BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  SB 360
                                                                  Page  1

          Date of Hearing:  July 5, 2011
          Counsel:       Sandy Uribe


                         ASSEMBLY COMMITTEE ON PUBLIC SAFETY
                                 Tom Ammiano, Chair

                   SB 360 (DeSaulnier) - As Amended:  May 10, 2011
                       As Proposed to be Amended in Committee
           
           
           SUMMARY  :  Makes changes to the Controlled Substance Utilization 
          Review and Evaluation System (CURES) and the Prescription Drug 
          Monitoring Program (PDMP).  Specifically,  this bill  :

          1)Expands the requirements imposed on security-printer 
            applicants to print prescription forms for controlled 
            substance prescriptions to include the names and addresses of 
            any individual owner, partner, corporate officer, manager, 
            agent, representative, employee or subcontractor with direct 
            access to, management of, or control over controlled substance 
            prescription forms; a signed statement regarding any prior 
            criminal convictions for these parties, and fingerprints for 
            the same.

          2)Clarifies that the fee assessed by the Department of Justice 
            (DOJ) to process the application of a security printer shall 
            be sufficient to cover inspections of security printers in 
            addition to the other costs specified by statutes.

          3)Requires that controlled substance forms shall be provided in 
            person only to established customers.  

          4)Requires a security printer to obtain the customer's photo 
            identification and log the information.  

          5)Limits the mailing of controlled substance only to an address 
            verified by the Drug Enforcement Agency (DEA) or Medical Board 
            of California.

          6)Requires a security printer to report the theft or loss of 
            controlled substance prescription forms to DOJ within 24 hours 
            of its occurrence.

          7)Requires DOJ to impose sanctions on security printers who 








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            violate applicable statutes and regulations, including failure 
            to comply with guidelines, failure to take reasonably 
            precautions to prevent dishonest or illegal actions with 
            regard to the access and control of security prescription 
            forms, and the theft or fraudulent use of a prescriber's 
            identity to obtain forms.

          8)Specifies that the sanctions for a violation of applicable 
            statutes and regulations are a fine of up to $1,000 for a 
            first violation, a fine of up to $2,500 for a second or 
            subsequent violation; disciplinary proceedings for suspension 
            or revocation of security printer status for third or 
            subsequent violations.

          9)Modifies the PDMP to include the following features:  

             a)   Allows any practitioner licensed to prescribe controlled 
               substances of Schedules II-IV or any pharmacist to apply to 
               participate in the PDMP, as specified; and,

             b)   Gives the program participant Internet access to view 
               the electronic history of controlled substances dispensed 
               to an individual under his or her case based on data 
               contained in CURES.

          10)Provides that a PDMP application may be denied, or a 
            subscriber suspended from the program for material 
            falsification of an application, failure to maintain effective 
            controls for access to the patient activity report, a 
            suspended or revoked DEA registration, an arrest for a drug 
            offense, or accessing information for any reason other than 
            patient care.

          11)Requires an authorized subscriber to notify DOJ within 10 
            days of any changes to the subscriber account.

          12)Allows, until July 12, 2012, a health care practitioner or 
            pharmacist to make a written request for controlled substance 
            history information about a person under the care of the 
            practitioner or pharmacist, in order to provide sufficient 
            time for subscribers to apply for access to PDMP.    

          13)Authorizes DOJ to audit the PDMP system and its users.

          14)Authorizes DOJ to establish regulations for a system to issue 








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            citations for unauthorized use of the CURES data by 
            subscribers with PDMP access, and provides for orders or 
            abatement, fines of up to $2,500 per violation, and a hearing 
            process if a subscriber is in violation of the CURES-PDMP 
            statutes or corresponding regulations.

          15)Requires citations issued by DOJ to be in writing, to 
            particularly describe the violation including a specific 
            citation to the statute or regulation violated, and to notify 
            the subscriber of the opportunities to request a hearing 
            and/or an informal conference, and the deadlines for 
            requesting them.

          16)Provides that the failure of a subscriber to pay a fine 
            within 30 days, or to comply with an abatement order within 
            the time subscribed, may result in disciplinary action unless 
            the citation is being appeal.

          17)Provides that any administrative fines collected shall be 
            deposited in the CURES Program Special Fund.

          18)Specifies that the sanctions authorized pursuant to this bill 
            shall be separate and in addition to any other administrative, 
            civil or criminal remedies, but that a criminal action may not 
            be initiated for a specific offense if a citation has been 
            issued for that matter, and that if a criminal action has been 
            filed, a citation cannot be issued for the same offense.  
            Notwithstanding this provision, nothing shall prevent DOJ from 
            prosecuting a suspension or revocation of a subscriber.

          19)Requires an affected PMDP prescriber to immediately report 
            the theft or loss of controlled substance prescription forms 
            to DOJ, and specifies the reporting shall be done no later 
            than three days after the discovery of the theft of loss.

           EXISTING LAW  :

          1)Requires health care providers to obtain prescription forms 
            for controlled substance prescriptions from security printers 
            approved by the DOJ.  İHealth and Safety Code (HSC) Section 
            11161.5(a).]

          2)Requires an entity applying be to security printer to include 
            specified information in its application and to provide 
            fingerprints for the purposes.  İHSC Section 11161.5(b).]








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          3)Requires DOJ to maintain the CURES for the electronic 
            monitoring of the prescribing and dispensing of Schedule II, 
            Schedule III, and Schedule IV controlled substances by all 
            practitioners authorized to prescribe or dispense these 
            controlled substances.  İHSC Section 11165(a).]

          4)Requires a dispensing pharmacy or clinic to provide specified 
            prescription data for each prescription for a Schedule II, 
            Schedule III, or Schedule IV controlled substance to DOJ on a 
            weekly basis.  İHSC Section 11165(d).]

          5)Allows a licensed health care practitioner who is eligible to 
            prescribe Schedule II, Schedule III, or Schedule IV controlled 
            substances, or a pharmacist to make a written request to DOJ 
            for the history of controlled substances dispensed to an 
            individual under his or her care.  İHSC Section 
            11165.1(a)(1).]

          6)Permits DOJ to give the history of controlled substances 
            dispensed to an individual based on data contained in CURES to 
            licensed health care practitioners and pharmacists providing 
            care or services to the individual in order to prevent the 
            inappropriate, improper, or illegal use of controlled 
            substances.  İHSC Section 11165.1(b).]

          7)Provides that the history of controlled substances dispensed 
            to an individual based on data contained in CURES that is 
            received by a practitioner or pharmacist from DOJ pursuant to 
            this section shall be considered medical information subject 
            to specified confidentiality provisions.  İHSC Section 
            11165.1(c).]

          8)Requires every practitioner, other than a pharmacist, who 
            prescribes or administers a controlled substance classified in 
            Schedule II, III or IV to record specified information 
            relating to the transaction.  (HSC Section 11190.)

           FISCAL EFFECT  :   Unknown

           COMMENTS  :   

           1)Author's Statement  :  According to the author, "Due to the rise 
            in prescription drug abuse, controlled drugs prescription 
            history information is available and maintained by the 








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            Department of Justice (DOJ) CURES program.  In 2009, the DOJ 
            launched an automated Prescription Drug Monitoring Program 
            (PDMP).  The program allows licensed health care practitioners 
            eligible to prescribe controlled substances access to patient 
            controlled substance prescription information.  Prescribers 
            and pharmacists can now make informed decisions about patient 
            care and detect patients who may be abusing controlled 
            substances by obtaining multiple prescriptions from various 
            practitioners.  However, current efforts at maintaining 
            privacy and control of CURES data are inadequate to protect 
            confidential patient information and to deter its misuse.

          "SB 360 will help to prevent the misuse of confidential 
            information collected through the CURES and ensure the 
            integrity of the program and process for practitioners and 
            pharmacists to appropriately use patient's controlled 
            substances history information.

          "The DOJ manages the California Security Prescription Printer 
            Program. While the DOJ has established guidelines for the 
            security of prescription forms, current law lacks sufficient 
            safeguards against theft and fraudulent use of prescription 
            pads and the DOJ has seen an increase in criminal enterprises 
            involved in prescription form theft and fraud.  SB 360 
            provides additional requirements and sanctions for Security 
            Printers to deter fraudulent use of prescription pads and the 
            illegal distribution of controlled substances."

           2)Background  :  The CURES was established in 1997 by AB 3042 
            (Takasugi), Chapter 738, Statutes of 1996, in response to 
            recommendations of the Controlled Substance Prescription 
            Advisory Council.  (SCR 74, 1992.)  The program initially was 
            intended to electronically monitor the prescribing and 
            dispensing of Schedule II controlled substances, such as 
            oxycodone.  The CURES provides for real-time electronic 
            transmission of specified prescription data to DOJ.  
            Essentially the data is analyzed for indications that 
            controlled substances are being improperly prescribed, or that 
            drug abusers are obtaining prescriptions from many doctors 
            (doctor shopping).  Currently, Physicians and pharmacists, 
            have access to CURES data through patient activity reports.

           3)Argument in Support  :  According to the  Attorney General's 
            Office  , the sponsor of this bill:  "Under existing law, CURES 
            provides for electronic monitoring of the prescribing and 








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            dispensing of Schedule II, III and IV controlled substances.  
            In 2009, DOJ launched the automated Prescription Drug 
            Monitoring Program (PDMP).  The program allows licenses heath 
            care practitioners to patient controlled substance 
            prescription information in real-time, 24 hours a day at the 
            point of care.  Prescribers and pharmacists can now make 
            informed decisions about patient care, and detect patients who 
            may be abusing controlled substances by obtaining multiple 
            prescriptions from various practitioners.  

          "The PDMP is a valuable investigative, preventative, and 
            educational tool for law enforcement, regulatory boards, and 
            health care providers.  However, current efforts at 
            maintaining privacy and control of CURES sate are inadequate 
            to protect confidential patient information, and to deter 
            misuse of confidential CURES data.  SB 360 authorizes DOJ to 
            initiate administrative enforcement actions to prevent and 
            deter misuse of confidential patient information collected 
            through the CURES program.  

          "Under existing law, DOJ also manages the California Security 
            Prescription Printer Program, including approval of "Security 
            Prescription Printer" applications.  Fraudulent prescriptions 
            are lucrative.  One blank prescription pad of 500 
            prescriptions can generate millions of dollars from the 
            illegal sale of controlled substances such as Oxycontin, 
            Xanax, or Vicodin.  DOJ has seen an increase in criminal 
            enterprises, from gangs to organized crime, involved in 
            prescription drug fraud.  Current law lacks adequate 
            safeguards against the theft and illegal distribution of 
            prescription pads from Security Prescription Printers.  SB 360 
            provides additional requirements and sanctions for Security 
            Printers and their employees who have direct contact with, or 
            access to, controlled substance prescription drug forms to 
            deter fraudulent prescriptions and illegal distribution of 
            controlled substances."

           4)Prior Legislation  :  

             a)   AB 2968 (Mullin), Chapter 286, Statutes of 2006, added 
               more information to the  requirements for a physician to 
               prescribe a controlled  substance, and required electronic 
               monitoring of Schedule IV drugs.

             b)   SB 734 (Torlakson), Chapter 487, Statutes of 2005, made 








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               various technical and clarifying changes to the CURES.  

             c)   SB 151 (Burton), Chapter 406, Statutes of 2004, made the 
               CURES reporting system permanent

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

           REGISTERED SUPPORT / OPPOSITION  :   

           Support 
           
          Department of Justice (Sponsor)
          California Narcotic Officers' Association
          California Peace Officers' Association
          California Police Chiefs Association
          California State Sheriffs' Association
          California Statewide Law Enforcement Association
          Consumer Attorneys of California
          Peace Officers Research Association of California

           Opposition 
          
          None

           
          Analysis Prepared by  :    Sandy Uribe / PUB. S. / (916) 319-3744