Is it acceptable to prescribe pregabalin (lyrica) to a patient with a history of non-adherence to a controlled substance agreement, as evidenced by a positive urine drug test?

From the Guidelines

Prescribing pregabalin after a patient has broken a controlled substance agreement with a positive urine drug test is generally not recommended. Pregabalin (Lyrica) is a Schedule V controlled substance with potential for misuse, and continuing to prescribe it to someone who has demonstrated non-adherence to a controlled substance agreement raises significant concerns about patient safety and appropriate medication use. The broken agreement indicates potential substance misuse issues that should be addressed before continuing controlled medications.

According to a study published in the Journal of Clinical Oncology 1, a universal precautions approach to assess and manage patients with chronic pain is recommended, which includes risk assessment, treatment agreements, and urine drug testing. The study found that adherence monitoring with a controlled substance agreement, periodic monitoring, periodic drug testing, pill counts, and education when necessary served to reduce controlled substance abuse and increase compliance.

Instead, the provider should consider non-controlled alternative medications for the patient's condition, refer them for substance use evaluation and treatment if appropriate, and develop a new treatment plan that prioritizes both effective symptom management and patient safety. The decision ultimately depends on the specific circumstances, including the nature of the substance detected, the patient's medical needs, their history of adherence, and the risk-benefit assessment.

A study published in the Annals of Internal Medicine 1 found that opioid risk assessment tools, treatment agreements, and urine drug testing are recommended to mitigate risks, although the evidence for these interventions is weak. The study also found that benzodiazepines and opioids are a high-risk combination, particularly in elderly adults, and that providers should exercise caution when prescribing these medications together.

A thoughtful conversation with the patient about the violation, exploring the reasons behind it, and discussing alternative treatment options is essential before making any prescribing decisions. As noted in a study published in JAMA 1, the underlying causes for worrisome behaviors such as urine drug test results that are negative for the prescribed opioid should be fully investigated, and subsequent opioid prescriptions should be based on the revised risk and benefit assessment.

In terms of specific guidance, a study published in the Annual Review of Medicine 1 found that opioid contracts are formal written agreements between prescribers and patients that define key aspects of opioid therapy, including potential risks and benefits of treatment, prescribing policies, methods for monitoring opioid use, expected behaviors, and consequences of violating the contract. The study also found that Prescription Drug Monitoring Programs (PDMPs) are statewide electronic databases that collect information on prescription of controlled prescription drugs designed to monitor information pertaining to suspected abuse or diversion.

Overall, the decision to prescribe pregabalin after a patient has broken a controlled substance agreement with a positive urine drug test should be made with caution and careful consideration of the patient's individual circumstances, and should prioritize patient safety and effective symptom management.

From the FDA Drug Label

1. Drug Abuse and Dpendence 9.1 Controlled Substance Pregabalin is a Schedule V controlled substance. Pregabalin is not known to be active at receptor sites associated with drugs of abuse. As with any CNS active drug, carefully evaluate patients for history of drug abuse and observe them for signs of pregabalin misuse or abuse (e.g., development of tolerance, dose escalation, drug-seeking behavior).
2. 2 Abuse In a study of recreational users (N=15) of sedative/hypnotic drugs, including alcohol, pregabalin (450 mg, single dose) received subjective ratings of "good drug effect," "high" and "liking" to a degree that was similar to diazepam (30 mg, single dose)
3. 3 Dependence In clinical studies, following abrupt or rapid discontinuation of pregabalin, some patients reported symptoms including insomnia, nausea, headache or diarrhea [see WARNINGS AND PRECAUTIONS (5.6)], consistent with physical dependence.

The patient has broken the controlled substance agreement with a positive urine drug test. Prescribing pregabalin in this scenario may not be appropriate due to the patient's history of drug abuse. The drug label recommends carefully evaluating patients for history of drug abuse and observing them for signs of pregabalin misuse or abuse. Given the patient's positive urine drug test, it is likely that they are at a higher risk for pregabalin misuse or abuse. Therefore, alternative treatment options should be considered. 2

From the Research

Prescribing Pregabalin with a Broken Controlled Substance Agreement

• Pregabalin is a Schedule V controlled substance, and its utility is not compromised by substantial limitation of access or the need for extra steps in prescribing 3.
• However, abuse potential is a consideration, and utilization should be carefully monitored, particularly in patients with a past or current history of substance abuse 3.
• If a patient has broken a controlled substance agreement with a positive urine drug test, it is essential to weigh the risks and benefits of prescribing pregabalin.
• There is limited evidence on the specific scenario of prescribing pregabalin after a broken controlled substance agreement, but studies suggest that treatment agreements and urine drug testing can help reduce opioid misuse in patients with chronic pain 4.

Considerations for Prescribing Pregabalin

• Pregabalin has been shown to be efficacious in treating neuropathic pain, including in patients with spinal-cord injury 5.
• The medication has a relatively high frequency of central nervous system adverse events, particularly dizziness and somnolence, which is a concern in the elderly 3.
• Urine drug testing is an important part of an overall treatment plan that includes chronic opioid prescribing, and it is recommended to be done routinely as part of a best practice program 6.
• Pregabalin's safety profile is well tolerated for the management of neuropathic pain, with benign central nervous system and systemic adverse effects 7.

Monitoring and Risk Management

• Patients with a history of substance abuse or a broken controlled substance agreement should be closely monitored for signs of misuse or diversion 3, 4.
• Risk management strategies, including baseline and periodic urine drug testing, behavioral monitoring, and prescription monitoring programs, can help minimize the risks associated with prescribing pregabalin 6.
• Clinicians should carefully evaluate the patient's individual circumstances and medical history before prescribing pregabalin, and regularly review and adjust the treatment plan as needed 7.