BILL NUMBER: SB 545 CHAPTERED 10/01/03 CHAPTER 652 FILED WITH SECRETARY OF STATE OCTOBER 1, 2003 APPROVED BY GOVERNOR OCTOBER 1, 2003 PASSED THE SENATE SEPTEMBER 9, 2003 PASSED THE ASSEMBLY SEPTEMBER 5, 2003 AMENDED IN ASSEMBLY SEPTEMBER 3, 2003 AMENDED IN ASSEMBLY AUGUST 26, 2003 AMENDED IN ASSEMBLY JULY 16, 2003 AMENDED IN ASSEMBLY JUNE 26, 2003 AMENDED IN SENATE JUNE 4, 2003 AMENDED IN SENATE MAY 20, 2003 INTRODUCED BY Senator Speier (Coauthor: Assembly Member Cohn) FEBRUARY 20, 2003 An act to amend Section 4052 of, and to add Section 682 to, the Business and Professions Code, relating to pharmacists. LEGISLATIVE COUNSEL'S DIGEST SB 545, Speier. Emergency contraception drug therapy. Existing law, the Pharmacy Law, provides for the licensing and regulation of the practice of pharmacy under the jurisdiction of the California State Board of Pharmacy. Existing law requires a pharmacist to provide consultation when furnishing drugs, with certain exceptions, and the board has set forth specific requirements applicable to the provision of consultation and the maintenance of patient medication records. Existing law authorizes a pharmacist, in addition to other functions, to initiate emergency contraception drug therapy if the pharmacist has completed a training program on emergency contraception and certain other conditions are met. This bill would instead authorize the pharmacist to furnish emergency contraception drug therapy subject to those conditions and would revise the training requirement. The bill would prohibit a pharmacist from requiring a patient to provide individually identifiable medical information, except as specified. The bill would also prohibit a pharmacist, or his or her employer or agent, from charging a separate consultation fee for the initiation of emergency contraception drug therapy, but would authorize an administrative fee not to exceed $10 above the retail cost of the drug. The bill would require a pharmacist, upon request, to disclose the total retail drug price for emergency contraception drug therapy. Existing law sets forth certain requirements and prohibitions for health care providers. This bill would prohibit an individual issuing a prescription or order for emergency contraception drug therapy through contact with a patient over the phone or through electronic means from charging an administrative fee of more than $10. Existing law makes it a misdemeanor to knowingly violate the Pharmacy Law. All other violations of that law are infractions unless otherwise indicated. Because this bill would create new prohibitions on pharmacists, the violation of which 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 490 that would become operative only if SB 490 and this bill are both enacted and become effective on or before January 1, 2004, and this bill is enacted last. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. It is the intent of the Legislature to ensure equality of access to pharmaceuticals for the women of California. In ensuring that access, the Legislature intends to eliminate barriers relating to women obtaining emergency contraception. SEC. 2. Section 682 is added to the Business and Professions Code, to read: 682. An individual authorized to prescribe emergency contraception who issues a prescription or order for emergency contraception drug therapy as a result of a patient contact by telephone or electronic means may not charge an administrative fee or fees totaling more than ten dollars ($10) for emergency contraception drug therapy services. This limitation is not intended to interfere with other contractually agreed-upon terms between an individual prescriber and a health care service plan, insurer, or disability insurer for payment directly to the prescriber by the plan or insurer. SEC. 3. 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) Furnish emergency contraception drug therapy in accordance with standardized procedures or protocols developed by the pharmacist and an authorized prescriber who is acting within his or her scope of practice, subject to the following requirements: (A) Prior to performing any procedure authorized under this paragraph, a pharmacist shall have completed a training program on emergency contraception that consists of at least one hour of approved continuing education on emergency contraception drug therapy. (B) 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 covered or insured 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. (C) 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. 3.5. 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) (A) Furnish emergency contraception drug therapy in accordance with either 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. (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 performing a procedure authorized under this paragraph, a pharmacist shall complete a training program on emergency contraception that 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 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. 4. Section 3.5 of this bill incorporates amendments to Section 4052 of the Business and Professions Code proposed by both this bill and SB 490. 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 Professions Code, and (3) this bill is enacted after SB 490, in which case Section 3 of this bill shall not become operative. SEC. 5. 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.