BILL ANALYSIS                                                                                                                                                                                                    Ó







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        |Hearing Date:April 15, 2013        |Bill No:SB                         |
        |                                   |445                                |
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                      SENATE COMMITTEE ON BUSINESS, PROFESSIONS 
                               AND ECONOMIC DEVELOPMENT
                          Senator Curren D. Price, Jr., Chair
                                           

                          Bill No:        SB 445Author:Price
                    As Introduced:     February 21, 2013 Fiscal:Yes

        
        SUBJECT:  Pharmacies: advertising: controlled substances.
        
        SUMMARY:  Prohibits pharmacies from advertising the sale of controlled  
        substances.    

        Existing law:
        
        1) Provides for the licensure and regulation of pharmacies,  
           pharmacists and wholesalers of dangerous drugs or devices by the  
           Board within the Department of Consumer Affairs (DCA).  

        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.  (Business and Professions  
           Code (BPC) § 4059)

        3) Requires advertisements for prescription drugs to be limited to  
           quantities consistent with good medical practice and include the  
           strength, dosage form and effective dates of the advertised price.   
           (BPC § 4121)

        4) Clarifies that the provisions do not apply to a hospital pharmacy  
           that is only accessible to hospital medical staff and personnel.   
           (Id.)

        This bill:  Prohibits an advertisement that promotes the sale or  
        dispensing of any controlled substances.






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        FISCAL EFFECT:  Unknown.  This bill is keyed fiscal by Legislative  
        Counsel.

        COMMENTS:
        
        1. Purpose.  The Author is the Sponsor of this bill. According to the  
           Author, there currently are no prohibitions on the advertisement of  
           controlled substances and this bill will play an important part in  
           limiting drug seeking behavior at pharmacies by prohibiting the  
           advertisement of controlled substances.  The Author is concerned  
           about rising numbers of prescription drug abuse in California and  
           throughout the nation.  The Author is also concerned that  
           concurrent with increased rates of prescription drug abuse there  
           are increased instances of crime, particularly robberies at  
           pharmacies, which are targeted for their inventories of  
           prescription painkillers, anti-anxiety drugs and other controlled  
           medications.  National data shows that since 2006, pharmacy  
           robberies have increased 82%.  Unfortunately, pharmacies have  
           become targets, often jeopardizing the safety of pharmacy staff and  
           patrons, for individuals seeking drugs for either personal use or  
           for sale on the streets (single pills can be worth up to $80 on the  
           black market).

           These types of robberies have occurred in California as recently as  
           this year.  In January, there were three separate pharmacy  
           robberies - two in South San Francisco and one in Amador County.   
           In the fall of 2010, there was a pharmacy robbery in Sacramento  
           County in which two pharmacy workers were shot and one ultimately  
           died.

        2. Controlled Substances.  Through the Controlled Substances Act of  
           1970, the federal government regulates the manufacture,  
           distribution and dispensing of controlled substances.  The act  
           ranks into five schedules those drugs known to have potential for  
           physical or psychological harm, based on three considerations: (a)  
           their potential for abuse; (b) their accepted medical use; and, (c)  
           their accepted safety under medical supervision.  

            Schedule I  controlled substances have a high potential for abuse  
           and no generally accepted medical use such as heroin, ecstasy, and  
           LSD. 

            Schedule II  controlled substances have a currently accepted medical  
           use in treatment, or a currently accepted medical use with severe  
           restrictions, and have a high potential for abuse and psychological  
           or physical dependence.  Schedule II drugs can be narcotics or  





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           non-narcotic.  Examples of Schedule II controlled substances  
           include morphine, methadone, Ritalin, Demerol, Dilaudid, Percocet,  
           Percodan, and Oxycontin. 

            Schedule III and IV  controlled substances have a currently accepted  
           medical use in treatment, less potential for abuse but are known to  
           be mixed in specific ways to achieve a narcotic-like end product.   
           Examples include drugs include Vicodin, Zanex, Ambien and other  
           anti-anxiety drugs.

            Schedule V  drugs have a low potential for abuse, a currently  
           accepted medical use and are available over the counter.

           The three classes of prescription drugs that are most commonly  
           abused are: opioids, which are most often prescribed to treat pain;  
           central nervous system (CNS) depressants, which are used to treat  
           anxiety and sleep disorders; and, stimulants which are prescribed  
           to treat the sleep disorder narcolepsy and attention-deficit  
           hyperactivity disorder (ADHD).  Each class can induce euphoria, and  
           when administered by routes other than recommended, such as  
           snorting or dissolving into liquid to drink or injection, can  
           intensify that sensation.  Opioids, in particular, act on the same  
           receptors as heroin and, therefore, can be highly addictive.   
           Common opioids are:  hydrocodone (Vicodin), oxycodone (OxyContin),  
           propoxyphene (Darvon), hydromorphone (Dilaudid), meperidine  
           (Demerol), and diphenoxylate (Lomotil).

        3. Prescription Drug Abuse.  For the past number of years, abuse of  
           prescription drugs (taking a prescription medication that is not  
           prescribed, or taking it for reasons or in dosages other than as  
           prescribed) to get high has become increasingly prevalent.  Federal  
           data shows that the abuse of prescription pain killers now ranks  
           second, just behind marijuana, as the nation's most widespread  
           illegal drug problem.  According to the 2008 National Survey on  
           Drug Use and Health (NSDUH), approximately 52 million Americans  
           aged 12 or older reported non-medical use of a psychotherapeutic at  
           some point in their lifetimes, representing 20.8% of the population  
           aged 12 or older.  The National Institute on Drug Abuse's (NIDA)  
           research report, Prescription Drugs: Abuse and Addiction, states  
           that the elderly are among those most vulnerable to prescription  
           drug abuse or misuse because they are prescribed more medications  
           than their younger counterparts.  Persons 65 years of age and above  
           comprise only 13 percent of the population, yet account for  
           approximately one-third of all medications prescribed in the United  
           States.  Older patients are more likely to be prescribed long-term  
           and multiple prescriptions, which could lead to unintentional  





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           misuse.  The report also notes that studies suggest that women are  
           more likely (in some cases, 55 percent more likely) than men to be  
           prescribed a prescription drug which potentially could be abused,  
           particularly narcotics and antianxiety drugs.  A 2010 report,  
           Monitoring the Future Study, showed that as many as 4 percent of  
           high school students and 3 percent of young adults say they have  
           used OxyContin in the past year.

           Abuse can stem from the fact that prescription drugs are legal and  
           potentially more easily accessible, as they can be found at home in  
           a medicine cabinet.  Data shows that individuals who misuse  
           prescription drugs, particularly teens, believe these substances  
           are safer than illicit drugs because they are prescribed by a  
           health care professional and thus are safe to take under any  
           circumstances.  NIDA data states that in actuality, prescription  
           drugs act directly or indirectly on the same brain systems affected  
           by illicit drugs, thus, their abuse carries substantial addiction  
           liability and can lead to a variety of other adverse health  
           effects. 

           The Senate Committee on Labor held a hearing on March 20, 2013  
           entitled, Opioids and the Workers Compensation System: A Discussion  
           on Mitigating Abuse and Ensuring Access, during which the committee  
           reviewed a series of studies conducted by the California Workers'  
           Compensation Institute (CWCI) which highlighted a rise in opiod  
           prescriptions by physicians in the state workers' compensation  
           system.  The studies identified trends in widespread, potential use  
           of Schedule II drugs by patients with low back pain, significant  
           growth in the prescribing of all Schedule II drugs in the workers'  
           compensation system, and found that 6.7 percent of all  
           prescriptions in the system for the first half of 2011 alone were  
           for opiods.

        4. Prescription Drug Deaths. A recent Centers for Disease Control  
           (CDC) analysis found that drug overdose deaths increased for the  
           11th consecutive year in 2010 and prescription drugs, particularly  
           opiod analgesics, are the top drugs leading the list of those  
           responsible for fatalities.  According to CDC, 38,329 people died  
           from a drug overdose in 2010, up from 37,004 deaths in 2009, and  
           16,849 deaths in 1999.  CDC found that nearly 60 percent of the  
           overdose deaths in 2010, involved pharmaceutical drugs, with opiods  
           associated with approximately 75 percent of these deaths.  Nearly  
           three out of four prescription drug overdoses are caused by opioid  
           pain relievers.  CDC recommends the use of Prescription Drug  
           Management Programs (PDMPs), with a focus on both patients at  
           highest risk in terms of prescription painkiller dosage, numbers of  





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           prescriptions and numbers of prescribers, as well as prescribers  
           who deviate from accepted medical practice and those with a high  
           proportion of doctor shoppers among their patients.  CDC also  
           recommends that PDMPs link to electronic health records systems so  
           that the information is better integrated into health care  
           providers' day-to-day practices.  CDC believes that state benefits  
           programs like Medicaid and workers' compensation should consider  
           monitoring prescription claims information and PDMP data for signs  
           and inappropriate use of controlled substances.  The organization  
           also acknowledges the value of PDMPs in taking regulatory action  
           against health care providers who do operate outside the limits of  
           appropriate medical practice when it comes to prescription drug  
           prescribing.    
           
           A current Los Angeles Times series, "Dying For Relief," has  
           highlighted the role of prescription drugs in overdose deaths as  
           determined through the examination of coroners' reports.  Reporters  
           conducted an analysis of coroners' reports for over 3000 deaths  
           occurring in four counties (Los Angeles, Orange, Ventura and San  
           Diego) where toxicology tests found a prescription drug in the  
           deceased's system, usually a painkiller, anti-anxiety drug or other  
           narcotic; coroners' investigators reported finding a container of  
           the same medication bearing the doctor's name, or records of a  
           prescription; the coroner determined that the drug caused or  
           contributed to the death.  The analysis found that in nearly half  
           of the cases where prescription drug toxicity was listed as the  
           cause of death, there was a direct connection to a prescribing  
           physician.  The Times created a database, the first of its kind,  
           linking overdose deaths to the doctors who prescribed drugs.  They  
           also found that more than 80 of the doctors whose names were listed  
           on prescription bottles found at the home of or on the body of a  
           decedent had been the prescribing physician for 3 or more dead  
           patients.  Their analysis found that one doctor was linked to as  
           many as 16 dead patients.  The approach that these reporters have  
           taken is unique in that they are specifically talking about abuse  
           and subsequent death to patients taking drugs prescribed by their  
           doctors. 

        5. Prescription Drug Monitoring and CURES.  With rising levels of  
           abuse, PDMPs are a critical tool in assisting law enforcement and  
           regulatory bodies with their efforts to reduce drug diversion.  
           Forty-nine states currently have monitoring programs.  California  
           has the oldest prescription drug monitoring program in the nation.   
           Of these 50 programs throughout the nation, seven are or will be  
           housed at the state's Department of Justice, 18 are or will be  
           housed at a state Department of Health or substance abuse agency  





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           and 25 are or will be housed at a state Board of Pharmacy or state  
           professional licensing agency.  There is currently momentum to  
           share data across these programs from state to state.  

           In California, the Controlled Substance Utilization Review and  
           Evaluation System (CURES) is an electronic tracking program that  
           reports all pharmacy (and specified types of prescriber) dispensing  
           of controlled drugs by drug name, quantity, prescriber, patient,  
           and pharmacy.  Data from CURES is managed by DOJ to assist state  
           law enforcement and regulatory agencies in their efforts to reduce  
           prescription drug diversion.  CURES provides information that  
           offers the ability to identify if a person is "doctor shopping"  
           (when a prescription-drug addict visits multiple doctors to obtain  
           multiple prescriptions for drugs, or uses multiple pharmacies to  
           obtain prescription drugs).  Information tracked in the system  
           contains the patient name, prescriber name, pharmacy name, drug  
           name, amount and dosage, and is available to law enforcement  
           agencies, regulatory bodies and qualified researchers.  The system  
           can also report on the following:  (1) top drugs prescribed for a  
           specific time period; 
           (2) drugs prescribed in a particular county; (3) doctor prescribing  
           data; (4) pharmacy dispensing data; and, is a critical tool for  
           assessing whether multiple prescriptions for the same patient may  
           exist.  CURES data can be obtained by the Medical Board of  
           California, Board of Pharmacy, Dental Board of California, Board of  
           Registered Nursing, Osteopathic Medical Board of California and  
           Veterinary Medical Board.  

           Since 2009, more than 8,000 doctors and pharmacists have signed up  
           to use CURES, which has more than 100 million prescriptions.  The  
           system also has been accessed more than 
           1 million times for patient activity reports and has been key in  
           investigations of doctor shoppers and nefarious physicians.   
           According to the AG's office, CURES assisted in targeting the top  
           50 doctor shoppers in the state, who averaged more than 100 doctor  
           and pharmacy visits to collect massive quantities of addictive  
           drugs and the crackdown led to the arrest of dozens of suspects.   
           CURES also provided information with the prescribing history of a  
           Southern California physician accused of writing hundreds of  
           fraudulent prescriptions to feed his patients' drug addictions,  
           seven of whom died from prescription-drug overdoses.  The system  
           has also been successful in alerting law enforcement and licensed  
           medical professionals to signs of illegal drug diversions,  
           including a criminal ring that stole the identities of eight  
           doctors, illegally wrote prescriptions, stole the identities of  
           dozens of innocent citizens who they designated as patients in  





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           order to fill the fraudulent prescriptions, resulting in the group  
           obtaining more than 11,000 pills of highly addictive drugs like  
           OxyContin and Vicodin. 
                  
        6. Related Legislation.   SB 62  (Price) requires coroner's reports to  
           be transmitted to various health practitioner boards in the event  
           that cause of death is determined to be prescription drug overdose.  
            The bill is also up for consideration in this Committee today.
           
            SB 670  (Steinberg) provides the Medical Board of California with  
           additional authority to inspect medical records and to limit the  
           prescribing ability of physicians during a pending investigation if  
           there is a reasonable suspicion the physician has engaged in  
           overprescribing of controlled substances that resulted in a  
           patient's death.  The bill is also up for consideration in this  
           Committee today.  

            SB 809  (DeSaulnier and Steinberg) is an urgency measure that makes  
           various changes to the funding and operation of the Controlled  
           Substances Utilization Review and Evaluation System (CURES)  
           Prescription Drug Monitoring Program (PDMP) including the  
           following: 
           (1) requiring practitioners and pharmacists to enroll in and  
           consult the CURES PDMP; 
           (2) increased licensing fees for prescribing health practitioners,  
           dispensers and wholesalers of controlled substances for the purpose  
           of providing ongoing funding to maintain the CURES PDMP; (3) a  
           one-time tax assessment on health insurance plans and workers  
           compensation insurers to fund the CURES modernization upgrade; and,  
           (4) annual taxes on drug manufacturers of Schedule II, III, and IV  
           controlled substances doing business in California to maintain the  
           CURES PDMP.  The bill is also up for consideration in this  
           Committee today.
        

        SUPPORT AND OPPOSITION:
        
         Support:  

        None on file as of April 9, 2013

         Opposition:  

        None on file as of April 9, 2013







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        Consultant:Sarah Mason