BILL NUMBER: SB 490 AMENDED BILL TEXT AMENDED IN ASSEMBLY SEPTEMBER 3, 2003 AMENDED IN ASSEMBLY JULY 16, 2003 AMENDED IN SENATE APRIL 24, 2003 AMENDED IN SENATE MARCH 27, 2003 INTRODUCED BY Senator Alpert (Coauthor: Senator Bowen) (Coauthor: Assembly Member Cohn) FEBRUARY 20, 2003 An act to amend Section 4052 of the Business and Professions Code, relating to pharmacy. LEGISLATIVE COUNSEL'S DIGEST SB 490, as amended, Alpert. Pharmacy: prescriptions. Existing law, the Pharmacy Law, creates the California State Board of Pharmacy and makes it responsible for regulating the practice of pharmacy. A knowing violation of the Pharmacy Law is a crime. Under that law, a pharmacist may not, in general, furnish a dangerous drug except upon the prescription of a physician, dentist, podiatrist, optometrist, or veterinarian. However, existing law authorizes a pharmacist to initiate emergency contraception drug therapy in accordance with standardized protocols developed by the pharmacist and an authorized prescriber acting within his or her scope of practice. This bill would also authorize a pharmacist to furnish emergency contraception drug therapy in accordance with a standardized procedure or protocol developed and approved by both the board and the Medical Board of California, in consultation with specified entities. The bill would require a pharmacist to complete a specified training program before performing emergency contraception drug therapy. Because a violation of this bill would be a crime, the 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. This bill would also incorporate additional changes to Section 4052 of the Business and Professions Code proposed by SB 545 that would become operative only if SB 545 and this bill are both enacted and become effective on or before January 1, 2004, and this bill is enacted last. Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. Section 4052 of the Business and Professions Code is amended to read: 4052. (a) Notwithstanding any other provision of law, a pharmacist may: (1) Furnish a reasonable quantity of compounded medication to a prescriber for office use by the prescriber. (2) Transmit a valid prescription to another pharmacist. (3) Administer, orally or topically, drugs and biologicals pursuant to a prescriber's order. (4) Perform the following procedures or functions in a licensed health care facility in accordance with policies, procedures, or protocols developed by health professionals, including physicians, pharmacists, and registered nurses, with the concurrence of the facility administrator: (A) Ordering or performing routine drug therapy related patient assessment procedures including temperature, pulse, and respiration. (B) Ordering drug therapy related laboratory tests. (C) Administering drugs and biologicals by injection pursuant to a prescriber's order (the administration of immunizations under the supervision of a prescriber may also be performed outside of a licensed health care facility). (D) Initiating or adjusting the drug regimen of a patient pursuant to an order or authorization made by the patient's prescriber and in accordance with the policies, procedures, or protocols of the licensed health care facility. (5) (A) Perform the following procedures or functions as part of the care provided by a health care facility, a licensed home health agency, a licensed clinic in which there is a physician oversight, a provider who contracts with a licensed health care service plan with regard to the care or services provided to the enrollees of that health care service plan, or a physician, in accordance, as applicable, with policies, procedures, or protocols of that facility, the home health agency, the licensed clinic, the health care service plan, or that physician, in accordance with subparagraph (C): (i) Ordering or performing routine drug therapy related patient assessment procedures including temperature, pulse, and respiration. (ii) Ordering drug therapy related laboratory tests. (iii) Administering drugs and biologicals by injection pursuant to a prescriber's order (the administration of immunizations under the supervision of a prescriber may also be performed outside of a licensed health care facility). (iv) Initiating or adjusting the drug regimen of a patient pursuant to a specific written order or authorization made by the patient's prescriber for the individual patient, and in accordance with the policies, procedures, or protocols of the health care facility, home health agency, licensed clinic, health care service plan, or physician. Adjusting the drug regimen does not include substituting or selecting a different drug, except as authorized by the protocol. The pharmacist shall provide written notification to the patient's prescriber, or enter the appropriate information in an electronic patient record system shared by the prescriber, of any drug regimen initiated pursuant to this clause within 24 hours. (B) A patient's prescriber may prohibit, by written instruction, any adjustment or change in the patient's drug regimen by the pharmacist. (C) The policies, procedures, or protocols referred to in this paragraph shall be developed by health care professionals, including physicians, pharmacists, and registered nurses, and, at a minimum, meet all of the following requirements: (i) Require that the pharmacist function as part of a multidisciplinary group that includes physicians and direct care registered nurses. The multidisciplinary group shall determine the appropriate participation of the pharmacist and the direct care registered nurse. (ii) Require that the medical records of the patient be available to both the patient's prescriber and the pharmacist. (iii) Require that the procedures to be performed by the pharmacist relate to a condition for which the patient has first been seen by a physician. (iv) Except for procedures or functions provided by a health care facility, a licensed clinic in which there is physician oversight, or a provider who contracts with a licensed health care plan with regard to the care or services provided to the enrollees of that health care service plan, require the procedures to be performed in accordance with a written, patient-specific protocol approved by the treating or supervising physician. Any change, adjustment, or modification of an approved preexisting treatment or drug therapy shall be provided in writing to the treating or supervising physician within 24 hours. (6) Manufacture, measure, fit to the patient, or sell and repair dangerous devices or furnish instructions to the patient or the patient's representative concerning the use of those devices. (7) Provide consultation to patients and professional information, including clinical or pharmacological information, advice, or consultation to other health care professionals. (8) (A) Furnish emergency contraception drug therapy in accordance with either of the following:(A)(i) Standardized procedures or protocols developed by the pharmacist and an authorized prescriber who is acting within his or her scope of practice.(B)(ii) Standardized procedures or protocols developed and approved by both the board and the Medical Board of California in consultation with the American College of Obstetricians and Gynecologists, the California Pharmacist Association, and other appropriate entities. Both the board and the Medical Board of California shall have authority to ensure compliance with thissubparagraphclause , and both boards are specifically charged with the enforcement of this provision with respect to their respective licensees. Nothing in thissubparagraphclause shall be construed to expand the authority of a pharmacist to prescribe any prescription medication.(9)(B) Prior to performing a procedure authorized underparagraph (8)this paragraph , a pharmacist shall complete a training program on emergency contraception consisting of at least one hour of approved continuing education on emergency contraception drug therapy. (b) (1) Prior to performing any procedure authorized by paragraph (4) of subdivision (a), a pharmacist shall have received appropriate training as prescribed in the policies and procedures of the licensed health care facility. (2) Prior to performing any procedure authorized by paragraph (5) of subdivision (a), a pharmacist shall have either (A) successfully completed clinical residency training or (B) demonstrated clinical experience in direct patient care delivery. (3) For each emergency contraception drug therapy initiated pursuant to paragraph (8) of subdivision (a), the pharmacist shall provide the recipient of the emergency contraception drugs with a standardized factsheet that includes, but is not limited to, the indications for use of the drug, the appropriate method for using the drug, the need for medical followup, and other appropriate information. The board shall develop this form in consultation with the State Department of Health Services, the American College of Obstetricians and Gynecologists, the California Pharmacists Association, and other health care organizations. The provisions of this section do not preclude the use of existing publications developed by nationally recognized medical organizations. (c) Nothing in this section shall affect the requirements of existing law relating to maintaining the confidentiality of medical records. (d) Nothing in this section shall affect the requirements of existing law relating to the licensing of a health care facility.SEC. 2.SEC. 1.5. Section 4052 of the Business and Professions Code is amended to read: 4052. (a) Notwithstanding any other provision of law, a pharmacist may: (1) Furnish a reasonable quantity of compounded medication to a prescriber for office use by the prescriber. (2) Transmit a valid prescription to another pharmacist. (3) Administer, orally or topically, drugs and biologicals pursuant to a prescriber's order. (4) Perform the following procedures or functions in a licensed health care facility in accordance with policies, procedures, or protocols developed by health professionals, including physicians, pharmacists, and registered nurses, with the concurrence of the facility administrator: (A) Ordering or performing routine drug therapy-related patient assessment procedures including temperature, pulse, and respiration. (B) Ordering drug therapy-related laboratory tests. (C) Administering drugs and biologicals by injection pursuant to a prescriber's order (the administration of immunizations under the supervision of a prescriber may also be performed outside of a licensed health care facility). (D) Initiating or adjusting the drug regimen of a patient pursuant to an order or authorization made by the patient's prescriber and in accordance with the policies, procedures, or protocols of the licensed health care facility. (5) (A) Perform the following procedures or functions as part of the care provided by a health care facility, a licensed home health agency, a licensed clinic in which there is a physician oversight, a provider who contracts with a licensed health care service plan with regard to the care or services provided to the enrollees of that health care service plan, or a physician, in accordance, as applicable, with policies, procedures, or protocols of that facility, the home health agency, the licensed clinic, the health care service plan, or that physician, in accordance with subparagraph (C): (i) Ordering or performing routine drug therapy-related patient assessment procedures including temperature, pulse, and respiration. (ii) Ordering drug therapy-related laboratory tests. (iii) Administering drugs and biologicals by injection pursuant to a prescriber's order (the administration of immunizations under the supervision of a prescriber may also be performed outside of a licensed health care facility). (iv) Initiating or adjusting the drug regimen of a patient pursuant to a specific written order or authorization made by the patient's prescriber for the individual patient, and in accordance with the policies, procedures, or protocols of the health care facility, home health agency, licensed clinic, health care service plan, or physician. Adjusting the drug regimen does not include substituting or selecting a different drug, except as authorized by the protocol. The pharmacist shall provide written notification to the patient's prescriber, or enter the appropriate information in an electronic patient record system shared by the prescriber, of any drug regimen initiated pursuant to this clause within 24 hours. (B) A patient's prescriber may prohibit, by written instruction, any adjustment or change in the patient's drug regimen by the pharmacist. (C) The policies, procedures, or protocols referred to in this paragraph shall be developed by health care professionals, including physicians, pharmacists, and registered nurses, and, at a minimum, meet all of the following requirements: (i) Require that the pharmacist function as part of a multidisciplinary group that includes physicians and direct care registered nurses. The multidisciplinary group shall determine the appropriate participation of the pharmacist and the direct care registered nurse. (ii) Require that the medical records of the patient be available to both the patient's prescriber and the pharmacist. (iii) Require that the procedures to be performed by the pharmacist relate to a condition for which the patient has first been seen by a physician. (iv) Except for procedures or functions provided by a health care facility, a licensed clinic in which there is physician oversight, or a provider who contracts with a licensed health care plan with regard to the care or services provided to the enrollees of that health care service plan, require the procedures to be performed in accordance with a written, patient-specific protocol approved by the treating or supervising physician. Any change, adjustment, or modification of an approved preexisting treatment or drug therapy shall be provided in writing to the treating or supervising physician within 24 hours. (6) Manufacture, measure, fit to the patient, or sell and repair dangerous devices or furnish instructions to the patient or the patient's representative concerning the use of those devices. (7) Provide consultation to patients and professional information, including clinical or pharmacological information, advice, or consultation to other health care professionals. (8)Initiate(A) Furnish emergency contraception drug therapy in accordance withstandardizedeither of the following: (i) Standardized procedures or protocols developed by the pharmacist and an authorized prescriber who is acting within his or her scope of practice.Prior(ii) Standardized procedures or protocols developed and approved by both the board and the Medical Board of California in consultation with the American College of Obstetricians and Gynecologists, the California Pharmacist Association, and other appropriate entities. Both the board and the Medical Board of California shall have authority to ensure compliance with this clause, and both boards are specifically charged with the enforcement of this provision with respect to their respective licensees. Nothing in this clause shall be construed to expand the authority of a pharmacist to prescribe any prescription medication. (B) Prior to performinganya procedure authorized under this paragraph, a pharmacist shallhave completedcomplete a training program on emergency contraception, which includes, but is not limited to, conduct of sensitive communications, quality assurance, referral to additional services, and documentationthat consists of at least one hour of approved continuing education on emergency contraception drug therapy . (C) A pharmacist, pharmacist's employer, or pharmacist's agent may not directly charge a patient a separate consultation fee for emergency contraception drug therapy services initiated pursuant to this paragraph, but may charge an administrative fee not to exceed ten dollars ($10) above the retail cost of the drug. Upon an oral, telephonic, electronic, or written request from a patient or customer, a pharmacist or pharmacist's employee shall disclose the total retail price that a consumer would pay for emergency contraception drug therapy. As used in this subparagraph, total retail price includes providing the consumer with specific information regarding the price of the emergency contraception drugs and the price of the administrative fee charged. This limitation is not intended to interfere with other contractually agreed upon terms between a pharmacist, a pharmacist's employer, or a pharmacist's agent, and a health care service plan or insurer. Patients who are insured or covered and receive a pharmacy benefit that covers the cost of emergency contraception shall not be required to pay an administrative fee. These patients shall be required to pay copayments pursuant to the terms and conditions of their coverage. The provisions of this subparagraph shall cease to be operative for dedicated emergency contraception drugs when these drugs are reclassified as over-the-counter products by the federal Food and Drug Administration. (D) A pharmacist may not require a patient to provide individually identifiable medical information that is not specified in Section 1707.1 of Title 16 of the California Code of Regulations before initiating emergency contraception drug therapy pursuant to this paragraph. (b) (1) Prior to performing any procedure authorized by paragraph (4) of subdivision (a), a pharmacist shall have received appropriate training as prescribed in the policies and procedures of the licensed health care facility. (2) Prior to performing any procedure authorized by paragraph (5) of subdivision (a), a pharmacist shall have either (A) successfully completed clinical residency training or (B) demonstrated clinical experience in direct patient care delivery. (3) For each emergency contraception drug therapy initiated pursuant to paragraph (8) of subdivision (a), the pharmacist shall provide the recipient of the emergency contraception drugs with a standardized factsheet that includes, but is not limited to, the indications for use of the drug, the appropriate method for using the drug, the need for medical followup, and other appropriate information. The board shall develop this form in consultation with the State Department of Health Services, the American College of Obstetricians and Gynecologists, the California Pharmacists Association, and other health care organizations. The provisions of this section do not preclude the use of existing publications developed by nationally recognized medical organizations. (c) Nothing in this section shall affect the requirements of existing law relating to maintaining the confidentiality of medical records. (d) Nothing in this section shall affect the requirements of existing law relating to the licensing of a health care facility. SEC. 2. Section 1.5 of this bill incorporates amendments to Section 4052 of the Business and Professions Code proposed by both this bill and SB 545. It shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2004, (2) each bill amends Section 4052 of the Business and Profession Code, and (3) this bill is enacted after SB 545, in which case Section 1 of this bill shall not become operative. 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.