BILL ANALYSIS Ó SENATE COMMITTEE ON PUBLIC SAFETY Senator Loni Hancock, Chair S 2011-2012 Regular Session B 3 6 0 SB 360 (DeSaulnier) As Amended April 14, 2011 Hearing date: May 3, 2011 Family; Health & Safety Codes JM:dl CONTROLLED SUBSTANCES HISTORY Source: Attorney General Prior Legislation: AB 2986 (Mullin) - Ch. 286, Stats. 2006 SB 1366 (Aanestad) - 2005-06, held in Senate Public Safety SB 734 (Torlakson) - Ch. 487, Stats. 2005 SB 151 (Burton) - Ch. 406, Stats. 2004 Support: California Statewide Law Enforcement Association; Consumer Attorneys of California; California State Sheriffs' Association; Peace Officers Research Association of California; California Narcotic Officers Association; California Police Chiefs Association Opposition:None known KEY ISSUES (More) SB 360 (DeSaulnier) PageB SHOULD SCHEDULES I, II, III and IV FOR CONTROLLED SUBSTANCES IN CURRENT LAW BE EXPANDED TO INCLUDE ADDITIONAL SUBSTANCES, AS SPECIFIED? (CONTINUED) SHOULD SPECIFIED CHANGES BE MADE TO THE LAW REGARDING SECURITY PRINTERS FOR PRESCRIPTION FORMS FOR CONTROLLED SUBSTANCE PRESCRIPTIONS, AS SPECIFIED? SHOULD THE CURES PRESCRIPTION DRUG MONITORING PROGRAM (PDMP) BE REVISED TO ALLOW PARTICIPATING CONTROLLED SUBSTANCE PRESCRIBERS AND PHARMACISTS TO ACCESS OVER THE INTERNET THE HISTORY OF CONTROLLED SUBSTANCE PRESCRIPTIONS OF PERSONS UNDER THEIR CARE, AS SPECIFIED? PURPOSE The purposes of this bill are to 1) add additional substances to schedules I and IV for controlled substances, as specified; 2) make certain changes to the law regarding security printers for prescription forms for controlled substance prescriptions, as specified; and 3) establish the CURES revise Prescription Drug Monitoring Program to allow controlled substance subscribers and pharmacists to have Internet access to the controlled substance prescription history of persons under their care, as specified. Existing law classifies controlled substances in five schedules according to their danger and potential for abuse. Schedule I (More) SB 360 (DeSaulnier) PageC controlled substances have the greatest restrictions and penalties, including prohibiting the prescribing of a Schedule I controlled substance. (Health & Saf. Code §§ 11054-11058.) Existing law provides penalties for sale, possession for sale or distribution, sale or distribution, and manufacturing of controlled substances. (Health & Saf. Code §§ 11350-11401.) Existing law , with numerous exceptions, includes the following penalties: Heroin, cocaine and other specified drugs (section references are to the Health and Safety Code): § § 11350 possession straight felony - prison term of 16 months, 2 years or 3 years<1> § § 11351 possession for sale or distribution - prison for 2, 3 or 4 years § § 11351.5 possession of cocaine base (crack) for sale - prison for 3, 4, 5 years § § 11352 sale or distribution - 3, 6 or 9 years Marijuana: § § 11357 possession - misdemeanor § § 11358 cultivation or processing - felony § § 11359 possession for sale - felony § § 11360 sale or distribution - felony, 2, 3 or 4 years Methamphetamine and other specified drugs: § § 11377 possession - alternate felony-misdemeanor § § 11378 possession for sale or distribution - felony --------------------------- <1> Hereinafter, a description of a crime as a "felony," without an additional explanation or description of the applicable prison sentence, means that the crime is punishable by imprisonment for 16 months, 2 years or 3 years. (More) SB 360 (DeSaulnier) PageD § § 11379 sale or distribution - felony, 2, 3 or 4 years Existing law includes numerous enhancement provisions for controlled substance crimes. These include enhancements based on the weight and volume of controlled substances and sale within a certain distance from a school. Examples of enhancements include the following: enhancement for weight of controlled substances involved in sale or distribution (Health & Safety Code § 11370.4, subdivision (b)); enhancement for weight or volume of controlled substance involved in manufacturing (Health & Saf. Code § 11379.8); and enhancement where person dies or suffers great bodily injury in the manufacturing of methamphetamine. Existing law provides that any person who manufactures, compounds, converts, produces, derives, processes, or prepares either directly or indirectly by chemical extraction or independently by means of chemical synthesis any controlled substance is guilty of a felony, punishable by imprisonment in the state prison for three, five or seven years, and by a fine of up to $50,000. (Health & Saf. Code § 11379.6.) Existing law provides that any person who possesses specified chemicals with the intent to manufacture a controlled substance is guilty of a felony and shall be punished by imprisonment in the state prison for two, four or six years. (Health & Saf. Code § 11383.) Existing law includes enhancements for controlled substance crimes that occur in specified places. For example, the enhancement triad for involving a minor in specified controlled substance crimes is three, six or nine years. (Health & Saf. Code § 11353.) There are a myriad other special penalty provisions. This bill would add additional substances to these schedules, as specified. Existing law includes the CURES (Controlled Substance Utilization Review and Evaluation System) system of electronic (More) SB 360 (DeSaulnier) PageE monitoring of Schedule II, III and IV controlled substance prescriptions. CURES provides for the electronic transmission of Schedule II, III and IV prescription data to the Department of Justice (DOJ) at the time prescriptions are dispensed. (Health & Saf. Code § 11165.) Existing law states that the purpose of CURES is to assist law enforcement and regulatory agencies in controlling diversion and abuse of Schedule II, III and IV controlled substances and for statistical analysis, education and research. (Health & Saf. Code § 11165, subd. (a).) Existing law provides that pharmacists, in filling a controlled substance prescription, shall provide to DOJ the patient's name, date of birth, the name, form, strength and quantity of the drug, and the pharmacy name, pharmacy number and the prescribing physician information. (Health & Saf. Code § 11165, subd. (d).) Existing law provides that a licensed health care practitioner eligible to prescribe Schedule II, III or IV controlled substances, or a pharmacist, may make a written request to the DOJ for the history of controlled substances dispensed to an individual based on the data in CURES. (Health & Saf. Code § 11165.1, subd. (a).) Existing law provides that the DOJ may initiate the referral of the history controlled substances dispensed to an individual, based on the CURES data, to licensed health care practitioners and pharmacists, as specified. (Health & Saf. Code § 11165.1, subd. (b).) Existing law provides that the history of controlled substances dispensed to a patient based on CURES data that is received by a practitioner or pharmacist shall be considered medical information, as specified. (Health & Saf. Code § 11165.1, subd. (c).) Existing law provides that CURES data "shall only be provided to appropriate state, local and federal persons or public agencies for disciplinary, civil or criminal purposes ?" CURES data (More) SB 360 (DeSaulnier) PageF shall also only be provided, as determined by DOJ, to other agencies or entities for educating practitioners and others, in lieu of disciplinary, civil or criminal actions. (Health & Saf. Code § 11165 subd. (b).) Existing law allows non-identifying CURES data to be provided to public and private entities for education, research, peer review and statistical analysis. (Health & Saf. Code § 11165, subd. (c).) Existing law provides that prescriptions for controlled substances must be made on special security forms to prevent copying or forgery of prescriptions. (Health & Saf. Code § 11162.1.) Existing law requires health practitioners who prescribe or administer a controlled substance classified in Schedule II to make a record containing the name and address of the patient, date, and the character, name, strength, and quantity of the controlled substance prescribed, as well as the pathology and purpose for which the controlled substance was administered or prescribed. (Health & Saf. Code § 11190, subd. (a)-(b).) Existing law requires prescribers who are authorized to dispense Schedule II, III or IV controlled substance in their office or place of practice to record and maintain information for each such prescription that includes the patient's name, address, gender, and date of birth, prescriber's license and license number, federal controlled substance registration number, state medical license number, NDC number of the controlled substance dispensed, quantity dispensed, diagnosis code, if available, and original date of dispensing. This information shall be provided to DOJ on a monthly basis. (Health & Saf. Code § 11190 subd. (c).) This bill provides that any security prescription form printer shall provide DOJ with the following information: the names and addresses of an owner, partner, corporate officer, manager, agent, representative, employee or subcontractor with direct (More) SB 360 (DeSaulnier) PageG access to, management of, or control over controlled substance prescription forms. This bill provides that a security printer shall inform DOJ if any owner, partner, corporate officer, manager, agent, representative, employee or subcontractor with direct access to, management of, or control over controlled substance prescription forms has been convicted of, or pleaded no contest, any crime. This bill directs DOJ to inform any owner, partner, corporate officer, manager, agent, representative, employee or subcontractor with direct access to, management of, or control over controlled substance prescription forms how to provide fingerprints and other required information to DOJ for criminal background checks. This bill requires that controlled substance forms shall be provided in person only to established customers. The printer shall obtain the customer's photo identification and log the information. Controlled substance forms shall only be mailed to an address verified by the DEA or Medical Board of California. This bill requires security printers to report theft of loss of controlled substance prescription forms to DOJ by fax or e-mail within 24 hours. This bill requires DOJ to impose sanctions on security printers who violate applicable statutes and regulations, as specified. This bill provides that the following security printer violations are subject to a fine of up to $1,000 for a first violation, a fine of up to $2,500 for each subsequent violation; a printer who violates these rules for a third time is subject to disciplinary proceeding for suspension or revocation of security printer status: failure to comply with guidelines; failure to take reasonable precautions to prevent dishonest or illegal actions concerning control of controlled substance forms; and (More) SB 360 (DeSaulnier) PageH theft or fraudulent use of a prescriber's identity to obtain forms. This bill establishes the Prescription Drug Monitoring Program (PDMP), with the following features: Any practitioner licensed to prescribe Schedules II through IV controlled substances or pharmacist may apply to participate in the PMDP, as specified. Under the PMDP the participating practitioner or pharmacist (subscriber) may access, using the Internet, the electronic history of controlled substances dispensed to an individual under his or her care based on data contained in CURES. A practitioner or pharmacist PDMP subscriber may access through the PDMP the number, amount, and type of controlled substances being dispensed to an individual under his or her care, in order to control the diversion and resultant abuse of, and to ensure the safe and lawful dispensing of, Schedule II, Schedule III, and Schedule IV controlled substances. DOJ may release to the subscribing practitioner or pharmacist the electronic history of controlled substances dispensed to a person under the care of the practitioner or pharmacist based on data in the CURES Prescription Drum Monitoring Program (PDMP). This bill provides that an application may be denied, or a subscriber suspended, for any of the following: materially falsifying an application; failing to maintain effective controls for access to the patient activity report; suspended or revoked DEA registration; arrest of a subscriber for a controlled substance offense; or accessing information for any reason except patient care. This bill provides that an authorized subscriber shall notify (More) SB 360 (DeSaulnier) PageI DOJ within 10 days of any changes to the subscriber account. This bill allows, until July 12, 2012, a health care practitioner or pharmacist to make a written request for controlled substance history information about a person under the care of the practitioner or pharmacist, in order to provide sufficient time for subscribers to apply for access to PDMP. This bill provides that DOJ may audit the PDMP system and its users. This bill provides that DOJ may establish, by regulation, a system for issuing a citation to a PDMP subscriber. This bill provides that the citation may contain an order or abatement or to pay a fine if the subscriber is in violation of the CURES-PDMP statutes or corresponding regulations: Citations shall be written and particularly describe the violation, including a specific citation of the statute or regulation violated. When appropriate, the citation shall include a reasonable time for abatement of the violation. An administrative fine shall not exceed $2,500 for each violation and shall be based on the gravity of the violation, the good faith of the subscriber and any previous violations. The citation shall inform the subscriber that he or she may, within 30 days of receiving a citation, request a hearing. A subscriber may, within 10 days of receiving a citation, request in writing an informal conference with DOJ. DOJ may, pursuant to the conference, affirm, modify or dismiss the citation. If the citation is affirmed, the subscriber may request a formal hearing. If the citation is modified, the original citation shall be deemed withdrawn and a new citation issued. The subscriber may request a formal hearing on the subsequent citation. (More) SB 360 (DeSaulnier) PageJ Failure to pay a fine within 30 days, or to comply with an order of abatement within the time prescribed to do so, may result in disciplinary action by DOJ, unless the citation is being appealed. If the citation is not contested and the fine is not paid, the subscriber's account will be terminated. A citation may be issued without a fine. Fines may be limited to particular violations. If a fine is paid, payment shall represent satisfactory resolution of the matter for public disclosure. Administrative fines shall be deposited in the CURES Program Special Fund and "shall provide support for costs association with hearings, maintenance, and updates to the ÝPDMP]." These sanctions shall be in separate form and in addition to any other administrative, civil or criminal remedies. A criminal action may not be initiated for a specific offense if a citation has been issued for that matter. A citation may not be issued for a specific offense, if a criminal action has been filed for that violation. However, nothing in the citation provisions shall prevent DOJ from prosecuting a suspension or revocation of a subscriber. RECEIVERSHIP/OVERCROWDING CRISIS AGGRAVATION For the last several years, severe overcrowding in California's prisons has been the focus of evolving and expensive litigation. As these cases have progressed, prison conditions have continued to be assailed, and the scrutiny of the federal courts over California's prisons has intensified. On June 30, 2005, in a class action lawsuit filed four years earlier, the United States District Court for the Northern District of California established a Receivership to take control of the delivery of medical services to all California state prisoners confined by the California Department of Corrections and Rehabilitation ("CDCR"). In December of 2006, (More) SB 360 (DeSaulnier) PageK plaintiffs in two federal lawsuits against CDCR sought a court-ordered limit on the prison population pursuant to the federal Prison Litigation Reform Act. On January 12, 2010, a three-judge federal panel issued an order requiring California to reduce its inmate population to 137.5 percent of design capacity -- a reduction at that time of roughly 40,000 inmates -- within two years. The court stayed implementation of its ruling pending the state's appeal to the U.S. Supreme Court. On Monday, June 14, 2010, the U.S. Supreme Court agreed to hear the state's appeal of this order and, on Tuesday, November 30, 2010, the Court heard oral arguments. A decision is expected as early as this spring. In response to the unresolved prison capacity crisis, in early 2007 the Senate Committee on Public Safety began holding legislative proposals which could further exacerbate prison overcrowding through new or expanded felony prosecutions. This bill does appear to aggravate the prison overcrowding crisis described above. COMMENTS 1. Need for This Bill According to the author: Due to the rise in prescription drug abuse, controlled drugs prescription history information is available and maintained by the Department of Justice (DOJ) CURES program. In 2009, the DOJ launched an automated Prescription Drug Monitoring Program (PDMP). The program allows licensed health care practitioners eligible to prescribe controlled substances access to patient controlled substance prescription information. Prescribers and pharmacists can now make informed decisions about patient care and detect patients who may be abusing controlled substances by obtaining (More) SB 360 (DeSaulnier) PageL multiple prescriptions from various practitioners. Current efforts at maintaining privacy and control of CURES data are inadequate to protect confidential patient information and to deter its misuse. The DOJ also manages the California Security Prescription Printer Program. While DOJ has established guidelines for the security of prescription forms, current law lacks sufficient safeguards against theft and fraudulent use of prescription pads. The DOJ has seen an increase in criminal enterprises involved in prescription theft and fraud. The existing list of controlled substances in Schedules II, III, and IV set forth in the California Health and Safety Code is out of date and no longer in conformity with the Federal controlled substances list. As a result, the CURES program is no longer collecting all controlled substance information as required by law. 2. Controlled Substance Schedules - Criteria for Listings The Federal Government classifies drugs into five schedules. (21 U.S.C. § 812.) California law generally follows federal law as to the assigned schedule, but does not set out the criteria for the schedules that are included in federal law. (Health and Safety Code Section 11054.) 21 U.S.C., Section 812 (b) includes the following explanations: Schedule I drugs are drugs that have no currently accepted medical use in treatment in the United States, have a high potential for abuse, and there is a lack of accepted safety for use of the drug or other substance under medical supervision. Schedule I drugs include but are not limited to cannabis, heroin, GHB, and ecstasy. Schedule II controlled substances have a currently accepted (More) SB 360 (DeSaulnier) PageM medical use in treatment, a high potential for abuse, which may lead to severe psychological or physical dependence. Schedule II drugs include but are not limited to Cocaine, Ritalin, oxdycodone, morphine, and amphetamines. Schedule III controlled substances have a currently accepted medical use in treatment, a potential for abuse that is less than that for Schedule I and II drugs, and abuse may lead to moderate or low physical dependence or high psychological dependence. Schedule III drugs include but are not limited to anabolic steroids, prescriptions that combine codeine or hydrocodone with aspirin or another non-narcotic ingredient, ketamine, and testosterone. Schedule IV drugs have a currently accepted medical use in treatment, have a low potential for abuse relative to the substances in Schedule III, and abuse may lead to limited physical dependence or psychological dependence. Schedule IV drugs include but are not limited to Xanax, Librium, Valium, talwin and Phenobarbital. Schedule V drugs have a low potential for abuse, have a currently accepted medical use in treatment, and abuse of the drug may lead to limited physical dependence or psychological dependence. Schedule V drugs include but are not limited to narcotic drugs containing active medicinal qualities other than those possessed by narcotic drugs alone, such as cough suppressants containing small amounts of codeine. 3. The CURES Program: Electronic Monitoring of Controlled Substance Prescriptions, Private Contractor The CURES program was established in 1997 by AB 3042 (Takasugi) in response to recommendations of the Controlled Substance Prescription Advisory Council. (SCR 74, 1992.) A CURE initially was intended to electronically monitor the prescribing and dispensing of Schedule II controlled substances such as oxycodone. CURES provides for real-time electronic transmission of specified prescription data to DOJ. Essentially the data is analyzed for indications that controlled substances are being (More) SB 360 (DeSaulnier) PageN improperly prescribed, or that drug abusers are obtaining prescriptions from many doctors (doctor shopping). Physicians and pharmacists, in addition to DOJ, have access to CURES data through PAR - patient activity reports. A private contractor - Atlantic Associates - collects CURES data for DOJ. The previous vendor was Infinite Solutions. 4. Confidentiality Concerns According to a report issued by the General Accounting Office (GAO) in May 2002: Both physicians who legitimately prescribe prescription drugs and patients who legitimately use them are concerned that the information collected, centrally maintained, and monitored by state PDMP's may be used inappropriately or compromised. ÝP]DMP's, particularly those with electronic databases, raise additional confidentiality concerns, however, because their databases contain complete dispensing records that can more quickly identify individual patients, physicians and pharmacies and provide an individual report on their prescription drug history. Physicians are concerned that their prescribing decisions and patterns may be questioned, and that they could be investigated without sufficient cause. Some physicians contend that patients may suffer because physicians will be reluctant to prescribe appropriate controlled substances to manage a patient's pain or treat their conditions?Patients are concerned that their personal information may be used inappropriately by those with authorized access or shared with unauthorized entities. (U.S. Gen. Accounting Office, Prescription Drugs, State Monitoring Programs Provide Useful Tool to Reduce Diversion, (May, 2002) p. 18; http://www.gao.gov/new.items/d02634.pdf.) (More) This appears to be a legitimate concern, given the number of persons and entities with access to this information. This bill provides penalties for unauthorized use of CURES data by those with PDMP access. The question is raised as to whether privacy may be better protected by preventive measures than penalties imposed after misuse of CURES information. WHAT MEASURES COULD BE IMPLEMENTED TO PREVENT MISUSE OF CURES DATA? WOULD PREVENTION OF MISUSE BE MORE EFFECTIVE THAN IMPOSING SANCTIONS AFTER MISUSE OF THE DATA OR IMPROPER ACCESS? 5. Prior Legislation Amending the CURES System AB 2986 (Mullin), Chapter 286, Statutes of 2006, required designated prescription forms for controlled substances and prescriptions for controlled substances to contain additional information identifying the final consumer and any refill information. AB 2986 also added Schedule IV drugs to the controlled substances subject to electronic reporting and monitoring system under CURES. SB 1366 (Aanestad), of the 2005-06 Legislative Session, would have removed the requirement that authorized persons write prescriptions for controlled substances on a specialized secured prescription form and would have allowed courts to issue an order prohibiting prescriber from prescribing controlled substances when the prescriber is charged with a specified felony offense. SB 1366 was held in the Senate Committee on Public Safety. SB 734 (Torlakson), Chapter 487, Statutes of 2005, made technical and clarifying changes to CURES. SB 151 (Burton), Chapter 406, Statutes of 2004, made the CURES reporting system permanent. 6. Expansion of Existing Felonies; Potential ROCA Remedy As explained in detail above, under existing law the unlawful possession of certain controlled substances (as well as other conduct relating to controlled substances) can be a felony. (More) SB 360 (DeSaulnier) PageP Because this bill would include additional substances in the schedules of controlled substances, it would violate ROCA. The Committee and the author may wish to consider the following amendments, which would remedy the bill's ROCA implications: 1) Strike additions to the California controlled substance schedules and related provisions. These amendments would strike SECTION 1 through SECTION 5 of the bill. (p. 3, line 1, through p. 22, line 24.) These amendments also would strike SECTION 13 through SECTION 24 of the bill. (p. 34, line 37 through p. 40, line 32.) 2) Direct prescribers and pharmacists to report to CURES prescriptions for controlled substances listed in Schedules II, III and IV of the federal controlled substance schedules. The bill could be amended to provide that prescribers and pharmacists shall report prescriptions for controlled substances to CURES that are listed in Schedules II, III and IV of the federal controlled substance schedules set out in 21 U.S.C. § 812 and as updated in 21 Code of Federal Regulations, Sections 1308.12, 1308.13 and 1308.14. ***************