BILL ANALYSIS                                                                                                                                                                                                    






                        SENATE HEALTH AND HUMAN SERVICES
                               COMMITTEE ANALYSIS
                        Senator Martha M. Escutia, Chair


          BILL NO:       AB 2018                                      
          A
          AUTHOR:        Thomson, et al.                              
          B
          AMENDED:       June 29, 2000
          HEARING DATE:  July 5, 2000                                 
          2
          FISCAL:        Appropriations                               
          0
                                                                      
          1
          CONSULTANT:                                                 
          8
          Umino / ak
                                        

                                     SUBJECT
                                         
                 Controlled Substances:  Schedule II Triplicate  
                                 Prescriptions

                                     SUMMARY  

          This bill makes changes to the existing triplicate  
          prescription requirements for Schedule II controlled  
          substances and requires the Attorney General to determine  
          if the electronic Controlled Substance Utilization Review  
          and Evaluation System should be continued on and after July  
          1, 2003.

                                     ABSTRACT  

          Existing federal and state laws rank controlled substances  
          according to their potential for abuse, accepted medical  
          use, and safety under medical supervision: 
          a. Schedule I substances (e.g., heroin) have a high  
             potential for abuse, no currently accepted medical use,  
             and lack accepted safety for use.
          b. Schedule II drugs (e.g., morphine, codeine, Demerol,  
             Dilaudid and Percodan) have a high potential for abuse,  
             accepted medical use in treatment, and severe  
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             psychological or physical dependence, if abused.
          c. Schedule III drugs (e.g., Vicodin, anabolic steroids,  
             codeine with aspirin or Tylenol) have less potential for  
             abuse than Schedule I and II, accepted medical use in  
             treatment, and moderate or low physical dependence or  
             high psychological dependence, if abused.
          d. Schedule IV drugs (e.g., Darvon, Valium, and Xanax) have  
             a low potential for abuse, accepted medical use in  
             treatment, and limited physical or psychological  
             dependence, if abused.
          e. Schedule V drugs have low potential for abuse relative  
             to Schedule IV, accepted medical use in treatment, and  
             limited physical or psychological dependence, if abused.

          Existing state law requires each prescription for a  
          controlled substance classified as Schedule II to be wholly  
          written in ink or indelible pencil in the handwriting of  
          the prescriber upon an official "triplicate" prescription  
          form issued by the Department of Justice (DOJ).  The  
          original and duplicate of the prescription must be  
          delivered to the pharmacist who fills the prescription and  
          must then transmit the original prescription to DOJ, as  
          specified.  

          Existing law also requires that the "triplicate"  
          prescription forms, which are issued by DOJ, must  (a) be  
          in serially numbered groups of not more than 100 forms, (b)  
          be furnished to an authorized practitioner, (c) be  
          nontransferable, and (d) bear the preprinted name, address,  
          category of professional licensure of the practitioner to  
          whom they are issued, and the federal registry number for  
          controlled substances.  

          Furthermore, existing law establishes the Controlled  
          Substance Utilization Review and Evaluation System (CURES)  
          pilot project within DOJ to electronically monitor the  
          prescribing and dispensing of Schedule II controlled  
          substances.  DOJ, in consultation with the Board of  
          Pharmacy, must submit annual reports to the Legislature  
          until January 1, 2002, on, among other things, the ability  
          of CURES to provide complete, accurate, and timely data on  
          Schedule II controlled substances prescribed and dispensed  
          in California.    

          This bill:
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          1.Allows a practitioner to orally, electronically, or in  
            writing request larger amounts of prescription blanks,  
            which are issued by DOJ in serially numbered groups of  
            not more than 100 forms each in triplicate.

          2.Deletes the requirement that DOJ limit the issuance of  
            triplicate prescription blanks to 100 forms during a  
            30-day period.

          3.Removes the provision that prevents DOJ from issuing more  
            than one "prescription group" to the same prescriber at  
            one time.

          4.Specifies that (a) the signature on each "triplicate"  
            prescription for a Schedule II controlled substance must  
            be wholly written in ink or indelible pencil in the  
            handwriting of the prescriber, and (b) each prescription  
            must contain specified information either typewritten or  
            handwritten by the physician or his or her employee.

          5.Allows a pharmacist to fill a Schedule II controlled  
            substance prescription, which contains an error or  
            errors, if (a) the pharmacist notifies the prescriber and  
            (b) the prescriber approves any correction.

          6.Requires a prescriber to fax or mail a corrected  
            prescription to the pharmacist within seven days of the  
            prescription being dispensed.

          7.Removes the provision that the sum of $1,050,000 is  
            appropriated from the Pharmacy Board Contingent Fund to  
            the Board of Pharmacy for the purpose of entering into an  
            interagency agreement with DOJ for the implementation,  
            operation, and evaluation of CURES.
           
          8.Requires the CURES pilot project to become inoperative on  
            July 1, 2003 and repeals the section on January 1, 2004,  
            unless the Attorney General determines and provides  
            timely written notification to the Legislature that the  
            CURES program should be continued on and after July 1,  
            2003, "on the basis that the CURES program provides more  
            timely data."

          9.Specifies that if the CURES program remains in effect on  
            or after July 1, 2003, then the requirement that a  
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            prescription for a Schedule II controlled substance must  
            be written on a triplicate prescription must terminate on  
            July 1, 2003 and must, instead, meet the same  
            prescription requirements for controlled substances  
            classified as Schedule III, IV, or V.

          10.Provides for additional emergency situations specified  
            in federal regulations, which allow a Schedule II  
            controlled substance to be dispensed by a oral, written,  
            or electronic data transmission and subject to specified  
            requirements.

                                  FISCAL IMPACT  

          Unknown
                            BACKGROUND AND DISCUSSION  

          The author reports that "triplicate prescriptions are an  
          administrative hassle for prescribers and can result in  
          inadequate relief for patients in pain. . . .  Studies  
          indicate that cancer-related pain could be well-controlled  
          in 80% to 90% of affected patients, but recent findings  
          indicate that more than 40% of cancer patients receive  
          inadequate pain relief."  According to the author, many  
          physicians do not have access to the full range of drugs  
          necessary to treat patients with severe pain, because they  
          do not have "triplicate" prescription forms.  As of  
          February 1999, only 40,333 of the 74,518  
          California-licensed physicians, who could prescribe  
          Schedule II controlled substances, had "triplicate"  
          prescription forms issued to them.  Furthermore, the author  
          believes that it is unnecessary to continue to require the  
          use of government-issued prescription forms when the same  
          data is being reported electronically through CURES.

          The Summit on Effective Pain Management, sponsored by the  
          State of California in 1994, supports some of the author's  
          views:
               "The triplicate prescription system - which must be  
               used when Schedule II controlled substances are  
               prescribed - is outdated, impractical for many modern  
               health care settings (especially long-term care), and  
               generally ineffective for monitoring and controlling  
               diversion of medications for non-therapeutic purposes.  
                Because of the administrative complexities of and  
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               implied intimidation by the triplicate system, almost  
               half of California's physicians have chosen not to  
               seek prescribing privileges of Schedule II  
               medications.  This system of oversight is often viewed  
               as persecution by physicians and pharmacists, and the  
               result is that patients in pain suffer." (Source:   
               California Department of Consumer Affairs, Summit on  
               Effective Pain Management: Removing Impediments to  
               Appropriate Prescribing, 1994) 
          
          The 1999 Controlled Substance Utilization Review and  
          Evaluation System (CURES) Report to the Legislature  
          recommends, among other things, seeking legislation to  
          establish CURES as a permanent operational program.  
          (Source: California Department of Justice, Bureau of  
          Narcotic Enforcement, and Department of Consumer Affairs,  
          Board of Pharmacy)

          Opponents to the previous version of this bill report that  
          the existing triplicate prescription program tracks the  
          prescribing of Scheduled II controlled substances that have  
          medical use, but are highly addictive and prone to be  
          diverted into the illicit market.  According to the  
          California Police Chiefs Association and the California  
          Peace Officer's Association, the triplicate prescription  
          program enables law enforcement to monitor the prescribing  
          of dangerous drugs and to minimize the chances of those  
          drugs being diverted into the illegal market.  These  
          associations also report that electronic transmission in  
          CURES is not secure and can be compromised by entering  
          false or incorrect data.  Furthermore, the opponents report  
          that CURES serves as a framework for analysis of the  
          triplicate prescription program; and, in fact, the  
          triplicate prescription program serves as a check against  
          CURES being compromised.

          The U.S. Department of Justice, Drug Enforcement  
          Administration, Office of Diversion Control, in a letter to  
          the Office of the Attorney General reports that "it appears  
          that the policies embodied in [a previous version of]  
          Assembly Bill 2018 are contrary to the best practices of  
          preventing the diversion of Schedule II controlled  
          substances in your state.  California's triplicate  
          prescription monitoring program has effectively cut off a  
          major source of pharmaceutical controlled substance  
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          diversion within the state and we applaud your efforts."   
          The Office of Diversion Control (ODC) states that because  
          California has had a triplicate prescription-monitoring  
          program in place since 1940, the state has avoided some of  
          the major drug problems encountered in other states in the  
          1970s and 1980s.  According to ODC,
                "[T]hose states that have utilized multiple copy  
               prescription forms indicate that forgeries have  
               decreased substantially. . . . The 18 states that  
               currently operate prescription monitoring programs  
               report a reduction in the illicit market availability  
               of legitimately produced controlled substances.  The  
               same states have also reported that prescription  
               monitoring programs enable them to conduct more  
               investigations with fewer resources since targets of  
               investigation can easily be identified."  

          Finally, ODC supports prescription-monitoring programs as  
          an effective law enforcement tool and recommends that state  
          agencies considering the operation of a controlled  
          substance prescription-monitoring program combine  
          electronic monitoring and an official serialized  
          prescription form.  ODC explains that "this combination  
          will be the most effective monitoring method for deterring,  
          preventing and reducing the diversion of licit controlled  
          substances into illicit use." 

          Prior Legislation
          AB 3042 (Takasugi, Chapter 738, Statutes of 1996) created  
          the CURES program on a pilot basis. 

          AB 2693 (Migden, Chapter 789, Statutes of 1998) exempts  
          Schedule II controlled substances for patients with a  
          terminal illness from triplicate prescription form  
          requirements. 

          SB 1308 (Committee on Business and Professions, Chapter  
          655, Statutes of 1999) extended the sunset date of the  
          CURES program to July 1, 2003, required DOJ to submit  
          annual status reports on the program to the Legislature.

                                  PRIOR ACTIONS

           Assembly Floor:               47-23 Do pass
          Assembly Appropriations:      21-0Do pass
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          Assembly Public Safety:         5-0Do pass as amended
          Assembly Health:              14-0Do pass 


                               POSITIONS IN SUPPORT  
                         Previous versions of this bill







































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          |California State Board of       |Hospice of Amador               |
          |Pharmacy (sponsor)              |Hospice by the Bay              |
          |AARP                            |Hospice Care of California      |
          |Adventist Health Home Care      |Hospice of the Central Coast    |
          |Services                        |Hospice of the Foothills, Grass |
          |Alliance of Catholic Health     |Valley                          |
          |Care                            |Hospice of InterHealth          |
          |American Academy of Pain        |Hospice of Marin                |
          |Medicine                        |Hospice of Napa Valley          |
          |American Academy of Pediatrics  |Hospice and Palliative Care of  |
          |American Cancer Society         |Contra Costa                    |
          |American Chronic Pain           |Hospice of Petaluma             |
          |Association                     |Hospice of Saddleback Valley,   |
          |American Federation of State,   |Laguna Hills                    |
          |        County and              |Hospice of San Joaquin          |
          |    Municipal Employees         |Hospice of the Sierra           |
          |American Medical Group          |Hospice of Tulare County, Inc.  |
          |Association                     |Hospice of the Valley           |
          |American Medical Women's        |Hospice of the Valleys          |
          |Association-CA Region           |Kaiser Permanente Medical Care  |
          |American Pain Foundation        |Program                         |
          |Americans for Better Care of    |Los Angeles County Medical      |
          |the Dying                       |Association                     |
          |Americans for Death for Dignity |Madrone Hospice, Yreka          |
          |Assisted Home Hospice           |Marian Medical Center, Santa    |
          |Association of Northern         |Maria                           |
          |California Oncologists          |Medical Board of California     |
          |Betty Ford Center               |Mercy Hospice, Redding          |
          |Board of Registered Nursing     |Mercy Hospital and Health       |
          |California Academy of           |Services, Merced                |
          |Ophthalmology                   |Mission Hospice, Inc. of San    |
          |California Academy of Family    |Mateo County                    |
          |Physicians                      |Mission Hospital Regional       |
          |California Arthritis Foundation |Medical Center                  |
          |Council                         |National IPA Coalition          |
          |California Association of       |NorthBay Hospice and            |
          |Health Facilities               |Bereavement                     |
          |California Association of       |Older Women's League of         |
          |Health Plans                    |California                      |
          |California Association of       |Orange County Medical           |
          |Health Services at Home         |Association                     |
          |California Association of Nurse |Osteopathic Physicians and      |
          |Anesthetists                    |Surgeons of California          |




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          |California Association of       |Pharmaceutical Research &       |
          |Public Hospitals and            |Manufacturers of America        |
          |    Health Systems              |Presbyterian Intercommunity     |
          |California Church IMPACT        |Hospital Home Services          |
          |California Coalition of Nurse   |Riverside County Medical        |
          |Practitioners California        |Association                     |
          |    Dental Association          |Sacramento-El Dorado Medical    |
          |California Disability Alliance  |Society                         |
          |California Grocers Association  |Saint Agnes Medical Center,     |
          |California Hospice and          |Fresno                          |
          |Palliative Care Association     |San Diego Hospice               |
          |California Hospital Medical     |Siskiyou County Sheriff-Coroner |
          |Center                          |Charles Byrd                    |
          |California Medical Association  |Solano County Medical Society   |
          |California Nurses Association   |Southern California Cancer Pain |
          |California Pharmacists          |Initiative                      |
          |Association                     |St. Elizabeth Hospice, Red      |
          |California Podiatric Medical    |Bluff                           |
          |Association                     |St. Joseph Health Foundation of |
          |California Psychiatric          |Northern California             |
          |Association                     |St. Joseph Health System        |
          |California Retailers            |St. Joseph Health System -      |
          |Association                     |Greater Sonoma County           |
          |California Society of           |St. Joseph Health               |
          |Anesthesiologists, Inc.         |System-Humboldt County          |
          |California Society of           |St. Joseph Health System,       |
          |Health-System Pharmacists       |Southern California Region      |
          |Catholic Healthcare West        |St. Joseph's Medical Center     |
          |Catholic Healthcare West Bay    |Sutter Hospice/Roseville        |
          |Area Region                     |TMJ Society of California       |
          |Catholic Healthcare West        |Torrance Memorial Home Health & |
          |Central Coast Region            |Hospice                         |
          |Catholic Healthcare West North  |Union of American Physicians    |
          |State Region                    |and Dentists                    |
          |Catholic Healthcare West, San   |United Food & Commercial        |
          |Joaquin-Sierra Region           |Workers Region 8                |
          |Citizens for the Right to Know  |    States Council              |
          |City and County of San          |Visiting Nurse Association and  |
          |Francisco                       |Hospice                         |
          |Coalition of Concerned Medical  |VITAS Healthcare Corporation    |
          |Professionals                   |VNA and Hospice of Northern     |
          |Congress of California Seniors  |California                      |
          |County Health Executives        |VNACare Hospice in the Home     |
          |Association of California       |Western Service Workers         |
          |Death With Dignity National     |Yolo County Medical Society     |
          |Center                          |Yolo County Sheriff's           |




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          |Dental Board of California      |Department                      |
          |Hospice Services of Lake County |ZG International Health Care    |
          |The Elizabeth Hospice           |Division                        |
          |Friends Committee on            |6 Individuals                   |
          |Legislation of California       |                                |
          |Greater Los Angeles Chapter of  |                                |
          |the Oncology Nursing Society    |                                |
          |Hoffmann Hospice                |                                |
          |Home Hospice                    |                                |
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                            POSITIONS IN OPPOSITION
                          Previous versions of this bill

          Association for Los Angeles Deputy Sheriffs
          Attorney General Bill Lockyer
          California District Attorneys Association
          California Narcotic Officers' Association
          California Peace Officers' Association
          California Police Chiefs Association
          California State Sheriffs' Association
          League of California Cities
          Los Angeles County Sheriff Leroy Baca
          Los Angeles Deputy Sheriffs, Inc. Association
          Los Angeles Police Protective League
          Peace Officers Research Association of California
          Riverside Sheriff's Association
          San Bernardino County Sheriff's Department 
          San Diego County Sheriff's Department




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