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:
- The number and frequency of substance prescriptions, including the rules for refills, should be outlined;
- The treatment goals should be clearly articulated;
- The measures for outcomes should be clearly defined;
- The risks and benefits of the use of the specific controlled substances should be identified;
- The patient’s responsibilities for the use of controlled substances should be identified (e.g., safeguarding the medication, not attempting to get pain medication from another provider without approval from the present provider, not to use any illegal substances, and not sharing, selling, or trading the medication)
- The single pharmacy the patient will use to fill the prescription should be identified;
- Permission to allow the physician to require the patient to undergo a random blood or urine drug test should be granted;
- Permission to allow the physician to consult with the dispensing pharmacist and any other professional who has provided healthcare to the patient should be given; and
- The consequences of contractual violation—including that if the patient breaches the agreement, the physician may stop prescribing the pain-control medicines or terminate the physician–patient relationship—should be delineated.
The controlled substance agreement should also remain a flexible document so as not to lead to unintended consequences. For example, if a patient requires an emergency procedure that requires the patient to take a controlled substance that is not included on the controlled substance agreement, the agreement should not be so rigid so that this situation results in a breach of the agreement.
Specifics for Opioids
There are also some key standards of practice for prescribing opioids that should be followed in conjunction with the execution of the pain contract, such as:
- Evaluation of the patient, including a pain history and assessment of the impact of pain on the patient, a directed physical examination, a review of previous diagnostic studies, a review of previous interventions, a drug history, and an assessment of coexisting diseases or conditions;
- Consultation with a specialist in pain medicine or with a psychologist, when necessary. Patients with signs or symptoms of substance abuse should be immediately referred to a pain management specialist, an addiction specialist, or an addiction facility as it pertains to drug abuse or addiction;
- Review of treatment efficacy should occur periodically to assess the functional status of the patient, the patient’s progress toward treatment objectives, opioid side effects, quality of life, and indications of medication misuse; and
- Documentation is essential to support the evaluation, the reason for prescribing an opioid, the nature and intensity of the pain, the overall pain management treatment plan, the presence of any recognized medical indications for the use of a controlled substance, any consultations received, and a periodic review of the status of the patient. Chart everything. The medical record should include, at a minimum:
- The complete medical history and a physical examination, including history of drug abuse or dependence;
- Diagnostic, therapeutic, and laboratory results;
- Evaluations and consultations;
- Treatment objectives;
- Discussion of risks and benefits;
- Medications, including date, type, dosage, and quantity prescribed;
- Instructions and agreements;
- Periodic reviews;
- Results of any drug testing;
- A photocopy of the patient’s government-issued photo identification; and
- If a written prescription for a controlled substance is given to the patient, a duplicate of the prescription.
Physicians who have these safeguards in place will be in a sounder position in the event they find themselves the target of the ongoing crackdown on physicians who are prescribing opiates outside the bounds of accepted medical practice. Also, be sure to check your state’s laws, as these agreements may be legally required. If you are using a controlled substance agreement template, now is the time to review it to ensure that all parties are best protected. If your practice has not yet started using a controlled substance agreement, now is the time to consult with a healthcare lawyer.
Steven M. Harris, Esq., is a nationally recognized healthcare attorney and a member of the law firm McDonald Hopkins, LLC. He may be reached at [email protected].