Clinical Cases Podcast Series-FREE NO CME-Informed Consent and Controlled Substance Agreements

Informed Consent and Controlled Substance Agreements

Pdf Summary

The “Compass Opioid Prescribing Treatment Guidance Toolkit” document explains that controlled substance agreements (CSAs) and informed consent for opioid therapy are core components of comprehensive opioid stewardship. While they can be combined into one form, they serve different purposes and are distinct processes.<br /><br />A Controlled Substance Agreement is described as a planning document that sets clear expectations for patients and establishes “rules of the road” for a clinical practice when prescribing controlled substances. It supports consistent clinician practice, educates patients about unsafe or illegal behaviors, and outlines monitoring steps used to reduce risks such as diversion, aberrant medication use, or substance use disorder. Examples of risk-mitigation practices noted include urine drug screening and pill counts.<br /><br />Informed consent is defined as an ongoing process between a physician and a competent patient about a specific medical intervention. For chronic opioid therapy, informed consent ensures the patient understands their diagnosis, the purpose of opioid treatment, and the potential risks, benefits, and alternatives. The document emphasizes that informed consent is especially important for long-term opioid use because of the many associated risks and complications.<br /><br />The toolkit recommends reviewing and updating both the CSA and informed consent at least annually. It then provides categories of sample resources, including short and longer CSA examples (from groups such as the AAFP Chronic Pain Toolkit and Oregon Pain Guidance), standalone informed consent documents (including a one-page version with a patient graphic and opioid education materials), and combined informed consent/CSA treatment agreements (from organizations such as Johns Hopkins, Pennsylvania, and Michigan OPEN). Additional tools include a high-risk consent and planning form for patients with increased risk and a shared decision-making tool for chronic opioid therapy.<br /><br />The document notes it was prepared by the Iowa Healthcare Collaborative under a CMS contract, with standard disclaimers about views and endorsements, and developed with Stader Opioid Consultants.

Keywords

opioid prescribing

controlled substance agreement

informed consent

chronic opioid therapy

opioid stewardship

risk mitigation

urine drug screening

pill counts

shared decision-making

treatment agreement