Existing law, the Pharmacy Law, establishes in the Department of Consumer Affairs the California State Board of Pharmacy to license and regulate the practice of pharmacy. The Pharmacy Law authorizes a prescriber or a prescribers authorized agent to electronically enter a prescription into a pharmacys or hospitals computer from a location outside of the pharmacy or hospital. The Pharmacy Law makes those provisions inapplicable to prescriptions for controlled substances classified in Schedule II, III, IV, or V, except as permitted pursuant to specified provisions. That law generally punishes a knowing violation of its provisions as a misdemeanor.

This bill would delete the provision making the authorization to electronically enter a prescription inapplicable to controlled substances. The bill would also authorize a pharmacist located and licensed in the state to, on behalf of a licensed health care facility, from a location outside of the facility, verify medication chart orders for appropriateness before administration consistent with federal requirements, as established in the health care facilitys policies and procedures. The bill would require a health care facility to maintain a record of a pharmacists verification of a medication chart order pursuant to that provision, as specified. By expanding the scope of the crime of violating the Pharmacy Law, this 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.

Existing law, the Pharmacy Law, establishes in the Department of Consumer Affairs the California State Board of Pharmacy to license and regulate the practice of pharmacy. The Pharmacy Law authorizes a prescriber or a prescribers authorized agent to electronically enter a prescription into a pharmacys or hospitals computer from a location outside of the pharmacy or hospital. The Pharmacy Law makes those provisions inapplicable to prescriptions for controlled substances classified in Schedule II, III, IV, or V, except as permitted pursuant to specified provisions. That law generally punishes a knowing violation of its provisions as a misdemeanor.

This bill would delete the provision making the authorization to electronically enter a prescription inapplicable to controlled substances. The bill would also authorize a pharmacist located and licensed in the state to, on behalf of a licensed health care facility, from a location outside of the facility, verify medication chart orders for appropriateness before administration consistent with federal requirements, as established in the health care facilitys policies and procedures. The bill would require a health care facility to maintain a record of a pharmacists verification of a medication chart order pursuant to that provision, as specified. By expanding the scope of the crime of violating the Pharmacy Law, this 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.

Existing law, the Pharmacy Law, establishes in the Department of Consumer Affairs the California State Board of Pharmacy to license and regulate the practice of pharmacy. The Pharmacy Law authorizes a prescriber or a prescribers authorized agent to electronically enter a prescription into a pharmacys or hospitals computer from a location outside of the pharmacy or hospital. The Pharmacy Law makes those provisions inapplicable to prescriptions for controlled substances classified in Schedule II, III, IV, or V, except as permitted pursuant to specified provisions. That law generally punishes a knowing violation of its provisions as a misdemeanor.

This bill would delete the provision making the authorization to electronically enter a prescription inapplicable to controlled substances. The bill would also authorize a pharmacist located and licensed in the state to, on behalf of a licensed health care facility, from a location outside of the facility, verify medication chart orders for appropriateness before administration consistent with federal requirements, as established in the health care facilitys policies and procedures. The bill would require a health care facility to maintain a record of a pharmacists verification of a medication chart order pursuant to that provision, as specified. By expanding the scope of the crime of violating the Pharmacy Law, this 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.

Existing law, the Pharmacy Law, establishes in the Department of Consumer Affairs the California State Board of Pharmacy to license and regulate the practice of pharmacy. The Pharmacy Law authorizes a prescriber or a prescribers authorized agent to electronically enter a prescription into a pharmacys or hospitals computer from a location outside of the pharmacy or hospital. The Pharmacy Law makes those provisions inapplicable to prescriptions for controlled substances classified in Schedule II, III, IV, or V, except as permitted pursuant to specified provisions. That law generally punishes a knowing violation of its provisions as a misdemeanor.

This bill would delete the provision making the authorization to electronically enter a prescription inapplicable to controlled substances. The bill would also authorize a pharmacist located and licensed in the state to, on behalf of a licensed health care facility, from a location outside of the facility, verify medication chart orders for appopriateness appropriateness before administration consistent with federal requirements, as established in the health care facilitys policies and procedures. The bill would require a health care facility to maintain a record of a pharmacists verification of a medication chart order pursuant to that provision, as specified. By expanding the scope of the crime of violating the Pharmacy Law, this 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.

Existing law, the Pharmacy Law, establishes in the Department of Consumer Affairs the California State Board of Pharmacy to license and regulate the practice of pharmacy. Existing law The Pharmacy Law authorizes a prescriber or a prescribers authorized agent to electronically enter a prescription into a pharmacys or hospitals computer from a location outside of the pharmacy or hospital. Existing law The Pharmacy Law makes those provisions inapplicable to prescriptions for controlled substances classified in Schedule II, III, IV, or V, except as permitted pursuant to specified provisions. That law generally punishes a knowing violation of its provisions as a misdemeanor.

This bill would delete the provision making the authorization to electronically enter a prescription inapplicable to controlled substances. The bill would also authorize a pharmacist located and licensed in the state to, on behalf of a licensed health care facility, from a location outside of the facility, verify medication chart orders for appopriateness before administration consistent with federal requirements, as established in the health care facilitys policies and procedures. The bill would require a health care facility to maintain a record of a pharmacists verification of a medication chart order pursuant to that provision, as specified. By expanding the scope of the crime of violating the Pharmacy Law, this bill would impose a state-mandated local program.

Existing law, the Pharmacy Law, establishes in the Department of Consumer Affairs the California State Board of Pharmacy to license and regulate the practice of pharmacy. Existing law authorizes a prescriber or a prescribers authorized agent to electronically enter a prescription into a pharmacys or hospitals computer from a location outside of the pharmacy or hospital. Existing law makes those provisions inapplicable to prescriptions for controlled substances classified in Schedule II, III, IV, or V, except as permitted pursuant to specified provisions.

This bill would delete the provision making the authorization to electronically enter a prescription inapplicable to controlled substances.

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 1557

Author:(Flora)

As Amended Ver:June 6, 2023

2/3 vote. Urgency

SUMMARY

Authorizes a pharmacist located and licensed in the state to, on behalf of a licensed hospital, from a location outside of the hospital, verify medication chart orders for appropriateness, as specified, and makes other technical changes.

Senate Amendments

Amend the urgency clause to correct the expiration date of a related waiver.

COMMENTS

Background. Pharmacists are healthcare professionals licensed to practice pharmacy, which includes dispensing prescription drugs, monitoring drug interactions, and counseling patients on the proper usage of drugs. They are also able to review medication orders from prescribers, checking for appropriateness before the medication is administered.

For hospitals participating in the federal Medicare and Medicaid programs, the Centers for Medicare and Medicaid Services (CMS) requires a pharmacist to review all non-emergency patient care orders before administration to a patient.

The State Operations Manual specifies that hospitals must have a process for reviewing all medication orders, except in emergencies, for appropriateness by a pharmacist before the first dose is dispensed. The hospitals must also have a process for resolving questions with the prescribing practitioner and documenting the discussion and outcome in the patient's medical record or pharmacy copy of the prescriber's order.

The review is encouraged to include:

1. Therapeutic appropriateness of a patient's medication regimen.
2. Therapeutic duplication in the patient's medication regimen.
3. Appropriateness of the drug, dose, frequency, and route of administration.
4. Real or potential medication-medication, medication-food, medication-laboratory test, and medication-disease interactions.
5. Real or potential allergies or sensitivities.
6. Other contraindications.

Remote Verification of Medication Orders. The Pharmacy Law does not explicitly require a pharmacist performing verification of medication orders to do so onsite. As such, the Board of Pharmacy has never taken action against a pharmacist that has verified medication orders from an offsite location.

However, in response to the COVID-19 pandemic, the Board of Pharmacy issued a waiver of the Pharmacy Law allowing the offsite verification of medication orders. The implication of the waiver is that the offsite verification of medication orders was previously prohibited. According to the board's waiver, existing law authorizes "a pharmacist to enter a prescription or an order into a pharmacy's or hospital's computer from any location outside of a pharmacy or hospital, under specified conditions…. [but it] does not permit a pharmacist to perform other steps in the dispensing process."

Based on this new interpretation, the use of offsite or remote verification violates the Pharmacy law. As a result, the Board of Pharmacy is sponsoring this bill to avoid severe disruptions in the continuity of care in hospitals. According to the board, many rural hospitals do not have pharmacists on premises 24 hours a day, meaning patients would not be able to receive medication until a pharmacist returned and performed the medication review. For larger hospitals, the number of medication orders that are remotely verified can number in the millions.

The Board of Pharmacy's waiver ends May 28, 2023. This bill would clarify that pharmacists are authorized to verify medication orders remotely, allowing the use of offsite medication order verifications indefinitely.

Electronic Entering of Schedule II, III, IV, or V Prescriptions or Orders. Existing law authorizes the electronic entering of prescriptions except for Schedule II, III, IV, or V drugs. This bill would delete the exemption for scheduled drugs. Under AB 2789 (Wood), Chapter 438, Statutes of 2018, beginning January 1, 2022, all prescriptions issued by a licensed healthcare practitioner to a California pharmacy must be submitted electronically.

According to the Author

"[This bill] is an important bill that would make permanent the authority for a state licensed pharmacist to conduct medication reviews outside of a California licensed hospital. This measure ensures that hospital patients have 24-hour access to a pharmacist to perform vital medication chart order review to ensure safe medication use. Many rural hospitals do not have a pharmacist on site during all hours of operations, which could delay medication administration. Also, during patient surges and unanticipated employee leave, on-site pharmacists may be insufficient to perform all necessary services, including compounding preparations, medication therapy reviews, and other duties while also conducting timely reviews of medication orders. [This bill's] straightforward approach ensures continuity of patient care while providing flexibility to hospitals in determining how best to manage medication reviews for patients."

Arguments in Support

The Board of Pharmacy (sponsor) writes in support "that not all health care facilities have 24-hour onsite pharmacist services, most notably in many rural areas. In response to the COVID-19 public health emergency, the Board issued a waiver that included provisions to allow for remote medication chart order review and believes such reviews have been performed appropriately and safely in the best interest of patients. [This bill] makes permanent this authority. The Board believes the permanent authority sought in this measure is in the best interest of Californians as it provides health care facilities flexibility in meeting federal requirements and ensuring continuity of patient care. Permanent authority for pharmacists to perform medication chart order reviews as specified in the bill is both appropriate and necessary to ensure patients have ready access to pharmacist care, even when a pharmacist is not on site or available to complete such reviews."

The California Hospital Association writes in support:

The Centers for Medicare & Medicaid Services requires a pharmacist review of all non-emergency medication orders prior to administration to patients. However, many rural hospitals do not have a pharmacist on site during all hours of operations, which could delay medication administration.

Also, during patient surges and unanticipated employee leave, on-site pharmacists may be insufficient to perform all necessary services, including compounding preparations, medication therapy reviews, and other duties while also conducting timely reviews of medication orders. Advancements in technology over the last few decades — along with waivers provided by the state Board of Pharmacy due to the COVID-19 pandemic — have enabled hospital pharmacists to remotely review and process medications and today millions of new orders are reviewed and processed off site prior to patient administration.

The waiver that allows hospitals to remotely process prescriptions is set to expire on May 28, 2023, and the passage of [this bill] is urgently needed so hospitals can continue to use this proven and safe practice. The flexibility permitted under [this bill] would help ensure that every new non-emergency medication for patients in California hospitals has been carefully reviewed by a pharmacist.

Arguments in Opposition

None on file

FISCAL COMMENTS

According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, no significant state costs anticipated.

VOTES:

ASM BUSINESS AND PROFESSIONS: 18-0-0

YES: Berman, Flora, Alanis, Alvarez, Bonta, Chen, Dixon, Gipson, Grayson, Irwin, Jackson, Lee, Lowenthal, McCarty, McKinnor, Stephanie Nguyen, Joe Patterson, Ting

ASM APPROPRIATIONS: 16-0-0

YES: Holden, Megan Dahle, Bryan, Calderon, Wendy Carrillo, Dixon, Mike Fong, Hart, Lowenthal, Mathis, Papan, Pellerin, Robert Rivas, Sanchez, Weber, Wilson

ASSEMBLY FLOOR: 75-0-5

YES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bauer-Kahan, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Chen, Connolly, Megan Dahle, Davies, Dixon, Essayli, Mike Fong, Vince Fong, Friedman, Gabriel, Gallagher, Garcia, Gipson, Grayson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Jones-Sawyer, Kalra, Lackey, Lee, Low, Lowenthal, Maienschein, Mathis, McCarty, Stephanie Nguyen, Ortega, Pacheco, Papan, Jim Patterson, Joe Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Schiavo, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Ward, Weber, Wilson, Wood, Zbur, Rendon

ABS, ABST OR NV: Flora, McKinnor, Muratsuchi, Wallis, Wicks

SENATE FLOOR: 39-0-1

YES: Allen, Archuleta, Ashby, Atkins, Becker, Blakespear, Bradford, Caballero, Cortese, Dahle, Dodd, Durazo, Eggman, Glazer, Gonzalez, Grove, Hurtado, Jones, Laird, Limón, McGuire, Menjivar, Min, Newman, Nguyen, Niello, Ochoa Bogh, Padilla, Portantino, Roth, Rubio, Seyarto, Skinner, Smallwood-Cuevas, Stern, Umberg, Wahab, Wiener, Wilk

ABS, ABST OR NV: Alvarado-Gil

UPDATED

VERSION: June 6, 2023

CONSULTANT: Vincent Chee / B. & P. / (916) 319-3301 FN: 0001174

 CONSENT  

Bill No: AB 1557

Author: Flora (R), et al.

Amended: 6/6/23 in Senate

Vote: 27 - Urgency

SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 13-0, 6/5/23

AYES: Roth, Nguyen, Alvarado-Gil, Archuleta, Ashby, Becker, Dodd, Eggman, Glazer, Niello, Smallwood-Cuevas, Wahab, Wilk

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

ASSEMBLY FLOOR: 75-0, 5/4/23 (Consent) - See last page for vote

SUBJECT: Pharmacy: electronic prescriptions

SOURCE: California State Board of Pharmacy

DIGEST:

This bill authorizes a California-licensed pharmacist to conduct medication chart order reviews remotely for a California-licensed hospital.

ANALYSIS:

Existing law:

1. Allows a prescriber to authorize their agent on their behalf to orally or electronically transmit a prescription to the furnisher. Requires the furnisher to make a reasonable effort to determine that the person who transmits the prescription is authorized to do so and to record the name of the authorized agent of the prescriber who transmits the order, except for Schedule II controlled substances. (Business and Professions Code (BPC) § 4071)
2. Authorizes a prescriber, a prescriber’s authorized agent, or a pharmacist to electronically enter a prescription or an order into a pharmacy’s or hospital’s computer from any location outside of the pharmacy or hospital with the permission of the pharmacy or hospital except for Schedule II, III, IV, or V controlled substances unless otherwise authorized. (BPC Section 4071.1)
3. Prohibits a dangerous drug or dangerous device from being dispensed pursuant to a prescription that has been electronically entered into a pharmacy’s computer without the prior approval of a pharmacist. (BPC Section 4071.1(c))

This bill:

1. Authorizes a pharmacist located and licensed in California to, on behalf of a hospital, from a location outside of the facility, verify medication chart orders for appropriateness before administration, consistent with federal requirements, as established in the facility’s policies and procedures. Requires that a record of verifications be kept according to existing recordkeeping requirements.
2. States this is an urgency measure, necessary to ensure that hospitals can continue to remotely process prescriptions.

Background

As part of the Board of Pharmacy’s response to the COVID-19 pandemic, it issued a “Remote Processing Waiver” that is expired on May 28, 2023. Under the provisions of the waiver, pharmacists performing remote processing were authorized to receive, interpret, evaluate, clarify, and approve medication orders and prescriptions, including medication orders and prescriptions for controlled substances. The waiver was broad and also extended provisions of BPC Section 4071.1 to allow for remote processing by pharmacy technicians and pharmacy interns to include nondiscretionary tasks, including prescription or order entry, other data entry, and insurance processing of prescriptions and medication orders under pharmacist supervision. The supervision in the waiver was specified to allow this to happen via technology that ensures a pharmacist is (1) readily available to answer questions of a pharmacy intern or pharmacy technician; and (2) verifies the work performed by the pharmacy intern or pharmacy technician.

Many hospitals are subject to Federal Centers for Medicare & Medicaid Services requirements for nonemergency orders to be reviewed by a pharmacist prior to administering medication to the patient and many hospitals, especially critical access and rural hospitals often do not have a pharmacist on site all the time. BOP is focusing even more narrowly to ensure that hospital pharmacists still have this authority. This bill codifies the waiver that expires soon by updating the law to authorize this remote medication processing.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

SUPPORT: (Verified 6/26/23)

California State Board of Pharmacy (source)

California Hospital Association

California Medical Association

California Pharmacists Association

California State Association of Psychiatrists

Cedars Sinai

Kaiser Permanente

Keck Medicine of University of Southern California

Sonoma Valley Hospital

Stanford Health Care

Sutter Health

Tenet Healthcare Corporation

OPPOSITION: (Verified 6/26/23)

None received

ARGUMENTS IN SUPPORT: The Board of Pharmacy notes that “not all health care facilities have 24-hour onsite pharmacist services, most notably in many rural areas…The Board believes the permanent authority sought in this measure is in the best interest of Californians as it provides health care facilities flexibility in meeting federal requirements and ensuring continuity of patient care. Permanent authority for pharmacists to perform medication chart order reviews as specified in the bill is both appropriate and necessary to ensure patients have ready access to pharmacist care, even when a pharmacist is not on site or available to complete such reviews.”

The California Hospital Association and a number of hospitals note that the Centers for Medicare & Medicaid Services requires a pharmacist to review all non-emergency medication orders prior to administration to patients. However, many rural hospitals do not have a pharmacist on-site during all hours of operation, which could delay medication administration. The groups state that “during patient surges and unanticipated employee leave, on-site pharmacists may be insufficient to perform all necessary services, including compounding preparations, medication therapy reviews, and other duties while also conducting timely reviews of medication orders. Advancements in technology over the last few decades, along with waivers provided by the state Board of Pharmacy due to the COVID-19 pandemic, have enabled hospital pharmacists to remotely review and process medications. Today, millions of new orders are reviewed and processed off-site prior to patient administration. The waiver that allows hospitals to remotely process prescriptions is set to expire on Aug. 9, 2023, and the passage of AB 1557 is urgently needed so hospitals can continue to use this proven and safe practice. The flexibility permitted under AB 1557 would help ensure that all new non-emergency medications prescribed to patients in California hospitals have been carefully reviewed by a pharmacist.”

The California Medical Association writes in support: “The bill is a common sense measure that alleviates administrative burdens and provides faster access to medically necessary treatments while ensuring patient safety by requiring verification of medication orders to be recorded.”

The California Pharmacists Association writes in support: “COVID has forever changed how we work and advances in technology have made it possible to work remotely effectively and safely in many areas of healthcare. Hospitals are facing many challenges, especially those in rural communities. Providing them some relief by allowing for remote processing of medications may help alleviate some of the strain as they grapple with staffing issues.”

Kaiser Permanente “believes that remote work by pharmacy personnel is a safe practice that allows for greater flexibility in managing our pharmacies’ operations. With the current waiver allowing hospitals to remotely process prescriptions expiring on May 28, 2023, this legislation is urgently needed. This bill allows for continued flexibility while still ensuring patient safety.”

ASSEMBLY FLOOR: 75-0, 5/4/23

AYES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bauer-Kahan, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Chen, Connolly, Megan Dahle, Davies, Dixon, Essayli, Mike Fong, Vince Fong, Friedman, Gabriel, Gallagher, Garcia, Gipson, Grayson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Jones-Sawyer, Kalra, Lackey, Lee, Low, Lowenthal, Maienschein, Mathis, McCarty, Stephanie Nguyen, Ortega, Pacheco, Papan, Jim Patterson, Joe Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Schiavo, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Ward, Weber, Wilson, Wood, Zbur, Rendon

NO VOTE RECORDED: Flora, McKinnor, Muratsuchi, Wallis, Wicks

Prepared by: Sarah Mason / B., P. & E.D. /

6/28/23 10:41:54

**** END ****

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Richard Roth, Chair

2023 - 2024 Regular

Bill No: AB 1557 Hearing Date: June 5, 2023

Subject: Pharmacy: electronic prescriptions

SUMMARY:

Authorizes a California-licensed pharmacist to conduct medication chart order reviews remotely for a California-licensed hospital.

Existing law:

1. Allows a prescriber to authorize their agent on their behalf to orally or electronically transmit a prescription to the furnisher. Requires the furnisher to make a reasonable effort to determine that the person who transmits the prescription is authorized to do so and to record the name of the authorized agent of the prescriber who transmits the order, except for Schedule II controlled substances. (Business and Professions Code (BPC) § 4071)
2. Authorizes a prescriber, a prescriber’s authorized agent, or a pharmacist to electronically enter a prescription or an order into a pharmacy’s or hospital’s computer from any location outside of the pharmacy or hospital with the permission of the pharmacy or hospital except for Schedule II, III, IV, or V controlled substances unless otherwise authorized. (BPC Section 4071.1)
3. Prohibits a dangerous drug or dangerous device from being dispensed pursuant to a prescription that has been electronically entered into a pharmacy’s computer without the prior approval of a pharmacist. (BPC Section 4071.1(c))

This bill:

1. Authorizes a pharmacist located and licensed in California to, on behalf of a hospital, from a location outside of the facility, verify medication chart orders for appropriateness before administration, consistent with federal requirements, as established in the facility’s policies and procedures. Requires that a record of verifications be kept according to existing recordkeeping requirements.
2. States this is an urgency measure, necessary to ensure that hospitals can continue to remotely process prescriptions.

FISCAL EFFECT:

This bill is keyed fiscal by Legislative Counsel. According to the Assembly Committee on Appropriations, the bill will result in minor and absorbable costs to the Board.

COMMENTS:

1. Purpose. The California State Board of Pharmacy (BOP) is the Sponsor of this bill. According to BOP, “To advance patient safety and reduce medication errors in hospitals and other care settings, the Centers for Medicare and Medicaid Services (CMS) requires a pharmacist review of all non-emergency patient care orders prior to administration to a patient. In response to the COVID-19 pandemic and the need for physical distancing, the California State Board of Pharmacy (Board), through its authority, granted a waiver of pharmacy law, expanding authority for remote processing by pharmacists under specified conditions. Through this process, the Board learned of challenges many hospitals experience in meeting CMSrequirements for pharmacy related services. Many rural hospitals do not have a pharmacist on site during all hours of operations. Futher, during patient surges and unanticipated employee leave, on site pharmacist resources may be insufficient to perform all necessary pharmacy services including compounding preparations, medication therapy reviews, and other pharmacy related services while also timely reviewing and approving medication orders.

The Board also received information regarding processes in place at licensed hospitals prior to the pandemic. These processes appeared to be the result of a misunderstanding of the legal requirements surrounding remote work by pharmacists providing care for inpatients.”

1. COVID-19 and Remote Processing Wavier. As part of BOP’s response to the COVID-19 pandemic, it issued a “Remote Processing Waiver” that is expired on May 28, 2023. Under the provisions of the waiver, pharmacists performing remote processing were authorized to receive, interpret, evaluate, clarify, and approve medication orders and prescriptions, including medication orders and prescriptions for controlled substances. The waiver was broad and also extended provisions of BPC Section 4071.1 to allow for remote processing by pharmacy technicians and pharmacy interns to include nondiscretionary tasks, including prescription or order entry, other data entry, and insurance processing of prescriptions and medication orders under pharmacist supervision. The supervision in the waiver was specified to allow this to happen via technology that ensures a pharmacist is (1) readily available to answer questions of a pharmacy intern or pharmacy technician; and (2) verifies the work performed by the pharmacy intern or pharmacy technician.

Many hospitals are subject to Federal CMS requirements for nonemergency orders to be reviewed by a pharmacist prior to administering medication to the patient and many hospitals, especially critical access and rural hospitals often do not have a pharmacist on site all the time. BOP is focusing even more narrowly to ensure that hospital pharmacists still have this authority. This bill codifies the waiver that expires soon by updating the law to authorize this remote medication processing.

1. Arguments in Support. BOP notes that “not all health care facilities have 24-hour onsite pharmacist services, most notably in many rural areas…The Board believes the permanent authority sought in this measure is in the best interest of Californians as it provides health care facilities flexibility in meeting federal requirements and ensuring continuity of patient care. Permanent authority for pharmacists to perform medication chart order reviews as specified in the bill is both appropriate and necessary to ensure patients have ready access to pharmacist care, even when a pharmacist is not on site or available to complete such reviews.”

The California Hospital Association and a number of hospitals note that the Centers for Medicare & Medicaid Services requires a pharmacist to review all non-emergency medication orders prior to administration to patients. However, many rural hospitals do not have a pharmacist on-site during all hours of operation, which could delay medication administration. The groups state that “during patient surges and unanticipated employee leave, on-site pharmacists may be insufficient to perform all necessary services, including compounding preparations, medication therapy reviews, and other duties while also conducting timely reviews of medication orders. Advancements in technology over the last few decades, along with waivers provided by the state Board of Pharmacy due to the COVID-19 pandemic, have enabled hospital pharmacists to remotely review and process medications. Today, millions of new orders are reviewed and processed off-site prior to patient administration. The waiver that allows hospitals to remotely process prescriptions is set to expire on Aug. 9, 2023, and the passage of AB 1557 is urgently needed so hospitals can continue to use this proven and safe practice. The flexibility permitted under AB 1557 would help ensure that all new non-emergency medications prescribed to patients in California hospitals have been carefully reviewed by a pharmacist.”

The California Medical Association writes in support: “The bill is a common sense measure that alleviates administrative burdens and provides faster access to medically necessary treatments while ensuring patient safety by requiring verification of medication orders to be recorded.”

The California Pharmacists Association writes in support: “COVID has forever changed how we work and advances in technology have made it possible to work remotely effectively and safely in many areas of healthcare. Hospitals are facing many challenges, especially those in rural communities. Providing them some relief by allowing for remote processing of medications may help alleviate some of the strain as they grapple with staffing issues.”

Kaiser Permanente “believes that remote work by pharmacy personnel is a safe practice that allows for greater flexibility in managing our pharmacies’ operations. With the current waiver allowing hospitals to remotely process prescriptions expiring on May 28, 2023, this legislation is urgently needed. This bill allows for continued flexibility while still ensuring patient safety.”

SUPPORT AND OPPOSITION:

Support:

California State Board of Pharmacy (Sponsor)

California Hospital Association
California Medical Association
California Pharmacists Association
Cedars Sinai
Kaiser Permanente
Sonoma Valley Hospital
Stanford Health Care
Sutter Health
Tenet Healthcare Corporation

Opposition:

None received

-- END --

Date of Hearing: April 26, 2023

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Chris Holden, Chair

ABPCA Bill Id:AB 1557

Author:(Flora) – As Amended Ver:April 12, 2023

Urgency: Yes State Mandated Local Program: Yes Reimbursable: No

SUMMARY:

This bill authorizes a pharmacist located and licensed in the state, on behalf of a licensed hospital and from a location outside of the hospital, to verify medication chart orders for appropriateness. This bill is an urgency statute necessary because the waiver that currently allows remote processing expires on May 28, 2023, and this bill must take effect immediately hospitals are to continue to remotely process prescriptions.

FISCAL EFFECT:

Minor and absorbable costs to the Board of Pharmacy.

COMMENTS:

1. Purpose. The author states:

AB 1557 is an important bill that would make permanent the authority for a state licensed pharmacist to conduct medication reviews outside of a California licensed hospital. This measure ensures that hospital patients have 24-hour access to a pharmacist to perform vital medication chart order review to ensure safe medication use. Many rural hospitals do not have a pharmacist on site during all hours of operations, which could delay medication administration. Also, during patient surges and unanticipated employee leave, on-site pharmacists may be insufficient to perform all necessary services, including compounding preparations, medication therapy reviews, and other duties while also conducting timely reviews of medication orders. AB 1557’s straightforward approach ensures continuity of patient care while providing flexibility to hospitals in determining how best to manage medication reviews for patients.

1. Background. In response to the COVID-19 pandemic, the Board of Pharmacy issued a waiver of the Pharmacy Law, allowing the offsite verification of medication orders. The waiver implied offsite verification of medication orders was previously prohibited, although the prohibition was not explicit. The Board of Pharmacy is sponsoring this bill to clarify pharmacists’ authority to conduct medication reviews from outside the hospital. According to the Board of Pharmacy, many rural hospitals do not have pharmacists on premises 24 hours a day, meaning patients would not be able to receive medication until a pharmacist returned and performed the medication review. The Board of Pharmacy reports that, for larger hospitals, the number of medication orders that are remotely verified can number in the millions.
   
2. Prior Legislation. SB 1379 (Ochoa Bogh), of the 2021-22 Legislative Session, would have authorized a pharmacist working for a hospital pharmacy to perform order entry and other data entry, perform prospective drug utilization review, interpret clinical data, perform insurance processing, perform therapeutic interventions, provide drug information, authorize the release of medication for administration, and perform other clinical services on behalf of a hospital pharmacy under the written authorization of a pharmacist-in-charge. SB 1379 was referred to, but not heard in the Senate Committee on Business, Professions, and Economic Development.

Analysis Prepared by: Allegra Kim / APPR. / (916) 319-2081

Date of Hearing: April 11, 2023

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Marc Berman, Chair

ABPCA Bill Id:AB 1557

Author:(Flora) – As Amended Ver:March 13, 2023

SUBJECT: Pharmacy: electronic prescriptions.

SUMMARY: Authorizes a pharmacist located and licensed in the state to, on behalf of a licensed hospital, from a location outside of the hospital, verify medication chart orders for appropriateness.

EXISTING LAW:

1. Regulates the practice of pharmacy under the Pharmacy Law and establishes the California State Board of Pharmacy until January 1, 2026, to administer and enforce the act. (Business and Professions Code (BPC) §§ 4000-4427)
2. Defines an “order,” as authorization for the administration of the ordered drug from hospital stocks when entered on the chart or medical record for a patient in a hospital, as specified. (BPC § 4019)
3. Authorizes a prescriber, a prescriber’s authorized agent, or a pharmacist to electronically enter a prescription or hospital order into a pharmacy’s or hospital’s computer from any location outside of the pharmacy or hospital with the permission of the pharmacy or hospital except for prescriptions for controlled substances classified in Schedule II, III, IV, or V. (BPC § 4071.1)
4. Requires prescriptions for a controlled substance classified in Schedule II, and makes optional for Schedule III, IV, or V, to be made on a controlled substance prescription form established under state law signed and dated by the prescriber in ink, as specified. (HSC § 11164(a))
5. Authorizes any controlled substance classified in Schedule III, IV, or V to be dispensed upon an oral or electronically transmitted prescription that must be produced in hard copy form and signed and dated by the pharmacist filling the prescription or by any other authorized person. (HSC § 11164(b))
6. Requires a health care practitioner authorized to issue a prescription to have the capability to issue an electronic data transmission prescription on behalf of a patient and to transmit that electronic data transmission prescription to a pharmacy selected by the patient. (BPC § 688(a))
7. Requires a pharmacy, pharmacist, or other practitioner authorized to dispense or furnish a prescription to have the capability to receive an electronic data transmission prescription on behalf of a patient. (BPC § 688(b))

THIS BILL:

1. Deletes the limitation against electronically entering prescriptions for controlled substances classified in Schedule II, III, IV, or V.
2. Authorizes a pharmacist to remotely verify medication chart orders for appropriateness before administration, consistent with federal requirements, if the following are met:
   1. The pharmacist is located and licensed in the state.
   2. The verification is on behalf of a licensed healthcare facility, as established in the healthcare facility’s policies and procedures.
3. Requires a healthcare facility to maintain a record of a pharmacist’s verification of medication chart orders.
4. Requires the verification record to meet the same requirements as those for records of manufacture and of sale, acquisition, receipt, shipment, or disposition of dangerous drugs or dangerous devices and records for the acquisition and disposition of dangerous drugs and dangerous devices by any entity licensed by the board.

FISCAL EFFECT: Unknown. This bill is keyed fiscal by the Legislative Counsel.

COMMENTS:

Purpose. This bill is sponsored by the Board of Pharmacy. According to the author, “[This bill] is an important bill that would make permanent the authority for a state licensed pharmacist to conduct medication reviews outside of a California licensed hospital. This measure ensures that hospital patients have 24-hour access to a pharmacist to perform vital medication chart order review to ensure safe medication use. Many rural hospitals do not have a pharmacist on site during all hours of operations, which could delay medication administration. Also, during patient surges and unanticipated employee leave, on-site pharmacists may be insufficient to perform all necessary services, including compounding preparations, medication therapy reviews, and other duties while also conducting timely reviews of medication orders. [This bill’s] straightforward approach ensures continuity of patient care while providing flexibility to hospitals in determining how best to manage medication reviews for patients.”

Background. Pharmacists are healthcare professionals licensed to practice pharmacy, which includes dispensing prescription drugs, monitoring drug interactions, and counseling patients on the proper usage of drugs. They are also able to review medication orders from prescribers, checking for appropriateness before the medication is administered.

For hospitals participating in the federal Medicare and Medicaid programs, the Centers for Medicare and Medicaid Services (CMS) requires a pharmacist to review all non-emergency patient care orders before administration to a patient.

The State Operations Manual specifies that hospitals must have a process for reviewing all medication orders, except in emergencies, for appropriateness by a pharmacist before the first dose is dispensed. The hospitals must also have a process for resolving questions with the prescribing practitioner and documenting the discussion and outcome in the patient’s medical record or pharmacy copy of the prescriber’s order.

The review is encouraged to include:

• Therapeutic appropriateness of a patient’s medication regimen.
• Therapeutic duplication in the patient’s medication regimen.
• Appropriateness of the drug, dose, frequency, and route of administration.
• Real or potential medication-medication, medication-food, medication-laboratory test, and medication-disease interactions.
• Real or potential allergies or sensitivities.
• Other contraindications.

Remote Verification of Medication Orders. The Pharmacy Law does not explicitly require a pharmacist performing verification of medication orders to do so onsite. As such, the Board of Pharmacy has never taken action against a pharmacist that has verified medication orders from an offsite location.

However, in response to the COVID-19 pandemic, the Board of Pharmacy issued a waiver of the Pharmacy Law allowing the offsite verification of medication orders. The implication of the waiver is that the offsite verification of medication orders was previously prohibited. According to the board’s waiver, existing law authorizes “a pharmacist to enter a prescription or an order into a pharmacy’s or hospital’s computer from any location outside of a pharmacy or hospital, under specified conditions…. [but it] does not permit a pharmacist to perform other steps in the dispensing process.”

Based on this new interpretation, the use of offsite or remote verification violates the Pharmacy law. As a result, the Board of Pharmacy is sponsoring this bill to avoid severe disruptions in the continuity of care in hospitals. According to the board, many rural hospitals do not have pharmacists on premises 24 hours a day, meaning patients would not be able to receive medication until a pharmacist returned and performed the medication review. For larger hospitals, the number of medication orders that are remotely verified can number in the millions.

The Board of Pharmacy’s waiver ends May 28, 2023. This bill would clarify that pharmacists are authorized to verify medication orders remotely, allowing the use of offsite medication order verifications indefinitely.

Electronic Entering of Schedule II, III, IV, or V Prescriptions or Orders. Existing law authorizes the electronic entering of prescriptions except for Schedule II, III, IV, or V drugs. This bill would delete the exemption for scheduled drugs. Under AB 2789 (Wood), Chapter 438, Statutes of 2018, beginning January 1, 2022, all prescriptions issued by a licensed healthcare practitioner to a California pharmacy must be submitted electronically.

Prior Related Legislation. SB 1379 (Ochoa Bogh) of 2022, which died pending a hearing in the Senate Committee on Business, Professions and Economic Development, would have authorized a pharmacist working for a hospital pharmacy to perform order entry and other data entry, perform prospective drug utilization review, interpret clinical data, perform insurance processing, perform therapeutic interventions, provide drug information, authorize the release of medication for administration, and perform other clinical services on behalf of a hospital pharmacy located in California and under the written authorization of a pharmacist-in-charge.

ARGUMENTS IN SUPPORT:

The Board of Pharmacy (sponsor) writes in support “that not all health care facilities have 24-hour onsite pharmacist services, most notably in many rural areas. In response to the COVID-19 public health emergency, the Board issued a waiver that included provisions to allow for remote medication chart order review and believes such reviews have been performed appropriately and safely in the best interest of patients. [This bill] makes permanent this authority. The Board believes the permanent authority sought in this measure is in the best interest of Californians as it provides health care facilities flexibility in meeting federal requirements and ensuring continuity of patient care. Permanent authority for pharmacists to perform medication chart order reviews as specified in the bill is both appropriate and necessary to ensure patients have ready access to pharmacist care, even when a pharmacist is not on site or available to complete such reviews.”

The California Hospital Association writes in support:

The Centers for Medicare & Medicaid Services requires a pharmacist review of all non-emergency medication orders prior to administration to patients. However, many rural hospitals do not have a pharmacist on site during all hours of operations, which could delay medication administration.

Also, during patient surges and unanticipated employee leave, on-site pharmacists may be insufficient to perform all necessary services, including compounding preparations, medication therapy reviews, and other duties while also conducting timely reviews of medication orders. Advancements in technology over the last few decades — along with waivers provided by the state Board of Pharmacy due to the COVID-19 pandemic — have enabled hospital pharmacists to remotely review and process medications and today millions of new orders are reviewed and processed off site prior to patient administration.

The waiver that allows hospitals to remotely process prescriptions is set to expire on May 28, 2023, and the passage of [this bill] is urgently needed so hospitals can continue to use this proven and safe practice. The flexibility permitted under [this bill] would help ensure that every new non-emergency medication for patients in California hospitals has been carefully reviewed by a pharmacist.

ARGUMENTS IN OPPOSITION:

None on file

AMENDMENTS:

The author has requested that an urgency clause be added to the bill:

On page 3, below line 15, insert:

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:

The waiver that currently allows for remote processing expires on May 28, 2023. It is necessary that this act take effect immediately to ensure that hospitals can continue to remotely process prescriptions.

REGISTERED SUPPORT:

California State Board of Pharmacy (sponsor)

California Hospital Association

California Medical Association

California Pharmacists Association

Cedars Sinai

Kaiser Permanente

Sonoma Valley Hospital

Stanford Health Care

Sutter Health

Tenet Healthcare Corporation

REGISTERED OPPOSITION:

None on file

Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301