Building a Bulletproof Controlled Substance Agreement
Doug Jorgensen
May 13, 2025
If you prescribe opioids, benzodiazepines, or stimulants, a controlled substance agreement (CSA) isn’t just good practice—it’s a critical layer of protection for you, your license, and your patients.
Too often, I see these agreements treated as boilerplate paperwork—something handed to a patient once, signed without discussion, and filed away until an audit. That’s not enough. A truly effective CSA is a living document, reinforced at every visit and tailored to your practice’s standards.
Why You Need a Controlled Substance Agreement
- Sets Clear Expectations – Patients know exactly what’s required for continued prescribing.
- Strengthens Compliance – Shows regulators you have risk mitigation measures in place.
- Provides Legal Protection – In the event of a complaint, your CSA becomes evidence that boundaries were set and agreed upon.
- Improves Patient Safety – Helps identify and address misuse early.
Core Elements of a Bulletproof CSA
- Purpose Statement
- Explain that the agreement is for the patient’s safety and to comply with state and federal laws.
- Explain that the agreement is for the patient’s safety and to comply with state and federal laws.
- Medication Use Guidelines
- Exact instructions for taking the medication.
- Prohibition of sharing, selling, or altering the medication.
- Exact instructions for taking the medication.
- Pharmacy Requirements
- A single designated pharmacy to reduce risk of diversion.
- A single designated pharmacy to reduce risk of diversion.
- Prescription Monitoring
- Patient acknowledges that you will check the PMP and may perform pill counts or urine drug screens without notice.
- Patient acknowledges that you will check the PMP and may perform pill counts or urine drug screens without notice.
- Appointment and Refill Policy
- No early refills.
- Missed appointments result in no prescription until rescheduled.
- No early refills.
- Grounds for Discontinuation
- PMP discrepancies, failed drug screens, aggressive behavior, or suspected diversion.
- PMP discrepancies, failed drug screens, aggressive behavior, or suspected diversion.
- Patient Acknowledgement
- A clear signature section confirming they understand and accept all terms.
- A clear signature section confirming they understand and accept all terms.
Making It More Than Paper
Here’s where many providers fail: they hand the agreement to the patient like a cell phone contract—sign here, no questions asked. The problem? That kills its value in a dispute.
Instead:
- Review it line-by-line with the patient at initiation.
- Document the discussion in your note: “Reviewed controlled substance agreement with patient, answered all questions, patient verbalized understanding.”
- Revisit it at least annually—or more often for high-risk patients.
When It Saves You
I once had a patient we terminated for abusive behavior, problem urines, and early refills. He complained to the licensing board. The patient claimed we violated his rights and harmed him. Because the CSA and our documentation was clear and we had both signed the CSA, the board dismissed the complaint outright.
Bottom Line
A controlled substance agreement is more than a form—it’s a cornerstone of safe, compliant prescribing.
If you’re going to prescribe, protect yourself. Build it right, use it consistently, and treat it as part of the care process—not just a formality.
About the Author
Douglas J. Jorgensen, DO, CPC, FAAO, FACOFP
Dr. Doug is a physician, consultant, and national educator on medical documentation accuracy, patient engagement, and compliance strategy. He helps healthcare organizations develop systems that make patients active partners in their own medical records.
