BILL ANALYSIS Ó AB 635 Page 1 CONCURRENCE IN SENATE AMENDMENTS AB 635 (Ammiano) As Amended August 22, 2013 Majority vote ----------------------------------------------------------------- |ASSEMBLY: |77-0 |(April 15, |SENATE: |36-0 |(September 6, | | | |2013) | | |2013) | ----------------------------------------------------------------- Original Committee Reference: JUD. SUMMARY : Revises provisions from the current pilot program authorizing prescription of opioid antagonists for treatment of drug overdose and limiting civil and criminal liability, expands these provisions statewide, and removes the 2016 sunset date. Specifically, this bill : 1)Permits a licensed health care provider who is authorized by law to prescribe an opioid antagonist, if acting with reasonable care, to prescribe and subsequently dispense or distribute an opioid antagonist to a person at risk of an opioid-related overdose or a family member, friend, or other person in a position to assist a person at risk of an opioid-related overdose. 2)Permits the licensed health care provider to issue a standing order 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. 3)Permits the licensed health care provider to issue a standing order for 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 the person at risk. 4)Provides 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. 5)Provides that any person who possesses or distributes an opioid antagonist pursuant to a prescription or standing AB 635 Page 2 order, or any person who acts with reasonable care in administering an opioid antagonist to a person experiencing an overdose, shall not be subject to professional review, be found liable in a civil action, or be subject to criminal prosecution for that act. 6)Requires a person who is prescribed or possesses an opioid antagonist pursuant to a standing order to receive the training provided by an opioid overdose prevention and treatment training program, except that this does not apply to a person who is prescribed an opioid antagonist directly from a licensed prescriber. 7)Deletes provisions restricting the scope of these provisions to seven pilot counties and establishing a 2016 sunset date, extending these provisions indefinitely and expanding authority for the program statewide. 8)Deletes the requirement that each local health jurisdiction that operates or registers an opioid overdose prevention and treatment training program must report specified data by January 1, 2015, to the Senate and Assembly Judiciary Committees. The Senate amendments revise the qualified immunity provisions for administration of an opioid antagonist, to provide that the immunity applies to a person not otherwise licensed to administer an opioid antagonist, but who has received the required training and who acts with reasonable care, in good faith and not for compensation. In addition, they clarify that a person who is prescribed an opioid antagonist directly from a licensed prescriber shall not be required to receive training from an opioid prevention and treatment training program. FISCAL EFFECT : None COMMENTS : Current law authorizes licensed health care providers to prescribe and distribute opioid antagonists for emergency treatment of drug overdose, if done in conjunction with an overdose prevention and treatment training program ("overdose prevention program"), without being subject to civil liability or criminal prosecution. This pilot authority, however, is currently limited to health care providers in only seven counties and is set to expire in 2016. This bill, co-sponsored by Harm Reduction Coalition and the California Society of Addiction Medicine, seeks to expand this authority statewide and AB 635 Page 3 remove the 2016 sunset date. Among other things, this bill would allow health care providers to independently prescribe or issue standing orders for the distribution or administration of naloxone, as specified, but not necessarily in conjunction with a local overdose prevention program. Opioid antagonists are a group of drugs routinely used in hospitals and in pre-hospital settings (i.e., by paramedics in the field) on patients who are suspected to be overdosing on opioids such as heroin, methadone, or oxycodone. The most common type of opioid antagonist is known as naloxone hydrochloride (or its brand name "Narcan"), and is approved by the federal Food and Drug Administration for the treatment of an opioid overdose. (Hereafter, this analysis will use the term "naloxone" interchangeably with the term "opioid antagonist.") Opioid overdoses are characterized by central nervous system and respiratory depression, leading to coma and death. Naloxone, like other opioid antagonists, has the ability to counteract depression of the central nervous and respiratory system caused by an opioid overdose. Naloxone is administered by injection into a vein or muscle, with intravenous injection providing for the fastest action. Once injected, naloxone takes effect after around two minutes, with effects lasting around 45 minutes, potentially saving the person's life. This bill would eliminate the pilot status of the naloxone project and its associated reporting requirements, extending these provisions statewide with no sunset date. According to the author and sponsor, additional data reported by participating pilot counties since 2010 demonstrates that the project has achieved a high rate of success in preventing overdose, coupled with the near total lack of any adverse events associated with administration of naloxone. In short, proponents of this bill contend that pilot project data demonstrate that naloxone prescription is safe and effective in saving lives without producing significant adverse events, thus justifying removal of the sunset date and pilot program status. Supporters contend that because naloxone cannot be self-administered by the person experiencing the overdose, it is wise to extend protection from liability to third parties who are trained to administer naloxone, or else they will simply avoid employing naloxone in an emergency even when it is available. They also report that county health workers who AB 635 Page 4 operate or who desire to operate a naloxone prescription program report are having difficulty finding health care providers who are comfortable writing prescriptions for a medication that will, by necessity, be administered by a third party, without reasonable liability protection. Furthermore, supporters assert that even so-called "frontline workers" who have taken overdose prevention trainings, and who often are in close contact with drug users at sites like homeless shelters and drug treatment facilities, nevertheless are reluctant to keep the naloxone close at hand for emergency response, without any legal protection for a third party who administrates naloxone. Under existing law, a licensed health care provider may prescribe naloxone "in conjunction with an opioid overdose prevention and treatment training program." This bill would strike that requirement and instead permit the health care provider to prescribe the drug as long as he or she acts with reasonable care and is authorized by law to prescribe an opioid antagonist. In order for naloxone to be available to potentially save lives outside the seven pilot counties, the author recognizes that its prescription cannot be limited to only those doctors working in conjunction with overdose prevention programs-particularly when such programs do not exist in many counties in the state, often because of lack of financial resources. The author notes that naloxone is: 1) non-addictive and regulated at the same level as prescription ibuprofen; 2) has no effect on a person if opioids are absent in their system; and, 3) can be safely administered by minimally trained laypeople, as has been demonstrated by data reported through the SB 767 pilot project. In addition, physicians who prescribe medications already have a professional duty to explain those medications to their patients and families, including indications, use, risks and benefits. For these reasons, the author contends that naloxone prescriptions need not be limited to only doctors operating in conjunction with a local overdose prevention program. This bill also authorizes licensed health care providers to issue a standing order for the distribution or the administration of the opioid antagonist to the person at risk, or his or her family member, friend or other person in assistance. Unlike a prescription, which facilitates direct access of the drug to the person for whose use it is intended, a AB 635 Page 5 standing order is a type of physician's order that allows other health care workers to exercise the order when certain predetermined conditions are met. Under this bill, an authorized physician may issue one of two kinds of standing orders. The first authorizes naloxone to be distributed to a person at risk for overdose, or a family member, friend, or other person in a position to assist in the case of an overdose. Distribution in this context is a preventive measure to increase the chance that naloxone will be available should an overdose event occur. The second type of standing order under this bill authorizes naloxone to be administered (i.e., injected) to help save the life of a person experiencing or reasonably suspected of experiencing an opioid overdose. With respect to liability for issuing a prescription or standing order, this bill provides 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 if he or she complies with the standards set forth by this bill. With respect to liability for possession of naloxone, this bill reasonably limits liability for any person who possesses or distributes naloxone if it was done pursuant to a prescription or standing order. At the same time, this bill requires a person who is prescribed or possesses an opioid antagonist pursuant to a standing order to receive the training provided by an opioid overdose prevention and treatment training program, except that this does not apply to a person who is prescribed an opioid antagonist directly from a licensed prescriber. Finally, with respect to the administration of naloxone, the bill limits civil and criminal liability for a person not otherwise licensed to administer an opioid antagonist, but who has received the required training and who acts with reasonable care in administering an opioid antagonist, in good faith and not for compensation, to someone who is experiencing or is suspected of experiencing an overdose. By limiting liability for naloxone prescription and use strictly pursuant to a prescription or standing order issued by a licensed health care professional, this bill seeks to encourage and enable more health care providers to prescribe naloxone, where appropriate, to certain patients at risk of opioid overdose-particularly important in light of evidence of a AB 635 Page 6 substantial epidemic of prescription drug overdoses. In addition, the author contends, this bill will remove an obstacle to the creation and expansion of more overdose prevention programs in California. Analysis Prepared by : Anthony Lew / JUD. / (916) 319-2334 FN: 0001912