Data released today on the CPHLR Prescription Drug Abuse Policy System at PDAPS.org capture the key features of state statutes and regulations related to informed consent for opioid prescribing in effect between January 1, 2014, and December 31, 2019.
The data detail the topics that must be communicated to the patient to obtain informed consent — including the specific risks that must be discussed — as well as whether that communication must be documented in writing. The dataset also captures the types of clinicians who are subject to the laws, the substances that trigger informed consent requirements, the specific circumstances that require informed consent to be obtained, and the enforcement mechanisms for the laws. Because laws and regulations for adults and minors offer differ within states, the dataset contains separate sections for these two populations.
The data were created following CPHLR’s policy surveillance process and may be used to understand and evaluate the nature of informed consent laws around the United States.
Here are a few trends we’re seeing in the laws as of December 31, 2019:
- While many states had different laws regulating informed consent prior to prescribing opioids to adults and minors, only California and South Carolina limited their regulation to minors. No states regulated only adults.
- More than 30 states required some form of written documentation to memorialize informed consent. However, fewer than half of those require signed documentation from the patient or their representative (12 states for adults, 14 for minors).
- New Mexico and South Dakota are the only states that required counseling on the availability of opioid antagonists like naloxone (Narcan).
- Fewer than half of states with informed consent requirements explicitly required the discussion of alternative treatments to opioid based treatments (17 for minors and 18 for adults).
- More than two-thirds of all states requiring informed consent include physicians in their list of practitioners. The notable exceptions are North Dakota, which only required informed consent for dentists, and Alaska, which regulated physicians (among a longer list) for minors, but only optometrists must obtain informed consent from adult patients.
- The risks required to be discussed by practitioners varied greatly from state to state and many that addressed the same type of concern were often worded differently.
This dataset was created in collaboration with subject matter expert Dr. Kao-Ping Chua, MD, PhD, Assistant Professor of Pediatrics, Susan B. Meister Child Health Evaluation and Research Center, Department of Pediatrics, University of Michigan Medical School, who conceptualized this project.