BILL ANALYSIS Ó SENATE JUDICIARY COMMITTEE Senator Noreen Evans, Chair 2013-2014 Regular Session AB 635 (Ammiano) As Amended April 11, 2013 Hearing Date: June 18, 2013 Fiscal: No Urgency: No RD SUBJECT Drug Overdose Treatment: Liability DESCRIPTION Existing law establishes a seven county pilot program, until January 1, 2016, which provides a qualified immunity to licensed health care providers who prescribe naloxone (a prescription drug to counteract an opiate overdose), and to unlicensed trained persons that administer naloxone in emergency situations where they believe, in good faith, that the other person is experiencing a drug overdose. This bill would expand the pilot program by removing the sunset, removing the restriction to only seven counties, authorizing licensed health care providers to also prescribe naloxone to third parties (family members, friends, or other persons in a position to assist a person at risk of an opioid-related overdose), as well as to issue standing orders for the distribution and/or administration of naloxone. This bill would also amend the program's limited liability provisions to instead confer: qualified immunity from civil liability, criminal prosecution, or professional review to licensed health care providers who issue prescriptions or standing orders pursuant to the program; and immunity from civil action or criminal prosecution, or professional review, to any persons who possess or distribute naloxone pursuant to a prescription or standing order, or acting with reasonable care in administering naloxone, as specified. (more) AB 635 (Ammiano) PageB of? This bill would also require that person who is prescribed naloxone or possesses it pursuant to a standing order receive training, as defined. BACKGROUND Opioid overdoses are characterized by central nervous system and respiratory depression, leading to coma and death. While there are various opioid antagonists, the most popular appears to be naloxone, which has the ability to counteract depression of the central nervous and respiratory system caused by an opioid overdose. Naloxone is administered by either injection into vein or muscle or via a nasal atomizer. Once administered, naloxone takes effect after around a minute, with effects lasting around 45 minutes, potentially saving the person's life. The New York Times August 21, 2005 article entitled The Shot That Saves, noted: If given early enough, naloxone can prevent damage to the brain caused by lack of oxygen and leave the victim unharmed. According to research . . . at least 75 percent of overdose deaths involve multiple drugs, usually mixtures of heroin and other depressants like alcohol. Removing the opioid from the mix with naloxone is often enough to revive victims. Naloxone itself is virtually harmless. Its most common side effects are withdrawal symptoms like nausea, shakiness and agitation in those who are physically dependent on opioids. While uncomfortable, these symptoms are not dangerous. Rarely, seizures can occur, but this risk is far lower than the risk to those who are not treated. The drug has no effect on those who haven't taken opioids. . . . According to a study published in the journal Drug and Alcohol Dependence, 57 percent of 1,184 hard drug users interviewed had witnessed at least one overdose. Medical help was sought in only two-thirds of the instances, and this was usually only after efforts to revive the victim by hitting him or rubbing him with ice had failed . . . . More than half of the drug users in the study cited fear of arrest as the main reason for delaying or failing to seek help. AB 635 (Ammiano) PageC of? In 2007, in order to facilitate the prescription of naloxone to trained individuals in California, SB 767 (Ridley-Thomas, Ch. 477, Stats. 2007) established a seven county pilot program through January 1, 2010, that provided licensed health care providers with a qualified immunity from civil liability or criminal prosecution when they prescribed naloxone. That immunity only applies where the health care provider dispensed that drug in connection with an opioid overdose prevention and training program - those programs, either registered or run by a local health jurisdiction, train individuals for how to recognize and respond to an opiate overdose. AB 2145 (Ammiano, Ch. 545, Stats. 2010) has since extended the sunset date for the program to January 1, 2016, extended the deadline for the reporting requirements to January 1, 2015, and added a new qualified immunity for unlicensed trained persons who administer an opioid antidote in emergency situations where they believe, in good faith, that the other person is experiencing a drug overdose. This bill would expand this program statewide, delete the sunset and the reporting requirements, and, among other things, modify the limited liability provisions for both licensed health care professionals who prescribe, dispense or distribute naloxone, as well as unlicensed persons who act with reasonable care to administer naloxone to a person is experiencing or is suspected to be experiencing an overdose. CHANGES TO EXISTING LAW Existing law , the California Uniform Controlled Substances Act, strictly regulates the distribution of controlled substances within California. (Health & Saf. Code Sec. 11000 et seq.) Existing law prohibits the prescription, administration, or dispensing of a controlled substance to an addict, except under certain circumstances. (Health & Saf. Code Sec. 11156; Bus. & Prof. Code Sec. 2241.) Existing law provides that a licensed health care provider who is permitted by law to prescribe an opioid antagonist may, if acting with reasonable care, prescribe and subsequently dispense or distribute an opioid antagonist in conjunction with an opioid overdose prevention and treatment training program, without being subject to civil liability or criminal prosecution. This immunity applies to the licensed health care provider even when the opioid antagonist is administered by and to someone other AB 635 (Ammiano) PageD of? than the person to whom it is prescribed. (Civ. Code Sec. 1714.22(b).) Existing law permits a person who is not otherwise licensed to administer an opioid antagonist to administer an opioid antagonist in an emergency without fee if the person has received the training information as specified and believes in good faith that the other person is experiencing a drug overdose. The person shall not, as a result of his or her acts or omissions, be liable for any violation of any professional licensing statute, or subject to any criminal prosecution arising from or related to the unauthorized practice of medicine or the possession of an opioid antagonist. (Civ. Code Sec. 1714.22(c).) Existing law requires that each local health jurisdiction that operates or registers an opioid overdose prevention and treatment training program, by January 1, 2015, collect, and report to the Senate and Assembly Judiciary Committees, specified data on programs within the jurisdiction, including, among other things: the number of opioid antagonist doses prescribed, the number of opioid antagonist doses administered, the number of individuals who received opioid antagonist injections who were properly revived and the number who were not revived, as well as the number of adverse events associated with an opioid antagonist dose that was distributed as part of an opioid overdose prevention and treatment training program. (Civ. Code Sec. 1714.22(d).) Existing law limits the application of this law to the Counties of Alameda, Fresno, Humboldt, Los Angeles, Mendocino, San Francisco, and Santa Cruz and includes a January 1, 2016 sunset. (Civ. Code Sec. 1714.22(e)-(f).) Existing law defines for these purposes "opioid antagonist" and "opioid overdose prevention and treatment training program." (Civ. Code Sec. 1714.22(a).) This bill would remove the restriction to the counties above and repeal the sunset date. This bill would authorize a licensed health care provider who is authorized by law to prescribe an opioid antagonist to, if acting with reasonable care, 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 AB 635 (Ammiano) PageE of? person in a position to assist a person at risk of an opioid-related overdose. This bill would permit a licensed health care provider who is authorized by law to prescribe an opioid antagonist to issue standing orders for: the distribution of 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; and the administration of an opioid antagonist to a person at risk of an opioid-related overdose by a family member, friend, or other person in a position to assist a person experiencing or reasonably suspected of experiencing an opioid overdose. This bill would provide that a licensed health care provider who acts with reasonable care shall not be subject to professional review, found liable in a civil action, or be subject to criminal prosecution for issuing a prescription or standing order pursuant to the bill. This bill would provide that, notwithstanding any other law, a person who possesses or distributes an opioid antagonist pursuant to a prescription or standing order shall not be subject to professional review, be found liable in a civil action, or be subject to criminal prosecution for this possession or distribution. This bill would provide that, notwithstanding any other law, a person who acts with reasonable care and administers an opioid antagonist to a person who is experiencing or is suspected of experiencing an overdose shall not be subject to professional review, be liable in a civil action, or be subject to criminal prosecution for this administration. This bill would require that a person who is prescribed an opioid antagonist or possesses it pursuant to a standing order shall receive the training provided by an opioid overdose prevention and treatment training program. COMMENT 1. Stated need for the bill According to the author: AB 635 (Ammiano) PageF of? Drug overdoses are now the leading cause of injury death in the United States, surpassing motor vehicle crash deaths. According to the most recent data released by the Centers for Disease Control and Prevention [(CDC)], there were 37,000 drug overdose deaths in the United States in 2009. In 2008, the most recent year data is available, there were 4,334 drug poisoning deaths in California. Counties experiencing the highest numbers of overdose deaths are: Alameda, Fresno, Kern, Los Angeles, Orange, Riverside, Sacramento, San Bernardino, San Diego, San Francisco, and Santa Clara Counties. According to the CDC, in 2009, 28,754 (91 percent) of all unintentional poisoning deaths were caused by drugs. The class of drugs known as prescription opioids, which includes such drugs as methadone, hydrocodone (Vicodin), and oxycodone (Oxycontin), was most commonly involved, followed by cocaine and heroin. Drug poisoning is the leading cause of injury death in California and its effects are felt throughout all sectors of the state. When a person overdoses on opioids he/she experiences depression of the central nervous system and is in danger of dying because the opioids slow down, and eventually stop, the person's breathing. Naloxone (also known as Narcan) is routinely used in hospitals and by paramedics in the field to revive individuals who are suspected to be overdosing on opioids. In California, overdose prevention programs operate in a handful of cities and counties, but have limited reach in terms of addressing the overdose issue statewide. Both SB 767 [(Ridley-Thomas, Ch. 477, Stats. 2007)] and AB 2145 [(Ammiano, Ch. 545, Stats. 2010)] only covered the [c]ounties of Alameda, Fresno, Humboldt, Los Angeles, Mendocino, San Francisco, and Santa Cruz. These counties were designated as pilot counties because they had existing overdose prevention programs in place already, through their local syringe access and disposal programs. The Harm Reduction Coalition is working with health advocates in Stanislaus, San Joaquin, Sacramento, Sonoma, San Diego, Kern, Santa Clara, Ventura and Orange counties who are either already doing independent naloxone distribution as part of an overdose prevention program, or would like to start, as they are now considered 'best practice' components of high quality programs that focus on the health of drug users. AB 635 (Ammiano) PageG of? AB 635 safely expands the availability and distribution of this life-saving drug. [ . . . ] 2. Pilot program reports demonstrate naloxone can be safely administered by trained lay persons and save a significant number of lives To reduce rates of fatal opioid exposure, naloxone, a nonscheduled prescription drug has been distributed as part of an emergency kit for opiate abusers in various cities, as victims of opioid overdoses may be unconscious, incapacitated, or otherwise unable to inject themselves. As noted in the Background, since 2007, seven California counties have been authorized by law to operate a pilot program to allow licensed health care providers to prescribe, dispense, or distribute naloxone even where they know that the opioid antagonist will be administered by and to some other than the person to whom it is prescribed. Pursuant to AB 2145, the author has submitted copies of reports submitted by Los Angeles, San Francisco, Santa Cruz, Humboldt, and Alameda in 2011 (Fresno and Mendocino have not had funds for these programs since 2009 and therefore did not have data to report). Overall, those reports tend to demonstrate that when used, in most cases, lives were saved. Many of the reports echoed that where the drug did not work, it's suspected that the person was already dead when it was administered. The adverse effects noted in these reports involved anger or vomiting, which are considered to be within the "normal range" of adverse outcomes, though the side effects can also include seizures. More specifically, a summary of the reports provided by the author demonstrates that in 2011: In two Alameda County programs, naloxone was prescribed and distributed to 225 individuals, 65 overdose treatments with naloxone were reported, and 64 people were successfully revived. Adverse events, such as anger, vomiting, confusion, were minor and associated with the rapid withdrawal caused by naloxone. In the one Humboldt County program, naloxone was prescribed and distributed to 13 trained clients in 2011, four overdose interventions were reported, and all four people were revived. No adverse events were reported. Between the three Los Angeles County programs, naloxone was prescribed and distributed to 199 individuals in 2011, 42 AB 635 (Ammiano) PageH of? overdose treatments with naloxone were reported, with 41 people successfully revived. The only adverse event reported was anger in one case, associated with the rapid withdrawal caused by naloxone. In the San Francisco County program, overdose prevention education and naloxone were provided to 1135 individuals between January 2010 and December 2011. Additionally, 680 previously-trained individuals returned for refills. During 2010-2011, 185 individuals reported using their naloxone and/or the skills learned in the training program to revive an overdosing person, and 182 were successful revived. No adverse events occurred outside of anger. In the Santa Cruz County program, training and distribution of naloxone was provided to 100 individuals and 10 overdose reversals using naloxone were reported, all of which were successful and had no adverse outcomes. Of note, the author and sponsor point out that the Center for Disease Control and Prevention reports that drug overdoses are now the leading cause of injury (i.e. accidental) death in the U.S., surpassing motor vehicle crash deaths, and this bill could help reduce those deaths. In support of the bill, the California Opioid Maintenance Providers writes that this bill would help "address needless overdose deaths that occur when either a person at risk of overdose or a friend or family member of such a person does not have access to the medications that can reverse the symptoms of overdose known as opioid antagonists. Multiple studies of overdose have shown that death rarely occurs immediately from a drug related overdose, and most deaths occur 1 to 3 hours after the initial dose of drugs. Many overdoses are reversible if the individual gets medical assistance in time." (Footnote citation omitted.) Accordingly, this bill seeks to expand the access and distribution of to this life-saving treatment by removing the limitation of the current pilot program to those seven counties and by permitting a licensed health care provider who is authorized by law to prescribe an opioid antagonist to, if acting with reasonable care, 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. In furtherance of that same goal, this bill would authorize a licensed health care provider to issue AB 635 (Ammiano) PageI of? standing orders<1> for the distribution and administration of an opioid antagonist to any of those persons, in order to assist a person at risk of an opioid-related overdose, or who is experiencing or is reasonably suspected to be experiencing an opioid overdose. 3. Limited liability provisions reduce the ability of an injured party to seek recovery and should therefore operate to serve important public policy in a measured fashion The existing pilot program provides a qualified immunity from civil liability and criminal prosecution to licensed health care providers who prescribe naloxone even when the opioid antagonist is administered by and to someone other than the person to whom it is prescribed, and to persons who administer the opioid antagonist in an emergency to another person who they believe in good faith to be experiencing an overdose. In order to increase the use of naloxone in emergency situations, this bill not only expands the explicit authorization for licensed health care providers to issue prescriptions and standing orders for naloxone, but it also seeks to remove barriers in the prescription, dispensing of, distribution, or administration of this drug by providing certain immunities for both licensed health care professionals and persons possessing, distributing, or administering the drug. Specifically, to reduce the hesitation of physicians or other licensed health care providers in prescribing naloxone, this bill would provide that a licensed health care provider who acts with reasonable care shall not be subject to professional review, be found liable in a civil action, or be subject to criminal prosecution for issuing a prescription or standing order in accordance with this bill. As acknowledged by the author, even in doing so, this bill will not prohibit a health care provider from being sued for negligence. Additionally, this bill seeks to reduce concerns of third parties (family members or friends) who fear lawsuits, criminal --------------------------- <1> Standing orders, which include protocols, generally prescribe the action to be taken in caring for a patient with a certain condition, including the dosage and route of administration for a drug or the schedule for the administration of a therapeutic procedure. The important characteristic of a standing order is that all the patients who meet the criteria for the order receive the same treatment. AB 635 (Ammiano) PageJ of? prosecution or being made subject to professional review for administering this medication or simply being in possession of this drug, by providing that notwithstanding any other law: (1) a person who possesses or distributes an opioid antagonist pursuant to a prescription or standing order shall not be subject to professional review, be found liable in a civil action, or be subject to criminal prosecution for this possession or distribution; and (2) a person who acts with reasonable care and administers an opioid antagonist to a person who is experiencing or is suspected of experiencing an overdose shall not be subject to professional review, be liable in a civil action, or be subject to criminal prosecution for this administration. As a general rule, California law provides that everyone is responsible, not only for the result of his or her willful acts, but also for an injury occasioned to another by his or her want of ordinary care or skill in the management of his or her property or person, except so far as the latter has, willfully or by want of ordinary care, brought the injury upon himself or herself. (Civ. Code Sec. 1714(a).) Although immunity provisions are rarely preferable because they, by their nature, prevent an injured party from seeking a particular type of recovery, the Legislature has in limited scenarios approved measured immunity from liability (as opposed to blanket immunities) to promote other policy goals that could benefit the public. a. This bill arguably promotes a policy goal of providing emergency treatment in a safe and reasonable manner to save lives . The California Attorneys for Criminal Justice, in support of this bill, writes that "many drug-related overdose deaths are caused by the attempt to avoid penalties. Deterrence policies that penalize California citizens for accessing medical services in the event of an emergency drug overdose show little to no effectiveness at reducing drug use. Furthermore, the costs of these deaths to the people of California far outweigh any policy benefit of reduced drug use. AB 635 would facilitate the ability of licensed professionals to provide aid to those who are in danger of opioid overdose without fear of reprisal for themselves or for those receiving that help." Proponents of this bill also note that: AB 635 (Ammiano) PageK of? The state's longest-running naloxone prescription program in San Francisco has provided over 3600 take-home naloxone prescriptions since 2003 through collaboration with the San Francisco Department of Public Health, using a "standing order" model with over 900 lives saved. In addition, prescribers at SFDPH public health clinics are co-prescribing naloxone with prescription opioids to their patients. However, many licensed health care practitioners still fear prescribing take-home opioid antagonists to their patients because of potential civil and criminal liability. As a matter of public policy, given the information submitted to the Committee, that generally demonstrates that opioid antagonists such as naloxone can be safely administered by trained individuals with substantial success and relatively few and comparatively minor adverse outcomes for individuals receiving the drug, the expansion of this program arguably appears justified. To the extent that qualified immunity provisions may help foster the growth of such programs and practices, this bill could feasibly help reduce the number of unnecessary drug overdoses in this state, as noted by many of the proponents of this bill. As commented by the California Public Defenders Association, writing in support of the bill: "[t]his bill recognizes that an individual who is potentially overdosing on an opioid substance should have the greatest possible access to an opioid antagonist that may possibly save that person's life." Thus, the question necessarily becomes whether the proposed immunity provisions would appropriately balance the public policy of saving lives where there is a reasonable method of providing assistance against the ability for an injured person to seek recourse for injuries sustained as a result of the administration of naloxone. (See Comment 3b below for further discussion). b. Amendments to ensure the immunity provisions are measured As noted above, despite the general disfavoring of immunity provisions for the reasons stated above, where there is a generally safe, reliable, and easily administrable treatment that can prevent unnecessary death, as a matter of public policy, it may be appropriate to confer a limited immunity as AB 635 (Ammiano) PageL of? a way of encouraging the provision of a potentially life-saving treatment. At the same time, qualified immunity, as opposed to blanket immunity, is preferable to ensure a party injured in the provision of this care can seek recourse in the courts in appropriate circumstances. Staff notes that this type of qualified immunity is not without precedent under California law. For example, there is a comparable California statute under existing law relating to automatic external defibrillators (AEDs), whereby this state encourages the provision of emergency care with a reduced risk of civil liability, in order to avoid preventable deaths. In the AED context, however, the qualified immunity does not apply in the case of personal injury or wrongful death which results from the gross negligence or willful or wanton misconduct by the person who uses the AED to render emergency care. (See Civ. Code Sec. 1714.21.) Earlier this year, this Committee heard and approved a bill, SB 669 (Huff), which sought to promote a wider use of epinephrine auto injectors (commonly referred to as epi-pens) to persons suffering anaphylactic shock due to an allergic reaction, which can quickly lead to death without treatment. To do so, that bill would have, among other things, provided immunity to any trained lay person who administers, in good faith, and without compensation, epinephrine auto injectors to another person in emergency situations. As amended in this Committee, that bill now mirrors the AED statutes to make the limited liability inapplicable where there was gross negligence or willful or wanton misconduct by the person rendering the emergency care. Arguably, because this bill seeks to encourage the rendering of emergency care in similar fashion (using naloxone as opposed to an epinephrine auto-injector or an AED), the scope of the immunity should also apply in similar fashion as well. Although the limited liability provisions of this bill have been drafted differently from the AED statute, the outcome would arguably be the same in that the licensed care provider must have acted with reasonable care in prescribing the opioid antagonist or issuing a standing order for it, and that the person administering the opioid antagonist must also have acted reasonably. That being said, as currently written, the bill is missing two AB 635 (Ammiano) PageM of? of the elements in the qualified immunity provisions of the AED statute and similar legislation passed out of this Committee-namely, (1) that the unlicensed person was trained and acted in compliance with that training, and (2) that the emergency care was rendered in good faith, and not for compensation (i.e. ensuring against application to, for example, an emergency medical technician in the performance of his or her job). Those elements are currently reflected in the qualified immunity provision of the existing pilot program. The following amendments would achieve consistency in law and also make a clarifying amendment: Suggested amendment: On page 4, line 5, strike "Notwithstanding any other law," and strike lines 7-10 inclusive. On page 4, line 5, after period insert "Notwithstanding any other law, a person not otherwise licensed to administer an opioid antagonist, but trained as required under subdivision (d), who acts with reasonable care in administering an opioid antagonist, in good faith and not for compensation, to a person who is experiencing or is suspected of experiencing an overdose shall not be subject to professional review, be liable in a civil action, or be subject to criminal prosecution for this administration." On page 3, line 37 and on page 4, line 3, strike "found" Support : Berkeley Needle Exchange Emergency Distribution; California Attorneys for Criminal Justice; California Association of Alcohol and Drug Program Executives, Inc. (CAADPE); California Opioid Maintenance Providers; California Public Defenders Association; Civil Justice Association of California (CJAC); City and County of San Francisco; Common Ground, the Westside HIV Community Center; County Alcohol and Drug Program Administrators Association of California (CADPAAC); Drug Policy Alliance (DPA); Harm Reduction Therapy Center; Homeless Health Care Los Angeles; Medical Board of California; National Coalition Against Prescription Drug Abuse; San Francisco Drug Users Union; Shasta Community Health Center; one individual AB 635 (Ammiano) PageN of? Opposition : None Known HISTORY Source : California Society of Addiction Medicine; Harm Reduction Coalition Related Pending Legislation : SB 669 (Huff) See Comment 3. Prior Legislation : AB 2145 (Ammiano, Ch. 545, Stats. 2010) See Background. AB 767 (Ridley-Thomas, Ch. 477, Stats. 2007) See Background. Prior Vote : Assembly Floor (Ayes 77, Noes 0) Assembly Judiciary Committee (Ayes 8, Noes 0) **************