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 15, 2000
          HEARING DATE:  June 21, 2000                                
          2
          FISCAL:        Appropriations                               
          0
                                                                      
          1
          CONSULTANT:                                                 
          8
          Umino / ak
                                        

                                     SUBJECT
                                         
                 Controlled Substances:  Schedule II Triplicate  
                                 Prescriptions

                                     SUMMARY  

          This bill repeals the requirement that Schedule II  
          controlled substances be written on an official  
          "triplicate" prescription issued by the Department of  
          Justice (DOJ) beginning January 1, 2003, and makes the  
          Controlled Substance Utilization Review and Evaluation  
          System (CURES) pilot project a permanent program.

                                     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 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 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:
          1.Repeals, on January 1, 2003, the requirement that  
            Schedule II controlled substances must be written on an  
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            official "triplicate" prescription form issued by DOJ.

          2.Specifies that beginning January 1, 2003, Schedule II  
            controlled substances must be subject to the same  
            requirements as controlled substances in Schedule III,  
            IV, or V, but, unlike the other controlled substances,  
            oral or electronic transmission of a Schedule II  
            controlled substance is not allowed.  

          3.Deletes the July 1, 2003 sunset for the CURES pilot  
            project, which results in a permanent program, and  
            deletes the requirement for DOJ to submit a report to the  
            Legislature on the ability of CURES to provide complete,  
            accurate, and timely data on Schedule II controlled  
            substances prescribed and dispensed in California.

                                  FISCAL IMPACT  

          The Assembly Committee on Appropriations reports ongoing  
          costs to operate the CURES program of about $300,000 per  
          year from the General Fund for contract and operation  
          costs.  Furthermore, the addition of four auditors to check  
          prescriptions against the CURES database will cost about  
          $300,000 annually from the General Fund.

                            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.

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          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  
               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 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, who oppose this  
          bill, 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.

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          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 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 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,
                "those 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. 
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          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.
          
          Comment:
          The author may wish to include a provision in this bill for  
          DOJ and the Board of Pharmacy to monitor the CURES program  
          until January 1, 2003 and report to the Legislature on:   
          (a) the completeness, accuracy, and timeliness of data for  
          Schedule II controlled substances, (b)  the effectiveness  
          of the information collected in investigating and  
          prosecuting individuals suspected of diversion activities,  
          and (c) improvements necessary to ensure effective  
          monitoring of Schedule II controlled substances to deter,  
          prevent, and reduce diversion.

                                  PRIOR ACTIONS

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







                               POSITIONS IN SUPPORT  













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




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          |    Health Systems              |Society                         |
          |California Church IMPACT        |Saint Agnes Medical Center,     |
          |California Coalition of Nurse   |Fresno                          |
          |Practitioners California        |San Diego Hospice               |
          |    Dental Association          |Siskiyou County Sheriff-Coroner |
          |California Disability Alliance  |Charles Byrd                    |
          |California Grocers Association  |Solano County Medical Society   |
          |California Hospice and          |Southern California Cancer Pain |
          |Palliative Care Association     |Initiative                      |
          |California Hospital Medical     |St. Elizabeth Hospice, Red      |
          |Center                          |Bluff                           |
          |California Medical Association  |St. Joseph Health Foundation of |
          |California Nurses Association   |Northern California             |
          |California Pharmacists          |St. Joseph Health System        |
          |Association                     |St. Joseph Health System -      |
          |California Podiatric Medical    |Greater Sonoma County           |
          |Association                     |St. Joseph Health               |
          |California Psychiatric          |System-Humboldt County          |
          |Association                     |St. Joseph Health System,       |
          |California Retailers            |Southern California Region      |
          |Association                     |St. Joseph's Medical Center     |
          |California Society of           |Sutter Hospice/Roseville        |
          |Anesthesiologists, Inc.         |TMJ Society of California       |
          |California Society of           |Torrance Memorial Home Health & |
          |Health-System Pharmacists       |Hospice                         |
          |Catholic Healthcare West        |Union of American Physicians    |
          |Catholic Healthcare West Bay    |and Dentists                    |
          |Area Region                     |United Food & Commercial        |
          |Catholic Healthcare West        |Workers Region 8                |
          |Central Coast Region            |    States Council              |
          |Catholic Healthcare West North  |Visiting Nurse Association and  |
          |State Region                    |Hospice                         |
          |Catholic Healthcare West, San   |VITAS Healthcare Corporation    |
          |Joaquin-Sierra Region           |VNA and Hospice of Northern     |
          |Citizens for the Right to Know  |California                      |
          |Coalition of Concerned Medical  |VNACare Hospice in the Home     |
          |Professionals                   |Western Service Workers         |
          |Congress of California Seniors  |Yolo County Medical Society     |
          |County Health Executives        |ZG International Health Care    |
          |Association of California       |Division                        |
          |Death With Dignity National     |6 Individuals                   |
          |Center                          |                                |
          |Dental Board of California      |                                |
          |Hospice Services of Lake County |                                |
          |The Elizabeth Hospice           |                                |
          |Friends Committee on            |                                |




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          |Legislation of California       |                                |
          |                                |                                |
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                            POSITIONS IN OPPOSITION
                          
          Association for Los Angeles Deputy Sheriffs
          Attorney General Bill Lockyer
          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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