Navigating the Legal Landscape: Responsibilities in Prescribing Opioids to Patients with Opioid Use Disorder

Opioid medications are categorized as Schedule II controlled substances under the Controlled Substances Act (CSA) due to their potential for abuse and physical/psychological dependency.¹ The prescribing of these medications is subject to a complex web of federal and state laws, designed to balance the needs of patients with the necessity to prevent misuse, diversion, and addiction. In this article, we examine the legal requirements and professional responsibilities that govern opioid prescribing on a federal level and in Missouri, with a particular focus on the obligations of healthcare providers when a patient is identified as having, or being at risk for, opioid use disorder.

The Legal Landscape

The requirements for prescribing narcotics and opioids are found in both federal and state law, as well as guidance. On the federal level, one of the primary controlling laws is the CSA, which is enforced by the Drug Enforcement Administration (DEA). On a state level, each state has its own statutes, regulations, and professional board guidelines, so the specific requirements for prescribing controlled substances can vary significantly from one state to another.

DEA Registration

Unless an exception applies, providers must obtain a valid registration from the DEA to dispense, prescribe, or handle controlled substances.² A separate registration is necessary for each principal place of business or professional practice where controlled substances are dispensed, unless the location is exempt under specific conditions (e.g. prescribing without dispensing or storing controlling substances at that location).³

State Authorization

Typically, providers must also be authorized by the state in which they are licensed to prescribe controlled substances. This state authorization is a prerequisite for obtaining and maintaining DEA registration.⁴ Specific requirements for state authorization vary by jurisdiction, so providers should be certain to check their state’s requirements in addition to federal mandates.⁵

In Missouri in order to prescribe controlled substances, a provider, called an “individual practitioner,” must first obtain a registration issued by the Department of Health and Senior Services (DHSS), Bureau of Narcotics and Dangerous Drugs (BNDD).⁶ As part of the BNDD registration application, “individual practitioners” are required to disclose their anticipated drug activities; practices that fall outside of these disclosed activities may be considered irresponsible prescribing and could result in revocation of the practitioner’s BNDD registration. DHSS has also promulgated a regulation, Determining Lawful Prescribing, Dispensing and Administering of Controlled Substances, which provides that determinations by DHSS of whether controlled substances are being lawfully prescribed, dispensed, and administered are made by reviewing Chapter 195, RSMo, 19 CSR 30, 21 U.S.C. 801-966, and 21 CFR 1300-1399, as well as other state statutes and rules, and protocols established by the respective licensing boards.⁷

Legitimate Medical Purpose and Professional Practice

Prescriptions for controlled substances must be issued for a legitimate medical purpose and in the usual course of professional practice. This standard is codified in 21 C.F.R. § 1306.04(a) and is a critical requirement for lawful prescribing of opioids.⁸

In Missouri, the Board of Registration for the Healing Arts (BHA) provides guidance for prescribing practices. Section 334.107, RSMo, authorizes the BHA to deny, revoke, or suspend the license of any physician who:

1. Prescribes, administers, or dispenses a controlled substance that is nontherapeutic in nature or manner, or fails to keep complete and accurate ongoing records of the diagnosis and treatment plan;

2. Fails to keep complete and accurate records of controlled substances received, prescribed, dispensed, administered, and disposed of, including the date of receipt, sale or disposal, name and address of the recipient, and the reason for disposal or dispensing;

3. Writes false or fictitious prescriptions for controlled substances; or

4. Prescribes, administers, or dispenses in a manner inconsistent with Missouri or federal drug control acts.⁹

Additionally, Missouri’s Comprehensive Drug Control Act states that a physician may prescribe controlled substances in good faith and only in the course of professional practice.¹⁰

Patient Information and Medical Need

Under the CSA, a prescribing practitioner must document the patient’s name, address, and medical need for the opioid prescription.¹¹ This documentation must be completed by a licensed and registered medical practitioner and must be available for inspection by the Attorney General.¹² The medical record should include a detailed medical history and physical examination, documenting the nature and intensity of the pain, current and past treatments, underlying or coexisting conditions, the effect of the pain on physical and psychological function, and any history of substance abuse.¹³

In Missouri, BNDD guidelines further require that the prescriber be properly registered, the patient must desire treatment for a legitimate illness or condition, a legitimate need must be established through assessment and diagnostic modalities, there must be a patient-provider relationship, and there must be reasonable correlation between the drugs prescribed and the patient’s legitimate needs.¹⁴

Treatment Plan and Monitoring

Providers should create a treatment plan, and the rationale for continuing or modifying therapy with opioid prescriptions must be documented. Monitoring of the patient’s use of controlled substances, including random urine screens, ensures compliance and allows for assessing the effectiveness of the treatment.¹⁵

In Missouri, initial prescriptions for acute pain are restricted to a seven-day supply unless exemptions apply (such as cancer, hospice, or end-of-life care).¹⁶ There are also specific prescribing limitations for certain providers, including dvance practice nurse practitioners (APRNs) and dentists, for some scheduled medications.¹⁷ Physicians with collaborative practice agreements with an APRN should be particularly aware of those limitations.¹⁸

Prescription and Training Requirements

Prescriptions must include specific information, including the date of issuance, the patient’s full name and address, the drug name, strength, dosage form, quantity prescribed, directions for use, and the provider’s name, address, and DEA registration number.¹⁹ Providers may need to complete specific training, such as courses on treating and managing patients with substance use disorders, depending on the nature of their practice and the substances they prescribe.²⁰

Record Keeping Requirements

Providers must maintain accurate records of controlled substances prescribed and comply with any DEA inspections pursuant to federal law.¹ Consequences for non-compliance with DEA inspections can range from loss of licensure to criminal prosecution, depending on the circumstances and the severity of any violations.²

Missouri law and BNDD regulations also require complete and accurate records of all controlled substances received, prescribed, dispensed, administered, and disposed of. Failure to maintain these records can result in disciplinary action by BNDD.

A Health Care Provider’s Responsibility to Report Opioid Addiction Under Federal and State Law and Guidelines

If a provider identifies or suspects that a patient is suffering from substance abuse disorder (SUD) or opioid use disorder (OUD), they should follow a structured, evidence-based, and ethical approach. Current guidelines and recommendations illustrate that the responsibility of the practitioner is to treat patients with SUD or OUD with special care and determine a path forward out of addiction. The exact steps may vary based on the specific jurisdiction, clinical setting, and severity of the addiction, but will generally include the following:³

Assess and Confirm Diagnosis

Providers should conduct a thorough assessment of each individual patient using validated screening tools (e.g., DSM-5 criteria for OUD⁴). Providers should also assess the severity of the addiction, risk of overdose, and co-occurring mental or physical health conditions. Further, utilizing a state’s Prescription Drug Monitoring Program⁵ (PDMP) that can assist a provider in determining whether a patient is visiting multiple providers and obtaining opioid prescriptions from more than one source, a pattern often referred to as provider hopping or doctor shopping.⁶

Ensure Patient Safety

If a provider determines that a patient is at risk of an overdose or withdrawal, they should provide or arrange for urgent care to address the patient’s immediate risks. Providers may also consider prescribing naloxone, a medication designed to rapidly reverse opioid overdose, and educating the patient and their family on its use. The Centers for Disease Control and Prevention (CDC) recommends offering naloxone to all patients who are prescribed opioids, particularly those at an increased risk for opioid overdose.⁷

Develop a Treatment Plan

Providers may discuss options with a patient such as Medication-Assisted Treatment (MAT), including prescriptions for buprenorphine, methadone, or naltrexone, as well as cognitive-behavioral therapy, contingency management, and the like.⁸ Moreover, providers should consider pairing an opioid prescription with a non-opioid alternative, and avoid prescribing opioids for chronic or undifferentiated pain.⁹

Coordinate Care and Provide Ongoing Support

Providers should consider referring a patient identified as having SUD or OUD to appropriate specialists and/or treatment programs. A multidisciplinary approach involving mental health professionals, Licensed clinical social workers, and other care team members may also be appropriate. Monitoring progress through regular follow-ups and addressing social determinants (e.g., access to housing, employment, and other support services) is also critical.¹⁰

Documentation and Legal Obligations

Providers confronted with a patient who is addicted to opioid medications should carefully record their assessments, discussions, and treatment plans. They must also follow all applicable local laws regarding reporting if the patient poses a risk to themselves or others.¹¹ When reporting a patient for suspected SUD or OUD, the provider should take care to maintain patient confidentiality, balancing their privacy obligations with their duty to the public in helping mitigate the ongoing opioid crisis.¹²

Missouri Law Definition of Addict

Missouri defines addict as a person who habitually uses one or more controlled substances to such an extent as to create a tolerance for such drugs, and who does not have a medical need for such drugs, or who is so far addicted to the use of such drugs as to have lost the power of self-control with reference to his or her addiction.¹

As mentioned above, in Missouri, regulations provide that a physician cannot prescribe controlled substances to a patient that the physician knows is using the medication in a non-therapeutic manner, unless the physician is approved and registered as a narcotic treatment program or a federally approved office-based opioid treatment provider.²

There is no shortage of cases that detail the legal consequences for health care practitioners that prescribe opioids or other narcotics with flagrant disregard for their patients’ status as addicts or risk that they may become dependent on those prescribed substances.³ What is clear is that a practitioner prescribing opioids or other narcotics to treat patient pain should always look closely for the indicators of SUD or OUD, as well as know their legal obligations as to privacy and reporting in their specific jurisdiction.

Best Practices for Prescribing Opioids

The CDC offers clinical practice guidelines for opioid prescribing, that emphasize a cautious and evidence-based approach to managing pain with opioids.⁴ These guidelines recommend that practitioners carefully evaluate the risks and benefits of opioid use, particularly for chronic pain, and prioritize non-opioid therapies when possible. For chronic pain, the CDC advises that opioid dosages should not exceed 90 morphine milligram equivalents (MME) per day, with extra precautions recommended for dosages above 50 MME/day. These guidelines also stress the importance of regular patient re-evaluation, monitoring signs of misuse, and using the lowest effective dose for the shortest duration necessary.⁵

The legal significance of these guidelines is evident in their influence on federal and state laws, as well as their use in legal proceedings. For instance, the guidelines have been cited in cases involving allegations of overprescription or inappropriate opioid prescribing practices. Courts have referenced the CDC’s recommendations to establish benchmarks for safe prescribing and to evaluate whether a practitioner’s actions deviated from accepted medical standards. In United States v. Moon⁶, the court noted that the defendant’s prescribing practices exceeded the CDC’s recommended dosages, contributing to findings of inappropriate prescribing. Similarly, in United States v. Bauer⁷, the court highlighted the risks associated with exceeding CDC-recommended dosages and prescribing opioids in combination with other controlled substances, which increased the risk of addiction and overdose.

Additionally, the guidelines have shaped federal initiatives and statutes aimed at addressing the opioid crisis. For example, the Federal Public Health and Welfare Code mandates the dissemination of evidence-based opioid prescribing guidelines, including the CDC’s, to healthcare providers to promote safer prescribing practices.⁸ This statute also supports education and awareness programs to mitigate the risks of opioid misuse and abuse. Furthermore, the guidelines have informed state-level legislation, such as West Virginia’s Opioid Reduction Act, which incorporates CDC recommendations to limit opioid prescriptions and promote alternative pain management strategies.⁹

Conclusion

The CDC’s opioid prescribing guidelines serve as a critical framework for promoting safe and effective pain management while minimizing the risks of opioid misuse and addiction. Their legal significance lies in their role as a standard for evaluating prescribing practices in both regulatory and judicial contexts, as well as their influence on public health policies and legislation. Therefore, in addition to following the above discussed federal legal requirements and guidelines, it is best practice for practitioners to stay current on research and reports published by the CDC and other similar organizations. While these recommendations do not necessarily carry the force of “law,” they do have considerable influence on the court decisions in this area and serve as a guidepost for determining whether a provider’s prescribing policies and practices are of the kind that should be prosecuted.