Amended  IN  Assembly  April 11, 2018
Amended  IN  Assembly  March 12, 2018

CALIFORNIA LEGISLATURE— 2017–2018 REGULAR SESSION

Assembly Bill No. 1998

Introduced by Assembly Member Rodriguez

February 01, 2018

An act to amend Section 11190 of, and to add Section 11154.5 to, add Section 11153.1 to the Health and Safety Code, relating to controlled substances.


LEGISLATIVE COUNSEL'S DIGEST


AB 1998, as amended, Rodriguez. Opioids: prescription limitations. safe prescribing protocol.
Existing law, the Uniform Controlled Substances Act, classifies opioids as Schedule II controlled substances and places restrictions on the prescription of those drugs, including prohibiting refills and specifying the requirements of a prescription for these drugs. Violation of these provisions and the Uniform Controlled Substances Act is a misdemeanor.
This bill would require, by June 1, 2019, every health care practitioner authorized to prescribe opioids classified as Schedule II and Schedule III to adopt a safe prescribing protocol, as specified. The bill would require the health care practitioner to note the reason the safe prescribing protocol was not followed if, in the health care practitioner’s professional judgment, adherence to the safe prescribing protocol is not appropriate for a patient’s condition. The bill would make the failure to develop or adhere to the protocol, except as specified, unprofessional conduct and enforceable by the health care practitioner’s licensing board. Because violation of these provisions is also a crime, the bill would create a new crime, thereby imposing a state-mandated local program.
The bill would require the State Department of Public Health, utilizing data from the CURES database for the year ending December 31, 2016, to monitor progress toward stated goals and to report this information to the Legislature annually.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.

This bill would prohibit a prescriber from prescribing an opioid in an amount greater that the patient needs for a 3-day period unless the prescriber believes, in his or her professional judgment, that a larger prescription is needed to treat a medical condition or that a larger prescription is necessary for the treatment of chronic pain. The bill would require a prescriber who writes a prescription for an opioid that is either larger than the 3-day supply or that is the 4th prescription without the dosage decreasing to include in the patient’s record why the excess or additional prescription was needed, what other medications were considered, the patient’s injury or illness, and the milligram dosage of the prescription. The bill would require the prescriber to take specified actions prior to prescribing an opioid, including informing the patient of the risks and treatment options for opioid addiction. By creating new crimes, this bill would impose a state-mandated local program.

Existing law imposes reporting requirements on practitioners prescribing Schedule II controlled substances and makes a violation of those reporting requirements a misdemeanor.

This bill would require, when a prescription is for an amount larger than that needed for 3 days or when the prescription is the 4th prescription without the dosage decreasing, the prescriber to report, in detail, why the excess or additional prescription was needed, what other medications were considered, the patient’s injury or illness, and the milligram dosage of the prescription. The bill would also require a prescriber who fails to submit the report required to be referred to the appropriate licensing board for administrative action, as deemed appropriate by that board. By creating a new crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: YES  

The people of the State of California do enact as follows:


SECTION 1.

 Section 11153.1 is added to the Health and Safety Code, to read:

11153.1.
 (a) It is the intent of the Legislature that by January 1, 2022, there shall be a ____% reduction in the number of prescriptions issued in California for opioids classified as Schedule II and Schedule III, as defined in Sections 11055 and 11056, respectively. It is also the intent of the Legislature that by January 1, 2022, there shall be a reduction of ____% in the quantity of doses authorized pursuant to prescriptions for opioids classified as Schedule II and Schedule III.
(b) By June 1, 2019, every health care practitioner authorized to prescribe opioids classified as Schedule II and Schedule III pursuant to Sections 11055 and 11056, respectively, shall adopt a safe prescribing protocol, as described in subdivision (c). A group of practitioners may adopt a safe prescribing protocol that applies to all parties as part of a business affiliation or contract with an organized provider group.
(c) The safe prescribing protocol shall be a written document promoting the appropriate and optimal selection, dosage, and duration of opioid prescriptions for patients, with the goal of reducing the misuse of opioids. The protocol shall include, but is not limited to, all of the following:
(1) The maximum dose and duration of prescriptions for adult patients experiencing acute pain.
(2) The maximum dose and duration of prescriptions for pediatric patients experiencing acute pain.
(3) Alternatives to opioid treatment, including nonpharmacological treatment options.
(4) Refill authorization practices.
(5) Coprescription of opioid antagonists to at-risk patients, including, but not limited to, patients who meet any of the following criteria:
(A) An opioid dosage of 90 morphine milligrams or more per day.
(B) Patients who are prescribed benzodiazepines.
(C) Patients with a history of substance use disorder.
(6) Referral guidelines and policies between primary care and specialty care, including, but not limited to, pain specialists.
(7) Mechanisms for prescriber peer-to-peer review and cooperation.
(8) Procedures for periodic review of the protocol for effectiveness in reducing opioid prescription.
(9) Procedures for updating the protocol, as appropriate.
(10) Mechanisms for patient education on the side effects of opioids, including the risk of addiction and overdose.
(d) The development of a safe prescribing protocol shall include review and consideration of evidence-based science, literature, research, and guidelines, including relevant recommendations and research from academia and consideration of existing guidelines and recommendations from groups including, but not limited to, the federal Centers for Disease Control and Prevention, the federal Centers for Medicare and Medicaid Services, the Medical Board of California, and the American Society of Addiction Medicine.
(e) A health care practitioner or a group of practitioners may adopt the federal Centers for Medicare and Medicaid Services opioid prescribing guidelines as the safe prescribing protocol.
(f) If, in the health care practitioner’s professional judgment, adherence to the safe prescribing protocol is not appropriate for a patient’s condition, the practitioner shall note in the patient’s medical record the reason the protocol was not followed.
(g) This section does not apply to a health care practitioner who is authorized to prescribe opioids if the prescription of those opioids is limited to patients undergoing treatment for chronic pain, cancer, substance use disorder, or hospice or end-of-life care.
(h) Failure to develop or adhere to the protocol established pursuant to this section, except as provided in subdivision (f), is unprofessional conduct and enforceable by the health care practitioner’s licensing board.
(i) The State Department of Public Health, utilizing data from the CURES database for the year ending December 31, 2016, shall monitor progress toward the goal stated in subdivision (a) and, notwithstanding Section 10231.5 of the Government Code, shall report this information to the Legislature annually. The report shall be submitted in compliance with Section 9795 of the Government Code.

SEC. 2.

 No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.
SECTION 1.Section 11154.5 is added to the Health and Safety Code, to read:
11154.5.

(a)A prescriber shall not prescribe an opioid listed in subdivision (b) or (c) of Section 11055 in an amount greater that the patient needs for a three-day period unless the prescriber believes, in his or her professional judgment, that a larger prescription is needed to treat a medical condition or that a larger prescription is necessary for the treatment of chronic pain. If a prescription is written for more than a three-day supply, the prescriber shall include in the patient’s record, in detail, why the excess prescription was needed, what other medications were considered, the patient’s injury or illness, and the milligram dosage of the prescription.

(b)When a prescriber writes a fourth prescription for an opioid listed in subdivision (b) or (c) of Section 11055 where the dosage of the prescription has not decreased, the prescriber shall include in the patient’s record, in detail, why the additional prescription is needed, what other medications were considered, the patient’s injury or illness, and the milligram dosage of the prescription.

(c)Prior to prescribing an opioid listed in subdivision (b) or (c) of Section 11055, a prescriber shall do all of the following:

(1)Consult with the patient regarding the quantity of the prescription and the option for a partial fill pursuant to Section 4052.10 of the Business and Professions Code.

(2)Inform the patient of the risks of opioid addiction and overdose.

(3)Inform the patient of the treatment options for opioid addiction, including medication-assisted therapy.

(4)Offer the patient a referral to psychological counseling and behavioral therapy.

(d)This section does not apply to prescriptions for either of the following:

(1)Management of pain associated with cancer.

(2)Use in palliative, end-of-life, or hospice care.

SEC. 2.Section 11190 of the Health and Safety Code is amended to read:
11190.

(a) Every practitioner, other than a pharmacist, who prescribes or administers a controlled substance classified in Schedule II shall make a record that, as to the transaction, shows all of the following:

(1)The name and address of the patient.

(2)The date.

(3)The character, including the name, strength, and quantity of controlled substances involved.

(b)The prescriber’s record shall show the pathology and purpose for which the controlled substance was administered or prescribed.

(c)(1) For each prescription for a Schedule II, Schedule III, or Schedule IV controlled substance that is dispensed by a prescriber pursuant to Section 4170 of the Business and Professions Code, the prescriber shall record and maintain the following information:

(A)Full name, address, and telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender and date of birth of the patient.

(B)The prescriber’s category of licensure and license number; federal controlled substance registration number; and the state medical license number of any prescriber using the federal controlled substance registration number of a government-exempt facility.

(C)NDC (National Drug Code) number of the controlled substance dispensed.

(D)Quantity of the controlled substance dispensed.

(E)ICD-9 (diagnosis code), if available.

(F)Number of refills ordered.

(G)Whether the drug was dispensed as a refill of a prescription or as a first-time request.

(H)Date of origin of the prescription.

(2)(A)Each prescriber that dispenses controlled substances shall provide the Department of Justice the information required by this subdivision on a weekly basis in a format set by the Department of Justice pursuant to regulation.

(B)The reporting requirement in this section shall not apply to the direct administration of a controlled substance to the body of an ultimate user.

(d)(1)For an opioid listed in subdivision (b) or (c) of Section 11055, when a prescription is for an amount larger than that needed for three days or when the prescription is the fourth prescription without the dosage decreasing, the practitioner shall report, in detail, why the longer or additional prescription was needed, what other medications were considered, the patient’s injury or illness, and the milligram dosage of the prescription.

(2)In addition to the penalties authorized by Section 11191, a practitioner who fails to submit the report required pursuant to this subdivision shall be referred to the appropriate licensing board for administrative action, as deemed appropriate by that board.

(e)The reporting requirement in this section for Schedule IV controlled substances shall not apply to any of the following:

(1)The dispensing of a controlled substance in a quantity limited to an amount adequate to treat the ultimate user involved for 48 hours or less.

(2)The administration or dispensing of a controlled substance in accordance with any other exclusion identified by the United States Health and Human Service Secretary for the National All Schedules Prescription Electronic Reporting Act of 2005.

(f)Notwithstanding paragraph (2) of subdivision (c), the reporting requirement of the information required by this section for a Schedule II or Schedule III controlled substance, in a format set by the Department of Justice pursuant to regulation, shall be on a monthly basis for all of the following:

(1)The dispensing of a controlled substance in a quantity limited to an amount adequate to treat the ultimate user involved for 48 hours or less.

(2)The administration or dispensing of a controlled substance in accordance with any other exclusion identified by the United States Health and Human Service Secretary for the National All Schedules Prescription Electronic Reporting Act of 2005.

SEC. 3.

No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.