BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  AB 1136
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          Date of Hearing:   April 23, 2013

              ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER  
                                     PROTECTION
                              Richard S. Gordon, Chair
                    AB 1136 (Levine) - As Amended:  April 15, 2013
           
          SUBJECT  :   Pharmacists:  drug disclosures.

           SUMMARY  :   Requires a pharmacist after July 1, 2014 to include a  
          written warning label on a prescription drug if the pharmacist  
          determines that the drug may impair a person's ability to  
          operate a vehicle or vessel.  Specifically,  this bill :  

          1)Requires, after July 1, 2014, a pharmacist to include a  
            written label on a drug container indicating that the drug may  
            impair a person's ability to operate a vehicle or vessel if  
            the pharmacist determines that the drug may have that effect. 

          2)Permits this warning to be printed on an auxiliary label that  
            is added to the prescription container. 

          3)Makes other technical and clarifying changes.

          4)States that no reimbursement is required by this act pursuant  
            to Section 6 of Article XIIIB of the California Constitution  
            because the only costs that may be incurred by a local agency  
            or school district will be incurred because this act creates a  
            new crime or infraction, eliminates a crime or infraction, or  
            changes the penalty for a crime or infraction, within the  
            meaning of Section 17556 of the Government Code, or changes  
            the definition of a crime within the meaning of Section 6 of  
            Article XIIIB of the California Constitution.

           EXISTING LAW  :

          1)Provides for the practice of pharmacy and the licensing and  
            regulation of pharmacies and pharmacists by the Board of  
            Pharmacy (BOP) within the Department of Consumer Affairs.   
            (Business and Professions Code (BPC) Section 4000 et seq.)

          2)Requires a pharmacist to inform a patient orally or in writing  
            of the harmful effects of a drug dispensed by prescription if  
            the drug poses substantial risk to the person consuming the  
            drug when taken in combination with alcohol or if the drug may  








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            impair a person's ability to drive a motor vehicle, if the  
            drug is determined by BOP to be a drug or drug type for which  
            this warning shall be given. (BPC 4074 (a))

          3)Permits BOP to develop regulations requiring additional  
            information or labeling. (BPC 4074 (b))

          4)Requires a health facility to establish and implement a  
            written policy to ensure that each patient receives  
            information, as specified, regarding each medication given at  
            the time of discharge. This information shall include the use  
            and storage of each medication, the precautions and relevant  
            warnings, and the importance of compliance with directions.  
            This information shall be given by a pharmacist or registered  
            nurse, unless already provided by a patient's prescriber, and  
            the written policy shall be developed in collaboration with a  
            physician, a pharmacist, and a registered nurse. The written  
            policy shall be approved by the medical staff. Nothing in  
            existing law shall be construed to require that only a  
            pharmacist provide this consultation. (BPC 4074 (d)).

          5)Requires that each prescription dispensed by a pharmacist must  
            be in a container meeting state and federal specifications and  
            correctly labeled, as specified, including:

             a)   Unless otherwise ordered by the prescriber, the  
               manufacturer's trade name of the drug or the generic name  
               and the name of the manufacturer, as specified;

             b)   The directions for the use of the drug;

             c)   The name of the patient or patients;

             d)   The name of the prescriber, as specified;

             e)   The date of issue;

             f)   The name and address of the pharmacy, and prescription  
               number or other means of identifying the prescription;

             g)   The strength of the drug or drugs dispensed;

             h)   The quantity of the drug or drugs dispensed;

             i)   The expiration date of the effectiveness of the drug  








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               dispensed;

             j)   The condition or purpose for which the drug was  
               prescribed if the condition or purpose is indicated on the  
               prescription; and,

             aa)  The physical description of the dispensed medication,  
               including its color, shape, and any identification code  
               that appears on the tablets or capsules. (BPC 4076)

           FISCAL EFFECT  :   Unknown

           COMMENTS  :    

           1)Purpose of this bill  .  This bill requires a pharmacist to  
            include a written warning label on a prescription drug if the  
            pharmacist determines the drug may impair a person's ability  
            to operate a vehicle or vessel.  This practice is already  
            permitted under current law, and is done voluntarily in many  
            pharmacies.  This bill is author sponsored.  

           2)Author's statement  .  According to the author, "In California  
            there is no requirement to include a warning label or sticker  
            on prescription medication which BOP identifies as capable of  
            impairing a person's ability to drive.  Current law only  
            requires that a pharmacist inform a patient orally or in  
            writing?  AB 1136 combats the growing epidemic of drugged  
            driving by mandating best practices among California  
            pharmacies to ensure that warning labels are included on  
            dangerous drugs."

           3)Current prescription drug labeling requirements  .  Current  
            regulations developed by BOP require each prescription  
            dispensed by a pharmacist to be in a container that meets  
            state and federal specifications.  Labels must already  
            include:

             a)   Unless otherwise ordered by the prescriber, the  
               manufacturer's trade name of the drug or the generic name  
               and the name of the manufacturer, as specified;

             b)   The directions for the use of the drug;

             c)   The name of the patient or patients;









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             d)   The name of the prescriber, as specified;

             e)   The date of issue;

             f)   The name and address of the pharmacy, and prescription  
               number or other means of identifying the prescription;

             g)   The strength of the drug or drugs dispensed;

             h)   The quantity of the drug or drugs dispensed;

             i)   The expiration date of the effectiveness of the drug  
               dispensed;

             j)   The condition or purpose for which the drug was  
               prescribed if the condition or purpose is indicated on the  
               prescription; and,

             aa)  The physical description of the dispensed medication,  
               including its color, shape, and any identification code  
               that appears on the tablets or capsules. 

            Current law also requires a pharmacist to inform a patient  
            orally or in writing of the harmful effects of a drug if the  
            drug poses substantial risk to the person when taken in  
            combination with alcohol or if the drug may impair a person's  
            ability to drive a motor vehicle.  According to the California  
            Pharmacists Association, the use of warning labels that  
            caution patients about driving while using dangerous  
            medications is already standard practice in most pharmacies.  

            This bill may also be read to permit a pharmacist to identify  
            drugs in addition to those drugs identified by BOP for this  
            additional warning. 

           4)Related legislation  .  SB 204 (Corbett) would require a  
            pharmacist to use translations of the directions for drug use  
            in non-English languages published on the Board's Internet Web  
            site, as applicable, when labeling a prescription container  
            and authorizes a pharmacist to translate the directions for  
            drug use into additional non-English languages if certified  
            translation services are utilized to complete the additional  
            translations.  SB 204 is pending in Senate Business,  
            Professions and Economic Development Committee.









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            SB 205 (Corbett) would require the information on a  
            prescription label to be printed in at least a 12-point sans  
            serif typeface.  SB 205 is pending in Senate Business,  
            Professions and Economic Development Committee.

            SB 289 (Correa) would make it unlawful for a person to drive a  
            motor vehicle if his or her blood contains any detectable  
            amount of a drug classified in Schedules I, II, III, or IV of  
            the California Uniform Controlled Substance Act, unless the  
            drug was consumed in accordance with a valid prescription  
            issued to the person by a licensed health care practitioner.   
            SB 289 is pending in Senate Public Safety Committee.

           5)Previous legislation  .  SB 472 (Corbett), Chapter 470, Statutes  
            of 2007, requires BOP to promulgate regulations that require,  
            on or before January 1, 2011, a standardized,  
            patient-centered, prescription drug label on all prescription  
            medication dispensed to patients in California. 

            AB 1276 (Karnette) of 2007 would have required prescribers of  
            medications to ask the patient whether to indicate the  
            intended purpose of the prescription on the prescription's  
            label.  AB 1276 died in the Assembly Business and Professions  
            Committee.

            AB 657 (Karnette) of 2005 would have required prescription  
            labels to include the intended purpose of the drug, if  
            indicated on the prescription, and would have required a  
            physician, dentist, optometrist, podiatrist, or other  
            specified drug prescriber to ask the patient or patient's  
            representative whether to indicate the intended purpose of the  
            prescription on the label.  AB 657 died in the Senate  
            Business, Professions and Economic Development Committee. 

            AB 288 (Mountjoy) of 2005 would have required the prescription  
            container to be labeled with the condition for which the drug  
            was prescribed, unless the patient, physician, or a parent or  
            legal guardian of a minor patient requests that the  
            information be omitted.  AB 288 died in the Assembly Health  
            Committee. 

            AB 2125 (Levine) of 2004 would have required a physician and  
            surgeon to indicate a patient's diagnosis on each  
            prescription, as specified, and required the prescription  
            label to include the condition for which the drug was  








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            described, unless the patient directs the pharmacist not to  
            include this information on the label.  AB 2125 died in the  
            Assembly Health Committee. 

            SB 292 (Speier), Chapter 544, Statutes of 2003, required  
            prescription labels to include a physical description of the  
            drug, including the color, shape, and any identification code  
            that appears on the tablet or capsule.

           6)Double referred  .  This bill is double-referred, having been  
            previously heard by the Assembly Health Committee on April 2,  
            2013 and approved on an 11-1 vote. 

           REGISTERED SUPPORT / OPPOSITION  :   

           Support 
           
          California Narcotic Officers' Association
          California Senior Legislature
          California State Sheriffs' Association

           Opposition 
           
          None on file. 
           
          Analysis Prepared by  :    Sarah Huchel / B.,P. & C.P. / (916)  
          319-3301