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SB-1240 Prescription drugs: CURES database.(2017-2018)

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Date Published: 04/09/2018 09:00 PM
SB1240:v98#DOCUMENT

Amended  IN  Senate  April 09, 2018

CALIFORNIA LEGISLATURE— 2017–2018 REGULAR SESSION

Senate Bill
No. 1240

Introduced by Senator Stone

February 15, 2018

An act to amend Section 4040 of, and to add Sections 4122.4 and Section 4122.5 to, the Business and Professions Code, and to amend Section 11165 of the Health and Safety Code, relating to pharmacy.


LEGISLATIVE COUNSEL'S DIGEST


SB 1240, as amended, Stone. Prescription drugs: CURES database.
The Pharmacy Law provides for the licensing and regulation of pharmacies, pharmacists, intern pharmacists, and pharmacy technicians by the California State Board of Pharmacy, which is within the Department of Consumer Affairs. That law defines “prescription” as an oral, written, or electronic transmission order that includes specified information, including a legible clear notice of the condition or purpose for which the drug is being prescribed if requested by the patient, and is issued by an authorized prescriber. That law makes a knowing violation of its provisions punishable as a crime and makes any other violation punishable as an infraction.
This bill would instead require a prescription, if in writing or transmitted electronically, to include an International Statistical Classification of Diseases, 10th revision (ICD-10) Code or a legible clear notice of the condition or purpose for which the drug is being prescribed, unless the patient requests this information to be omitted and would require a prescription transmitted orally to include either an ICD-10 Code of a description of the condition or purpose for which the drug is being prescribed. The bill would require a pharmacist, prior to processing clinical checks for prescriptions and dispensing the prescriptions, to review the most recent continuity of care document provided by the health care facility or physician and surgeon treating the patient. The bill would also require a pharmacy to immediately convey prescription profile information of a patient to a requesting pharmacy caring for that patient, except for the price and cost of a prescription. By placing new requirements on a pharmacist and a pharmacy pharmacy, this bill would expand an existing crime, and would, therefore, result in a state-mandated local program.
Existing law classifies certain controlled substances into designated schedules. Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by all practitioners authorized to prescribe, administer, furnish, or dispense these controlled substances. Existing law requires dispensing pharmacies and clinics to report specified information for each prescription of a Schedule II, Schedule III, or Schedule IV controlled substance to the department.
This bill would additional apply those requirements to Schedule V controlled substances and dangerous drugs, as defined, and would additionally require a description of the diagnosis, condition, or purpose for which the prescription was issued and the directions for use to be provided to the Department of Justice.
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 4040 of the Business and Professions Code is amended to read:

4040.
 (a) “Prescription” means an oral, written, or electronic transmission order that is both of the following:
(1) Given individually for the person or persons for whom ordered that includes all of the following:
(A) The name or names and address of the patient or patients.
(B) The name and quantity of the drug or device prescribed and the directions for use.
(C) The date of issue.
(D) Either rubber stamped, typed, or printed by hand or typeset, the name, address, and telephone number of the prescriber, his or her license classification, and his or her federal registry number, if a controlled substance is prescribed.
(E) If in writing or transmitted electronically, International Statistical Classification of Diseases, 10th revision (ICD-10) Code or a legible, clear notice of the condition or purpose for which the drug is being prescribed, unless the patient requests this information to be omitted. If transmitted orally, either the International Statistical Classification of Diseases, 10th revision (ICD-10) Code or a description of the condition or purpose for which the drug is being prescribed.
(F) If in writing, signed by the prescriber issuing the order, or the certified nurse-midwife, nurse practitioner, physician assistant, or naturopathic doctor who issues a drug order pursuant to Section 2746.51, 2836.1, 3502.1, or 3640.5, respectively, or the pharmacist who issues a drug order pursuant to Section 4052.1, 4052.2, or 4052.6.
(2) Issued by a physician, dentist, optometrist, podiatrist, veterinarian, or naturopathic doctor pursuant to Section 3640.7 or, if a drug order is issued pursuant to Section 2746.51, 2836.1, 3502.1, or 3460.5, by a certified nurse-midwife, nurse practitioner, physician assistant, or naturopathic doctor licensed in this state, or pursuant to Section 4052.1, 4052.2, or 4052.6 by a pharmacist licensed in this state.
(b) Notwithstanding subdivision (a), a written order of the prescriber for a dangerous drug, except for any Schedule II controlled substance, that contains at least the name and signature of the prescriber, the name and address of the patient in a manner consistent with paragraph (2) of subdivision (a) of Section 11164 of the Health and Safety Code, the name and quantity of the drug prescribed, directions for use, and the date of issue may be treated as a prescription by the dispensing pharmacist as long as any additional information required by subdivision (a) is readily retrievable in the pharmacy. In the event of a conflict between this subdivision and Section 11164 of the Health and Safety Code, Section 11164 of the Health and Safety Code shall prevail.
(c) “Electronic transmission prescription” includes both image and data prescriptions. “Electronic image transmission prescription” means any prescription order for which a facsimile of the order is received by a pharmacy from a licensed prescriber. “Electronic data transmission prescription” means any prescription order, other than an electronic image transmission prescription, that is electronically transmitted from a licensed prescriber to a pharmacy.
(d) The use of commonly used abbreviations shall not invalidate an otherwise valid prescription.
(e) Nothing in the amendments made to this section (formerly Section 4036) at the 1969 Regular Session of the Legislature shall be construed as expanding or limiting the right that a chiropractor, while acting within the scope of his or her license, may have to prescribe a device.

SEC. 2.Section 4122.4 is added to the Business and Professions Code, to read:
4122.4.

A pharmacist, prior to processing clinical checks for prescriptions and dispensing the prescriptions, shall review the most recent continuity of care document provided by the health care facility or physician and surgeon treating the patient.

SEC. 3.SEC. 2.

 Section 4122.5 is added to the Business and Professions Code, to read:

4122.5.
 A pharmacy shall immediately convey prescription profile information of a patient to a requesting pharmacy caring for that patient, except that the price and cost of a prescription shall not be included.

SEC. 4.SEC. 3.

 Section 11165 of the Health and Safety Code is amended to read:

11165.
 (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances and dangerous drugs, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, schedule V controlled substances and dangerous drugs, and for statistical analysis, education, and research, the Department of Justice shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and Internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances and the prescribing, ordering, administering, furnishing, and dispensing of dangerous drugs by all practitioners authorized to prescribe, order, administer, furnish, or dispense those dangerous drugs.
(b) The Department of Justice may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.
(c) (1) The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.
(2) (A) CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the Department of Justice, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the Department of Justice, for educational, peer review, statistical, or research purposes, provided that patient information, including any information that may identify the patient, is not compromised. Further, data disclosed to any individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to any third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The Department of Justice shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.
(B) Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances or do not prescribe, order, administer, furnish, or dispense dangerous drugs shall not be provided data obtained from CURES.
(3) In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patient’s CURES patient activity report as long as no additional CURES data is provided and keep a copy of the report in the patient’s medical record in compliance with subdivision (d) of Section 11165.1.
(d) For each prescription for a dangerous drug or a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, and 1308.14, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the Department of Justice as soon as reasonably possible, but not more than seven days after the date a dangerous drug or controlled substance is dispensed, in a format specified by the Department of Justice:
(1) Full name, address, and, if available, 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 ultimate user.
(2) The prescriber’s category of licensure, license number, national provider identifier (NPI) number, if applicable, the 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.
(3) Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.
(4) National Drug Code (NDC) number of the controlled substance or dangerous drug dispensed.
(5) Quantity of the controlled substance or dangerous drug dispensed.
(6) International Statistical Classification of Diseases, 10th revision (ICD-10) Code.
(7) Number of refills ordered.
(8) Whether the controlled substance or dangerous drug was dispensed as a refill of a prescription or as a first-time request.
(9) Date of origin of the prescription.
(10) Date of dispensing of the prescription.
(11) Description of the diagnosis, condition, or purpose for which the prescription was issued.
(12) The directions for use.
(e) The Department of Justice may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. All prescriber and dispenser invitees shall be licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.
(f) The Department of Justice shall, prior to upgrading CURES, consult with prescribers licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).
(g) The Department of Justice may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.
(h) For purposes of this section, “dangerous drug” has the same meaning as defined in Section 4022 of the Business and Professions Code.

SEC. 5.SEC. 4.

 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.