BILL ANALYSIS                                                                                                                                                                                                    






                           SENATE JUDICIARY COMMITTEE
                            Martha M. Escutia, Chair
                           2001-2002 Regular Session


          AB 1589                                                A
          Assembly Member Simitian                               B
          As Amended July 16, 2001
          Hearing Date:  August 21, 2001                         1
          Business and Professions Code                          5
          GMO:cjt                                                8
                                                                 9

                                     SUBJECT
                                         
            Healing Arts:  Electronic Transmission of Prescriptions


                                   DESCRIPTION  

          This bill would require the Medical Board to consult with  
          the Board of Pharmacy and to commission a study that  
          evaluates the electronic transmission of prescriptions by  
          physicians and other specified health care providers and  
          report the results of such study to the Legislature on or  
          before January 1, 2003.  The report would include  
          recommendations for methods to encourage physicians and  
          other health care providers to issue prescriptions by  
          electronic transmission and for systems that would protect  
          patient identity, including the use of digital  
          certification of prescriptions.  The bill would define  
          digital certification.

          The bill contains findings based upon a 1999 report by the  
          Institute of Medicine relating to medication-related errors  
          in the health care system.

                                    BACKGROUND  

          On February 22, 2000, the White House announced new  
          initiatives "to improve patient safety and assure health  
          care quality," adopting virtually every recommendation of  
          the Institute of Medicine (IOM) report released in  
          November, 1999.  Among the initiatives are those that  
          relate to reductions in medication-related errors, such as  
                                                                 
          (more)



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          1) regulations requiring over 6,000 hospitals participating  
          in Medicare to have in place error reduction programs that  
          include new systems to decrease medication-related errors;  
          (2) comprehensive plans for a nationwide system of error  
          reporting; and (3) increased use of computer technology to  
          decrease serious medication-related errors.

          Based on the IOM report, SB 1875 (Speier, Chapter 816,  
          Statutes of 2000) made it a condition of licensure that  
          specified health care facilities implement a formal plan,  
          on or before January 1, 2005, to eliminate or substantially  
          reduce medication-related errors in the facility.

          The IOM report also contains the following information  
          relating to prescriptions:
           Nearly all three billion prescriptions issued each year  
            in the United States are handwritten by physicians;
           Illegible prescriptions result in more that 150 million  
            inquiries each year by pharmacists for clarification from  
            the issuing physician;
           Less than five percent of physicians use computer  
            technology to prescribe medications.

          The Assembly Health Committee has been researching various  
          e-health issues, including e-prescriptions.  According to  
          the author, Palo Alto Medical Foundation has begun testing  
          a new web-based system that allows patients to view their  
          own medical records, request appointments, and renew  
          prescriptions online.  Also, New Jersey is considering new  
          rules to allow physicians to e-mail prescriptions to a  
          pharmacy, a move aimed at reducing errors caused by  
          illegible handwriting of prescriptions. 

          This bill focuses on prescriptions issued by physicians and  
          other specified health care providers.  

                             CHANGES TO EXISTING LAW
           
           Existing law  requires the California State Medical Board to  
          regulate the practitioners of medicine and other healing  
          arts.  

           Existing law  authorizes the California State Board of  
          Pharmacy to adopt rules and regulations relating to the  
          practice of pharmacy, and the dispensing of drugs or  
                                                                       




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          devices pursuant to a prescription of a person licensed to  
          prescribe such drugs or devices.

           This bill  would require the Medical Board to consult with  
          the Board of Pharmacy and to commission a study regarding  
          the electronic transmittal of prescriptions by physicians  
          and surgeons, dentists, optometrists, podiatrists,  
          veterinarians, certified nurse midwives, nurse  
          practitioners, physician assistants, or pharmacists acting  
          within the scope of their practice.

           The bill  would require the Board to report to the  
          Legislature on the results of the study on or before  
          January 1, 2003, and to include in the report  
          recommendations on how to encourage such use of electronic  
          transmittal of prescriptions and of systems to protect  
          patient identity, including use of digital certification of  
          prescriptions, as defined.
          

                                     COMMENT
           
          1.    Need for the bill

             This bill is one of a number of bills looking at  
            eliminating medication-related errors in the health care  
            system that were identified by the IOM report. 
            SB 1875 (Speier, Ch. 816, Statutes of 2000) took the  
            White House initiatives issued in February 2000 pursuant  
            to the IOM report and made it a condition of licensure  
            for health care facilities to adopt a formal plan to  
            prevent medication-related errors in the facilities.   
            Covered health care facilities have until January 1, 2005  
            to adopt those formal plans. 

            It is generally agreed by proponents and opponents of  
            this line of legislation that information regarding the  
            frequency and nature of medication-related errors is  
            essential in improving the quality of care provided by  
            the health care system in this country.  While hospital  
            care has become safer over the years because of advances  
            in surgical techniques and practice, medical commentators  
            have argued that prevention of errors continue to be the  
            single source of improvement in mortality rate  
            statistics. [Troyen A. Brennan, M.D., J.D, M.P.H., The  
                                                                       




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            Institute of Medicine Report on Medical Errors - Could It  
            Do Harm?, the New England Journal of Medicine, Vol. 342,  
            No. 15, April 13, 2000.]

            Since prescriptions can only be dispensed by a pharmacist  
            pursuant to a prescription issued by an authorized  
            professional (or the pharmacist, if within the scope of  
            his or her practice) it is logical that accuracy of the  
            communication regarding the prescribed medicine be the  
            target of any attempts to improve the health care system,  
            or at least to reduce medication-related errors that  
            create unintended problems for the patient.

            The author states that "[A]s the industry explores  
            options to make health care delivery more efficient and  
            cost-effective, there is a need to develop standard  
            protocols regarding signature verification, security, and  
            interfacing with current requirements relative to  
            prescribing drugs or oversight of drug prescription will  
            become unsound."

          2.    Medical Board to commission a study

             AB 1589 would require the California State Medical Board  
            to consult with the Board of Pharmacy and to commission a  
            study on the subject of issuing prescriptions by  
            electronic transmission, and to report to the Legislature  
            on the subject by January 1, 2003.  The report must  
            contain recommendations on encouraging those authorized  
            to prescribe to use electronic transmission of the  
            prescriptions, and on systems that would allow electronic  
            transmission while protecting patient information.

            It is entirely appropriate for the two boards to work  
            together on this subject, because while one is liable for  
            the appropriateness and accuracy of the prescription  
            issued, the other is liable for the accuracy of  
            dispensing the drugs or devices to the patient.   
            Communication between them must be clear and unequivocal,  
            so that a patient may not be victimized by taking the  
            wrong medication or wrong dosage of the right medication.

            However, the switch from illegibly handwritten  
            prescriptions to electronically transmitted prescriptions  
            is fraught with questions relating to privacy of  
                                                                       




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            information relating to the patient, the physician's  
            responsibility releasing medical information (which  
            prescriptions would be) to a third party, and liability  
            as between the physician and the pharmacist for errors  
            and omissions.

            This is the reason why a slower approach, such as this  
            one taken by AB 1589, is superior to one that simply  
            allows a physician to email a prescription to the  
            patient's choice of pharmacist.  The report to be made to  
            the Legislature should provide some guideline to the  
            Legislature as to what protections should be enacted by  
            statute, and what should be left to regulation by the  
            healing arts boards and commissions.

          3.    Prescriptions to be covered

             The study authorized by this bill would cover  
            prescriptions made by not only doctors, but also  
            dentists, optomerists, podiatrists, veterinarians,  
            certified nurse midwives, nurse practitioners, physician  
            assistants, or pharmacists acting within the scope of  
            their practice.  These professionals are listed in  
            Section 4024 of the Business and Professions Code as  
            those authorized to prescribe drugs or devices that a  
            pharmacist may dispense.  It is assumed that these  
            licensed professionals are licensed in the State of  
            California.

            However, Business and Professions Code Section 4008 also  
            permits the Board of Pharmacy to adopt regulations  
            permitting the pharmacist to dispense drugs or devices  
            prescribed by a person licensed out of state where that  
            person, if licensed in California in the same licensure  
            classification would, under California law, be permitted  
            to prescribe drugs or devices, and where the pharmacist  
            has first interviewed the patient to determine the  
            authenticity of the prescription.

            SHOULD THE STUDY ALSO COVER PRESCRIPTIONS MADE BY  
            OUT-OF-STATE LICENSED DOCTORS AND HEALTH CARE PROVIDERS,  
            AS SPECIFIED?

            Especially with the mobility of the country's population,  
            and the supposed efficiency and convenience of  
                                                                       




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            e-prescriptions, this subject should probably be included  
            in the Medical Board's commissioned study.

          4.    Support from the Medical Board and the Board of  
          Pharmacy

             According to the Board of Pharmacy, "[e]lectronic  
            prescribing has been proven to substantially reduce the  
            incidence of medication errors and has the potential to  
            bring substantial operating efficiencies to prescribing  
            and dispensing processes."  The Board reports that  
            electronic prescribing has begun to take hold in the  
            hospital setting and experience in one hospital found a  
            50% reduction in medication errors and a two-hour  
            reduction in the time required to process the order and  
            administer the drug to the patient.  However, the Board  
            states, technology for electronic prescribing in  
            outpatient settings has only become available recently,  
            and the study required by the bill will provide  
            recommendations on how to speed its adoption.

            The Medical Board makes the same points, but adds that  
            since commercially available computerized systems are  
            very expensive and tailored for hospital systems, it is  
            important to examine the feasibility of having such  
            systems in individual physicians' offices and the risks  
            of having such systems widely used.

            As well, the California Medical Association supports the  
            bill and mentions that its Project SAFECARE (Strategic  
            Alliance for Effective Care and Reduction of Errors) Task  
            Force is looking into criteria that physicians may  
            consider when taking advantage of this new technology.

          5.    Effect of the Uniform Electronic Transactions Act

             The study should also consider the practical and legal  
            effect of the Uniform Electronic Transactions Act, Civil  
            Code Sections 1633.1 et seq. [SB 820 (Sher), Chapter 428,  
            Statutes of 1999] on prescriptions, since that Act  
            governs all electronic transactions, including business  
            and commercial transactions, except those specifically  
            excepted from the Act.  Medical prescriptions are not  
            specifically excepted from the Act.  

                                                                       




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            The application of the Act, which details the procedure  
            for the transmission, receipt and operative effect of an  
            electronic transaction, will have to be examined in light  
            of the privacy issues complicating use of electronically  
            transmitted prescriptions, the confidentiality of medical  
            information as required by the Civil Code, and  
            professional and ethical responsibilities of physicians  
            and other licensees who are authorized to prescribe  
            medications.


          6.    Suggested amendment to Medical Board report and  
          recommendations  

            This bill would specify that the report submitted by the  
            Medical Board to the Legislature include recommendations  
            "for methods to encourage physicians [and other specified  
            health care providers] to issue prescriptions by  
            electronic transmission and for systems that would  
            protect patient identity?"

            This language presupposes that the report would conclude  
            that prescriptions by electronic transmissions  should be  
            encouraged and that only protection of the patient's  
            identity is necessarily considered in developing systems  
            that could be used to transmit those prescriptions.

            In light of the concerns raised in the above comments,  
            the language of the bill should probably be revised to  
            state that the Board's report should include  
            recommendations on whether electronic transmittal of  
            prescriptions should be encouraged, and if so, how  
            (keeping in mind the obstacles that small clinics or  
            single-physician clinics would have in using an  
            electronic transmission system).  The recommendations  
            should also address systems to protect not only the  
            patient's identity but also his or her privacy, which is  
            a concept that, in light of the current debate over  
            personal information made available online, is much  
            larger and more complex than simple personal identity.

            SHOULD THE LANGUAGE REGARDING THE MEDICAL BOARD'S REPORT  
            BE REVISED AS SUGGESTED?

          Support:  California Medical Board; California Board of  
                                                                       




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                 Pharmacy, California Medical Association; California  
                 Optometric Association

          Opposition:  None Known

                                     HISTORY
           
          Source:  Author

          Related Pending Legislation:  AB 1490 (Thomson) - would  
                                provide for patients to access  
                                laboratory test results online; this  
                                bill will be heard in Committee  
                                today.
                                
                                AB 826 (Cohn) - would authorize a  
                                pharmacist to initiate the drug  
                                regimen of a patient in a health  
                                facility pursuant to a written order  
                                or prescription  and would authorize  
                                the pharmacist to provide written or  
                                electronic notification of that  
                                action.  This bill is on the Senate  
                                Third Reading File.

          Prior Legislation:  SB 1875 (Speier, Chapter 816, Statutes  
          of 2000)
                            
          Prior Vote: Asm. Health (Ayes 13, Noes 0)
                    Asm. Appr. (Consent)
                    Asm. Flr. (Ayes 75, Noes 0) (Consent)
                    Sen. B. & P. (Ayes 5, Noes 0).
          
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