Bill Text: CA AB401 | 2017-2018 | Regular Session | Amended

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Pharmacy: remote dispensing site pharmacy: telepharmacy: shared clinic office space.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Passed) 2017-10-07 - Chaptered by Secretary of State - Chapter 548, Statutes of 2017. [AB401 Detail]

Download: California-2017-AB401-Amended.html

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Amended  IN  Assembly  March 21, 2017

CALIFORNIA LEGISLATURE— 2017–2018 REGULAR SESSION

Assembly Bill

No. 401

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Introduced by Assembly Member Aguiar-Curry

February 09, 2017

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An act to amend Sections 4059.5 and 4181 Section 4059.5 of, to add Sections 4044.3, 4044.6, and 4044.7 to, and to add Article 8 (commencing with Section 4130) to Chapter 9 of Division 2 of, the Business and Professions Code, relating to pharmacy.

LEGISLATIVE COUNSEL'S DIGEST

AB 401, as amended, Aguiar-Curry. Pharmacy: remote dispensing site pharmacy: telepharmacy.

Existing law, the Pharmacy Law, requires the California State Board of Pharmacy, which is within the department Department of Consumer Affairs, to license and regulate the practice of pharmacy, including pharmacists, pharmacy technicians, and pharmacies.

This bill would authorize a remote dispensing site pharmacy to use a telepharmacy system, as specified, and would require the board to issue a remote dispensing site pharmacy license for certain purposes and authorizes the board to establish, by regulation, locations eligible for a remote dispensing site pharmacy, as specified. to a remote dispensing site pharmacy that meets all the requirements for licensure. The bill would require a remote dispensing site pharmacy to be located in a medically underserved area, as defined, unless otherwise approved by the board. The bill would authorize a pharmacy located in this state to serve as a supervising pharmacy to provide telepharmacy services for up to 3 2 remote dispensing site pharmacies and requires a pharmacist from the supervising pharmacy to, among other things, be capable of being on site at the remote dispensing pharmacy within 6 hours. pharmacies. The bill would require a remote dispensing site pharmacy to utilize specified security communications systems and security systems.

Existing law prohibits the ordering of dangerous drugs and devices by an entity not licensed by the board, except as otherwise provided, and requires the order to be delivered to the licensed premises and signed for by a pharmacist.

This bill would authorize a licensed remote dispensing site pharmacy, as defined, to order dangerous drugs and devices and controlled substances and authorizes a registered pharmacy technician meeting specified requirements to receive and sign for the delivered order. The bill would require any controlled substances signed for by a pharmacy technician to be stored separately from existing inventory until they are reviewed and countersigned by a pharmacist.

Existing law requires every pharmacy to designate a pharmacist-in-charge, as specified, and requires the pharmacist-in-charge to be responsible for the pharmacy’s compliance with all state and federal laws pertaining to the practice of pharmacy.

This bill would authorize a pharmacist to serve as a pharmacist-in-charge of no more than 3 2 remote dispensing site pharmacies, in addition to serving as a pharmacist-in-charge of a supervising pharmacy, and would require the pharmacist-in-charge and the pharmacist-on-duty at the supervising pharmacy to be responsible for ensuring sufficient staffing, as specified.

Existing law authorizes a pharmacy technician to perform packaging, manipulative, repetitive, or other nondiscretionary tasks only while assisting, and while under the direct supervision and control of, a pharmacist and prohibits the ratio of pharmacy technicians performing these tasks to any additional pharmacists from exceeding 2 to 1, except as specified.

This bill would instead authorize a registered pharmacy technician, who meets certain requirements, to work at a remote dispensing site pharmacy and to perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system. The bill would prohibit a pharmacy technician working at a remote dispensing site pharmacy from performing certain tasks, including receiving a new prescription order orally. The bill would authorize a pharmacist at a supervising pharmacy to supervise up to 2 pharmacy technicians at each remote dispensing site pharmacy in addition to any pharmacy technicians being supervised at the supervising pharmacy.

Existing law makes a violation of any of its provisions punishable as a crime.

By expanding the scope of an existing crime, this bill would result in 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.

Digest Key

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

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Bill Text

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

SECTION 1.

 (a) The Legislature hereby finds and declares all of the following:

(1) Greater access to health care professionals improves patient outcomes. Patients see their pharmacist more often than any other health care professional. Making pharmacists readily available should be a top priority of the state.

(2) Health care delivery and technology are evolving. Utilizing technology to connect patients to pharmacists in areas where there is no access will improve medication adherence and outcomes.

(3) Over 30 percent of patients never fill their prescriptions. According to a study by Kaiser, this number drops to 5 percent when patients have more convenient access to a pharmacy. Lack of convenient access to a pharmacy leads to lower rates of medication adherence and, according to the New England Healthcare Institute, nonadherence leads to over $290 billion in avoidable medial spending each year.

(4) Seventy-seven percent of rural counties are designated as health professional shortage areas. In California there are 115 identified areas located in 47 counties where the closest pharmacy is more than 10 miles away.

(5) In rural communities, the geographic and economic realities make it difficult to maintain a pharmacy. Between 2003 and 2013, there was a 12.1-percent decrease in rural pharmacies. Remote dispensing site pharmacies create an economically feasible way to bring pharmacy access to these underserved areas through the use of technology.

(b) It is the intent of the Legislature to enact legislation that will promote policies to allow all California patients, regardless of location, to have access to a pharmacist, thereby increasing medication adherence.

SECTION 1.SEC. 2.

 Section 4044.3 is added to the Business and Professions Code, to read:

4044.3.

 “Remote Dispensing Site Pharmacy” dispensing site pharmacy” means a licensed pharmacy located in this state that is operated by a supervising pharmacy and staffed by one or more qualified registered pharmacy technicians where pharmaceutical care services, including, but not limited to, the storage and dispensing of prescription drugs and controlled substances, drug regimen review, and patient counseling, are remotely monitored or provided, or both, by a licensed pharmacist through the use of telepharmacy technology.

SEC. 2.SEC. 3.

 Section 4044.6 is added to the Business and Professions Code, to read:

4044.6.

 “Supervising pharmacy” means a licensed pharmacy located in this state that oversees the activities of a remote dispensing site pharmacy.

SEC. 3.SEC. 4.

 Section 4044.7 is added to the Business and Professions Code, to read:

4044.7.

 “Telepharmacy” means a system that is used by a supervising pharmacy for the purpose of monitoring the dispensing of prescription drugs and provides for related drug regimen review and patient counseling by an electronic method, including, but not limited to, the use of audio, visual, still image capture, and store and forward technology.

SEC. 4.SEC. 5.

 Section 4059.5 of the Business and Professions Code is amended to read:

4059.5.

 (a) Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, the designated representative shall sign for and receive the delivery.

(b) A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate user’s agent.

(c) Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.

(d) Notwithstanding any other law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.

(e) A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.

(f) Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:

(1) The drugs are placed in a secure storage facility in the same building as the pharmacy.

(2) Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.

(3) The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.

(4) The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.

(5) The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.

The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.

(g) Notwithstanding subdivision (a), dangerous drugs and devices and controlled substances may be ordered by a remote dispensing site pharmacy licensed by the board and may be signed for and received by a registered pharmacy technician, who meets the qualifications of Section 4132, at the remote site. A controlled substance signed for by a pharmacy technician under this section shall be stored separately from existing inventory until the time the controlled substance is reviewed and countersigned by a pharmacist. The receipt and storage of a controlled substance by a pharmacy technician under this section shall be maintained on video that is accessible to the supervising pharmacy and shall be maintained for 90 days.

SEC. 5.SEC. 6.

 Article 8 (commencing with Section 4130) is added to Chapter 9 of Division 2 of the Business and Professions Code, to read:

Article  8. Telepharmacy Systems and Remote Dispensing Site Pharmacies

4130.

 (a) If A telepharmacy system may be used for the dispensing of prescription drugs and providing related drug regimen review and patient counseling services at a remote dispensing site pharmacy.

(b) If all of the requirements of this article and other relevant provisions of this chapter are met, the board shall issue a remote dispensing site pharmacy license for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the site is to be located.

(b)In order to further the goal of increasing access to dispensing and pharmaceutical care services, the board may establish, by regulation, locations eligible for a remote dispensing site pharmacy license that shall include medically underserved areas and populations and health profession shortage areas, as determined by the federal Department of Health and Human Services, the federal Health Resources and Services Administration, and health care facilities and clinics regulated by the state.

(c) (1) A remote dispensing site pharmacy shall only be located in a medically underserved area unless otherwise approved by the board. For purposes of this section, a “medically underserved area” means a location that does not have a pharmacy that serves the general public within 10 road miles of the remote dispensing site.

(2) Notwithstanding paragraph (1), if a pharmacy serving the general public is later established within 10 road miles of a remote dispensing site pharmacy, the remote dispensing site pharmacy may continue to operate.

(d) A remote dispensing site pharmacy shall only be staffed by pharmacists or pharmacy technicians, or both, and shall not employ any unlicensed personnel.

4131.

 (a) A pharmacy located in this state may serve as a supervising pharmacy to provide telepharmacy services for up to three two remote dispensing site pharmacies.

(b) A supervising pharmacy shall not be located greater than 150 road miles from a remote dispensing site pharmacy, unless otherwise approved by the board.

(c) (1) Except as otherwise provided in paragraph (2), a supervising pharmacy and remote dispensing site pharmacy shall be under common ownership.

(2) If a supervising pharmacy and a remote dispensing site pharmacy are not under common ownership, the supervising pharmacy and remote dispensing site pharmacy shall enter into a written contract or agreement that specifies the services to be provided and the responsibilities and accountabilities of each party in fulfilling the terms of the contract or agreement, consistent with all federal and state laws.

(b)

(d) Unless staffed by a pharmacist, a remote dispensing site pharmacy shall be staffed by at least one registered pharmacy technician meeting the qualifications of Section 4132. A technician shall remain under the direct supervision and control of a pharmacist at the supervising pharmacy at all times that the remote dispensing site pharmacy is operational. For the purposes of this article, direct supervision and control does not require the pharmacist to be physically present at the remote dispensing site pharmacy, but the pharmacist shall use a telepharmacy system to supervise operations electronically through audio and visual technology from the supervising pharmacy.

(c)

(e) Notwithstanding any law, a pharmacist may serve as the pharmacist-in-charge for no more than three two remote dispensing site pharmacies in addition to serving as pharmacist-in-charge of a supervising pharmacy.

(d)

(f) Notwithstanding any law, the pharmacist-in-charge of the remote dispensing site pharmacy and the pharmacist-on-duty at the supervising pharmacy shall be responsible for ensuring that both the supervising pharmacy and remote dispensing site pharmacy are sufficiently staffed to allow for appropriate supervision, which is supervision that would not be reasonably expected to result in an unreasonable risk of harm to public health, safety, or welfare.

(e)A pharmacist from the supervising pharmacy shall be capable of being on site at the remote dispensing pharmacy within six hours of notice that his or her presence is required.

4132.

 (a) Notwithstanding In addition to the requirements of Section 4202, a pharmacy technician working at a remote dispensing site pharmacy shall have both of the following:

(1) At least one year of experience in the past three years working in retail pharmacy practice.

(2) Completed a documented training program on proper use of the telepharmacy system at the remote dispensing site pharmacy.

(b) Notwithstanding Section 4115, a registered pharmacy technician may perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks at a remote dispensing site pharmacy under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system.

(b)In order to qualify to work at a remote dispensing site pharmacy, a registered pharmacy technician shall meet all additional qualifications as established by the board through regulation.

(c) A pharmacy technician at a remote dispensing site pharmacy shall not do any of the following:

(1) Receive a new prescription order orally from a prescriber or other person authorized to prescribe by law.

(2) Consult with a patient or his or her agent regarding a prescription, either prior to or after dispensing, or regarding any medical information contained in a patient medication record system or patient chart.

(3) Identify, evaluate, or interpret a prescription.

(4) Interpret the clinical data in a patient medication record system or patient chart.

(5) Consult with any prescriber, nurse, or other health care professional or authorized agent thereof.

(6) Supervise the packaging of drugs and check the packaging procedure and product upon completion.

(7) Perform any function that requires the professional judgment of a licensed pharmacist.

(c)

(d) Notwithstanding Section 4115, a pharmacist at a supervising pharmacy may supervise up to two pharmacy technicians at each remote dispensing site pharmacy. This subdivision shall not be construed to alter a pharmacist’s ability to also supervise pharmacy technicians at the supervising pharmacy.

4133.

 (a) A telepharmacy system shall maintain a video and audio communication system that provides for effective communication between the supervising pharmacy and the remote dispensing site pharmacy’s personnel and patients.

(b) The A telepharmacy system shall facilitate adequate pharmacist supervision and allow the appropriate exchange of visual, verbal, and written communications for patient counseling and other matters involved in the lawful dispensing of drugs.

(c)The remote dispensing site shall retain a recording of facility surveillance, excluding patient communications, for a minimum of 30 days.

(c) Patient counseling shall be provided using audio-visual communication for all prescriptions dispensed from a remote dispensing site pharmacy.

(d) A telepharmacy system shall be able to do all of the following:

(1) Identify and record the pharmacy technician preparing each prescription and the supervising pharmacist who reviewed and authorized the dispensing of the prescription.

(2) Require a pharmacist to review and compare the electronic image of any new prescription presented at the remote dispensing site pharmacy with the data entry record of the prescription.

(3) Require the pharmacy technician to use barcode technology to verify the accuracy of the drug to be dispensed.

(4) Require remote visual confirmation by a pharmacist at the supervising pharmacy of the drug stock bottle and the drug to be dispensed prior to dispensing.

(5) Ensure that a prescription is not sold or delivered to a patient prior to a pharmacist performing final verification of the accuracy of the prescription and releasing the prescription for sale and delivery.

(d)

(e) The video and audio communication system used to counsel and interact with each patient or patient’s caregiver shall be secure and compliant with the federal Health Insurance Portability and Accountability Act (Public Law 104-191).

(e)The board shall certify acceptable video and audio communication systems for use in remote dispensing sites.

(f) All records of prescriptions dispensed shall be maintained at the remote dispensing site pharmacy and shall be maintained for three years after the filling of the prescription.

4134.

 (a) A pharmacist from the supervising pharmacy shall complete a monthly in-person, self-inspection of each remote dispensing site pharmacy using a form designated by the board and shall retain all inspection reports.

(b) A perpetual inventory shall be kept for all controlled substances stored at a remote dispensing site pharmacy.

(c)An audit of at least three controlled substances at the remote dispensing site pharmacy shall be completed and documented quarterly by a pharmacist from the supervising pharmacy.

(c) All controlled substances at a remote dispensing site pharmacy shall be stored in a secure cabinet or safe that is locked.

(d) A pharmacist from the supervising pharmacy shall perform inventory and inventory reconciliation functions at a remote dispensing site pharmacy to detect and prevent the loss of any controlled substance.

(e) The pharmacist-in-charge of a remote dispensing site pharmacy shall review all inventory and inventory reconciliation reports taken and shall establish and maintain secure methods to prevent losses of any controlled substance. The board shall develop written policies and procedures for performing the inventory reconciliation reports required by this section.

(f) A pharmacist from the supervising pharmacy shall compile an inventory reconciliation report of all Schedule II controlled substances at a remote dispensing site pharmacy at least once every three months. This compilation shall require all of the following:

(1) A physical count, not an estimate, of all quantities of Schedule II controlled substances at the remote dispensing site pharmacy. The biennial inventory of controlled substances as required under federal law may serve as one of the mandated inventories under this section in the year that the federal biennial inventory is performed, provided that the biennial inventory was taken no more than three months from the last inventory required by this section.

(2) A review of all acquisitions and dispositions of Schedule II controlled substances since the last inventory reconciliation report.

(3) A comparison of paragraphs (1) and (2) in order to determine if there are any variances.

(4) All records used to compile each inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.

(g) A remote dispensing site pharmacy shall report to the board, in writing, any identified losses of controlled substances and possible causes of the loss within 30 days of discovering the loss unless the cause of loss is theft, diversion, or self-use in which case the report shall be made within 14 days of discovering the loss. If the remote dispensing site pharmacy is unable to identify the cause of the loss, the remote dispensing site pharmacy shall undertake further investigation to identify the cause of the loss and security improvements necessary to prevent any additional losses of controlled substances.

(h) Possible causes of overages shall be identified in writing and incorporated into the inventory reconciliation report.

(i) The inventory reconciliation report shall be dated and signed by the individual or individuals performing the inventory and countersigned by the pharmacist-in-charge of the remote dispensing site pharmacy. A countersignature shall not be required if the pharmacist-in-charge personally completed the inventory reconciliation report. The inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.

4135.

 (a) While closed, a remote dispensing site pharmacy shall utilize an alarm or other comparable monitoring system to protect its equipment, records, and supply of drugs, devices, and other restricted sale items from unauthorized access, acquisition, or use.

(b) Unless a pharmacist is present at the remote dispensing site pharmacy, a remote dispensing site pharmacy shall not be open or its employees allowed access to it during times the supervising pharmacy is closed. The security system shall allow for tracking of entries into the remote dispensing site pharmacy and the pharmacist-in-charge shall periodically review the record of entries.

(c)If controlled substances are maintained or dispensed from the remote dispensing site pharmacy, the remote dispensing site pharmacy shall comply with all applicable state and federal requirements for the security and recordkeeping requirements of controlled substances.

(c) The remote dispensing site pharmacy shall retain a recording of facility surveillance, excluding patient communications, for a minimum of 90 days.

SEC. 6.Section 4181 of the Business and Professions Code is amended to read:

4181.

(a)Prior to the issuance of a clinic license authorized under Section 4180, the clinic shall comply with all applicable laws and regulations of the State Department of Public Health relating to the drug distribution service to ensure that inventories, security procedures, training, protocol development, recordkeeping, packaging, labeling, dispensing, and patient consultation occur in a manner that is consistent with the promotion and protection of the health and safety of the public. The policies and procedures to implement the laws and regulations shall be developed and approved by the consulting pharmacist, the professional director, and the clinic administrator.

(b)The dispensing of drugs in a clinic shall be performed only by a physician, a pharmacist, or other person lawfully authorized to dispense drugs, and only in compliance with all applicable laws and regulations, including, but not limited to, Article 8 (Commencing with Section 4130).

SEC. 7.

 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.