California Senate Bill SB1039 Amended / Bill

 BILL NUMBER: SB 1039AMENDED BILL TEXT AMENDED IN ASSEMBLY JUNE 18, 2014 AMENDED IN ASSEMBLY JUNE 5, 2014 AMENDED IN SENATE MAY 5, 2014 AMENDED IN SENATE APRIL 10, 2014 AMENDED IN SENATE MARCH 28, 2014 INTRODUCED BY Senator Hernandez FEBRUARY 18, 2014 An act to amend Sections 4052.6 and 4115 of, and to add Sections 4119.6 and 4119.7 to, the Business and Professions Code, and to amend Sections 11150 and 11210 of, and to add Section 1250.06 to, the Health and Safety Code, relating to pharmacy. LEGISLATIVE COUNSEL'S DIGEST SB 1039, as amended, Hernandez. Pharmacy. (1) Existing law, the Pharmacy Law, the violation of which is a crime, provides for the licensure and regulation of pharmacies, pharmacists, intern pharmacists, and pharmacy technicians by the California State Board of Pharmacy. The Pharmacy Law authorizes an intern pharmacist to perform all functions of a pharmacist, and authorizes a pharmacy technician to perform packaging, manipulative, repetitive, or other nondiscretionary tasks, in each case under supervision of a pharmacist, as specified. This bill would authorize a pharmacy technician to perform packaging  , including emergency supply packaging and sealing in or for hospitals, hospital unit inspections, and other physical  , manipulative, repetitive, or other nondiscretionary tasks  under supervision   only while assisting and while under the direct supervision and control  of a pharmacist, as specified.  This bill would also authorize, in a licensed health care facility, as defined, a pharmacy technician's duties to include, among other things, sealing emergency containers for use in the health care facility.  (2) Existing law authorizes a pharmacy to furnish a dangerous drug or dangerous device to a licensed health care facility for storage in a secured emergency pharmaceutical supplies container maintained within the facility in accordance with facility regulations of the State Department of Public Health and other existing law requirements, as specified. This bill would authorize  a pharmacy to furnish a dangerous drug or dangerous device to the emergency medical services system of a licensed general acute care hospital, as defined, for storage in a secured emergency pharmaceutical supplies container maintained within the hospital in accordance with the hospital's policies and procedures. The bill would require both the hospital and the dispensing pharmacy to maintain records pertaining to the dangerous drugs or dangerous devices furnished to the hospital's emergency medical services system for at least 3 years. The bill would also authorize a pharmacy to furnish a dangerous drug or dangerous device to a licensed general acute care hospital pursuant to preprinted or electronic standing orders, order sets, and protocols established under the policies and procedures of a licensed general acute care hospital under specified conditions. The bill would require a pharmacist, a pharmacy technician, or  an intern pharmacist, under the direct supervision and control of a pharmacist, to  stock, replenish, and  inspect the drugs maintained in the  hospital at least once per month, and to report any irregularities, as specified.   emergency pharmaceutical supplies container and the emergency medical system supplies of a licensed general acute care   hospital, as defined.   This bill would   authorize an intern pharmacist to inspect the drugs maintained in a licensed health care facility, as defined, pursuant to policies and procedures of the health care facility. This bill would also authorize a licensed health care facility to dispense or furnish dangerous drugs and dangerous devices to inpatients and patients upon discharge pursuant to preprinted or electronic standing orders, order sets, and protocols, as specified. This bill would require licensed health care facilities to store and maintain drugs in accordance with national standards regarding the storage area and refrigerator or freezer temperature and in accordance with the manufacturers' guidelines.  Because a violation of certain provisions of the bill would be a crime, the bill would create a state-mandated local program. (3) Existing law authorizes a pharmacist recognized by the board as an advanced practice pharmacist to perform specified functions, including performing patient assessments. This bill would also authorize a pharmacist recognized by the board as an advanced practice pharmacist to order patient assessments. (4) Existing law authorizes a pharmacist to initiate or adjust the drug regimen of a patient under specified circumstances. Existing law authorizes specified practitioners, including a pharmacist acting within the scope of an authorized pilot project, to prescribe, furnish, or administer controlled substances to a patient suffering from a disease, ailment, injury, or infirmity, but only when in good faith he or she believes the disease, ailment, injury, or infirmity requires the treatment, and only in the quantity and for the length of time as reasonably necessary. This bill would modify that list of practitioners to include a pharmacist initiating or adjusting the drug regimen of a patient as authorized under existing law. (5) Existing law provides for the licensure and inspection of health facilities, including general acute care hospitals, by the State Department of Public Health. Existing regulations require a hospital to have a pharmacy on the premises or a pharmacy license, as specified. Existing regulations also require the hospital to consult the pharmacist on the proper methods of, among other things, repackaging and labeling bulk cleaning agents. This bill would instead provide that a licensed general acute care hospital or an acute psychiatric hospital, as defined, is not required to consult a pharmacist regarding repackaging and labeling of bulk cleaning agents, solvents, chemicals, and nondrug hazardous substances  except for areas where sterile compounding is performed  . (6) 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. State-mandated local program: yes. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. Section 4052.6 of the Business and Professions Code is amended to read: 4052.6. (a) A pharmacist recognized by the board as an advanced practice pharmacist may do all of the following: (1) Order and perform patient assessments. (2) Order and interpret drug therapy-related tests. (3) Refer patients to other health care providers. (4) Participate in the evaluation and management of diseases and health conditions in collaboration with other health care providers. (5) Initiate, adjust, or discontinue drug therapy in the manner specified in paragraph (4) of subdivision (a) of Section 4052.2. (b) A pharmacist who adjusts or discontinues drug therapy shall promptly transmit written notification to the patient's diagnosing prescriber or enter the appropriate information in a patient record system shared with the prescriber, as permitted by that prescriber. A pharmacist who initiates drug therapy shall promptly transmit written notification to, or enter the appropriate information into, a patient record system shared with the patient's primary care provider or diagnosing provider, as permitted by that provider. (c) This section shall not interfere with a physician's order to dispense a prescription drug as written, or other order of similar meaning. (d) Prior to initiating or adjusting a controlled substance therapy pursuant to this section, a pharmacist shall personally register with the federal Drug Enforcement Administration. (e) A pharmacist who orders and interprets tests pursuant to paragraph (2) of subdivision (a) shall ensure that the ordering of those tests is done in coordination with the patient's primary care provider or diagnosing prescriber, as appropriate, including promptly transmitting written notification to the patient's diagnosing prescriber or entering the appropriate information in a patient record system shared with the prescriber, when available and as permitted by that prescriber. SEC. 2. Section 4115 of the Business and Professions Code is amended to read: 4115. (a) A pharmacy technician may perform packaging,  including emergency supply packaging and sealing in or for hospitals, hospital unit inspections, and other physical,  manipulative, repetitive, or other nondiscretionary tasks, only while assisting, and while under the direct supervision and control of a pharmacist.  The pharmacist shall be responsible for the duties performed under his or her supervision by a technician.  (b) This section does not authorize the performance of any tasks specified in subdivision (a) by a pharmacy technician without a pharmacist on duty. (c) This section does not authorize a pharmacy technician to perform any act requiring the exercise of professional judgment by a pharmacist. (d) The board shall adopt regulations to specify tasks pursuant to subdivision (a) that a pharmacy technician may perform under the supervision of a pharmacist. Any pharmacy that employs a pharmacy technician shall do so in conformity with the regulations adopted by the board. (e) No person shall act as a pharmacy technician without first being licensed by the board as a pharmacy technician. (f) (1) A pharmacy with only one pharmacist shall have no more than one pharmacy technician performing the tasks specified in subdivision (a). The ratio of pharmacy technicians performing the tasks specified in subdivision (a) to any additional pharmacist shall not exceed 2:1, except that this ratio shall not apply to personnel performing clerical functions pursuant to Section 4116 or 4117. This ratio is applicable to all practice settings, except for an inpatient of a licensed health facility, a patient of a licensed home health agency, as specified in paragraph (2), an inmate of a correctional facility of the Department of Corrections and Rehabilitation, and for a person receiving treatment in a facility operated by the State Department of State Hospitals, the State Department of Developmental Services, or the Department of Veterans Affairs. (2) The board may adopt regulations establishing the ratio of pharmacy technicians performing the tasks specified in subdivision (a) to pharmacists applicable to the filling of prescriptions of an inpatient of a licensed health facility and for a patient of a licensed home health agency. Any ratio established by the board pursuant to this subdivision shall allow, at a minimum, at least one pharmacy technician for a single pharmacist in a pharmacy and two pharmacy technicians for each additional pharmacist, except that this ratio shall not apply to personnel performing clerical functions pursuant to Section 4116 or 4117. (3) A pharmacist scheduled to supervise a second pharmacy technician may refuse to supervise a second pharmacy technician if the pharmacist determines, in the exercise of his or her professional judgment, that permitting the second pharmacy technician to be on duty would interfere with the effective performance of the pharmacist' s responsibilities under this chapter. A pharmacist assigned to supervise a second pharmacy technician shall notify the pharmacist in charge in writing of his or her determination, specifying the circumstances of concern with respect to the pharmacy or the pharmacy technician that have led to the determination, within a reasonable period, but not to exceed 24 hours, after the posting of the relevant schedule. No entity employing a pharmacist may discharge, discipline, or otherwise discriminate against any pharmacist in the terms and conditions of employment for exercising or attempting to exercise in good faith the right established pursuant to this paragraph. (g) Notwithstanding subdivisions (a) and (b), the board shall by regulation establish conditions to permit the temporary absence of a pharmacist for breaks and lunch periods pursuant to Section 512 of the Labor Code and the orders of the Industrial Welfare Commission without closing the pharmacy. During these temporary absences, a pharmacy technician may, at the discretion of the pharmacist, remain in the pharmacy but may only perform nondiscretionary tasks. The pharmacist shall be responsible for a pharmacy technician and shall review any task performed by a pharmacy technician during the pharmacist's temporary absence. Nothing in this subdivision shall be construed to authorize a pharmacist to supervise pharmacy technicians in greater ratios than those described in subdivision (f). (h) The pharmacist on duty shall be directly responsible for the conduct of a pharmacy technician supervised by that pharmacist.  (i) In a health care facility licensed under subdivision (a) of Section 1250 of the Health and Safety Code, a pharmacy technician's duties may include any of the following.   (1) Packaging emergency supplies for use in the health care facility and the hospital's emergency medical system as authorized under Section 4119.   (2) Sealing emergency containers for use in the health care facility.   (3) Performing monthly checks of the drug supplies stored throughout the health care facility. Irregularities shall be reported within 24 hours to the pharmacist in charge and the director or chief executive officer of the health care facility in accordance with the health care facility's policies and procedures.  SEC. 3. Section 4119.6 is added to the Business and Professions Code, to read:  4119.6. (a) Notwithstanding any other law, a pharmacy may furnish a dangerous drug or dangerous device to the emergency medical services system of a licensed general acute care hospital, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, for storage in a secured emergency pharmaceutical supplies container maintained within the hospital in accordance with the hospital's policies and procedures. A pharmacy technician or   4119.6.   An  intern pharmacist under the direct supervision and control, as defined in Section 4023.5, of a pharmacist may stock, replenish, and inspect the  hospital's  emergency pharmaceutical supplies container  and the emergency medical system supplies of a licensed general acute care   hospital, as defined in subdivision (a) of  Section 1250 of the Health and Safety Code  .  (b) Both the hospital and the dispensing pharmacy acting under this section shall maintain records of each request by, and dangerous drugs or dangerous devices furnished to, the hospital's emergency medical services system, for at least three years.   (c) Controlled substances shall be furnished to the hospital's emergency medical services system under this section in accordance with the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code).  SEC. 4. Section 4119.7 is added to the Business and Professions Code, to read: 4119.7. (a)  Notwithstanding any other law, a pharmacy may furnish a dangerous drug or dangerous device to a licensed general acute care hospital, as defined in   A health care facility licensed under  subdivision (a) of Section 1250 of the Health and Safety Code,  may administer, dispense, or furnish dangerous drugs and dangerous devices to inpatients or patients upon discharge  pursuant to preprinted or electronic standing orders, order sets, and protocols established under the policies and procedures of the  hospital, as approved according to the policies of the hospital's governing body,   health care facility,  if the order is promptly  dated, timed, and authenticated in the medical record of the patient to whom the dangerous drug or dangerous device  is dispensed by the ordering practitioner or another practitioner responsible for the care of that patient and authorized by the hospital's policies and procedures to write orders.   will be provided.  (b)  The hospital   A health care facility licensed under subdivision (a) of Section 1250 of the Health and Safety Code  shall store and maintain drugs in accordance with national standards regarding the storage area and refrigerator or freezer temperature, and otherwise pursuant to the manufacturer's guidelines.  The health care facility's policies and procedures shall specify these storage parameters.  (c)  (1)     A pharmacist, pharmacy technician, or an   An  intern pharmacist under the direct supervision and control, as defined in Section 4023.5, of a pharmacist, shall inspect the drugs maintained in the  hospital   health care facility  at least once per month. The  hospital   health care facility  shall establish specific written policies and procedures for inspections pursuant to this paragraph.  (2) The person conducting the inspection pursuant to paragraph (1) shall report any irregularities to the director or chief executive officer of the hospital, or other person holding an equivalent position, and in accordance with the hospital's policy.  SEC. 5. Section 1250.06 is added to the Health and Safety Code, immediately following Section 1250.05, to read: 1250.06. A licensed general acute care hospital, as defined pursuant to subdivision (a) of Section 1250, or an acute psychiatric hospital, as defined pursuant to subdivision (b) of Section 1250, is not required to consult a pharmacist regarding repackaging and labeling of bulk cleaning agents, solvents, chemicals, and nondrug hazardous substances used throughout the  hospital.   hospital except for areas where sterile compounding is performed.  SEC. 6. Section 11150 of the Health and Safety Code is amended to read: 11150. No person other than a physician, dentist, podiatrist, or veterinarian, or naturopathic doctor acting pursuant to Section 3640.7 of the Business and Professions Code, or pharmacist acting within the scope of a project authorized under Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of Division 107 or within the scope of Section 4052.1, 4052.2, or 4052.6 of the Business and Professions Code, a registered nurse acting within the scope of a project authorized under Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of Division 107, a certified nurse-midwife acting within the scope of Section 2746.51 of the Business and Professions Code, a nurse practitioner acting within the scope of Section 2836.1 of the Business and Professions Code, a physician assistant acting within the scope of a project authorized under Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of Division 107 or Section 3502.1 of the Business and Professions Code, a naturopathic doctor acting within the scope of Section 3640.5 of the Business and Professions Code, or an optometrist acting within the scope of Section 3041 of the Business and Professions Code, or an out-of-state prescriber acting pursuant to Section 4005 of the Business and Professions Code shall write or issue a prescription. SEC. 7. Section 11210 of the Health and Safety Code is amended to read: 11210. A physician, surgeon, dentist, veterinarian, naturopathic doctor acting pursuant to Section 3640.7 of the Business and Professions Code, or podiatrist, or pharmacist acting within the scope of a project authorized under Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of Division 107 or within the scope of Section 4052.1, 4052.2, or 4052.6 of the Business and Professions Code, or registered nurse acting within the scope of a project authorized under Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of Division 107, or physician assistant acting within the scope of a project authorized under Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of Division 107, or naturopathic doctor acting within the scope of Section 3640.5 of the Business and Professions Code, or an optometrist acting within the scope of Section 3041 of the Business and Professions Code may prescribe for, furnish to, or administer controlled substances to his or her patient when the patient is suffering from a disease, ailment, injury, or infirmities attendant upon old age, other than addiction to a controlled substance. The physician, surgeon, dentist, veterinarian, naturopathic doctor acting pursuant to Section 3640.7 of the Business and Professions Code, or podiatrist, or pharmacist acting within the scope of a project authorized under Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of Division 107 or within the scope of Section 4052.1, 4052.2, or 4052.6 of the Business and Professions Code, or registered nurse acting within the scope of a project authorized under Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of Division 107, or physician assistant acting within the scope of a project authorized under Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of Division 107, or naturopathic doctor acting within the scope of Section 3640.5 of the Business and Professions Code, or an optometrist acting within the scope of Section 3041 of the Business and Professions Code shall prescribe, furnish, or administer controlled substances only when in good faith he or she believes the disease, ailment, injury, or infirmity requires the treatment. The physician, surgeon, dentist, veterinarian, or naturopathic doctor acting pursuant to Section 3640.7 of the Business and Professions Code, or podiatrist, or pharmacist acting within the scope of a project authorized under Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of Division 107 or within the scope of Section 4052.1, 4052.2, or 4052.6 of the Business and Professions Code, or registered nurse acting within the scope of a project authorized under Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of Division 107, or physician assistant acting within the scope of a project authorized under Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of Division 107, or a naturopathic doctor acting within the scope of Section 3640.5 of the Business and Professions Code, or an optometrist acting within the scope of Section 3041 of the Business and Professions Code shall prescribe, furnish, or administer controlled substances only in the quantity and for the length of time as are reasonably necessary. SEC. 8. 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.