BILL ANALYSIS Ó ----------------------------------------------------------------------- |Hearing Date:April 15, 2013 |Bill No:SB | | |445 | ----------------------------------------------------------------------- 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. SB 445 Page 2 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 SB 445 Page 3 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 SB 445 Page 4 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 SB 445 Page 5 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 SB 445 Page 6 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 SB 445 Page 7 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 SB 445 Page 8 Consultant:Sarah Mason