Existing law establishes the State Department of Health Care Services within the California Health and Human Services Agency. The Naloxone Distribution Project (NDP) is administratively created by the department to reduce opioid-related overdose deaths by providing free naloxone hydrochloride to eligible entities.

This bill would require the department to conduct outreach to each of the tribal governments in California for the purpose of advising them of the availability of naloxone hydrochloride or another opioid antagonist through the NDP. The bill would require the department to provide technical assistance to the tribal entities applying for naloxone kits through the NDP if requested to do so by the tribal government. The bill would require the department to report to the Legislature and to the Assembly and Senate Health Committees, the results of the outreach program, as specified, annually on or before March 31 of each year, beginning on March 31, 2025. The bill would repeal these provisions on March 31, 2027.

Existing law establishes the State Department of Health Care Services within the California Health and Human Services Agency. The Naloxone Distribution Project (NDP) is administratively created by the department to reduce opioid-related overdose deaths by providing free naloxone hydrochloride to eligible entities.

This bill would require the department to conduct outreach to each of the tribal governments in California for the purpose of advising them of the availability of naloxone hydrochloride or another opioid antagonist through the NDP. The bill would require the department to provide technical assistance to the tribal entities applying for naloxone kits through the NDP if requested to do so by the tribal government. The bill would require the department to report to the Legislature and to the Assembly and Senate Health Committees, the results of the outreach program, as specified, annually on or before March 31 of each year, beginning on March 31, 2025. The bill would repeal these provisions on March 31, 2027.

Existing law, as added by the Substance Abuse and Crime Prevention Act of 2000, adopted by voters as Proposition 36 at the November 7, 2000, statewide general election, requires that persons convicted of certain nonviolent drug possession offenses be granted probation and participate in and complete an appropriate drug treatment program as a condition of that probation.

Existing law, inoperative on July 1, 2013, requires the State Department of Alcohol and Drug Programs to administer and award grants to counties, based on an approved plan, to supplement funding provided under the above-described act for the purpose of funding substance abuse testing for eligible offenders.

This bill would make technical, nonsubstantive changes to one of those provisions.

 THIRD READING  

Bill No: AB 1233

Author: Waldron (R)

Amended: 3/23/23 in Assembly

Vote: 21

SENATE HEALTH COMMITTEE: 12-0, 6/7/23

AYES: Eggman, Nguyen, Glazer, Gonzalez, Grove, Hurtado, Limón, Menjivar, Roth, Rubio, Wahab, Wiener

SENATE APPROPRIATIONS COMMITTEE: 7-0, 9/1/23

AYES: Portantino, Jones, Ashby, Bradford, Seyarto, Wahab, Wiener

ASSEMBLY FLOOR: 79-0, 4/27/23 (Consent) - See last page for vote

SUBJECT: Substance abuse: Naloxone Distribution Project: tribal governments

SOURCE: Author

DIGEST:

This bill requires the Department of Health Care Services (DHCS), until March 31, 2027, to conduct outreach and provide technical assistance to tribal governments, as specified, regarding the Naloxone Distribution Project; and requires DHCS to report specified information to the Legislature.

ANALYSIS: Existing law authorizes licensed health care providers to issue a standing order for the distribution or the administration of naloxone or any other opioid antagonist that is approved by the United States Food and Drug Administration (FDA) for the treatment of an opioid overdose to a person at risk of overdose, or family members, friends, or other persons in a position to assist a person at risk of an opioid-related overdose. Requires a person who is prescribed or possesses naloxone or any other opioid antagonist pursuant to a standing order to receive training, as specified. [CIV §1714.22, et seq.]

This bill:

1. Requires DHCS to conduct outreach to each of the tribal governments in California to advise them of the availability of naloxone or another opioid antagonist through the Naloxone Distribution Project (NDP). Requires DHCS to provide technical assistance on the application process for the NDP if requested by a tribal government.
2. Requires DHCS to report to the Legislature and Assembly and Senate Health Committees the results of the outreach efforts annually, beginning on March 31, 2025. Requires the report to include:
3. The tribes that participated in the NDP as a result of DHCS’s outreach;
4. The number of applicants that participated in the NDP as a result of DHCS’s outreach; and,
5. The effectiveness of the outreach and the NDP in lowering both opioid overdoses and deaths within the Native-American community.
6. Sunsets this bill on March 31, 2027.

Comments

1. Author’s statement. According to the author, this bill aims to support tribal communities dealing with substance abuse by aiding them in accessing medical supplies effectively. Additionally, this bill acknowledges the significance of empowering tribal governments to make decisions that align with the unique needs of their respective communities. This bill requires the DHCS to provide technical assistance and crucial outreach to those tribal entities applying for naloxone kits through the NDP if requested to do so by a tribal government. This bill would help the Native American community that has been vulnerable and underserved since the European settlers arrived.
2. Naloxone. According to the U.S. Surgeon General, naloxone is an opioid antagonist that is used to temporarily reverse the effects of an opioid overdose, namely slowed or stopped breathing. Expanding the awareness and availability of this medication is a key part of the public health response to the opioid epidemic. Naloxone is a safe antidote to a suspected overdose and, when given in time, can save a life. Research shows that when naloxone and overdose education are available to community members, overdose deaths decrease in those communities. Therefore, increasing the availability and targeted distribution of naloxone is a critical component of our efforts to reduce opioid-related overdose deaths and, when combined with the availability of effective treatment, to ending the opioid epidemic. In most states, including California, people who are or who know someone at risk for opioid overdose can go to a pharmacy or community-based program, to get trained on naloxone administration, and receive naloxone by “standing order,” i.e., without a patient-specific prescription. Most states have laws designed to protect health care professionals for prescribing and dispensing naloxone from civil and criminal liabilities, as well as Good Samaritan laws to protect people who administer naloxone or call for help during an opioid overdose emergency. Naloxone is used by police officers, emergency medical technicians, and non-emergency first responders to reverse opioid overdoses. There are two FDA-approved naloxone products for community use that are available by prescription, but too few community members are aware of the important role they can play to save lives. The U.S. Surgeon General advises patients and the public to talk with their doctor or pharmacist about obtaining naloxone; learn the signs of opioid overdose, like pinpoint pupils, slowed breathing or loss of consciousness; and, get trained to administer naloxone in the case of a suspected emergency.
3. Statewide standing order for naloxone distribution. CDPH issued a statewide standing order for naloxone in June 2018. The order allows organizations and entities, including K-12 schools, colleges, and universities, to distribute naloxone to a person who is at risk of experiencing an overdose or an individual in a position to assist an at-risk person. Staff of community organizations and other entities distributing naloxone under the statewide standing order are required to receive training, and are also required to provide training to individuals who receive naloxone from them. Organizations may apply to use the statewide standing order and meet certain terms and conditions. A separate distribution program administered through DHCS makes use of the statewide standing order and allows various entities to apply for and obtain naloxone at no cost.
4. NDP. The NDP aims to reduce opioid overdose deaths through the provision of free naloxone. Entities can apply to DHCS to have naloxone shipped directly to their address. Eligible entities include:
5. Law enforcement such as police departments, county jails, and probation;
6. Fire, emergency medical services (EMS), and first responders;
7. Schools and universities;
8. County public health and behavioral health departments; and,
9. Community organizations, such as harm reduction organizations or community opioid coalitions.

Since it began in October 2018, the NDP has distributed more than 2.2 million kits of naloxone, which have been used to reverse more than 140,000 overdoses. The NDP receives State General Funds and opioid settlement funds from the Janssen and Distributors (J&D) Settlement Agreements.

1. Recent FDA approval. On March 29, 2023, the U.S. Food and Drug Administration (FDA) approved four-milligram naloxone nasal spray for over-the-counter (OTC), nonprescription, use—the first naloxone product approved for use without a prescription. This action, according to the FDA, paves the way for the life-saving medication to reverse an opioid overdose to be sold directly to consumers in places like drug stores, convenience stores, grocery stores, and gas stations, as well as online. The timeline for availability and price of this OTC product is determined by the manufacturer. The FDA will work with all stakeholders to help facilitate the continued availability of naloxone nasal spray products during the time needed to implement the switch from prescription to OTC status, which may take months. Other formulations and dosages of naloxone will remain available by prescription only. In its November 15, 2022, announcement related to the preliminary assessment for the OTC approval, the FDA specified it was assessing whether certain naloxone drug products—up to four milligrams nasal spray and up to two milligrams autoinjector for intramuscular or subcutaneous use—would be approved as safe and effective for nonprescription use.

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

According to the Senate Appropriations Committee, DHCS estimates costs to perform the outreach and reporting activities to be $314,000 in 2024-25 and $296,000 in 2025-26 and ongoing (General Fund and federal funds).

SUPPORT: (Verified 8/22/23)

California Tribal Business Alliance

County Behavioral Health Directors Association of California

Sister Warriors Freedom Coalition

OPPOSITION: (Verified 8/22/23)

None received

ARGUMENTS IN SUPPORT: The Sister Warriors Freedom Coalition states that American Indians and Alaskan Natives make up approximately 2% of the California population, but nationally this group has the highest opioid-related death rates. This bill would provide California’s tribal governments with the resources and education they need in order to help prevent opioid-related deaths in their community. Sister Warriors states that this bill helps ensure tribal communities that are struggling with drug misuse are able to apply to obtain medical supplies that will help save lives while simultaneously recognizing the importance of letting the tribal governments work independently in the interest of their communities. As we are in the midst of an opioid epidemic, it is imperative that these life-saving medications are available to one of our most vulnerable communities.

ASSEMBLY FLOOR: 79-0, 4/27/23

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, Flora, 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, McKinnor, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, 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, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Rendon

NO VOTE RECORDED: Jim Patterson

Prepared by: Reyes Diaz / HEALTH / (916) 651-4111

9/2/23 12:11:13

**** END ****

SENATE COMMITTEE ON

Senator Anthony Portantino, Chair

2023 - 2024 Regular Session

AB 1233 (Waldron) - Substance abuse: Naloxone Distribution Project: tribal governments

Bill Summary:

AB 1233 would require the Department of Health Care Services (DHCS) to conduct outreach and provide technical assistance to tribal governments, as specified, regarding the Naloxone Distribution Project.

Fiscal Impact:

DHCS estimates costs to perform the outreach and reporting activities to be $314,000 in 2024-25 and $296,000 in 2025-26 and ongoing (General Fund and federal funds).

Background:

According to the U.S. Surgeon General, naloxone is an opioid antagonist that is used to temporarily reverse the effects of an opioid overdose, namely slowed or stopped breathing. The California Department of Public Health issued a statewide standing order for naloxone in June 2018. The order allows organizations and entities, including k-12 schools, colleges, and universities, to distribute naloxone to a person who is at risk of experiencing an overdose or an individual in a position to assist an at-risk person. Staff of community organizations and other entities distributing naloxone under the statewide standing order are required to receive training, and are also required to provide training to individuals who receive naloxone from them. Organizations may apply to use the statewide standing order and meet certain terms and conditions.

The Naloxone Distribution Project (NDP), administered by DHCS, aims to reduce opioid overdose deaths through the provision of free naloxone. Entities can apply to DHCS to have naloxone shipped directly to their address. Eligible entities include:

a) Law enforcement such as police departments, county jails, and probation;

b) Fire, emergency medical services (EMS), and first responders;

c) Schools and universities;

d) County public health and behavioral health departments; and,

e) Community organizations, such as harm reduction organizations or community opioid coalitions.

Proposed Law:

Specific provisions of the bill would:

• Require DHCS to conduct outreach to each of the tribal governments in California to advise them of the availability of naloxone or another opioid antagonist through the NDP.
• Require DHCS to provide technical assistance on the application process for the NDP if requested by a tribal government.
• Require DHCS to report to the Legislature and Assembly and Senate Health Committees the results of the outreach efforts annually, beginning on March 31, 2025.
• Sunset the bill on March 31, 2027.

-- END --

SENATE COMMITTEE ON HEALTH

Senator Dr. Susan Talamantes Eggman, Chair

BILL NO: AB 1233

SUBJECT: Substance abuse: Naloxone Distribution Project: tribal governments

SUMMARY:

Requires the Department of Health Care Services (DHCS), until March 31, 2027, to conduct outreach and provide technical assistance to tribal governments, as specified, regarding the Naloxone Distribution Project. Requires DHCS to report specified information to the Legislature.

Existing law: Authorizes licensed health care providers to issue a standing order for the distribution or the administration of naloxone or any other opioid antagonist that is approved by the United States Food and Drug Administration (FDA) for the treatment of an opioid overdose to a person at risk of overdose, or family members, friends, or other persons in a position to assist a person at risk of an opioid-related overdose. Requires a person who is prescribed or possesses naloxone or any other opioid antagonist pursuant to a standing order to receive training, as specified. [CIV §1714.22, et seq.]

This bill:

1. Requires the Department of Health Care Services (DHCS) to conduct outreach to each of the tribal governments in California to advise them of the availability of naloxone or another opioid antagonist through the Naloxone Distribution Project (NDP). Requires DHCS to provide technical assistance on the application process for the NDP if requested by a tribal government.
2. Requires DHCS to report to the Legislature and Assembly and Senate Health Committees the results of the outreach efforts annually, beginning on March 31, 2025. Requires the report to include:
3. The tribes that participated in the NDP as a result of DHCS’s outreach;
4. The number of applicants that participated in the NDP as a result of DHCS’s outreach; and,
5. The effectiveness of the outreach and the NDP in lowering both opioid overdoses and deaths within the Native-American community.
6. Sunsets this bill on March 31, 2027.

FISCAL EFFECT:

According to the Assembly Appropriations Committee, costs to DHCS are unknown, but expected to be less than $30,000 per year (General Fund and opioid settlement funds). According to the California Tribal Court-State Court Forum, there are approximately 110 federally recognized tribes and 81 groups seeking federal recognition in California. Because NDP already reports program data on the California Medication-Assisted Treatment Expansion Project website, the requirement to annually report data to the Legislature is not expected to add significant cost.

PRIOR VOTES:

COMMENTS:

1. Author’s statement. According to the author, this bill aims to support tribal communities dealing with substance abuse by aiding them in accessing medical supplies effectively. Additionally, this bill acknowledges the significance of empowering tribal governments to make decisions that align with the unique needs of their respective communities. This bill requires the DHCS to provide technical assistance and crucial outreach to those tribal entities applying for naloxone kits through the NDP if requested to do so by a tribal government. This bill would help the Native American community that has been vulnerable and underserved since the European settlers arrived.
2. Naloxone. According to the U.S. Surgeon General, naloxone is an opioid antagonist that is used to temporarily reverse the effects of an opioid overdose, namely slowed or stopped breathing. Expanding the awareness and availability of this medication is a key part of the public health response to the opioid epidemic. Naloxone is a safe antidote to a suspected overdose and, when given in time, can save a life. Research shows that when naloxone and overdose education are available to community members, overdose deaths decrease in those communities. Therefore, increasing the availability and targeted distribution of naloxone is a critical component of our efforts to reduce opioid-related overdose deaths and, when combined with the availability of effective treatment, to ending the opioid epidemic. In most states, including California, people who are or who know someone at risk for opioid overdose can go to a pharmacy or community-based program, to get trained on naloxone administration, and receive naloxone by “standing order,” i.e., without a patient-specific prescription. Most states have laws designed to protect health care professionals for prescribing and dispensing naloxone from civil and criminal liabilities, as well as Good Samaritan laws to protect people who administer naloxone or call for help during an opioid overdose emergency. Naloxone is used by police officers, emergency medical technicians, and non-emergency first responders to reverse opioid overdoses. There are two FDA-approved naloxone products for community use that are available by prescription, but too few community members are aware of the important role they can play to save lives. The U.S. Surgeon General advises patients and the public to talk with their doctor or pharmacist about obtaining naloxone; learn the signs of opioid overdose, like pinpoint pupils, slowed breathing or loss of consciousness; and, get trained to administer naloxone in the case of a suspected emergency.
3. Statewide standing order for naloxone distribution. CDPH issued a statewide standing order for naloxone in June 2018. The order allows organizations and entities, including K-12 schools, colleges, and universities, to distribute naloxone to a person who is at risk of experiencing an overdose or an individual in a position to assist an at-risk person. Staff of community organizations and other entities distributing naloxone under the statewide standing order are required to receive training, and are also required to provide training to individuals who receive naloxone from them. Organizations may apply to use the statewide standing order and meet certain terms and conditions. A separate distribution program administered through DHCS makes use of the statewide standing order and allows various entities to apply for and obtain naloxone at no cost.
4. NDP. The NDP aims to reduce opioid overdose deaths through the provision of free naloxone. Entities can apply to DHCS to have naloxone shipped directly to their address. Eligible entities include:
5. Law enforcement such as police departments, county jails, and probation;
6. Fire, emergency medical services (EMS), and first responders;
7. Schools and universities;
8. County public health and behavioral health departments; and,
9. Community organizations, such as harm reduction organizations or community opioid coalitions.

Since it began in October 2018, the NDP has distributed more than 2.2 million kits of naloxone, which have been used to reverse more than 140,000 overdoses. The NDP receives State General Funds and opioid settlement funds from the Janssen and Distributors (J&D) Settlement Agreements.

1. Recent FDA approval. On March 29, 2023, the U.S. Food and Drug Administration (FDA) approved four-milligram naloxone nasal spray for over-the-counter (OTC), nonprescription, use—the first naloxone product approved for use without a prescription. This action, according to the FDA, paves the way for the life-saving medication to reverse an opioid overdose to be sold directly to consumers in places like drug stores, convenience stores, grocery stores, and gas stations, as well as online. The timeline for availability and price of this OTC product is determined by the manufacturer. The FDA will work with all stakeholders to help facilitate the continued availability of naloxone nasal spray products during the time needed to implement the switch from prescription to OTC status, which may take months. Other formulations and dosages of naloxone will remain available by prescription only. In its November 15, 2022, announcement related to the preliminary assessment for the OTC approval, the FDA specified it was assessing whether certain naloxone drug products—up to four milligrams nasal spray and up to two milligrams autoinjector for intramuscular or subcutaneous use—would be approved as safe and effective for nonprescription use.
2. Related legislation. SB 234 (Portantino, Hurtado, and Umberg) requires schools, college campuses, stadiums, concert venues, and amusement parks to, at all times, maintain unexpired doses of naloxone hydrochloride or any other opioid antagonist. Requires these entities to ensure that at least two employees are aware of the location of the naloxone or other opioid antagonist. SB 234 is pending in the Assembly.

SB 472 (Hurtado) requires each individual public school operated by a school district, county office of education, or charter school to maintain at least two doses of naloxone or another opioid antagonist on its campus. SB 472 was held on the Senate Appropriations Committee suspense file.

SB 641 (Roth) requires DHCS to make all approved formulations and dosage strengths of naloxone or any other FDA-approve opioid antagonist that are indicated for the emergency treatment of known or suspected opioid overdose available through the NDP. SB 641 is pending in the Assembly.

AB 24 (Haney) requires a person or entity that owns, manages, or is responsible for a bar, gas station, public library, or single-room occupancy hotel in a county that is experiencing an opioid overdose crisis to acquire and post an opioid antagonist kit in areas that are readily accessible only by employees, including, but not limited to, a break room, and to restock the opioid antagonist kit after each use. AB 24 was held on the Assembly Appropriations Committee suspense file.

1. Prior legislation. SB 367 (Hurtado, Chapter 218, Statutes of 2022), requires each community college and California State University campus, and requests University of California campuses with on-campus health centers, to distribute opioid overdose reversal medication in accordance with the statewide standing order issued by the State Public Health Officer and to participate in the NPD.
2. Support. The Sister Warriors Freedom Coalition states that American Indians and Alaskan Natives make up approximately 2% of the California population, but nationally this group has the highest opioid-related death rates. This bill would provide California’s tribal governments with the resources and education they need in order to help prevent opioid-related deaths in their community. Sister Warriors states that this bill helps ensure tribal communities that are struggling with drug misuse are able to apply to obtain medical supplies that will help save lives while simultaneously recognizing the importance of letting the tribal governments work independently in the interest of their communities. As we are in the midst of an opioid epidemic, it is imperative that these life-saving medications are available to one of our most vulnerable communities.

SUPPORT AND OPPOSITION:

Support: County Behavioral Health Directors Association of California

Sister Warriors Freedom Coalition

Oppose: None received

-- END --

Date of Hearing: April 19, 2023

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Chris Holden, Chair

ABPCA Bill Id:AB 1233

Author:(Waldron) – As Amended Ver:March 23, 2023

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

SUMMARY:

This bill requires the Department of Health Care Services (DHCS) to conduct an outreach program to each of the tribal governments in California for the purpose of advising them of the availability of naloxone hydrochloride or another opioid antagonist through DHCS’ Naloxone Distribution Project (NDP), and to provide technical assistance if requested. This bill also requires DHCS to annually report specified data to the Legislature and repeals its provisions on March 31, 2027.

FISCAL EFFECT:

Costs to DHCS are unknown, but expected to be less than $30,000 per year (General Fund and opioid settlement funds).

According to the California Tribal Court-State Court Forum, there are approximately 110 federally recognized tribes and 81 groups seeking federal recognition in California.
Because NDP already reports program data on the California MAT [medication-assisted treatment] Expansion Project website, the requirement to annually report data to the Legislature is not expected to add significant cost.

COMMENTS:

1. Purpose. According to the author:

The fentanyl epidemic that is sweeping our beautiful state is unfortunately no stranger to tribal lands. We have seen a push for opioid antigens in schools, libraries, and other public places, but sadly, Native American reservations have been left out. It is important we ensure that communities struggling with drug misuse are able to properly apply for and obtain medical supplies while also recognizing the importance of letting individual tribal governments do what is best for their tribes.

1. California Tribal Communities. There are approximately 110 federally recognized American Indian/Alaska Native (AI/AN) tribes in California and 81 non-federally recognized tribes petitioning for federal recognition through the Bureau of Indian Affairs. Tribes in California currently have nearly 100 separate reservations or Rancherias.
2. Opioid Overdoses/Overdose Deaths among AI/AN. AI/AN are more likely to die from an overdose of opioids, including prescription painkillers and heroin, than are members of other groups in the US. In 2022, the Journal of the American Medical Association reported that drug overdose mortality had increased from 2018 through the COVID-19 pandemic for almost all groups examined, with increases primarily attributed to fentanyl and fentanyl analogs, and methamphetamine. By March to August 2021, the highest drug overdose death rates were among AI/AN men age 15 to 34 years and Black and AI/AN men age 35 to 64 years. Abuse of opioid prescription pain relievers has widespread effects throughout AI/AN communities, including overdose, overdose death, opioid use disorder, and neonatal abstinence syndrome (a postnatal drug withdrawal syndrome that may result in lower weight and higher mortality rates, and require pharmacotherapy to mitigate withdrawal).
3. NDP. Established in October 2018, the NDP aims to reduce opioid overdose deaths through the provision of free naloxone in nasal spray and intramuscular formulations. The NDP is funded by state the General Fund, Opioid Settlement Funds, and federal grants and is administered by DHCS. Eligible entities, including law enforcement agencies, emergency medical services, schools and universities, county public health and behavioral health departments, tribal agencies, and community organizations, apply to DHCS to have naloxone shipped directly to their addresses.
   
   As of April 5, 2023, the NDP had approved 7,532 applications, distributed more than 2.27 million naloxone kits, and reported more than 143,000 opioid overdose reversals. Of the 7,389 applications, 11% were from the “Other” category of organizations that would include tribal governments. Of the 96,588 naloxone kits distributed to “Other” organizations, 14% were distributed to tribal entities.
   
4. Related Legislation.
   1. AB 24 (Haney) requires a person or entity that owns, manages, or is responsible for a designated facilitys such as a bar, gas station, public library, residential hotel, in a county that is experiencing an opioid overdose crisis, to acquire and post an opioid antagonist kit. AB 24 is pending in this committee.
   2. AB 33 (Bains) establishes the Fentanyl Addiction and Overdose Prevention Task Force to collect and organize data on fentanyl abuse in California and evaluate approaches to increase public awareness. AB 33 is pending in Assembly Public Safety Committee.
   3. SB 10 (Cortese) requires local educational agencies and county offices of education to include strategies for the prevention and treatment of an opioid overdose in school safety plans, and requires the California Department of Education to develop training materials for school personnel, parents and guardians, and pupils. SB 10 is pending in Senate Health Committee.
   4. SB 641 (Roth) requires DHCS, as part of the NDP, to make all FDA-approved formulations and dosage strengths of naloxone that are indicated for the emergency treatment of opioid overdose available to NDP applicants. SB 641 is pending in Senate Health Committee.

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

Date of Hearing: March 28, 2023

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 1233

Author:(Waldron) – As Amended Ver:March 23, 2023

SUBJECT: Substance abuse: Naloxone Distribution Project: tribal governments.

SUMMARY: Requires the Department of Health Care Services (DHCS) to conduct an outreach program to each of the tribal governments in California for the purpose of advising them of the availability of naloxone hydrochloride or another opioid antagonist through the DHCS’ Naloxone Distribution Project (NDP). Requires DHCS to also provide technical assistance, if requested by the tribal government, to those tribal entities applying for naloxone kits through the NDP. Requires, beginning March 31, 2025, DHCS to report annually specified data to the Legislature and to the Assembly and Senate Health Committees on the results of the outreach program on or before March 31 of each year. Sunsets the provisions of this bill on March 31, 2027.

EXISTING LAW:

1. Grants DHCS the sole authority in state government to administer, license, certify, and regulate all substance use disorder (SUD) functions and programs. [Health and Safety Code (HSC) §11750, et seq.]
2. Classifies controlled substances under the California Uniform Controlled Substances Act, into five schedules and places the greatest restrictions and penalties on the use of those substances placed in Schedule I. Classifies the drug fentanyl in Schedule II. [HSC §11054-11058]
   
3. Permits a pharmacy to furnish naloxone hydrochloride or another opioid antagonist to a school district, county office of education, or charter school pursuant to existing law if certain requirements are met. [ Business and Professions Code (BPC) § 49414.3]
4. Establishes within the California Health and Human Services Agency (CHHSA) a grant program to reduce fentanyl overdoses and use throughout the state by providing six one-time grants: two in northern California, two in the central valley, and two in southern California. [Welfare and Institutions Code §3200]
5. Authorizes a pharmacy, wholesaler, or manufacturer to furnish naloxone hydrochloride or other opioid antagonists to a law enforcement agency if specified conditions are met. [BPC §4119.9]
6. Authorizes the State Department of Public Health (DPH), in order to reduce the rate of fatal overdose from opioid drugs including heroin and prescription opioids, to award funding to local health departments, local government agencies, or on a competitive basis to community-based organizations, regional opioid prevention coalitions, or both, to support or establish programs that provide naloxone, or any other opioid antagonist that is approved by the United States Food and Drug Administration (FDA) for the treatment of an opioid overdose, to first responders and to at-risk opioid users through programs that serve at-risk drug users, including, but not limited to, syringe exchange and disposal programs, homeless programs, and substance use disorder treatment providers. [HSC §1179.80]

FISCAL EFFECT: Unknown. This bill has not yet been analyzed by a fiscal committee.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, the fentanyl epidemic that is sweeping California is unfortunately no stranger to tribal lands. There is increased pressure to provide for opioid antigens in schools, libraries, and other public places, but sadly, Native American reservations have been left out. The author concludes, it is important we ensure that communities struggling with drug misuse are able to properly apply for and obtain medical supplies while also recognizing the importance of letting individual tribal governments do what is best for their tribes.
2. BACKGROUND.
   1. California Tribal Communities. According to the 2020 Census data, California is home to more people of American Indian/Alaska Native (AI/AN) heritage than any other state in the country. There are currently 109 federally recognized AI/AN tribes in California and several non-federally recognized tribes petitioning for federal recognition through the Bureau of Indian Affairs-Office of Federal Recognition. Tribes in California currently have nearly 100 separate reservations or Rancherias. There are also a number of individual Indian trust allotments. These lands constitute “Indian Country” and different jurisdictional laws and requirements apply in Indian Country. There are also about 45 tribal communities of formerly recognized tribes that were terminated as part of the United States’ termination policy in the 1950s or tribal communities that were never recognized by the federal government. According to the 2020 Census, more than 630,000 people who identify as AI/AN live in California, a nearly 74% increase from the official figure reported a decade ago. When considered more broadly to include AI/AN in combination with another race, that number grows to about 1.4 million people: a 94.9% increase since 2010. This second, broader group now makes up 3.6% of all Californians, in comparison to 1.9% 10 years ago.
   2. Opioid Overdoses/Overdose Deaths among AI/AN. AI/AN communities in the US have been hit especially hard by opioid use disorder (OUD) and its consequences. AI/AN are more likely to die from an overdose of opioids, including prescription painkillers and heroin, than other groups in the US. Overdose deaths due to opioid abuse have increased among AI/AN since 2000. Overdose deaths involving opioids among the AI/AN population have increased by 191% since 2010. As of 2020, the number of overdose deaths among these communities is 27.4 per 100,000. 
      
      In September of 2022, the Journal of the American Medical Association’s “Network Open” reported that drug overdose mortality had increased from March to August 2018 through the COVID-19 pandemic for almost all groups examined, with increases primarily attributed to fentanyl/analogs and methamphetamine. By March to August 2021, across sexes, the highest drug overdose death rates were among AI/AN men aged 15 to 34 years and Black and AI/AN men aged 35 to 64 years. Within every age, racial, and ethnic group, rates were higher in men, and the highest drug overdose death rates were among AI/NA
      
      Historical trauma, poverty, and violence are some of the main factors contributing to the increased risk of addiction among AI/AN. While in the US, about 4.6% of non-natives die of a prescription opioid overdose; the rate among AI/AN is 50% higher. More than 2 million people in the United States are estimated to have a SUD related to prescription opioids or heroin at any time, according to the Substance Abuse and Mental Health Services’ Administration 2016 National Survey on Drug Use and Health. However, this rate is even higher for those who live on reservations or other tribal lands: about 10% of adults living on reservations were diagnosed with OUD. Additionally, substance dependence is higher among AI/AN than any other group in the country

The Tribal Epidemiology Center in October of 2018, in a paper entitled, “The Opioid Epidemic in Indian Country – What Tribal Leaders in Arizona Need to Know” reported that nationally, abuse of opioid prescription pain relievers has widespread effects throughout AI/AN communities including drug poisoning (i.e. overdose), overdose death, OUD, and infants born with Neonatal Abstinence Syndrome (a postnatal drug withdrawal syndrome found in newborns that results from invitro exposure to opioids or other substances wherein chronic exposure may result in lower birth weights, higher mortality rates and require pharmacotherapy to mitigate withdrawal).

Nationally, every year between 2008 and 2015, AI/AN residing in metropolitan and non-metropolitan areas had the highest drug overdose death rates per 100,000 persons compared to other groups. Among AI/AN, overdose deaths involving opioids increased from 1999 to 2016. The age-adjusted rate of opioid related overdose deaths in 2016 was more than four times the rate in 1999 (2.9 per 100,000 in 1999 vs. 13.9 in 2016). According to the 2016 National Survey of Drug Use and Health, 4.1% (63,000) of AI/AN aged 12 or older reported misuse of opioids in the past year (similar to the national average). Additionally, 1.4% (22,000) of AI/AN aged 12 or older reported misuse of opioids in the past month (similar to the national average). Of concern are the 1.7% (3,000) of AI/AN aged 12 to 17 who misused opioids in the past month – this is almost double the national average of 1.0%.

• 1. NDP. Established in October of 2018, the NDP aims to reduce opioid overdose deaths through the provision of free naloxone in nasal spray and intramuscular formulations. The NDP is funded by State General Funds, Opioid Settlement Funds, and federal grants and is administered by DHCS. Entities apply to DHCS to have naloxone shipped directly to their address. Eligible entities under the NDP include law enforcement agencies such as police departments, county jails and probation departments; fire, emergency medical services, and first responders; schools and universities, county public health and behavioral health departments; tribal agencies, harm reduction organizations; and, community organizations such as local opioid coalitions.
     
     As of March 6, 2023, the NDP had approved more than 72,000 applications; distributed more than 2.1 million naloxone kits; and had reported opioid overdose reversals of more than 137,000. Of the 7,200 applications, only 11%, or 792, were from the “Other” category of organizations that tribal governments would fall under. Of the 94,260 naloxone kits distributed to the 792 “Other” organizations, 14%, or 13,196, kits were distributed to tribal entities.
     
     The NDP application process requires applicants to agree to the following terms and conditions:
     1. Certify that the authorized person, communication, and mailing information is correct;
     2. Ensure that any of its affiliates or subcontractors apply for their organization;
     3. Agrees to provide a copy of a valid and active business license, Federal Employer ID Number or tax exempt letter;
     4. Agree to provide a copy of a naloxone standing order that can be obtained at DPH standing order application or a physician’s prescription;
     5. If the naloxone request is for more than 48 units, the organization/entity will provide a comprehensive summary with the application to validate their request;
     6. Agree to allow the DHCS to contact the organization/entity using the information provided on the application form; and,
     7. Agree to allow the DHCS to use the information provided on the application form to track the use of the naloxone distribution and conduct other public health and epidemiological surveillance activities.

1. RELATED LEGISLATION.
   1. AB 24 (Haney) requires a person or entity that owns, manages, or is responsible for a designated facility, defined as a bar (as defined) gas station, public library, residential hotel (as defined) in a county that is experiencing an opioid overdose crisis, as defined by DPH, to acquire and post an opioid antagonist kit, which includes an instructional poster and opioid antagonist nasal spray, in areas that are readily accessible only by employees, including, but not limited to, a break room, and to restock the opioid antagonist kit after each use. Provides immunity for liability. Requires DPH to identify the at risk counties, provide opioid antagonist kits free of charge, create the opioid antagonist poster with easy-to-understand instructions and graphics on the administration of the attached opioid antagonist nasal spray, and to make the determination on how best to allocate and distribute its limited supply of opioid antagonist among its various programs in the event of an opioid antagonist supply shortage. Makes a violation of these subject to a civil penalty of not more than $1,000. AB 24 is pending in the Assembly Health Committee.
   2. AB 33 (Bains) establishes the Fentanyl Addiction and Overdose Prevention Task Force to undertake specified duties relating to reducing fentanyl abuse. AB 33 is pending in Assembly Public Safety.
   3. SB 10 (Cortese) requires local educational agencies and County Offices of Education to include strategies for the prevention and treatment of an opioid overdose in their school safety plans. Requires the California Department of Education to develop training materials on the use of emergency opioid antagonists for school personnel, and safety materials for parents, guardians, and pupils in conjunction with the CHHSA. SB 10 is pending in the Senate Health Committee.
   4. SB 641 (Roth) requires DHCS, as part of the NDP, to make all FDA-approved formulations and dosage strengths of naloxone that are indicated for the emergency treatment of known or suspected opioid overdose available to NDP applicants. SB 641 makes legislative findings and declarations. SB 641 is pending in Senate Rules.
2. PREVIOUS LEGISLATION.
   1. AB 2365 (Jim Patterson), Chapter 783, Statutes of 2022, requires CHHSA to establish a grant program to reduce fentanyl overdoses and use throughout the state by giving out six one-time grants to increase local efforts in education, testing, recovery, and support services, as specified. Requires the participating entities to provide the CHHSA with specified information on the results of the program and requires CHHSA to report those results to the Legislature and Governor’s office on or before January 1, 2026.
   2. SB 57 (Weiner) from 2021 would have authorized the City and County of San Francisco, the County of Los Angeles, the City of Los Angeles, and the City of Oakland to approve entities to operate overdose prevention programs until January 1, 2028. SB 57 was vetoed by the Governor who stated in part:

“I have long supported the cutting edge of harm reduction strategies. However, I am acutely concerned about the operations of safe injection sites without strong, engaged local leadership and well-documented, vetted, and thoughtful operational and sustainability plans. The unlimited number of safe injection sites that this bill would authorize - facilities which could exist well into the later part of this decade - could induce a world of unintended consequences. It is possible that these sites would help improve the safety and health of our urban areas, but if done without a strong plan, they could work against this purpose. These unintended consequences in cities like Los Angeles, San Francisco, and Oakland cannot be taken lightly. Worsening drug consumption challenges in these areas is not a risk we can take.

REGISTERED SUPPORT / OPPOSITION:

Support

None on file.

Opposition

None on file.

Analysis Prepared by: Judith Babcock / HEALTH / (916) 319-2097