BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | SB 482| |Office of Senate Floor Analyses | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- UNFINISHED BUSINESS Bill No: SB 482 Author: Lara (D) Amended: 8/19/16 Vote: 21 SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 7-1, 4/27/15 AYES: Hill, Block, Galgiani, Hernandez, Jackson, Mendoza, Wieckowski NOES: Bates NO VOTE RECORDED: Berryhill SENATE APPROPRIATIONS COMMITTEE: 5-2, 5/18/15 AYES: Lara, Beall, Hill, Leyva, Mendoza NOES: Bates, Nielsen SENATE FLOOR: 28-11, 5/28/15 AYES: Allen, Beall, Block, Cannella, De León, Galgiani, Glazer, Hall, Hancock, Hernandez, Hertzberg, Hill, Hueso, Jackson, Lara, Leno, Leyva, Liu, McGuire, Mendoza, Mitchell, Monning, Pavley, Roth, Runner, Vidak, Wieckowski, Wolk NOES: Anderson, Bates, Berryhill, Fuller, Gaines, Huff, Moorlach, Morrell, Nguyen, Nielsen, Stone NO VOTE RECORDED: Pan ASSEMBLY FLOOR: 80-0, 8/24/16 - See last page for vote SUBJECT: Controlled substances: CURES database SOURCE: California Narcotic Officers Association Consumer Attorneys of California DIGEST: This bill requires a health care provider authorized to prescribe, order, administer, or furnish a controlled substance to consult the Controlled Substances Utilization Review and SB 482 Page 2 Evaluation System (CURES) prior to prescribing a Schedule II, III or IV drug to a patient for the first and at least once every four months thereafter if the substance remains part of the treatment of the patient. Assembly Amendments add exemptions from the responsibility proposed in the bill to consult the CURES system, including while a patient is admitted to a certain type of facility, if a patient receives a non-refillable five-day supply or less prescription in conjunction with a surgery, and in the event of a technological failure or inability to access the CURES system. Amendments also clarify that regulatory boards under the Department of Consumer Affairs (DCA) that oversee practitioners who do not prescribe, order, administer, furnish, or dispense controlled substances shall not have access to CURES and also clarify that health care providers may share CURES data with the patient the provider receives information from the system about. ANALYSIS: Existing law: 1)Specifies certain requirements regarding the dispensing and furnishing of dangerous drugs and devices, and prohibits a person from furnishing any dangerous drug or device except upon the prescription of a physician, dentist, podiatrist, optometrist, veterinarian or naturopathic doctor. (Business and Professions Code (BPC) § 4059) 2)Defines "opiate" as any substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having addiction-forming or addiction-sustaining liability. (Health and Safety Code (HSC) § 11020) 3)Classifies controlled substances in five schedules according to their danger and potential for abuse. (HSC § 11054-11058) 4)Prohibits any person other than a physician, dentist, podiatrist, veterinarian, naturopathic doctor (according to specific requirements outlined in their practice act), SB 482 Page 3 pharmacist (under certain circumstances), certified nurse-midwife (according to specific requirements outlined in their practice act), nurse practitioner (according to specific requirements outlined in their practice act), licensed optometrist, out-of-state prescriber acting in an emergency situation or certain health professionals (a pharmacist, registered nurse or physician assistant) acting within the scope of an experimental health workforce project authorized by the Office of Statewide Health Planning and Development (HSC § 128125 et seq) from writing or issuing a prescription for a controlled substance. (HSC § 11150) 5)Specifies that a prescription for a controlled substance shall only be issued for a legitimate medical purpose and establishes responsibility for proper prescribing on the prescribing practitioner. States that a violation shall result in imprisonment for up to one year or a fine of up to $20,000, or both. (HSC § 11153) 6)Establishes CURES for electronic monitoring of Schedule II, III and IV controlled substance prescriptions. CURES provides for the electronic transmission of Schedule II, III and IV controlled substance prescription information to the Department of Justice (DOJ) at the time prescriptions are dispensed. (HSC § 11165) 7)Provides that pharmacies or clinics, in filling a prescription for a federally Scheduled II, III or IV drug, shall provide weekly information to DOJ including the patient's name, date of birth, the name, form, strength and quantity of the drug, and the pharmacy name, pharmacy number and the prescribing physician information. (HSC § 11165 (d)) 8)Provides that a licensed health care practitioner eligible to prescribe Schedule II, III or IV controlled substances, or a pharmacist, shall apply to participate in the CURES Prescription Drug Monitoring Program (PDMP) by January 1, 2016. Authorizes DOJ to deny an application or suspend a subscriber for certain violations and falsifying information. Provides that the history of controlled substances dispensed to a patient based on CURES data that is received by a practitioner or pharmacist shall be considered medical SB 482 Page 4 information, subject to provisions of the Confidentiality of Medical Information Act. (HSC § 11165.1) This bill: 1)Requires prescribers (authorized to write prescriptions according to HSC Section 11150 outlined above) to access and consult CURES prior to prescribing a Schedule II, Schedule III or Schedule IV controlled substance for the first time to a patient and at least once every four months when that prescribed controlled substance remains part of the treatment. Provides that if the patient has an existing prescription for a Schedule II or Schedule III controlled substance, the health care practitioner shall not prescribe any additional controlled substances until the health care practitioner determines there is a legitimate need. 2)Provides that failure by a prescriber to consult CURES as specified above is cause for disciplinary action by the prescriber's appropriate licensing board. Requires the licensing boards of all prescribers authorized to write or issue prescriptions for controlled substances to notify all authorized prescribers of the requirement for consulting CURES. 3)Provides that failure by a prescriber to consult CURES as specified above is cause for disciplinary action by the prescriber's appropriate licensing board. Requires the licensing boards of all prescribers authorized to write or issue prescriptions for controlled substances to notify all authorized prescribers of the requirement for consulting CURES. 4)Provides that notwithstanding any other provision, a prescriber shall not be in violation of the requirements in this bill during any time period in which the CURES system is suspended or not accessible or the Internet is not operational. Delays implementation of the above provisions until the DOJ certifies that the CURES database is ready for statewide use. 5)Exempts the following from the requirement in 1) above: SB 482 Page 5 a) A veterinarian b) A pharmacist c) A health care practitioner who prescribes, orders, administers, or furnishes a controlled substance in the emergency department of a general acute care hospital and the quantity of the controlled substance does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use d) A health care practitioner who prescribes, orders, or furnishes a controlled substance to be administered to a patient while the patient is admitted to a licensed clinic, an outpatient setting as defined, a health facility as defined, and a county medical facility as defined e) A health care practitioner who prescribes, orders, administers, or furnishes a controlled substance to a patient as part of the patient's treatment for a surgical procedure and the quantity of the controlled substance does not exceed a nonrefillable five-day supply of the controlled substance to be used in accordance with the directions for use, in any of the facilities in d) above as well as a place of practice as defined f) A health care practitioner who prescribes, orders, administers, or furnishes a controlled substance to a patient currently receiving hospice care g) A health practitioner or their designee when it is not reasonably possible for a health care practitioner to access the information in CURES in a timely manner. h) A health practitioner when the quantity of controlled substance prescribed, ordered, administered, or furnished does not exceed a nonrefillable five-day supply of the controlled substance to be used in accordance with the directions for use and no refill of the controlled substance is allowed. SB 482 Page 6 i) A health practitioner who is not able to access CURES because it is not operational, as determined by DOJ, or when CURES cannot be accessed by a health care practitioner because of a temporary technological or electrical failure. j) A health care practitioner if CURES cannot be accessed because of technological limitations that are not reasonably within his or her control. aa) A health care practitioner who determines that consulting CURES would result in a patient's inability to obtain a prescription in a timely manner and thereby adversely impact the patient's medical condition, provided that the quantity of the controlled substance does not exceed a nonrefillable five-day supply if the controlled substance were used in accordance with the directions for use 1)Provides that notwithstanding any other provision, a prescriber shall not be in violation of the requirements in this bill during any time period in which the CURES system is suspended or not accessible or the Internet is not operational. Delays implementation of the above provisions until the DOJ certifies that the CURES database is ready for statewide use. Background For the past number of years, abuse of prescription drugs (taking a prescription medication that is not prescribed for you, or taking it for reasons or in dosages other than as prescribed) to get high has become increasingly prevalent. Federal data for 2014 shows that in the past year, abuse of prescription pain killers now ranks second, just behind marijuana, as the nation's most widespread illegal drug problem. Abuse can stem from the fact that prescription drugs are legal and potentially more easily accessible, as they can be found at home in a medicine cabinet. Data shows that individuals who misuse prescription drugs, particularly teens, believe these substances are safer than illicit drugs because they are prescribed by a health care professional and thus are safe to SB 482 Page 7 take under any circumstances. A 2013 Centers for Disease Control and Prevention (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% of the overdose deaths in 2010, involved pharmaceutical drugs, with opioids associated with approximately 75% of these deaths. Nearly three out of four prescription drug overdoses are caused by opioid pain relievers. With rising levels of abuse, PDMPs are a critical tool in assisting law enforcement and regulatory bodies with their efforts to reduce drug diversion. There are 49 states that currently have monitoring programs (Missouri is the only state currently without a PDMP). California has the oldest prescription drug monitoring program in the nation, CURES which is an electronic tracking program that reports all pharmacy (and specified types of prescriber) dispensing of controlled drugs by drug name, quantity, prescriber, patient, and pharmacy. Data from CURES is managed by DOJ to assist state law enforcement and regulatory agencies in their efforts to reduce prescription drug diversion. CURES provides information that offers the ability to identify if a person is "doctor shopping" (when a prescription-drug addict visits multiple doctors to obtain multiple prescriptions for drugs, or uses multiple pharmacies to obtain prescription drugs). Information tracked in the system contains the patient name, prescriber name, pharmacy name, drug name, amount and dosage, and is available to law enforcement agencies, regulatory bodies and qualified researchers. The system can also report on the top drugs prescribed for a specific time period, drugs prescribed in a particular county, doctor prescribing data, pharmacy dispensing data, and is a critical tool for assessing whether multiple prescriptions for the same patient may exist. In addition to the Board of Pharmacy, CURES data can be obtained by the Medical Board of California, Dental Board of California, Board of Registered Nursing, Osteopathic Medical Board of California and Veterinary Medical Board. SB 482 Page 8 The upgraded system, CURES 2.0, became operational in late 2015. The new interface has significantly improved timeframes for accessing information, navigating through the system and general usability. Licensees can apply directly within the web based system, a significant shortfall of the prior CURES which required applicants to submit notarized paper applications to DOJ. Prescribers and dispensers are able to easily generate patient activity reports and can securely send communications to one another about a mutual patient through the system. Through CURES 2.0, prescribers can receive daily informational alerts about patients who reach various prescribing thresholds, based on patterns indicative of at-risk patient behavior, which can be used to determine if action by the prescriber is necessary. FISCAL EFFECT: Appropriation: No Fiscal Com.:YesLocal: No According to the Assembly Appropriations Committee, boards within DCA that license health professionals will incur likely minor and absorbable costs to notify licensees and enforce this bill's requirements, as well as make any necessary information technology changes. The 2016-17 Budget provides $500,000 from the CURES Fund for additional user outreach and staffing support. There are no anticipated costs to DOJ. SUPPORT: (Verified8/24/16) California Narcotic Officers' Association (co-source) Consumer Attorneys of California (co-source) Acclamation Insurance Management Services American Insurance Association Blue Shield of California California Chamber of Commerce California Dental Association California Pharmacists Association California Teamsters Center for Public Interest Law Children's Advocacy Institute Consumer Watchdog SB 482 Page 9 National Alliance on Mental Illness Pacific Business Group on Health Peace Officers Research Association of California PRIUM Small Business California Teamsters OPPOSITION: (Verified8/24/16) Association of Northern California Oncologists Doctor's Company The US Oncology Network ASSEMBLY FLOOR: 80-0, 8/24/16 AYES: Achadjian, Alejo, Travis Allen, Arambula, Atkins, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Quirk, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Rendon Prepared by:Sarah Mason / B., P. & E.D. / (916) 651-4104 8/30/16 14:38:11 **** END **** SB 482 Page 10