Existing law classifies certain controlled substances into designated schedules. Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by all practitioners authorized to prescribe, administer, furnish, or dispense these controlled substances. Existing law requires dispensing pharmacies and clinics to report specified information for each prescription of a Schedule II, Schedule III, or Schedule IV controlled substance to the department.

This bill would require a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance to consult the CURES database to review a patients controlled substance history no earlier than 24 hours, or the previous business day, before prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient for the first time and at least once every 4 months thereafter if the substance remains part of the treatment of the patient. The bill would exempt a veterinarian and a pharmacist from this requirement. The bill would also exempt a health care practitioner from this requirement under specified circumstances, including, among others, if prescribing, ordering, administering, or furnishing a controlled substance to a patient receiving hospice care, to a patient admitted to a specified facility for use while on facility premises, or to a patient as part of a treatment for a surgical procedure in a specified facility if the quantity of the controlled substance does not exceed a nonrefillable 5-day supply of the controlled substance that is to be used in accordance with the directions for use. The bill would require, if a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance is not required to consult the CURES database the first time he or she prescribes, orders, administers, or furnishes a controlled substance to a patient pursuant to one of those exemptions, the health care practitioner to consult the CURES database before subsequently prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient and at least once every 4 months thereafter if the substance remains part of the treatment of the patient.

This bill would provide that a health care practitioner who fails to consult the CURES database is required to be referred to the appropriate state professional licensing board solely for administrative sanctions, as deemed appropriate by that board. The bill would make the above-mentioned provisions operative 6 months after the Department of Justice certifies that the CURES database is ready for statewide use and that the department has adequate staff, user support, and education, as specified.

This bill would also exempt a health care practitioner, pharmacist, and any person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, from civil or administrative liability arising from any false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for any resulting failure of the CURES database to accurately or timely report that information.

Existing law requires the operation of the CURES database to comply with all applicable federal and state privacy and security laws and regulations. Existing law authorizes the disclosure of data obtained from the CURES database to agencies and entities only for specified purposes and requires the Department of Justice to establish policies, procedures, and regulations regarding the use, access, disclosure, and security of the information within the CURES database.

This bill would authorize a health care practitioner to provide a patient with a copy of the patients CURES patient activity report if no additional CURES data is provided. The bill would also prohibit a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances from obtaining data from the CURES database.

Existing law classifies certain controlled substances into designated schedules. Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by all practitioners authorized to prescribe, administer, furnish, or dispense these controlled substances. Existing law requires dispensing pharmacies and clinics to report specified information for each prescription of a Schedule II, Schedule III, or Schedule IV controlled substance to the department.

This bill would require a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance to consult the CURES database to review a patients controlled substance history no earlier than 24 hours, or the previous business day, before prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient for the first time and at least once every 4 months thereafter if the substance remains part of the treatment of the patient. The bill would exempt a veterinarian and a pharmacist from this requirement. The bill would also exempt a health care practitioner from this requirement under specified circumstances, including, among others, if prescribing, ordering, administering, or furnishing a controlled substance to a patient receiving hospice care, to a patient admitted to a specified facility for use while on facility premises, or to a patient as part of a treatment for a surgical procedure in a specified facility if the quantity of the controlled substance does not exceed a nonrefillable 5-day supply of the controlled substance that is to be used in accordance with the directions for use. The bill would require, if a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance is not required to consult the CURES database the first time he or she prescribes, orders, administers, or furnishes a controlled substance to a patient pursuant to one of those exemptions, the health care practitioner to consult the CURES database before subsequently prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient and at least once every 4 months thereafter if the substance remains part of the treatment of the patient.

This bill would provide that a health care practitioner who fails to consult the CURES database is required to be referred to the appropriate state professional licensing board solely for administrative sanctions, as deemed appropriate by that board. The bill would make the above-mentioned provisions operative 6 months after the Department of Justice certifies that the CURES database is ready for statewide use and that the department has adequate staff, user support, and education, as specified.

This bill would also exempt a health care practitioner, pharmacist, and any person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, from civil or administrative liability arising from any false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for any resulting failure of the CURES database to accurately or timely report that information.

Existing law requires the operation of the CURES database to comply with all applicable federal and state privacy and security laws and regulations. Existing law authorizes the disclosure of data obtained from the CURES database to agencies and entities only for specified purposes and requires the Department of Justice to establish policies, procedures, and regulations regarding the use, access, disclosure, and security of the information within the CURES database.

This bill would authorize a health care practitioner to provide a patient with a copy of the patients CURES patient activity report if no additional CURES data is provided. The bill would also prohibit a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances from obtaining data from the CURES database.

Existing law classifies certain controlled substances into designated schedules. Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by all practitioners authorized to prescribe, administer, furnish, or dispense these controlled substances. Existing law requires dispensing pharmacies and clinics to report specified information for each prescription of a Schedule II, Schedule III, or Schedule IV controlled substance to the department.

This bill would require a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance to consult the CURES database to review a patients controlled substance history no earlier than 24 hours, or the previous business day, before prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient for the first time and at least once every 4 months thereafter if the substance remains part of the treatment of the patient. The bill would exempt a veterinarian and a pharmacist from this requirement. The bill would also exempt a health care practitioner from this requirement under specified circumstances, including, among others, if prescribing, ordering, administering, or furnishing a controlled substance to a patient receiving hospice care, to a patient admitted to a specified facility for use while on facility premises, or to a patient as part of a treatment for a surgical procedure in a specified facility if the quantity of the controlled substance does not exceed a nonrefillable 5-day supply of the controlled substance that is to be used in accordance with the directions for use. The bill would require, if a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance is not required to consult the CURES database the first time he or she prescribes, orders, administers, or furnishes a controlled substance to a patient pursuant to one of those exemptions, the health care practitioner to consult the CURES database before subsequently prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient and at least once every 4 months thereafter if the substance remains part of the treatment of the patient.

This bill would provide that a health care practitioner who knowingly fails to consult the CURES database is required to be referred to the appropriate state professional licensing board solely for administrative sanctions, as deemed appropriate by that board. The bill would make the above-mentioned provisions operative 6 months after the Department of Justice certifies that the CURES database is ready for statewide use. use and that the department had adequate staff, user support, and education, as specified.

This bill would also exempt a health care practitioner, pharmacist, and any person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, from civil or administrative liability arising from any false, incomplete, or inaccurate inaccurate, or misattributed information submitted, to or reported by, submitted to, reported by, or relied upon in the CURES database or for any resulting failure of the CURES database to accurately or timely report that information.

Existing law classifies certain controlled substances into designated schedules. Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by all practitioners authorized to prescribe prescribe, administer, furnish, or dispense these controlled substances. Existing law requires dispensing pharmacies and clinics to report specified information for each prescription of a Schedule II, Schedule III, or Schedule IV controlled substance to the department.

This bill would require a health care practitioner authorized to prescribe, order, administer, furnish, or dispense or furnish a controlled substance to consult the CURES database to review a patients controlled substance history no earlier than 24 hours hours, or the previous business day, before prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient for the first time and at least once every 4 months thereafter if the substance remains part of the treatment of the patient. The bill would exempt a veterinarian from this requirement. The bill would also exempt a health care practitioner from this requirement under specified circumstances, including, among others, if prescribing, ordering, administering, furnishing, or dispensing or furnishing a controlled substance to a patient receiving hospice care, to a patient admitted to a specified facility, facility for use while on facility premises, or to a patient as part of a treatment for a surgical procedure in a specified facility if the quantity of the controlled substance does not exceed a nonrefillable 5-day supply of the controlled substance that is to be used in accordance with the directions for use. The bill would exempt a health care practitioner from this requirement if it is not reasonably possible for him or her to access the information in the CURES database in a timely manner, another health care practitioner or designee authorized to access the CURES database is not reasonably available, and the quantity of controlled substance prescribed, ordered, administered, furnished, or dispensed does not exceed a nonrefillable 5-day supply of the controlled substance that is to be used in accordance with the directions for use and no refill of the controlled substance is allowed. The bill would require, if a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance is not required to consult the CURES database the first time he or she prescribes, orders, administers, or furnishes a controlled substance to a patient pursuant to one of those exemptions, the health care practitioner to consult the CURES database before subsequently prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient and at least once every 4 months thereafter if the substance remains part of the treatment of the patient.

This bill would provide that a health care practitioner who knowingly fails to consult the CURES database is required to be referred to the appropriate state professional licensing board solely for administrative sanctions, as deemed appropriate by that board. The bill would make the above-mentioned provisions operative 6 months after the Department of Justice certifies that the CURES database is ready for statewide use.

This bill would also exempt a health care practitioner, pharmacist, and any person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, from civil or administrative liability arising from any false, incomplete, or inaccurate information submitted, to or reported by, the CURES database or for any resulting failure of the CURES database to accurately or timely report that information.

Existing law classifies certain controlled substances into designated schedules. Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by all practitioners authorized to prescribe or dispense these controlled substances. Existing law requires dispensing pharmacies and clinics to report specified information for each prescription of a Schedule II, Schedule III, or Schedule IV controlled substance to the department.

This bill would require a health care practitioner authorized to prescribe, order, administer, furnish, or dispense a controlled substance to consult the CURES database to review a patients controlled substance history no earlier than 24 hours before prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient for the first time and at least annually once every 4 months thereafter if the substance remains part of the treatment of the patient. The bill would exempt a veterinarian from this requirement. The bill would also exempt a health care practitioner from this requirement under specified circumstances, including, among others, if prescribing, ordering, administering, furnishing, or dispensing a controlled substance to a patient receiving hospice care, to a patient admitted to a specified facility, or to a patient as part of a treatment for a surgical procedure in a specified facility if the quantity of the controlled substance does not exceed a nonrefillable 5-day supply of the controlled substance that is to be used in accordance with the directions for use. The bill would exempt a health care practitioner from this requirement if it is not reasonably possible for him or her to access the information in the CURES database in a timely manner, another health care practitioner or designee authorized to access the CURES database is not reasonably available, and the quantity of controlled substance prescribed, ordered, administered, furnished, or dispensed does not exceed a nonrefillable 5-day supply of the controlled substance that is to be used in accordance with the directions for use and no refill of the controlled substance is allowed.

The bill would provide that a health care practitioner who knowingly fails to consult the CURES database is required to be referred to the appropriate state professional licensing board solely for administrative sanctions, as deemed appropriate by that board. The bill would make the above-mentioned provisions operative 6 months after the Department of Justice certifies that the CURES database is ready for statewide use.

The bill would also exempt a health care practitioner, pharmacist, and any person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, from civil or administrative liability arising from any false, incomplete, or inaccurate information submitted, to or reported by, the CURES database or for any resulting failure of the CURES database to accurately or timely report that information.

Existing law classifies certain controlled substances into designated schedules. Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by all practitioners authorized to prescribe or dispense these controlled substances. Existing law requires dispensing pharmacies and clinics to report specified information for each prescription of a Schedule II, Schedule III, or Schedule IV controlled substance to the department.

Existing law classifies certain controlled substances into designated schedules. Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by all practitioners authorized to prescribe or dispense these controlled substances. Existing law requires dispensing pharmacies and clinics to report specified information for each prescription of a Schedule II, Schedule III, or Schedule IV controlled substance to the department.

This bill would require all prescribers, as defined, prescribing a Schedule II or Schedule III controlled substance, to consult a patients electronic history in the CURES database before prescribing the controlled substance to the patient for the first time. The bill would also require the prescriber to consult the CURES database at least annually when the prescribed controlled substance remains part of the patients treatment. The bill would prohibit prescribing an additional Schedule II or Schedule III controlled substance to a patient with an existing prescription until the prescriber determines that there is a legitimate need for the controlled substance.

The bill would make the failure to consult a patients electronic history in the CURES database a cause for disciplinary action by the prescribers licensing board and would require the licensing boards to notify all prescribers authorized to prescribe controlled substances of these requirements. The bill would provide that a prescriber is not in violation of these requirements during any time that the CURES database is suspended or not accessible, or during any time that the Internet is not operational. if a specified condition exists, including any time that the CURES database is suspended or not accessible, an inability to access the CURES database in a timely manner because of an emergency, when the controlled substance is prescribed to a patient receiving hospice care, or when the controlled substance is directly administered to the patient by the person prescribing the controlled substance. The bill would make its provisions operative upon the Department of Justices certification that the CURES database is ready for statewide use.

Existing law classifies certain controlled substances into designated schedules. Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by all practitioners authorized to prescribe or dispense these controlled substances. Existing law requires dispensing pharmacies and clinics to report specified information for each prescription of a Schedule II, Schedule III, or Schedule IV controlled substance to the department.

This bill would require all prescribers, as defined, prescribing a Schedule II or Schedule III controlled substance, and all dispensers, as defined, dispensing a Schedule II or Schedule III controlled substance, to consult a patients electronic history in the CURES database before prescribing or dispensing the controlled substance to the patient for the first time. The bill would also require the prescriber to consult the CURES database at least annually when the prescribed controlled substance remains part of the patients treatment. The bill would prohibit prescribing an additional Schedule II or Schedule III controlled substance to a patient with an existing prescription until the prescriber determines that there is a legitimate need for the controlled substance.

The bill would make the failure to consult a patients electronic history in the CURES database a cause for disciplinary action by the prescribers or dispensers licensing board and would require the respective licensing boards licensing boards to notify all licensees prescribers authorized to prescribe or dispense controlled substances of these requirements. The bill would provide that a prescriber or dispenser is not in violation of these requirements during any time that the CURES database is suspended or not accessible, or during any time that the Internet is not operational. The bill would make its provisions operative upon the Department of Justices certification that the CURES database is ready for statewide use.

Existing law classifies certain controlled substances into designated schedules. Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by all practitioners authorized to prescribe or dispense these controlled substances. Existing law requires dispensing pharmacies and clinics to report specified information for each prescription of a Schedule II, Schedule III, or Schedule IV controlled substance to the department, no more than 7 days after the controlled substance was dispensed.

This bill would specify that the dispensing pharmacies and clinics are required to report the specified information to the department no more than 7 business days after the controlled substance was dispensed.

 UNFINISHED BUSINESS  

Bill No: SB 482

Author: Lara (D)

Amended: 8/19/16

Vote: 21

SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 7-1, 4/27/15

AYES: Hill, Block, Galgiani, Hernandez, Jackson, Mendoza, Wieckowski

NOES: Bates

NO VOTE RECORDED: Berryhill

SENATE APPROPRIATIONS COMMITTEE: 5-2, 5/18/15

AYES: Lara, Beall, Hill, Leyva, Mendoza

NOES: Bates, Nielsen

SENATE FLOOR: 28-11, 5/28/15

AYES: Allen, Beall, Block, Cannella, De León, Galgiani, Glazer, Hall, Hancock, Hernandez, Hertzberg, Hill, Hueso, Jackson, Lara, Leno, Leyva, Liu, McGuire, Mendoza, Mitchell, Monning, Pavley, Roth, Runner, Vidak, Wieckowski, Wolk

NOES: Anderson, Bates, Berryhill, Fuller, Gaines, Huff, Moorlach, Morrell, Nguyen, Nielsen, Stone

NO VOTE RECORDED: Pan

ASSEMBLY FLOOR: 80-0, 8/24/16 - See last page for vote

SUBJECT: Controlled substances: CURES database

SOURCE: California Narcotic Officers’ Association

Consumer Attorneys of California

DIGEST: This bill requires a health care provider authorized to prescribe, order, administer, or furnish a controlled substance to consult the Controlled Substances Utilization Review and Evaluation System (CURES) prior to prescribing a Schedule II, III or IV drug to a patient for the first and at least once every four months thereafter if the substance remains part of the treatment of the patient.

Assembly Amendments add exemptions from the responsibility proposed in the bill to consult the CURES system, including while a patient is admitted to a certain type of facility, if a patient receives a non-refillable five-day supply or less prescription in conjunction with a surgery, and in the event of a technological failure or inability to access the CURES system. Amendments also clarify that regulatory boards under the Department of Consumer Affairs (DCA) that oversee practitioners who do not prescribe, order, administer, furnish, or dispense controlled substances shall not have access to CURES and also clarify that health care providers may share CURES data with the patient the provider receives information from the system about.

ANALYSIS:

Existing law:

1. 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)
2. Defines “opiate” as any substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having addiction-forming or addiction-sustaining liability. (Health and Safety Code (HSC) § 11020)
3. Classifies controlled substances in five schedules according to their danger and potential for abuse. (HSC § 11054-11058)
4. Prohibits any person other than a physician, dentist, podiatrist, veterinarian, naturopathic doctor (according to specific requirements outlined in their practice act), pharmacist (under certain circumstances), certified nurse-midwife (according to specific requirements outlined in their practice act), nurse practitioner (according to specific requirements outlined in their practice act), licensed optometrist, out-of-state prescriber acting in an emergency situation or certain health professionals (a pharmacist, registered nurse or physician assistant) acting within the scope of an experimental health workforce project authorized by the Office of Statewide Health Planning and Development (HSC § 128125 et seq) from writing or issuing a prescription for a controlled substance. (HSC § 11150)
5. Specifies that a prescription for a controlled substance shall only be issued for a legitimate medical purpose and establishes responsibility for proper prescribing on the prescribing practitioner. States that a violation shall result in imprisonment for up to one year or a fine of up to $20,000, or both. (HSC § 11153)
6. Establishes CURES for electronic monitoring of Schedule II, III and IV controlled substance prescriptions. CURES provides for the electronic transmission of Schedule II, III and IV controlled substance prescription information to the Department of Justice (DOJ) at the time prescriptions are dispensed. (HSC § 11165)
7. Provides that pharmacies or clinics, in filling a prescription for a federally Scheduled II, III or IV drug, shall provide weekly information to DOJ including 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. (HSC § 11165 (d))
8. Provides that a licensed health care practitioner eligible to prescribe Schedule II, III or IV controlled substances, or a pharmacist, shall apply to participate in the CURES Prescription Drug Monitoring Program (PDMP) by January 1, 2016. Authorizes DOJ to deny an application or suspend a subscriber for certain violations and falsifying information. 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, subject to provisions of the Confidentiality of Medical Information Act. (HSC § 11165.1)

This bill:

1. Requires prescribers (authorized to write prescriptions according to HSC Section 11150 outlined above) to access and consult CURES prior to prescribing a Schedule II, Schedule III or Schedule IV controlled substance for the first time to a patient and at least once every four months when that prescribed controlled substance remains part of the treatment. Provides that if the patient has an existing prescription for a Schedule II or Schedule III controlled substance, the health care practitioner shall not prescribe any additional controlled substances until the health care practitioner determines there is a legitimate need.
2. Provides that failure by a prescriber to consult CURES as specified above is cause for disciplinary action by the prescriber’s appropriate licensing board. Requires the licensing boards of all prescribers authorized to write or issue prescriptions for controlled substances to notify all authorized prescribers of the requirement for consulting CURES.
3. Provides that failure by a prescriber to consult CURES as specified above is cause for disciplinary action by the prescriber’s appropriate licensing board. Requires the licensing boards of all prescribers authorized to write or issue prescriptions for controlled substances to notify all authorized prescribers of the requirement for consulting CURES.
4. Provides that notwithstanding any other provision, a prescriber shall not be in violation of the requirements in this bill during any time period in which the CURES system is suspended or not accessible or the Internet is not operational. Delays implementation of the above provisions until the DOJ certifies that the CURES database is ready for statewide use.
5. Exempts the following from the requirement in 1) above:
6. A veterinarian
7. A pharmacist
8. A health care practitioner who prescribes, orders, administers, or furnishes a controlled substance in the emergency department of a general acute care hospital and the quantity of the controlled substance does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use
9. A health care practitioner who prescribes, orders, or furnishes a controlled substance to be administered to a patient while the patient is admitted to a licensed clinic, an outpatient setting as defined, a health facility as defined, and a county medical facility as defined
10. A health care practitioner who prescribes, orders, administers, or furnishes a controlled substance to a patient as part of the patient’s treatment for a surgical procedure and the quantity of the controlled substance does not exceed a nonrefillable five-day supply of the controlled substance to be used in accordance with the directions for use, in any of the facilities in d) above as well as a place of practice as defined
11. A health care practitioner who prescribes, orders, administers, or furnishes a controlled substance to a patient currently receiving hospice care
12. A health practitioner or their designee when it is not reasonably possible for a health care practitioner to access the information in CURES in a timely manner.
13. A health practitioner when the quantity of controlled substance prescribed, ordered, administered, or furnished does not exceed a nonrefillable five-day supply of the controlled substance to be used in accordance with the directions for use and no refill of the controlled substance is allowed.
14. A health practitioner who is not able to access CURES because it is not operational, as determined by DOJ, or when CURES cannot be accessed by a health care practitioner because of a temporary technological or electrical failure.
15. A health care practitioner if CURES cannot be accessed because of technological limitations that are not reasonably within his or her control.
16. A health care practitioner who determines that consulting CURES would result in a patient’s inability to obtain a prescription in a timely manner and thereby adversely impact the patient’s medical condition, provided that the quantity of the controlled substance does not exceed a nonrefillable five-day supply if the controlled substance were used in accordance with the directions for use
17. Provides that notwithstanding any other provision, a prescriber shall not be in violation of the requirements in this bill during any time period in which the CURES system is suspended or not accessible or the Internet is not operational. Delays implementation of the above provisions until the DOJ certifies that the CURES database is ready for statewide use.

Background

For the past number of years, abuse of prescription drugs (taking a prescription medication that is not prescribed for you, or taking it for reasons or in dosages other than as prescribed) to get high has become increasingly prevalent. Federal data for 2014 shows that in the past year, abuse of prescription pain killers now ranks second, just behind marijuana, as the nation’s most widespread illegal drug problem. 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. A 2013 Centers for Disease Control and Prevention (CDC) analysis found that drug overdose deaths increased for the 11th consecutive year in 2010 and prescription drugs, particularly opioid 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% of the overdose deaths in 2010, involved pharmaceutical drugs, with opioids associated with approximately 75% of these deaths. Nearly three out of four prescription drug overdoses are caused by opioid pain relievers.

With rising levels of abuse, PDMPs are a critical tool in assisting law enforcement and regulatory bodies with their efforts to reduce drug diversion. There are 49 states that currently have monitoring programs (Missouri is the only state currently without a PDMP). California has the oldest prescription drug monitoring program in the nation, CURES which 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 top drugs prescribed for a specific time period, drugs prescribed in a particular county, doctor prescribing data, pharmacy dispensing data, and is a critical tool for assessing whether multiple prescriptions for the same patient may exist. In addition to the Board of Pharmacy, CURES data can be obtained by the Medical Board of California, Dental Board of California, Board of Registered Nursing, Osteopathic Medical Board of California and Veterinary Medical Board.

The upgraded system, CURES 2.0, became operational in late 2015. The new interface has significantly improved timeframes for accessing information, navigating through the system and general usability. Licensees can apply directly within the web based system, a significant shortfall of the prior CURES which required applicants to submit notarized paper applications to DOJ. Prescribers and dispensers are able to easily generate patient activity reports and can securely send communications to one another about a mutual patient through the system. Through CURES 2.0, prescribers can receive daily informational alerts about patients who reach various prescribing thresholds, based on patterns indicative of at-risk patient behavior, which can be used to determine if action by the prescriber is necessary.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No

According to the Assembly Appropriations Committee, boards within DCA that license health professionals will incur likely minor and absorbable costs to notify licensees and enforce this bill’s requirements, as well as make any necessary information technology changes. The 2016-17 Budget provides $500,000 from the CURES Fund for additional user outreach and staffing support. There are no anticipated costs to DOJ.

SUPPORT: (Verified 8/24/16)

California Narcotic Officers’ Association (co-source)

Consumer Attorneys of California (co-source)

Acclamation Insurance Management Services

American Insurance Association

Blue Shield of California

California Chamber of Commerce

California Dental Association

California Pharmacists Association

California Teamsters

Center for Public Interest Law Children’s Advocacy Institute

Consumer Watchdog

National Alliance on Mental Illness

Pacific Business Group on Health

Peace Officers Research Association of California

PRIUM

Small Business California

Teamsters

OPPOSITION: (Verified 8/24/16)

Association of Northern California Oncologists

Doctor’s Company

The US Oncology Network

ASSEMBLY FLOOR: 80-0, 8/24/16

AYES: Achadjian, Alejo, Travis Allen, Arambula, Atkins, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Quirk, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Rendon

Prepared by: Sarah Mason / B., P. & E.D. / (916) 651-4104

8/30/16 14:38:11

**** END ****

SENATE THIRD READING

STR Bill Id:SB 482

Author:(Lara)

As Amended Ver:August 19, 2016

Majority vote

SENATE VOTE: 28-11

SUMMARY: Requires a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance to consult the Controlled Substance Utilization Review and Evaluation System (CURES) database before prescribing certain controlled substances, as specified. Specifically, this bill:

1. Authorizes a health care practitioner to provide a patient with a copy of the patient's CURES patient activity report as long as no additional CURES data is provided and keep a copy of the report in the patient's medical record if provided or kept in compliance with the Confidentiality of Medical Information Act, as specified.
2. Requires a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance to consult the CURES database to review a patient's controlled substance history before prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient for the first time and at least four months thereafter if the substance remains part of the treatment of the patient.
3. Defines "first time" to mean the initial occurrence in which a health care practitioner, in his or her role as a health care practitioner, intends to prescribe, order, administer, or furnish a Schedule II, Schedule III, or Schedule IV controlled substance to a patient and has not previously prescribed a controlled substance to the patient.
4. Requires a health care practitioner to obtain a patient's controlled substance history from the CURES database no earlier than 24 hours, or the previous business day, before he or she prescribes, orders, administers, or furnishes a Schedule II, Schedule III, or Schedule IV controlled substance to the patient.
5. Specifies that a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.
6. Exempts veterinarians and pharmacists from the duty to consult the CURES database.
7. Exempts health care practitioners from the duty to consult the CURES database in any of the following circumstances:
   1. If a health care practitioner prescribes, orders, or furnishes a controlled substance to be administered to a patient while the patient is admitted to any of the following facilities or during an emergency transfer between any of the following facilities for use while on facility premises:
      1. A clinic licensed under the Department of Public Health (DPH).
      2. An outpatient setting.
      3. A health facility, including acute care hospitals and skilled nursing facilities.
      4. A county medical facility.
   2. If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance in the emergency department of a general acute care hospital and the quantity of the controlled substance does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use.
   3. If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient currently receiving hospice care.
   4. If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient as part of the patient's treatment for a surgical procedure and the quantity of the controlled substance does not exceed a nonrefillable five-day supply of the controlled substance to be used in accordance with the directions for use, use in any of the following facilities:
      1. A clinic licensed under the Department of Public Health (DPH).
      2. An outpatient setting.
      3. A health facility, including acute care hospitals and skilled nursing facilities.
      4. A county medical facility.
      5. A dental place of practice.
   5. Any time all of the following specified circumstances are satisfied and requires a health care practitioner who does not consult the CURES database under the circumstances to document the reason he or she did not consult the database in the patient's medical record. The required circumstances are as follows:
      1. It is not reasonably possible for a health care practitioner to access the information in the CURES database in a timely manner.
      2. Another health care practitioner or designee authorized to access the CURES database is not reasonably available.
      3. The quantity of controlled substance prescribed, ordered, administered, or furnished does not exceed a nonrefillable five-day supply of the controlled substance to be used in accordance with the directions for use and no refill of the controlled substance is allowed.
   6. If the CURES database is not operational, as determined by the Department of Justice (DOJ), or when it cannot be accessed by a health care practitioner because of a temporary technological or electrical failure. Requires a health care practitioner to, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within his or her control.
   7. If the CURES database cannot be accessed because of technological limitations that are not reasonably within the control of a health care practitioner.
   8. If the CURES database cannot be accessed because it would result in a patient's inability to obtain a prescription in a timely manner, as specified.
8. Provides that, if a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance is not required to consult the CURES database the first time he or she prescribes, orders, administers, or furnishes a controlled substance to a patient pursuant to one of those exemptions, the health care practitioner shall consult the CURES database before subsequently prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient and at least once every four months thereafter if the substance remains part of the treatment of the patient.
9. Requires that a health care practitioner who fails to consult the CURES database, be referred to the appropriate state professional licensing board solely for administrative sanctions, as deemed appropriate by that board.
10. Provides that the requirement to consult the CURES database does not create a private cause of action against a health care practitioner.
11. Provides that the requirement does not limit a health care practitioner's liability for the negligent failure to diagnose or treat a patient.
12. Provides that the requirement is not operative until six months after the DOJ certifies that the CURES database is ready for statewide use and that the DOJ has adequate staff, as specified. Requires the DOJ to notify the Secretary of State and the office of the Legislative Counsel of the date of the certification.
13. States that all applicable state and federal privacy laws govern the duties required by this bill.
14. States that the provisions of this bill, once they become law, are severable. States that if any provision or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.
15. Makes technical and conforming changes.

FISCAL EFFECT: According to the Assembly Appropriations Committee:

1. Boards within the Department of Consumer Affairs that license health professionals will incur likely minor and absorbable costs to notify licensees and enforce the bill's requirements, as well as make any necessary information technology changes (various fee-supported special funds). The 2016-17 budget provides $500,000 from the CURES Fund for additional user outreach and staffing support.
2. No anticipated costs to the Department of Justice, who administers CURES. An upgrade to the CURES system was completed last year to address shortcomings in usability and reliability. The DOJ indicates the upgraded system is designed to accommodate high usage by prescribers and will be able to accommodate the projected demand if this bill is enacted.

COMMENTS:

Purpose. This bill is co-sponsored by the Consumer Attorneys of California and the California Narcotics Officers' Association. According to the author, "According to the Centers for Disease Control and Prevention, drug overdoses are the top cause of accidental death in the United States. Nearly 23,000 people died from an overdose of pharmaceuticals in 2013 nationally – more than 70% of them from opiate prescription painkillers. The CURES database is an invaluable investigative, preventative, and educational tool for law enforcement and the healthcare community. The current voluntary approach has not been able to attract sufficient participation to make it truly effective. SB 482 requires all prescribers to consult the CURES system before issuing Schedule II, III, and IV drugs. This will enable prescribers to make informed decisions about their patient's care and limit the number of people who doctor shop and over use prescription drugs."

Background. According to the United States Drug Enforcement Agency, drugs, substances, and certain chemicals used to make drugs are classified into five distinct categories or schedules depending upon the drug's acceptable medical use and the drug's abuse or dependency potential. Schedule I drugs have the highest potential for abuse while Schedule V is the lowest.

Prescription Drug Overdose Deaths. According to the Centers for Disease Control and Prevention (CDC), drug overdoses are the top cause of accidental deaths in the United States. Overdose deaths involving prescription opioids have quadrupled since 1999, as well as sales of these prescription drugs. Additionally, approximately 20% of prescribers prescribe 80% of all prescription painkillers.

In the years spanning 1999 to 2014, over 165,000 people died in the United States from overdoses related to prescription opioids. During this time period, overdose rates were highest among people age 25 to 54 years. Overdose rates were higher among non-Hispanic whites and American Indian or Alaskan Natives, compared to non-Hispanic blacks and Hispanics. In addition, men were more likely to die from overdose, but the mortality gap between men and women is closing.

CURES. In 1996, California enacted the first prescription monitoring drug program in the United States. According to the California Department of Justice, CURES is a database of Schedule II, III, and IV controlled substance prescriptions dispensed in California serving the public health, regulatory oversight agencies, and law enforcement. Access to CURES is limited to licensed prescribers and licensed pharmacists strictly for patients in their direct care; and regulatory board staff and law enforcement personnel for official oversight or investigatory purposes.

CURES receives about one million prescription records per week. The database contains approximately 400 million entries of controlled substance prescriptions dispensed in California. The system retains seven years of prescription data that is de-identified.

As of February 5, 2016, there were 74,258 registrants of the CURES system. All California licensed prescribers authorized to prescribe scheduled drugs are required to register for access to CURES version 2.0 by July 1, 2016, or upon issuance of a Drug Enforcement Administration Controlled Substance Registration Certificate, whichever occurs later. Licensed pharmacists must register for access to CURES 2.0 by July 1, 2016, or upon issuance of a Board of Pharmacy Pharmacist License, whichever occurs later (Health and Safety Code Section 11165.1). Use of CURES by prescribers and dispensers for prescription abuse prevention or intervention is voluntary.

Other States. Forty-nine states currently have prescription drug monitoring programs. Approximately 24 states have mandates for prescribers to check a state based prescription drug monitoring system (National Alliance for Model State Drug Laws, Reporting Requirements and Exemptions to Reporting, 2014).

Significantly improved public health outcomes have been seen in states that have required prescribers to check their drug monitoring systems. According to information obtained from the CDC, in 2012, Tennessee required prescribers to check the state's prescription drug monitoring program (PDMP) before prescribing painkillers. Within one year, there was a 36% decline in patients who were seeing multiple prescribers to obtain the same drugs. In Virginia, the number of doctor shoppers fell by 73% after use of the database became mandatory. In Oklahoma, which requires mandatory checks for methadone, overdose rates dropped approximately 21% in a single year.

There are current efforts to link PDMP systems nationwide. The National Association of Boards of Pharmacies (NABP) InterConnect system permits authorized PDMP users in participating states to access interstate data by logging directly into the state PDMP in which they are a registered user. Currently, 33 states, excluding California, have PDMPs that are linked to the NABP InterConnect system.

Analysis Prepared by: Le Ondra Clark Harvey Ph.D. / B. & P. / (916) 319-3301 FN: 0004683

SENATE THIRD READING

STR Bill Id:SB 482

Author:(Lara)

As Amended Ver:August 1, 2016

Majority vote

SENATE VOTE: 28-11

SUMMARY: This bill requires a health care practitioner, as specified, authorized to prescribe, order, administer, or furnish a controlled substance to consult the Controlled Substance Utilization Review and Evaluation System (CURES) database before prescribing certain controlled substances, as specified. Specifically, this bill:

1. Authorizes a health care practitioner to provide a patient with a copy of the patient's CURES patient activity report and keep a copy of the report in the patient's medical record if reasonable care has been taken to ensure that the report is provided or kept, as specified.
2. Requires a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance to consult the CURES database to review a patient's controlled substance history before prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient for the first time and at least four months thereafter if the substance remains part of the treatment of the patient.
3. Defines "first time" to mean the initial occurrence in which a health care practitioner, in his or her role as a health care practitioner, intends to prescribe, order, administer, or furnish a Schedule II, Schedule III, or Schedule IV controlled substance to a patient and has not previously prescribed a controlled substance to the patient.
4. Requires a health care practitioner to obtain a patient's controlled substance history from the CURES database no earlier than 24 hours, or the previous business day, before he or she prescribes, orders, administers, or furnishes a Schedule II, Schedule III, or Schedule IV controlled substance to the patient.
5. Exempts veterinarians from the duty to consult the CURES database.
6. Exempts health care practitioners from the duty to consult the CURES database in any of the following circumstances:
   1. If a health care practitioner prescribes, orders, or furnishes a controlled substance to be administered to a patient while the patient is admitted to any of the following facilities or during an emergency transfer between any of the following facilities for use while on facility premises:
      1. A clinic licensed under the Department of Public Health (DPH).
      2. An outpatient setting.
      3. A health facility, including acute care hospitals and skilled nursing facilities.
      4. A county medical facility.
   2. If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance in the emergency department of a general acute care hospital and the quantity of the controlled substance does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use.
   3. If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient currently receiving hospice care.
   4. If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient as part of the patient's treatment for a surgical procedure and the quantity of the controlled substance does not exceed a nonrefillable five-day supply of the controlled substance to be used in accordance with the directions for use, use in any of the following facilities:
      1. A clinic licensed under the Department of Public Health (DPH).
      2. An outpatient setting.
      3. A health facility, including acute care hospitals and skilled nursing facilities.
      4. A county medical facility.
      5. A dental place of practice.
   5. Any time all of the following specified circumstances are satisfied and requires a health care practitioner who does not consult the CURES database under the circumstances to document the reason he or she did not consult the database in the patient's medical record. The required circumstances are as follows:
      1. It is not reasonably possible for a health care practitioner to access the information in the CURES database in a timely manner.
      2. Another health care practitioner or designee authorized to access the CURES database is not reasonably available.
      3. The quantity of controlled substance prescribed, ordered, administered, or furnished does not exceed a nonrefillable five-day supply of the controlled substance to be used in accordance with the directions for use and no refill of the controlled substance is allowed.
   6. If the CURES database is not operational, as determined by the Department of Justice (DOJ), or when it cannot be accessed by a health care practitioner because of a temporary technological or electrical failure. Requires a health care practitioner to, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within his or her control.
   7. If the CURES database cannot be accessed because of technological limitations that are not reasonably within the control of a health care practitioner.
   8. If the CURES database cannot be accessed because of exceptional circumstances, as demonstrated by a health care practitioner.
7. Requires that a health care practitioner who knowingly fails to consult the CURES database, be referred to the appropriate state professional licensing board solely for administrative sanctions, as deemed appropriate by that board.
8. Provides that the requirement to consult the CURES database does not create a private cause of action against a health care practitioner.
9. Provides that the requirement does not limit a health care practitioner's liability for the negligent failure to diagnose or treat a patient.
10. Provides that the requirement is not operative until six months after the DOJ certifies that the CURES database is ready for statewide use. Requires the DOJ to notify the Secretary of State and the office of the Legislative Counsel of the date of the certification.
11. States that all applicable state and federal privacy laws govern the duties required by this bill.
12. States that the provisions of this bill, once they become law, are severable. States that if any provision or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.
13. Provides that, if a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance is not required to consult the CURES database the first time he or she prescribes, orders, administers, or furnishes a controlled substance to a patient pursuant to one of those exemptions, the health care practitioner shall consult the CURES database before subsequently prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient and at least once every four months thereafter if the substance remains part of the treatment of the patient.

FISCAL EFFECT: According to the Assembly Appropriations Committee:

1. Boards within the Department of Consumer Affairs that license health professionals will incur likely minor and absorbable costs to notify licensees and enforce the bill's requirements, as well as make any necessary information technology changes (various fee-supported special funds). The 2016-17 budget provides $500,000 from the CURES Fund for additional user outreach and staffing support.
2. No anticipated costs to the Department of Justice, who administers CURES. An upgrade to the CURES system was completed last year to address shortcomings in usability and reliability. The DOJ indicates the upgraded system is designed to accommodate high usage by prescribers and will be able to accommodate the projected demand if this bill is enacted.

COMMENTS:

Purpose. This bill is co-sponsored by the Consumer Attorneys of California and the California Narcotics Officers' Association. According to the author, "According to the Centers for Disease Control and Prevention, drug overdoses are the top cause of accidental death in the United States. Nearly 23,000 people died from an overdose of pharmaceuticals in 2013 nationally – more than 70% of them from opiate prescription painkillers. The CURES database is an invaluable investigative, preventative, and educational tool for law enforcement and the healthcare community. The current voluntary approach has not been able to attract sufficient participation to make it truly effective. SB 482 requires all prescribers to consult the CURES system before issuing Schedule II, III, and IV drugs. This will enable prescribers to make informed decisions about their patient's care and limit the number of people who doctor shop and over use prescription drugs."

Background. According to the United States Drug Enforcement Agency, drugs, substances, and certain chemicals used to make drugs are classified into five distinct categories or schedules depending upon the drug's acceptable medical use and the drug's abuse or dependency potential. Schedule I drugs have the highest potential for abuse while Schedule V is the lowest.

Prescription Drug Overdose Deaths. According to the Centers for Disease Control and Prevention (CDC), drug overdoses are the top cause of accidental deaths in the United States. Overdose deaths involving prescription opioids have quadrupled since 1999, as well as sales of these prescription drugs. Additionally, approximately 20% of prescribers prescribe 80% of all prescription painkillers.

In the years spanning 1999 to 2014, over 165,000 people died in the United States from overdoses related to prescription opioids. During this time period, overdose rates were highest among people age 25 to 54 years. Overdose rates were higher among non-Hispanic whites and American Indian or Alaskan Natives, compared to non-Hispanic blacks and Hispanics. In addition, men were more likely to die from overdose, but the mortality gap between men and women is closing.

CURES. In 1996, California enacted the first prescription monitoring drug program in the United States. According to the California Department of Justice, CURES is a database of Schedule II, III, and IV controlled substance prescriptions dispensed in California serving the public health, regulatory oversight agencies, and law enforcement. Access to CURES is limited to licensed prescribers and licensed pharmacists strictly for patients in their direct care; and regulatory board staff and law enforcement personnel for official oversight or investigatory purposes.

CURES receives about one million prescription records per week. The database contains approximately 400 million entries of controlled substance prescriptions dispensed in California. The system retains seven years of prescription data that is de-identified.

As of February 5, 2016, there were 74, 258 registrants of the CURES system. All California licensed prescribers authorized to prescribe scheduled drugs are required to register for access to CURES version 2.0 by July 1, 2016, or upon issuance of a Drug Enforcement Administration Controlled Substance Registration Certificate, whichever occurs later. Licensed pharmacists must register for access to CURES 2.0 by July 1, 2016, or upon issuance of a Board of Pharmacy Pharmacist License, whichever occurs later (Health and Safety Code Section 11165.1). Use of CURES by prescribers and dispensers for prescription abuse prevention or intervention is voluntary.

Other States. Forty-nine states currently have prescription drug monitoring programs. Approximately 24 states have mandates for prescribers to check a state based prescription drug monitoring system (National Alliance for Model State Drug Laws, Reporting Requirements and Exemptions to Reporting, 2014).

Significantly improved public health outcomes have been seen in states that have required prescribers to check their drug monitoring systems. According to information obtained from the CDC, in 2012, Tennessee required prescribers to check the state's prescription drug monitoring program (PDMP) before prescribing painkillers. Within one year, there was a 36% decline in patients who were seeing multiple prescribers to obtain the same drugs. In Virginia, the number of doctor shoppers fell by 73% after use of the database became mandatory. In Oklahoma, which requires mandatory checks for methadone, overdose rates dropped approximately 21% in a single year.

There are current efforts to link PDMP systems nationwide. The National Association of Boards of Pharmacies (NABP) InterConnect system permits authorized PDMP users in participating states to access interstate data by logging directly into the state PDMP in which they are a registered user. Currently, 33 states, excluding California, have PDMPs that are linked to the NABP InterConnect system.

Analysis Prepared by: Le Ondra Clark Harvey Ph.D. / B. & P. / (916) 319-3301 FN: 0003857

Date of Hearing: August 3, 2016

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez, Chair

SBPCA Bill Id:SB 482

Author:(Lara) – As Amended Ver:August 1, 2016

Urgency: No State Mandated Local Program: No Reimbursable: No

SUMMARY:

This bill requires a health care practitioner, as specified, authorized to prescribe, order, administer, or furnish a controlled substance to consult the Controlled Substance Utilization Review and Evaluation System (CURES) database before prescribing specified controlled substances. It also:

1. Requires health care practitioners to check CURES upon initial prescriptions, and regularly as long as the controlled substances continue to be prescribed, as well as no earlier than 24 hours before the prescribing or furnishing.
2. Specifies liability provisions, including provisions that: (a) protect health care practitioners from liability related to false, incomplete, or inaccurate information contained in the CURES database; (b) specify it does not limit liability for negligent failure to diagnose and treat a patient; and (c) specify it does not create a private cause of action.
3. Contains a number of exemptions from the bill’s requirements, including based on specified circumstances, quantities of drugs, and type of practitioner (for instance, it excludes medication dispensed during emergency transport, medication dispensed by veterinarians, and medication administered to patients in hospice care, as defined).
4. Specifies a practitioner who knowingly fails to consult the CURES database must be referred to the appropriate state professional licensing board solely for administrative sanctions, as deemed appropriate by that board.
5. Allow health care practitioners to provide a copy of the patient's CURES patient activity report, as long as reasonable care is used to comply with medical confidentiality laws.

FISCAL EFFECT:

1. Boards within the Department of Consumer Affairs that license health professionals will incur likely minor and absorbable costs to notify licensees and enforce the bill's requirements, as well as make any necessary information technology changes (various fee-supported special funds). The 2016-17 budget provides $500,000 from the CURES Fund for additional user outreach and staffing support.
2. No anticipated costs to the Department of Justice, who administers CURES. An upgrade to the CURES system was completed last year to address shortcomings in usability and reliability. The DOJ indicates the upgraded system is designed to accommodate high usage by prescribers and will be able to accommodate the projected demand if this bill is enacted.

COMMENTS:

1. Purpose. This bill is co-sponsored by the Consumer Attorneys of California and the California Narcotics Officers’ Association, who indicate the current voluntary approach has not been able to attract sufficient participation to make use of CURES truly effective for preventing prescription drug abuse. This bill, by requiring providers to consult the CURES system, is intended to enable prescribers to make informed decisions about their patient’s care and to limit the number of people who doctor-shop and overuse prescription drugs.
2. Background. Under current law, the DOJ manages CURES, a system used to track prescriptions of Schedule II, III, and IV drugs—generally, drugs accepted for medical use with moderate to significant potential for addiction or abuse. Pharmacies are required to submit information on those prescriptions when they are dispensed. Prescribers, law enforcement personnel, and regulatory agencies are authorized to access CURES. For example, a physician can access CURES to review whether a patient has already been prescribed controlled substances before issuing a new prescription.
3. Prior Legislation. SB 809 (DeSaulnier, Statutes of 2013) raised licensing fees on health care providers by $6 to fund CURES and required health care providers who can prescribe or furnish controlled substances to apply for access to CURES by January 1, 2016.
4. Support. In addition to the co-sponsors, this bill is supported by the American Insurance Association, California Chamber of Commerce, California Teamsters Public Affairs Council, Center for Public Interest Law, Consumer Watchdog, National Alliance on Mental Illness, and ShatterProof – a national organization committed to preventing and ending stigma related to prescription drug and alcohol addiction.
5. Opposition. The California Medical Association (CMA) is opposed to this bill unless amended. CMA cites a number of issues related to the bill, and to implementation and administration of CURES more generally. Requested amendments include, among others, allowing a third party to make a determination of readiness before the bill is implemented and the creation of additional parameters around access to CURES among other entities, such as governmental entities.

CMA also noted the prior version of the bill created a conflict around information privacy, whereby the bill would have potentially lead providers to use CURES information to make treatment decisions that must be recorded in a medical record that is accessible to the patient, which conflicts with an interpretation of current law that prohibits a clinician from sharing with a patient such information. The author has recently amended this bill (see provision 5 in the summary) to address this issue.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

 THIRD READING  

Bill No: SB 482

Author: Lara (D)

Amended: 4/30/15

Vote: 21

SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 7-1, 4/27/15

AYES: Hill, Block, Galgiani, Hernandez, Jackson, Mendoza, Wieckowski

NOES: Bates

NO VOTE RECORDED: Berryhill

SENATE APPROPRIATIONS COMMITTEE: 5-2, 5/18/15

AYES: Lara, Beall, Hill, Leyva, Mendoza

NOES: Bates, Nielsen

SUBJECT: Controlled substances: CURES database

SOURCE: California Narcotic Officers’ Association

Consumer Attorneys of California

DIGEST: This bill requires prescribers to consult the Controlled Substances Utilization Review and Evaluation System (CURES) prior to prescribing a Schedule II or III drug to a patient for the first time and delays implementation of this requirement until the Department of Justice (DOJ) certifies that the CURES database is ready for statewide use.

ANALYSIS:

Existing law:

1. 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)

2. Defines “opiate” as any substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having addiction-forming or addiction-sustaining liability. (Health and Safety Code (HSC) § 11020)

3. Classifies controlled substances in five schedules according to their danger and potential for abuse. (HSC § 11054-11058)

4. Prohibits any person other than a physician dentist, podiatrist, veterinarian, naturopathic doctor (according to specific requirements outlined in their practice act), pharmacist (under certain circumstances), certified nurse-midwife (according to specific requirements outlined in their practice act), nurse practitioner (according to specific requirements outlined in their practice act), licensed optometrist, out-of-state prescriber acting in an emergency situation or certain health professionals (a pharmacist, registered nurse or physician assistant) acting within the scope of an experimental health workforce project authorized by the Office of Statewide Health Planning and Development (HSC § 128125 et seq) from writing or issuing a prescription for a controlled substance. (HSC § 11150)

5. Specifies that a prescription for a controlled substance shall only be issued for a legitimate medical purpose and establishes responsibility for proper prescribing on the prescribing practitioner. States that a violation shall result in imprisonment for up to one year or a fine of up to $20,000, or both. (HSC § 11153)

6. Establishes CURES for electronic monitoring of Schedule II, III and IV controlled substance prescriptions. CURES provides for the electronic transmission of Schedule II, III and IV controlled substance prescription information to DOJ at the time prescriptions are dispensed. (HSC § 11165)

7. Provides that pharmacies or clinics, in filling a prescription for a federally Scheduled II, III or IV drug, shall provide weekly information to DOJ including 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. (HSC § 11165 (d))

8. Provides that a licensed health care practitioner eligible to prescribe Schedule II, III or IV controlled substances, or a pharmacist, shall apply to participate in the CURES Prescription Drug Monitoring Program (PDMP) by January 1, 2016. Authorizes DOJ to deny an application or suspend a subscriber for certain violations and falsifying information. 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, subject to provisions of the Confidentiality of Medical Information Act. (HSC § 11165.1)

This bill:

1. Requires prescribers (authorized to write prescriptions according to HSC Section 11150 outlined above, excluding veterinarians) to access and consult CURES prior to prescribing a Schedule II or Schedule III controlled substance for the first time to a patient and at least annually when that prescribed controlled substance remains part of the treatment. Provides that if the patient has an existing prescription for a Schedule II or Schedule III controlled substance, the health care practitioner shall not prescribe any additional controlled substances until the health care practitioner determines there is a legitimate need.

2. Provides that failure by a prescriber to consult CURES as specified above is cause for disciplinary action by the prescriber’s appropriate licensing board. Requires the licensing boards of all prescribers authorized to write or issue prescriptions for controlled substances to notify all authorized prescribers of the requirement for consulting CURES.

3. Provides that notwithstanding any other provision, a prescriber shall not be in violation of the requirements in this bill during any time period in which the CURES system is suspended or not accessible or the Internet is not operational. Delays implementation of the above provisions until the DOJ certifies that the CURES database is ready for statewide use.

Background

For the past number of years, abuse of prescription drugs (taking a prescription medication that is not prescribed for you, or taking it for reasons or in dosages other than as prescribed) to get high has become increasingly prevalent. Federal data for 2014 shows that in the past year, abuse of prescription pain killers now ranks second, just behind marijuana, as the nation’s most widespread illegal drug problem. 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. A 2013 Centers for Disease Control and Prevention (CDC) analysis found that drug overdose deaths increased for the 11th consecutive year in 2010 and prescription drugs, particularly opioid 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% of the overdose deaths in 2010, involved pharmaceutical drugs, with opioids associated with approximately 75% of these deaths. Nearly three out of four prescription drug overdoses are caused by opioid pain relievers.

With rising levels of abuse, PDMPs are a critical tool in assisting law enforcement and regulatory bodies with their efforts to reduce drug diversion. There are 49 states that currently have monitoring programs (Missouri is the only state currently without a PDMP). California has the oldest prescription drug monitoring program in the nation, CURES which 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 top drugs prescribed for a specific time period, drugs prescribed in a particular county, doctor prescribing data, pharmacy dispensing data, and is a critical tool for assessing whether multiple prescriptions for the same patient may exist. In addition to the Board of Pharmacy, CURES data can be obtained by the Medical Board of California, Dental Board of California, Board of Registered Nursing, Osteopathic Medical Board of California and Veterinary Medical Board. DOJ is currently in the process of modernizing CURES to more efficiently serve prescribers, pharmacists and entities that may utilize the data contained within the system and expects that the new CURES 2.0 system will be operational on July 1, 2015.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No

According to the Senate Appropriations Committee:

• No significant costs are anticipated by DOJ. DOJ has almost completed a substantial upgrade to CURES and anticipates that by July 2015 CURES will have the capability to meet the demand expected due to this bill.

• Minor costs to the relevant boards that license prescribers, such as the Medical Board of California, the Osteopathic Medical Board, and the Dental Board. Licensing boards will incur some additional cost to notify their licensees of the new requirement to check CURES. Those costs are expected to be minor for the impacted boards.

SUPPORT: (Verified 5/20/15)

California Narcotic Officers’ Association (co-source)

Consumer Attorneys of California (co-source)

Association for Los Angeles Deputy Sheriffs

California Association of Code Enforcement Officers

California Chamber of Commerce

California College and University Police Chiefs Association

California Conference Board of the Amalgamated Transit Union

California Conference of Machinists

California Congress of Seniors

California Correctional Supervisors Organization

California Teamsters Public Affairs Council

Consumer Federation of California

Consumer Watchdog

Engineers and Scientists of California, IFPTE Local 20, AFL-CIO

International Faith Based Coalition

International Longshore and Warehouse Union

Los Angeles Police Protective League

Pacific Compensation Insurance Company

Professional and Technical Engineers, IFPTE Local 21, AFL-CIO

Riverside Sheriffs Organization

Union of American Physicians and Dentists

UNITE-HERE, AFL-CIO

Utility Workers Union of America

OPPOSITION: (Verified 5/20/15)

Association of Northern California Oncologists

California Chapter of American Emergency Room Physicians

California Dental Association

California Medical Association

The Doctor’s Company

ARGUMENTS IN SUPPORT: Supporters believe that the CURES database is an effective reference point in assuring that a patient is not engaged in prescription drug abuse and that this bill will save lives.

ARGUMENTS IN OPPOSITION: Opponents believe that this bill will create an unnecessary regulatory burden to prescribing and increase the threat of litigation, both of which would have a detrimental impact on patient care while adding limited value to addressing prescription drug abuse. Opponents argue that the mandate in this bill will fall disproportionately on patients with a legitimate medical issue and that once a functional CURES system is in place, the mandates imposed by this bill will not be necessary, as physicians support the CURES database and want to have it as a tool in their clinical practice.

Prepared by: Sarah Mason / B., P. & E.D. / (916) 651-4104

5/21/15 9:16:48

**** END ****

 THIRD READING 

Bill No: SB 482

Author: Lara (D)

Amended: 4/30/15

Vote: 21

SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 7-1, 4/27/15

AYES: Hill, Block, Galgiani, Hernandez, Jackson, Mendoza, Wieckowski

NOES: Bates

NO VOTE RECORDED: Berryhill

SENATE APPROPRIATIONS COMMITTEE: 5-2, 5/18/15

AYES: Lara, Beall, Hill, Leyva, Mendoza

NOES: Bates, Nielsen

SUBJECT: Controlled substances: CURES database

SOURCE: California Narcotic Officers’ Association

Consumer Attorneys of California

DIGEST: This bill requires prescribers to consult the Controlled Substances Utilization Review and Evaluation System (CURES) prior to prescribing a Schedule II or III drug to a patient for the first time and delays implementation of this requirement until the Department of Justice (DOJ) certifies that the CURES database is ready for statewide use.

ANALYSIS:

Existing law:

1. 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)

2. Defines “opiate” as any substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having addiction-forming or addiction-sustaining liability. (Health and Safety Code (HSC) § 11020)

3. Classifies controlled substances in five schedules according to their danger and potential for abuse. (HSC § 11054-11058)

4. Prohibits any person other than a physician dentist, podiatrist, veterinarian, naturopathic doctor (according to specific requirements outlined in their practice act), pharmacist (under certain circumstances), certified nurse-midwife (according to specific requirements outlined in their practice act), nurse practitioner (according to specific requirements outlined in their practice act), licensed optometrist, out-of-state prescriber acting in an emergency situation or certain health professionals (a pharmacist, registered nurse or physician assistant) acting within the scope of an experimental health workforce project authorized by the Office of Statewide Health Planning and Development (HSC § 128125 et seq) from writing or issuing a prescription for a controlled substance. (HSC § 11150)

5. Specifies that a prescription for a controlled substance shall only be issued for a legitimate medical purpose and establishes responsibility for proper prescribing on the prescribing practitioner. States that a violation shall result in imprisonment for up to one year or a fine of up to $20,000, or both. (HSC § 11153)

6. Establishes CURES for electronic monitoring of Schedule II, III and IV controlled substance prescriptions. CURES provides for the electronic transmission of Schedule II, III and IV controlled substance prescription information to DOJ at the time prescriptions are dispensed. (HSC § 11165)

7. Provides that pharmacies or clinics, in filling a prescription for a federally Scheduled II, III or IV drug, shall provide weekly information to DOJ including 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. (HSC § 11165 (d))

8. Provides that a licensed health care practitioner eligible to prescribe Schedule II, III or IV controlled substances, or a pharmacist, shall apply to participate in the CURES Prescription Drug Monitoring Program (PDMP) by January 1, 2016. Authorizes DOJ to deny an application or suspend a subscriber for certain violations and falsifying information. 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, subject to provisions of the Confidentiality of Medical Information Act. (HSC § 11165.1)

This bill:

1. Requires prescribers (authorized to write prescriptions according to HSC Section 11150 outlined above, excluding veterinarians) to access and consult CURES prior to prescribing a Schedule II or Schedule III controlled substance for the first time to a patient and at least annually when that prescribed controlled substance remains part of the treatment. Provides that if the patient has an existing prescription for a Schedule II or Schedule III controlled substance, the health care practitioner shall not prescribe any additional controlled substances until the health care practitioner determines there is a legitimate need.

2. Provides that failure by a prescriber to consult CURES as specified above is cause for disciplinary action by the prescriber’s appropriate licensing board. Requires the licensing boards of all prescribers authorized to write or issue prescriptions for controlled substances to notify all authorized prescribers of the requirement for consulting CURES.

3. Provides that notwithstanding any other provision, a prescriber shall not be in violation of the requirements in this bill during any time period in which the CURES system is suspended or not accessible or the Internet is not operational. Delays implementation of the above provisions until the DOJ certifies that the CURES database is ready for statewide use.

Background

For the past number of years, abuse of prescription drugs (taking a prescription medication that is not prescribed for you, or taking it for reasons or in dosages other than as prescribed) to get high has become increasingly prevalent. Federal data for 2014 shows that in the past year, abuse of prescription pain killers now ranks second, just behind marijuana, as the nation’s most widespread illegal drug problem. 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. A 2013 Centers for Disease Control and Prevention (CDC) analysis found that drug overdose deaths increased for the 11th consecutive year in 2010 and prescription drugs, particularly opioid 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% of the overdose deaths in 2010, involved pharmaceutical drugs, with opioids associated with approximately 75% of these deaths. Nearly three out of four prescription drug overdoses are caused by opioid pain relievers.

With rising levels of abuse, PDMPs are a critical tool in assisting law enforcement and regulatory bodies with their efforts to reduce drug diversion. There are 49 states that currently have monitoring programs (Missouri is the only state currently without a PDMP). California has the oldest prescription drug monitoring program in the nation, CURES which 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 top drugs prescribed for a specific time period, drugs prescribed in a particular county, doctor prescribing data, pharmacy dispensing data, and is a critical tool for assessing whether multiple prescriptions for the same patient may exist. In addition to the Board of Pharmacy, CURES data can be obtained by the Medical Board of California, Dental Board of California, Board of Registered Nursing, Osteopathic Medical Board of California and Veterinary Medical Board. DOJ is currently in the process of modernizing CURES to more efficiently serve prescribers, pharmacists and entities that may utilize the data contained within the system and expects that the new CURES 2.0 system will be operational on July 1, 2015.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No

According to the Senate Appropriations Committee:

• No significant costs are anticipated by DOJ. DOJ has almost completed a substantial upgrade to CURES and anticipates that by July 2015 CURES will have the capability to meet the demand expected due to this bill.

• Minor costs to the relevant boards that license prescribers, such as the Medical Board of California, the Osteopathic Medical Board, and the Dental Board. Licensing boards will incur some additional cost to notify their licensees of the new requirement to check CURES. Those costs are expected to be minor for the impacted boards.

SUPPORT: (Verified 5/20/15)

California Narcotic Officers’ Association (co-source)

Consumer Attorneys of California (co-source)

Association for Los Angeles Deputy Sheriffs

California Association of Code Enforcement Officers

California Chamber of Commerce

California College and University Police Chiefs Association

California Conference Board of the Amalgamated Transit Union

California Conference of Machinists

California Congress of Seniors

California Correctional Supervisors Organization

California Teamsters Public Affairs Council

Consumer Federation of California

Consumer Watchdog

Engineers and Scientists of California, IFPTE Local 20, AFL-CIO

International Faith Based Coalition

International Longshore and Warehouse Union

Los Angeles Police Protective League

Pacific Compensation Insurance Company

Professional and Technical Engineers, IFPTE Local 21, AFL-CIO

Riverside Sheriffs Organization

Union of American Physicians and Dentists

UNITE-HERE, AFL-CIO

Utility Workers Union of America

OPPOSITION: (Verified 5/21/15)

Association of Northern California Oncologists

CalDerm

California Chapter of American Emergency Room Physicians

California Dental Association

California Medical Association

The Doctor’s Company

ARGUMENTS IN SUPPORT: Supporters believe that the CURES database is an effective reference point in assuring that a patient is not engaged in prescription drug abuse and that this bill will save lives.

ARGUMENTS IN OPPOSITION: Opponents believe that this bill will create an unnecessary regulatory burden to prescribing and increase the threat of litigation, both of which would have a detrimental impact on patient care while adding limited value to addressing prescription drug abuse. Opponents argue that the mandate in this bill will fall disproportionately on patients with a legitimate medical issue and that once a functional CURES system is in place, the mandates imposed by this bill will not be necessary, as physicians support the CURES database and want to have it as a tool in their clinical practice.

Prepared by: Sarah Mason / B., P. & E.D. / (916) 651-4104

5/21/15 16:22:59

**** END ****

SENATE COMMITTEE ON APPROPRIATIONS

Senator Ricardo Lara, Chair

2015 - 2016 Regular Session

SB 482 (Lara) - Controlled substances: CURES database

This bill does not meet the criteria for referral to the Suspense File.

Bill Summary:

SB 482 would require prescribers to consult the Controlled Substances Utilization Review and Evaluation System (CURES) prior to prescribing a Schedule II or III drug to a patient for the first time.

Fiscal Impact:

• No significant costs are anticipated by the Department of Justice. The Department has almost completed a substantial upgrade to CURES and anticipates that by July 2015 the system will have the capability to meet the demand expected due to this bill.

• Minor costs to the relevant boards that license prescribers, such as the Medical Board of California, the Osteopathic Medical Board, and the Dental Board. Licensing boards will incur some additional cost to notify their licensees of the new requirement to check CURES. Those costs are expected to be minor for the impacted boards.

Background:

Under current law, the California Department of Justice manages the Controlled Substances Utilization Review and Evaluation System (CURES). This system is used to track prescriptions of Schedule II, III, and IV drugs. Pharmacies are required to submit information on those prescriptions when they are dispensed. Prescribers (such as physicians), law enforcement personnel, and regulatory agencies are authorized to access CURES. For example, a physician (who has been approved by the Department of Justice) can access CURES to review whether a patient has already been prescribed controlled substances before issuing a new prescription.

SB 809 (DeSaulnier, Statutes of 2013) raised licensing fees on health care providers by $6 to fund CURES and requires health care providers who can prescribe or furnish controlled substances to apply for access to CURES by January 1, 2016. In addition, CURES is currently being upgraded to address shortcomings in usability and reliability, at a cost of $3.4 million. This upgrade is scheduled to be complete by July 2015. The Department of Justice indicates that the upgraded system is designed to accommodate high usage by prescribers and will be able to accommodate the increased demand if this bill is enacted.

Proposed Law:

SB 482 would require prescribers to consult the Controlled Substances Utilization Review and Evaluation System (CURES) prior to prescribing a Schedule II or III drug to a patient for the first time and annually when the controlled substance remains part of the treatment.

Other provisions of the bill would:

• If a patient has an existing prescription for a Schedule II or III drug, prohibit the prescriber from prescribing an additional controlled substance until the prescriber determines that there is a legitimate need for that controlled substance;

• Make failure to consult CURES a cause for disciplinary action by the prescriber’s licensing board;

• Require licensing boards to notify prescribers of this requirement;

• Provide that failure to access CURES when the system is inaccessible is not a violation of the requirements of the bill;

• Make the requirements of the bill inoperative until the Department of Justice determines CURES is ready for statewide use.

Related Legislation:

• AB 611 (Dahle) would authorize an individual designated to investigate a holder of a professional license to apply for access to CURES, for the purpose of investigating a licensee. That bill was held in the Assembly Business and Professions Committee.

• SB 1258 (DeSaulnier, 2014) would have made a variety of changes to the ways that controlled substances are prescribed and tracked in CURES and would have placed other requirements on prescribing controlled substances. That bill was held on this committee’s Suspense File.

-- END --

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Jerry Hill, Chair

2015 - 2016 Regular

Bill No: SB 482 Hearing Date: April 27, 2015

Subject: Controlled substances: CURES database.

SUMMARY: Requires prescribers to consult the Controlled Substances Utilization Review and Evaluation System (CURES) prior to prescribing a Schedule II or III drug to a patient for the first time and requires a dispenser to consult the CURES system prior to dispensing a Schedule II or III drug to patient for the first time. Delays implementation of the above provisions until the Department of Justice certifies that the CURES database is ready for statewide use.

Existing law, the Business and Professions Code (BPC):

1. Establishes the Medical Practice Act which provides for the licensing and regulation of physicians and surgeons by the Medial Board of California (MBC) within the Department of Consumer Affairs (DCA).

2. Establishes the Dental Practice Act which provides for the licensing and regulation of dentists by the Dental Board of California within DCA.

3. Establishes the Veterinary Medicine Practice Act which provides for the licensing and regulation of veterinarians and registered veterinary technicians by the Veterinary Medical Board within DCA.
   
   

4. Establishes the Nursing Practice Act which provides for the certification and regulation of registered nurses, nurse practitioners and advanced practice nurses by the Board of Registered Nursing within DCA.

4. Provides that a certified nurse-midwife may furnish or order drugs or devices, including controlled substances, if furnished or ordered incidentally to the provision of family planning services, routine health care or perinatal care, or care rendered consistent with the certified nurse-midwife’s practice; occurs under physician and surgeon supervision; and is in accordance with standardized procedures or protocols as specified. (BPC § 2746.51)
   
   

5. Provides that a nurse practitioner may furnish or order drugs or devices, including controlled substances, if it is consistent with a nurse practitioner’s educational preparation or for which clinical competency has been established and maintained; occurs under physician and surgeon supervision; and is in accordance with standardized procedures or protocols as specified. (BPC § 2836.1)

4. Establishes the Physician Assistant Practice Act which provides for the licensing of physician assistants by the Physician Assistant Committee, under the MBC, within the DCA.

4. Provides that a physician assistant while under the supervision of a physician and surgeon may administer or provide medication to a patient, or transmit orally or in writing a drug order under specified conditions and protocols adopted by the supervising physician and surgeon. (BPC § 3502.1)

4. Establishes the Osteopathic Act which provides for the licensing and regulation of osteopathic physicians and surgeons by the Osteopathic MBC within the DCA.

4. Establishes the Naturopathic Doctors Act which provides for the licensing of naturopathic doctors by the Naturopathic Medicine Committee within the Osteopathic Medical Board of California within the DCA.

4. Establishes the Optometry Practice Act which provides for the licensure of optometrists by the California State Board of Optometry within the DCA.

4. Establishes the Podiatric Act which provides for the licensure of doctors of podiatric medicine by the California Board of Podiatric Medicine within the DCA.

4. Establishes the Pharmacy Law which provides for the licensure and regulation of pharmacies, pharmacists and wholesalers of dangerous drugs or devices by the Board of Pharmacy within the DCA.

4. Defines “dispense” as the furnishing of drugs or devices upon a prescription from a physician, dentist, optometrist, podiatrist, veterinarian, or naturopathic doctor or upon an order to furnish drugs or transmit a prescription from a certified nurse-midwife, nurse practitioner, physician assistant, naturopathic doctor, or pharmacist acting within the scope of his or her practice. Dispense also means and refers to the furnishing of drugs or devices directly to a patient by a physician, dentist, optometrist, podiatrist, or veterinarian, or by a certified nurse-midwife, nurse practitioner, naturopathic doctor, or physician assistant acting within the scope of his or her practice. (BPC § 4024)

4. 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. (BPC § 4059)

Existing law, the Health and Safety Code (HSC), establishes the California Uniform Controlled Substances Act which regulates controlled substances.
(HSC § 11000 et seq.)

1. Defines “dispense” to deliver a controlled substance to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing, furnishing, packaging, labeling, or compounding necessary to prepare the substance for that delivery and “dispenser” as a practitioner who dispenses. (HSC §§ 11010 and 11011)

2. Defines “drug” as:

1. Substances recognized as drugs in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them.

2. Substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals.

3. Substances (other than food) intended to affect the structure or any function of the body of man or animals. (Health and Safety Code (HSC) § 11014)

3. Defines “opiate” as any substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having addiction-forming or addiction-sustaining liability. (HSC § 11020)

4. Defines “practitioner” as a physician, dentist, veterinarian, podiatrist, or pharmacist, registered nurse or physician assistant acting within the scope of an experimental health workforce projects authorized by the Office of Statewide Health Planning and Development (HSC § 128125 et seq.), a certified nurse-midwife according to BPC provisions outlined above, a nurse practitioner according to BPC provisions outlined above, a physician assistant according to BPC provisions outlined above, or an optometrist licensed under the Optometry Practice Act. Includes in the definition of “practitioner” a pharmacy, hospital, or other institution licensed, registered, or otherwise permitted to distribute, dispense, conduct research with respect to, or to administer, a controlled substance in the course of professional practice or research in this state. Also includes in the definition of “practitioner” a scientific investigator, or other person licensed, registered, or otherwise permitted, to distribute, dispense, conduct research with respect to, or administer, a controlled substance in the course of professional practice or research in this state. (BPC § 11026)

5. Classifies controlled substances in five schedules according to their danger and potential for abuse. (HSC § 11054-11058)

6. Prohibits any person other than a physician, dentist, podiatrist, veterinarian, naturopathic doctor (according to BPC provisions outlined above), pharmacist (according to BPC provisions above), certified nurse-midwife (according to BPC provisions outlined above), nurse practitioner (according to BPC provisions above) ; a pharmacist or registered nurse or physician assistant acting within the scope of an experimental health workforce project authorized by the Office of Statewide Health Planning and Development (HSC § 128125 et seq.); an optometrist licensed under the Optometry Practice Act., or an out-of-state prescriber acting in an emergency situation from writing or issuing a prescription for a controlled substance.
   (HSC § 11150)

7. Specifies that a prescription for a controlled substance shall only be issued for a legitimate medical purpose and establishes responsibility for proper prescribing on the prescribing practitioner. States that a violation shall result in imprisonment for up to one year or a fine of up to $20,000, or both. (HSC § 11153)

8. Requires special prescription forms for controlled substances to be obtained from security printers approved by DOJ, establishes certain criteria for features on the forms and requires controlled substance prescriptions to be made on the specified form. (HSC §§ 11161.5, 11162.1, 11164)

9. Establishes the Controlled Substances Utilization Review and Evaluation System (CURES) for electronic monitoring of Schedule II, III and IV controlled substance prescriptions. The CURES provides for the electronic transmission of Schedule II, III and IV controlled substance prescription information to the Department of Justice (DOJ) at the time prescriptions are dispensed. (HSC § 11165)

10. 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. (HSC § 11165 (a))

11. Establishes privacy protections for patient data and specifies that CURES data can only be accessed by appropriate state, local and federal persons or public agencies for disciplinary, civil or criminal actions. Specifies that CURES data 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. Authorizes non-identifying CURES data to be provided to public and private entities for education, research, peer review and statistical analysis. (HSC § 11165 (c))

12. Provides that pharmacies or clinics, in filling a prescription for a federally Scheduled II, III or IV drug, shall provide weekly information to DOJ including 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. (HSC § 11165 (d))

13. Provides that a licensed health care practitioner eligible to prescribe Schedule II, III or IV controlled substances, or a pharmacist, shall apply to participate in the CURES Prescription Drug Monitoring Program (PDMP) by January 1, 2016. Authorizes DOJ to deny an application or suspend a subscriber for certain violations and falsifying information. 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, subject to provisions of the Confidentiality of Medical Information Act. (HSC § 11165.1)

14. 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. (HSC § 11190 (a) and (b))

15. 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 three years 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. Requires that this information be provided to DOJ on a monthly basis. (HSC § 11190 (c))

This bill:

1. Requires prescribers (authorized to write prescriptions according to HSC § 11150 outlined above, excluding veterinarians) to access and consult CURES prior to prescribing a Schedule II or Schedule III controlled substance for the first time to a patient and at least annually when that prescribed controlled substance remains part of the treatment. Provides that if the patient has an existing prescription for a Schedule II or Schedule III controlled substance, the health care practitioner shall not prescribe any additional controlled substances until the health care practitioner determines there is a legitimate need.

2. Requires dispensers (as defined by HSC § 11011) to also access and consult CURES prior to dispensing a Schedule II or Schedule III controlled substance for the first time to that patient. Provides that if the patient has an existing prescription for a Schedule II or Schedule III controlled substance, the dispenser shall not dispense any additional controlled substances until the dispenser checks CURES.

3. Provides that failure by a prescriber or dispenser to consult CURES as specified above is cause for disciplinary action by the prescriber or dispenser’s appropriate licensing board.

4. Requires the licensing boards of all prescribers and dispensers authorized to write or issue prescriptions for controlled substances to notify all authorized prescribers or dispensers of the requirement for consulting CURES.

5. Provides that notwithstanding any other provision, a prescriber or dispenser shall not be in violation of the requirements in this bill during any time period in which the CURES system is suspended or not accessible or the Internet is not operational.

6. Delays implementation of the above provisions until the DOJ certifies that the CURES database is ready for statewide use.

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

COMMENTS:

1. Purpose. This bill is sponsored by the Consumer Attorneys of California and the California Narcotics Officers. According to the Author, for the last decade the number of deaths due to drug overdoses of prescription drugs has dramatically increased. The Author cites data from the Centers for Disease Control (CDC) estimating that 44 people die every day from an overdose of prescription drugs. According to the Author, “This is a serious and deadly problem for our state…While California was the first state to create a drug monitoring system, it has lagged behind others in realizing the full potential its system. Other states like New York and Tennessee have required prescribers to check their respective state drug monitoring systems and seen dramatic decreases in drug overdoses and deaths.”

The Author is concerned that in California, prescribers and dispensers of Schedule II and III drugs must enroll in CURES by January 2016, but they are not required to consult the system when prescribing or dispensing. According to the Author, “in order to eliminate doctor shopping and minimize the over prescription of narcotics, it is critical prescribers and dispensers use CURES every time they write or dispense a new prescription.” The Author states that “Ultimately this bill will ensure prescribers and dispensers are utilizing CURES to improve public health outcomes and limit the number of Californians who die as a result of a drug overdose.”

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 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 relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics.

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 inject, 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).

In August of 2014, the federal Drug Enforcement Administration (DEA), rescheduled hydrocodone combination products from Schedule III to Schedule II of the Controlled Substances Act. DEA requested a scientific and medical recommendation from the federal Health and Human Services Agency (HHS) regarding a change of schedule for hydrocodone combination products in 2009. The Food and Drug Administration (FDA), within HHS, considered the eight statutorily required factors related to the abuse potential of hydrocodone, including questions about the products’ actual or relative potential for abuse, their liability to cause psychic or physiological dependence, and dangers they might pose to public health. According to the FDA, hydrocodone is the most prescribed opioid in the United States, including 137 million prescriptions in 2013. The FDA notes that while it is useful in the treatment of pain, it has also contributed significantly to the very serious problem of opioid misuse and abuse in the United States. HHS ultimately recommended to DEA that hydrocodone combination products be reclassified into Schedule II, a more restrictive category of controlled substances that includes other opioid drugs for pain like morphine and oxycodone. The reclassification is aimed at limiting the risks of these potentially addictive but important pain-relieving products and will result in the following: Now, if a patient needs additional medication, the prescriber must issue a new prescription. Phone–in refills for these products are no longer allowed. In emergencies, small supplies can be authorized until a new prescription can be provided for the patient. Patients will still have access to reasonable quantities of medication, generally up to a 30-day supply.

HHS also recommended including rescheduling in “a broad-based set of actions targeting abuse prevention.” HHS identified a need to work with prescribers and patients to make certain that patients are prescribed the right number of doses of hydrocodone for a patient’s need to avoid unused hydrocodone being available for abuse as well as the need for. HHS advised that the use and abuse of hydrocodone combination products be monitored carefully to assess the impact of rescheduling on public health. HHS noted that based on the results of this monitoring, the agency may need to take additional actions to “support the appropriate use of hydrocodone combination products while reducing their tragic abuse.”

3. Prescription Drug Abuse. For the past number of years, abuse of prescription drugs (taking a prescription medication that is not prescribed for you, or taking it for reasons or in dosages other than as prescribed) to get high has become increasingly prevalent. Federal data for 2014 shows that in the past year, 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 any 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 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 drug which can 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.

3. Prescription Drug Deaths. A 2013 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 PDMPs with a focus on both patients at highest risk in terms of prescription painkiller dosage, numbers of 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.

3. 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. There are 49 states that currently have monitoring programs (Missouri is the only state currently without a PDMP). California has the oldest prescription drug monitoring program in the nation. Of these 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 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. The National Boards of Pharmacy (NABP) currently operates a PDMP, InterConnect that allows participating states across to be linked, providing a more effective means of combating drug diversion and drug abuse nationwide. It was anticipated that approximately 30 states will be sharing data or in a Memorandum of Understanding to share data using InterConnect by the end of 2014.

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.

AB 3042 (Takasugi, Chapter 738, Statutes of 1996) established a three year pilot program, beginning in July 1997, for the electronic monitoring of prescribing and dispensing of Schedule II controlled substances. Subsequent legislation (SB 1308, Committee on Business and Professions, Chapter 655, Statutes of 1999) extended the sunset date on the CURES program to July 1, 2003 and required DOJ to submit annual status reports on the program to the Legislature. In 2002, the Legislature passed AB 2655 (Matthews, Chapter 345, Statutes of 2002) which extended the CURES program to 2008 and provided access to CURES data by licensed health care providers. Finally, in 2003, SB 151 (Burton, Chapter 406, Statutes of 2003) made the program permanent. In 2009, then Attorney General Brown launched an online CURES system at DOJ to replace the previous system that required mailing or faxing written requests for information, giving health professionals (doctors, pharmacists, midwives, and registered nurses), law enforcement agencies and medical profession regulatory boards instant computer access to patients' controlled-substance records. SB 809 (Chapter 400, Statutes of 2013) established a funding mechanism to update and maintain CURES, required all prescribing health care practitioners to apply to access CURES information, and established processes and procedures for regulating prescribing licensees through CURES and securing private information.

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 top drugs prescribed for a specific time period, drugs prescribed in a particular county, doctor prescribing data, pharmacy dispensing data, and is a critical tool for assessing whether multiple prescriptions for the same patient may exist. In addition to the Board, CURES data can be obtained by the MBC, 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 order to fill the fraudulent prescriptions, resulting in the group obtaining more than 11,000 pills of highly addictive drugs like OxyContin and Vicodin.

DOJ is currently in the process of modernizing CURES to more efficiently serve prescribers, pharmacists and entities that may utilize the data contained within the system and expects that the new CURES 2.0 system will be operational on July 1, 2015.

6. Related Legislation This Session. AB 611 (Dahle) authorizes an individual designated to investigate a holder of a professional license to apply to the DOJ to obtain approval to access information contained in the CURES PDMP regarding the controlled substance history of an applicant or a licensee, for the purpose of investigating the alleged substance abuse of a licensee. Clarifies that only a subscriber who is a health care practitioner or a pharmacist may have an application denied or be suspended for accessing subscriber information for any reason other than caring for his or her patients. Specifies that an application may be denied, or a subscriber may be suspended, if a subscriber who has been designated to investigate the holder of a professional license accesses information for any reason other than investigating the holder of a professional license.
   (Status: The bill is currently pending in the Assembly Committee on Business and Professions.)

6. Prior Related Legislation. SB 500 (Lieu) of 2014 would have required the MBC to update prescriber standards for controlled substances once every five years and add the American Cancer Society, specialists in pharmacology and specialists in addiction medicine to the entities the MBC may consult with in developing the standards. (Status: The bill was amended to deal with a different subject.)

SB 1258 (DeSaulnier) of 2014 would have made several changes to the ways that controlled substances are prescribed and tracked in CURES and would have required medical providers to use electronic prescribing systems, would have required additional reporting of controlled substance prescribing, and would have placed additional restrictions on the prescribing of controlled substances.
(Status: The bill was held in the Senate Committee on Appropriations.)

SB 809 (DeSaulnier, Chapter 400, Statutes of 2013) established a funding mechanism to update and maintain CURES, required all prescribing health care practitioners to apply to access CURES information, and established processes and procedures for regulating prescribing licensees through CURES and securing private information.

SB 616 (DeSaulnier) of 2012 would have increased fees, up to $10 per licensee that is authorized to prescribe or dispense controlled substances, to fund CURES. (Status: The measure failed passage in the Assembly Committee on Business, Professions and Consumer Protection.)

SB 360 (DeSaulnier, Chapter 418, Statutes of 2011) updated CURES to reflect the new PDMP and authorizes DOJ to initiate administrative enforcement actions to prevent the misuse of confidential information collected through CURES.

SB 1071 (DeSaulnier) of 2010 would have imposed a tax on manufacturers or importers of Schedule II, III and IV controlled substances to pay for ongoing costs of the CURES program. Fees would have been collected by the BOE, at the rate of $0.0025 per pill included in Schedule II, III, and IV. (Status: The bill was held in the Senate Committee on Health.)

AB 2516 (Mendoza) of 2008 required a doctor to ensure that any prescription he or she make be electronically transmitted to a patient’s pharmacy of choice.
(Status: The measure was never heard in a policy committee of the Legislature.)

AB 1298 (Jones, Chapter 699, Statutes of 2007) sought to protect the privacy of personally identifiable unencrypted medical and health insurance information by requiring any state agency or business that operates in California to inform any potentially affected state resident of the loss of that individual’s health information. The bill also prohibited any organization that holds electronic personal health record data from disclosing that information without patient consent.

ABX1 (Nunez) of 2007 would have required that by January 1, 2012 all prescribers, prescribers’ agents, and pharmacies, have ability to transmit and receive e-prescriptions, and would have given licensing boards the authority to enforce this requirement. (Status: The measure failed passage in the Senate Committee on Health.)

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.

SB 734 (Torlakson, Chapter 487, Statutes of 2005) authorized tamper resistant online access to the CURES system for authorized physicians, pharmacists and law enforcement, pending the acquisition of private funding.

SB 151 (Burton, Chapter 406, Statutes of 2004) made CURES permanent, among other provisions.

AB 3042 (Takasugi, Chapter 738, Statutes of 1996) establishes CURES as a three-year pilot program.

6. Arguments in Support. According to law enforcement organizations like the California Association of Code Enforcement Officers, California College and University Police Chiefs Association, California Correctional Supervisors Organization, California Narcotic Officers’ Association (Sponsor), Los Angeles Los Angeles Police Protective League and Riverside Sheriffs Organization, the CURES database is an effective reference point in assuring that a patient is not engaged in prescription. The organizations state that this bill will save lives.

The Consumer Attorneys of California (CAOC) cite the growing problem of prescription drug use and the current lack of requirement that health care prescribers and dispensers check the CURES database as rationale for this bill’s passage. According to CAOC, the current voluntary approach has not been able to attract sufficient participation to make it truly effective and that it is critical to prevent overdose deaths and addiction from occurring in the first place by attacking its problem at the source.

The Consumer Federation of California (CFC) also writes in support of this bill, stating that only 6 percent of doctors now use CURES even though it has been operational since 2009. According to CFC, “curbing prescription drug abuse and doctor shopping could save an estimated $300 million annually for what is now spent by our state and local governments on prescription drugs for Medi-Cal patients.”

Consumer Watchdog writes that prescription drug abuse is at epidemic levels and databases like CURES can reduce a patient’s risk for overdose and provide an opportunity to intervene with patients who are abusing medications.

Labor organizations like the California Conference Board of the Amalgamated Transit Union, California Conference of Machinists, California Teamsters Public Affairs Council, Engineers and Scientists of California, IFPTE Local 20, AFL-CIO, International Longshore and Warehouse Union, Professional and Technical Engineers, IFPTE Local 21, AFL-CIO, UNITE-HERE, AFL-CIO and Utility Workers Union of America support this bill, writing that they are alarmed about the growing trend of prescription drug abuse which affects workers directly as often they are prescribed pain medications for injuries on the job and it’s time we took decisive action to prevent prescription drug addiction.

The International Faith Based Coalition welcomes the changes contemplated by this bill and notes that this strategy has been instituted in a number of other states with universal reduction in prescription drug abuse as well as in overdose deaths.

6. Concerns. The California Pharmacists Association (CPhA), California Retailers Association (CRA) and National Association of Chain Drug Stores (NACDS) all write to express concerns about this bill. CPhA pharmacists use their professional judgment to determine when specific interventions are necessary and appropriate, in addition to following guidance provided by the Board of Pharmacy for specified “red flags” and as such, states that it is not clear that the mandates in SB 482 are necessary for pharmacists.

CRA and NACDS are very concerned that the new system will not have the ability to handle the volume of inquiries nor will the system effectively integrate with pharmacy technology systems. The organizations note that pharmacists fill hundreds of prescriptions a day and cannot work with a state system that delays, or a system that creates and overly burdensome requirement that cannot be efficiently and effectively utilized.

6. Arguments in Opposition. The California Medical Association (CMA) is opposed to this bill. CMA writes that at its most basic, this bill legislates the practice of medicine which the organization opposes. According to CMA, this bill establishes a nebulous and problematic prohibition against prescribing an additional controlled substance until the prescriber determines that there is a legitimate need and cites instances in which a patient may be prescribed two controlled substances, which will create liability for a physician in any malpractice case in which a patient is prescribed controlled substances. CMA believes that the mandate in this bill will fall disproportionately on patients with a legitimate medical issue and that once a functional CURES system is in place, the mandates imposed by this bill will not be necessary, as physicians support the CURES database and want to have it as a tool in their clinical practice. The organization also cites existing efforts by the Medical Board in its updated guidelines for prescribing controlled substances, Board of Pharmacy precedential decision that a pharmacist must inquire whenever he or she believes a prescription may not have been written for a legitimate medical purpose and reclassification of hydrocodone products from Schedule III to Schedule II by the DEA to view the impact of the mandate for checking CURES outlined in this bill. According to CMA, this bill will create an unnecessary regulatory burden to prescribing and increase the threat of litigation, both of which would have a detrimental impact on patient care while adding limited value to addressing prescription drug abuse.

CVS Health is opposed to this bill unless the author amends the bill to remove the obligation of the dispenser to consult the CURES system prior to dispensing a particular prescription and encourage CURES 2.0 to require data uploads every
24 hours. According to CVS Health, CVS Health’s pharmacy operations would be directly and unnecessarily impacted by this bill based on the requirement that pharmacists consult and access the database prior to dispensing. CVS Health also believes that CURES should be updated every 24 hours, not as soon as reasonably possible as outlined under current law. CVS Health cites its utilization of patient-level data to trigger alerts for pharmacists to identify “aberrant behavior in patients as well as controlled substance prescribers. These red flags have been identified …to help us make appropriate determinations for when dispensing of a controlled substance should not occur.”

Rite Aid Corporation opposes this bill, writing that the bill’s requirements are duplicative of one another, as both physicians and pharmacists would be required to consult CURES prior to prescribing or dispensing Schedule II or Schedule III drugs for the first time to a patient. Rite Aid questions “the impact this bill will have on preventing abusive behavior given that under current law, data is only reported to the CURES system once weekly.” According to Rite Aid, physicians consulting CURES would not even be reviewing up to date information.

According to The Doctor’s Company, this bill would subject prescribers to discipline for failure to access a system that currently experiences many interruptions in accessibility. TDC doubts that the proposed upgrade will be fully functional as intended and that an outside, independent analysis attesting to the upgraded system’s readiness would help develop confidence in a system that has been underfunded and experienced other operational problems in the past.

6. Author’s Amendments. In response to concerns raised above related to a mandate for dispensers to consult CURES prior to dispensing a Schedule II or Schedule III to a patient for the first time, the Author is amending this bill to delete provisions related to dispensers.

On page 3, strike lines 4 through 11.

On page 3, in line 14, after “prescriber”, strike “or dispenser”.

On page 3, in line 15, after “prescribers”, strike “and dispensers”.

On page 3, in line 18, after “prescriber”, strike “or dispenser”.

On page 3, strike lines 27 through 28.

On page 3, in line 29, after “section” strike “the following terms shall have the following meanings” and strike lines 27 through 31.

On page 3, in line 29, after “section” insert “Prescriber” means a health care practitioner who is authorized to write or issue prescriptions under Section 11150, excluding veterinarians.”

(b) A dispenser shall access and consult the CURES database

for the electronic history of controlled substances dispensed to a

patient under his or her care before dispensing a Schedule II or

Schedule III controlled substance for the first time to that patient.

If the patient has an existing prescription for a Schedule II or

Schedule III controlled substance, the dispenser shall not dispense

an additional controlled substance until the dispenser checks the

CURES database.

(c) Failure to consult a patient’s electronic history as required

by subdivision (a) or (b) is cause for disciplinary action by the

respective licensing board of the prescriber or dispenser. The

licensing boards of all prescribers and dispensers authorized to

write or issue prescriptions for controlled substances shall notify

these licensees of the requirements of this section.

(d) Notwithstanding any other law, a prescriber or dispenser

is not in violation of this section during any period of time in which

the CURES database is suspended or not accessible or any period

of time in which the Internet is not operational.

(e) This section shall not become operative until the Department

of Justice certifies that the CURES database is ready for statewide

use.

(f) For purposes of this section, the following terms shall have

the following meanings:

(1) “Dispenser” means a person who is authorized to dispense

a controlled substance under Section 11011.

(2) “Prescriber” means a health care practitioner who is

authorized to write or issue prescriptions under Section 11150,

excluding veterinarians. “Prescriber” means a health care practitioner who is

authorized to write or issue prescriptions under Section 11150,

excluding veterinarians.

SUPPORT AND OPPOSITION:

Support:

California Association of Code Enforcement Officers

California College and University Police Chiefs Association

California Conference Board of the Amalgamated Transit Union

California Conference of Machinists

California Correctional Supervisors Organization

California Narcotic Officers’ Association (Co-Sponsor)

California Teamsters Public Affairs Council

Consumer Attorneys of California (Co-Sponsor)

Consumer Federation of California

Consumer Watchdog

Engineers and Scientists of California, IFPTE Local 20, AFL-CIO

International Faith Based Coalition

International Longshore and Warehouse Union

Los Angeles Police Protective League

Professional and Technical Engineers, IFPTE Local 21, AFL-CIO

Riverside Sheriffs Organization

UNITE-HERE, AFL-CIO

Utility Workers Union of America

Concerns:

California Pharmacists Association (CPhA)

California Retailers Association (CRA)

National Association of Chain Drug Stores (NACDS)

Opposition:

California Medical Association (CMA)

CVS Health

Rite Aid Corporation

The Doctor’s Company (TDC)

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