BILL ANALYSIS                                                                                                                                                                                                    Ó




                   Senate Appropriations Committee Fiscal Summary
                            Senator Kevin de León, Chair


          AB 1136 (Levine) - Pharmacists: drug disclosures.
          
          Amended: April 15, 2013         Policy Vote: B&P 10-0
          Urgency: No                     Mandate: Yes
          Hearing Date: July 1, 2013      Consultant: Brendan McCarthy
          
          This bill does not meet the criteria for referral to the  
          Suspense File.
          
          
          Bill Summary: AB 1136 would require a pharmacist to include a  
          written label on a prescription drug container indicating that  
          the drug may impair the ability to operate a vehicle, if  
          applicable.

          Fiscal Impact: Potential one-time costs up to $75,000 to update  
          existing regulations on prescription drug labeling (Pharmacy  
          Board Contingent Fund). The bill does not explicitly require the  
          adoption of regulations. However, because there are existing  
          regulations that govern prescription drug labels, the Board of  
          Pharmacy is likely to incorporate the requirements of this bill  
          into the existing regulations.

          Background: Under current law and regulation, pharmacists are  
          required to follow certain standards when labeling prescription  
          medications. Information required to be on the label includes  
          the drug name, dosage, directions, the prescriber, the  
          dispensing pharmacy, and other information.

          Current law also includes a requirement that pharmacists notify  
          patients, either orally or in writing, about the potential  
          hazards of a prescription drug, under specified conditions.  
          Specifically, when the Board of Pharmacy has determined that a  
          specific drug should come with a warning from a pharmacist and  
          the drug poses a substantial risk to the patient when taken in  
          combination with alcohol or if the drug may impair a person's  
          ability to drive a motor vehicle, a pharmacist is required to  
          provide notification to the patient.

          Proposed Law: AB 1136 would require a pharmacist to include a  
          written label on a prescription drug container indicating that  
          the drug may impair the ability to operate a vehicle or vessel.








          AB 1136 (Levine)
          Page 1



          A pharmacist would be required to include this additional  
          warning label, if in the pharmacists professional judgment, the  
          drug may impair a person's ability to operate a vehicle or  
          vessel.

          The label required under the bill may be printed on an auxiliary  
          label affixed to the prescription container.

          This requirement would be in addition to the existing  
          notification requirements in law.

          The requirements of the bill would go into effect on July 1,  
          2014.
          Related Legislation: 
              SB 204 (Corbett) would require a pharmacist to use  
              translations of the directions for use in non-English  
              languages published on the Board of Pharmacy's website. That  
              bill is in the Assembly Health Committee.
              SB 205 (Corbett) would require certain information on a  
              prescription label to be printed in 12-point font. That bill  
              is in the Assembly Business, Professions, and Consumer  
              Protection Committee.

          Staff Comments: The only mandated costs imposed on local  
          agencies from the bill relate to crimes and infractions, which  
          are not reimbursable under the California Constitution.