BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | SB 1438| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- THIRD READING Bill No: SB 1438 Author: Pavley (D), et al. Amended: 5/21/14 Vote: 21 SENATE HEALTH COMMITTEE : 9-0, 4/24/14 AYES: Hernandez, Morrell, Beall, De León, DeSaulnier, Evans, Monning, Nielsen, Wolk SENATE PUBLIC SAFETY COMMITTEE : 6-0, 4/29/14 AYES: Hancock, Anderson, Knight, Liu, Mitchell, Steinberg NO VOTE RECORDED: De León SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8 SUBJECT : Controlled substances: opioid antagonists SOURCE : Author DIGEST : This bill clarifies that peace officers are included among the persons authorized to receive and distribute opioid antagonists, as specified. Requires the Emergency Medical Services Authority (EMSA) to develop and adopt training and standards, and promulgate regulations, for all prehospital emergency care personnel regarding the use and administration of naloxone hydrochloride (naloxone) and other opioid antagonists. Permits this training to also be conducted at the discretion of the medical director of the local emergency medical services agency (LEMSA). Clarifies that both of those types of trainings satisfy specified requirements allowing for immunity from CONTINUED SB 1438 Page 2 criminal and civil liability for administering an opioid antagonist. Additionally, permits the Attorney General (AG), to authorize hospitals and trauma centers to share information with local law enforcement agencies and LEMSAs. Limits the data that may be provided by hospitals and trauma centers to the number of overdoses and the substances suspected as the primary cause of the overdoses. Senate Floor Amendments of 5/21/14 delete the authority of a LEMSA to establish its own training, standards, and regulations in the use and authorization of naloxone and other opioid antagonists and instead authorize the medical director of a LEMSA to use discretion in determining when training completed by personnel satisfies part of the training requirements established by EMSA. ANALYSIS : Existing law: Civil Code 1.Defines "opioid antagonist" as naloxone that is approved by the federal Food and Drug Administration (FDA) for the treatment of an opioid overdose. 2.Allows 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. Allows a licensed health care provider to issue standing orders for these purposes. 3.Requires 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. Specifies that a person who is prescribed naloxone directly from a licensed prescriber, and not through a standing order, is not subject to the training requirement. 4.Exempts a health care provider who acts with reasonable care in issuing a prescription for naloxone and any person who possesses, distributed, or administers naloxone, with reasonable care, from professional review, civil action, or SB 1438 Page 3 criminal prosecution. Health and Safety Code 5.Requires EMSA to 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. Requires EMSA to promulgate regulations for use by all prehospital emergency care personnel. 6.Requires the AG to encourage research on the misuse and abuse of controlled substances. Allows the AG 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. This bill: 1.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. Adds peace officers to the list of people who can receive standing orders for the distribution of an opioid antagonist for this purpose. 2.Requires EMSA to develop, and after approval by the Commission on Emergency Medical Services, adopt training and standards for all prehospital emergency care personnel on the statewide use and administration of naloxone and other opioid antagonists and to promulgate regulations for this purpose. Allows EMSA to adopt existing training and standards for this purpose. 3.Permits pertinent training completed by prehospital emergency care personnel, at the discretion of the medical director of the LEMSA, to be used to satisfy part of the training requirements established pursuant to (1) above regarding the use and administration of naloxone and other opoid antagonists by prehospital emergency care personnel. 4.Permits the AG to authorize hospitals and trauma centers to SB 1438 Page 4 share information with local law enforcement and LEMSAs about controlled substance overdose trends. Specifies that this information is limited to the number of overdoses and the substances suspected as the primary cause of the overdoses and requires the information to be shared in a matter that ensures patient confidentiality. 5.Clarifies that the training described in (1) and (2) satisfy the requirements allowing for immunity from criminal and civil liability for administering an opioid antagonist, as specified. Background 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%) 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. Naloxone . 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 by decreased breathing or heart rate or loss of consciousness. The National Institute on Drug Abuse's Internet 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 to 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 SB 1438 Page 5 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 Internet Web site. 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's) Internet 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. Prior Legislation AB 635 (Ammiano, Chapter 707, Statutes of 2013) expanded the program in AB 2145 (Ammiano, Chapter 545, Statutes 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 1438 Page 6 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. 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/she has completed training and passed a test. Required EMSA to develop guidelines relating to the county certification programs. SB 1134 (Escutia, 2001) contained, among other things, the provisions in SB 1695 above. SB 1134 was vetoed by Governor Davis who cited cost reasons related to provisions in the bill that required grants for drug overdose prevention programs. SB 851 (Oller, 2001) required the EMSA to develop and implement procedures and protocols to permit EMT-I's in Sierra County to obtain training and certification to safely administer emergency medical procedures, including naloxone, that are outside of their scope of practice. This bill died in the Senate Health and Human Services Committee. FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes Local: No SUPPORT : (Verified 5/22/14) California Chapter of the American College of Emergency Physicians California Pharmacists Association California State Sheriffs' Association Drug Policy Alliance Emergency Medical Services Administrators' Association of California ARGUMENTS IN SUPPORT : The DPA writes that this bill is an SB 1438 Page 7 urgently needed measure to allow first responders to administer opiate overdose reversal medication, naloxone, to a person at risk of a fatal overdose. Naloxone has been extensively researched and widely used by a number of health care entities for decades and several states have already expanded usage to peace officers with no reports of negative outcomes for patient safety. DPA believes this bill is part of a comprehensive strategy to combat the epidemic of opiate overdoses in California. JL:e 5/22/14 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END ****