Legal Updates: As Opioids for Pain Treatment Come Under Greater Scrutiny, Controlled Substance Agreements Matter More

Steven M. Harris, Esq.

Controlled substance agreements, pain contracts, pain management contracts, medication contracts, opioid treatment agreements, informed consent forms, patient contracts for controlled substances. They go by different names, but they all mean the same thing: A signed agreement between the physician and patient that explains the conditions under which the patient will be prescribed opioid pain medications for the relief of chronic pain. Physicians often employ these types of agreements so that the parties are on the same page with regard to the requirements the patient must follow to take the drugs safely.

Controlled substance agreements have become more important than ever with the recent activity in state legislatures, including the passage of intractable pain treatment laws and the issuance of policy from state boards of medical examiners on the use of opioids in pain treatment. In fact, controlled substance agreements are now required to be executed in certain states, such as Florida.

Physicians are increasingly turning to controlled substance agreements as a means of balancing the competing consequences of pain treatment, addiction, respiratory depression, tolerance, and diversion on the one hand and fear of regulatory action on the other hand. Physicians, facing investigation or prosecution by the Drug Enforcement Administration, are using controlled substance agreements as evidence that 1) the controlled substances were prescribed, administered, and dispensed for legitimate medical purposes; 2) patients are adequately informed in unity; and 3) the physician acted in the usual course of professional practice and otherwise in accordance with laws and regulations governing controlled substances.

Although some patient advocates argue that controlled substance agreements invade patients’ privacy and damage the trust that is essential to the physician–patient relationship, when used effectively, controlled substance agreements are a valuable way for physicians and patients to communicate what the expectations are for the treatment of chronic pain using opioids and how the patients can use the medications safely to avoid overuse and misuse. The agreement can provide a framework to discuss the issues that come up in a treatment plan, especially where substance abuse, including addiction to pain medication, is a serious problem.

What the Agreement Should Address

There is not, however, one preprinted, standardized controlled substance agreement that is binding on all patients, under all circumstances, for all states and legal jurisdictions. In fact, to the contrary, patients should have individualized plans for care that comprehensively address their physical, psychological, and social needs. There are, however, some key provisions that should be included in any controlled substance agreement, such as: