BILL ANALYSIS Ó AB 1535 Page 1 CONCURRENCE IN SENATE AMENDMENTS AB 1535 (Bloom) As Amended June 24, 2014 Majority vote ----------------------------------------------------------------- |ASSEMBLY: |73-0 |(May 8, 2014) |SENATE: |35-0 |(August 7, | | | | | | |2014) | ----------------------------------------------------------------- Original Committee Reference: B., P. & C.P. SUMMARY : Permits a pharmacist to furnish naloxone hydrochloride (NH) pursuant to standardized procedures or protocols developed and approved by the California Board of Pharmacy (BOP) and the Medical Board of California (MBC). The Senate amendments authorize BOP to adopt emergency regulations to establish the standardized procedures or protocols. FISCAL EFFECT : According to the Senate Appropriations Committee: 1)One-time costs less than $75,000 to develop protocols and adopt regulations by the MBC (Contingent Fund of the MBC). 2)One-time costs less than $75,000 to develop protocols and adopt regulations by the BOP (Pharmacy Board Contingent Fund). 3)Minor anticipated enforcement costs to the BOP (Pharmacy Board Contingent Fund). COMMENTS : 1)Purpose of this bill. This bill will allow a pharmacist to furnish 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, pursuant to standardized procedures or protocols developed and approved by BOP and MBC. This bill will enable the wider distribution of a safe, easy-to-administer and life-saving drug in accordance with recommendations from the United States Department of Health and Human Services. This bill is sponsored by the Drug Policy AB 1535 Page 2 Alliance. 2)Naloxone hydrochloride. NH is an antidote to opioids. It is traditionally used in the hospital setting to reverse the effects of opiates given during surgery, and may be given to newborns to decrease the effects of opiates received by the pregnant mother prior to delivery. It is currently available by prescription only, but is not a scheduled drug. NH reverses an overdose by blocking the central nervous system effects of several types of opiate medications such as morphine, oxycodone, methadone, or illegal substances such as heroin. According to its Food and Drug Administration (FDA) approved label, NH only causes pharmacologic effects if there are opioids in someone's body. This means that if NH is administered to someone who is not overdosing, nothing will happen. NH is not addictive and has not shown to produce either physical or psychological dependence. According to the Opioid Overdose Toolkit from the Substance Abuse and Mental Health Services Administration, a division of the United States Department of Health and Human Services: The safety profile of NH is remarkably high, especially when used in low doses and titrated to effect. When given to individuals who are not opioid-intoxicated or opioid-dependent, NH produces no clinical effects, even at high doses. Moreover, while rapid opioid withdrawal in tolerant patients may be unpleasant, it is not life-threatening. NH can be safely be used to manage opioid overdose in pregnant women. NH is administered by injection into a large muscle, such as the thighs, buttocks, or shoulder, or through a nasal spray, and can reverse the effects of an opioid overdose. The purpose is to restart the patient's breathing, but may not necessarily cause complete revival. NH is effective for 30 to 90 minutes, during which time emergency services should be sought for the patient. When injected into an overdose victim whose heart is still beating, "it's virtually 100% effective," said Wilson Compton, deputy director at the National Institute on Drug Abuse. AB 1535 Page 3 According to the National Institute of Health, NH has a shelf life of approximately two years and should be stored at room temperature and away from direct light. A typical injectable or nasal spray NH kit costs $15 to $25 per dose. 3)Current California pharmacist furnishing laws. California pharmacists are currently authorized to furnish the following medications without a prescription after appropriate training and pursuant to specified conditions: a) Emergency contraception drug therapy and self-administered hormonal contraceptives; b) Nicotine replacement products; c) Prescription medications not requiring a diagnosis that are recommended by the Centers for Disease Control and Prevention (CDC) for individuals traveling outside of the United States; d) Administer immunizations; and, e) Initiate and administer epinephrine. 4)Calls for greater access. There are several community-based efforts underway (discussed further below) to encourage physicians to prescribe NH concurrently with opioids for patients who meet criteria for higher overdose risk. However, data on concurrent prescription rates are limited and not suggestive of frequent application. Medi-Cal data of 2013 provided by this bill's sponsors indicate that while 62% of Medi-Cal prescribers prescribe opioids, less than two-tenths of 1% prescribe NH. The findings of a 2012 Morbidity and Mortality Weekly Report (MMWR), a publication of the CDC, suggests that wider distribution of NH and training in its administration might prevent numerous deaths from opioid overdoses and save thousands of dollars in public funds. However, nearly half of the responding NH programs reported problems obtaining NH due to cost and supply chain availability. The MMWR report framed this as a significant public health issue: "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 AB 1535 Page 4 and administer naloxone to those in need." 5)Role of pharmacists in furnishing NH. According to a March 2014 research letter published in the Journal of the American Medical Association, the highest-risk and highest-use group of opioid users is more likely to obtain opioids from a physician's prescription than from a drug dealer. And these prescriptions are filled at pharmacies. The Center for Pharmacy Services (CPS), a community pharmacy in Pittsburgh, Pennsylvania, collaborated with the Overdose Prevention Project to develop a model that enlists pharmacists in overdose prevention. The model uses pharmacists to educate patients and physicians about opioid safety and the effectiveness of prophylactic prescription of NH to prevent fatal overdose. Beginning in February 2011, patients presenting at CPS with a prescription for an opioid analgesic were offered counseling on opioid safety, including potential side effects, how to take opioid pain relievers safely, possible signs of opioid over-medication and/or overdose, and safe disposal of unused prescription medicines. Patients are also provided with opioid safety educational materials. The patient and/or caregiver also receives instruction on how to identify and effectively respond to an overdose and how to administer naloxone. In the CPS program, a patient who receives the opioid safety education can request a prescription for NH. The pharmacist facilitates this by fax, sending a simple form to the prescribing physician requesting they sign an order to prescribe NH along with the opioids prescribed. This bill seeks to follow the CPS model by allowing pharmacists to furnish NH pursuant to a protocol, thereby streamlining the process by which an individual receives the drug. AB 1535 Page 5 Analysis Prepared by : Sarah Huchel / B., P.& C.P. / (916) 319-3301 FN: 0004293