BILL ANALYSIS                                                                                                                                                                                                    



                                                                    AB 2018
                                                                    Page  1


          ASSEMBLY THIRD READING
          AB 2018 (Thomson)
          As Amended May 3, 2000
          Majority vote 

           HEALTH              14-0        PUBLIC SAFETY       5-0         
           
           ----------------------------------------------------------------- 
          |Ayes:|Gallegos, Bates,          |Ayes:|Washington, Cedillo,      |
          |     |Aanestad, Davis, Cox,     |     |Firebaugh, Keeley, Romero |
          |     |Firebaugh, Kuehl,         |     |                          |
          |     |Granlund, Thomson,        |     |                          |
          |     |Vincent, Wayne, Wesson,   |     |                          |
          |     |Wildman, Zettel           |     |                          |
          |     |                          |     |                          |
          |-----+--------------------------+-----+--------------------------|
          |     |                          |     |                          |
           ----------------------------------------------------------------- 
           APPROPRIATIONS      21-0                                    
           
           ----------------------------------------------------------------- 
          |Ayes:|Migden, Campbell,         |     |                          |
          |     |Ackerman, Alquist,        |     |                          |
          |     |Aroner, Ashburn, Brewer,  |     |                          |
          |     |Cedillo, Corbett, Davis,  |     |                          |
          |     |Kuehl, Maldonado, Papan,  |     |                          |
          |     |Romero, Runner, Shelley,  |     |                          |
          |     |Thomson, Wesson, Wiggins, |     |                          |
          |     |Wright, Zettel            |     |                          |
          |     |                          |     |                          |
           ----------------------------------------------------------------- 
           SUMMARY  :  Repeals, on January 1, 2003, the requirement that  
          Schedule II controlled substances be written on an official  
          prescription form (triplicate form) issued by the Department of  
          Justice (DOJ), and repeals the sunset date of the Controlled  
          Substance Utilization Review and Evaluation System (CURES) pilot  
          project, thereby making this program permanent.  Specifically,  
           this bill  :  

          1)Repeals, on January 1, 2003, provisions of law relating to the  
            triplicate prescription requirement for Schedule II controlled  
            substances (as specified in existing law below).

          2)Includes, beginning on January 1, 2003, Schedule II controlled  








                                                                    AB 2018
                                                                    Page  2


            substances within existing provisions of law governing the  
            prescribing of controlled substances listed in Schedules III,  
            IV and V, except for provisions permitting the oral and  
            electronic transmission of prescriptions for controlled  
            substances.

          3)Repeals the July 1, 2003 sunset date of the CURES project, and  
            repeals references to "pilot project," thereby making this  
            program permanent, and repeals a requirement that DOJ, in  
            consultation with the Board of Pharmacy (Board), submit an  
            annual report on the CURES pilot project.

           EXISTING LAW  :

          1)Prohibits any person from furnishing any dangerous drug or  
            device except upon the prescription of a physician, dentist,  
            podiatrist, optometrist or veterinarian.

          2)Establishes the California Uniform Controlled Substances Act,  
            which lists controlled substances in five schedules, with  
            Schedule I containing substances with the highest restrictions  
            (generally illegal), and Schedule V the least restrictive.   
            Schedule II substances are generally the most dangerous  
            substances that can still be legally prescribed (e.g.,  
            morphine, Demerol, and Percodan).

          3)Requires each prescription for a controlled substance  
            classified in Schedule II to be wholly written in ink or  
            indelible pencil in the handwriting of the prescriber upon an  
            official prescription form, in triplicate, issued by DOJ.   
            Requires the original and duplicate of the prescription to be  
            delivered to the pharmacist filling the prescription.   
            Requires the duplicate to be retained by the pharmacist, and  
            the original to be transmitted to DOJ at the end of the month  
            in which the prescription was filled.

          4)Requires triplicate prescription blanks to be issued by DOJ in  
            serially numbered groups of not more than 100 forms each, and  
            to be furnished to any practitioner authorized to write a  
            prescription for Schedule II controlled substances.  Requires  
            the prescription blanks to bear the preprinted name, address,  
            and category of professional licensure of the practitioner to  
            whom they are issued, and the federal registry number for  
            controlled substances.  Permits DOJ to charge a fee for the  








                                                                    AB 2018
                                                                    Page  3


            prescription blanks sufficient to reimburse the DOJ for the  
            actual costs associated with the preparation, processing, and  
            filing of the forms.  Provides that any unauthorized person  
            possessing a triplicate prescription blank is guilty of a  
            misdemeanor.

          5)Exempts orders for controlled substances from the prescription  
            procedure, including the triplicate form for Schedule II  
            substances, when used by a patient in a hospital, as long as  
            specified information is recorded in the patient's medical  
            record.

          6)Exempts Schedule II prescriptions from the triplicate  
            procedure when prescribed for use by a patient who has a  
            terminal illness, defined in part as an illness that will, in  
            the judgment of the physician, bring about the death of the  
            patient within a period of one year.  These prescriptions must  
            meet certain requirements, including a requirement that they  
            be wholly written in the handwriting of the prescriber.

          7)Establishes the CURES Pilot Project within DOJ for the  
            electronic monitoring of the prescribing and dispensing of  
            Schedule II controlled substance in order to assist law  
            enforcement and regulatory agencies in their efforts to  
            control the diversion and resultant abuse of Schedule II  
            controlled substances.  The CURES Pilot Project was  
            established on July 1, 1997, and is required to be  
            administered concurrently with the existing triplicate  
            prescription process to examine the comparative efficiencies  
            between the two systems.

           FISCAL EFFECT  :  According to the Assembly Appropriations  
          Committee analysis:  

          1)Ongoing costs to operate CURES of about $300,000 per year  
            [General Fund (GF)].  (Current CURES funding, from a $1  
            million appropriation from the Pharmacy Board Contingent Fund,  
            expires in 2000-2001.)

          2)In addition to the $300,000 in contract and operating costs,  
            DOJ contends it will need auditors to check prescriptions  
            against the CURES database.  Four auditors cost about $300,000  
            (GF) annually.









                                                                    AB 2018
                                                                    Page  4


           COMMENTS  :  According to the author, triplicate prescriptions are  
          an administrative hassle for prescribers and can result in  
          inadequate relief for patients in pain.  The author states that  
          for patients, pain management is frequently reported to be poor,  
          and the author argues that triplicates interfere with the  
          patient-physician relationship.  The author cites a study  
          published in 1993 in the "Annals of Internal Medicine" that  
          showed physicians practicing in states requiring multiple copy  
          prescriptions were more likely to cite physician reluctance to  
          prescribe opioids and concern about excessive drug regulation as  
          barriers to cancer pain management when compared to physicians  
          in other states.  The author states that researchers have found  
          that multiple copy prescription programs result in prescribers  
          substituting drugs that do not require a triplicate for those  
          that do.  The author further asserts that many physicians do not  
          have the full range of tools necessary to treat patients with  
          severe pain because they do not have triplicate forms.   
          According to the author, only 40,333 of the 74,518  
          California-licensed physicians with Schedule II privileges had  
          triplicates issued to them.  Finally, the author points to the  
          Institute of Medicine's 1997 book "Approaching Death: Improving  
          Care at the End of Life", which recommends the "reform of  
          prescription laws?that impede effective use of opioids to  
          releive pain and suffering."  The author also cites a  
          recommendation from the 1994 California Pain Summit that  
          California "replace the requirement for a special, state-issued  
          prescription form (triplicate system) with electronic monitoring  
          of controlled substances prescriptions that can foster better,  
          more effective pain management and better diversion detection."

          AB 3042 (Takasugi), Chapter 738, Statutes of 1996, established  
          the CURES Pilot Project, which was to begin July 1, 1997.  As  
          required by Chapter 738, a report prepared by DOJ, in  
          consultation with the Board, was submitted to the Legislature in  
          January of 1999 regarding the implementation of CURES.   
          According to this report, CURES has been implemented in a timely  
          and cost-effective manner.  At the time of the report, automated  
          collection of Schedule II prescription data from the state's  
          5,000 pharmacies had been in place for almost one year, and the  
          data analysis and on-line communications linkage to the state  
          agencies had also been established in its initial phase.   
          According to the report, in 1995, the triplicate program reached  
          its peak production level by manually entering data from 256,303  
          triplicate prescription forms into the computer system.  Since  








                                                                    AB 2018
                                                                    Page  5


          1995, productivity has steadily declined, and in 1998 only  
          39,945 triplicate prescription forms, representing 1.7% of the  
          total, were manually entered into the system.  The report states  
          that CURES has solved the data entry backlog problem experience  
          by the triplicate program.  Through CURES, DOJ and  
          medical-related licensing boards have ready access to up-to-date  
          information on Schedule II drug prescriptions.  In the first  
          seven months that CURES was operational, a total of 892,985  
          Schedule II prescriptions were transmitted by pharmacies into  
          the CURES system.  The report made several recommendations,  
          including making CURES permanent, and reclassifying, as  
          appropriate, current triplicate prescription program staff to  
          classifications more suitable to the investigative and  
          analytical duties they will perform for CURES.

          This bill is sponsored by the Board.  According to the Board,  
          under the triplicate program, once the original is mailed by the  
          pharmacy to DOJ, these prescriptions must be entered manually  
          into a computer system and/or filed in boxes for manual  
          searches.  This labor-intensive system resulted in fewer than 2%  
          of all triplicate prescriptions being entered into DOJ's  
          computer system in recent years.  The Board states that CURES,  
          instead, works by having pharmacies make electronic copies of  
          all Schedule II prescriptions dispensed each month.  The  
          electronic data from all California pharmacies is then compiled  
          into a statewide database that is provided to DOJ.  The Board  
          states that it is sponsoring this legislation because the CURES  
          program has clearly established that electronic monitoring is a  
          superior alternative to collecting the more than 2 million paper  
          prescriptions that are written each year.  The Board argues that  
          the CURES system makes identifying patterns of abuse and  
          diversion of prescription drugs into illicit markets much easier  
          because all data is readily available for analysis.  The Board  
          states that with CURES, the triplicate prescription process has  
          out-lived its utility.

          Numerous organizations are in support of this bill.  The  
          American Cancer Society (ACS) states in support that research  
          indicates less than half of cancer patients get adequate relief  
          of their pain even though the means to relieve almost all cancer  
          pain currently exists.  ACS states that it has found there is a  
          dichotomy between the effort to restrict the availability of  
          controlled substances and the need to adequately and  
          compassionately treat patients experiencing pain, and ACS has  








                                                                    AB 2018
                                                                    Page  6


          long supported CURES as a way to address both concerns.   
          Americans for Death with Dignity (ADD) states that physician's  
          fears about law enforcement are not idle fears given the lack of  
          understanding about the use of opioid drugs as acceptable  
          medical practice by both medical boards and physicians in this  
          country.  ADD points to studies in the early 1990s which  
          revealed appalling statistics of medical board members and  
          physicians who thought that prescribing narcotics to relieve  
          pain was an illegal act and/or not acceptable treatment, which  
          it is neither.  ADD argues that it is time to eliminate the  
          stigma of triplicate prescriptions for the medical use of  
          narcotics for terminally ill and dying patients.

          This bill is opposed by the California Peace Officers'  
          Association (CPOA) and the California Police Chiefs Association  
          (CPCA).  CPOA and CPCA state that California's triplicate system  
          enables law enforcement to monitor the distribution of Schedule  
          II controlled substances statewide through the issuance of  
          serialized triplicate prescription forms and the receipt and  
          review of cashed triplicates, and allows them to respond to  
          specific law enforcement or regulatory inquiry and to forward  
          investigative leads to prevent diversion of prescription drugs  
          into the illegal market, all without interfering with lawful  
          prescribing practices.  CPOA and CPCA state that serialized  
          prescription forms are a useful tool in eliminating forgery and  
          counterfeiting, and point out in contrast that states that do  
          not have such a program are prone to high incidences of forgery  
          of prescriptions.  For instance, CPOA and CPCA state that New  
          York reported a 12% forgery rate prior to the implementation of  
          its state-serialized program, while implementation of the  
          program slashed the forgery rate down to .0006%.  CPOA and CPCA  
          state that surveys done by DOJ report that Oklahoma, Nevada,  
          North Carolina and Mississippi, which do not have a serialized  
          prescription program, have reported high incidences of forgeries  
          and counterfeited prescription pads.  CPOA and CPCA state that  
          perhaps there will be a time when CURES will have sufficient  
          safeguards to operate as a "stand-alone" monitoring strategy,  
          but until CURES has technology to ensure security, or to be able  
          to capture signatures, fingerprints or retinal scans,  
          abandonment of the serialized triplicate system is premature.


           Analysis Prepared by  :  Vincent D. Marchand / HEALTH / (916)  
          319-2097                                               FN:  








                                                                    AB 2018
                                                                    Page  7


          0004884