BILL ANALYSIS Ó SENATE COMMITTEE ON PUBLIC SAFETY Senator Loni Hancock, Chair S 2013-2014 Regular Session B 1 4 3 SB 1438 (Pavley) 8 As Amended: April 10, 2014 Hearing date: April 29, 2014 Civil Code and Health and Safety Code JM:sl OPIOID ANTAGONISTS HISTORY Source: Author Prior Legislation: AB 635 (Ammiano) - Ch. 707, Stats. 2013 SB 767 (Ridley-Thomas) - Ch. 477, Stats. 2007 SB 1695 (Escutia), Chapter 678, Statutes of 2002 Support: Drug Policy Alliance; California State Sheriffs' Association; Emergency Medical Services Administrators' Association of California; California Chapter of the American College of Emergency Physicians Association Opposition:None known KEY ISSUES SHOULD PEACE OFFICERS BE SPECIFICALLY ADDED TO THE LIST OF PERSONS - SUCH AS FAMILY MEMBERS OF AN OVERDOSE VICTIM - AUTHORIZED TO ADMINISTER AN OPIOID ANTAGONIST TO REVERSE AN OVERDOSE? SHOULD THE STATE EMERGENCY MEDICAL SERVICES AUTHORITY DEVELOP STANDARDS AND PUBLISH REGULATIONS FOR ADMINISTRATION OF THE OPIOID ANTAGONIST NALOXONE BY ALL PREHOSPITAL EMERGENCY CARE PERSONNEL? SHOULD LOCAL EMERGENCY MEDICAL SERVICE AGENCIES BE AUTHORIZED TO DEVELOP THEIR OWN STANDARDS AND REGULATIONS IN LIEU OF ADOPTION OR USE OF THE STATE STANDARDS? (More) SB 1438 (Pavley) Page 2 PURPOSE The purposes of this bill are to 1) specifically include peace officers in a list of persons, including family members of a person at risk of an opioid overdose, authorized to administer the opioid antagonist naloxone; 2) direct the State Emergency Medical Services Authority to develop standards and promulgate regulations for administration of naloxone by all prehospital emergency care personnel; and 3) authorize local emergency medical agencies to adopt their own standards and promulgate regulations for administration of naloxone by prehospital emergency care personnel under jurisdiction of the local agency. Existing law (Civil Code § 1714.22) provisions relevant to this bill: An opioid antagonist is defined as naloxone hydrochloride (naloxone) that is approved by the Federal Food and Drug Administration (FDA) for the treatment of an opioid overdose. A licensed health care provider who is authorized to prescribe naloxone to prescribe and dispense or distribute the medication to a person at risk of an overdose or to a family member, friend, or other person in a position to assist the person at risk of overdose. A licensed health care provider to issue standing orders for these purposes. A person who is prescribed or possesses naloxone pursuant to a standing order to receive training by an overdose prevention and treatment training program, as specified. A person who is prescribed naloxone directly from a licensed prescriber, and not through a standing order, is not subject to the training requirement. A health care provider who acts with reasonable care in issuing a prescription for naloxone and any person who (More) SB 1438 (Pavley) Page 3 possesses, distributed, or administers naloxone, with reasonable care, from professional review, civil action, or criminal prosecution. Relevant Health and Safety Code Provisions in Existing Law The Emergency Medical Services Authority (EMSA) shall establish training and standards for all prehospital emergency care personnel, as defined, regarding the characteristics and method of assessment and treatment of anaphylactic reactions and the use of epinephrine. EMSA shall promulgate regulations for use by all prehospital emergency care personnel. (Health & Saf. Code § 1797.197.) The Attorney General shall encourage research on the misuse and abuse of controlled substances. Allows the Attorney General to develop new and improved approaches, techniques, systems, equipment, and devices to strengthen enforcement of the Controlled Substances Act, and to enter into contracts entities, as specified, to conduct demonstrations or special projects that bear directly on the misuse and abuse of controlled substances. (Health & Saf. Code § 11601.) This bill adds peace officers to the list of people who can receive a prescription for an opioid antagonist for the purpose of assisting a person at risk of an opioid-related overdose. This bill adds peace officers to the list of people who can receive standing orders for the distribution of an opioid antagonist for this purpose. This bill requires EMSA to establish training and standards for all prehospital emergency care personnel on the use and administration of naloxone and other opioid antagonists and to promulgate regulations for this purpose. This bill allows EMSA to designate existing training and standards for this purpose. This bill allows a local emergency medical services agency to (More) SB 1438 (Pavley) Page 4 develop training and standards and to promulgate regulations for prehospital emergency medical care personnel under its jurisdiction who use and administer naloxone in lieu of those developed by EMSA. This bill authorizes hospitals and trauma centers to share information with local law enforcement and local emergency medical services agencies about controlled substance overdose trends. Specifies that this information shall only include the number of overdoses and the substances suspected as the primary cause of the overdoses and shall ensure patient confidentiality. RECEIVERSHIP/OVERCROWDING CRISIS AGGRAVATION For the last several years, severe overcrowding in California's prisons has been the focus of evolving and expensive litigation relating to conditions of confinement. On May 23, 2011, the United States Supreme Court ordered California to reduce its prison population to 137.5 percent of design capacity within two years from the date of its ruling, subject to the right of the state to seek modifications in appropriate circumstances. Beginning in early 2007, Senate leadership initiated a policy to hold legislative proposals which could further aggravate the prison overcrowding crisis through new or expanded felony prosecutions. Under the resulting policy, known as "ROCA" (which stands for "Receivership/ Overcrowding Crisis Aggravation"), the Committee held measures that created a new felony, expanded the scope or penalty of an existing felony, or otherwise increased the application of a felony in a manner which could exacerbate the prison overcrowding crisis. Under these principles, ROCA was applied as a content-neutral, provisional measure necessary to ensure that the Legislature did not erode progress towards reducing prison overcrowding by passing legislation, which would increase the prison population. In January of 2013, just over a year after the enactment of the historic Public Safety Realignment Act of 2011, the State of California filed court documents seeking to vacate or modify the federal court order requiring the state to reduce its prison (More) SB 1438 (Pavley) Page 5 population to 137.5 percent of design capacity. The State submitted that the, ". . . population in the State's 33 prisons has been reduced by over 24,000 inmates since October 2011 when public safety realignment went into effect, by more than 36,000 inmates compared to the 2008 population . . . , and by nearly 42,000 inmates since 2006 . . . ." Plaintiffs opposed the state's motion, arguing that, "California prisons, which currently average 150% of capacity, and reach as high as 185% of capacity at one prison, continue to deliver health care that is constitutionally deficient." In an order dated January 29, 2013, the federal court granted the state a six-month extension to achieve the 137.5 % inmate population cap by December 31, 2013. The Three-Judge Court then ordered, on April 11, 2013, the state of California to "immediately take all steps necessary to comply with this Court's . . . Order . . . requiring defendants to reduce overall prison population to 137.5% design capacity by December 31, 2013." On September 16, 2013, the State asked the Court to extend that deadline to December 31, 2016. In response, the Court extended the deadline first to January 27, 2014 and then February 24, 2014, and ordered the parties to enter into a meet-and-confer process to "explore how defendants can comply with this Court's June 20, 2013 Order, including means and dates by which such compliance can be expedited or accomplished and how this Court can ensure a durable solution to the prison crowding problem." The parties were not able to reach an agreement during the meet-and-confer process. As a result, the Court ordered briefing on the State's requested extension and, on February 10, 2014, issued an order extending the deadline to reduce the in-state adult institution population to 137.5% design capacity to February 28, 2016. The order requires the state to meet the following interim and final population reduction benchmarks: 143% of design bed capacity by June 30, 2014; 141.5% of design bed capacity by February 28, 2015; and, 137.5% of design bed capacity by February 28, 2016. If a benchmark is missed the Compliance Officer (a position created by the February 10, 2016 order) can order the release of (More) SB 1438 (Pavley) Page 6 inmates to bring the State into compliance with that benchmark. In a status report to the Court dated February 18, 2014, the state reported that as of February 12, 2014, California's 33 prisons were at 144.3 percent capacity, with 117,686 inmates. 8,768 inmates were housed in out-of-state facilities. The ongoing prison overcrowding litigation indicates that prison capacity and related issues concerning conditions of confinement remain unresolved. While real gains in reducing the prison population have been made, even greater reductions may be required to meet the orders of the federal court. Therefore, the Committee's consideration of ROCA bills -bills that may impact the prison population - will be informed by the following questions: Whether a measure erodes realignment and impacts the prison population; Whether a measure addresses a crime which is directly dangerous to the physical safety of others for which there is no other reasonably appropriate sanction; Whether a bill corrects a constitutional infirmity or legislative drafting error; Whether a measure proposes penalties which are proportionate, and cannot be achieved through any other reasonably appropriate remedy; and, Whether a bill addresses a major area of public safety or criminal activity for which there is no other reasonable, appropriate remedy. COMMENTS 1. Need for This Bill According to the author: California and the nation are in the midst of a drug abuse crisis. Addiction to heroin and other opiates - including prescription pain-killers - is impacting the lives of Californians across the state. Drug overdoses are now the most common cause of accidental death, with an estimated 16,651 fatalities linked to (More) SB 1438 (Pavley) Page 7 opioid painkillers in 2010. While heroin overdoses have increased nationwide, prescription opioids, such as Vicodin and OxyContin, have caused more deaths than heroin and cocaine overdoses combined. This bill would expand the pool of emergency responders who carry the drug naloxone that helps resuscitate victims from an opiate overdose. While naloxone, an opiate antidote that reverses opiate overdoses, has been used by paramedics and advanced emergency medical technicians (EMTs) to save lives for the last few decades in the state, current law is unclear about the ability of other first emergency responders, such as law enforcement, to use this medication. Recently, California has taken several steps to prevent overdose fatalities. Legislation enacted last year expanded the use of naloxone for health care providers, family, friends and other persons who may assist overdose victims, but the law has been interpreted to lack specific clarity about law enforcement's ability to carry and administer the drug. While paramedics and EMTs are often the first to respond to a medical emergency, some localities report that peace officers are increasingly the first to encounter an overdose victim. A recent internal survey within the San Diego Sheriff's Department found that Sheriff's deputies responded to over 200 overdose-related emergency calls in the first nine months of 2013, and in over 50 percent of those cases, the Sheriff's deputy was the first emergency responder on the scene. Last month, in recognition of the nationwide surge in opiate overdoses, U.S. Attorney General Eric Holder echoed the plea made by the director of the White House Office of National Drug Control Policy, to train and equip law enforcement officers with naloxone. (More) SB 1438 (Pavley) Page 8 First responder expansion might not be needed in every jurisdiction, but communities should assess their current resources and local needs. In Ventura County, a portion of which the author represents, from 2008-2011, opioid overdoes-related emergency room visits increased 49 percent, and accidental opioid-related deaths increased 35 percent in the same time frame. The rising rates in the County propelled the start of an organization called "Not One More" by two mothers who lost their children to drug overdoses. They now provide community training on the use of naloxone and some off-duty police have attended the recent trainings. Since their last training, new trainees have already been credited with saving two lives. SB 1438 is intended to save lives by making naloxone available to all first responders, including law enforcement personnel. When a person overdoses, unless these is rapid action to reverse the opioid's effects, getting the overdose victim to a hospital is frequently too late. 2. Deaths Related to Opioid Overdose According to the Centers for Disease Control and Prevention (CDC), there were nearly 37,000 drug overdose deaths in the United States in 2008 and approximately 4,300 drug poisoning deaths in California. Counties experiencing the highest numbers of overdose deaths were Alameda, Fresno, Kern, Los Angeles, Orange, Riverside, Sacramento, San Bernardino, San Diego, San Francisco, and Santa Clara. In 2009, 28,754 (91 percent) of all unintentional poisoning deaths were caused most commonly by prescription opioids, which include such drugs as methadone, hydrocodone (Vicodin), and oxycodone (Oxycontin), followed by cocaine and heroin. 3. Naloxone Background According to the FDA, naloxone, which is not a controlled substance, rapidly reverses the effects of opioid overdose and is the standard treatment for overdose, which is characterized (More) SB 1438 (Pavley) Page 9 by decreased breathing or heart rate or loss of consciousness. The National Institute on Drug Abuse's Web site states that, as of March 2014, 17 states have passed laws that allow for wider prescribing of naloxone to those who can help prevent overdoses, such as family and friends of drug addicts and a wide array of emergency personnel, like police and firefighters. Some overdose prevention programs use syringes fitted with atomizers to enable the medication to be sprayed into the nose. In April 2014, the FDA announced the approval of a new hand-held auto-injector to reverse opioid overdose. The medication is injected into the muscle or under the skin. The new device provides verbal instruction, similar to an automated defibrillator. The FDA granted a fast-track designation, which is designed to facilitate development and to expedite the review of drugs to treat serious conditions and fill unmet medical need, according to the FDA's Web site. 4. Results of Naloxone Distribution and Administration A 2012 CDC report on programs known to distribute naloxone documented the reversal of more than 10,000 heroin overdoses. The programs provided opioid overdose education and naloxone to drug users and to those who might be present during a drug overdose in order to help reduce overdose deaths. However, of the 48 programs that responded, nearly half reported problems in obtaining naloxone related to cost and a shortage of supply. According to the Drug Policy Alliance's (DPA) Web site, naloxone has been safely and effectively used for more than 40 years in ambulances and emergency rooms across the country. Naloxone has no potential for abuse and side effects are rare. DPA also cites ongoing research showing that expanding access to naloxone does not promote increased drug use or risk-taking behavior that results in unintended overdoses. 5. Related Pending and Prior Legislation AB 1535 (Bloom) would authorize a pharmacist to furnish naloxone if the pharmacist provides a consultation to ensure the education of the person to whom the drug is furnished and notification to the patient's primary care provider of drugs or (More) SB 1438 (Pavley) Page 10 devices furnished to the patient. The bill would prohibit a pharmacist from permitting a person to waive the consultation and requires a pharmacist to complete a training program on the use of opioid antagonists prior to furnishing naloxone. AB 1535 is currently in the Assembly Appropriations Committee. AB 635 (Ammiano), Chapter 707, Statutes of 2013, expanded the program in AB 2145 (Ammiano) Chapter 545, Statues of 2010 statewide, deleted the sunset date and the reporting requirements and modified the limited liability provisions for both licensed health care professionals who prescribe, dispense, or distribute naloxone and unlicensed persons who act with reasonable care to administer naloxone to a person who is experiencing or is suspected to be experiencing an overdose. AB 2145 (Ammiano) extended the sunset date of the seven-county pilot program established under SB 767 (Ridley-Thomas), Chapter 477, Statutes of 2007, to January 1, 2016, extended to January 1, 2015, the deadline for the requirement of local health jurisdictions operating an overdose prevention program to report, as specified, to the Senate and Assembly Committees on Judiciary and added immunity for unlicensed trained people who administer an opioid antidote in emergency situations during which they believe that a person is experiencing a drug overdose. SB 767 (Ridley-Thomas) established a seven-county pilot program until January 1, 2010, in which licensed health care providers were given immunity from civil liability or criminal prosecution when they prescribed naloxone to a person in connection with an opioid overdose prevention and training program on how to recognize and respond to an opiate overdose. SB 767 required local health jurisdictions operating an overdose prevention program to report, as specified, to the Senate and Assembly Committees on Judiciary by January 1, 2010. SB 1695 (Escutia), Chapter 678, Statutes of 2002, authorized counties to establish training and certification programs to permit an EMT-I to administer naloxone by means other than intravenous injection if he or she has completed training and passed a test. SB 1695 required EMSA to develop guidelines relating to the county certification programs. (More) SB 1438 (Pavley) Page 11 6. Amendment accepted by Author in Health Committee to be Taken in Public Safety (More) The Senate Health Committee suggested an amendment to prevent conflicts in the provisions concerning standards and regulations developed by the California EMSA and local emergency medical service authorities. The author agreed to take the amendments in this committee. The Senate Health Committee analysis described the amendment as follows: This bill allows a local EMS agency to develop training, standards, and regulations for prehospital emergency medical care personnel for the use and administration of naloxone, in lieu of those developed by the EMSA. To help prevent a conflict, Committee staff suggests the following amendment to ensure that both local EMS agency and EMSA training, standards, and regulations are in line with best practices in the Substance Abuse and Mental Health Administration's Opioid Overdose Prevention Toolkit. The amendments are in bold italics: Section 1797.197 of the Health and Safety Code: (a) The authority shall establish training and standards for all prehospital emergency care personnel, as defined pursuant to in paragraph (2) of subdivision (a) of Section 1797.189, regarding the characteristics and method of assessment and treatment of anaphylactic reactions and the use of epinephrine. The authority shall promulgate regulations regarding these matters for use by all prehospital emergency care personnel. (b) (1) The authority shall establish training and standards for all prehospital emergency care personnel, as defined in paragraph (2) of subdivision (a) of Section 1797.189, regarding the use and administration of naloxone hydrochloride and other opioid antagonists. The authority shall promulgate regulations regarding these matters for use by all prehospital emergency care personnel. The authority may designate existing training and standards for the use and administration of naloxone hydrochloride or another opioid antagonist to satisfy the requirements of this section. (More) SB 1438 (Pavley) Page 13 (2) A local EMS agency may develop its own training and standards, and may promulgate regulations, in lieu of the training and standards and regulations developed by the authority pursuant to paragraph (1), for the purpose of considering local need, regarding the use and administration of naloxone hydrochloride and other opioid antagonists by prehospital emergency care personnel under the jurisdiction of that local EMS agency. (3) The training, standards, and regulations in paragraphs (1) and (2) of subdivision (b) shall be in line with best practices in the Substance Abuse and Mental Health Services Administration's Opioid Overdose Prevention Toolkit. (34) The training described in paragraphs (1) and (2) shall satisfy the requirements of paragraph (1) of subdivision (d) of Section 1714.22 of the Civil Code. ***************