BILL ANALYSIS                                                                                                                                                                                                    Ó



          SENATE COMMITTEE ON
          BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
                              Senator Jerry Hill, Chair
                                2015 - 2016  Regular 

          Bill No:            SB 482          Hearing Date:    April 27,  
          2015
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          |Author:   |Lara                                                  |
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          |Version:  |April 16, 2015                                        |
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          |Urgency:  |No                     |Fiscal:    |Yes              |
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          |Consultant|Sarah Mason                                           |
          |:         |                                                      |
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                  Subject:  Controlled substances:  CURES database.

          SUMMARY:  Requires prescribers to consult the Controlled  
          Substances Utilization Review and Evaluation System (CURES)  
          prior to prescribing a Schedule II or III drug to a patient for  
          the first time and requires a dispenser to consult the CURES  
          system prior to dispensing a Schedule II or III drug to patient  
          for the first time.  Delays implementation of the above  
          provisions until the Department of Justice certifies that the  
          CURES database is ready for statewide use.

          Existing law, the Business and Professions Code (BPC):

          1) Establishes the Medical Practice Act which provides for the  
             licensing and regulation of physicians and surgeons by the  
             Medial Board of California (MBC) within the Department of  
             Consumer Affairs (DCA).

          2) Establishes the Dental Practice Act which provides for the  
             licensing and regulation of dentists by the Dental Board of  
             California within DCA.

          3) Establishes the Veterinary Medicine Practice Act which  
             provides for the licensing and regulation of veterinarians  
             and registered veterinary technicians by the Veterinary  
             Medical Board within DCA.

          4)Establishes the Nursing Practice Act which provides for the  
            certification and regulation of registered nurses, nurse  







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            practitioners and advanced practice nurses by the Board of  
            Registered Nursing within DCA. 

          5)Provides that a certified nurse-midwife may furnish or order  
            drugs or devices, including controlled substances, if  
            furnished or ordered incidentally to the provision of family  
            planning services, routine health care or perinatal care, or  
            care rendered consistent with the certified nurse-midwife's  
            practice; occurs under physician and surgeon supervision; and  
            is in accordance with standardized procedures or protocols as  
            specified.  (BPC § 2746.51)

          6)Provides that a nurse practitioner may furnish or order drugs  
            or devices, including controlled substances, if it is  
            consistent with a nurse practitioner's educational preparation  
            or for which clinical competency has been established and  
            maintained; occurs under physician and surgeon supervision;  
            and is in accordance with standardized procedures or protocols  
            as specified.  (BPC § 2836.1)

          7)Establishes the Physician Assistant Practice Act which  
            provides for the licensing of physician assistants by the  
            Physician Assistant Committee, under the MBC, within the DCA.   
             

          8)Provides that a physician assistant while under the  
            supervision of a physician and surgeon may administer or  
            provide medication to a patient, or transmit orally or in  
            writing a drug order under specified conditions and protocols  
            adopted by the supervising physician and surgeon.  (BPC §  
            3502.1)

          9)Establishes the Osteopathic Act which provides for the  
            licensing and regulation of osteopathic physicians and  
            surgeons by the Osteopathic MBC within the DCA.

          10)Establishes the Naturopathic Doctors Act which provides for  
            the licensing of naturopathic doctors by the Naturopathic  
            Medicine Committee within the Osteopathic Medical Board of  
            California within the DCA.

          11)Establishes the Optometry Practice Act which provides for the  
            licensure of optometrists by the California State Board of  
            Optometry within the DCA.








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          12)Establishes the Podiatric Act which provides for the  
            licensure of doctors of podiatric medicine by the California  
            Board of Podiatric Medicine within the DCA.

          13)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 within the  
            DCA.  

          14)Defines "dispense" as the furnishing of drugs or devices upon  
            a prescription from a physician, dentist, optometrist,  
            podiatrist, veterinarian, or naturopathic doctor or upon an  
            order to furnish drugs or transmit a prescription from a  
            certified nurse-midwife, nurse practitioner, physician  
            assistant, naturopathic doctor, or pharmacist acting within  
            the scope of his or her practice.  Dispense also means and  
            refers to the furnishing of drugs or devices directly to a  
            patient by a physician, dentist, optometrist, podiatrist, or  
            veterinarian, or by a certified nurse-midwife, nurse  
            practitioner, naturopathic doctor, or physician assistant  
            acting within the scope of his or her practice.  (BPC § 4024)

          15)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.  (BPC §  
            4059)
          
          Existing law, the Health and Safety Code (HSC), establishes the  
          California Uniform Controlled Substances Act which regulates  
          controlled substances.  
          (HSC § 11000 et seq.)

          1)Defines "dispense" to deliver a controlled substance to an  
            ultimate user or research subject by or pursuant to the lawful  
            order of a practitioner, including the prescribing,  
            furnishing, packaging, labeling, or compounding necessary to  
            prepare the substance for that delivery and "dispenser" as a  
            practitioner who dispenses.  (HSC §§ 11010 and 11011)
                                                               
          2)Defines "drug" as: 









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             a)   Substances recognized as drugs in the official United  
               States Pharmacopoeia, official Homeopathic Pharmacopoeia of  
               the United States, or official National Formulary, or any  
               supplement to any of them.

             b)   Substances intended for use in the diagnosis, cure,  
               mitigation, treatment, or prevention of disease in man or  
               animals.

             c)   Substances (other than food) intended to affect the  
               structure or any function of the body of man or animals.   
               (Health and Safety Code (HSC) § 11014)

          1)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.  (HSC § 11020)

          2)Defines "practitioner" as a physician, dentist, veterinarian,  
            podiatrist, or pharmacist, registered nurse or physician  
            assistant acting within the scope of an experimental health  
            workforce projects authorized by the Office of Statewide  
            Health Planning and Development (HSC § 128125 et seq.), a  
            certified nurse-midwife according to BPC provisions outlined  
            above, a nurse practitioner according to BPC provisions  
            outlined above, a physician assistant according to BPC  
            provisions outlined above, or an optometrist licensed under  
            the Optometry Practice Act.  Includes in the definition of  
            "practitioner" a pharmacy, hospital, or other institution  
            licensed, registered, or otherwise permitted to distribute,  
            dispense, conduct research with respect to, or to administer,  
            a controlled substance in the course of professional practice  
            or research in this state.  Also includes in the definition of  
            "practitioner" a scientific investigator, or other person  
            licensed, registered, or otherwise permitted, to distribute,  
            dispense, conduct research with respect to, or administer, a  
            controlled substance in the course of professional practice or  
            research in this state.  (BPC § 11026)

          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  








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            BPC provisions outlined above), pharmacist (according to BPC  
            provisions above), certified nurse-midwife (according to BPC  
            provisions outlined above), nurse practitioner (according to  
            BPC provisions above) ; a pharmacist or 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.);  an  
            optometrist licensed under the Optometry Practice Act., or an  
            out-of-state prescriber acting in an emergency situation 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)Requires special prescription forms for controlled substances  
            to be obtained from security printers approved by DOJ,  
            establishes certain criteria for features on the forms and  
            requires controlled substance prescriptions to be made on the  
            specified form.  (HSC §§ 11161.5, 11162.1, 11164)

          7)Establishes the Controlled Substances Utilization Review and  
            Evaluation System (CURES) for electronic monitoring of  
            Schedule II, III and IV controlled substance prescriptions.   
            The 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)

          8)States that the purpose of CURES is to assist law enforcement  
            and regulatory agencies in controlling diversion and abuse of  
            Schedule II, III and IV controlled substances and for  
            statistical analysis, education and research.  (HSC § 11165  
            (a))

          9)Establishes privacy protections for patient data and specifies  
            that CURES data can only be accessed by appropriate state,  
            local and federal persons or public agencies for disciplinary,  
            civil or criminal actions.  Specifies that CURES data shall  








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            also only be provided, as determined by DOJ, to other agencies  
            or entities for educating practitioners and others, in lieu of  
            disciplinary, civil or criminal actions.  Authorizes  
            non-identifying CURES data to be provided to public and  
            private entities for education, research, peer review and  
            statistical analysis.  (HSC § 11165 (c))

          10)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))

          11)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  
            information, subject to provisions of the Confidentiality of  
            Medical Information Act.  (HSC § 11165.1)

          12)Requires health practitioners who prescribe or administer a  
            controlled substance classified in Schedule II to make a  
            record containing the name and address of the patient, date,  
            and the character, name, strength, and quantity of the  
            controlled substance prescribed, as well as the pathology and  
            purpose for which the controlled substance was administered or  
            prescribed.  (HSC § 11190 (a) and (b))

          13)Requires prescribers who are authorized to dispense Schedule  
            II, III or IV controlled substance in their office or place of  
            practice to record and maintain information for three years  
            for each such prescription that includes the patient's name,  
            address, gender, and date of birth,  prescriber's license and  
            license number, federal controlled substance registration  
            number, state medical license number, NDC number of the  
            controlled substance dispensed, quantity dispensed, diagnosis  
            code, if available, and original date of dispensing.  Requires  
            that this information be provided to DOJ on a monthly basis.   








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            (HSC § 11190 (c))
          
          This bill:

          1)Requires prescribers (authorized to write prescriptions  
            according to HSC § 11150 outlined above, excluding  
            veterinarians) to access and consult CURES prior to  
            prescribing a Schedule II or Schedule III controlled substance  
            for the first time to a patient and at least annually 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)Requires dispensers (as defined by HSC § 11011) to also access  
            and consult CURES prior to dispensing a Schedule II or  
            Schedule III controlled substance for the first time to that  
            patient.  Provides that if the patient has an existing  
            prescription for a Schedule II or Schedule III controlled  
            substance, the dispenser shall not dispense any additional  
            controlled substances until the dispenser checks CURES.

          3)Provides that failure by a prescriber or dispenser to consult  
            CURES as specified above is cause for disciplinary action by  
            the prescriber or dispenser's appropriate licensing board. 

          4)Requires the licensing boards of all prescribers and  
            dispensers authorized to write or issue prescriptions for  
            controlled substances to notify all authorized prescribers or  
            dispensers of the requirement for consulting CURES.

          5)Provides that notwithstanding any other provision, a  
            prescriber or dispenser 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.

          6)Delays implementation of the above provisions until the DOJ  
            certifies that the CURES database is ready for statewide use.

          
          FISCAL EFFECT:  Unknown.  This bill has been keyed "fiscal" by  








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          Legislative Counsel.

          
          COMMENTS:
          
          1. Purpose.  This bill is sponsored by the  Consumer Attorneys of  
             California  and the  California Narcotics Officers  .  According  
             to the Author, for the last decade the number of deaths due  
             to drug overdoses of prescription drugs has dramatically  
             increased.  The Author cites data from the Centers for  
             Disease Control (CDC) estimating that 44 people die every day  
             from an overdose of prescription drugs. According to the  
             Author, "This is a serious and deadly problem for our  
             state?While California was the first state to create a drug  
             monitoring system, it has lagged behind others in realizing  
             the full potential its system.  Other states like New York  
             and Tennessee have required prescribers to check their  
             respective state drug monitoring systems and seen dramatic  
             decreases in drug overdoses and deaths."

             The Author is concerned that in California, prescribers and  
             dispensers of Schedule II and III drugs must enroll in CURES  
             by January 2016, but they are not required to consult the  
             system when prescribing or dispensing.  According to the  
             Author, "in order to eliminate doctor shopping and minimize  
             the over prescription of narcotics, it is critical  
             prescribers and dispensers use CURES every time they write or  
             dispense a new prescription."  The Author states that  
             "Ultimately this bill will ensure prescribers and dispensers  
             are utilizing CURES to improve public health outcomes and  
             limit the number of Californians who die as a result of a  
             drug overdose."

          2. Controlled Substances.  Through the Controlled Substances Act  
             of 1970, the federal government regulates the manufacture,  
             distribution and dispensing of controlled substances.  The  
             act ranks into five schedules those drugs known to have  
             potential for physical or psychological harm, based on three  
             considerations: (a) their potential for abuse; (b) their  
             accepted medical use; and, (c) their accepted safety under  
             medical supervision.  
             
              Schedule I  controlled substances have a high potential for  
             abuse and no generally accepted medical use such as heroin,  








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             ecstasy, and LSD. 
              
             Schedule II  controlled substances have a currently accepted  
             medical use in treatment, or a currently accepted medical use  
             with severe restrictions, and have a high potential for abuse  
             and psychological or physical dependence.  Schedule II drugs  
             can be narcotics or non-narcotic.  Examples of Schedule II  
             controlled substances include morphine, methadone, Ritalin,  
             Demerol, Dilaudid, Percocet, Percodan, and Oxycontin. 
              
             Schedule III and IV  controlled substances have a currently  
             accepted medical use in treatment, less potential for abuse  
             but are known to be mixed in specific ways to achieve a  
             narcotic-like end product.  Examples include drugs include  
             Vicodin, Zanex, Ambien and other anti-anxiety drugs.
              
             Schedule V  drugs have a low potential for abuse relative to  
             substances listed in Schedule IV and consist primarily of  
             preparations containing limited quantities of certain  
             narcotics.

             The three classes of prescription drugs that are most  
             commonly abused are: opioids, which are most often prescribed  
             to treat pain; central nervous system (CNS) depressants,  
             which are used to treat anxiety and sleep disorders; and  
             stimulants, which are prescribed to treat the sleep disorder  
             narcolepsy and attention-deficit hyperactivity disorder  
             (ADHD).  Each class can induce euphoria, and when  
             administered by routes other than recommended, such as  
             snorting or dissolving into liquid to drink or inject, can  
             intensify that sensation.  Opioids, in particular, act on the  
             same receptors as heroin and, therefore, can be highly  
             addictive.  Common opioids are:  hydrocodone (Vicodin),  
             oxycodone (OxyContin), propoxyphene (Darvon), hydromorphone  
             (Dilaudid), meperidine (Demerol), and diphenoxylate  
             (Lomotil).

             In August of 2014, the federal Drug Enforcement  
             Administration (DEA), rescheduled hydrocodone combination  
             products from Schedule III to Schedule II of the Controlled  
             Substances Act.  DEA requested a scientific and medical  
             recommendation from the federal Health and Human Services  
             Agency (HHS) regarding a change of schedule for hydrocodone  
             combination products in 2009.  The Food and Drug  








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             Administration (FDA), within HHS, considered the eight  
             statutorily required factors related to the abuse potential  
             of hydrocodone, including questions about the products'  
             actual or relative potential for abuse, their liability to  
             cause psychic or physiological dependence, and dangers they  
             might pose to public health.  According to the FDA,  
             hydrocodone is the most prescribed opioid in the United  
             States, including 137 million prescriptions in 2013.  The FDA  
             notes that while it is useful in the treatment of pain, it  
             has also contributed significantly to the very serious  
             problem of opioid misuse and abuse in the United States.  HHS  
             ultimately recommended to DEA that hydrocodone combination  
             products be reclassified into Schedule II, a more restrictive  
             category of controlled substances that includes other opioid  
             drugs for pain like morphine and oxycodone.  The  
             reclassification is aimed at limiting the risks of these  
             potentially addictive but important pain-relieving products  
             and will result in the following:  Now, if a patient needs  
             additional medication, the prescriber must issue a new  
             prescription. Phone-in refills for these products are no  
             longer allowed.  In emergencies, small supplies can be  
             authorized until a new prescription can be provided for the  
             patient.  Patients will still have access to reasonable  
             quantities of medication, generally up to a 30-day supply. 

             HHS also recommended including rescheduling in "a broad-based  
             set of actions targeting abuse prevention."  HHS identified a  
             need to work with prescribers and patients to make certain  
             that patients are prescribed the right number of doses of  
                                                                            hydrocodone for a patient's need to avoid unused hydrocodone  
             being available for abuse as well as the need for.  HHS  
             advised that the use and abuse of hydrocodone combination  
             products be monitored carefully to assess the impact of  
             rescheduling on public health.  HHS noted that based on the  
             results of this monitoring, the agency may need to take  
             additional actions to "support the appropriate use of  
             hydrocodone combination products while reducing their tragic  
             abuse." 

          3. Prescription Drug Abuse.  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  








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             the past year, abuse of prescription pain killers now ranks  
             second, just behind marijuana, as the nation's most  
             widespread illegal drug problem.  According to the 2008  
             National Survey on Drug Use and Health (NSDUH), approximately  
             52 million Americans aged 12 or older reported non-medical  
             use of any psychotherapeutic at some point in their  
             lifetimes, representing 20.8% of the population aged 12 or  
             older.  The National Institute on Drug Abuse's (NIDA)  
             research report Prescription Drugs: Abuse and Addiction  
             states that the elderly are among those most vulnerable to  
             prescription drug abuse or misuse because they are prescribed  
             more medications than their younger counterparts.  Persons 65  
             years of age and above comprise only 13 percent of the  
             population, yet account for approximately one-third of all  
             medications prescribed in the United States.  Older patients  
             are more likely to be prescribed long-term and multiple  
             prescriptions, which could lead to unintentional misuse.  The  
             report also notes that studies suggest that women are more  
             likely (in some cases, 55 percent more likely) than men to be  
             prescribed a drug which can be abused, particularly narcotics  
             and antianxiety drugs.  A 2010 report, Monitoring the Future  
             Study, showed that as many as 4 percent of high school  
             students and 3 percent of young adults say they have used  
             OxyContin in the past year.

             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 take under any circumstances.  NIDA data  
             states that in actuality, prescription drugs act directly or  
             indirectly on the same brain systems affected by illicit  
             drugs, thus, their abuse carries substantial addiction  
             liability and can lead to a variety of other adverse health  
             effects. 

          4. Prescription Drug Deaths.  A 2013 CDC analysis found that  
             drug overdose deaths increased for the 11th consecutive year  
             in 2010 and prescription drugs, particularly opiod  
             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  








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             2009, and 16,849 deaths in 1999.  CDC found that nearly 60  
             percent of the overdose deaths in 2010, involved  
             pharmaceutical drugs, with opiods associated with  
             approximately 75 percent of these deaths.  Nearly three out  
             of four prescription drug overdoses are caused by opioid pain  
             relievers.  CDC recommends the use of PDMPs with a focus on  
             both patients at highest risk in terms of prescription  
             painkiller dosage, numbers of prescriptions and numbers of  
             prescribers, as well as prescribers who deviate from accepted  
             medical practice and those with a high proportion of doctor  
             shoppers among their patients.  CDC also recommends that  
             PDMPs link to electronic health records systems so that the  
             information is better integrated into health care providers'  
             day-to-day practices.  CDC believes that state benefits  
             programs like Medicaid and workers' compensation should  
             consider monitoring prescription claims information and PDMP  
             data for signs and inappropriate use of controlled  
             substances.  The organization also acknowledges the value of  
             PDMPs in taking regulatory action against health care  
             providers who do operate outside the limits of appropriate  
             medical practice when it comes to prescription drug  
             prescribing.    

          5. Prescription Drug Monitoring and CURES.  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.  Of these  
             programs throughout the nation, seven are or will be housed  
             at the state's Department of Justice, 18 are or will be  
             housed at a state Department of Health or substance abuse  
             agency and 25 are or will be housed at a state Board of  
             Pharmacy or state professional licensing agency.  There is  
             currently momentum to share data across these programs from  
             state to state.  The National Boards of Pharmacy (NABP)  
             currently operates a PDMP, InterConnect that allows  
             participating states across to be linked, providing a more  
             effective means of combating drug diversion and drug abuse  
             nationwide.  It was anticipated that approximately 30 states  
             will be sharing data or in a Memorandum of Understanding to  
             share data using InterConnect by the end of 2014.     
             








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             In California, the Controlled Substance Utilization Review  
             and Evaluation System (CURES) 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.  

              AB 3042  (Takasugi, Chapter 738, Statutes of 1996) established  
             a three year pilot program, beginning in July 1997, for the  
             electronic monitoring of prescribing and dispensing of  
             Schedule II controlled substances.  Subsequent legislation  
             (  SB 1308  , Committee on Business and Professions, Chapter 655,  
             Statutes of 1999) extended the sunset date on the CURES  
             program to July 1, 2003 and required DOJ to submit annual  
             status reports on the program to the Legislature.  In 2002,  
             the Legislature passed  AB 2655  (Matthews, Chapter 345,  
             Statutes of 2002) which extended the CURES program to 2008  
             and provided access to CURES data by licensed health care  
             providers.  Finally, in 2003,  SB 151  (Burton, Chapter 406,  
             Statutes of 2003) made the program permanent.  In 2009, then  
             Attorney General Brown launched an online CURES system at DOJ  
             to replace the previous system that required mailing or  
             faxing written requests for information, giving health  
             professionals (doctors, pharmacists, midwives, and registered  
             nurses), law enforcement agencies and medical profession  
             regulatory boards instant computer access to patients'  
             controlled-substance records.  SB 809 (Chapter 400, Statutes  
             of 2013) established a funding mechanism to update and  
             maintain CURES, required all prescribing health care  
             practitioners to apply to access CURES information, and  
             established processes and procedures for regulating  
             prescribing licensees through CURES and securing private  
             information.       

             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  








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             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, CURES data can be  
             obtained by the MBC, Dental Board of California, Board of  
             Registered Nursing, Osteopathic Medical Board of California  
             and Veterinary Medical Board.  

             Since 2009, more than 8,000 doctors and pharmacists have  
             signed up to use CURES, which has more than 100 million  
             prescriptions.  The system also has been accessed more than 1  
             million times for patient activity reports and has been key  
             in investigations of doctor shoppers and nefarious  
             physicians.  According to the AG's office, CURES assisted in  
             targeting the top 50 doctor shoppers in the state, who  
             averaged more than 100 doctor and pharmacy visits to collect  
             massive quantities of addictive drugs and the crackdown led  
             to the arrest of dozens of suspects.  CURES also provided  
             information with the prescribing history of a Southern  
             California physician accused of writing hundreds of  
             fraudulent prescriptions to feed his patients' drug  
             addictions, seven of whom died from prescription-drug  
             overdoses.  The system has also been successful in alerting  
             law enforcement and licensed medical professionals to signs  
             of illegal drug diversions, including a criminal ring that  
             stole the identities of eight doctors, illegally wrote  
             prescriptions, stole the identities of dozens of innocent  
             citizens who they designated as patients in order to fill the  
             fraudulent prescriptions, resulting in the group obtaining  
             more than 11,000 pills of highly addictive drugs like  
             OxyContin and Vicodin.  

             DOJ is currently in the process of modernizing CURES to more  
             efficiently serve prescribers, pharmacists and entities that  
             may utilize the data contained within the system and expects  
             that the new CURES 2.0 system will be operational on July 1,  
             2015.

          6. Related Legislation This Session.   AB 611 (Dahle) authorizes  
             an individual designated to investigate a holder of a  
             professional license to apply to the DOJ to obtain approval  
             to access information contained in the CURES PDMP regarding  
             the controlled substance history of an applicant or a  








          SB 482 (Lara)                                           Page 15  
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             licensee, for the purpose of investigating the alleged  
             substance abuse of a licensee.  Clarifies that only a  
             subscriber who is a health care practitioner or a pharmacist  
             may have an application denied or be suspended for accessing  
             subscriber information for any reason other than caring for  
             his or her patients.  Specifies that an application may be  
             denied, or a subscriber may be suspended, if a subscriber who  
             has been designated to investigate the holder of a  
             professional license accesses information for any reason  
             other than investigating the holder of a professional  
             license.  
          (  Status:   The bill is currently pending in the Assembly  
             Committee on Business and Professions.) 

          7. Prior Related Legislation.  SB 500  (Lieu) of 2014 would have  
             required the MBC to update prescriber standards for  
             controlled substances once every five years and add the  
             American Cancer Society, specialists in pharmacology and  
             specialists in addiction medicine to the entities the MBC may  
             consult with in developing the standards.  (  Status:   The bill  
             was amended to deal with a different subject.)  

              SB 1258  (DeSaulnier) of 2014 would have made several changes  
             to the ways that controlled substances are prescribed and  
             tracked in CURES and would have required medical providers to  
             use electronic prescribing systems, would have required  
             additional reporting of controlled substance prescribing, and  
             would have placed additional restrictions on the prescribing  
             of controlled substances.  
             (  Status:   The bill was held in the Senate Committee on  
             Appropriations.)   

              SB 809  (DeSaulnier, Chapter 400, Statutes of 2013)  
             established a funding mechanism to update and maintain CURES,  
             required all prescribing health care practitioners to apply  
             to access CURES information, and established processes and  
             procedures for regulating prescribing licensees through CURES  
             and securing private information.     
           
               SB 616  (DeSaulnier) of 2012 would have increased fees, up to  
             $10 per licensee that is authorized to prescribe or dispense  
             controlled substances, to fund CURES.  (  Status:   The measure  
             failed passage in the Assembly Committee on Business,  
             Professions and Consumer Protection.)








          SB 482 (Lara)                                           Page 16  
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              SB 360  (DeSaulnier, Chapter 418, Statutes of 2011) updated  
             CURES to reflect the new PDMP and authorizes DOJ to initiate  
             administrative enforcement actions to prevent the misuse of  
             confidential information collected through CURES.

              SB 1071  (DeSaulnier) of 2010 would have imposed a tax on  
             manufacturers or importers of Schedule II, III and IV  
             controlled substances to pay for ongoing costs of the CURES  
             program.  Fees would have been collected by the BOE, at the  
             rate of $0.0025 per pill included in Schedule II, III, and  
             IV.  (  Status:   The bill was held in the Senate Committee on  
             Health.) 

              AB 2516  (Mendoza) of 2008 required a doctor to ensure that  
             any prescription he or she make be electronically transmitted  
             to a patient's pharmacy of choice.  
             ( Status:   The measure was never heard in a policy committee  
             of the Legislature.)
              
             AB 1298  (Jones, Chapter 699, Statutes of 2007) sought to  
             protect the privacy of personally identifiable unencrypted  
             medical and health insurance information by requiring any  
             state agency or business that operates in California to  
             inform any potentially affected state resident of the loss of  
             that individual's health information. The bill also  
             prohibited any organization that holds electronic personal  
             health record data from disclosing that information without  
             patient consent.  

              ABX1  (Nunez) of 2007 would have required that by January 1,  
             2012 all prescribers, prescribers' agents, and pharmacies,  
             have ability to transmit and receive e-prescriptions, and  
             would have given licensing boards the authority to enforce  
             this requirement.  (  Status:   The measure failed passage in  
             the Senate Committee on Health.)  
           
             AB 2986  (Mullin, Chapter 286, Statutes of 2006) required  
             designated prescription forms for controlled substances and  
             prescriptions for controlled substances to contain additional  
             information identifying the final consumer and any refill  
             information.

              SB 734  (Torlakson, Chapter 487, Statutes of 2005) authorized  








          SB 482 (Lara)                                           Page 17  
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             tamper resistant online access to the CURES system for  
             authorized physicians, pharmacists and law enforcement,  
             pending the acquisition of private funding.

              SB 151  (Burton, Chapter 406, Statutes of 2004) made CURES  
             permanent, among other provisions.

              AB 3042  (Takasugi, Chapter 738, Statutes of 1996) establishes  
             CURES as a three-year pilot program.

          8. Arguments in Support.  According to law enforcement  
             organizations like the  California Association of Code  
             Enforcement Officers  ,  California College and University  
             Police Chiefs Association  ,  California Correctional  
             Supervisors Organization  ,  California Narcotic Officers'  
             Association  (Sponsor),  Los Angeles Los Angeles Police  
             Protective League  and  Riverside Sheriffs Organization  , the  
             CURES database is an effective reference point in assuring  
             that a patient is not engaged in prescription.  The  
             organizations state that this bill will save lives.
             
             The  Consumer Attorneys of California (CAOC)  cite the growing  
             problem of prescription drug use and the current lack of  
             requirement that health care prescribers and dispensers check  
             the CURES database as rationale for this bill's passage.   
             According to CAOC, the current voluntary approach has not  
             been able to attract sufficient participation to make it  
             truly effective and that it is critical to prevent overdose  
             deaths and addiction from occurring in the first place by  
             attacking its problem at the source.

             The  Consumer Federation of California (CFC)  also writes in  
             support of this bill, stating that only 6 percent of doctors  
             now use CURES even though it has been operational since 2009.  
              According to CFC, "curbing prescription drug abuse and  
             doctor shopping could save an estimated $300 million annually  
             for what is now spent by our state and local governments on  
             prescription drugs for Medi-Cal patients."

              Consumer Watchdog  writes that prescription drug abuse is at  
             epidemic levels and databases like CURES can reduce a  
             patient's risk for overdose and provide an opportunity to  
             intervene with patients who are abusing medications.









          SB 482 (Lara)                                           Page 18  
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             Labor organizations like the  California Conference Board of  
             the Amalgamated Transit Union  ,  California Conference of  
             Machinists  ,  California Teamsters Public Affairs Council  ,  
              Engineers and Scientists of California, IFPTE Local 20,  
             AFL-CIO  ,  International Longshore and Warehouse Union  ,  
              Professional and Technical Engineers, IFPTE Local 21,  
             AFL-CIO  ,  UNITE-HERE, AFL-CIO  and  Utility Workers Union of  
             America  support this bill, writing that they are alarmed  
             about the growing trend of prescription drug abuse which  
             affects workers directly as often they are prescribed pain  
             medications for injuries on the job and it's time we took  
             decisive action to prevent prescription drug addiction. 

             The  International Faith Based Coalition  welcomes the changes  
             contemplated by this bill and notes that this strategy has  
             been instituted in a number of other states with universal  
             reduction in prescription drug abuse as well as in overdose  
             deaths.

          9. Concerns.  The  California Pharmacists Association (CPhA  ),  
              California Retailers Association (CRA)  and  National  
             Association of Chain Drug Stores (NACDS)  all write to express  
             concerns about this bill.  CPhA pharmacists use their  
             professional judgment to determine when specific  
             interventions are necessary and appropriate, in addition to  
             following guidance provided by the Board of Pharmacy for  
             specified "red flags" and as such, states that it is not  
             clear that the mandates in SB 482 are necessary for  
             pharmacists.

             CRA and NACDS are very concerned that the new system will not  
             have the ability to handle the volume of inquiries nor will  
             the system effectively integrate with pharmacy technology  
             systems.  The organizations note that pharmacists fill  
             hundreds of prescriptions a day and cannot work with a state  
             system that delays, or a system that creates and overly  
             burdensome requirement that cannot be efficiently and  
             effectively utilized.

          10.Arguments in Opposition.  The  California Medical Association   
             (CMA) is opposed to this bill.  CMA writes that at its most  
             basic, this bill legislates the practice of medicine which  
             the organization opposes.  According to CMA, this bill  
             establishes a nebulous and problematic prohibition against  








          SB 482 (Lara)                                           Page 19  
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             prescribing an additional controlled substance until the  
             prescriber determines that there is a legitimate need and  
             cites instances in which a patient may be prescribed two  
             controlled substances, which will create liability for a  
             physician in any malpractice case in which a patient is  
             prescribed controlled substances.  CMA believes that the  
             mandate in this bill will fall disproportionately on patients  
             with a legitimate medical issue and that once a functional  
             CURES system is in place, the mandates imposed by this bill  
             will not be necessary, as physicians support the CURES  
             database and want to have it as a tool in their clinical  
             practice.  The organization also cites existing efforts by  
             the Medical Board in its updated guidelines for prescribing  
             controlled substances, Board of Pharmacy precedential  
             decision that a pharmacist must inquire whenever he or she  
             believes a prescription may not have been written for a  
             legitimate medical purpose and reclassification of  
             hydrocodone products from Schedule III to Schedule II by the  
             DEA to view the impact of the mandate for checking CURES  
             outlined in this bill.  According to CMA, this bill will  
             create an unnecessary regulatory burden to prescribing and  
             increase the threat of litigation, both of which would have a  
             detrimental impact on patient care while adding limited value  
             to addressing prescription drug abuse.   
              
             CVS Health  is opposed to this bill unless the author amends  
             the bill to remove the obligation of the dispenser to consult  
             the CURES system prior to dispensing a particular  
             prescription and encourage CURES 2.0 to require data uploads  
             every 
                       24 hours.  According to CVS Health, CVS Health's pharmacy  
             operations would be directly and unnecessarily impacted by  
             this bill based on the requirement that pharmacists consult  
             and access the database prior to dispensing.  CVS Health also  
             believes that CURES should be updated every 24 hours, not as  
             soon as reasonably possible as outlined under current law.   
             CVS Health cites its utilization of patient-level data to  
             trigger alerts for pharmacists to identify "aberrant behavior  
             in patients as well as controlled substance prescribers.   
             These red flags have been identified ?to help us make  
             appropriate determinations for when dispensing of a  
             controlled substance should not occur."   

             Rite Aid Corporation  opposes this bill, writing that the  








          SB 482 (Lara)                                           Page 20  
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             bill's requirements are duplicative of one another, as both  
             physicians and pharmacists would be required to consult CURES  
             prior to prescribing or dispensing Schedule II or Schedule  
             III drugs for the first time to a patient.  Rite Aid  
             questions "the impact this bill will have on preventing  
             abusive behavior given that under current law, data is only  
             reported to the CURES system once weekly."  According to Rite  
             Aid, physicians consulting CURES would not even be reviewing  
             up to date information.

             According to  The Doctor's Company  , this bill would subject  
             prescribers to discipline for failure to access a system that  
             currently experiences many interruptions in accessibility.   
             TDC doubts that the proposed upgrade will be fully functional  
             as intended and that an outside, independent analysis  
             attesting to the upgraded system's readiness would help  
             develop confidence in a system that has been underfunded and  
             experienced other operational problems in the past.  
          11.Author's Amendments.  In response to concerns raised above  
             related to a mandate for dispensers to consult CURES prior to  
             dispensing a Schedule II or Schedule III to a patient for the  
             first time, the Author is amending this bill to delete  
             provisions related to dispensers.

             On page 3, strike lines 4 through 11.

             On page 3, in line 14, after "prescriber", strike "or  
             dispenser".

             On page 3, in line 15, after "prescribers", strike "and  
             dispensers".

             On page 3, in line 18, after "prescriber", strike "or  
             dispenser".

             On page 3, strike lines 27 through 28.

             On page 3, in line 29, after "section" strike "the following  
             terms shall have the following meanings" and strike lines 27  
             through 31.

             On page 3, in line 29, after "section" insert "Prescriber"  
             means a health care practitioner who is authorized to write  
             or issue prescriptions under Section 11150, excluding  








          SB 482 (Lara)                                           Page 21  
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             veterinarians."

                (b) A dispenser shall access and consult the CURES database
               for the electronic history of controlled substances  
             dispensed to a
               patient under his or her care before dispensing a Schedule  
             II or
               Schedule III controlled substance for the first time to  
             that patient.
               If the patient has an existing prescription for a Schedule  
             II or
               Schedule III controlled substance, the dispenser shall not  
             dispense
               an additional controlled substance until the dispenser  
             checks the
               CURES database.
              
               (c) Failure to consult a patient's electronic history as  
             required
               by subdivision (a) or (b) is cause for disciplinary action  
             by the
               respective licensing board of the prescriber  or dispenser  .  
             The
               licensing boards of all prescribers  and dispensers   
             authorized to
               write or issue prescriptions for controlled substances  
             shall notify
               these licensees of the requirements of this section.

               (d) Notwithstanding any other law, a prescriber  or  
             dispenser  
               is not in violation of this section during any period of  
             time in which
               the CURES database is suspended or not accessible or any  
             period
               of time in which the Internet is not operational.

               (e) This section shall not become operative until the  
             Department
               of Justice certifies that the CURES database is ready for  
             statewide
               use.

               (f) For purposes of this section,  the following terms shall  








          SB 482 (Lara)                                           Page 22  
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             have
               the following meanings:
                   (1) "Dispenser" means a person who is authorized to  
             dispense
               a controlled substance under Section 11011.
                   (2) "Prescriber" means a health care practitioner who  
             is
               authorized to write or issue prescriptions under Section  
             11150,
               excluding veterinarians.   "Prescriber" means a health care  
             practitioner who is
               authorized to write or issue prescriptions under Section  
             11150,
               excluding veterinarians.
           
          SUPPORT AND OPPOSITION:
          
           Support:  

          California Association of Code Enforcement Officers
          California College and University Police Chiefs Association
          California Conference Board of the Amalgamated Transit Union
          California Conference of Machinists
          California Correctional Supervisors Organization
          California Narcotic Officers' Association (Co-Sponsor)
          California Teamsters Public Affairs Council
          Consumer Attorneys of California (Co-Sponsor)
          Consumer Federation of California
          Consumer Watchdog
          Engineers and Scientists of California, IFPTE Local 20, AFL-CIO
          International Faith Based Coalition
          International Longshore and Warehouse Union
          Los Angeles Police Protective League
          Professional and Technical Engineers, IFPTE Local 21, AFL-CIO
          Riverside Sheriffs Organization
          UNITE-HERE, AFL-CIO
          Utility Workers Union of America

           Concerns:

           California Pharmacists Association (CPhA)
          California Retailers Association (CRA)
          National Association of Chain Drug Stores (NACDS)









          SB 482 (Lara)                                           Page 23  
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           Opposition:  

          California Medical Association (CMA)
          CVS Health
          Rite Aid Corporation
          The Doctor's Company (TDC)


                                      -- END --