A Guide to State Opioid Prescribing Policies

Pain Policy and Regulation: Missouri

Summary

Missouri has a variety of laws, rules, and guidelines relating to the use of controlled medication, pain management and palliative care. Missouri licensees should consult with their licensing board and read all relevant material. This document contains general summaries of Missouri's basic legal/regulatory material on the use of controlled medications to treat pain.

Missouri Intractable Pain Treatment Act

"Intractable pain" means a pain state in which the cause of pain cannot be removed or otherwise treated and which in the generally accepted course of medical practice no relief or cure of the cause of the pain is possible or none has been found after reasonable efforts that have been documented in the physician's medical records.

"Therapeutic purpose" means the use of controlled substances in acceptable doses with appropriate indication for the treatment of pain. Any other use is nontherapeutic.

A physician treating a patient for intractable pain may prescribe controlled substances for therapeutic purposes. Notwithstanding any other provision of law to the contrary, a physician may prescribe, administer, or dispense controlled substances for a therapeutic purpose to a person diagnosed and treated by a physician for a condition resulting in intractable pain, if such diagnosis and treatment has been documented in the physician's medical records.

No physician will be subject to disciplinary action by the Board solely for prescribing, administering, or dispensing controlled substances when they are prescribed, administered, or dispensed for a therapeutic purpose for a person diagnosed and treated by a physician for a condition resulting in intractable pain, if such diagnosis and treatment has been documented in the physician's medical records.

The Intractable Pain Treatment Act does not apply to those persons being treated by a physician for chemical dependency resulting from the use of controlled substances not related to the therapeutic purposes of treatment of intractable pain. Likewise, it does not permit a physician to prescribe, administer, or dispense controlled substances to a person the physician knows or should know is using controlled substances in a manner not related to the therapeutic purpose.

Important Note: Under the Missouri Intractable Pain Treatment Act, "drug dependency or the possibility of drug dependency in and of itself is not a reason to withhold or prohibit the prescribing, administering or dispensing of controlled substances for the therapeutic purpose of treatment of a person for intractable pain, nor shall dependency relating solely to such prescribing, administering or dispensing subject a physician to disciplinary action by the board."

Important Note: The Board is permitted to pursue the investigation of any physician who improperly prescribes controlled substances and fails to keep required records. This is grounds for license denial, suspension, or revocation.

General List of Missouri Guidelines/Position Statements Relating to Pain Management

Missouri has the following guidelines/position statements relating in some manner to the use of controlled medications to treat pain or opioid addiction:

• A Guide to Prescribing, Administering and Dispensing Controlled Substances
• Guidelines for Opioid Addiction Treatment in the Medical Office
• Guidelines for the Use of Controlled Substances for the Treatment of Pain
• Healing Arts and Pharmacy Internet Prescribing and Dispensing Guidelines
• Palliative Care Guidelines

All of these guidelines/position statements can be found at the Web site of the Missouri Division of Professional Registration at: http://www.pr.mo.gov/healingarts-guidelines-positions.asp

A Guide to Prescribing, Administering, and Dispensing Controlled Substances

Prescribing controlled substance medications is always a balancing act, and the physician must do his or her best to safely and effectively treat patients and at the same time avoid prescription practices that could potentially foster drug misuse or abuse.

Physicians have a legal and ethical responsibility to uphold the law and to help protect society from drug abuse. Physicians must also protect their medical practice from becoming an easy target for drug diversion. Physicians have a legal responsibility to learn about and review the state and federal requirements for the prescribing and dispensing of controlled substances. If the physician fails to abide by the legal requirements, he or she is subject to the loss or restriction of controlled substances privileges and discipline by the appropriate professional state licensing board.

Prohibition Against Self-Prescribing. Controlled drugs for a practitioner's personal treatment must be prescribed by another appropriate practitioner as part of an established practitioner/patient relationship. Practitioners are prohibited by law from prescribing or dispensing controlled drugs for their personal use except in a true medical emergency.

Recommendation Against Prescribing to Office Staff or Family Members. It is recommended that practitioners not prescribe, dispense, or administer controlled drugs to office staff or family members. If the physician does decide to treat family members or employees, the physician must do so under the auspices of a legitimate patient/physician relationship and in "good faith." This includes performing a proper evaluation, maintaining a chart, listing a diagnosis, developing a plan of treatment and prognosis, and using the same documentation and standard of care used for other patients. If the practitioner does prescribe, dispense or administer to office staff or family members, the physician must treat these individuals in the same manner as other patients.

A legitimate physician-patient relationship exists when a patient has a medical complaint, a medical history has been taken, a physical examination has been performed, and a legitimate clinical relationship exists between the medical complaint, the medical history, the physical examination, and the drug prescribed.

Guidelines for the Use of Controlled Substances for the Treatment of Pain

Missouri adopted a Guideline on the Use of Controlled Substances for the Treatment of Pain, which is based on the Federation of State Medical Boards' Model Guidelines. The key elements of the Missouri Guideline are set forth below.

Evaluation of the Patient. A complete medical history and physical examination must be conducted and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of controlled substances.

Treatment Plan. The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate whether any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the cause of the pain and the extent to which the pain is associated with physical and psychosocial impairment.

Informed Consent and Agreement for Treatment. The physician should discuss the risks and benefits of the use of controlled substances with the patient or a guardian or caregiver if the patient is incompetent. The patient should receive prescriptions from one physician and one pharmacy where possible. If the patient is determined to be at high risk for medication abuse or has a history of substance abuse, the physician should consider the use of a written agreement between physician and patient outlining patient responsibilities, including:

• Urine/serum medication levels screening when requested;
• Number and frequency of all prescription refills; and
• Reasons for which drug therapy may be discontinued (ie, violation of agreement).

Periodic Review. The physician should review the course of treatment and any new information about the cause of the pain at reasonable intervals based on the individual circumstances of the patient. Continuation or modification of therapy should depend on the physician's evaluation of progress toward stated treatment objectives, such as improvement in patient's pain intensity and improved physical and/or psychosocial function (ie, ability to work, need for healthcare resources, ability to carry out activities of daily living, and quality of social life). If treatment goals are not being achieved despite medication adjustments, the physician should reevaluate the appropriateness of continued treatment. The physician should monitor patient compliance with medication usage and related treatment plans.

Consultation. The physician should be willing to refer the patient as necessary for additional evaluation and treatment to achieve treatment objectives. Special attention should be given to those patients with pain who are at risk for misusing their medications and those whose living arrangements pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder may require extra care, monitoring, documentation and consultation with or referral to an expert in the management of such patients.

Medical Records. The physician should keep accurate records that include the following:

• Complete medical history and results of physical examination;
• Diagnostic, therapeutic, and laboratory results;
• Evaluations and consultations;
• Treatment objectives;
• Discussion of risks and benefits;
• Treatment history;
• Medications (including date, type, dosage, and quantity prescribed);
• Instructions and agreements; and
• Periodic reviews.

Records should remain current and be maintained in an accessible manner and readily available for review.

Compliance With Controlled Substances Laws and Regulations

To prescribe, dispense, or administer controlled substances, the physician must be licensed in the state and comply with applicable federal and state regulations. Physicians are referred to the Practitioner's Manual of the U.S. Drug Enforcement Administration and (any relevant documents issued by the state medical board) for specific rules governing controlled substances as well as applicable state regulations. The Practitioner's Manual can be found at the DEA Diversion Web site at http://www.deadiversion.usdoj.gov.

Definitions Used in the Missouri Guideline

Acute Pain. Acute pain is the normal, predicted physiologic response to an adverse chemical, thermal, or mechanical stimulus and is associated with surgery, trauma, and acute illness. It is generally time-limited and is responsive to opioid therapy, among other therapies.

Addiction. Addiction is a neurobehavioral syndrome with genetic and environmental influences that results in psychological dependence on the use of substances for their psychic effects and is characterized by compulsive use despite harm. Addiction may also be referred to by terms such as "drug dependence" and "psychological dependence." Physical dependence and tolerance are normal physiologic consequences of extended opioid therapy for pain and should not be considered addiction.

Analgesic Tolerance. Analgesic tolerance is the need to increase the dose of opioid to achieve the same level of analgesia. Analgesic tolerance may or may not be evident during opioid treatment and does not equate with addiction.

Chronic Pain. A pain state that is persistent and in which the cause of the pain cannot be removed or otherwise treated. Chronic pain may be associated with a long-term incurable or intractable medical condition or disease.

Pain. An unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.

Physical Dependence. Physical dependence on a controlled substance is a physiologic state of neuroadaptation that is characterized by the emergence of a withdrawal syndrome if drug use is stopped or decreased abruptly, or if an antagonist is administered. Physical dependence is an expected result of opioid use. Physical dependence, by itself, does not equate with addiction.

Pseudoaddiction. Pseudoaddiction is a pattern of drug-seeking behavior of patients with pain who are receiving inadequate pain management that can be mistaken for addiction.

Substance Abuse. Substance abuse is the use of any substance(s) for nontherapeutic purposes or use of medication for purposes other than those for which it is prescribed.

Tolerance. Tolerance is a physiologic state resulting from regular use of a drug in which an increased dosage is needed to produce the same effect, or a reduced effect is observed with a constant dose.

Missouri Palliative Care Guideline

The Missouri Board of Healing Arts encourages physicians to follow these guidelines when treating patients who are terminally ill.

Evaluating the Patient. Patients with life-limiting chronic illness should be given an option of palliative care, and prognostic guidelines should be used to identify patients who are entering the terminal period of their lives. The assessment should include the patient's disease state, prognosis, physical symptoms, and psychosocial and spiritual concerns. Coexisting disease and the impact of symptoms on functioning should be documented. The needs of the family or other caregivers for information and support should be assessed.

Understanding the Patient's Goals and Values. Discussions between the patient and physician about advanced directives and goals and values of the patient are central to palliative care. These discussions should be initiated as early as possible in the clinical course to maximize patient input to decision-making. The Board advises that physicians should ask the patient to name which person or persons should serve as substitute decision-maker if the patient is no longer able to participate in decision-making. The physician should document the patient's preferences in an advance directive. The substitute decision-maker should follow the patient's expressed wishes.

Discussing Treatment Options. You should carefully explain the burdens and benefits of shifting from curative treatment to palliative care to the patient or substitute decision-maker to obtain informed consent for the care plan. You should base your plan on the goals of the patient or those expressed in the patient's advance directive. You should also seek the consensus of the family. Decisions about resuscitation and withholding and withdrawing treatment should be consistent with these goals.

Aggressive Management of Pain and Symptoms. It is the ethical responsibility of the physician to provide pain and symptom management that promotes the best quality of life for the patient. Physical symptoms may not be controlled by standard treatment when the patient has unrelieved emotional or spiritual suffering. You should use multidisciplinary assessment and treatment to define and address the many dimensions of suffering. The Missouri Intractable Pain Treatment Act is relevant here.

Team Approach. A team approach in this setting is advisable. Examples of such teams are a hospice program, an informal group of skilled professionals, or a palliative care consultation team.

Documentation. Good documentation protects patient preferences. All discussions and treatment decisions should be documented in the medical record and should be accessible for guiding subsequent decisions. To evaluate effectiveness of treatment, a standard pain scale should be used for documentation of pain assessment and treatment response.