Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacies and wholesalers by the California State Board of Pharmacy within the Department of Consumer Affairs. Existing law also regulates manufacturers. Existing law authorizes a pharmacy to furnish naloxone hydrochloride or other opioid antagonists to a school district, county office of education, or charter school if specified criteria are met.

This bill would authorize a pharmacy, wholesaler, or manufacturer to furnish naloxone hydrochloride or other opioid antagonists to a law enforcement agency, as provided.

Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacies and wholesalers by the California State Board of Pharmacy within the Department of Consumer Affairs. Existing law also regulates manufacturers. Existing law authorizes a pharmacy to furnish naloxone hydrochloride or other opioid antagonists to a school district, county office of education, or charter school if specified criteria are met.

This bill would authorize a pharmacy, wholesaler, or manufacturer to furnish naloxone hydrochloride or other opioid antagonists to a law enforcement agency, as provided.

Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacies and wholesalers by the California State Board of Pharmacy within the Department of Consumer Affairs. Existing law also regulates manufacturers. Existing law authorizes a pharmacy to furnish naloxone hydrochloride or other opioid antagonists to a school district, county office of education, or charter school if specified criteria are met.

This bill would authorize a pharmacy or wholesaler pharmacy, wholesaler, or manufacturer to furnish naloxone hydrochloride or other opioid antagonists to a law enforcement agency, as provided.

Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacies and wholesalers by the California State Board of Pharmacy within the Department of Consumer Affairs. Existing law authorizes a pharmacy to furnish naloxone hydrochloride or other opioid antagonists to a school district, county office of education, or charter school if specified criteria are met.

This bill would authorize a pharmacy or wholesaler to furnish naloxone hydrochloride or other opioid antagonists to a law enforcement agency, as provided.

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 2256

Author:(Santiago)

As Amended Ver:June 6, 2018

Majority vote

Original Committee Reference: B. & P.

SUMMARY: authorizes a pharmacy or wholesaler to furnish naloxone hydrochloride (naloxone) or another opioid antagonist to law enforcement agencies, under specified conditions.

The Senate amendments additionally authorize a manufacturer to furnish naloxone hydrochloride or other opioid antagonists to law enforcement agencies and make technical corrections.

EXISTING LAW:

1. Establishes the California State Board of Pharmacy within the Department of Consumer Affairs and provides for the licensure and regulation of pharmacies and wholesalers by the Board. (Business and Professions Code Section (BPC) 4000 et seq.)
2. Prohibits a person from furnishing any dangerous drug or device, except upon the prescription of a physician, dentist, podiatrist, optometrist, veterinarian, or naturopathic doctor. (BPC 4059)
3. Authorizes a pharmacist to furnish naloxone hydrochloride (without a prescription) in accordance with standardized procedures or protocols developed and approved by the Board of Pharmacy and the Medical Board of California. (BPC 4052.01)
4. Authorizes a pharmacy to furnish naloxone hydrochloride or another opioid antagonist to a school district, county office of education, or charter school, provided specified conditions are met. (BPC 4119.8)
5. Authorizes a licensed health care provider who is authorized by law to prescribe an opioid antagonist to prescribe and subsequently dispense or distribute an opioid antagonist to a person at risk of an opioid-related overdose or to a family member, friend, or other person in a position to assist a person at risk of an opioid-related overdose. (Civil Code Section 1714.22)

THIS BILL: Notwithstanding any other law, authorizes a pharmacy, wholesaler, or manufacturer to furnish naloxone hydrochloride or other opioid antagonists to a law enforcement agency if the following conditions are met:

1. The naloxone hydrochloride or other opioid antagonists are furnished exclusively for use by the employees of the law enforcement agency who have completed training provided by the law enforcement agency, and
2. Records regarding the acquisition and disposition of naloxone hydrochloride or other opioid antagonists furnished pursuant to this section shall be maintained by the law enforcement agency for a period of three years from the date the records were created. The law enforcement agency shall be responsible for monitoring the supply of naloxone hydrochloride or other opioid antagonists and ensuring the destruction of expired naloxone hydrochloride or other opioid antagonists.

FISCAL EFFECT: According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, no significant state fiscal impact is anticipated.

COMMENTS: Naloxone hydrochloride and other opioid antagonists. Naloxone hydrochloride (brand name Narcan) is an opioid antagonist. This means that naloxone blocks the effects of opioids on the central nervous system, stopping the effects of an opioid overdose such as suppressed breathing. Naloxone can be administered through an intravenous injection, through an intermuscular injection, or via a nasal spray. Naloxone was approved by the federal Food and Drug Administration for the treatment of opioid overdose in 1971 and is available as a generic medication. Naloxone is considered a non-narcotic drug; it does not have any serious side-effects and has a low potential for abuse

Use of Naloxone by law enforcement agencies. According to the federal Bureau of Justice Assistance, law enforcement agencies in 41 states have adopted programs to provide naloxone to law enforcement officers for use when responding to opioid overdoses.

The Los Angeles County Sheriff's Department implemented a program, beginning in 2015, to provide naloxone to patrol officers. Since that time, the Department has distributed over 2,500 doses of naloxone. According to the Department, its officers have used naloxone 13 times in response to an opioid overdose, saving 11 lives.

Access to Naloxone by law enforcement agencies. Under current law and regulation by the Board of Pharmacy, a pharmacist may furnish naloxone, without a prescription, provided that the pharmacist has completed specified training and provides information to the person receiving the naloxone. This authority allows any person, whether or not they have an existing prescription for an opioid, to receive naloxone.

However, the authority to furnish naloxone without a prescription does not extend to wholesalers. Since law enforcement agencies would generally prefer to purchase naloxone in bulk from a wholesaler, most law enforcement agencies that have deployed naloxone have relied on a physician within a local health department or other government agency to write a standing prescription for the agency to purchase naloxone. Law enforcement agencies have argued that this process delays access to naloxone by their officers without providing a substantial public benefit.

Analysis Prepared by: Brendan McCarthy / B. & P. / (916) 319-3301 FN: 0003677

 CONSENT  

Bill No: AB 2256

Author:

:

Vote:

SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 8-0, 6/11/18

AYES: Hill, Fuller, Dodd, Galgiani, Glazer, Hernandez, Pan, Wilk

NO VOTE RECORDED: Newman

SENATE PUBLIC SAFETY COMMITTEE: 7-0, 6/19/18

AYES: Skinner, Anderson, Bradford, Jackson, Mitchell, Stone, Wiener

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

ASSEMBLY FLOOR: 73-0, 5/10/18 (Consent) - See last page for vote

SUBJECT:

SOURCE: Los Angeles County Sheriff’s Department

DIGEST:

This bill authorizes a pharmacy, wholesaler, or manufacturer to provide naloxone hydrochloride (NH) or another opioid antagonist to law enforcement agencies, under specified conditions.

ANALYSIS:

Existing law:

1. Permits a pharmacist to furnish NH in accordance with standardized procedures or protocols developed and approved by both the Board of Pharmacy and Medical Board of California, in consultation with the California Society of Addiction Medicine, the California Pharmacists Association, and other appropriate entities. Requires a pharmacist to complete a training program on the use of opioid antagonists that consists of at least one hour of approved continuing education on the use of NH. (BPC § 4052.01) 
2. Authorizes a pharmacy to furnish NH or another opioid antagonist to a school district, county office of education (COE), or charter school if all the NH or another opioid antagonist is furnished exclusively for use at a school district school-site, COE school-site, or charter school, and a physician and surgeon provides a written order that specifies the quantity. (BPC § 4119.08)
3. Authorizes a licensed health care provider to prescribe and dispense NH to a person at risk of an opioid-related overdose or to a family member, friend, or other person in a position to assist a person at risk of an opioid related overdose.  Authorizes a licensed health care provider to issue standing orders for the administration of NH to a person at risk of an opioid-related overdose, a family member, friend, or other person in a position to assist a person experiencing or reasonably suspected of experiencing an overdose. (Civil Code § 1714.22)
4. Requires a person who is prescribed or possesses NH pursuant to a standing order to receive training provided by an opioid overdose prevention and treatment training program operated by a local health jurisdiction or that is registered by a local health jurisdiction. (Id.)

This bill permits a pharmacy, wholesaler, or manufacturer to furnish NH or other opioid antagonists to a law enforcement agency if the NH or opioid antagonist is furnished exclusively for use by employees of the law enforcement agency that have completed the specified training provided by the law enforcement agency and the law enforcement agency maintains records of the acquisition and disposition of NH or other opioid antagonists for a period of three years from the date the records are created.

Background

Prescription Drug Deaths. Prescription opioids continue to be involved in more overdose deaths than any other drug.  The National Institute on Drug Abuse reports that more than 1,700 young adults died from prescription drug overdose in 2014, a four-fold increase from 1999, nearly five persons per day.  According to the Centers for Disease Control (CDC), overdose deaths involving prescription opioids have quadrupled since 1999.  CDC found that from 1999 to 2015, more than 183,000 people died in the U.S. from overdoses related to prescription opioids.  CDC notes that the most common drugs involved in prescription opioid overdose deaths are methadone, oxycodone and hydrocodone.  According to the CDC, among those who died from prescription opioid overdose between 1999 and 2014, overdose rates were highest among people aged 25 to 54, overdose rates were higher among non-Hispanic whites and American Indian or Alaskan Natives, compared to non-Hispanic blacks and Hispanics and men were more likely to die from overdose, but the mortality gap between men and women is closing. 

NH.  NH, better known as Narcan, is an opioid antidote that can reverse a drug overdose.  NH reverses depression of the central nervous system and respiratory systems that have shut down during an overdose.  NH is commonly used when a person excessively uses morphine, oxycodone, methadone, or illegal substances such as heroin.  NH is meant to sustain breathing for 30-90 minutes, during which time emergency medical services should be sought for the patient.  The drug is non-narcotic, does not produce intoxication, and has no potential for addiction or abuse.  NH also only causes pharmacological effects if there are opioids in someone’s body.  If NH is administered to someone who is not overdosing, no adverse effects will happen.

NH is typically administered intramuscularly, which causes the drug to act within one minute and last up to 45 minutes.  The emergency treatment works like the well-known EpiPen, an epinephrine auto-injector for serious allergic reactions, as it is injected into the muscle and does not require training, making it more user-friendly.  NH may also be administered via intravenously, subcutaneous (under the skin), or intranasally.   A typical injectable or nasal spray NH kit costs $15-$25 per dose.

California is one of a number of states that have recently enacted legislation to address the public health concern of prescription drug overdose.  Seventeen states and the District of Columbia, have enacted laws expanding access to NH.  Most notably, programs that have required police officers to carry NH have been proven successful at curbing overdose deaths.  According to a report by CNN, “The police department in Quincy, Massachusetts was the first in the nation to require its officers to carry naloxone and has successfully reversed 211 overdoses with a success rate of over 95%.”  New York recently implemented a similar idea in Suffolk County, where 563 lives were saved last year alone.

Community based programs have existed since 1996 to get NH into the hands of those able to help.  The national advocacy organization Harm Reduction Coalition (HRC) reports that there are currently over 200 take-home NH programs in communities throughout the United States that help to increase access to NH and training education on overdose. In 2010, HRC surveyed 50 of these programs and reported the results in the February 17, 2012 issue of Morbidity and Mortality Weekly Report (MMWR), a publication of the CDC.  The survey found that since these programs first began, 53,032 persons were trained on the use of NH and the programs received reports of 10,171 overdose reversals.  Other community based projects like Project Lazarus and Operation OpioidSAFE in North Carolina are working to increase the accessibility of NH.  Education is provided by these programs about opioid safety and the administration of NH however these programs are limited in their funding and geographic reach. 

Despite evidence that shows widening distribution of NH helps decrease drug overdose deaths, its implementation faces some difficulties.  MMWR reports that “nearly half (43.7%) of the responding opioid overdose programs reported problems obtaining naloxone related to cost and the supply chain. Price increases of some formulations of naloxone appear to restrict current program activities and the possibility of new programs. Economic pressures on state and local budgets could decrease funding of opioid overdose prevention activities.  To address the substantial increases in opioid-related drug overdose deaths, public health agencies could consider comprehensive measures that include teaching laypersons how to respond to overdoses and administer naloxone to those in need.”

FISCAL EFFECT: Appropriation: Fiscal Com.: Local:

SUPPORT: (Verified 7/2/18)

Los Angeles County Sheriff’s Department (source)

California Academy of Family Physicians

California Chapter of the American College of Emergency Physicians

California Dental Association

California Pharmacists Association

California Police Chiefs Association

California Retailers Association

California Society of Addiction Medicine

California State Sheriff’s Association

League of California Cities

Los Angeles County Professional Peace Officers Association

National Association of Chain Drug Stores

National Association of Social Workers, California Chapter

OPPOSITION: (Verified 7/2/18)

None received

ARGUMENTS IN SUPPORT: Supporters write that when the Los Angeles Sheriff’s Department first attempted to acquire Naloxone, they encountered a road block due to the fact they did not have a prescription, issued by a physician, allowing their agency to purchase it. This caused an unnecessary delay of acquiring Naloxone by weeks. This in turn delayed their ability to deploy the lifesaving supply to the field. According to supporters, the use of naloxone ensures that a person experiencing an opioid overdose lives long enough for emergency medical care to arrive and see this legislation as a “positive move by removing a barrier for law enforcement to provide this essential lifesaving medication, giving the maximum opportunity for people who have experienced an overdose to be rescued with naloxone and have a second chance.”

ASSEMBLY FLOOR: 73-0, 5/10/18

AYES: Acosta, Aguiar-Curry, Arambula, Baker, Berman, Bigelow, Bloom, Bonta, Brough, Burke, Caballero, Calderon, Carrillo, Cervantes, Chau, Chávez, Chen, Chiu, Choi, Chu, Cooper, Cunningham, Dahle, Daly, Eggman, Flora, Fong, Frazier, Gallagher, Eduardo Garcia, Gipson, Gloria, Gonzalez Fletcher, Gray, Grayson, Harper, Holden, Irwin, Jones-Sawyer, Kalra, Kamlager-Dove, Kiley, Lackey, Levine, Limón, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Muratsuchi, Nazarian, O'Donnell, Patterson, Quirk, Quirk-Silva, Reyes, Rodriguez, Rubio, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Voepel, Waldron, Weber, Wood, Rendon

NO VOTE RECORDED: Travis Allen, Cooley, Friedman, Cristina Garcia, Obernolte

Prepared by:

7/3/18 15:43:55

**** END ****

SENATE COMMITTEE ON PUBLIC SAFETY

Senator Nancy Skinner, Chair

2017 - 2018 Regular

Bill No: AB 2256 Hearing Date: June 19, 2018

Subject: Law Enforcement Agencies: Opioid Antagonist

HISTORY

Source: Los Angeles Sheriff’s Department

Prior Legislation: AB 1748 (Mayes), Ch. 557, Stats. 2016

AB 1535 (Bloom), Ch. 326, Stats. 2014

Support: California Academy of Family Physicians; California Chapter of the American College of Emergency Physicians; California Pharmacists Association; California Police Chiefs Association; California Retailers Association; California Society of Addiction Medicine; California State Sheriff’s Association; League of California Cities; Los Angeles County Professional Peace Officers Association; National Association of Chain Drug Stores; National Association of Social Workers, California Chapter

Opposition: None known

Assembly Floor Vote: 73 - 0

PURPOSE

The purpose of this bill is to authorize a pharmacy, wholesaler, or manufacturer to provide naloxone hydrochloride or another opioid antagonist to law enforcement agencies, under specified conditions.

Existing law authorizes a pharmacist to furnish naloxone in accordance with standardized procedures or protocols developed and approved by both the Board and Medical Board of California, in consultation with the California Society of Addiction Medicine, the California Pharmacists Association, and other appropriate entities.  (Bus. & Prof. Code, § 4052.01, subd. (a).)

Existing law requires the standardized procedures or protocols to include:

1. Procedures to ensure education of the person to whom the drug is furnished, including, but not limited to opioid overdose prevention, recognition, and response, safe administration of naloxone, potential side effects or adverse events, and the imperative to seek emergency medical care for the patient.
2. Procedures to ensure the education of the person to whom the drug is furnished regarding the availability of the drug treatment programs.
3. Procedures for the notification of the patient’s primary care provider with patient consent of any drugs or devises furnished to the patient, or entry of appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider, and with patient consent. (Bus. & Prof. Code, § 4052.01, subd. (a)(1)-(3).)

Existing law prohibits a pharmacist furnishing naloxone from allowing a person receiving naloxone to waive the drug consultation. (Bus. & Prof. Code, § 4052.01, subd. (b).)

Existing law requires a pharmacist to complete a training program on the use of opioid antagonists that consists of at least one hour of approved continuing education on the use of naloxone. (Bus. & Prof. Code, § 4052.01, subd. (c).)

Existing law authorizes a pharmacy to furnish naloxone or another opioid antagonist to a school district, county office of education (COE), or charter school if all the naloxone or another opioid antagonist is furnished exclusively for use at a school district school-site, COE school-site, or charter school, and a physician and surgeon provides a written order that specifies the quantity of naloxone or another opioid antagonist to be furnished. (Bus. & Prof. Code, § 4119.8, subd. (a).)

Existing law requires records regarding the acquisition and disposition of naloxone or another opioid antagonist furnished to be maintained by the school district, COE, or charter school for a period of three years from the date the records were created.  Requires the school district, COE, or charter school to be responsible for monitoring the supply of naloxone or another opioid antagonist and ensuring the destruction of expired naloxone or another opioid antagonist. (Bus. & Prof. Code, § 4119.8, subd. (b).)

Existing law authorizes a licensed health care provider to prescribe and dispense naloxone to a person at risk of an opioid-related overdose or to a family member, friend, or other person in a position to assist a person at risk of an opioid-related overdose.  (Civ. Code, § 1714.22, subd. (b).)

Existing law authorizes a licensed health care provider to issue standing orders for the administration of naloxone to a person at risk of an opioid-related overdose, a family member, friend, or other person in a position to assist a person experiencing or reasonably suspected of experiencing an overdose. (Civ. Code, § 1714.22, subd. (c).)

Existing law requires a person who is prescribed or possesses naloxone pursuant to a standing order to receive training provided by an opioid overdose prevention and training program. (Civ. Code, § 1714.22, subd. (d)(1).)

Existing law defines “opioid overdose prevention and treatment training program” as any program operated by a local health jurisdiction or that is registered by a local health jurisdiction to train individuals to prevent, recognize, and respond to an opiate overdose, and that provides, at a minimum, training in all of the following:

1. The causes of an opiate overdose.
2. Mouth to mouth resuscitation.
3. How to contact appropriate emergency medical services.
4. How to administer naloxone.
5. Does not require a person who is prescribed naloxone directly from a licensed prescriber to receive training from an opioid prevention and treatment training program.  (Civ. Code, § 1714.22, subd. (a)(2).)

This bill authorizes a pharmacy, wholesaler, or manufacturer to furnish naloxone hydrochloride or other opioid antagonists to a law enforcement agency if both of the following are met:

1. The naloxone or other opioid antagonist is furnished exclusively for use by employees of the law enforcement agency who have completed training, provided by the law enforcement agency, in administering naloxone or other opioid antagonists.
2. Records regarding the acquisition and disposition of naloxone or other opioid antagonists furnished pursuant to this section shall be maintained by the law enforcement agency for a period of three years from the date the records were created. The law enforcement agency shall be responsible for monitoring the supply of naloxone hydrochloride or other opioid antagonists and ensuring the destruction of expired naloxone hydrochloride or other opioid antagonists.

COMMENTS

1. Need for This Bill

According to the author:

Under current law and regulation by the Board of Pharmacy, a pharmacist may furnish naloxone, without a prescription, provided that the pharmacist has completed specified training and provides information to the person receiving the naloxone. This authority allows any person, whether or not they have an existing prescription for an opioid, to receive naloxone. However, the authority to furnish naloxone without a prescription does not extend to wholesalers. Since law enforcement agencies would generally prefer to purchase naloxone in bulk from a wholesaler, most law enforcement agencies that have deployed naloxone have relied on a physician within a local health department or other government agency to write a standing prescription for the agency to purchase naloxone. Law enforcement agencies have argued that this process delays access to naloxone by their officers without providing a substantial public benefit.

1. Prescription Drug Deaths

Prescription opioids continue to be involved in more overdose deaths than any other drug. According to the Centers for Disease Control (CDC), overdose deaths involving prescription opioids have quadrupled since 1999. CDC found that from 1999 to 2015, more than 183,000 people died in the U.S. from overdoses related to prescription opioids. CDC notes that the most common drugs involved in prescription opioid overdose deaths are methadone, oxycodone, and hydrocodone.

1. Naloxone

Naloxone, better known by the brand name Narcan, is an opioid antidote that can reverse a drug overdose. Naloxone reverses depression of the central nervous system and respiratory systems that have shut down during an overdose. Naloxone is commonly used when a person excessively uses morphine, oxycodone, methadone, or illegal substances such as heroin. Naloxone is meant to sustain breathing for 30-90 minutes, during which time emergency medical services should be sought for the patient. The drug is non-narcotic, does not produce intoxication, and has no potential for addiction or abuse. Naloxone also only causes pharmacological effects if there are opioids in someone’s body.  If naloxone is administered to someone who is not overdosing, no adverse effects will happen.

Naloxone is typically administered intramuscularly, which causes the drug to act within one minute and last up to 45 minutes. The emergency treatment works like the well-known EpiPen, an epinephrine auto-injector for serious allergic reactions, as it is injected into the muscle and does not require training, making it more user-friendly. Naloxone may also be administered via intravenously, subcutaneous (under the skin), or intranasally. A typical injectable or nasal spray naloxone kit costs $15-$25 per dose.

1. Access to and Use of NH

California is one of a number of states that have recently enacted legislation to address the public health concern of prescription drug overdose. Seventeen states and the District of Columbia, have enacted laws expanding access to naloxone. Most notably, programs that have required police officers to carry naloxone have been proven successful at curbing overdose deaths. According to a report by CNN, “The police department in Quincy, Massachusetts was the first in the nation to require its officers to carry naloxone and has successfully reversed 211 overdoses with a success rate of over 95%.”  (<https://www.cnn.com/2014/05/27/us/new-york-police-heroin-antidote/index.html> [as of Jun. 13, 2018].) NYPD officers have been equipped with and trained to administer naloxone since 2014. (Id.)

According to the Assembly Business and Professions Committee analysis, the federal Bureau of Justice Assistance reported that law enforcement agencies in 41 states have adopted programs to provide naloxone to law enforcement officers for use when responding to opioid overdoses. Deputies with the Los Angeles County Sheriff’s Department began carrying nasal spray naloxone in 2017. (<http://www.latimes.com/local/lanow/la-me-ln-sheriff-narcan-overdose-20170615-story.html> [as of Jun. 13, 2018].)

Under current law and regulation by the Board of Pharmacy, a pharmacist may furnish naloxone, without a prescription, provided that the pharmacist has completed specified training and provides information to the person receiving the naloxone. This authority allows any person, whether or not they have an existing prescription for an opioid, to receive naloxone. However, the authority to furnish naloxone without a prescription does not extend to wholesalers. Since law enforcement agencies would generally prefer to purchase naloxone in bulk from a wholesaler, most law enforcement agencies that have deployed naloxone have relied on a physician within a local health department or other government agency to write a standing prescription for the agency to purchase naloxone. Law enforcement agencies have argued that this process delays access to naloxone by their officers without providing a substantial public benefit.

-- END --

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Jerry Hill, Chair

2017 - 2018 Regular

Bill No: AB 2256 Hearing Date: June 11, 2018

Subject: Law enforcement agencies: opioid antagonist

SUMMARY:

Authorizes a pharmacy, wholesaler, or manufacturer to provide naloxone hydrochloride (NH) or another opioid antagonist to law enforcement agencies, under specified conditions.

Existing law:

1. Permits a pharmacist to furnish NH in accordance with standardized procedures or protocols developed and approved by the Board and MBC.  (BPC § 4052.01) 
2. Permits a pharmacist to furnish NH in accordance with standardized procedures or protocols developed and approved by both the Board and Medical Board of California, in consultation with the California Society of Addiction Medicine, the California Pharmacists Association, and other appropriate entities.  (Id.) 
3. Requires the standardized procedures or protocols to include:
4. Procedures to ensure education of the person to whom the drug is furnished, including, but not limited to opioid overdose prevention, recognition, and response, safe administration of NH, potential side effects or adverse events, and the imperative to seek emergency medical care for the patient.
5. Procedures to ensure the education of the person to whom the drug is furnished regarding the availability of the drug treatment programs.
6. Procedures for the notification of the patient’s primary care provider with patient consent of any drugs or devises furnished to the patient, or entry of appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider, and with patient consent. (Id.)
7. Prohibits a pharmacist furnishing NH from allowing a person receiving NH to waive the drug consultation. (Id.)
8. Requires a pharmacist to complete a training program on the use of opioid antagonists that consists of at least one hour of approved continuing education on the use of NH. (Id.)
9. Authorizes a pharmacy to furnish naloxone or another opioid antagonist to a school district, county office of education (COE), or charter school if all the naloxone or another opioid antagonist is furnished exclusively for use at a school district school-site, COE school-site, or charter school, and a physician and surgeon provides a written order that specifies the quantity of naloxone or another opioid antagonist to be furnished. (BPC § 4119.08)
10. Requires records regarding the acquisition and disposition of naloxone or another opioid antagonist furnished to be maintained by the school district, COE, or charter school for a period of three years from the date the records were created.  Requires the school district, COE, or charter school to be responsible for monitoring the supply of naloxone or another opioid antagonist and ensuring the destruction of expired naloxone or another opioid antagonist.  (Id.)
11. Authorizes a licensed health care provider to prescribe and dispense NH to a person at risk of an opioid-related overdose or to a family member, friend, or other person in a position to assist a person at risk of an opioid related overdose.  (Civil Code (CC) § 1714.22)
12. Authorizes a licensed health care provider to issue standing orders for the administration of NH to a person at risk of an opioid-related overdose, a family member, friend, or other person in a position to assist a person experiencing or reasonably suspected of experiencing an overdose. (Id.)
13. Requires a person who is prescribed or possesses NH pursuant to a standing order to receive training provided by an opioid overdose prevention and treatment training program operated by a local health jurisdiction or that is registered by a local health jurisdiction that provides, at a minimum, training in (Id.):
    1. The causes of an opiate overdose.
    2. Mouth to mouth resuscitation.
    3. How to contact appropriate emergency medical services.
    4. How to administer NH.
14. Does not require a person who is prescribed NH directly from a licensed prescriber

to receive training from an opioid prevention and treatment training program.  (Id.)

This bill:

1. Permits a pharmacy, wholesaler, or manufacturer to furnish NH or other opioid antagonists to a law enforcement agency if both the following conditions are met:
   1. The NH or opioid antagonist is furnished exclusively for use by employees of the law enforcement agency that have completed the specified training provided by the law enforcement agency.
   2. The law enforcement agency maintains records of the acquisition and disposition of NH or other opioid antagonists for a period of three years from the date the records are created. The law enforcement agency shall also monitor the supply of NH or other opioid antagonists and ensure the destruction of expired NH or other opioid antagonists.

FISCAL EFFECT:

This bill is keyed fiscal by Legislative Counsel. According to the Assembly Committee on Appropriations analysis dated May 2, 2018, this bill has negligible fiscal impact.

COMMENTS:

1. Purpose. The Los Angeles County Sheriff’s Department is the sponsor of this bill. According to the Author, “under current law and regulation by the Board of Pharmacy, a pharmacist may furnish naloxone, without a prescription, provided that the pharmacist has completed specified training and provides information to the person receiving the naloxone. This authority allows any person, whether or not they have an existing prescription for an opioid, to receive naloxone. However, the authority to furnish naloxone without a prescription does not extend to wholesalers. Since law enforcement agencies would generally prefer to purchase naloxone in bulk from a wholesaler, most law enforcement agencies that have deployed naloxone have relied on a physician within a local health department or other government agency to write a standing prescription for the agency to purchase naloxone. Law enforcement agencies have argued that this process delay access to naloxone by their officers without providing a substantial public benefit.”
2. Prescription Drug Deaths.  Prescription opioids continue to be involved in more overdose deaths than any other drug.  The National Institute on Drug Abuse reports that more than 1,700 young adults died from prescription drug overdose in 2014, a 4-fold increase from 1999, nearly 5 persons per day.  According to the Centers for Disease Control (CDC), overdose deaths involving prescription opioids have quadrupled since 1999.  CDC found that from 1999 to 2015, more than 183,000 people died in the U.S. from overdoses related to prescription opioids.  CDC notes that the most common drugs involved in prescription opioid overdose deaths are methadone, oxycodone and hydrocodone.  According to the CDC, among those who died from prescription opioid overdose between 1999 and 2014, overdose rates were highest among people aged 25 to 54, overdose rates were higher among non-Hispanic whites and American Indian or Alaskan Natives, compared to non-Hispanic blacks and Hispanics and men were more likely to die from overdose, but the mortality gap between men and women is closing. 
3. Naloxone Hydrochloride.  Naloxone Hydrochloride (NH), better known as Narcan, is an opioid antidote that can reverse a drug overdose.  NH reverses depression of the central nervous system and respiratory systems that have shut down during an overdose.  NH is commonly used when a person excessively uses morphine, oxycodone, methadone, or illegal substances such as heroin.  NH is meant to sustain breathing for 30-90 minutes, during which time emergency medical services should be sought for the patient.  The drug is non-narcotic, does not produce intoxication, and has no potential for addiction or abuse.  NH also only causes pharmacological effects if there are opioids in someone’s body.  If NH is administered to someone who is not overdosing, no adverse effects will happen.

NH is typically administered intramuscularly, which causes the drug to act within one minute and last up to 45 minutes.  The emergency treatment works like the well-known EpiPen, an epinephrine auto-injector for serious allergic reactions, as it is injected into the muscle and does not require training, making it more user-friendly.  NH may also be administered via intravenously, subcutaneous (under the skin), or intranasally.   A typical injectable or nasal spray NH kit costs $15-$25 per dose.

California is one of a number of states that have recently enacted legislation to address the public health concern of prescription drug overdose.  Seventeen states and the District of Columbia, have enacted laws expanding access to NH.  Most notably, programs that have required police officers to carry NH have been proven successful at curbing overdose deaths.  According to a report by CNN, “The police department in Quincy, Massachusetts was the first in the nation to require its officers to carry naloxone and has successfully reversed 211 overdoses with a success rate of over 95%.”  New York recently implemented a similar idea in Suffolk County, where 563 lives were saved last year alone.

Community based programs have existed since 1996 to get NH into the hands of those able to help.  The national advocacy organization Harm Reduction Coalition (HRC) reports that there are currently over 200 take-home NH programs in communities throughout the United States that help to increase access to NH and training education on overdose.   

In 2010, HRC surveyed 50 of these programs and reported the results in the February 17, 2012 issue of Morbidity and Mortality Weekly Report (MMWR), a publication of the CDC.  The survey found that since these programs first began, 53,032 persons were trained on the use of NH and the programs received reports of 10,171 overdose reversals.  Other community based projects like Project Lazarus and Operation OpioidSAFE in North Carolina are working to increase the accessibility of NH.  Education is provided by these programs about opioid safety and the administration of NH however these programs are limited in their funding and geographic reach. 

Despite evidence that shows widening distribution of NH helps decrease drug overdose deaths, its implementation faces some difficulties.  MMWR reports that “nearly half (43.7%) of the responding opioid overdose programs reported problems obtaining naloxone related to cost and the supply chain. Price increases of some formulations of naloxone appear to restrict current program activities and the possibility of new programs. Economic pressures on state and local budgets could decrease funding of opioid overdose prevention activities.  To address the substantial increases in opioid-related drug overdose deaths, public health agencies could consider comprehensive measures that include teaching laypersons how to respond to overdoses and administer naloxone to those in need.”

1. Related Legislation This Year. AB 2384 (Arambula) would require health care service plans that provide prescription drug benefits and maintains one or more drug formularies to include specified medication-assisted treatment prescription drugs approved by the United States Food and Drug Administration, including NH in at least one form of administration. (Status: This bill is pending in the Senate Committee on Rules.)

AB 2760 (Wood) would require a prescriber to offer a prescription for NH or another opioid antagonist for patients when certain conditions are present and to provide specified education to those patients. (Status: This bill is pending in the Senate Committee on Business, Professions and Economic Development.)

1. Prior Related Legislation. AB 1748 (Mayes, Chapter 557, Statutes of 2016) authorized school nurses and other trained personnel to use NH or another opioid antagonist to provide emergency medical aid to persons suffering, or reasonably believed to be suffering, from an opioid overdose. This bill also authorized pharmacies to furnish NH without a prescription, to a school district, county office of education, or charter school.

AB 1535 (Bloom, Chapter 326, Statutes of 2014) authorized a pharmacist to furnish NH pursuant to standardized procedures and protocols developed and approved jointly by the Board of Pharmacy (BOP) and the Medical Board of California (MBC).

1. Arguments in Support. The Los Angeles County Sheriff’s Department, in support, writes “according to the United States (U.S.) Department of Health and Human Services, 116 people died every day from opioid related drug overdoses in 2016. Any delay in the acquisition of Naloxone is unnecessary and ultimately delays the delivery of the lifesaving tool to our peace officers in the field.”

The California Academy of Family Physicians writes “when the Los Angeles Sheriff’s Department first attempted to acquire Naloxone, they encountered a road block due to the fact they did not have a prescription, issued by a physician, allowing their agency to purchase it. This caused an unnecessary delay of acquiring Naloxone by weeks. This in turn delayed their ability to deploy the lifesaving supply to the field.”

The California Pharmacists Association states that the “use of naloxone ensures that a person experiencing an opioid overdose lives long enough for emergency medical care to arrive. The CPhA sees this legislation as a positive move by removing a barrier for law enforcement to provide this essential lifesaving medication, giving the maximum opportunity for people who have experienced an overdose to be rescued with naloxone and have a second chance.”

According to the Los Angeles County Professional Peace Officers Association, “approximately 80 percent of opioid overdose deaths are unintended. At highest risk are the elderly and medically ill who are already medically compromised (this is typically not someone addicted to opioids but are taking opioids for pain as prescribed by a medical doctor). More than 1,200 law enforcement agencies nationwide carry naloxone, which can save the life of someone who has overdosed on painkillers, heroin or other opioid drugs as well as cure an officer’s overexposure when responding to a call.”

NOTE:

Double-referral to Senate Committee on Public Safety, second.

SUPPORT AND OPPOSITION:

Support:

Los Angeles County Sheriff’s Department (Sponsor)

California Academy of Family Physicians

California Chapter of the American College of Emergency Physicians

California Dental Association

California Pharmacists Association

California Police Chiefs Association

California Society of Addiction Medicine

California State Sheriff’s Association

League of California Cities

Los Angeles County Professional Peace Officers Association

National Association of Social Workers, California Chapter

Opposition:

None on file as of June 5, 2018.

-- END --

Date of Hearing: May 2, 2018

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez Fletcher, Chair

ABPCA Bill Id:AB 2256

Author:(Santiago) – As Introduced Ver:February 13, 2018

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

SUMMARY:

This bill allows a pharmacy or wholesaler to furnish naloxone hydrochloride or another opioid antagonist to a law enforcement agency if the opioid antagonist is exclusively for use by employees of the agency and transaction records are maintained, as specified.

FISCAL EFFECT:

Negligible.

COMMENTS:

1. Purpose. This bill intends to make it easier for law enforcement agencies to purchase, in bulk, medications that reverse opioid overdose. This bill is supported by law enforcement and health professionals and has no opposition.
2. Background. Naloxone hydrochloride (brand name Narcan) is an opioid antagonist that blocks the effects of opioids on the central nervous system, stopping the effects of an opioid overdose such as suppressed breathing. Under current law and regulation by the Board of Pharmacy, a pharmacist may furnish naloxone without a prescription, provided the pharmacist has completed specified training and give information to the person receiving the naloxone. However, the authority to furnish naloxone without a prescription does not extend to wholesalers. Since law enforcement agencies would generally prefer to purchase naloxone in bulk from a wholesaler, most agencies have relied on a physician within a local health department or other government agency to write a standing prescription for the agency to purchase naloxone. Law enforcement agencies have argued this process delays access to naloxone by their officers without providing a substantial public benefit.
3. Related Legislation. There is a large number of bills introduced this year addressing various aspects of the opioid epidemic, including improvements to CURES, limits on opioid prescribing, higher reimbursement for drug treatment providers, and improved access to naloxone, which can prevent death from overdose.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: April 24, 2018

Chief Counsel: Gregory Pagan

ASSEMBLY COMMITTEE ON

Reginald Byron Jones-Sawyer, Sr., Chair

ABPCA Bill Id:

Author:() – As Ver:

SUMMARY: Allows a pharmacy or wholesaler to furnish naloxone hydrochloride or another opioid antagonist to a law enforcement agency, as specified. Specifically, this bill:

1. Provides that notwithstanding any other law, a pharmacy or wholesaler to furnish naloxone hydrochloride or another opioid antagonists to a law enforcement agency if both the following conditions are met:
   1. The naloxone hydrochloride or another opioid antagonist is furnished exclusively for use by employees of the law enforcement agency who have completed training, provided by the law enforcement agency, in administering naloxone or another opioid antagonist; and
   2. Records regarding the acquisition and disposition of naloxone hydrochloride or another opioid antagonist furnished pursuant to this section shall be maintained by the law enforcement agency for a period of three years from the date the records were created. The law enforcement agency shall be responsible for monitoring the supply of naloxone hydrochloride or another opioid antagonist and ensuring the destruction of expired naloxone hydrochloride or another opioid antagonist.

EXISTING LAW:

1. Establishes the California State Board of Pharmacy within the Department of Consumer Affairs and provides for the licensure and regulation of pharmacies and wholesalers by the Board. (Bus. & Prof. Code, § 4000 et seq.)
2. Prohibits a person from furnishing any dangerous drug or device, except upon the prescription of a physician, dentist, podiatrist, optometrist, veterinarian, or naturopathic doctor. (Bus. and Prof. Code, § 4059.)
3. Authorizes a pharmacist to furnish naloxone hydrochloride (without a prescription) in accordance with standardized procedures or protocols developed and approved by the Board of Pharmacy and the Medical Board of California. (Bus. & Prof. Code, § 4052.01.)
4. Authorizes a pharmacy to furnish naloxone hydrochloride or another opioid antagonist to a school district, county office of education, or charter school, provided specified conditions are met. (Bus. and Prof. Code, § 4119.8.)
5. Authorizes a licensed health care provider who is authorized by law to prescribe an opioid antagonist to prescribe and subsequently dispense or distribute an opioid antagonist to a person at risk of an opioid-related overdose or to a family member, friend, or other person in a position to assist a person at risk of an opioid-related overdose. (Civ. Code, § 1714.22)

FISCAL EFFECT: Unknown

COMMENTS:

1. Author's Statement: According to the author, "Here in California we are no strangers to the opioid crisis, for so many reasons people in our communities are falling to addictions. These individuals are our mothers, fathers, neighbors, and friends. We have an opportunity to fight back and save lives. Often time law enforcement is the first called in case of reported overdose. AB 2265 will remove the barrier currently in place by allowing law enforcement agencies the ability to acquire Naloxone without first obtaining a prescription.
2. Background: In October of 2017, the White House declared the opioid crisis a public health emergency, formally recognizing what had long been understood to be a growing epidemic responsible for devastation in communities across the country. According to the Centers for Disease Control and Prevention, as many as 50,000 Americans died of an opioid overdose in 2016, representing a 28 percent increase over the previous year.  Additionally, the number of Americans who died of an overdose of fentanyl and other opioids more than doubled during that time with nearly 20,000 deaths.  These death rates compare to, and potentially exceed, those at the height of the AIDS epidemic.

Opioids are a class of drugs prescribed and administered by health professionals to manage pain. Modern use of the term “opioid” typically describes both naturally occurring opiates derived from the opium poppy as well as their manufactured synthetics.  Common examples of prescription opioids include oxycodone (OxyContin, Percocet); hydrocodone (Vicodin, Norco, Lorcet); codeine; morphine; and fentanyl.  Heroin is also an opioid.

In addition to providing pain relief, opioids can be used as a cough suppressant, an antidiarrheal, a method of sedation, and a treatment for shortness of breath.  The majority of pharmaceutical opioids are Schedule II drugs under the federal Controlled Substances Act, considered by the federal Drug Enforcement Agency (DEA) to have a high potential for abuse that may lead to severe psychological or physical dependence.  However, combination drugs containing lower doses of opioids combined with other active ingredients are typically less restricted; for example, cough syrups containing low doses of codeine are frequently classified Schedule V medications.

The abuse of prescription drugs was historically viewed as a criminal concern analogous to street narcotics cases regularly investigated by law enforcement.  In recent years, however, an expert consensus has evolved around the opinion that the opioid crisis must be addressed through the lens of public health policy.  This belief is supported by research demonstrating how health professionals may have inadvertently contributed to the origins of the crisis.  It is widely accepted that health professionals will play a necessarily critical role in any meaningful solutions.

In the opioid crisis’s broader national context, there has been a persistent perception that California represents a relatively minor segment of an epidemic more typically identified with states like New Hampshire and West Virginia.  However, there is significant evidence that communities in California have been much harder hit than may be generally believed. For example, in 2015, several rural counties in California saw as many or more drug overdose deaths per 100,000 residents than some Midwestern states.  It has been reported than some small counties had more opioid prescriptions than residents.  In total, the California Department of Public Health estimates that nearly 2,000 Californians died of an opioid overdose in 2016.

In February of 2018, a bipartisan coalition of California State Assemblymembers announced a package of legislation aimed at combating the opioid crisis.  The bills have been presented as representing a diversity of approaches to curbing overprescription, encouraging treatment, and preventing diversion.  The potential of each proposed measure to effectively address the epidemic of prescription drug abuse must be evaluated in proportion to any added burden to those health professionals who remain tasked with ensuring that legitimate treatment continues to be provided to patients with pain management needs.

1. Naloxone hydrochloride and other opioid antagonists. Naloxone hydrochloride (brand name Narcan) is an opioid antagonist. This means that naloxone blocks the effects of opioids on the central nervous system, stopping the effects of an opioid overdose such as suppressed breathing. Naloxone can be administered through an intravenous injection, through an intermuscular injection, or via a nasal spray. Naloxone was approved by the federal Food and Drug Administration for the treatment of opioid overdose in 1971 and is available as a generic medication. Naloxone is considered a non-narcotic drug; it does not have any serious side-effects and has a low potential for abuse.
2. Prior Legislation:
   1. AB 1748 (Mayes), Chapter 557, Statutes of 2016, authorizes school nurses and other trained personnel to use naloxone or another opioid antagonist to provide emergency medical aid to persons suffering, or reasonably believed to be suffering, from an opioid overdose. AB 1748 also authorizes pharmacies to furnish naloxone without a prescription, to a school district, county office of education, or charter school.
   2. AB 1535 (Bloom), Chapter 326, Statutes of 2014, authorizes pharmacists to furnish naloxone without a prescription, pursuant to standardized procedures developed by the Board of Pharmacy and the Medical Board of California.

REGISTERED SUPPORT / OPPOSITION:

Support

California Academy of Family Physicians

California Dental Association

California Pharmacists Association

California Police Chiefs Association

California State Sheriffs' Association

Los Angeles County Professional Peace Officers Association

Los Angeles County Sheriff's Association

National Association of Social Workers, California Chapter

Opposition

None

Analysis Prepared by:

Date of Hearing: April 10, 2018

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Evan Low, Chair

ABPCA Bill Id:AB 2256 (

Author:Santiago) – As Introduced Ver:February 13, 2018

NOTE: This bill is double-referred and if passed by this committee it will be referred to the Assembly Committee on Public Safety.

SUBJECT: Law enforcement agencies: opioid antagonist

SUMMARY: This bill authorizes a pharmacy or wholesaler to furnish naloxone hydrochloride (naloxone) or another opioid antagonist to law enforcement agencies, under specified conditions.

EXISTING LAW:

1. Establishes the California State Board of Pharmacy within the Department of Consumer Affairs and provides for the licensure and regulation of pharmacies and wholesalers by the Board. (Business and Professions Code Section 4000 et seq.)
2. Prohibits a person from furnishing any dangerous drug or device, except upon the prescription of a physician, dentist, podiatrist, optometrist, veterinarian, or naturopathic doctor. (Business and Professions Code Section 4059)
3. Authorizes a pharmacist to furnish naloxone hydrochloride (without a prescription) in accordance with standardized procedures or protocols developed and approved by the Board of Pharmacy and the Medical Board of California. (Business and Professions Code Section 4052.01)
4. Authorizes a pharmacy to furnish naloxone hydrochloride or another opioid antagonist to a school district, county office of education, or charter school, provided specified conditions are met. (Business and Professions Code Section 4119.8)
5. Authorizes a licensed health care provider who is authorized by law to prescribe an opioid antagonist to prescribe and subsequently dispense or distribute an opioid antagonist to a person at risk of an opioid-related overdose or to a family member, friend, or other person in a position to assist a person at risk of an opioid-related overdose. (Civil Code Section 1714.22)

THIS BILL: Notwithstanding any other law, authorizes a pharmacy or wholesaler to furnish naloxone hydrochloride or another opioid antagonist to a law enforcement agency if the following conditions are met:

1. The naloxone hydrochloride or another opioid antagonist is furnished exclusively for use by the employees of the law enforcement agency who have completed training provided by the law enforcement agency, and
2. Records regarding the acquisition and disposition of naloxone hydrochloride or another opioid antagonist furnished pursuant to this section shall be maintained by the law enforcement agency for a period of three years from the date the records were created. The law enforcement agency shall be responsible for monitoring the supply of naloxone hydrochloride or another opioid antagonist and ensuring the destruction of expired naloxone hydrochloride or another opioid antagonist.

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

COMMENTS:

Background: Overview of the Opioid Crisis.  In October of 2017, the White House declared the opioid crisis a public health emergency, formally recognizing what had long been understood to be a growing epidemic responsible for devastation in communities across the country. According to the Centers for Disease Control and Prevention, as many as 50,000 Americans died of an opioid overdose in 2016, representing a 28 percent increase over the previous year.  Additionally, the number of Americans who died of an overdose of fentanyl and other opioids more than doubled during that time with nearly 20,000 deaths.  These death rates compare to, and potentially exceed, those at the height of the AIDS epidemic.

Opioids are a class of drugs prescribed and administered by health professionals to manage pain.  Modern use of the term “opioid” typically describes both naturally occurring opiates derived from the opium poppy as well as their manufactured synthetics.  Common examples of prescription opioids include oxycodone (OxyContin, Percocet); hydrocodone (Vicodin, Norco, Lorcet); codeine; morphine; and fentanyl.  Heroin is also an opioid.

In addition to providing pain relief, opioids can be used as a cough suppressant, an antidiarrheal, a method of sedation, and a treatment for shortness of breath.  The majority of pharmaceutical opioids are Schedule II drugs under the federal Controlled Substances Act, considered by the federal Drug Enforcement Agency (DEA) to have a high potential for abuse that may lead to severe psychological or physical dependence.  However, combination drugs containing lower doses of opioids combined with other active ingredients are typically less restricted; for example, cough syrups containing low doses of codeine are frequently classified Schedule V medications.

The abuse of prescription drugs was historically viewed as a criminal concern analogous to street narcotics cases regularly investigated by law enforcement.  In recent years, however, an expert consensus has evolved around the opinion that the opioid crisis must be addressed through the lens of public health policy.  This belief is supported by research demonstrating how health professionals may have inadvertently contributed to the origins of the crisis.  It is widely accepted that health professionals will play a necessarily critical role in any meaningful solutions.

In the opioid crisis’s broader national context, there has been a persistent perception that California represents a relatively minor segment of an epidemic more typically identified with states like New Hampshire and West Virginia.  However, there is significant evidence that communities in California have been much harder hit than may be generally believed.  For example, in 2015, several rural counties in California saw as many or more drug overdose deaths per 100,000 residents than some Midwestern states.  It has been reported than some small counties had more opioid prescriptions than residents.  In total, the California Department of Public Health estimates that nearly 2,000 Californians died of an opioid overdose in 2016.

In February of 2018, a bipartisan coalition of California State Assemblymembers announced a package of legislation aimed at combating the opioid crisis.  The bills have been presented as representing a diversity of approaches to curbing overprescription, encouraging treatment, and preventing diversion.  The potential of each proposed measure to effectively address the epidemic of prescription drug abuse must be evaluated in proportion to any added burden to those health professionals who remain tasked with ensuring that legitimate treatment continues to be provided to patients with pain management needs.

Naloxone hydrochloride and other opioid antagonists. Naloxone hydrochloride (brand name Narcan) is an opioid antagonist. This means that naloxone blocks the effects of opioids on the central nervous system, stopping the effects of an opioid overdose such as suppressed breathing. Naloxone can be administered through an intravenous injection, through an intermuscular injection, or via a nasal spray. Naloxone was approved by the federal Food and Drug Administration for the treatment of opioid overdose in 1971 and is available as a generic medication. Naloxone is considered a non-narcotic drug; it does not have any serious side-effects and has a low potential for abuse

Use of Naloxone by law enforcement agencies. According to the federal Bureau of Justice Assistance, law enforcement agencies in 41 states have adopted programs to provide naloxone to law enforcement officers for use when responding to opioid overdoses.

The Los Angeles County Sheriff’s Department implemented a program, beginning in 2015, to provide naloxone to patrol officers. Since that time, the Department has distributed over 2,500 doses of naloxone. According to the Department, its officers have used naloxone 13 times in response to an opioid overdose, saving 11 lives.

Access to Naloxone by law enforcement agencies. Under current law and regulation by the Board of Pharmacy, a pharmacist may furnish naloxone, without a prescription, provided that the pharmacist has completed specified training and provides information to the person receiving the naloxone. This authority allows any person, whether or not they have an existing prescription for an opioid, to receive naloxone.

However, the authority to furnish naloxone without a prescription does not extend to wholesalers. Since law enforcement agencies would generally prefer to purchase naloxone in bulk from a wholesaler, most law enforcement agencies that have deployed naloxone have relied on a physician within a local health department or other government agency to write a standing prescription for the agency to purchase naloxone. Law enforcement agencies have argued that this process delays access to naloxone by their officers without providing a substantial public benefit.

Current Related Legislation:

AB 1751 (Low) would provide a framework for the CURES PDMP to connect with other states that comply with California’s patient privacy and data security standards. This bill will be heard in this committee on April 10^th.

AB 1752 (Low) would add Schedule V drugs to the CURES database and change the requirement for pharmacists to report dispensed prescriptions from seven days to the following business day. This bill will be heard in this committee on April 10^th.

AB 1753 (Low) would limit the number of security printers authorized to manufacture prescription pads and linking uniquely serialized pads with CURES. This bill will be heard in this committee on April 10^th.

AB 1963 (Waldron) would incentivize medical providers to become certified prescribers of medication-assisted treatment by increasing the reimbursement rates for providers who prescribe these drug treatments. This bill is pending in the Assembly Health Committee.

AB 2086 (Gallagher) would allow prescribers of controlled substances to review a list of patients for whom they are listed as being the prescriber. This bill will be heard in this committee on April 10^th.

AB 2384 (Arambula) would remove barriers to medication-assisted treatment, such as prior authorization requirements and limits on coverage. This bill is pending in the Assembly Health Committee.

AB 2486 (McCarty) would establish the Opioid Prevention and Rehabilitation Program Fund to treat opioid addiction by providing existing programs the additional funding. This bill is pending in the Assembly Health Committee.

AB 2487 (McCarty) would add opioid addiction training as a continuing medical education requirement for certain physicians in order to increase the availability of buprenorphine treatment. This bill will be heard in this committee on April 10^th.

AB 2741 (Burke) would limit all opioid prescriptions for minors to a maximum of 5 days, with exceptions, and require a prescriber to discuss risks related to opioid medication with the minor and the minor’s parent or guardian and obtain written consent prior to writing the prescription. This bill will be heard in this committee on April 10^th.

AB 2760 (Wood) would require a prescriber to prescribe naloxone hydrochloride for patients when certain conditions are present and to provide specified education to those patients and their households. This bill will be heard in this committee on April 10^th.

AB 2783 (O’Donnell) would reconcile discrepancies between California’s controlled substance schedules and the corresponding federal controlled substance schedules. This bill is pending in the Assembly Public Safety Committee.

AB 2789 (Wood) would require that prescriptions be submitted electronically, with limited exceptions. This bill will be heard in this committee on April 10^th.

AB 2859 (Caballero) would increase safe storage practices among parents to prevent access to prescription drugs in the home by children and adolescents. This bill will be heard in this committee on April 10^th.

Prior related legislation:

AB 1748 (Mayes), Chapter 557, Statutes of 2016, authorizes school nurses and other trained personnel to use naloxone or another opioid antagonist to provide emergency medical aid to persons suffering, or reasonably believed to be suffering, from an opioid overdose. That bill also authorizes pharmacies to furnish naloxone without a prescription, to a school district, county office of education, or charter school.

AB 1535 (Bloom), Chapter 326, Statutes of 2014, authorizes pharmacists to furnish naloxone without a prescription, pursuant to standardized procedures developed by the Board of Pharmacy and the Medical Board of California.

ARGUMENTS IN SUPPORT:

In support of the bill, the Los Angeles County Sheriff’s Department writes “according to the United States Department of Health and Human Services, 116 people died every day from opioid related drug overdoses in 2016. As more law enforcement agencies throughout the U.S. implement a Naloxone program within their agencies, the number of persons saved from potential lethal overdoses rises accordingly”.

According to the California Police Chiefs Association, “this opioid antagonist allows law enforcement to stabilize the condition of the overdose victim until paramedics arrive on the scene”.

REGISTERED SUPPORT / OPPOSITION:

Support

Los Angeles County Sheriff’s Department (sponsor)

California Academy of Family Physicians

California Pharmacists Association

California Police Chiefs Association

Opposition

None on file.

Analysis Prepared by: Brendan McCarthy / B. & P. / (916) 319-3301