BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                            



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                                    THIRD READING


          Bill No:  SB 204
          Author:   Corbett (D)
          Amended:  5/23/13
          Vote:     21

           
           SENATE BUSINESS, PROF. & ECON. DEV. COMMITTEE  :  7-2, 4/22/13
          AYES:  Price, Block, Corbett, Hernandez, Hill, Padilla, Yee
          NOES:  Emmerson, Wyland
          NO VOTE RECORDED:  Galgiani

           SENATE APPROPRIATIONS COMMITTEE  :  4-1, 5/13/13
          AYES:  De León, Lara, Padilla, Steinberg
          NOES:  Hill
          NO VOTE RECORDED:  Walters, Gaines


           SUBJECT  :    Prescription drugs:  labeling

           SOURCE  :     California Pan-Ethnic Health Network


           DIGEST  :    This bill requires, beginning January 1, 2016,  
          translations of the directions for use in non-English languages  
          published on the Board of Pharmacys (Board) Web site to be used,  
          as applicable, when labeling a prescription container;  
          authorizes the directions for use to be translated into  
          additional non-English languages if certified translation  
          services are utilized to complete the additional translations;  
          authorizes a pharmacy to provide its own translations of the  
          directions for use established by Board regulation in the  
          non-English languages published on the Board's Web site;  
          provides that a pharmacist who "reasonably believes" that  
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          translated directions for use contain an error due to software  
          or equipment malfunction, may provide English language  
          directions for use; and states that a pharmacist who "reasonably  
          uses" translations of the direction for use in non-English  
          languages published on the Board's Web site has not breached  
          his/her legal duty if those translations contain an error and  
          the pharmacist did not know, or did not have reason to know, of  
          the error.

           Senate Floor Amendments  of 5/23/13 recast some provisions in  
          this bill; insert language authorizing a pharmacy to provide its  
          own translations of directions for use; state that a pharmacist  
          who "reasonably believes" that translated directions for use  
          contain an error due to software or equipment malfunction may  
          provide English language directions for use; and state that a  
          pharmacist who "reasonably uses" translations for the directions  
          for use that are published on the Board's Web site has not  
          breached their legal duty if those translations contain an error  
          that the pharmacist was not aware of.  [Note:  According to the  
          author, these amendments are intended to "address opposition's  
          arguments."  Specifically, the opposition testified in policy  
          committee that this bill raised significant concerns about  
          pharmacist liability in the event that pharmacists are not able  
          to determine if the translation is correct and thus may provide  
          patients the wrong printed directions for use.]

           ANALYSIS  :    

          Existing law:

          1. Requires that each prescription dispensed by a pharmacist  
             must be in a container complying with state and federal law  
             and correctly labeled, as specified.  

          2. Requires the Board to promulgate regulations on or before  
             January 1, 2011, for a standardized, patient-centered,  
             prescription drug label on all prescription medication  
             dispensed in the state. 
           
          3. Requires the Board, when considering the requirements for  
             prescription labels, to consider medical literacy research,  
             improved directions for use, improved font types and sizes,  
             placement of information that is patient-centered, the needs  
             of patients with limited English proficiency, the needs of  

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             senior citizens, and technology requirements necessary to  
             implement the standards.

          This bill:

          1. Provides that, beginning January 1, 2016, translations of the  
             directions for use in non-English languages published on the  
             Board's Web site shall be used, as applicable, when labeling  
             a prescription container.

          2. Allows the translation of the directions for use, established  
             by Board regulation, into additional non-English languages if  
             certified translation services are utilized to complete the  
             additional translations.  

          3. Authorizes a pharmacy to provide its own translations of the  
             direction for use, established by Board regulation, in the  
             non-English languages published on the Board's Web site when  
             labeling a prescription container.

          4. States that a pharmacist who "reasonably believes" that  
             translated direction for use contain an error due to software  
             or equipment malfunction, may provide English language  
             directions for use.

          5. States that a pharmacist who "reasonably uses" translations  
             of the directions for use in non-English languages published  
             on the Board's Web site has not breached his/her legal duty  
             if the published translations contain an error and the  
             pharmacist did not know or did not have reason to know, of  
             the error.

           Background
           
           Medication errors and legislative response  .  According to the  
          Journal of the American Medical Association, 46% of adults  
          cannot understand the information listed on their prescription  
          drug labels.  Furthermore, the Institute of Medicine of the  
          National Academies, medication errors are among the most common  
          medical errors, harming at least 1.5 million people annually.   
          Families USA reports that 90% of Medicare patients take  
          medications for chronic conditions with nearly half of them  
          taking five or more medications a day.  Given the large numbers  
          of prescriptions that may be prescribed, it is not easily  

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          discernible what the purpose for each of these medications is.   
          This increases the chances that a patient may take the wrong  
          medication increasing the likelihood of serious injury or death.  
           

          SCR 49 (Speier, Resolution Chapter 123, Statutes of 2005)  
          established the Medication Errors Panel (Panel) which published  
          a report in March 2007 entitled "Prescription for Improving  
          Patient Safety:  Addressing Medication Errors."  The report  
          listed six general goals to reduce medication errors.  Under  
          each goal were recommendations and methods to accomplish each  
          recommendation.  The Panel report states that "the information  
          that consumers need to know about their medication is often  
          complex and may include unfamiliar language or concepts.   
          Expecting a consumer to retain all the pertinent knowledge from  
          a brief verbal encounter may not be reasonable in many  
          instances."  The Panel acknowledged that there are a variety of  
          factors which may increase an individual's risk for experiencing  
          a medication error.  These include (1) low health literacy; (2)  
          limited English proficiency; (3) cultural incongruence with  
          healthcare providers; (4) physical, cognitive and/or other  
          impairments that make understanding and/or complying with  
          medication instructions difficult; (5) age at either end of the  
          age spectrum (the variability of a medication's response,  
          metabolism and dose increases in children and seniors); (6)  
          multiple medications; (7) multiple prescribers; (8)  
          non-prescription medication use (including herbals, dietary  
          supplements, alcohol, and tobacco); and (9) medication  
          procurement from more than one pharmacy including mail-order.   
          The Panel stated that these factors must be taken into  
          consideration in the development of any consumer education  
          efforts.  

          One bill was pursued in response to the Panel report  SB 472  
          (Corbett, Chapter 470, Statutes of 2007), the California Patient  
          Medication Safety Act, sought to deal with the lack of  
          uniformity in prescription drug labels throughout the state and  
          the resulting confusion and medication errors that may arise.   
          Much of the conversation during the SB 472 debate focused on the  
          fact that individual pharmacies design and format their own  
          labels, resulting in a lack of standards across all pharmacies  
          which adversely affects medication users who are elderly, suffer  
          from poor vision, have difficulty reading and understanding  
          instructions on labels or have limited English proficiency.  The  

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          bill required the Board to promulgate regulations on or before  
          January 1, 2011, that require a standardized, patient-centered,  
          prescription drug label on all prescription medicine dispensed  
          to patients.  Additionally, the Board was required to report to  
          the Legislature by January 1, 2010, on its progress in  
          implementing these regulations.

           Implementation of a standardized prescription drug label by the  
          Board  .  California was the first state to require redesigned  
          prescription container labels to emphasize information most  
          important to consumers offering an element of safety and  
          consistency since prescription labels are the key source of  
          patients' reference for information when taking medications in  
          their homes.  Part of this current requirement also ensures that  
          oral interpreter services are available to limited English  
          speaking patients in pharmacies, to insure such patients have  
          access to information about how to take their medications.

          The Board was charged with promulgating regulations that require  
          a standardized, patient-centered prescription drug container  
          label for all prescription drugs dispensed to patients in  
          California.  The Board reported on its efforts in a January 2010  
          report to the Legislature.  The Board established a "SB 472  
          Medication Label Subcommittee" in January of 2008, to conduct  
          public forums and to work with organizations and individuals to  
          develop recommendations to implement the provisions of the law  
          to establish a patient-centered prescription drug label.  In May  
          2008, the Board developed an open-ended prescription label  
          survey for distribution at public outreach events.  A total of  
          606 consumers completed the surveys.  When asked what to change  
          on the prescription label, the top responses were:  print should  
          be larger or darker (30.1%); nothing needs to be changed on the  
          label (24.6%); and include purpose of drug (12%).

          The Board concluded that most consumers participating in the  
          survey requested larger and bolder type font on prescription  
          labels to increase readability.  Many participants suggested  
          that if a generic drug is provided, the prescription label  
          should state the name of the generic drug name and the  
          brand-name it is generic for.  They also noted that color  
          printing and highlighting on labels brings attention to  
          important information.  Some participants suggested that the  
          labels themselves be color-coded to help differentiate between  
          multiple medications and family members.  Many consumers  

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          responded that they want to know "what the drug is for" and  
          suggested that "purpose of drug" be printed directly on  
          prescription labels. 

          The Board approved a regulation per the requirements set forth  
          in SB 472 after engaging in a lengthy process.  The Board  
          conducted outreach, hearings and information gathering sessions  
          throughout 2008, to collect data from the public on prescription  
          labels and standards for those labels.  The Board considered  
          testimony and information provided from the public, the  
          pharmaceutical industry, pharmacy professionals and literacy  
          subject matter experts on medical literacy research, improved  
          directions for use, improved font types and sizes, the placement  
          of information that is patient-centered, the needs of patients  
          with limited English proficiency, the needs of senior citizens,  
          and technology requirements necessary to implement the standards  
          developed.  Board members were also provided with research  
          articles on designing patient-centered labels.  In 2009, the  
          Board discussed the requirements of the regulation at regularly  
          scheduled meetings.  

          Throughout early 2010, the Board held regulation hearings to  
          adopt the proposed regulation, a new section at Title 16  
          California Code of Regulations Section 1707.5 - "Requirements  
          For Patient-Centered Prescription Container Labels."  The  
          regulation outlines that the following items must be clustered  
          into one area of the label that comprises at least 50% of the  
          label, using at least a 10-point font sans serif typeface,  
          listing these items in the following order:  (1) name of the  
          patient; (2) name of the drug and strength of the drug ("name of  
          the drug" means either the manufacturer's trade name, or the  
          generic name and the name of the manufacturer); (3) directions  
          for use; and (4) purpose or condition, if entered onto the  
          prescription by the prescriber, or otherwise known to the  
          pharmacy, and its inclusion on the label is requested by the  
          patient.

          The regulation also requires pharmacies to have policies and  
          procedures in place to help patients with limited or no English  
          proficiency, understand the information on the label in the  
          patient's language.  The pharmacy's policies and procedures must  
          be specified in writing, and must include, at minimum, the  
          selected means to identify the patient's language, and to  
          provide interpretive services in the patient's language.   

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          Pharmacies must provide, at minimum, interpretive services in  
          the patient's language, if interpretive services in such  
          language are available, during all hours that the pharmacy is  
          open, either in person by pharmacy staff or by use of a  
          third-party interpretive service available by telephone at or  
          adjacent to the pharmacy counter.  

           FISCAL EFFECT  :    Appropriation:  No   Fiscal Com.:  Yes    
          Local:  Yes

          According to the Senate Appropriations Committee, there are  
          potential one-time costs of about $75,000 to adopt regulations  
          by the Board (Pharmacy Board Contingent Fund).

           SUPPORT  :   (Verified  5/6/13) (Unable to reverify at time of  
          writing)

          California Pan-Ethnic Health Network (source)
          Asian American Center for Advancing Justice
          Asian Americans for Civil Rights and Equality 
          Asian Law Alliance
          Asian Pacific American Legal Center
          Asian Pacific Community in Action
          Asian Pacific Islander Caucus for Public Health 
          California Alliance for Retired Americans
          California Communities United Institute
          California Health Advocates
          California Immigrant Policy Center
          California State Retirees, Chapter 1
          Health Through Action Arizona
          Latino Coalition for a Healthy California 
          Paramedics Plus
          Southeast Asia Resource Action Center California
          Street Level Health Project
          Visión y Compromiso
          Western Center on Law and Poverty
          Worksite Wellness LA

           OPPOSITION  :    (Verified  5/29/13) 

          California Grocers Association
          California Korean American Pharmacists Association
          California Pharmacists Association
          California Retailers Association

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          National Association of Chain Drug Stores
          Rite Aid

           ARGUMENTS IN SUPPORT  :    According to the author's office,  
          existing regulations provide for interpretation services at a  
          pharmacy, but neither existing law, nor existing regulations,  
          provide for translated directions on prescription medication  
          container labels.  The author states that "It is troubling that  
          studies show about 1/3 of California pharmacies are not  
          providing translated directions in the patient's preferred  
          language, upon request.  Patients cannot follow directions if  
          they cannot read them.  This large population of Californians is  
          in danger of misusing their prescription medications and  
          suffering an adverse drug event because the directions are  
          provided in a language they cannot read."  According to the  
          author's office, adverse drug events cause over 700,000  
          emergency room visits around the country every year, and every  
          year almost 120,000 patients are hospitalized after an emergency  
          room visit for adverse drug events.   

          The bill's sponsor, California Pan-Ethnic Health Network  
          (CPEHN), writes that "for prescription drug labels to meet the  
          needs of California's limited English proficient patients,  
          pharmacies should utilize the translated instructions provided  
          by the Board of Pharmacy.  This will provide limited English  
          patients with prescription instructions that they will  
          understand which helps increase patient compliance and reduce  
          medical errors."  CPEHN states that in California, 40% of  
          individuals speak a language other than English at home and an  
          estimated six to seven million are limited English proficient.

          The Asian Law Alliance, California Health Advocates, California  
          Immigrant Policy Center, and Street Level Health Project state  
          that millions of Californians will have increased access to  
          health care coverage and prescription medications with the  
          implementation of the federal Patient Protection and Affordable  
          Care Act, among them patients with limited English proficiency  
          who will benefit from a translated label.  They believe that  
          this bill will finally provide these patients prescription drug  
          instructions that they understand which will help reduce medical  
          errors and improve quality of care.

           ARGUMENTS IN OPPOSITION  :    The California Grocers Association  
          (CGA) is concerned that the requirements in this bill are  

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          unworkable and could lead to additional confusion for patients  
          and providers.  CGA points out that some pharmacies already  
          provide oral or written translation services based on community  
          needs, and that requiring pharmacies to use rigid pre-set use  
          translations will disrupt those pharmacies' practices despite  
          the fact that there is no evidence the system is failing to meet  
          consumer safety needs.
            
          The California Retailers Association (CRA) cites that this bill  
          may be premature.  "The current regulation for the label just  
          became effective less than two years ago, after the Board and  
          stakeholders went through a lengthy rule-making process.   CRA  
          believes that before we adopt changes to the current label  
          standard, it is important to determine whether there is a need  
          for these changes and whether these changes would provide  
          consumers with added benefit."  CRA also expresses concern that  
          patient safety may be jeopardized by improper translations, and  
          cites the difficulty of providing accurate written translations,  
          as demonstrated by the Board's struggle to adopt standard  
          translations for the five languages currently translated.  Many  
          languages have different dialects and some languages have  
          multiple ways of stating the same thing.  This bill may do a  
          disservice to limited English proficient individuals throughout  
          the state if they are provided with translation that is wrong,  
          faulty, or does not match with their specific understanding or  
          ability to read the dialect used on the label.  CRA states that  
          allowing a patient to communicate with a live translator over  
          the phone will enable a dialogue, and should provide the patient  
          with more accurate instructions, the opportunity to ask  
          questions in their primary language, and greater assistance than  
          a translated label would provide.  CRA also points out that many  
          pharmacies have invested in labeling software that does not have  
          the flexibility to accommodate incorporating different languages  
          into the label.  Many pharmacies would have to bear significant  
          costs to purchase software enhancements that would be necessary  
          for them to comply with the translation requirements of this  
          bill.

          The California Pharmacists Association (CPhA) cites the  
          reasonable balance that was struck during the Board's  
          exhaustive, collaborative rulemaking process to implement a  
          standardized label and lack of data indicating that the existing  
          regulations are insufficient to protect patients.  CPhA believes  
          that pharmacists would lose their ability to verify the accuracy  

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          of directions printed in a language other than English and notes  
          the risk of patient harm, as discussed during the rulemaking  
          process that can result from misinterpretation of directions  
          printed in a non-English language.

          Rite Aid states that there is no need for the requirements  
          imposed by this bill and that there is no evidence that the  
          current practice of pharmacies providing live translation  
          services involving a three-way consultation between the patient,  
          pharmacist and translator over the phone is not working  
          effectively.   
           

          MW:k  5/29/13   Senate Floor Analyses 

                           SUPPORT/OPPOSITION:  SEE ABOVE

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