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