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California Comprehensive Overdose Treatment Protection Signed by Governor

GOVERNOR SIGNS COMPREHENSIVE OVERDOSE TREATMENT PROTECTION

SACRAMENTO, CA — Governor Brown signed AB 635, authored by Assembly member Ammiano, to decrease overdose fatalities in California by increasing the distribution of an opioid overdose antidote, naloxone. Drug overdoses are now the leading cause of accidental death in the United States, surpassing motor vehicle crash deaths.

This legislation protects doctors and other licensed health professionals who prescribe and distribute naloxone to those who need it, including at-risk illicit or prescription drug users and potential bystanders to an overdose. It also clarifies that treatment providers and other non-medical personnel are able to distribute the prescription antidote under a doctor’s “standing orders”. This practice translates into significant cost savings for individuals and taxpayers. Additionally, the bill will encourage health care providers to begin prescribing naloxone to patients on chronic opioid pain medications in order to address the prescription drug overdose epidemic.

Harm Reduction Coalition (HRC), bill co-sponsor with the California Society of Addiction Medicine, applauded the legislature. “In California, overdose prevention programs have operated in a handful of cities and counties, but have had limited reach in terms of addressing the overdose issue statewide because of potential legal concerns” explained HRC California Director, Hilary McQuie. “We applaud Governor Brown for joining this bipartisan consensus to protect the programs already operating, remove the obstacles for those that want to start, and clarify that prescribers may employ the ‘best practice’ of prescribing naloxone to those at greatest risk for overdose.”

Overdose prevention programs distribute the life-saving drug naloxone (also known as Narcan®), which reverses an opioid overdose from drugs like heroin, oxycodone, morphine, or methadone by restoring an overdosing person’s breathing and heart rate. The state’s longest-running overdose prevention program, the Drug Overdose Prevention and Education Project (DOPE) in San Francisco, a program of the Harm Reduction Coalition, has provided over 3600 take-home naloxone prescriptions since 2003 in collaboration with the San Francisco Department of Public Health, with over 1000 lives saved. In addition, clinicians at SFDPH public health clinics started co-prescribing naloxone with prescription opioids this year to their patients. According to a Centers for Disease Control report, overdose prevention programs distributing naloxone in the US have trained over 50,000 laypersons to revive someone during an overdose to date, resulting in over 10,000 overdose reversals using naloxone. However, many licensed health care practitioners still fear prescribing take-home opioid antagonists like naloxone to their patients because of potential civil and criminal liability.

INFORMATION ON THE CALIFORNIA OVERDOSE TREATMENT ACT

As of January 1, 2014, the provisions of AB 635, The Overdose Treatment Act, will become law. This law is designed to encourage California health care providers and community programs to widely distribute naloxone to treat opioid overdose incidents.

Naloxone is used in opioid overdoses to counteract life-threatening depression of the central nervous system and respiratory system, allowing an overdosing person to breathe normally. Naloxone is a nonscheduled (i.e., non-addictive), inexpensive prescription medication with the same level of regulation as prescription ibuprofen. Naloxone only works if a person has opioids in their system; the medication has no effect if opioids are absent. Although traditionally administered by emergency response personnel, naloxone can be administered by minimally trained laypeople, which makes it ideal for treating overdose in people who have been prescribed opioid pain medication and in people who use heroin and other illicit opioids.

AB 635 is an expansion of previous naloxone-related legislation in California, now allowing for the prescription and distribution of naloxone throughout the state. The law:

  • Provides protection to licensed health care professionals statewide from civil and criminal liability when, if acting with reasonable care, they prescribe, dispense, or oversee the distribution via a standing order of naloxone via an overdose prevention program or standard medical practice.
  • Permits individuals to possess and administer naloxone in an emergency and protect these individuals from civil or criminal prosecution for practicing medicine without a license.
  • Clarifies that licensed prescribers are encouraged to prescribe naloxone to individual patients on chronic opioid pain medications in order to address the prescription drug overdose epidemic.

Currently in the US, over 50 successful overdose prevention programs operating over 200 sites have been established in 19 states to provide lay community members (including drug users, their friends and family members) with the training and tools necessary to intervene effectively when they witness a drug overdose. These programs are providing overdose prevention, recognition, and response training, including training in calling 911, rescue breathing and utilization of take-home prescriptions of naloxone to drug users and their loved ones. To date, according to a CDC report, overdose prevention programs distributing naloxone have trained over 50,000 laypersons to revive someone during an overdose, resulting in over 10,000 overdose reversals using naloxone.

California’s longest-running naloxone prescription program in San Francisco has provided over 4,000 take-home naloxone prescriptions since 2003 through collaboration with the San Francisco Department of Public Health. To date, over 1000 lives have been saved by laypersons trained by this program who administered their take-home naloxone during an overdose.

In addition to community-based naloxone distribution programs that mostly serve high-risk heroin users, there are new pilot initiatives in California to prescribe naloxone directly to patients receiving opioid medications for chronic pain. San Francisco General Hospital has piloted this intervention in several clinics targeting chronic pain patients in order to address the potential overdose risk in this population.

For technical assistance on implementing naloxone distribution or co-prescription, please contact the Harm Reduction Coalition, 510-444-6969

Text of AB 635:

(b) A licensed health care provider who is authorized by law to prescribe an opioid antagonist may, 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. 

(c) (1) A licensed health care provider  who is authorized by law to prescribe an opioid antagonist may 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.

 (2) A licensed health care provider who is authorized by law to prescribe an opioid antagonist may issue standing orders 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 a person experiencing or reasonably suspected of experiencing an opioid overdose. 

 (d) (1) A person who is prescribed or possesses an opioid pursuant to a standing order shall receive the training provided by an opioid overdose prevention and treatment training program. 

(2) 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.

(e) A licensed health care provider who acts with reasonable care shall not be subject to professional review, be liable in a civil action, or be subject to criminal prosecution for issuing a prescription or order pursuant to subdivision (b) or (c). 

(f) 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 liable in a civil action, or be subject to criminal prosecution for this possession or distribution. Notwithstanding any other law, a person not otherwise licensed to administer an opioid antagonist, but trained as required under paragraph (1) of 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. 

What this means for prescribers:

If you have prescribing privileges in California, you can prescribe naloxone to someone who is an opioid user (prescription or illicit), or to their caregiver, partner, family member or friend (3rd party prescriptions). For more information on prescribing naloxone, please see www.prescribetoprevent.org

You can also issue a standing order for the dispensing of naloxone by health care workers, including nurses, or overdose prevention specialists who work directly with substance using individuals, such as outreach workers or case managers. For more on standing orders, see: http://harmreduction.org/issues/overdose-prevention/tools-best-practices/manuals-best-practice/

What this means for programs that want to start distributing naloxone:

If you have a prescriber on staff, that prescriber can issue a standing order to dispense naloxone. In most programs operating under a standing order, the order allows for trained health workers to provide the instruction on overdose prevention and response, and to dispense the naloxone kits. For an example of a standing order, see the San Francisco Department of Public Health’s order to dispense: http://harmreduction.org/issues/overdose-prevention/tools-best-practices/sample-program-materials/

If you do not have a prescriber on staff, you may need to make connections with sympathetic prescribers who would be willing to work with your program. For tips on how to approach a potential collaborating prescriber, see page 22 of the Guide to Developing & Managing Overdose Prevention & Take-Home Naloxone Projects, a comprehensive manual on implementing naloxone distribution programs. It also includes sample documents, case studies, naloxone kit materials and ordering information, sample educational materials and more.

What this means for lay persons who possess or use naloxone during an overdose:

Anyone who has received a prescription for naloxone from a prescriber, pharmacy or overdose prevention program is allowed by law to possess and use naloxone during an overdose situation without fear of criminal or civil sanctions of any kind.

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