BILL ANALYSIS                                                                                                                                                                                                    






                                 SENATE HEALTH
                               COMMITTEE ANALYSIS
                        Senator Deborah V. Ortiz, Chair


          BILL NO:       SCR 49                                       
          S
          AUTHOR:        Speier                                       
          C
          AMENDED:       June 15, 2005                                
          R
          HEARING DATE:  June 22, 2005                               
          FISCAL:        Non-Fiscal                                   
          4
                                                                      
          9
          CONSULTANT:                                                
          Margolis / ag
                                        

                                     SUBJECT
                                         
               Medication errors:  creation of legislative panel

                                     SUMMARY  

          This resolution makes findings related to the dangers and  
          causes of medication errors, and resolves that a special  
          panel be formed by the California Legislature to study the  
          causes of medication errors and submit a final report to  
          the Senate Committee on Health by June 1, 2006.

                                     ABSTRACT  

          Existing law:
          1.Requires every pharmacy to establish a quality assurance  
            program that documents mediation errors attributable to  
            the pharmacy or its personnel.  

          This bill:
          Includes the following findings:
          1.Numerous studies establish that medication errors cause  
            injury and death. 

          2.The Institute of Medicine estimates annual drug-related  
            morbidity and mortality costs to be approximately $77  
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            million nationally.  

          3.Research demonstrates that medication errors result from  
            the failures of a complex healthcare system and are not  
            the fault of individual healthcare providers.  

          4.Over 17,000 trade and generic products exist, for which  
            many of the names are similar, and many are packaged  
            similarly.  

          5.Many factors contribute to a poor understanding by  
            patients about their prescriptions.

          6.Improved communication between patients and their health  
            professionals is the most effective means of reducing  
            medication errors.  
          Resolves that:
          1.The Legislature convene a special panel to study causes  
            of medication errors no later than October 1, 2005.  

          2.The panel recommend improvements, additions, or changes  
            to improve the health care system by reducing medication  
            errors.  

          3.The panel shall consist of appointees of the Health  
            Committees of the Senate and Assembly.  

          4.The Speaker of the Assembly shall appoint a member of the  
            faculty of a school of pharmacy; representatives of: the  
            California Pharmacists Association, the California  
            Association of Health Plans, the Pharmaceutical Research  
            and Manufacturers of America, the California Medical  
            Association, the Assembly Republican Caucus; and a  
            consumer representative.  

          5.The Senate Committee on Rules shall designate the panel's  
            chair and appoint representatives from: the California  
            Retailers Association Chain Drug Committee, the Generic  
            Pharmaceutical Association, the California Society of  
            Hospital Pharmacists, a public health organization, the  
            California Nurses Association, the American Association  
            of Retired People, and the Senate Republican Caucus.  

          6.The panel shall submit to the Senate Committee on Health  
                                                           
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            a preliminary report by March 1, 2006, and a final report  
            by June 1, 2006.  

          7.The members of the panel shall not receive compensation  
            but shall be reimbursed for travel expenses, and the  
            panel shall be funded by private sources.  

                                  FISCAL IMPACT  

          This is a non-fiscal bill and requires that the panel be  
          funded by private sources.  

                            BACKGROUND AND DISCUSSION  

          Medical errors
          A seminal 1999 report by the Institute of Medicine (IOM),  
          To Err Is Human: Building a Safer Health System,  
          effectively launched a national discussion about the  
          seriousness and gravity of medical errors in this country.   
          The report states that between 44,000 and 98,000 people die  
          in hospitals each year as a result of medical errors that  
          could have been prevented.  According to the report,  
          "Preventable medical errors in hospitals exceed  
          attributable deaths to such feared threats as motor-vehicle  
          wrecks, breast cancer, and AIDS."  The report describes the  
          high and varied types of costs that result from medical  
          errors, totaling between $17 and $29 billion per year in  
          hospitals nationwide.  Other costs cited include: loss of  
          trust in health care; physical and psychological  
          discomforts for patients; loss of morale and frustration by  
          providers; lost worker productivity; and increased school  
          absences by children.

          The IOM study explores the causes of medical errors and  
          concludes that "The majority of medical errors do not  
          result from individual recklessness?errors are caused by  
          faulty systems, processes, and conditions that lead people  
          to make mistakes or fail to prevent them."  Within this  
          report, the IOM lays out a comprehensive strategy to reduce  
          preventable medical errors, concluding that the ways to  
          prevent these errors already are known.  The strategy  
          includes the following four major goals:

          1.Establish a national focus to create leadership,  
                                                           
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            research, tools, and protocols to enhance the knowledge  
            base about safety.  Specifically, the IOM recommended  
            that Congress create a "Center for Patient Safety, within  
            the Agency for Healthcare Research and Quality (AHRQ), to  
            set national safety goals, develop a research agenda, and  
            develop, disseminate, and evaluate tools for identifying  
            and analyzing errors, among other tasks.  
          
          2.Develop a nationwide public mandatory reporting system  
            and encourage health care organizations and practitioners  
            to develop and participate in voluntary reporting  
            systems.  State governments would be required to collect  
            standardized information; hospitals would be required to  
            begin reporting first, and eventually all health care  
            organizations would report.  
          
          3.Raise performance standards and expectations for  
            improvements in safety through the actions of oversight  
            organizations, professional groups, and group purchasers  
            of health care.  The IOM argues that setting and  
            enforcing explicit performance standards for patient  
            safety through regulatory and related mechanisms, such as  
            licensing, certification, and accreditation can define  
            minimum performance levels for health professionals.  The  
            report states that professional societies should become  
            leaders in encouraging and demanding improvements in  
            patient safety, by setting their own performance  
            standards, communicating with members about safety, and  
            collaborating across disciplines.  Public and private  
            purchasers are urged to make safety a prime concern in  
            their contracting decisions.  
          
          4.Implement safety systems in health care organizations to  
            ensure safe practices at the delivery level.  The report  
            states that, "Safety should be an explicit organizational  
            goal that is demonstrated by strong leadership on the  
            part of clinicians, executives, and governing bodies."   
            This includes: designing jobs and working conditions for  
            safety; standardizing and simplifying equipment,  
            supplies, and processes; and enabling care providers to  
            avoid reliance on memory.  
          
          According to the IOM, many actions have occurred to  
          implement these strategies since the issuance of the report  
                                                           
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          in 1999, including:
           Congress appropriated $50 million to the AHQR to: develop  
            and test new technologies; conduct large-scale  
            demonstration projects; and support new and established  
            multidisciplinary teams of researchers in health-care  
            facilities and organizations.

           The National Academy for State Health Policy convened  
            leaders from both the executive and legislative branches  
            of the states to discuss approaches to improving patient  
            safety.

           The Leapfrog Group, an association of private and public  
            sector group purchasers, unveiled a market-based strategy  
            to improve safety and quality.
           The Council on Graduate Medical Education and the  
            National Advisory Council on Nurse Education and Practice  
            held a joint meeting on educational models to ensure  
            patient safety.

          In May of 2005, two of the original authors (Lucien Leape,  
          M.D., and Donald Berwick, M.D.) of To Err is Human  
          published a follow-up study of progress made in the five  
          years following the IOM report.  The authors conclude that,  
          "The groundwork for improving safety has been laid in these  
          past five years but progress is frustratingly slow."  They  
          also state that small improvements can be seen at the  
          margins, but the overall national situation remains largely  
          the same.  This follow-up report cites the following  
          barriers to change: creating a culture of safety requires  
          changes that physicians may perceive as threats to their  
          autonomy and authority; fear of malpractice liability leads  
          to an unwillingness to discuss or admit errors; the  
          complexity of the health care industry; a lack of  
          leadership; the lack of measures to gauge progress; and the  
          current reimbursement system that rewards less-safe care.   
          Leape and Berwick argue that the single most important next  
          step is to set and adhere to "strict, ambitious,  
          quantitative, and well-tracked national goals."

          Medication errors
          The National Coordinating Council for Medication Error  
          Reporting and Prevention is dedicated to preventing medical  
          errors specific to medications.  The organization includes  
                                                           
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          the following members:  AARP, American Health Care  
          Association, American Hospital Association, American  
          Medical Association, American Nurses Association, American  
          Pharmacists Association, American Society of Health-System  
          Pharmacists, Food and Drug Administration, Generic  
          Pharmaceutical Association, and others.  This organization  
          has issued recommendations on reducing medication errors in  
          non-health care settings, reducing errors associated with  
          verbal medication orders, reducing errors related to  
          administration of drugs, error-prone aspects of dispensing  
          medications, labeling and packaging of drugs, and more.

          The California Pharmacists Association, the sponsor of the  
          bill, writes in support that "SCR 49 will create a  
          credentialed panel to study the systemic causes of these  
          errors, and make substantive recommendations to reduce them  
          for the protection of the public and for healthcare cost  
          reductions."  The California Nurses Association states in  
          support that this panel "will bring together a diverse  
          group of individuals to look at the cause of millions of  
          needless consumer deaths or disabilities due to preventable  
          medication errors."  Kaiser Permanente writes in support of  
          the bill that, "This panel would be able to take an  
          informed, independent look at new technologies and  
          different processes that could be used to reduce medication  
          errors."

















                                                           
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          Prior legislation
           SR 44 (Burton, 2004) -- requires the Senate to establish  
            the California Commission on the Fair Administration of  
            Justice to study and review the administration of  
            criminal justice in California, to determine the extent  
            to which that process has failed in the past, resulting  
            in wrongful executions or the wrongful convictions of  
            innocent persons.  The Commission must be funded  
            privately and make recommendations to the Legislature and  
            Governor by December 31, 2007.  

           SCA 39 (Soto, Chapter 142, Statutes of 2001) -- required  
            the Senate Committee on Public Employment and Retirement  
            to convene a panel to study the funding of pharmacy  
            benefits, co-payments, and other benefit structures of  
            the Public Employees' Medical and Hospital Care Act  
            program, and report back to the Committee by June 1,  
            2002.  The sponsor of SCR 49 states that the SCA 39  
            process was considered successful by those involved and  
            that valuable recommendations were produced by the panel.  
             

          Author's amendment
          The author would like to offer an amendment in Committee to  
          add to the panel a representative of the Consumer  
          Healthcare Products Association, to be appointed by the  
          Senate Rules Committee.  

                                    POSITIONS  

          Support:       California Pharmacists Association (sponsor)
                         California Nurses Association
                         Kaiser Permanente

          Oppose:   None received.






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