| 1 | | - | Assembly Bill No. 2037 CHAPTER 647 An act to add Section 4119.11 to the Business and Professions Code, relating to healing arts, and declaring the urgency thereof, to take effect immediately. [ Approved by Governor September 21, 2018. Filed with Secretary of State September 21, 2018. ] LEGISLATIVE COUNSEL'S DIGESTAB 2037, Bonta. Pharmacy: automated patient dispensing systems.Existing law, the Pharmacy Law, the knowing 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 a pharmacy to provide pharmacy services to specified licensed health facilities through the use of an automated drug delivery system owned and operated by the pharmacy that need not be located at the same location as the pharmacy. The Pharmacy Law also authorizes specified licensed health clinics, including nonprofit and free clinics, to use an automated drug delivery system, operated under the authorization of a pharmacist, and under which the clinic is responsible for the safety and security of the drugs in the system.This bill would provide an alternative program to authorize a pharmacy located in the state to provide pharmacy services to the patients of covered entities, as defined, that are eligible for discount drug programs under federal law, as specified, through the use of an automated patient dispensing system, as defined.This bill would provide that, under the alternative program, the responsibility for the operation, maintenance, and security of the automated patient dispensing system would be the responsibility of the pharmacy. The pharmacy would also be responsible for, among other things, obtaining a license from the board to operate the automated patient dispensing system at the covered entity, paying an application and renewal fee, and developing, and annually reviewing written policies and procedures with respect to various topics, including maintaining the security of the system and the dangerous drugs and devices within the system. The bill would require that the drugs dispensed from the system be labeled in accordance with existing law and that records of each transaction be made. The bill would require the pharmacy to complete an annual self-assessment pursuant to existing law.Because a knowing violation of these requirements 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 declare that it is to take effect immediately as an urgency statute.Digest Key Vote: 2/3 Appropriation: NO Fiscal Committee: YES Local Program: YES Bill TextThe people of the State of California do enact as follows:SECTION 1. Section 4119.11 is added to the Business and Professions Code, to read:4119.11. (a) A pharmacy located in the state may provide pharmacy services to the patients of a covered entity, as defined in Section 256b of Title 42 of the United States Code, through the use of an automated patient dispensing system located on the premises of the covered entity or on the premises of medical professional practices under contract to provide medical services to covered entity patients, which need not be the same location as the pharmacy, if all of the following conditions are met:(1) The pharmacy obtains a license from the board to operate the automated patient dispensing system at the covered entity or affiliated site. As part of the application, the pharmacy shall provide the address at which the automated patient dispensing system shall be placed and identify the covered entity. A separate license shall be required for each location and shall be renewed annually concurrent with the pharmacy license. The application and renewal fee shall be three hundred dollars ($300) and may be increased to five hundred dollars ($500). The board is authorized to lower the renewal fee to not less than two hundred dollars ($200) if a lower fee level will provide sufficient resources to support the regulatory activities.(2) The pharmacy providing the pharmacy services to the patients of the covered entity, including, unless otherwise prohibited by any other law, patients enrolled in the Medi-Cal program, shall be under contract with that covered entity as described in Section 4126 to provide those pharmacy services through the use of the automated patient dispensing system.(3) Drugs stored in an automated patient dispensing system shall be part of the inventory of the pharmacy providing pharmacy services to the patients of the covered entity and drugs dispensed from the automated patient dispensing system shall be considered to have been dispensed by that pharmacy.(4) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated patient dispensing system separate from other pharmacy records.(5) The pharmacy shall be solely responsible for the security, operation, and maintenance of the automated patient dispensing system.(6) The pharmacy shall provide training regarding the operation and use of the automated patient dispensing system to both pharmacy and covered entity personnel using the system.(7) The operation of the automated patient dispensing system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the patients of the covered entity. The pharmacist need not be physically present at the site of the automated patient dispensing system and may supervise the system electronically.(8) Notwithstanding Section 4107, the board may issue a license for the operation of an automated patient dispensing system at an address for which it has issued another site license.(9) The board, within 30 days after receipt of an application for an automated patient dispensing system license, shall conduct a prelicensure inspection at the proposed location of the automated patient dispensing system. Relocation of the automated patient dispensing system shall require a new application for licensure. Replacement of an automated patient dispensing system shall require notice to the board within 30 days.(10) The automated patient dispensing system license shall be canceled by operation of law if the underlying pharmacy license is not current, valid, and active. Upon reissuance or reinstatement of the underlying pharmacy license, a new application for an automated patient dispensing system license may be submitted to the board.(11) A pharmacy that holds an automated patient dispensing system license shall advise the board in writing within 30 days if use of the automated patient dispensing system is discontinued.(b) For purposes of this section, the following definitions shall apply:(1) An automated drug delivery system (ADDS) means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. An ADDS shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. (2) An automated patient dispensing system (APDS) is an ADDS for storage and dispensing of prescribed drugs directly to patients pursuant to prior authorization by a pharmacist. (3) An automated unit dose system (AUDS) is an ADDS for storage and retrieval of unit doses of drugs for administration to patients by persons authorized to perform these functions. (c) (1) An automated patient dispensing system shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. (2) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.(d) Drugs from the automated patient dispensing system may be dispensed directly to the patient if all of the following requirements are met:(1) The pharmacy shall develop, implement, and annually review written policies and procedures with respect to all of the following:(A) Maintaining the security of the automated patient dispensing system and the dangerous drugs and devices within that automated patient dispensing system.(B) Determining and applying inclusion criteria regarding which drugs and devices are appropriate for placement in the automated patient dispensing system and for which patients.(C) Ensuring that patients are aware that consultation with a pharmacist is available for any prescription medication, including those delivered via the automated patient dispensing system.(D) Describing assignment of responsibilities to, and training of, pharmacy personnel, and other personnel using the automated patient dispensing system at the location where the automated patient dispensing system is placed, regarding maintenance and filing procedures for the automated patient dispensing system.(E) Orienting participating patients on the use of the automated patient dispensing system, notifying patients when expected prescription medications are not available in the automated patient dispensing system, and ensuring that patient use of the automated patient dispensing system does not interfere with delivery of drugs and devices.(F) Ensuring delivery of drugs and devices to patients expecting to receive them from the automated patient dispensing system in the event the automated patient dispensing system is disabled or malfunctions.(2) The automated patient dispensing system shall only be used for patients who have signed a written consent demonstrating their informed consent to receive prescribed drugs and devices from an automated patient dispensing system and whose use of the automated patient dispensing system meet the criteria pursuant to paragraph (1).(3) The automated patient dispensing system shall have a means to identify each patient and only release the identified patients drugs and devices to the patient or the patients agent.(4) A pharmacist shall perform all clinical services conducted as part of the dispensing process, including, but not limited to, drug utilization review and consultation.(5) Drugs shall be dispensed from the automated patient dispensing system only upon authorization from a pharmacist after the pharmacist has reviewed the prescription and the patients profile for potential contraindications and adverse drug reactions.(6) All prescribed drugs and devices dispensed from the automated patient dispensing system for the first time shall be accompanied by a consultation conducted by a pharmacist licensed by the board via a telecommunications link that has two-way audio and video.(7) The automated patient dispensing system shall include a notice, prominently posted on the automated patient dispensing system, that provides the name, address, and telephone number of the pharmacy that holds the automated patient dispensing system license for that automated patient dispensing system.(8) The labels on all drugs dispensed by the automated patient dispensing system shall comply with Section 4076 of this code and with Section 1707.5 of Title 16 of the California Code of Regulations.(9) Any complaint, error, or omission involving the automated patient dispensing system shall be reviewed as part of the pharmacys quality assurance program pursuant to Section 4125.(10) The board shall not issue a pharmacy more than 15 licenses for automated patient dispensing system units under this section. Consistent with Section 4001.1, the board may adopt regulations to reduce the number of automated patient dispensing system licenses that may be issued to a pharmacy.(11) The pharmacy holding the license for the automated patient dispensing system shall maintain the policies and procedures developed pursuant to paragraph (1) for three years after the last date of use of that automated patient dispensing system.(e) Access to the automated patient dispensing system shall be controlled and tracked using an identification or password system or biosensor. A system that is accessed via a password system shall include a camera that records a picture of the individual accessing the machine. Picture records shall be maintained for a minimum of 180 days.(f) The automated patient dispensing system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.(g) The stocking of an automated patient dispensing system shall be performed by a pharmacist. If the automated patient dispensing system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met:(1) The task of placing drugs into the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.(2) The removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.(3) The pharmacy, in conjunction with the covered entity, has developed policies and procedures to ensure that the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are properly placed into the automated patient dispensing system.(h) Review of the drugs contained within, and the operation and maintenance of, the automated patient dispensing system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated patient dispensing system, an inspection of the automated patient dispensing system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.(i) A pharmacy holding an automated patient dispensing system license shall complete an annual self-assessment, performed pursuant to Section 1715 of Title 16 of the California Code of Regulations, evaluating the pharmacys compliance with pharmacy law relating to the use of the automated patient dispensing system. All information regarding operation, maintenance, compliance, error, omissions, or complaints pertaining to the automated patient dispensing system shall be included in the self-assessment.(j) The pharmacy shall comply with all recordkeeping and quality assurance requirements pursuant to this chapter, and shall maintain those records within the pharmacy holding the automated patient dispensing system license and separately from other pharmacy records.SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB 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 XIIIB of the California Constitution.SEC. 3. This act is an urgency statute necessary for the immediate preservation of the public peace, health, or safety within the meaning of Article IV of the California Constitution and shall go into immediate effect. The facts constituting the necessity are:(a) Approximately 115 communities in 47 California counties do not have a pharmacist within 10 miles, creating a barrier to necessary health care. Many of these communities are susceptible to wild fires, enhancing the need for immediate access to medications and to the advice and care of pharmacists.(b) Rural and isolated communities desperately lack comprehensive pharmacy services. Automated dispensing, remotely performed by a pharmacist, brings a high level of pharmacy care and medication availability to these communities.(c) Through the use of automated patient dispensing systems, pharmacists can immediately provide medication to underserved patients, and improve and promote patient health by means of appropriate drug use, drug-related therapy, and communication for clinical and consultative purposes.(d) In less-isolated communities, the pharmacist is on the front line of health care as the medical professional that the patient sees most often. It is necessary to bring that level of care to millions of people in the state.(e) Therefore, in order to provide pharmacy services through the use of an automated patient dispensing system as soon as possible, it is necessary that this act take effect immediately. |
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| 1 | + | Enrolled September 05, 2018 Passed IN Senate August 31, 2018 Passed IN Assembly August 31, 2018 Amended IN Senate August 24, 2018 Amended IN Assembly May 25, 2018 CALIFORNIA LEGISLATURE 20172018 REGULAR SESSION Assembly Bill No. 2037Introduced by Assembly Member BontaFebruary 06, 2018 An act to add Section 4119.11 to the Business and Professions Code, relating to healing arts, and declaring the urgency thereof, to take effect immediately.LEGISLATIVE COUNSEL'S DIGESTAB 2037, Bonta. Pharmacy: automated patient dispensing systems.Existing law, the Pharmacy Law, the knowing 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 a pharmacy to provide pharmacy services to specified licensed health facilities through the use of an automated drug delivery system owned and operated by the pharmacy that need not be located at the same location as the pharmacy. The Pharmacy Law also authorizes specified licensed health clinics, including nonprofit and free clinics, to use an automated drug delivery system, operated under the authorization of a pharmacist, and under which the clinic is responsible for the safety and security of the drugs in the system.This bill would provide an alternative program to authorize a pharmacy located in the state to provide pharmacy services to the patients of covered entities, as defined, that are eligible for discount drug programs under federal law, as specified, through the use of an automated patient dispensing system, as defined.This bill would provide that, under the alternative program, the responsibility for the operation, maintenance, and security of the automated patient dispensing system would be the responsibility of the pharmacy. The pharmacy would also be responsible for, among other things, obtaining a license from the board to operate the automated patient dispensing system at the covered entity, paying an application and renewal fee, and developing, and annually reviewing written policies and procedures with respect to various topics, including maintaining the security of the system and the dangerous drugs and devices within the system. The bill would require that the drugs dispensed from the system be labeled in accordance with existing law and that records of each transaction be made. The bill would require the pharmacy to complete an annual self-assessment pursuant to existing law.Because a knowing violation of these requirements 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 declare that it is to take effect immediately as an urgency statute.Digest Key Vote: 2/3 Appropriation: NO Fiscal Committee: YES Local Program: YES Bill TextThe people of the State of California do enact as follows:SECTION 1. Section 4119.11 is added to the Business and Professions Code, to read:4119.11. (a) A pharmacy located in the state may provide pharmacy services to the patients of a covered entity, as defined in Section 256b of Title 42 of the United States Code, through the use of an automated patient dispensing system located on the premises of the covered entity or on the premises of medical professional practices under contract to provide medical services to covered entity patients, which need not be the same location as the pharmacy, if all of the following conditions are met:(1) The pharmacy obtains a license from the board to operate the automated patient dispensing system at the covered entity or affiliated site. As part of the application, the pharmacy shall provide the address at which the automated patient dispensing system shall be placed and identify the covered entity. A separate license shall be required for each location and shall be renewed annually concurrent with the pharmacy license. The application and renewal fee shall be three hundred dollars ($300) and may be increased to five hundred dollars ($500). The board is authorized to lower the renewal fee to not less than two hundred dollars ($200) if a lower fee level will provide sufficient resources to support the regulatory activities.(2) The pharmacy providing the pharmacy services to the patients of the covered entity, including, unless otherwise prohibited by any other law, patients enrolled in the Medi-Cal program, shall be under contract with that covered entity as described in Section 4126 to provide those pharmacy services through the use of the automated patient dispensing system.(3) Drugs stored in an automated patient dispensing system shall be part of the inventory of the pharmacy providing pharmacy services to the patients of the covered entity and drugs dispensed from the automated patient dispensing system shall be considered to have been dispensed by that pharmacy.(4) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated patient dispensing system separate from other pharmacy records.(5) The pharmacy shall be solely responsible for the security, operation, and maintenance of the automated patient dispensing system.(6) The pharmacy shall provide training regarding the operation and use of the automated patient dispensing system to both pharmacy and covered entity personnel using the system.(7) The operation of the automated patient dispensing system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the patients of the covered entity. The pharmacist need not be physically present at the site of the automated patient dispensing system and may supervise the system electronically.(8) Notwithstanding Section 4107, the board may issue a license for the operation of an automated patient dispensing system at an address for which it has issued another site license.(9) The board, within 30 days after receipt of an application for an automated patient dispensing system license, shall conduct a prelicensure inspection at the proposed location of the automated patient dispensing system. Relocation of the automated patient dispensing system shall require a new application for licensure. Replacement of an automated patient dispensing system shall require notice to the board within 30 days.(10) The automated patient dispensing system license shall be canceled by operation of law if the underlying pharmacy license is not current, valid, and active. Upon reissuance or reinstatement of the underlying pharmacy license, a new application for an automated patient dispensing system license may be submitted to the board.(11) A pharmacy that holds an automated patient dispensing system license shall advise the board in writing within 30 days if use of the automated patient dispensing system is discontinued.(b) For purposes of this section, the following definitions shall apply:(1) An automated drug delivery system (ADDS) means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. An ADDS shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. (2) An automated patient dispensing system (APDS) is an ADDS for storage and dispensing of prescribed drugs directly to patients pursuant to prior authorization by a pharmacist. (3) An automated unit dose system (AUDS) is an ADDS for storage and retrieval of unit doses of drugs for administration to patients by persons authorized to perform these functions. (c) (1) An automated patient dispensing system shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. (2) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.(d) Drugs from the automated patient dispensing system may be dispensed directly to the patient if all of the following requirements are met:(1) The pharmacy shall develop, implement, and annually review written policies and procedures with respect to all of the following:(A) Maintaining the security of the automated patient dispensing system and the dangerous drugs and devices within that automated patient dispensing system.(B) Determining and applying inclusion criteria regarding which drugs and devices are appropriate for placement in the automated patient dispensing system and for which patients.(C) Ensuring that patients are aware that consultation with a pharmacist is available for any prescription medication, including those delivered via the automated patient dispensing system.(D) Describing assignment of responsibilities to, and training of, pharmacy personnel, and other personnel using the automated patient dispensing system at the location where the automated patient dispensing system is placed, regarding maintenance and filing procedures for the automated patient dispensing system.(E) Orienting participating patients on the use of the automated patient dispensing system, notifying patients when expected prescription medications are not available in the automated patient dispensing system, and ensuring that patient use of the automated patient dispensing system does not interfere with delivery of drugs and devices.(F) Ensuring delivery of drugs and devices to patients expecting to receive them from the automated patient dispensing system in the event the automated patient dispensing system is disabled or malfunctions.(2) The automated patient dispensing system shall only be used for patients who have signed a written consent demonstrating their informed consent to receive prescribed drugs and devices from an automated patient dispensing system and whose use of the automated patient dispensing system meet the criteria pursuant to paragraph (1).(3) The automated patient dispensing system shall have a means to identify each patient and only release the identified patients drugs and devices to the patient or the patients agent.(4) A pharmacist shall perform all clinical services conducted as part of the dispensing process, including, but not limited to, drug utilization review and consultation.(5) Drugs shall be dispensed from the automated patient dispensing system only upon authorization from a pharmacist after the pharmacist has reviewed the prescription and the patients profile for potential contraindications and adverse drug reactions.(6) All prescribed drugs and devices dispensed from the automated patient dispensing system for the first time shall be accompanied by a consultation conducted by a pharmacist licensed by the board via a telecommunications link that has two-way audio and video.(7) The automated patient dispensing system shall include a notice, prominently posted on the automated patient dispensing system, that provides the name, address, and telephone number of the pharmacy that holds the automated patient dispensing system license for that automated patient dispensing system.(8) The labels on all drugs dispensed by the automated patient dispensing system shall comply with Section 4076 of this code and with Section 1707.5 of Title 16 of the California Code of Regulations.(9) Any complaint, error, or omission involving the automated patient dispensing system shall be reviewed as part of the pharmacys quality assurance program pursuant to Section 4125.(10) The board shall not issue a pharmacy more than 15 licenses for automated patient dispensing system units under this section. Consistent with Section 4001.1, the board may adopt regulations to reduce the number of automated patient dispensing system licenses that may be issued to a pharmacy.(11) The pharmacy holding the license for the automated patient dispensing system shall maintain the policies and procedures developed pursuant to paragraph (1) for three years after the last date of use of that automated patient dispensing system.(e) Access to the automated patient dispensing system shall be controlled and tracked using an identification or password system or biosensor. A system that is accessed via a password system shall include a camera that records a picture of the individual accessing the machine. Picture records shall be maintained for a minimum of 180 days.(f) The automated patient dispensing system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.(g) The stocking of an automated patient dispensing system shall be performed by a pharmacist. If the automated patient dispensing system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met:(1) The task of placing drugs into the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.(2) The removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.(3) The pharmacy, in conjunction with the covered entity, has developed policies and procedures to ensure that the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are properly placed into the automated patient dispensing system.(h) Review of the drugs contained within, and the operation and maintenance of, the automated patient dispensing system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated patient dispensing system, an inspection of the automated patient dispensing system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.(i) A pharmacy holding an automated patient dispensing system license shall complete an annual self-assessment, performed pursuant to Section 1715 of Title 16 of the California Code of Regulations, evaluating the pharmacys compliance with pharmacy law relating to the use of the automated patient dispensing system. All information regarding operation, maintenance, compliance, error, omissions, or complaints pertaining to the automated patient dispensing system shall be included in the self-assessment.(j) The pharmacy shall comply with all recordkeeping and quality assurance requirements pursuant to this chapter, and shall maintain those records within the pharmacy holding the automated patient dispensing system license and separately from other pharmacy records.SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB 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 XIIIB of the California Constitution.SEC. 3. This act is an urgency statute necessary for the immediate preservation of the public peace, health, or safety within the meaning of Article IV of the California Constitution and shall go into immediate effect. The facts constituting the necessity are:(a) Approximately 115 communities in 47 California counties do not have a pharmacist within 10 miles, creating a barrier to necessary health care. Many of these communities are susceptible to wild fires, enhancing the need for immediate access to medications and to the advice and care of pharmacists.(b) Rural and isolated communities desperately lack comprehensive pharmacy services. Automated dispensing, remotely performed by a pharmacist, brings a high level of pharmacy care and medication availability to these communities.(c) Through the use of automated patient dispensing systems, pharmacists can immediately provide medication to underserved patients, and improve and promote patient health by means of appropriate drug use, drug-related therapy, and communication for clinical and consultative purposes.(d) In less-isolated communities, the pharmacist is on the front line of health care as the medical professional that the patient sees most often. It is necessary to bring that level of care to millions of people in the state.(e) Therefore, in order to provide pharmacy services through the use of an automated patient dispensing system as soon as possible, it is necessary that this act take effect immediately. |
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| 11 | 23 | | |
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| 12 | 24 | | LEGISLATIVE COUNSEL'S DIGEST |
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| 13 | 25 | | |
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| 14 | 26 | | ## LEGISLATIVE COUNSEL'S DIGEST |
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| 15 | 27 | | |
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| 16 | 28 | | AB 2037, Bonta. Pharmacy: automated patient dispensing systems. |
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| 17 | 29 | | |
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| 18 | 30 | | Existing law, the Pharmacy Law, the knowing 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 a pharmacy to provide pharmacy services to specified licensed health facilities through the use of an automated drug delivery system owned and operated by the pharmacy that need not be located at the same location as the pharmacy. The Pharmacy Law also authorizes specified licensed health clinics, including nonprofit and free clinics, to use an automated drug delivery system, operated under the authorization of a pharmacist, and under which the clinic is responsible for the safety and security of the drugs in the system.This bill would provide an alternative program to authorize a pharmacy located in the state to provide pharmacy services to the patients of covered entities, as defined, that are eligible for discount drug programs under federal law, as specified, through the use of an automated patient dispensing system, as defined.This bill would provide that, under the alternative program, the responsibility for the operation, maintenance, and security of the automated patient dispensing system would be the responsibility of the pharmacy. The pharmacy would also be responsible for, among other things, obtaining a license from the board to operate the automated patient dispensing system at the covered entity, paying an application and renewal fee, and developing, and annually reviewing written policies and procedures with respect to various topics, including maintaining the security of the system and the dangerous drugs and devices within the system. The bill would require that the drugs dispensed from the system be labeled in accordance with existing law and that records of each transaction be made. The bill would require the pharmacy to complete an annual self-assessment pursuant to existing law.Because a knowing violation of these requirements 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 declare that it is to take effect immediately as an urgency statute. |
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| 19 | 31 | | |
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| 20 | 32 | | Existing law, the Pharmacy Law, the knowing 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 a pharmacy to provide pharmacy services to specified licensed health facilities through the use of an automated drug delivery system owned and operated by the pharmacy that need not be located at the same location as the pharmacy. The Pharmacy Law also authorizes specified licensed health clinics, including nonprofit and free clinics, to use an automated drug delivery system, operated under the authorization of a pharmacist, and under which the clinic is responsible for the safety and security of the drugs in the system. |
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| 21 | 33 | | |
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| 22 | 34 | | This bill would provide an alternative program to authorize a pharmacy located in the state to provide pharmacy services to the patients of covered entities, as defined, that are eligible for discount drug programs under federal law, as specified, through the use of an automated patient dispensing system, as defined. |
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| 23 | 35 | | |
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| 24 | 36 | | This bill would provide that, under the alternative program, the responsibility for the operation, maintenance, and security of the automated patient dispensing system would be the responsibility of the pharmacy. The pharmacy would also be responsible for, among other things, obtaining a license from the board to operate the automated patient dispensing system at the covered entity, paying an application and renewal fee, and developing, and annually reviewing written policies and procedures with respect to various topics, including maintaining the security of the system and the dangerous drugs and devices within the system. The bill would require that the drugs dispensed from the system be labeled in accordance with existing law and that records of each transaction be made. The bill would require the pharmacy to complete an annual self-assessment pursuant to existing law. |
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| 25 | 37 | | |
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| 26 | 38 | | Because a knowing violation of these requirements would be a crime, the bill would impose a state-mandated local program. |
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| 27 | 39 | | |
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| 28 | 40 | | 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. |
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| 29 | 41 | | |
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| 30 | 42 | | This bill would provide that no reimbursement is required by this act for a specified reason. |
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| 31 | 43 | | |
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| 32 | 44 | | This bill would declare that it is to take effect immediately as an urgency statute. |
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| 33 | 45 | | |
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| 34 | 46 | | ## Digest Key |
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| 35 | 47 | | |
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| 36 | 48 | | ## Bill Text |
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| 37 | 49 | | |
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| 38 | 50 | | The people of the State of California do enact as follows:SECTION 1. Section 4119.11 is added to the Business and Professions Code, to read:4119.11. (a) A pharmacy located in the state may provide pharmacy services to the patients of a covered entity, as defined in Section 256b of Title 42 of the United States Code, through the use of an automated patient dispensing system located on the premises of the covered entity or on the premises of medical professional practices under contract to provide medical services to covered entity patients, which need not be the same location as the pharmacy, if all of the following conditions are met:(1) The pharmacy obtains a license from the board to operate the automated patient dispensing system at the covered entity or affiliated site. As part of the application, the pharmacy shall provide the address at which the automated patient dispensing system shall be placed and identify the covered entity. A separate license shall be required for each location and shall be renewed annually concurrent with the pharmacy license. The application and renewal fee shall be three hundred dollars ($300) and may be increased to five hundred dollars ($500). The board is authorized to lower the renewal fee to not less than two hundred dollars ($200) if a lower fee level will provide sufficient resources to support the regulatory activities.(2) The pharmacy providing the pharmacy services to the patients of the covered entity, including, unless otherwise prohibited by any other law, patients enrolled in the Medi-Cal program, shall be under contract with that covered entity as described in Section 4126 to provide those pharmacy services through the use of the automated patient dispensing system.(3) Drugs stored in an automated patient dispensing system shall be part of the inventory of the pharmacy providing pharmacy services to the patients of the covered entity and drugs dispensed from the automated patient dispensing system shall be considered to have been dispensed by that pharmacy.(4) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated patient dispensing system separate from other pharmacy records.(5) The pharmacy shall be solely responsible for the security, operation, and maintenance of the automated patient dispensing system.(6) The pharmacy shall provide training regarding the operation and use of the automated patient dispensing system to both pharmacy and covered entity personnel using the system.(7) The operation of the automated patient dispensing system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the patients of the covered entity. The pharmacist need not be physically present at the site of the automated patient dispensing system and may supervise the system electronically.(8) Notwithstanding Section 4107, the board may issue a license for the operation of an automated patient dispensing system at an address for which it has issued another site license.(9) The board, within 30 days after receipt of an application for an automated patient dispensing system license, shall conduct a prelicensure inspection at the proposed location of the automated patient dispensing system. Relocation of the automated patient dispensing system shall require a new application for licensure. Replacement of an automated patient dispensing system shall require notice to the board within 30 days.(10) The automated patient dispensing system license shall be canceled by operation of law if the underlying pharmacy license is not current, valid, and active. Upon reissuance or reinstatement of the underlying pharmacy license, a new application for an automated patient dispensing system license may be submitted to the board.(11) A pharmacy that holds an automated patient dispensing system license shall advise the board in writing within 30 days if use of the automated patient dispensing system is discontinued.(b) For purposes of this section, the following definitions shall apply:(1) An automated drug delivery system (ADDS) means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. An ADDS shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. (2) An automated patient dispensing system (APDS) is an ADDS for storage and dispensing of prescribed drugs directly to patients pursuant to prior authorization by a pharmacist. (3) An automated unit dose system (AUDS) is an ADDS for storage and retrieval of unit doses of drugs for administration to patients by persons authorized to perform these functions. (c) (1) An automated patient dispensing system shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. (2) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.(d) Drugs from the automated patient dispensing system may be dispensed directly to the patient if all of the following requirements are met:(1) The pharmacy shall develop, implement, and annually review written policies and procedures with respect to all of the following:(A) Maintaining the security of the automated patient dispensing system and the dangerous drugs and devices within that automated patient dispensing system.(B) Determining and applying inclusion criteria regarding which drugs and devices are appropriate for placement in the automated patient dispensing system and for which patients.(C) Ensuring that patients are aware that consultation with a pharmacist is available for any prescription medication, including those delivered via the automated patient dispensing system.(D) Describing assignment of responsibilities to, and training of, pharmacy personnel, and other personnel using the automated patient dispensing system at the location where the automated patient dispensing system is placed, regarding maintenance and filing procedures for the automated patient dispensing system.(E) Orienting participating patients on the use of the automated patient dispensing system, notifying patients when expected prescription medications are not available in the automated patient dispensing system, and ensuring that patient use of the automated patient dispensing system does not interfere with delivery of drugs and devices.(F) Ensuring delivery of drugs and devices to patients expecting to receive them from the automated patient dispensing system in the event the automated patient dispensing system is disabled or malfunctions.(2) The automated patient dispensing system shall only be used for patients who have signed a written consent demonstrating their informed consent to receive prescribed drugs and devices from an automated patient dispensing system and whose use of the automated patient dispensing system meet the criteria pursuant to paragraph (1).(3) The automated patient dispensing system shall have a means to identify each patient and only release the identified patients drugs and devices to the patient or the patients agent.(4) A pharmacist shall perform all clinical services conducted as part of the dispensing process, including, but not limited to, drug utilization review and consultation.(5) Drugs shall be dispensed from the automated patient dispensing system only upon authorization from a pharmacist after the pharmacist has reviewed the prescription and the patients profile for potential contraindications and adverse drug reactions.(6) All prescribed drugs and devices dispensed from the automated patient dispensing system for the first time shall be accompanied by a consultation conducted by a pharmacist licensed by the board via a telecommunications link that has two-way audio and video.(7) The automated patient dispensing system shall include a notice, prominently posted on the automated patient dispensing system, that provides the name, address, and telephone number of the pharmacy that holds the automated patient dispensing system license for that automated patient dispensing system.(8) The labels on all drugs dispensed by the automated patient dispensing system shall comply with Section 4076 of this code and with Section 1707.5 of Title 16 of the California Code of Regulations.(9) Any complaint, error, or omission involving the automated patient dispensing system shall be reviewed as part of the pharmacys quality assurance program pursuant to Section 4125.(10) The board shall not issue a pharmacy more than 15 licenses for automated patient dispensing system units under this section. Consistent with Section 4001.1, the board may adopt regulations to reduce the number of automated patient dispensing system licenses that may be issued to a pharmacy.(11) The pharmacy holding the license for the automated patient dispensing system shall maintain the policies and procedures developed pursuant to paragraph (1) for three years after the last date of use of that automated patient dispensing system.(e) Access to the automated patient dispensing system shall be controlled and tracked using an identification or password system or biosensor. A system that is accessed via a password system shall include a camera that records a picture of the individual accessing the machine. Picture records shall be maintained for a minimum of 180 days.(f) The automated patient dispensing system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.(g) The stocking of an automated patient dispensing system shall be performed by a pharmacist. If the automated patient dispensing system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met:(1) The task of placing drugs into the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.(2) The removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.(3) The pharmacy, in conjunction with the covered entity, has developed policies and procedures to ensure that the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are properly placed into the automated patient dispensing system.(h) Review of the drugs contained within, and the operation and maintenance of, the automated patient dispensing system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated patient dispensing system, an inspection of the automated patient dispensing system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.(i) A pharmacy holding an automated patient dispensing system license shall complete an annual self-assessment, performed pursuant to Section 1715 of Title 16 of the California Code of Regulations, evaluating the pharmacys compliance with pharmacy law relating to the use of the automated patient dispensing system. All information regarding operation, maintenance, compliance, error, omissions, or complaints pertaining to the automated patient dispensing system shall be included in the self-assessment.(j) The pharmacy shall comply with all recordkeeping and quality assurance requirements pursuant to this chapter, and shall maintain those records within the pharmacy holding the automated patient dispensing system license and separately from other pharmacy records.SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB 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 XIIIB of the California Constitution.SEC. 3. This act is an urgency statute necessary for the immediate preservation of the public peace, health, or safety within the meaning of Article IV of the California Constitution and shall go into immediate effect. The facts constituting the necessity are:(a) Approximately 115 communities in 47 California counties do not have a pharmacist within 10 miles, creating a barrier to necessary health care. Many of these communities are susceptible to wild fires, enhancing the need for immediate access to medications and to the advice and care of pharmacists.(b) Rural and isolated communities desperately lack comprehensive pharmacy services. Automated dispensing, remotely performed by a pharmacist, brings a high level of pharmacy care and medication availability to these communities.(c) Through the use of automated patient dispensing systems, pharmacists can immediately provide medication to underserved patients, and improve and promote patient health by means of appropriate drug use, drug-related therapy, and communication for clinical and consultative purposes.(d) In less-isolated communities, the pharmacist is on the front line of health care as the medical professional that the patient sees most often. It is necessary to bring that level of care to millions of people in the state.(e) Therefore, in order to provide pharmacy services through the use of an automated patient dispensing system as soon as possible, it is necessary that this act take effect immediately. |
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| 40 | 52 | | The people of the State of California do enact as follows: |
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| 42 | 54 | | ## The people of the State of California do enact as follows: |
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| 44 | 56 | | SECTION 1. Section 4119.11 is added to the Business and Professions Code, to read:4119.11. (a) A pharmacy located in the state may provide pharmacy services to the patients of a covered entity, as defined in Section 256b of Title 42 of the United States Code, through the use of an automated patient dispensing system located on the premises of the covered entity or on the premises of medical professional practices under contract to provide medical services to covered entity patients, which need not be the same location as the pharmacy, if all of the following conditions are met:(1) The pharmacy obtains a license from the board to operate the automated patient dispensing system at the covered entity or affiliated site. As part of the application, the pharmacy shall provide the address at which the automated patient dispensing system shall be placed and identify the covered entity. A separate license shall be required for each location and shall be renewed annually concurrent with the pharmacy license. The application and renewal fee shall be three hundred dollars ($300) and may be increased to five hundred dollars ($500). The board is authorized to lower the renewal fee to not less than two hundred dollars ($200) if a lower fee level will provide sufficient resources to support the regulatory activities.(2) The pharmacy providing the pharmacy services to the patients of the covered entity, including, unless otherwise prohibited by any other law, patients enrolled in the Medi-Cal program, shall be under contract with that covered entity as described in Section 4126 to provide those pharmacy services through the use of the automated patient dispensing system.(3) Drugs stored in an automated patient dispensing system shall be part of the inventory of the pharmacy providing pharmacy services to the patients of the covered entity and drugs dispensed from the automated patient dispensing system shall be considered to have been dispensed by that pharmacy.(4) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated patient dispensing system separate from other pharmacy records.(5) The pharmacy shall be solely responsible for the security, operation, and maintenance of the automated patient dispensing system.(6) The pharmacy shall provide training regarding the operation and use of the automated patient dispensing system to both pharmacy and covered entity personnel using the system.(7) The operation of the automated patient dispensing system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the patients of the covered entity. The pharmacist need not be physically present at the site of the automated patient dispensing system and may supervise the system electronically.(8) Notwithstanding Section 4107, the board may issue a license for the operation of an automated patient dispensing system at an address for which it has issued another site license.(9) The board, within 30 days after receipt of an application for an automated patient dispensing system license, shall conduct a prelicensure inspection at the proposed location of the automated patient dispensing system. Relocation of the automated patient dispensing system shall require a new application for licensure. Replacement of an automated patient dispensing system shall require notice to the board within 30 days.(10) The automated patient dispensing system license shall be canceled by operation of law if the underlying pharmacy license is not current, valid, and active. Upon reissuance or reinstatement of the underlying pharmacy license, a new application for an automated patient dispensing system license may be submitted to the board.(11) A pharmacy that holds an automated patient dispensing system license shall advise the board in writing within 30 days if use of the automated patient dispensing system is discontinued.(b) For purposes of this section, the following definitions shall apply:(1) An automated drug delivery system (ADDS) means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. An ADDS shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. (2) An automated patient dispensing system (APDS) is an ADDS for storage and dispensing of prescribed drugs directly to patients pursuant to prior authorization by a pharmacist. (3) An automated unit dose system (AUDS) is an ADDS for storage and retrieval of unit doses of drugs for administration to patients by persons authorized to perform these functions. (c) (1) An automated patient dispensing system shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. (2) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.(d) Drugs from the automated patient dispensing system may be dispensed directly to the patient if all of the following requirements are met:(1) The pharmacy shall develop, implement, and annually review written policies and procedures with respect to all of the following:(A) Maintaining the security of the automated patient dispensing system and the dangerous drugs and devices within that automated patient dispensing system.(B) Determining and applying inclusion criteria regarding which drugs and devices are appropriate for placement in the automated patient dispensing system and for which patients.(C) Ensuring that patients are aware that consultation with a pharmacist is available for any prescription medication, including those delivered via the automated patient dispensing system.(D) Describing assignment of responsibilities to, and training of, pharmacy personnel, and other personnel using the automated patient dispensing system at the location where the automated patient dispensing system is placed, regarding maintenance and filing procedures for the automated patient dispensing system.(E) Orienting participating patients on the use of the automated patient dispensing system, notifying patients when expected prescription medications are not available in the automated patient dispensing system, and ensuring that patient use of the automated patient dispensing system does not interfere with delivery of drugs and devices.(F) Ensuring delivery of drugs and devices to patients expecting to receive them from the automated patient dispensing system in the event the automated patient dispensing system is disabled or malfunctions.(2) The automated patient dispensing system shall only be used for patients who have signed a written consent demonstrating their informed consent to receive prescribed drugs and devices from an automated patient dispensing system and whose use of the automated patient dispensing system meet the criteria pursuant to paragraph (1).(3) The automated patient dispensing system shall have a means to identify each patient and only release the identified patients drugs and devices to the patient or the patients agent.(4) A pharmacist shall perform all clinical services conducted as part of the dispensing process, including, but not limited to, drug utilization review and consultation.(5) Drugs shall be dispensed from the automated patient dispensing system only upon authorization from a pharmacist after the pharmacist has reviewed the prescription and the patients profile for potential contraindications and adverse drug reactions.(6) All prescribed drugs and devices dispensed from the automated patient dispensing system for the first time shall be accompanied by a consultation conducted by a pharmacist licensed by the board via a telecommunications link that has two-way audio and video.(7) The automated patient dispensing system shall include a notice, prominently posted on the automated patient dispensing system, that provides the name, address, and telephone number of the pharmacy that holds the automated patient dispensing system license for that automated patient dispensing system.(8) The labels on all drugs dispensed by the automated patient dispensing system shall comply with Section 4076 of this code and with Section 1707.5 of Title 16 of the California Code of Regulations.(9) Any complaint, error, or omission involving the automated patient dispensing system shall be reviewed as part of the pharmacys quality assurance program pursuant to Section 4125.(10) The board shall not issue a pharmacy more than 15 licenses for automated patient dispensing system units under this section. Consistent with Section 4001.1, the board may adopt regulations to reduce the number of automated patient dispensing system licenses that may be issued to a pharmacy.(11) The pharmacy holding the license for the automated patient dispensing system shall maintain the policies and procedures developed pursuant to paragraph (1) for three years after the last date of use of that automated patient dispensing system.(e) Access to the automated patient dispensing system shall be controlled and tracked using an identification or password system or biosensor. A system that is accessed via a password system shall include a camera that records a picture of the individual accessing the machine. Picture records shall be maintained for a minimum of 180 days.(f) The automated patient dispensing system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.(g) The stocking of an automated patient dispensing system shall be performed by a pharmacist. If the automated patient dispensing system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met:(1) The task of placing drugs into the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.(2) The removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.(3) The pharmacy, in conjunction with the covered entity, has developed policies and procedures to ensure that the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are properly placed into the automated patient dispensing system.(h) Review of the drugs contained within, and the operation and maintenance of, the automated patient dispensing system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated patient dispensing system, an inspection of the automated patient dispensing system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.(i) A pharmacy holding an automated patient dispensing system license shall complete an annual self-assessment, performed pursuant to Section 1715 of Title 16 of the California Code of Regulations, evaluating the pharmacys compliance with pharmacy law relating to the use of the automated patient dispensing system. All information regarding operation, maintenance, compliance, error, omissions, or complaints pertaining to the automated patient dispensing system shall be included in the self-assessment.(j) The pharmacy shall comply with all recordkeeping and quality assurance requirements pursuant to this chapter, and shall maintain those records within the pharmacy holding the automated patient dispensing system license and separately from other pharmacy records. |
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| 46 | 58 | | SECTION 1. Section 4119.11 is added to the Business and Professions Code, to read: |
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| 47 | 59 | | |
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| 48 | 60 | | ### SECTION 1. |
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| 50 | 62 | | 4119.11. (a) A pharmacy located in the state may provide pharmacy services to the patients of a covered entity, as defined in Section 256b of Title 42 of the United States Code, through the use of an automated patient dispensing system located on the premises of the covered entity or on the premises of medical professional practices under contract to provide medical services to covered entity patients, which need not be the same location as the pharmacy, if all of the following conditions are met:(1) The pharmacy obtains a license from the board to operate the automated patient dispensing system at the covered entity or affiliated site. As part of the application, the pharmacy shall provide the address at which the automated patient dispensing system shall be placed and identify the covered entity. A separate license shall be required for each location and shall be renewed annually concurrent with the pharmacy license. The application and renewal fee shall be three hundred dollars ($300) and may be increased to five hundred dollars ($500). The board is authorized to lower the renewal fee to not less than two hundred dollars ($200) if a lower fee level will provide sufficient resources to support the regulatory activities.(2) The pharmacy providing the pharmacy services to the patients of the covered entity, including, unless otherwise prohibited by any other law, patients enrolled in the Medi-Cal program, shall be under contract with that covered entity as described in Section 4126 to provide those pharmacy services through the use of the automated patient dispensing system.(3) Drugs stored in an automated patient dispensing system shall be part of the inventory of the pharmacy providing pharmacy services to the patients of the covered entity and drugs dispensed from the automated patient dispensing system shall be considered to have been dispensed by that pharmacy.(4) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated patient dispensing system separate from other pharmacy records.(5) The pharmacy shall be solely responsible for the security, operation, and maintenance of the automated patient dispensing system.(6) The pharmacy shall provide training regarding the operation and use of the automated patient dispensing system to both pharmacy and covered entity personnel using the system.(7) The operation of the automated patient dispensing system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the patients of the covered entity. The pharmacist need not be physically present at the site of the automated patient dispensing system and may supervise the system electronically.(8) Notwithstanding Section 4107, the board may issue a license for the operation of an automated patient dispensing system at an address for which it has issued another site license.(9) The board, within 30 days after receipt of an application for an automated patient dispensing system license, shall conduct a prelicensure inspection at the proposed location of the automated patient dispensing system. Relocation of the automated patient dispensing system shall require a new application for licensure. Replacement of an automated patient dispensing system shall require notice to the board within 30 days.(10) The automated patient dispensing system license shall be canceled by operation of law if the underlying pharmacy license is not current, valid, and active. Upon reissuance or reinstatement of the underlying pharmacy license, a new application for an automated patient dispensing system license may be submitted to the board.(11) A pharmacy that holds an automated patient dispensing system license shall advise the board in writing within 30 days if use of the automated patient dispensing system is discontinued.(b) For purposes of this section, the following definitions shall apply:(1) An automated drug delivery system (ADDS) means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. An ADDS shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. (2) An automated patient dispensing system (APDS) is an ADDS for storage and dispensing of prescribed drugs directly to patients pursuant to prior authorization by a pharmacist. (3) An automated unit dose system (AUDS) is an ADDS for storage and retrieval of unit doses of drugs for administration to patients by persons authorized to perform these functions. (c) (1) An automated patient dispensing system shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. (2) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.(d) Drugs from the automated patient dispensing system may be dispensed directly to the patient if all of the following requirements are met:(1) The pharmacy shall develop, implement, and annually review written policies and procedures with respect to all of the following:(A) Maintaining the security of the automated patient dispensing system and the dangerous drugs and devices within that automated patient dispensing system.(B) Determining and applying inclusion criteria regarding which drugs and devices are appropriate for placement in the automated patient dispensing system and for which patients.(C) Ensuring that patients are aware that consultation with a pharmacist is available for any prescription medication, including those delivered via the automated patient dispensing system.(D) Describing assignment of responsibilities to, and training of, pharmacy personnel, and other personnel using the automated patient dispensing system at the location where the automated patient dispensing system is placed, regarding maintenance and filing procedures for the automated patient dispensing system.(E) Orienting participating patients on the use of the automated patient dispensing system, notifying patients when expected prescription medications are not available in the automated patient dispensing system, and ensuring that patient use of the automated patient dispensing system does not interfere with delivery of drugs and devices.(F) Ensuring delivery of drugs and devices to patients expecting to receive them from the automated patient dispensing system in the event the automated patient dispensing system is disabled or malfunctions.(2) The automated patient dispensing system shall only be used for patients who have signed a written consent demonstrating their informed consent to receive prescribed drugs and devices from an automated patient dispensing system and whose use of the automated patient dispensing system meet the criteria pursuant to paragraph (1).(3) The automated patient dispensing system shall have a means to identify each patient and only release the identified patients drugs and devices to the patient or the patients agent.(4) A pharmacist shall perform all clinical services conducted as part of the dispensing process, including, but not limited to, drug utilization review and consultation.(5) Drugs shall be dispensed from the automated patient dispensing system only upon authorization from a pharmacist after the pharmacist has reviewed the prescription and the patients profile for potential contraindications and adverse drug reactions.(6) All prescribed drugs and devices dispensed from the automated patient dispensing system for the first time shall be accompanied by a consultation conducted by a pharmacist licensed by the board via a telecommunications link that has two-way audio and video.(7) The automated patient dispensing system shall include a notice, prominently posted on the automated patient dispensing system, that provides the name, address, and telephone number of the pharmacy that holds the automated patient dispensing system license for that automated patient dispensing system.(8) The labels on all drugs dispensed by the automated patient dispensing system shall comply with Section 4076 of this code and with Section 1707.5 of Title 16 of the California Code of Regulations.(9) Any complaint, error, or omission involving the automated patient dispensing system shall be reviewed as part of the pharmacys quality assurance program pursuant to Section 4125.(10) The board shall not issue a pharmacy more than 15 licenses for automated patient dispensing system units under this section. Consistent with Section 4001.1, the board may adopt regulations to reduce the number of automated patient dispensing system licenses that may be issued to a pharmacy.(11) The pharmacy holding the license for the automated patient dispensing system shall maintain the policies and procedures developed pursuant to paragraph (1) for three years after the last date of use of that automated patient dispensing system.(e) Access to the automated patient dispensing system shall be controlled and tracked using an identification or password system or biosensor. A system that is accessed via a password system shall include a camera that records a picture of the individual accessing the machine. Picture records shall be maintained for a minimum of 180 days.(f) The automated patient dispensing system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.(g) The stocking of an automated patient dispensing system shall be performed by a pharmacist. If the automated patient dispensing system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met:(1) The task of placing drugs into the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.(2) The removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.(3) The pharmacy, in conjunction with the covered entity, has developed policies and procedures to ensure that the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are properly placed into the automated patient dispensing system.(h) Review of the drugs contained within, and the operation and maintenance of, the automated patient dispensing system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated patient dispensing system, an inspection of the automated patient dispensing system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.(i) A pharmacy holding an automated patient dispensing system license shall complete an annual self-assessment, performed pursuant to Section 1715 of Title 16 of the California Code of Regulations, evaluating the pharmacys compliance with pharmacy law relating to the use of the automated patient dispensing system. All information regarding operation, maintenance, compliance, error, omissions, or complaints pertaining to the automated patient dispensing system shall be included in the self-assessment.(j) The pharmacy shall comply with all recordkeeping and quality assurance requirements pursuant to this chapter, and shall maintain those records within the pharmacy holding the automated patient dispensing system license and separately from other pharmacy records. |
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| 52 | 64 | | 4119.11. (a) A pharmacy located in the state may provide pharmacy services to the patients of a covered entity, as defined in Section 256b of Title 42 of the United States Code, through the use of an automated patient dispensing system located on the premises of the covered entity or on the premises of medical professional practices under contract to provide medical services to covered entity patients, which need not be the same location as the pharmacy, if all of the following conditions are met:(1) The pharmacy obtains a license from the board to operate the automated patient dispensing system at the covered entity or affiliated site. As part of the application, the pharmacy shall provide the address at which the automated patient dispensing system shall be placed and identify the covered entity. A separate license shall be required for each location and shall be renewed annually concurrent with the pharmacy license. The application and renewal fee shall be three hundred dollars ($300) and may be increased to five hundred dollars ($500). The board is authorized to lower the renewal fee to not less than two hundred dollars ($200) if a lower fee level will provide sufficient resources to support the regulatory activities.(2) The pharmacy providing the pharmacy services to the patients of the covered entity, including, unless otherwise prohibited by any other law, patients enrolled in the Medi-Cal program, shall be under contract with that covered entity as described in Section 4126 to provide those pharmacy services through the use of the automated patient dispensing system.(3) Drugs stored in an automated patient dispensing system shall be part of the inventory of the pharmacy providing pharmacy services to the patients of the covered entity and drugs dispensed from the automated patient dispensing system shall be considered to have been dispensed by that pharmacy.(4) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated patient dispensing system separate from other pharmacy records.(5) The pharmacy shall be solely responsible for the security, operation, and maintenance of the automated patient dispensing system.(6) The pharmacy shall provide training regarding the operation and use of the automated patient dispensing system to both pharmacy and covered entity personnel using the system.(7) The operation of the automated patient dispensing system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the patients of the covered entity. The pharmacist need not be physically present at the site of the automated patient dispensing system and may supervise the system electronically.(8) Notwithstanding Section 4107, the board may issue a license for the operation of an automated patient dispensing system at an address for which it has issued another site license.(9) The board, within 30 days after receipt of an application for an automated patient dispensing system license, shall conduct a prelicensure inspection at the proposed location of the automated patient dispensing system. Relocation of the automated patient dispensing system shall require a new application for licensure. Replacement of an automated patient dispensing system shall require notice to the board within 30 days.(10) The automated patient dispensing system license shall be canceled by operation of law if the underlying pharmacy license is not current, valid, and active. Upon reissuance or reinstatement of the underlying pharmacy license, a new application for an automated patient dispensing system license may be submitted to the board.(11) A pharmacy that holds an automated patient dispensing system license shall advise the board in writing within 30 days if use of the automated patient dispensing system is discontinued.(b) For purposes of this section, the following definitions shall apply:(1) An automated drug delivery system (ADDS) means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. An ADDS shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. (2) An automated patient dispensing system (APDS) is an ADDS for storage and dispensing of prescribed drugs directly to patients pursuant to prior authorization by a pharmacist. (3) An automated unit dose system (AUDS) is an ADDS for storage and retrieval of unit doses of drugs for administration to patients by persons authorized to perform these functions. (c) (1) An automated patient dispensing system shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. (2) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.(d) Drugs from the automated patient dispensing system may be dispensed directly to the patient if all of the following requirements are met:(1) The pharmacy shall develop, implement, and annually review written policies and procedures with respect to all of the following:(A) Maintaining the security of the automated patient dispensing system and the dangerous drugs and devices within that automated patient dispensing system.(B) Determining and applying inclusion criteria regarding which drugs and devices are appropriate for placement in the automated patient dispensing system and for which patients.(C) Ensuring that patients are aware that consultation with a pharmacist is available for any prescription medication, including those delivered via the automated patient dispensing system.(D) Describing assignment of responsibilities to, and training of, pharmacy personnel, and other personnel using the automated patient dispensing system at the location where the automated patient dispensing system is placed, regarding maintenance and filing procedures for the automated patient dispensing system.(E) Orienting participating patients on the use of the automated patient dispensing system, notifying patients when expected prescription medications are not available in the automated patient dispensing system, and ensuring that patient use of the automated patient dispensing system does not interfere with delivery of drugs and devices.(F) Ensuring delivery of drugs and devices to patients expecting to receive them from the automated patient dispensing system in the event the automated patient dispensing system is disabled or malfunctions.(2) The automated patient dispensing system shall only be used for patients who have signed a written consent demonstrating their informed consent to receive prescribed drugs and devices from an automated patient dispensing system and whose use of the automated patient dispensing system meet the criteria pursuant to paragraph (1).(3) The automated patient dispensing system shall have a means to identify each patient and only release the identified patients drugs and devices to the patient or the patients agent.(4) A pharmacist shall perform all clinical services conducted as part of the dispensing process, including, but not limited to, drug utilization review and consultation.(5) Drugs shall be dispensed from the automated patient dispensing system only upon authorization from a pharmacist after the pharmacist has reviewed the prescription and the patients profile for potential contraindications and adverse drug reactions.(6) All prescribed drugs and devices dispensed from the automated patient dispensing system for the first time shall be accompanied by a consultation conducted by a pharmacist licensed by the board via a telecommunications link that has two-way audio and video.(7) The automated patient dispensing system shall include a notice, prominently posted on the automated patient dispensing system, that provides the name, address, and telephone number of the pharmacy that holds the automated patient dispensing system license for that automated patient dispensing system.(8) The labels on all drugs dispensed by the automated patient dispensing system shall comply with Section 4076 of this code and with Section 1707.5 of Title 16 of the California Code of Regulations.(9) Any complaint, error, or omission involving the automated patient dispensing system shall be reviewed as part of the pharmacys quality assurance program pursuant to Section 4125.(10) The board shall not issue a pharmacy more than 15 licenses for automated patient dispensing system units under this section. Consistent with Section 4001.1, the board may adopt regulations to reduce the number of automated patient dispensing system licenses that may be issued to a pharmacy.(11) The pharmacy holding the license for the automated patient dispensing system shall maintain the policies and procedures developed pursuant to paragraph (1) for three years after the last date of use of that automated patient dispensing system.(e) Access to the automated patient dispensing system shall be controlled and tracked using an identification or password system or biosensor. A system that is accessed via a password system shall include a camera that records a picture of the individual accessing the machine. Picture records shall be maintained for a minimum of 180 days.(f) The automated patient dispensing system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.(g) The stocking of an automated patient dispensing system shall be performed by a pharmacist. If the automated patient dispensing system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met:(1) The task of placing drugs into the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.(2) The removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.(3) The pharmacy, in conjunction with the covered entity, has developed policies and procedures to ensure that the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are properly placed into the automated patient dispensing system.(h) Review of the drugs contained within, and the operation and maintenance of, the automated patient dispensing system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated patient dispensing system, an inspection of the automated patient dispensing system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.(i) A pharmacy holding an automated patient dispensing system license shall complete an annual self-assessment, performed pursuant to Section 1715 of Title 16 of the California Code of Regulations, evaluating the pharmacys compliance with pharmacy law relating to the use of the automated patient dispensing system. All information regarding operation, maintenance, compliance, error, omissions, or complaints pertaining to the automated patient dispensing system shall be included in the self-assessment.(j) The pharmacy shall comply with all recordkeeping and quality assurance requirements pursuant to this chapter, and shall maintain those records within the pharmacy holding the automated patient dispensing system license and separately from other pharmacy records. |
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| 53 | 65 | | |
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| 54 | 66 | | 4119.11. (a) A pharmacy located in the state may provide pharmacy services to the patients of a covered entity, as defined in Section 256b of Title 42 of the United States Code, through the use of an automated patient dispensing system located on the premises of the covered entity or on the premises of medical professional practices under contract to provide medical services to covered entity patients, which need not be the same location as the pharmacy, if all of the following conditions are met:(1) The pharmacy obtains a license from the board to operate the automated patient dispensing system at the covered entity or affiliated site. As part of the application, the pharmacy shall provide the address at which the automated patient dispensing system shall be placed and identify the covered entity. A separate license shall be required for each location and shall be renewed annually concurrent with the pharmacy license. The application and renewal fee shall be three hundred dollars ($300) and may be increased to five hundred dollars ($500). The board is authorized to lower the renewal fee to not less than two hundred dollars ($200) if a lower fee level will provide sufficient resources to support the regulatory activities.(2) The pharmacy providing the pharmacy services to the patients of the covered entity, including, unless otherwise prohibited by any other law, patients enrolled in the Medi-Cal program, shall be under contract with that covered entity as described in Section 4126 to provide those pharmacy services through the use of the automated patient dispensing system.(3) Drugs stored in an automated patient dispensing system shall be part of the inventory of the pharmacy providing pharmacy services to the patients of the covered entity and drugs dispensed from the automated patient dispensing system shall be considered to have been dispensed by that pharmacy.(4) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated patient dispensing system separate from other pharmacy records.(5) The pharmacy shall be solely responsible for the security, operation, and maintenance of the automated patient dispensing system.(6) The pharmacy shall provide training regarding the operation and use of the automated patient dispensing system to both pharmacy and covered entity personnel using the system.(7) The operation of the automated patient dispensing system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the patients of the covered entity. The pharmacist need not be physically present at the site of the automated patient dispensing system and may supervise the system electronically.(8) Notwithstanding Section 4107, the board may issue a license for the operation of an automated patient dispensing system at an address for which it has issued another site license.(9) The board, within 30 days after receipt of an application for an automated patient dispensing system license, shall conduct a prelicensure inspection at the proposed location of the automated patient dispensing system. Relocation of the automated patient dispensing system shall require a new application for licensure. Replacement of an automated patient dispensing system shall require notice to the board within 30 days.(10) The automated patient dispensing system license shall be canceled by operation of law if the underlying pharmacy license is not current, valid, and active. Upon reissuance or reinstatement of the underlying pharmacy license, a new application for an automated patient dispensing system license may be submitted to the board.(11) A pharmacy that holds an automated patient dispensing system license shall advise the board in writing within 30 days if use of the automated patient dispensing system is discontinued.(b) For purposes of this section, the following definitions shall apply:(1) An automated drug delivery system (ADDS) means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. An ADDS shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. (2) An automated patient dispensing system (APDS) is an ADDS for storage and dispensing of prescribed drugs directly to patients pursuant to prior authorization by a pharmacist. (3) An automated unit dose system (AUDS) is an ADDS for storage and retrieval of unit doses of drugs for administration to patients by persons authorized to perform these functions. (c) (1) An automated patient dispensing system shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. (2) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years.(d) Drugs from the automated patient dispensing system may be dispensed directly to the patient if all of the following requirements are met:(1) The pharmacy shall develop, implement, and annually review written policies and procedures with respect to all of the following:(A) Maintaining the security of the automated patient dispensing system and the dangerous drugs and devices within that automated patient dispensing system.(B) Determining and applying inclusion criteria regarding which drugs and devices are appropriate for placement in the automated patient dispensing system and for which patients.(C) Ensuring that patients are aware that consultation with a pharmacist is available for any prescription medication, including those delivered via the automated patient dispensing system.(D) Describing assignment of responsibilities to, and training of, pharmacy personnel, and other personnel using the automated patient dispensing system at the location where the automated patient dispensing system is placed, regarding maintenance and filing procedures for the automated patient dispensing system.(E) Orienting participating patients on the use of the automated patient dispensing system, notifying patients when expected prescription medications are not available in the automated patient dispensing system, and ensuring that patient use of the automated patient dispensing system does not interfere with delivery of drugs and devices.(F) Ensuring delivery of drugs and devices to patients expecting to receive them from the automated patient dispensing system in the event the automated patient dispensing system is disabled or malfunctions.(2) The automated patient dispensing system shall only be used for patients who have signed a written consent demonstrating their informed consent to receive prescribed drugs and devices from an automated patient dispensing system and whose use of the automated patient dispensing system meet the criteria pursuant to paragraph (1).(3) The automated patient dispensing system shall have a means to identify each patient and only release the identified patients drugs and devices to the patient or the patients agent.(4) A pharmacist shall perform all clinical services conducted as part of the dispensing process, including, but not limited to, drug utilization review and consultation.(5) Drugs shall be dispensed from the automated patient dispensing system only upon authorization from a pharmacist after the pharmacist has reviewed the prescription and the patients profile for potential contraindications and adverse drug reactions.(6) All prescribed drugs and devices dispensed from the automated patient dispensing system for the first time shall be accompanied by a consultation conducted by a pharmacist licensed by the board via a telecommunications link that has two-way audio and video.(7) The automated patient dispensing system shall include a notice, prominently posted on the automated patient dispensing system, that provides the name, address, and telephone number of the pharmacy that holds the automated patient dispensing system license for that automated patient dispensing system.(8) The labels on all drugs dispensed by the automated patient dispensing system shall comply with Section 4076 of this code and with Section 1707.5 of Title 16 of the California Code of Regulations.(9) Any complaint, error, or omission involving the automated patient dispensing system shall be reviewed as part of the pharmacys quality assurance program pursuant to Section 4125.(10) The board shall not issue a pharmacy more than 15 licenses for automated patient dispensing system units under this section. Consistent with Section 4001.1, the board may adopt regulations to reduce the number of automated patient dispensing system licenses that may be issued to a pharmacy.(11) The pharmacy holding the license for the automated patient dispensing system shall maintain the policies and procedures developed pursuant to paragraph (1) for three years after the last date of use of that automated patient dispensing system.(e) Access to the automated patient dispensing system shall be controlled and tracked using an identification or password system or biosensor. A system that is accessed via a password system shall include a camera that records a picture of the individual accessing the machine. Picture records shall be maintained for a minimum of 180 days.(f) The automated patient dispensing system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system.(g) The stocking of an automated patient dispensing system shall be performed by a pharmacist. If the automated patient dispensing system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met:(1) The task of placing drugs into the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist.(2) The removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container.(3) The pharmacy, in conjunction with the covered entity, has developed policies and procedures to ensure that the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are properly placed into the automated patient dispensing system.(h) Review of the drugs contained within, and the operation and maintenance of, the automated patient dispensing system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated patient dispensing system, an inspection of the automated patient dispensing system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system.(i) A pharmacy holding an automated patient dispensing system license shall complete an annual self-assessment, performed pursuant to Section 1715 of Title 16 of the California Code of Regulations, evaluating the pharmacys compliance with pharmacy law relating to the use of the automated patient dispensing system. All information regarding operation, maintenance, compliance, error, omissions, or complaints pertaining to the automated patient dispensing system shall be included in the self-assessment.(j) The pharmacy shall comply with all recordkeeping and quality assurance requirements pursuant to this chapter, and shall maintain those records within the pharmacy holding the automated patient dispensing system license and separately from other pharmacy records. |
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| 55 | 67 | | |
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| 56 | 68 | | |
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| 57 | 69 | | |
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| 58 | 70 | | 4119.11. (a) A pharmacy located in the state may provide pharmacy services to the patients of a covered entity, as defined in Section 256b of Title 42 of the United States Code, through the use of an automated patient dispensing system located on the premises of the covered entity or on the premises of medical professional practices under contract to provide medical services to covered entity patients, which need not be the same location as the pharmacy, if all of the following conditions are met: |
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| 59 | 71 | | |
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| 60 | 72 | | (1) The pharmacy obtains a license from the board to operate the automated patient dispensing system at the covered entity or affiliated site. As part of the application, the pharmacy shall provide the address at which the automated patient dispensing system shall be placed and identify the covered entity. A separate license shall be required for each location and shall be renewed annually concurrent with the pharmacy license. The application and renewal fee shall be three hundred dollars ($300) and may be increased to five hundred dollars ($500). The board is authorized to lower the renewal fee to not less than two hundred dollars ($200) if a lower fee level will provide sufficient resources to support the regulatory activities. |
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| 61 | 73 | | |
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| 62 | 74 | | (2) The pharmacy providing the pharmacy services to the patients of the covered entity, including, unless otherwise prohibited by any other law, patients enrolled in the Medi-Cal program, shall be under contract with that covered entity as described in Section 4126 to provide those pharmacy services through the use of the automated patient dispensing system. |
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| 63 | 75 | | |
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| 64 | 76 | | (3) Drugs stored in an automated patient dispensing system shall be part of the inventory of the pharmacy providing pharmacy services to the patients of the covered entity and drugs dispensed from the automated patient dispensing system shall be considered to have been dispensed by that pharmacy. |
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| 65 | 77 | | |
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| 66 | 78 | | (4) The pharmacy shall maintain records of the acquisition and disposition of dangerous drugs stored in the automated patient dispensing system separate from other pharmacy records. |
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| 67 | 79 | | |
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| 68 | 80 | | (5) The pharmacy shall be solely responsible for the security, operation, and maintenance of the automated patient dispensing system. |
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| 69 | 81 | | |
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| 70 | 82 | | (6) The pharmacy shall provide training regarding the operation and use of the automated patient dispensing system to both pharmacy and covered entity personnel using the system. |
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| 71 | 83 | | |
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| 72 | 84 | | (7) The operation of the automated patient dispensing system shall be under the supervision of a licensed pharmacist acting on behalf of the pharmacy providing services to the patients of the covered entity. The pharmacist need not be physically present at the site of the automated patient dispensing system and may supervise the system electronically. |
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| 73 | 85 | | |
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| 74 | 86 | | (8) Notwithstanding Section 4107, the board may issue a license for the operation of an automated patient dispensing system at an address for which it has issued another site license. |
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| 75 | 87 | | |
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| 76 | 88 | | (9) The board, within 30 days after receipt of an application for an automated patient dispensing system license, shall conduct a prelicensure inspection at the proposed location of the automated patient dispensing system. Relocation of the automated patient dispensing system shall require a new application for licensure. Replacement of an automated patient dispensing system shall require notice to the board within 30 days. |
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| 77 | 89 | | |
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| 78 | 90 | | (10) The automated patient dispensing system license shall be canceled by operation of law if the underlying pharmacy license is not current, valid, and active. Upon reissuance or reinstatement of the underlying pharmacy license, a new application for an automated patient dispensing system license may be submitted to the board. |
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| 79 | 91 | | |
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| 80 | 92 | | (11) A pharmacy that holds an automated patient dispensing system license shall advise the board in writing within 30 days if use of the automated patient dispensing system is discontinued. |
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| 81 | 93 | | |
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| 82 | 94 | | (b) For purposes of this section, the following definitions shall apply: |
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| 83 | 95 | | |
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| 84 | 96 | | (1) An automated drug delivery system (ADDS) means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of drugs. An ADDS shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. |
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| 85 | 97 | | |
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| 86 | 98 | | (2) An automated patient dispensing system (APDS) is an ADDS for storage and dispensing of prescribed drugs directly to patients pursuant to prior authorization by a pharmacist. |
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| 87 | 99 | | |
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| 88 | 100 | | (3) An automated unit dose system (AUDS) is an ADDS for storage and retrieval of unit doses of drugs for administration to patients by persons authorized to perform these functions. |
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| 89 | 101 | | |
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| 90 | 102 | | (c) (1) An automated patient dispensing system shall collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability. |
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| 91 | 103 | | |
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| 92 | 104 | | (2) Transaction information shall be made readily available in a downloadable format for review and inspection by individuals authorized by law. These records shall be maintained by the pharmacy for a minimum of three years. |
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| 93 | 105 | | |
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| 94 | 106 | | (d) Drugs from the automated patient dispensing system may be dispensed directly to the patient if all of the following requirements are met: |
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| 95 | 107 | | |
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| 96 | 108 | | (1) The pharmacy shall develop, implement, and annually review written policies and procedures with respect to all of the following: |
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| 97 | 109 | | |
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| 98 | 110 | | (A) Maintaining the security of the automated patient dispensing system and the dangerous drugs and devices within that automated patient dispensing system. |
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| 99 | 111 | | |
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| 100 | 112 | | (B) Determining and applying inclusion criteria regarding which drugs and devices are appropriate for placement in the automated patient dispensing system and for which patients. |
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| 101 | 113 | | |
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| 102 | 114 | | (C) Ensuring that patients are aware that consultation with a pharmacist is available for any prescription medication, including those delivered via the automated patient dispensing system. |
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| 103 | 115 | | |
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| 104 | 116 | | (D) Describing assignment of responsibilities to, and training of, pharmacy personnel, and other personnel using the automated patient dispensing system at the location where the automated patient dispensing system is placed, regarding maintenance and filing procedures for the automated patient dispensing system. |
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| 105 | 117 | | |
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| 106 | 118 | | (E) Orienting participating patients on the use of the automated patient dispensing system, notifying patients when expected prescription medications are not available in the automated patient dispensing system, and ensuring that patient use of the automated patient dispensing system does not interfere with delivery of drugs and devices. |
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| 107 | 119 | | |
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| 108 | 120 | | (F) Ensuring delivery of drugs and devices to patients expecting to receive them from the automated patient dispensing system in the event the automated patient dispensing system is disabled or malfunctions. |
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| 109 | 121 | | |
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| 110 | 122 | | (2) The automated patient dispensing system shall only be used for patients who have signed a written consent demonstrating their informed consent to receive prescribed drugs and devices from an automated patient dispensing system and whose use of the automated patient dispensing system meet the criteria pursuant to paragraph (1). |
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| 111 | 123 | | |
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| 112 | 124 | | (3) The automated patient dispensing system shall have a means to identify each patient and only release the identified patients drugs and devices to the patient or the patients agent. |
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| 113 | 125 | | |
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| 114 | 126 | | (4) A pharmacist shall perform all clinical services conducted as part of the dispensing process, including, but not limited to, drug utilization review and consultation. |
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| 115 | 127 | | |
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| 116 | 128 | | (5) Drugs shall be dispensed from the automated patient dispensing system only upon authorization from a pharmacist after the pharmacist has reviewed the prescription and the patients profile for potential contraindications and adverse drug reactions. |
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| 117 | 129 | | |
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| 118 | 130 | | (6) All prescribed drugs and devices dispensed from the automated patient dispensing system for the first time shall be accompanied by a consultation conducted by a pharmacist licensed by the board via a telecommunications link that has two-way audio and video. |
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| 119 | 131 | | |
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| 120 | 132 | | (7) The automated patient dispensing system shall include a notice, prominently posted on the automated patient dispensing system, that provides the name, address, and telephone number of the pharmacy that holds the automated patient dispensing system license for that automated patient dispensing system. |
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| 121 | 133 | | |
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| 122 | 134 | | (8) The labels on all drugs dispensed by the automated patient dispensing system shall comply with Section 4076 of this code and with Section 1707.5 of Title 16 of the California Code of Regulations. |
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| 123 | 135 | | |
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| 124 | 136 | | (9) Any complaint, error, or omission involving the automated patient dispensing system shall be reviewed as part of the pharmacys quality assurance program pursuant to Section 4125. |
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| 125 | 137 | | |
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| 126 | 138 | | (10) The board shall not issue a pharmacy more than 15 licenses for automated patient dispensing system units under this section. Consistent with Section 4001.1, the board may adopt regulations to reduce the number of automated patient dispensing system licenses that may be issued to a pharmacy. |
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| 127 | 139 | | |
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| 128 | 140 | | (11) The pharmacy holding the license for the automated patient dispensing system shall maintain the policies and procedures developed pursuant to paragraph (1) for three years after the last date of use of that automated patient dispensing system. |
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| 129 | 141 | | |
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| 130 | 142 | | (e) Access to the automated patient dispensing system shall be controlled and tracked using an identification or password system or biosensor. A system that is accessed via a password system shall include a camera that records a picture of the individual accessing the machine. Picture records shall be maintained for a minimum of 180 days. |
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| 131 | 143 | | |
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| 132 | 144 | | (f) The automated patient dispensing system shall make a complete and accurate record of all transactions that will include all users accessing the system and all drugs added to, or removed from, the system. |
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| 133 | 145 | | |
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| 134 | 146 | | (g) The stocking of an automated patient dispensing system shall be performed by a pharmacist. If the automated patient dispensing system utilizes removable pockets, cards, drawers, similar technology, or unit of use or single dose containers as defined by the United States Pharmacopeia, the stocking system may be done outside of the facility and be delivered to the facility if all of the following conditions are met: |
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| 135 | 147 | | |
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| 136 | 148 | | (1) The task of placing drugs into the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers is performed by a pharmacist, or by an intern pharmacist or a pharmacy technician working under the direct supervision of a pharmacist. |
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| 137 | 149 | | |
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| 138 | 150 | | (2) The removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are transported between the pharmacy and the facility in a secure tamper-evident container. |
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| 139 | 151 | | |
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| 140 | 152 | | (3) The pharmacy, in conjunction with the covered entity, has developed policies and procedures to ensure that the removable pockets, cards, drawers, similar technology, or unit of use or single dose containers are properly placed into the automated patient dispensing system. |
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| 141 | 153 | | |
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| 142 | 154 | | (h) Review of the drugs contained within, and the operation and maintenance of, the automated patient dispensing system shall be done in accordance with law and shall be the responsibility of the pharmacy. The review shall be conducted on a monthly basis by a pharmacist and shall include a physical inspection of the drugs in the automated patient dispensing system, an inspection of the automated patient dispensing system machine for cleanliness, and a review of all transaction records in order to verify the security and accountability of the system. |
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| 143 | 155 | | |
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| 144 | 156 | | (i) A pharmacy holding an automated patient dispensing system license shall complete an annual self-assessment, performed pursuant to Section 1715 of Title 16 of the California Code of Regulations, evaluating the pharmacys compliance with pharmacy law relating to the use of the automated patient dispensing system. All information regarding operation, maintenance, compliance, error, omissions, or complaints pertaining to the automated patient dispensing system shall be included in the self-assessment. |
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| 145 | 157 | | |
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| 146 | 158 | | (j) The pharmacy shall comply with all recordkeeping and quality assurance requirements pursuant to this chapter, and shall maintain those records within the pharmacy holding the automated patient dispensing system license and separately from other pharmacy records. |
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| 147 | 159 | | |
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| 148 | 160 | | SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB 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 XIIIB of the California Constitution. |
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| 149 | 161 | | |
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| 150 | 162 | | SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB 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 XIIIB of the California Constitution. |
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| 151 | 163 | | |
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| 152 | 164 | | SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB 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 XIIIB of the California Constitution. |
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| 153 | 165 | | |
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| 154 | 166 | | ### SEC. 2. |
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| 155 | 167 | | |
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| 156 | 168 | | SEC. 3. This act is an urgency statute necessary for the immediate preservation of the public peace, health, or safety within the meaning of Article IV of the California Constitution and shall go into immediate effect. The facts constituting the necessity are:(a) Approximately 115 communities in 47 California counties do not have a pharmacist within 10 miles, creating a barrier to necessary health care. Many of these communities are susceptible to wild fires, enhancing the need for immediate access to medications and to the advice and care of pharmacists.(b) Rural and isolated communities desperately lack comprehensive pharmacy services. Automated dispensing, remotely performed by a pharmacist, brings a high level of pharmacy care and medication availability to these communities.(c) Through the use of automated patient dispensing systems, pharmacists can immediately provide medication to underserved patients, and improve and promote patient health by means of appropriate drug use, drug-related therapy, and communication for clinical and consultative purposes.(d) In less-isolated communities, the pharmacist is on the front line of health care as the medical professional that the patient sees most often. It is necessary to bring that level of care to millions of people in the state.(e) Therefore, in order to provide pharmacy services through the use of an automated patient dispensing system as soon as possible, it is necessary that this act take effect immediately. |
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| 157 | 169 | | |
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| 158 | 170 | | SEC. 3. This act is an urgency statute necessary for the immediate preservation of the public peace, health, or safety within the meaning of Article IV of the California Constitution and shall go into immediate effect. The facts constituting the necessity are:(a) Approximately 115 communities in 47 California counties do not have a pharmacist within 10 miles, creating a barrier to necessary health care. Many of these communities are susceptible to wild fires, enhancing the need for immediate access to medications and to the advice and care of pharmacists.(b) Rural and isolated communities desperately lack comprehensive pharmacy services. Automated dispensing, remotely performed by a pharmacist, brings a high level of pharmacy care and medication availability to these communities.(c) Through the use of automated patient dispensing systems, pharmacists can immediately provide medication to underserved patients, and improve and promote patient health by means of appropriate drug use, drug-related therapy, and communication for clinical and consultative purposes.(d) In less-isolated communities, the pharmacist is on the front line of health care as the medical professional that the patient sees most often. It is necessary to bring that level of care to millions of people in the state.(e) Therefore, in order to provide pharmacy services through the use of an automated patient dispensing system as soon as possible, it is necessary that this act take effect immediately. |
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| 159 | 171 | | |
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| 160 | 172 | | SEC. 3. This act is an urgency statute necessary for the immediate preservation of the public peace, health, or safety within the meaning of Article IV of the California Constitution and shall go into immediate effect. The facts constituting the necessity are: |
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| 161 | 173 | | |
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| 162 | 174 | | ### SEC. 3. |
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| 163 | 175 | | |
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| 164 | 176 | | (a) Approximately 115 communities in 47 California counties do not have a pharmacist within 10 miles, creating a barrier to necessary health care. Many of these communities are susceptible to wild fires, enhancing the need for immediate access to medications and to the advice and care of pharmacists. |
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| 165 | 177 | | |
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| 166 | 178 | | (b) Rural and isolated communities desperately lack comprehensive pharmacy services. Automated dispensing, remotely performed by a pharmacist, brings a high level of pharmacy care and medication availability to these communities. |
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| 167 | 179 | | |
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| 168 | 180 | | (c) Through the use of automated patient dispensing systems, pharmacists can immediately provide medication to underserved patients, and improve and promote patient health by means of appropriate drug use, drug-related therapy, and communication for clinical and consultative purposes. |
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| 169 | 181 | | |
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| 170 | 182 | | (d) In less-isolated communities, the pharmacist is on the front line of health care as the medical professional that the patient sees most often. It is necessary to bring that level of care to millions of people in the state. |
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| 171 | 183 | | |
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| 172 | 184 | | (e) Therefore, in order to provide pharmacy services through the use of an automated patient dispensing system as soon as possible, it is necessary that this act take effect immediately. |
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