Is it acceptable to prescribe pregabalin (Lyrica) to a patient who has violated a controlled substance agreement?

From the Guidelines

No, it is not okay to prescribe pregabalin if a patient has broken a controlled substance agreement. According to the American Society of Clinical Oncology clinical practice guideline 1, when a patient breaks a controlled substance agreement, it indicates a high risk of diversion or drug abuse, and prescribing another controlled substance like pregabalin would not be appropriate. The guideline suggests that in such cases, the healthcare provider should reassess the patient's condition, consider non-controlled medication alternatives, and address any underlying substance use disorders 1.

Key Considerations

• Pregabalin is classified as a Schedule V controlled substance due to its potential for abuse and dependence.
• Breaking a controlled substance agreement indicates potential misuse, diversion, or other concerning behaviors.
• Healthcare providers should prioritize non-controlled medication alternatives for pain or anxiety management.
• Addressing underlying substance use disorders and referring the patient to pain management specialists or addiction treatment may be necessary.

Clinical Approach

When a patient breaks a controlled substance agreement, the healthcare provider should:

• Reassess the patient's condition to determine the best course of treatment.
• Consider alternative medications or therapies that do not have abuse potential.
• Document the violation thoroughly and discuss with the patient why the agreement was broken.
• Develop a new treatment plan that prioritizes the patient's safety and well-being, while also minimizing the risk of diversion or misuse 1.

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.

Prescribing pregabalin after breaking a controlled substance agreement is not explicitly addressed in the provided drug label. However, given that pregabalin is a Schedule V controlled substance and the label advises to carefully evaluate patients for history of drug abuse, it is prudent to exercise caution when considering prescribing pregabalin to a patient who has broken a controlled substance agreement.

• The label recommends monitoring patients for signs of misuse or abuse, such as development of tolerance, dose escalation, or drug-seeking behavior.
• Physical dependence has been reported in clinical studies, with symptoms including insomnia, nausea, headache, or diarrhea after abrupt or rapid discontinuation of pregabalin. 2

From the Research

Pregabalin Prescription and Controlled Substance Agreement

• Pregabalin is a Schedule V controlled substance due to its potential for abuse and dependence 3, 4.
• The risk of abuse and misuse is higher in individuals with a history of psychiatric disorders or substance use disorder 5.
• Patients with opioid use disorders may also be at an increased risk of abusing gabapentinoids, including pregabalin 5.
• Health professionals and prescribers should be aware of the risk for misuse of pregabalin and monitor signs of misuse and abuse, especially in high-risk populations 5.

Breaking Controlled Substance Agreement

• There is no direct evidence in the provided studies that addresses the specific scenario of prescribing pregabalin if a controlled substance agreement is broken.
• However, it is essential to consider the potential risks of abuse and misuse associated with pregabalin, particularly in patients with a history of substance use disorder or psychiatric disorders 3, 4, 5.

Considerations for Prescribing Pregabalin

• Pregabalin has demonstrated efficacy in managing neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and as adjunctive therapy for adult patients with partial onset seizures 3, 4, 6.
• The most common adverse events associated with pregabalin are dizziness and somnolence 3, 4, 6.
• Pregabalin's safety profile is generally well-tolerated, but its use can be associated with benign central nervous system and systemic adverse effects 7.