BILL ANALYSIS Ó ----------------------------------------------------------------------- |Hearing Date:June 16, 2014 |Bill No:AB | | |1535 | ----------------------------------------------------------------------- SENATE COMMITTEE ON BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT Senator Ted W. Lieu, Chair Bill No: AB 1535Author:Bloom As Amended:April 1, 2014 Fiscal: Yes SUBJECT: Pharmacists: Naloxone Hydrochloride. SUMMARY: Permits a pharmacist to furnish naloxone hydrochloride (NH) without a prescription pursuant to standardized procedures and protocols developed and approved jointly by the California Board of Pharmacy (Board) and the Medical Board of California (MBC). Existing law: 1)Establishes the Pharmacy Law which provides for the licensure and regulation of pharmacies, pharmacists and wholesalers of dangerous drugs or devices by the Board of Pharmacy (Board) within the Department of Consumer Affairs (DCA). 2)Licenses and regulates physicians and surgeons under the Medical Practice Act (Act) by the Medical Board of California (MBC). 3)Permits pharmacists to perform the following procedures under physician protocols in licensed health care facilities: (BPC §4052.1) a) Order and perform routine drug therapy-related patient assessment procedures. b) Order drug therapy-related laboratory tests. c) Administer drugs and biologicals by injection pursuant to a prescriber's order. d) Initiate or adjust a patient's drug regimen pursuant to AB 1535 Page 2 authorization or order by the patient's prescriber. 1)Permits pharmacists in a number of specified settings to do the following: (BPC § 4052.2) a) Order and perform routine drug therapy-related patient assessment procedures. b) Order drug therapy-related laboratory tests. c) Administer drugs and biologicals by injection pursuant to a prescriber's order. d) Initiate or adjust a patient's drug regimen pursuant to authorization or order by the patient's treating prescriber. Prohibits the substitution or selection of a different drug unless authorized by protocol and requires prescriber notification of initiated drug regimens to be transmitted within 24 hours. e) Specifies that a patient's treating prescriber may prohibit pharmacists from making any changes or adjustments to patients' drug regimens. f) Requires the governing policies, procedures and protocols to be developed by specified health professionals and established minimum requirements for those policies, procedures and protocols. g) Requires pharmacists performing procedures authorized by this section to have successfully completed clinical residency training or demonstrated clinical experience in direct patient care delivery. 5) Authorizes an advanced practice pharmacist (APP) recognized by the Board to do all of the following: (BPC § 4052.6) a) Perform patient assessments. b) Order and interpret drug-therapy related tests, ensuring that the ordering of those tests is done in coordination with the patient's primary care provider or diagnosing prescriber, as appropriate, including promptly transmitting written notification to the patient's diagnosing prescriber or entering the appropriate information in a patient record system shared with the prescriber, when available and as permitted by that AB 1535 Page 3 prescriber. c) Refer patients to other health care providers. d) Participate in the evaluation or management of diseases and health conditions in collaboration with other health care providers. e) Initiate, adjust or discontinue drug therapy pursuant to the authority established in current law for pharmacists to perform certain procedures in a licensed health care facility. 1) Provides that an APP who adjusts or discontinues drug therapy shall promptly transmit written notification to the patient's diagnosing prescriber or enter the appropriate information into a patient record system shared with the prescriber. Provides that an APP who initiates drug therapy shall promptly transmit written notification or enter the appropriate information into a patient record system shared with the patient's primary care provider or diagnosing provider. (Id.) 2) Requires an APP to register with the DEA prior to initiating or adjusting a controlled substance. (Id.) 8)Authorizes a licensed health care provider to prescribe and dispense NH 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. (Civil Code (CC) § 1714.22) 9)Authorizes a licensed health care provider to issue standing orders for the administration of NH to a person at risk of an opioid-related overdose, a family member, friend, or other person in a position to assist a person experiencing or reasonably suspected of experiencing an overdose. (Id.) 10)Requires a person who is prescribed or possesses NH pursuant to a standing order to receive training provided by an opioid overdose prevention and treatment training program operated by a local health jurisdiction or that is registered by a local health jurisdiction that provides, at a minimum, training in (Id.): a) The causes of an opiate overdose. b) Mouth to mouth resuscitation. c) How to contact appropriate emergency medical services. AB 1535 Page 4 d) How to administer NH. 11)Does not require a person who is prescribed NH directly from a licensed prescriber to receive training from an opioid prevention and treatment training program. (Id.) This bill: 1) Permits a pharmacist to furnish NH in accordance with standardized procedures or protocols developed and approved by the Board and MBC. 2) Permits a pharmacist to furnish NH in accordance with standardized procedures or protocols developed and approved by both the Board and MBC, in consultation with the California Society of Addiction Medicine, the California Pharmacists Association, and other appropriate entities. 3) Requires the Board and MBC to include in the standardized procedures or protocols: a) Procedures to ensure education of the person to whom the drug is furnished, including, but not limited to opioid overdose prevention, recognition, and response, safe administration of NH, potential side effects or adverse events, and the imperative to seek emergency medical care for the patient. b) Procedures to ensure the education of the person to whom the drug is furnished regarding the availability of the drug treatment programs. c) Procedures for the notification of the patient's primary care provider with patient consent of any drugs or devises furnished to the patient, or entry of appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider, and with patient consent. 1) Prohibits a pharmacist furnishing NH from allowing a person receiving NH to waive the drug consultation. 2) Requires a pharmacist to complete a training program on the use of opioid antagonists that consists of at least one hour of approved continuing education on the use NH. 3) Authorizes Board and MBC to ensure compliance with this bill, and states that each board is charged with enforcing this bill with AB 1535 Page 5 respect to its respective licensees. 4) States that this bill does not expand the authority of a pharmacist to prescribe any prescription medication. FISCAL EFFECT: This measure is keyed "fiscal" by Legislative Counsel. According to the Assembly Appropriations Committee analysis dated April 30, 2014, this bill will result in minor one-time costs, under $100,000, to the MBC and to the Board to jointly develop standardized procedures and protocols and related training and educational content. The analysis also stated that the bill will result in minor and absorbable ongoing costs to both boards for enforcement. COMMENTS: 1.Purpose. This bill is sponsored by the Drug Policy Alliance and the California Pharmacists Association . According to the Author, "Drug overdose deaths by prescription pain pills and heroin have reached the point of becoming a public health crisis in California. We urgently need an environmental, public health intervention right now to reduce these deaths. This bill, which authorizes the Medical Board of California and the Board of Pharmacy to develop a statewide protocol for pharmacists to furnish naloxone, will widen access to this successful and safe live-saving drug. Naloxone reverses an opioid overdose, and should be widely available in order to combat the drug overdose crisis. Pharmacists are highly trained professionals who are readily accessible to the public in many communities, and allowing them to do this is of enormous importance to families across California and to public health as a whole." 2.Prescription Drug Deaths. A 2013 Centers for Disease Control (CDC) analysis found that drug overdose deaths increased for the 11th consecutive year in 2010 and prescription drugs, particularly opioid analgesics, are the top drugs leading the list of those responsible for fatalities. According to CDC, 38,329 people died from a drug overdose in 2010, up from 37,004 deaths in 2009, and 16,849 deaths in 1999. CDC found that nearly 60 percent of the overdose deaths in 2010, involved pharmaceutical drugs, with opioids associated with approximately 75 percent of these deaths. Nearly three out of four prescription drug overdoses are caused by opioid pain relievers. 3.Naloxone Hydrochloride. Naloxone Hydrochloride (NH), better known as Narcan, is an opioid antidote that can reverse a drug overdose. AB 1535 Page 6 NH reverses depression of the central nervous system and respiratory systems that have shut down during an overdose. NH is commonly used when a person excessively uses morphine, oxycodone, methadone, or illegal substances such as heroin. NH is meant to sustain breathing for 30-90 minutes, during which time emergency medical services should be sought for the patient. The drug is non-narcotic, does not produce intoxication, and has no potential for addiction or abuse. NH also only causes pharmacological effects if there are opioids in someone's body. If NH is administered to someone who is not overdosing, no adverse effects will happen. NH is typically administered intramuscularly, which causes the drug to act within one minute and last up to 45 minutes. The emergency treatment works like the well-known EpiPen, an epinephrine auto-injector for serious allergic reactions, as it is injected into the muscle and does not require training, making it more user-friendly. NH may also be administered via intravenously, subcutaneous (under the skin), or intranasally. A typical injectable or nasal spray NH kit costs $15-$25 per dose. California is one of a number of states that have recently enacted legislation to address the public health concern of prescription drug overdose. 17 states and the District of Columbia, have enacted laws expanding access to NH. Most notably, programs that have required police officers to carry NH have been proven successful at curbing overdose deaths. According to a report by CNN, "The police department in Quincy, Massachusetts was the first in the nation to require its officers to carry naloxone and has successfully reversed 211 overdoses with a success rate of over 95%." New York recently implemented a similar idea in Suffolk County, where 563 lives were saved last year alone. Community based programs have existed since 1996 to get NH into the hands of those able to help. The national advocacy organization Harm Reduction Coalition (HRC) reports that there are currently over 200 take-home NH programs in communities throughout the United States that help to increase access to NH and training education on overdose. In 2010, HRC surveyed 50 of these programs and reported the results in the February 17, 2012 issue of Morbidity and Mortality Weekly Report (MMWR), a publication of the CDC. The survey found that since these programs first began, 53,032 persons were trained on the use of NH and the programs received reports of 10,171 overdose reversals. Other community based projects like Project Lazarus and Operation OpioidSAFE in North Carolina are working to increase the AB 1535 Page 7 accessibility of NH. Education is provided by these programs about opioid safety and the administration of NH however these programs are limited in their funding and geographic reach. Despite evidence that shows widening distribution of NH helps decrease drug overdose deaths, its implementation faces some difficulties. MMWR reports that "nearly half (43.7%) of the responding opioid overdose programs reported problems obtaining naloxone related to cost and the supply chain. Price increases of some formulations of naloxone appear to restrict current program activities and the possibility of new programs. Economic pressures on state and local budgets could decrease funding of opioid overdose prevention activities. To address the substantial increases in opioid-related drug overdose deaths, public health agencies could consider comprehensive measures that include teaching laypersons how to respond to overdoses and administer naloxone to those in need." 4.The Role of Pharmacists in Expanding Access to Naloxone. The Center for Pharmacy Services (CPS), a community pharmacy in Pittsburg, Pennsylvania recently collaborated with the Overdose Prevention Project to enlist pharmacists in overdose prevention. This project used pharmacists to educate patients and physicians about opioid safety and the effectiveness of NH to prevent fatal overdose. After training, patients that showed up at CPS with a NH prescription were offered counseling on opioid safety, taught how to take opioid pain relievers safely, and demonstrated how to safely dispose of unused prescription medicines. The caregiver and patient were additionally taught how to identify an overdose and how to administrate NH. This program is unique in that any person that goes through the CPS program and receives the opioid safety education can request a prescription for naloxone. The pharmacist facilitates this by fax, sending a simple form to the prescribing physician requesting they sign an order to prescribe naloxone along with the opioids prescribed. This bill mirrors this approach to expand the distribution of NH. 5.Related Legislation This Year. SB 500 (Lieu) requires MBC to update prescriber standards for controlled substances once every five years and adds the American Cancer Society, specialists in pharmacology and specialists in addiction medicine, to the entities MBC may consult with in developing the standards. ( Status: The bill is currently pending in the Assembly Business, Professions, and Consumer Protection.) SB 1438 (Pavley) requires the Emergency Medical Services Authority AB 1535 Page 8 (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 and other opioid antagonists. This bill also permits, at the discretion of the medical director of the local EMS agency, that pertinent training completed by pre-hospital emergency care personnel may be used to satisfy part of the training requirements regarding the use and administration of naloxone hydrochloride and other opioid antagonists by pre-hospital emergency care personnel. Both types of training satisfy specified requirements allowing for immunity from criminal and civil liability for administering an opioid antagonist. Lastly, this bill would permit the Attorney General to authorize hospitals and trauma centers to share information with local law enforcement and medical service agencies about controlled substances. SB 1438 would limit 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. ( Status: This bill is currently pending in the Assembly). 6.Prior Related Legislation. AB 635 (Ammiano, Chapter 707, Statutes of 2013) expanded an existing pilot program which provides qualified immunity to licensed health care providers who prescribe NH by removing the program's sunset date, expanding the program's reach from seven to all counties, authorizing licensed health care providers to prescribe NH 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 NH. AB 831 (Bloom) of 2013 would have established, within the California Health and Human Services Agency, a temporary working group to develop a plan to reduce the rate of fatal drug overdoses in the state. The bill would have also required the temporary working group to make recommendations to the Chair of the Senate Committee on Health and the Chair of Assembly Committee on Health on or before January 1, 2015. ( Status: This bill was held under submission in the Assembly Committee on Appropriations.) AB 2145 (Ammiano, Chapter 545, Statutes of 2010) authorized a person who is not otherwise licensed to administer an opioid antagonist in an emergency without fee if the person has received specified training information and believes in good faith that the other person is experiencing a drug overdose. The bill prohibited a person, as a result of his or her acts or omissions, from being liable for any violation of any professional licensing statute, or subject to any criminal prosecution arising from or related to the AB 1535 Page 9 unauthorized practice of medicine or the possession of an opioid antagonist. AB 767 (Ridley-Thomas, Chapter 477, Statutes of 2007) authorized, until January 1, 2011, a licensed health care provider, who is already permitted to prescribe an opioid antagonist and if acting with reasonable care, to 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. The bill also required a local health jurisdiction that operates or registers an opioid overdose prevention and treatment training program to collect prescribed data and report it to the Senate and Assembly Committees on Judiciary by January 1, 2010. The bill only applied to certain counties. 7.Arguments in Support. Supporters of this measure write that "public health experts agree that increasing access to naloxone is a key strategy in preventing drug overdose deaths." They note that in California, naloxone is currently available only by prescription and from a very small number of programs operating under standing orders from a physician and the next logical step in combating the epidemic of overdose in California is to allow community pharmacies to provide naloxone and counseling to at-risk patients. Supporters also cite the recognition that pharmacists are "among the most highly trusted healthcare professionals" who are trained experts at working with "patients at risk of the harms associated with prescription medications. Pharmacists interact with patients and their family members more often than many physicians. They are well positioned to provide overdose prevention information and naloxone to patients on long-term or high-dose opioid therapies, their caregivers and others who may witness an accidental overdose." Supporters believe this bill is a simple, low-to-no-cost solution that would move California in the right direction toward reducing accidental overdose fatalities. SUPPORT AND OPPOSITION: Support: California Pharmacists Association (Sponsor) Drug Policy Alliance (Sponsor) A New PATH Addiction Research and Treatment Amity Foundation Bay Area Addiction Recovery Treatment (BAART) AB 1535 Page 10 Behind the Orange Curtain Broadway Treatment Center Broken No More California Hospital Association California Mental Health Directors Association California Narcotic Officers' Association California Opioid Maintenance Providers California Retailers Association California Society of Addiction Medicine Center for Living and Learning County Alcohol and Drug Program Administrators Association of California CRI-HELP, Inc. Drug and Alcohol Addiction Awareness and Prevention Program Families ACT! Fred Brown Recovery Services Gateways Hospital and Mental Health Center Grief Recovery After a Substance Passing Health Officers Association of California Health Right 360 Hillview Mental Health Center Homeless Health Care Los Angeles Hope of the Valley Rescue Mission In Depth Legal Services for Prisoners with Children Los Angeles Centers for Alcohol and Drug Abuse Los Angeles Community Action Network Los Angeles HIV Drug and Alcohol Task Force Mary Magdalene Project Medical Board of California National Federation of Independent Business Not One More Paramedics Plus Paving the Way Foundation Phoenix House of Los Angeles Primary Purpose Sober Living Homes San Fernando Recovery Center SANE (Safer Alternatives Through Networking and Education) SHIELDS For Families Soberspace Solace Opposition: None on file as of June 11, 2014. AB 1535 Page 11 Consultant: Mark Mendoza