A Guide to State Opioid Prescribing Policies

Pain Policy and Regulation: California

Summary

California has one of the oldest set of guidelines and rules relating to the use of controlled substances to treat pain. California is also one of the best states for updating its materials and for making its materials easy to locate on the Medical Board's Web site, which is at http://www.medbd.ca.gov. All California physicians should read all Board materials very carefully and make sure they understand the various pain-related rules.

Registrant Responsibilities

A registrant is personally responsible for knowledge of and compliance with the provisions, requirements, and procedures and with knowledge of and compliance with all other federal, state, and local laws and regulations applicable to the purchase, acquisition, possession, storage, maintenance, and dispensation of and record-keeping and reporting for medication.

State Prescription Drug Monitoring Program

The State of California designed its prescription drug monitoring program, known as CURES, to help reduce pharmaceutical drug diversion without affecting legitimate medical practice and patient care. The CURES Program captures information about the prescribing/dispensing of controlled substances in schedules II through IV. The CURES program provides patient activity reports (PAR) to the medical community, investigative referrals to law enforcement field offices, print out requests to outside law enforcement for assistance in investigations, specialized reports to researchers, and statistical data to determine drug trends either statewide or region specific.

General Prescribing/Dispensing Rules (2241 and 2241.1)

A physician and surgeon MAY prescribe, dispense, or administer prescription drugs, including prescription controlled substances, to a person addicted to drugs who under the physician's or surgeon's treatment FOR A PURPOSE OTHER THAN maintenance on, or detoxification from, prescription drugs or controlled substances.

A physician and surgeon MAY prescribe, dispense, or administer prescription drugs or prescription controlled substances to a person who is addicted to drugs FOR PURPOSES OF maintenance on, or detoxification from, prescription drugs or controlled substances ONLY AS SET FORTH BELOW. Physicians and surgeons ARE NOT authorized to prescribe, dispense, or administer dangerous drugs or controlled substances to a person he or she knows or reasonably believes is using or will use the drugs or substances for a nonmedical purpose.

Prescription drugs or controlled substances may also be administered or applied by a physician and surgeon, or by a registered nurse acting under the instruction and supervision of a physician or surgeon, under the following circumstances:

1. Emergency treatment of a patient whose addiction is complicated by the presence of incurable disease, acute accident, illness, or injury, or the infirmities attendant upon age.
2. Treatment of addicts in state-licensed institutions where the patient is kept under restraint and control, or in city or county jails or state prisons.
3. Treatment of addicts as provided for by Section 11217.5 of the California Health and Safety Code.

"Addict" means a person whose actions are characterized by craving in combination with one or more of the following:

1. Impaired control over drug use;
2. Compulsive use; or
3. Continued use despite harm.

A person whose drug-seeking behavior is primarily the result of inadequate control of pain is not addicted within the meaning of this section or Section 2241.5.

A physician and surgeon MAY prescribe for or dispense or administer dangerous drugs or prescription controlled substances to a person under his or her treatment FOR THE TREATMENT OF pain or for a condition causing pain, including but not limited to, intractable pain.

No physician and surgeon will be subject to disciplinary action for prescribing, dispensing, or administering dangerous drugs or prescription controlled substances in accordance with this rule. However, the Board still has the power to take any action under its authority against a physician or surgeon who commits any of the violations set out in this rule. Read the entire rule. Violations include, but are not limited to: (1) failing to perform an appropriate prior examination and having no medical indication for prescribing, dispensing, or furnishing dangerous drugs; (2) failing to keep complete and accurate records of purchases and disposals of substances listed in the California Uniform Controlled Substances Act or controlled substances scheduled in the federal law; or (3) writing false or fictitious prescriptions for controlled substances.

A physician and surgeon must exercise reasonable care in determining whether a particular patient or condition or the complexity of a patient's treatment, including but not limited to a current or recent pattern of drug abuse, requires consultation with or referral to a more qualified specialist.

California Pain Management Investigation Guidelines

The California Board of Medicine publishes a set of investigation guidelines used during disciplinary inquiries and investigations. California physicians should read the entire set of guidelines, which may be found http://www.medbd.ca.gov/pain_investigations.pdf.

California Guidelines on the Use of Controlled Medications to Treat Pain

California first adopted its policy statement entitled "Prescribing Controlled Substances for Pain" in 1994. The California Medical Board later revised this document and now calls it the "Guidelines for the Use of Controlled Substances for the Treatment of Pain." The main purpose of the revision was to expand the scope of the 1994 policy statement from patients with intractable pain to all patients with pain.

California recognizes that the "inappropriate prescribing of controlled substances, including opioids, can lead to drug abuse or diversion and can also lead to ineffective management of pain, unnecessary suffering of patients, and increased health costs." Significantly, the California Medical Board recognizes that "some physicians do not treat pain appropriately due to a lack of knowledge or concern about pain, and others may fail to treat pain properly due to fear of discipline by the Medical Board."

The California Medical Board published its current guidelines with the intent of improving pain management in California and to help physician avoid undertreatment, overtreatment, or other inappropriate treatment of a patient's pain.

The Medical Board expects physicians and surgeons to follow the standard of care in managing patients with pain and to use the following guidelines when doing so.

History/Physical Examination

The physician must accomplish a medical history and physical examination, which includes an assessment of the pain, physical and psychological functioning, a substance abuse history, history of prior pain treatment, an assessment of underlying or coexisting diseases or conditions, and documentation of the presence of a recognized medical indication for the use of a controlled substance. The physician should take care and realize that "the prescribing of controlled substances for pain may require referral to one or more consulting physicians." Likewise, "the complexity of the history and physical examination may vary based on the practice location. In the emergency department, the operating room, at night or on the weekends, the physician and surgeon may not always be able to verify the patient's history and past medical treatment. In continuing care situations for chronic pain management, the physician and surgeon should have a more extensive evaluation of the history, past treatment, diagnostic tests and physical exam."

Treatment Plan, Objectives

The physician should create a treatment plan that states objectives by which the treatment plan can be evaluated, such as pain relief and/or improved physical and psychosocial function, and should indicate whether any further diagnostic evaluations or other treatments are planned. The physician and surgeon should tailor pharmacologic therapy to the individual medical needs of each patient. Multiple treatment modalities and/or a rehabilitation program may be necessary if the pain is complex or is associated with physical and psychosocial impairment. Physicians and surgeons may use control of pain, increase in function, and improved quality of life as criteria to evaluate the treatment plan. When the patient is requesting opioid medications for pain and inconsistencies are identified in the history, presentation, behaviors, or physical findings, physicians and surgeons who make a clinical decision to withhold opioid medications should document the basis for their decision.

Informed Consent

The physician and surgeon should discuss the risks and benefits of the use of controlled substances and other treatment modalities with the patient, caregiver or guardian. The California Medical Board does not require a written consent or pain agreement for chronic use but suggests that such a document may make it easier for the physician and surgeon to document patient education, the treatment plan, and informed consent. Patient, guardian, and caregiver attitudes about medicines may influence the patient's use of medications for relief from pain.

Periodic Review

The physician and surgeon should periodically review the course of the patient's treatment and any new information about the cause of the pain or the patient's state of health. Continuation or modification of controlled substances for pain management therapy depends on the physician's evaluation of progress toward treatment objectives. If the patient's progress is unsatisfactory, the physician and surgeon should assess the appropriateness of continued use of the current treatment plan and consider the use of other therapeutic modalities. It is important to note that the management of patients with controlled substances requires monthly, quarterly, or semiannual visits as required by the standard of care. The patient's satisfactory response to treatment may include the patient's decreased pain, increased level of function, or improved quality of life. Physicians should consider information from family members or other caregivers in determining the patient's response to treatment.

Consultation

The physician and surgeon should consider referring the patient as necessary for additional evaluation and treatment to achieve treatment objectives. Complex pain problems may require consultation with a pain medicine specialist. In addition, physicians should give special attention to those patients with pain who are at risk for misusing their medications, including those whose living arrangements pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse requires extra care, monitoring, documentation, and consultation with addiction medicine specialists, and may entail the use of agreements between the provider and the patient that specify the rules for medication use and consequences for misuse. It is very important for the physician to coordinate care when prescribing controlled substances on a chronic basis. In situations where there is dual diagnosis of opioid dependence and intractable pain, both of which are being treated with controlled substances, protections apply to physicians and surgeons who prescribe controlled substances for intractable pain, provided the physician complies with the requirements of the general standard of care and California Business and Professions Code section 2241.5.

Records

The physician and surgeon should keep accurate and complete records according to items above, including the medical history and physical examination, other evaluations and consultations, treatment plan objectives, informed consent, treatments, medications, rationale for changes in the treatment plan or medications, agreements with the patient, and periodic reviews of the treatment plan. Physicians should document periodic reviews at least annually or more frequently as warranted. Physicians should document pain levels, levels of function, and quality of life. Medical documentation should include both subjective complaints of patient and caregiver and objective findings by the physician.

Compliance With Controlled Substances Laws and Regulations

To prescribe controlled substances, the physician and surgeon must be appropriately licensed in California, have a valid controlled substances registration, and comply with federal and state regulations for issuing controlled substances prescriptions. Physicians and surgeons should review the Drug Enforcement Administration's (DEA) Practitioner Manual (available at http://www.deadiversion.usdoj.gov/pubs/manuals/pract/index.html) and the Medical Board's Guidebook to Laws Governing the Practice of Medicine by Physicians and Surgeons (which is currently being revised) for specific rules governing issuance of controlled substances prescriptions. It is important to note there is no minimum or maximum number of medications that the physician may prescribe to a patient under either federal or California law. Physicians and surgeons who supervise physician assistants (PAs) or nurse practitioners (NPs) should carefully review the respective supervision requirements. Additional information on PA supervision requirements is available at: http://www.physicianassistant.ca.gov. PAs are able to obtain their own DEA number to use when writing prescriptions for drug orders for controlled substances. Current law permits physician assistants to write and sign prescription drug orders when authorized to do so by their supervising physician for schedule II to IV drugs. Further, a PA may only administer, provide, or transmit a drug order for schedule II through schedule V controlled substances with the advanced approval by a supervising physician for a specific patient.

To ensure that a PA's actions involving the prescribing, administration, or dispensing of drugs is in strict accordance with the directions of the physician, every time a PA administers or dispenses a drug or transmits a drug order, the physician supervisor must sign and date the patient's medical record or drug chart within 7 days. (Section 1399.545(f) of the California Code of Regulations.)

NPs are allowed to furnish schedule III through V controlled substances under written protocols.

Important Notice

Although it is lawful under both federal and California law to prescribe controlled substances for the treatment of pain, there are limitations on the prescribing of controlled substances to or for patients for the treatment of chemical dependency. The California Intractable Pain Treatment Act (CIPTA) does not apply to those persons being treated by the physician and surgeon only for chemical dependency because of use of drugs or controlled substances. The CIPTA does not authorize a physician and surgeon to prescribe, dispense, or administer controlled substances to a person the practitioner knows to be using the prescribed drugs or controlled substances for nontherapeutic purposes. At the same time, California law permits the prescribing, furnishing, or administering of controlled substances to or for a patient who has a disease, ailments, injury, or infirmities attendant on old age, other than addiction, and the CIPTA does apply to "a practitioner who is prescribing controlled substances for intractable pain, as long as that practitioner is not also treating the patient for chemical dependency."