BILL ANALYSIS                                                                                                                                                                                                    Ó







         ----------------------------------------------------------------------- 
        |Hearing Date:April 23, 2012        |Bill No:SB                         |
        |                                   |1301                               |
         ----------------------------------------------------------------------- 


                      SENATE COMMITTEE ON BUSINESS, PROFESSIONS 
                               AND ECONOMIC DEVELOPMENT
                          Senator Curren D. Price, Jr., Chair
                                           

                        Bill No:        SB 1301Author:Hernandez
                     As Amended:April 16, 2012          Fiscal:Yes

        
        SUBJECT:  Prescription drugs:  90-day supply. 
        
        SUMMARY:  Authorizes a pharmacist to dispense not more than a 90-day 
        supply of medication pursuant to a valid prescription that specifies 
        the initial dispensing of a lesser amount followed by periodic refills 
        of that amount if the patient has completed an initial 30-day supply 
        of the medication, as specified.

        Existing law:
        
       1)Establishes the practice of pharmacy and provides for the licensing 
          and regulation of pharmacies and pharmacists by the Board of 
          Pharmacy (Board) within the Department of Consumer Affairs. 

       2)Specifies certain requirements regarding the dispensing and 
          furnishing of dangerous drugs and devices, and prohibits a person 
          from furnishing any dangerous drug or device except upon the 
          prescription of a physician, dentist, podiatrist, optometrist, 
          veterinarian or naturopathic doctor, as specified.  (BPC § 4059) 

       3)Prohibits a prescription for any dangerous drug or dangerous device 
          from being refilled except upon authorization of the prescriber, as 
          specified.  (BPC § 4063)

       4)Permits a prescription for a dangerous drug or dangerous device to be 
          refilled without the prescriber's authorization if the prescriber is 
          unavailable to authorize the refill and if, in the pharmacist's 
          professional judgment, failure to refill the prescription might 
          interrupt the patient's ongoing care and have a significant adverse 
          effect on the patient's well-being.  Specifies that the prescription 





                                                                        SB 1301
                                                                         Page 2



          may be filled only after making every reasonable effort to contact 
          the prescriber.  Requires the pharmacist to inform the patient and 
          the prescriber that the prescription was refilled under this 
          circumstance.  (BPC § 4064)

       5)Provides that psychotropic medication or psychotropic drugs are those 
          medications administered for the purpose of affecting the central 
          nervous system to treat psychiatric disorders or illnesses.  These 
          medications include, but are not limited to, anxiolytic agents, 
          antidepressants, mood stabilizers, antipsychotic medications, 
          anti-Parkinson agents, hypnotics, medications for dementia, and 
          psychostimulants.  (Welfare and Institutions Code § 369.5 (d))

        This bill:

       1)Authorizes a pharmacist to dispense not more than a 90-day supply of 
          medication pursuant to a valid prescription that specifies the 
          initial dispensing of a lesser amount followed by periodic refills 
          of that amount if the patient has completed an initial 30-day supply 
          of the medication and all of the following requirements are 
          satisfied:

           a)   The total quantity of dosage units dispensed does not exceed 
             the total quantity of dosage units authorized by the prescriber 
             on the prescription, including refills.

           b)   The prescriber has not specified on the prescription that 
             dispensing the prescription in an initial amount followed by 
             periodic refills is medically necessary.

           c)   The pharmacist is exercising his or her professional judgment.

       1)Requires a pharmacist dispensing pursuant to these provisions to 
          notify the prescriber of the change in the quantity dispensed.

       2)Specifies that the above provisions do not apply to psychotropic 
          medication or psychotropic drugs as defined in Welfare and 
          Institutions Code Section 369.5 (d).

       3)Specifies that the above provisions shall not be construed to require 
          a health care service plan, health insurer, workers' compensation 
          insurance plan, pharmacy benefits manager, or any other person or 
          entity, including, but not limited to, a state program or state 
          employer, to provide coverage for a dangerous drug in a manner 
          inconsistent with a beneficiary's plan benefit.






                                                                        SB 1301
                                                                         Page 3




        FISCAL EFFECT:  Unknown.  This bill has been keyed "fiscal" by 
        Legislative Counsel. 

        
        COMMENTS:
        
       1.Purpose.  This bill is sponsored by  California Retailers Association  
          (Sponsor) in order to permit a pharmacist to dispense up to a 90-day 
          supply of a drug, other than a controlled substance and psychotropic 
          medication, as defined in Welfare and Institutions Code Section 
          369.5 (d), pursuant to a prescription that specifies the initial 
          dispensing of a lesser amount followed by periodic refills of that 
          amount if certain requirements are met.

       According to the Sponsor and the National Association of Chain Drug 
          Stores (NACDS), a single chain drug store makes approximately 4.5 
          million calls a month to get authorization to dispense a 
          prescription refill in excess of a 30-day supply.  Because 
          physicians are typically busy and unable to take these calls, 
          consumers end up either having to wait for authorization or they end 
          up settling for the 30-day supply and leaving before the physician 
          calls back.

       The Sponsor states that not only are these calls burdensome to the 
          physicians and pharmacists, the patient is ultimately inconvenienced 
          and will need to return to the pharmacy two additional times and pay 
          two additional co-payments that he or she would have saved under 
          this bill.

       The 90-day retail prescription option proposed in this measure offers 
          value to the health care system but, more importantly, to the 
          consumer, according to the Sponsor, and allows physicians to focus 
          on more essential patient needs.

       2.Background.  According to a 2005 Federal Trade Commission study, 
          private-sector entities that offer prescription drug insurance 
          coverage, such as employers, labor unions, and managed care 
          companies, often hire pharmacy benefit managers (PBMs) to manage 
          these insurance benefits.  Many PBMs use mail-order pharmacies to 
          manage prescription drug costs.  Many plan sponsors have encouraged 
          patients with chronic conditions who require repeated refills to 
          seek the discounts that 90-day prescriptions and high-volume 
          mail-order pharmacies can offer.  

       One way of managing growing medication costs is by using larger 





                                                                        SB 1301
                                                                         Page 4



          prescription volumes.  An article titled "Ninety-day versus 
          thirty-day drug dispensing systems" published in American Journal of 
          Health-System Pharmacy (July 2001) reported a study involving the 
          U.S. Veterans Affairs San Diego Healthcare System which showed that 
          dispensing less expensive drugs for 90-days rather than 30-days to 
          patients with chronic diseases would result in significant cost 
          savings without compromising safety, despite the possibility of 
          increased wastage when drugs are discontinued.

       3.Practices in Other States.  According to the Sponsor, 20 states have 
          varying statutes that in some way permit 90-day dispensing (Alaska, 
          Arizona, Colorado, Florida, Hawaii, Idaho, Illinois, Kentucky, Main, 
          Michigan, Montana, Nebraska, New York, North Carolina, Rhode Island, 
          South Carolina, South Dakota, Texas, Vermont, and Wyoming).  For 
          example, New York mandates that if a health plan or insurer offers a 
          90-day supply through a mail-order pharmacy, the enrollee can obtain 
          the same supply at a retail pharmacy, provided the pharmacy accepts 
          the same contractual terms and conditions as the mail-order 
          pharmacy.  Indiana has legislation pending on the Governor's desk 
          that permits 90-days' worth of medication upon the request of the 
          patient if the patient has completed an initial 30-day supply of the 
          drug.  However, a pharmacist is required to notify the prescriber of 
          the change in the quantity filled and comply with state and federal 
          laws and regulations concerning the dispensing limitations 
          concerning a prescription drug.
       
       4.Arguments in Support.  The  California Retailers Association  , in 
          sponsoring the bill, writes:  "With our aging population, health 
          care costs will rise dramatically and prescription drug expenditures 
          will also increase as more people are diagnosed with conditions that 
          require maintenance drugs.  Consumers want and deserve the option of 
          obtaining a 90-day prescription for their convenience and to allow 
          them to better adhere to their medical regimen."

        Walgreens  writes that in California, when a patient presents a 
          pharmacist a prescription for a medication with refills, the 
          pharmacist is limited to a 30-day supply.  If the patient requests a 
          combined refill, the pharmacy must contact the prescriber to get 
          their approval before dispensing the refill.  In California, 
          Walgreens makes 4.5 million of these contacts a month.  Walgreens 
          lists a number of benefits to this bill:  Increases convenience for 
          patients as they would not need to return to the pharmacy multiple 
          times to refill a prescription; increases access to prescription 
          medications and pharmacy services for those patients in rural and 
          inner city areas where travel to a pharmacy is less convenient; 
          reduces administrative burdens on the physician by negating the need 





                                                                        SB 1301
                                                                         Page 5



          for office phone contacts to verify approval for appropriate refill 
          prescriptions; saves the patient co-payments, where coverage 
          permits; improves medication adherence, by ensuring fewer trips to 
          the pharmacy for refill prescriptions; enhances patient choice to 
          receive their prescription refills at their community pharmacy 
          (which results in face to face interaction, advice and counseling 
          from their trusted and chosen pharmacist); emergency planning 
          personnel  recommend having more than a 30-day supply of needed 
          medications in case of disaster.

        California Pharmacists Association  (CPhA) believes the bill takes a 
          relatively small yet meaningful step to safely increase efficiency 
          in the health care delivery system.  CPhA states the bill allows 
          pharmacists to utilize their professional judgment to provide 
          medications in amounts that are most convenient to their patients.  
          This is a safe way to make getting prescriptions filled a more 
          consumer-friendly process, according to CPhA.

        California Healthcare Institute  states that the health care system 
          bears significant costs through patients suffering from chronic 
          diseases that are not adhering to their prescribed treatment 
          regimen.  By allowing patients to receive up to 90-days worth of a 
          refill prescription, SB 1301 will make it easier for patients to 
          adhere to their treatment regimen, live healthier lives and lower 
          costs throughout the health care system.

        5. Recent Amendments.  This bill was amended and passed by the Senate 
           Health Committee on April 11, 2010.  According to the Sponsor, 
           these amendments were intended to address concerns with the bill, 
           including those raised by the California Psychiatric Association 
           (CPA) who expressed concern that from a psychiatric physician 
           standpoint, many psychiatric medications are toxic or lethal, and 
           that potential is increased significantly when a patient presents 
           with suicidal ideation.  The phrase "psychotropic drug" is a term 
           referring to psychiatric medicines that alter chemical levels in 
           the brain which impact mood and behavior.  Thus the bill has been 
           amended to not allow a pharmacist to dispense a 90-day supply of a 
           psychotropic drug under the provisions of the bill. 

        In discussing this measure with Committee staff, the Sponsor has 
           indicated that the amendment requiring a patient to complete an 
           initial 30-day supply of the medication before a pharmacist could 
           dispense a 90-day supply was made out of drug waste and disposal 
           concerns.  Allergic or adverse reactions to medication would 
           typically be apparent within the first month.  However, if a three 
           month supply were initially dispensed, consumers may very well find 





                                                                        SB 1301
                                                                         Page 6



           themselves having to dispose of the balance of a prescription that 
           they cannot use.


         NOTE:   Double-referral to Health Committee, first.  This bill was 
        heard in Senate Health Committee on April 11 and approved by a 8 to 1 
        vote.
        

        SUPPORT AND OPPOSITION:
        
         Support  :  

        California Retailers Association (Sponsor)
        Aging Services of California
        BIOCOM
        California Healthcare Institute
        California Pharmacists Association
        Los Angeles County Board of Supervisors
        Mental Health America of California
        Walgreens
        7 pharmacies

         Opposition  :  

        None received as of April 17, 2012



        Consultant:G. V. Ayers