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Do Controlled Substance Agreements Improve Care Quality for Opioid Patients?


A Mayo Clinic study has surprising findings about how controlled substance agreements impact patients on long-term opioid therapy.



Patients on controversial, long-term opioid therapy are known to often have significantly more healthcare visits.

A recent study found that physicians can even be reluctant to prescribe opioids due to issues surrounding patient safety. Some studies even suggest that so-called “pain” contracts often stigmatize the patient and erode trust between patient and physician.

But sticking to an opioid-controlled substance agreement appears to reduce the overall number of healthcare visits for these patients while maintaining safety, according to a new research study.


controlled substance agreement

offers patients a structure and reduces the chances that patients seek medical assistance to further manage or diagnose their pain. According to the Cleveland Clinic Journal of Medicine, the purpose of a controlled substance agreement is to improve adherence, obtain informed consent, outline the prescribing policies of the practice, and mitigate risk.

"The signing of this agreement engages the patient in a standardized care process model allowing for reliable provision of opioids for pain control and mandating screening for mental health conditions, routine clinical or telephonic follow-up and at least annual face-to-face visits, electronic health record documentation of every refill, checking of the state prescription monitoring program, and regular urine drug testing," says Jon Ebbert, MD, a Mayo Clinic primary care physician.

Ebbert and colleagues, conducted the study to understand the impact of controlled substance agreements on healthcare utilization.

In this case, the signing of the agreement engages the patient in a standardized care process model allowing for reliable provision of opioids for pain control and mandating psychological screening, pain monitoring, refill documentation, evaluation of opioid use through prescription monitoring programs, and urine drug testing. It also includes guidance on only having one care team prescribe opioids; recommendations for safe medication storage; not sharing medications; dose changes without contacting the prescribing provider; requirements for urine drug testing; and expectations for follow-up appointments.

Read: Alternative Payment Model Launches for Addiction Recovery

The study, published in Mayo Clinic Proceedings, included 772 Mayo Clinic patients enrolled in a controlled substance agreement from July 1 to December 31, 2015. The researchers used billing data to compare patients’ visits for one year before and after the agreement to evaluate how many patients had increased or decreased healthcare visits.

Patients enrolled in an opioid controlled substance agreement appeared to notably reduce primary care visits while not increasing use of emergency department services, according to the study. Mean primary care visits went from 3.92 for the 12 months before establishing a controlled substance agreement, to 0.69 after it was established. Among patients with chronic health issues, the agreement was linked to decreased hospitalizations and primary care and specialty visits. The agreement also played a role in the number of healthcare visits based on age, among other patient factors.

“Controlled substance agreements are associated with decreased healthcare utilization especially among sicker patients,” says Ebbert, who is also a researcher in the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery. “Healthcare executives should support reimbursement models for care processes around establishing and maintaining controlled substance agreements.”

Ebbert wants healthcare executive to know three things about controlled substance agreements:

  • Controlled substance agreements represent an opportunity to improve the care of patients with chronic non-cancer pain.
  • Controlled substance agreements are associated with decreased healthcare utilization especially among sicker patients.
  • Controlled substance agreements can be advanced through reimbursement models supporting their establishment and use.
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