologic effects of the medication?
Buprenorphine is an opioid agonist and shares many effects of this class of medication. Since it is a DEA Schedule III medication, buprenorphine falls under 49 CFR-391.41 (b) (12), which allows DEA-scheduled medications to be used only when it is prescribed by a licensed medical practitioner who is familiar with the driver’s medical history and has advised the driver that the substance will not adversely affect the driver’s ability to operate a commercial motor vehicle safely. The Medical Examiner should have the commercial driver prescribing provider fill out MCSA-5895 –391.41 CMV DRIVER MEDICATION FORM to make this determination. Based on this information, the medical examiner should determine how long the driver has been on a stable dose of the medication, any recent changes in dosage, and plans for long-term use versus tapering.
2. What is the underlying condition for which the medication is being taken?
Suboxone is used as a treatment for chronic pain, as well as for opioid dependence. If the commercial driver has chronic pain, the Medical Examiner should determine whether that condition affects the ability of the driver to perform the essential duties of a commercial driver and has been adequately controlled using Suboxone. On the other hand, if the driver uses Suboxone to treat opioid dependence, the medical examiner must determine that the patient is in remission, preferably in a structured program to maintain sobriety. If the driver initially failed a drug test, the employer will need the SAP release before allowing the driver to return to duty.
3. What are the side effects of the medication?
Suboxone has a number of side effects, including drowsiness, constipation, abdominal pain and nausea, headache, and difficulty concentrating. Most of the side effects will dissipate over time when the patient is on a stable dosage.
4. Are there interactions with other medications the drivers using?
The Medical Examiner should evaluate any other medications on the driver’s list. Other drugs such as benzodiazepines or over-the-counter medications such as diphenhydramine will potentiate the effects of Suboxone and should be avoided.
5. What is the effect of missed doses, rebound, or withdrawal?
Cessation of long-term use of Suboxone can precipitate an opioid withdrawal syndrome. Therefore, the driver must be in a stable program with a medical provider familiar with the driver’s medical history.
6. Are there difficulties with medication storage or refills while on the road?
Like any DEA-scheduled medication, interstate drivers will find it very difficult to refill their prescriptions when driving duties take them out of their home state. Therefore, it must be stressed that drivers have adequate medication for use during any long-haul assignments. The final decision of whether to certify a commercial driver on Suboxone and for how long, ultimately rests upon the Certified Medical Examiner. These decisions can be difficult. The decision should always be based on the balance between public safety and the individual driver’s right to work.
