Existing law, the Uniform Controlled Substances Act, classifies opioids as Schedule II controlled substances and places restrictions on the prescription of those drugs, including prohibiting refills and specifying the requirements of a prescription for these drugs. Violation of these provisions and the Uniform Controlled Substances Act is a misdemeanor.

This bill would require, by July 1, 2019, every health care practitioner practitioner, with the exception of veterinarians, who prescribes, orders, administers, or furnishes opioids classified as Schedule II and Schedule III to adopt, review, and periodically update a safe opioid prescribing policy, as specified. The bill would prohibit the safe opioid prescribing policy from placing a limitation on the prescription, ordering, administration, or furnishing of opioids to patients with prescribed conditions. The bill would require a health care practitioner who determines, based on his or her professional judgment, that the safe prescribing policy is not appropriate for a specific patients treatment, to provide adequate documentation in the patients record to support the treatment decision. The bill would make the failure to establish or adopt a safe opioid prescribing policy to be referred to the appropriate state professional licensing board for administrative sanctions. Because violation of these provisions is also a crime, the bill would create a new crime, thereby imposing a state-mandated local program.

The bill would require the State Department of Public Health, utilizing data from the CURES database, to submit a report detailing progress toward the stated goals of declining opioid prescriptions, as specified.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Uniform Controlled Substances Act, classifies opioids as Schedule II controlled substances and places restrictions on the prescription of those drugs, including prohibiting refills and specifying the requirements of a prescription for these drugs. Violation of these provisions and the Uniform Controlled Substances Act is a misdemeanor.

This bill would require, by July 1, 2019, every health care practitioner who prescribes, orders, administers, or furnishes opioids classified as Schedule II and Schedule III to adopt, review, and periodically update a safe opioid prescribing policy, as specified. The bill would prohibit the safe opioid prescribing policy from placing a limitation on the prescription, ordering, administration, or furnishing of opioids to patients with prescribed conditions. The bill would require a health care practitioner who determines, based on his or her professional judgment, that the safe prescribing policy is not appropriate for a specific patients treatment, to provide adequate documentation in the patients record to support the treatment decision. The bill would make the failure to establish or adopt a safe opioid prescribing policy to be referred to the appropriate state professional licensing board for administrative sanctions. Because violation of these provisions is also a crime, the bill would create a new crime, thereby imposing a state-mandated local program.

The bill would require the State Department of Public Health, utilizing data from the CURES database, to submit a report detailing progress toward the stated goals of declining opioid prescriptions, as specified.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Uniform Controlled Substances Act, classifies opioids as Schedule II controlled substances and places restrictions on the prescription of those drugs, including prohibiting refills and specifying the requirements of a prescription for these drugs. Violation of these provisions and the Uniform Controlled Substances Act is a misdemeanor.

This bill would require, by June July 1, 2019, every health care practitioner authorized to prescribe who prescribes, orders, administers, or furnishes opioids classified as Schedule II and Schedule III to adopt adopt, review, and periodically update a safe opioid prescribing protocol, policy, as specified. The bill would prohibit the safe opioid prescribing policy from placing a limitation on the prescription, ordering, administration, or furnishing of opioids to patients with prescribed conditions. The bill would require the a health care practitioner to note the reason the safe prescribing protocol was not followed if, in the health care practitioners professional judgment, adherence to the safe prescribing protocol is not appropriate for a patients condition. who determines, based on his or her professional judgment, that the safe prescribing policy is not appropriate for a specific patients treatment, to provide adequate documentation in the patients record to support the treatment decision. The bill would make the failure to develop or adhere to the protocol, except as specified, unprofessional conduct and enforceable by the health care practitioners establish or adopt a safe opioid prescribing policy to be referred to the appropriate state professional licensing board. board for administrative sanctions. Because violation of these provisions is also a crime, the bill would create a new crime, thereby imposing a state-mandated local program.

The bill would require the State Department of Public Health, utilizing data from the CURES database for the year ending December 31, 2016, to monitor progress toward stated goals and to report this information to the Legislature annually. database, to submit a report detailing progress toward the stated goals of declining opioid prescriptions, as specified.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Uniform Controlled Substances Act, classifies opioids as Schedule II controlled substances and places restrictions on the prescription of those drugs, including prohibiting refills and specifying the requirements of a prescription for these drugs. Violation of these provisions and the Uniform Controlled Substances Act is a misdemeanor.

Existing law, the Uniform Controlled Substances Act, classifies opioids as Schedule II controlled substances and places restrictions on the prescription of those drugs, including prohibiting refills and specifying the requirements of a prescription for these drugs. Under existing law a practitioner may dispense directly to an ultimate user a Schedule II controlled substance in an amount not to exceed a 72-hour supply when the patient is not expected to require any additional amount of the controlled substance beyond the 72 hours. Violation of these provisions is a misdemeanor.

This bill would prohibit a practitioner prescriber from prescribing an opioid in an amount greater that the patient needs for a 3-day period unless the practitioner prescriber believes, in his or her professional judgment, that a larger prescription is needed to treat a medical condition or that a larger prescription is necessary for the treatment of chronic pain. The bill would require a practitioner prescriber who writes a prescription for an opioid that is either larger than the 3-day supply or that is the 4th prescription without the dosage decreasing to include in the patients record why the excess or additional prescription was needed, what other medications were considered, the patients injury or illness, and the milligram dosage of the prescription. The bill would require the practitioner prescriber to take specified actions prior to prescribing an opioid, including informing the patient of the risks and treatment options for opioid addiction. By creating new crimes, this bill would impose a state-mandated local program.

Existing law imposes reporting requirements on practitioners prescribing Schedule II controlled substances and makes a violation of those reporting requirements a misdemeanor.

This bill would require, when a prescription is for an amount larger than that needed for 3 days or when the prescription is the 4th prescription without the dosage decreasing, the practitioner prescriber to report, in detail, why the excess or additional prescription was needed, what other medications were considered, the patients injury or illness, and the milligram dosage of the prescription. The bill would also require a practitioner prescriber who fails to submit the report required to be referred to the appropriate licensing board for administrative action, as deemed appropriate by that board. By creating a new crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Uniform Controlled Substances Act, classifies opioids as Schedule II controlled substances and places restrictions on the prescription of those drugs, including prohibiting refills and specifying the requirements of a prescription for these drugs. Under existing law a practitioner may dispense directly to an ultimate user a Schedule II controlled substance in an amount not to exceed a 72-hour supply when the patient is not expected to require any additional amount of the controlled substance beyond the 72 hours. Violation of these provisions is a misdemeanor.

This bill would prohibit a practitioner from prescribing an opioid in an amount greater that the patient needs for a 3-day period unless the practitioner believes, in his or her professional judgment, that a larger prescription is needed to treat a medical condition or that a larger prescription is necessary for the treatment of chronic pain. The bill would require a practitioner who writes a prescription for an opioid that is either larger than the 3-day supply or that is the 4th prescription without the dosage decreasing to include in the patients record why the excess or additional prescription was needed, what other medications were considered, the patients injury or illness, and the milligram dosage of the prescription. The bill would require the practitioner to take specified actions prior to prescribing an opioid, including informing the patient of the risks and treatment options for opioid addiction. By creating new crimes, this bill would impose a state-mandated local program.

The bill would remove the ability of a practitioner to dispense a 72-hour supply of a Schedule II controlled substance directly to the patient when the patient is not expected to require any additional amount of the controlled substance beyond the 72 hours.

Existing law imposes reporting requirements on practitioners prescribing Schedule II controlled substances and makes a violation of those reporting requirements a misdemeanor.

This bill would require, when a prescription is for an amount larger than that needed for 3 days or when the prescription is the 4th prescription without the dosage decreasing, the practitioner to report, in detail, why the excess or additional prescription was needed, what other medications were considered, the patients injury or illness, and the milligram dosage of the prescription. The bill would also require a practitioner who fails to submit the report required to be referred to the appropriate licensing board for administrative action, as deemed appropriate by that board. By creating a new crime, this bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

SENATE COMMITTEE ON APPROPRIATIONS

Senator Anthony Portantino, Chair

2017 - 2018 Regular Session

AB 1998 (Rodriguez) - Opioids: safe prescribing policy

This bill meets the criteria for referral to the Suspense File.

Bill Summary:

1. Requires, by July 1, 2019, health care practitioners who prescribe, order, administer, or furnish opioids to establish or adopt a safe opioid prescribing policy. Requires the Department of Public Health, by July 1, 2024, to submit a report to the Legislature and publish to the public, using data from the Controlled Substance Utilization Review and Evaluation System (CURES) database, detailing progress towards the goal of a downward trend in opioid prescriptions.

Fiscal Impact:

• No fiscal impact to Board of Pharmacy.
• Minor and absorbable workload associated with anticipated minor increase in enforcement work for the Board of Optometry, the Board of Podiatric Medicine, the Board of Registered Nursing, the Dental Board, the Medical Board, the Osteopathic Medical Board, and the Physician Assistant Board (the boards authorized to prescribe opioids). Absorbable IT impact (approximately $2,500 per Board but can be absorbed by redirecting existing maintenance resources).
• No impact to the Department of State Hospitals whose prescribing physicians include physicians, surgeons, and psychiatrists, and our hospital pharmacies before July 1, 2019.  No anticipated special costs associated with compliance.
• The DOJ anticipates costs of $8,000 General Fund in fiscal year 2019-20 and $7,000 General Fund ongoing, in order to process the anticipated increase in arrest prints since the bill would create a new crime. The DOJ anticipates there would be an increase in the CalID program and overtime hours for the record management branch to coordinate with the Criminal Justice Statistics Center for National Incident-Based Reporting System (NIBRS) and Bureau of Criminal Statistics (BCS) codes.
• $156,000 (special fund) in fiscal year 2019-20 and $301,317 (special fund) in 2020-21 for Department of Public Health to develop the one-time report and monitor CURES. The funding could either be used administratively to establish positions in the department.

Background:

1. The Department of Consumer Affairs (DCA) licenses and regulations health care professionals including: physicians and surgeons, dentists, veterinarians; registered nurses, nurse practitioners (NP) and certified nurse-midwives; physician assistants (PA); osteopathic physicians and surgeons; naturopathic doctors (ND); optometrists; doctors of podiatric medicine; and, pharmacies, pharmacists and wholesalers of dangerous drugs or devices. A physician and surgeon may not prescribe, dispense, or administer dangerous drugs or controlled substances to a person he or she knows or reasonably believes is using or will use the drugs or substances for a nonmedical purpose.

The Department of Justice (DOJ) maintains the CURES database for the electronic monitoring of the prescribing and dispensing of Schedule II - IV controlled substances. Dispensing pharmacies and clinics must report specified information for each controlled substance. 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. In addition, California law requires prescription forms for controlled substance prescriptions to be written on tamper-proof forms.

Proposed Law:

The bill includes the following provisions, among others:

• Requires every health care practitioner, who furnishes opioids, to adopt a safe opioid prescribing policy. By July 1, 2019, every health care practitioner who prescribes, administers, or furnishes opioids classified as Schedule II and Schedule III pursuant to Sections 11055 and 11056, respectively, must establish or adopt a safe opioid prescribing policy, as defined. A group of practitioners, including a hospital pharmacy and therapeutics committee, may adopt a safe opioid prescribing policy that applies to all parties as part of a business affiliation or contract with an organized provider group. The bill exempts licensed veterinarians from the bill’s provisions.

A health care practitioner or group of practitioners, including a hospital pharmacy and therapeutics committee, is deemed to have satisfied this section by adopting a nationally or professionally recognized guideline, or a guideline established by the state licensing board or commission that was updated after January 1, 2015, for the use of opioids for managing pain if the guideline meets specified criteria.

• Defines safe opioid prescribing policy. The safe opioid prescribing policy must be a written document promoting the appropriate dosage and duration of opioid prescriptions for a health care provider’s patients, with the goal of reducing the overall prescription, administration, or furnishing of opioids to the lowest effective dose and the shortest duration necessary to treat the patient. The policy must address specified information, including dosage and duration of prescription for patients, alternatives to opioid treatment, and recommendations for continued use of opioids for addiction risk and pain management.

The development of a safe opioid prescribing policy must include review and consideration of evidence-based science, literature, research, and guidelines, including relevant recommendations and research from academia and consideration of existing guidelines and recommendations.

• Requires referral to licensing board for failure to adopt safe prescribing policy. A health care practitioner who fails to establish or adopt a safe opioid prescribing policy must be referred to the appropriate state professional licensing board solely for administrative sanctions, as deemed appropriate by that board. ‘

The bill does not create a private right of action against a health care practitioner nor does it limit a health care practitioner’s liability for the negligent failure to diagnose or treat a patient.

• Requires the Department of Public Health (CDPH) to submit a legislative report. By July 1, 2024, and until July 1, 2028, the State Department of Public Health must submit a report to the Legislature and publish to the public, using data from the CURES database. The department may, and is encouraged to, contract with an independent academic entity, including the University of California, to prepare the report with specified information.

Related Legislation:

1. The Legislature has deliberated proposals related to opioids in recent past, including:

• SB 641 (Lara of 2017) prohibits the DOJ from releasing data in CURES to a law enforcement agency except pursuant to a warrant. SB 641 is pending consideration in Assembly Appropriations Committee.
• SB 1109 (Bates) requires warning labels for opioid prescription drug containers; requires that the Opioid Factsheet for Patients be provided to athletes engaged in after-school youth sports; requires that prescribers discuss the dangers of opioid abuse and addiction with a minor patient or their parent or guardian prior to prescribing an opioid; and requires that existing trainings for prescribers related to pain management include addiction risks associated with Schedule II drugs. SB 641 is pending consideration in Assembly Appropriations Committee.
• SB 1229 (Stone, 2018) requires pharmacists dispensing any opioid medication to a patient or the patient’s agent for the first time to provide oral consultation before dispensing the medication and prohibits a pharmacist from dispensing the medication if the patient or the patient’s agent declines the consultation. SB 1229 is pending in the Senate Business, Professions, and Economic Development Committee.
• AB 2741 (Burke, 2018) limits all opioid prescriptions for minors to a maximum of five days, with exceptions, and require a prescriber to discuss risks related to opioid medication with the minor and the minor’s parent or guardian and obtain written consent prior to writing the prescription.

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SENATE COMMITTEE ON HEALTH

Senator Dr. Richard Pan, Chair

BILL NO: AB 1998

SUBJECT: Opioids: safe prescribing policy

SUMMARY:

1. Requires health care practitioners who prescribe, order, administer, or furnish opioids to establish or adopt a safe opioid prescribing policy. Requires the Department of Public Health to submit a report to the Legislature and publish to the public, using data from the Controlled Substance Utilization Review and Evaluation System database, detailing progress towards the goal of a continued downward trend in opioid prescriptions.

Existing law:

1. Establishes licensing boards within the Department of Consumer Affairs (DCA), which provide for the licensing and regulation of health care professionals, including: physicians (under the Medical Practice Act); dentists (under the Dental Practice Act); veterinarians (under the Veterinary Medicine Practice Act); registered nurses (RN), nurse practitioners (NP) and certified nurse-midwives (CNM) (under the Nursing Practice Act); physician assistants (PA) (under the Physician Assistant Practice Act); osteopathic physicians and surgeons (under the Osteopathic Medical Practice Act); naturopathic doctors (ND) (under the Naturopathic Doctors Act); optometrists (under the Optometry Practice Act); doctors of podiatric medicine (under the Podiatric Act) and; pharmacies, pharmacists, and wholesalers of dangerous drugs or devices (under the Pharmacy Law). [BPC §500, et seq.]
2. Establishes the Uniform Controlled Substances Act, which 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. Defines a controlled substance as any substance listed in the Uniform Controlled Substances Act in California law. Classifies controlled substances in five schedules according to their danger and potential for abuse. [HSC §11020, BPC §4021, and HSC §11054-11058]
3. Prohibits any person other than a physician, dentist, podiatrist, veterinarian, and other specified health care providers (such as CNMs, NPs, NDs, RNs, PAs, optometrists, and pharmacists under specified circumstances) from writing or issuing a prescription. [HSC §11150]

This bill:

1. Requires every health care practitioner who prescribes, orders, administers, or furnishes opioids classified as Schedule II and Schedule III, by July 1, 2019, to establish or adopt a safe opioid prescribing policy (prescribing policy). Permits a group of practitioners, including a hospital pharmacy and therapeutics committee, to adopt a prescribing policy that applies to all parties as part of a business affiliation or contract with an organized provider group.
2. Deems a health care practitioner or group of practitioners, including a hospital pharmacy and therapeutics committee (P&T committee), to have satisfied this requirement by adopting a nationally or professionally recognized guideline, or a guideline established by the state licensing board or commission that was updated after January 1, 2015, for the use of opioids for managing pain if the guideline meets the criteria specified in this bill.
3. Requires the prescribing policy to be a written document promoting the appropriate dosage and duration of opioid prescriptions for patients, with the goal of reducing the overall prescription, ordering, administration, or furnishing of opioids to the lowest effective dose and the shortest duration necessary to treat the patient. Requires the policy to address, but not be limited to:
4. The appropriate dose and duration of prescriptions for adult patients, as applicable, experiencing acute pain;
5. The appropriate dose and duration of prescriptions for pediatric patients, as applicable, experiencing acute pain;
6. Alternatives to opioid treatment, including nonpharmacological treatment options and referral to specialty care, as appropriate;
7. Recommendations for assessing patients’ continued use of opioids for pain management; and,
8. Recommendations for counseling patients on overdose and addiction risk and response.
9. Requires the prescribing policy to include a requirement that the prescriber offer a prescription for naloxone hydrochloride or another drug approved by the United States Food and Drug Administration (FDA) for the complete or partial reversal of opioid depression to a patient when:
10. The prescription dosage for the patient is 90 morphine milligrams or more of an opioid medication per day;
11. An opioid medication is prescribed concurrently with a prescription for benzodiazepine; or,
12. The patient presents an increased risk for overdose, including a patient with a history of overdose, with a history of substance use disorder (SUD), or at risk of returning to a high dose of opioid medication to which the patient is no longer tolerant.
13. Requires the development of a prescribing policy to include review and consideration of evidence-based science, literature, research, and guidelines, including relevant recommendations and research from academia and consideration of existing guidelines and recommendations from groups including, but not limited to, the federal Centers for Disease Control and Prevention (CDC), the federal Centers for Medicare and Medicaid Services (CMS), the Medical Board of California (MBC), and the American Society of Addiction Medicine (ASAM).
14. Requires the prescribing policy to be reviewed periodically and updated according to applicable scientific studies and available data.
15. Requires a prescriber, when he or she determines based on his or her professional judgment that the safe prescribing policy is not appropriate for a specific patient’s treatment, to provide adequate documentation in the patient’s record to support the treatment decision.
16. Requires a health care practitioner who prescribes, orders, administers, or furnishes opioids classified as Schedule II or Schedule III to a hospital patient to follow the guideline or policy of that hospital’s P&T committee.
17. Prohibits the safe opioid prescribing policy from placing limitations on the prescription, ordering, administration, or furnishing of opioids to patients undergoing treatment for chronic pain, cancer, SUD, sickle cell disease with acute intermittent porphyria, hospice, or end-of-life care.
18. Requires a health care practitioner who fails to establish or adopt a prescribing policy to be referred to the appropriate state professional licensing board solely for administrative sanctions, as deemed appropriate by that board.
19. Specifies that this bill does not create a private right of action against a health care practitioner, nor does it limit a health care practitioner’s liability for the negligent failure to diagnose or treat a patient.
20. States the intent of the Legislature that, from July 1, 2019 to July 1, 2023, opioid prescriptions in California continue in a year-over-year downward trend consistent with the average trend established between 2014 and 2017. Requires Department of Public Health

(DPH), by July 1, 2024, to submit a report to the Legislature and publish to the public, using data from the Controlled Substance Utilization Review and Evaluation System (CURES) database, detailing progress towards that goal. Permits DPH to contract with an independent academic entity, including the University of California, to prepare the report. Requires the report to address, but not be limited to:

1. The overall number of opioid prescriptions, rates of opioid prescriptions per 1,000 persons, and morphine milligram equivalents per year in the years 2019 to 2023, inclusive. Requires this information to be provided in total, and by prescribing license;
2. The overall year-by-year change in opioid prescriptions, rates of opioid prescription per 1,000 persons, and morphine milligram equivalents from the years 2019 to 2023;
3. The progress made toward reducing the over-prescription of opioids;
4. Recommendations for whether further reduction of opioid prescription is needed; and,
5. Information, if available, on opioid prescriptions by geographic location.
6. Requires DPH, before publishing the final report, to provide opportunity for feedback on the draft report by relevant stakeholders.

FISCAL EFFECT:

According to the Assembly Appropriations Committee:

1. Minor costs to DPH to monitor and report to the Legislature on reductions in opioid prescriptions.
2. Potential minor enforcement costs, as well as minor information technology costs to add new enforcement codes, to health care boards within DCA that license prescribers, including the MBC, the Osteopathic Medical Board of California, the Board of Registered Nursing, and Physician Assistant Board (various fee-supported special funds).
3. Unknown General Fund costs, potentially in excess of $150,000, to the California Department of Corrections and Rehabilitation Division of Juvenile Justice and the Department of State Hospitals to develop compliant protocols.

PRIOR VOTES:

COMMENTS:

1. Author’s statement. According to the author, as an Emergency Medical Technician for over three decades, I have responded to far too many fatal overdose incidents which destroy families and communities. Given that almost half of opioid related overdose deaths come from prescriptions, it is time that we ensure excessive prescriptions are limited while providing physicians the flexibility to properly care for patients. The opioid crisis is real and as more potent drugs are being added to the market, something must be done to save lives from addiction, or worse.
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.
3. CURES database. Existing law requires the Department of Justice (DOJ) to maintain the CURES database for the electronic monitoring of the prescribing and dispensing of Schedule II - 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 DOJ. 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. In addition, California law requires prescription forms for controlled substance prescriptions to be written on tamper-proof forms.
4. Opioid use and SUDs. Nearly 22 million Americans are thought to have some kind of SUD; of these, 1.9 million are addicted to prescription painkillers, and an estimated 586,000 are addicted to heroin. Since 2008, more than 115,000 Americans have died from overdoses of prescription painkillers (7,400 deaths in California over the last five years), and nearly 39,000 have died from heroin overdoses (an overall death rate of nine per 100,000 in 2014).
   

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. Results from the 2016 National Survey on Drug Use and Health found that 11.8 million people age 12 or older misused opioids in the past year, the vast majority of whom misused prescription pain relievers. Among people 12 or older who misused pain relievers in the past year, about half (53%) indicated that they obtained the last pain relievers they misused from a friend or relative. The National Institute on Drug Abuse (NIDA) reports young adults (age 18 to 25) are the biggest abusers of prescription opioid pain relievers, ADHD stimulants, and anti-anxiety drugs. In 2014, more than 1,700 young adults died from prescription drug (mainly opioid) overdoses, more than died from overdoses of any other drug, including heroin and cocaine combined, and many more needed emergency treatment. The nonmedical use of prescription drugs is highest among young adults. Six percent of 12 to 17 year-olds, 12% of 18 to 25 year olds and 5% those over age 26 used prescription drugs nonmedically in the past year.

Prescription opioids continue to be involved in more overdose deaths than any other drug. According to the CDC, overdose deaths involving prescription opioids have quadrupled since 1999. CDC found that from 1999 to 2016, more than 200,000 people died in the U.S. from overdoses related to prescription opioids. The CDC notes that the most common drugs involved in prescription opioid overdose deaths are methadone, oxycodone, and hydrocodone. According to the CDC, among those who died from prescription opioid overdose in 2016, overdose rates were highest among people aged 25 to 54, overdose rates were higher among non-Hispanic whites and American Indian or Alaskan Natives, compared to non-Hispanic blacks and Hispanics, and men were more likely to die from overdose.

1. Guidelines for prescribing controlled substances. For certain types of medication, and certain types of medication prescribed to certain types of patients, guidelines on appropriate and safe prescribing practices can serve as helpful tools for providers, patients and regulatory boards. In 1994, MBC unanimously adopted a policy statement entitled “Prescribing Controlled Substances for Pain.” Stemming from studies and discussions about controlled substances, this policy statement was designed to provide guidance to improve prescriber standards for pain management, while simultaneously undermining opportunities for drug diversion and abuse. The guidelines outlined appropriate steps related to a patient’s examination, treatment plan, informed consent, periodic review, consultation, records, and compliance with controlled substances laws. Subsequent to MBC’s 1994 action, legislation that took effect in 2002 (AB 487, Aroner, Chapter 518, Statutes of 2001) created a task force to revisit the 1994 guidelines to develop standards assuring competent review in cases concerning the under-treatment and under-medication of a patient's pain and also required continuing education courses for physicians in the subjects of pain management and the treatment of terminally ill and dying patients. AB 2198 (Houston, Chapter 350, Statutes of 2006) updated California law governing the use of drugs to treat pain by clarifying that health care professionals with a medical basis, including the treatment of pain, for prescribing, furnishing, dispensing, or administering dangerous drugs or prescription controlled substances, may do so without being subject to disciplinary action or prosecution.

MBC currently encourages all licensees to consult the policy statement and Guidelines for Prescribing Controlled Substances for Pain which were updated in 2014 based on input from a MBC Prescribing Task Force that held multiple meetings to identify best practices. According to the MBC website, “The board strongly urges physicians and surgeons to view effective pain management as a high priority in all patients, including children, the elderly, and patients who are terminally ill. Pain should be assessed and treated promptly, effectively and for as long as pain persists. The medical management of pain should be based on up-to-date knowledge about pain, pain assessment and pain treatment. Pain treatment may involve the use of several medications and non-pharmacological treatment modalities, often in combination. For some types of pain, the use of medications is emphasized and should be pursued vigorously; for other types, the use of medications is better de-emphasized in favor of other therapeutic modalities. Physicians and surgeons should have sufficient knowledge or utilize consultations to make such judgments for their patients. Medications, in particular opioid analgesics, are considered the cornerstone of treatment for pain associated with trauma, surgery, medical procedures, or cancer.” MBC intends for the guidelines to educate physicians on effective pain management in California by avoiding under treatment, overtreatment, or other inappropriate treatment of a patient’s pain. Reduction of prescription overdose deaths is also an objective of the updated guidelines.

1. Double referral. This bill was heard in the Senate Business and Professions Committee on April 16, 2018 and passed with a 9-0 vote.
2. Related legislation. SB 641 (Lara of 2017) prohibits the DOJ from releasing data in CURES to a law enforcement agency except pursuant to a warrant. SB 641 is set for hearing in the Assembly Health Committee on June 26, 2018.

SB 1109 (Bates) requires warning labels for opioid prescription drug containers; requires that the Opioid Factsheet for Patients be provided to athletes engaged in after-school youth sports; requires that prescribers discuss the dangers of opioid abuse and addiction with a minor patient or their parent or guardian prior to prescribing an opioid; and requires that existing trainings for prescribers related to pain management include addiction risks associated with Schedule II drugs. SB 1109 is set for hearing in the Assembly Health Committee on June 26, 2018.

SB 1229 (Stone) requires pharmacists dispensing any opioid medication to a patient or the patient’s agent for the first time to provide oral consultation before dispensing the medication and prohibits a pharmacist from dispensing the medication if the patient or the patient’s agent declines the consultation. SB 1229 is pending in the Senate Business, Professions, and Economic Development Committee.

AB 2486 (McCarty) requires a contract entered into by the Department of Health Care Services and a drug manufacturer under the Medi-Cal program that includes a prescription drug that contains an active opioid ingredient, to provide for a state rebate, in addition to other existing rebates, which would be proportional to the utilization of prescription drugs containing active opioid ingredients pursuant to a specified formula. AB 2486 is set for hearing on June 27, 2018 in this Committee.

AB 2487 (McCarty) requires physicians to complete a mandatory CE course on the treatment and management of opiate-dependent patients which includes eight hours of training in buprenorphine treatment of opioid use disorder within six months of first receiving federal Drug Enforcement Agency registration. AB 2487 is set for hearing on June 25, 2018 in the Senate Business, Professions, and Economic Development Committee.

AB 2741 (Burke) limits all opioid prescriptions for minors to a maximum of five days, with exceptions, and require a prescriber to discuss risks related to opioid medication with the minor and the minor’s parent or guardian and obtain written consent prior to writing the prescription.

AB 2760 (Wood) requires certain prescriptions for opioids to also include a co-prescription for naloxone or another opioid antagonist. AB 2760 is pending in the Senate Business, Professions, and Economic Development Committee.

AB 2859 (Caballero) requires a pharmacy that dispenses Schedule II, III, or IV controlled substances to display safe storage products, as defined, for sale within the pharmacy department. AB 2859 is set for hearing in the Business, Professions, and Economic Development Committee on June 25, 2018.

AB 2174 (Waldron) requires DPH, upon appropriation by the Legislature or receipt of adequate state or federal grant funding, and in consultation with stakeholders as appropriate, to develop, coordinate, implement and oversee a comprehensive multicultural public awareness campaign, designed to combat the growing heroin and opioid medication epidemic in the state. AB 2174 was held on the Assembly Appropriations Committee suspense file.

1. Prior legislation. SB 419 (Portantino of 2017) would have required prescribers to provide education to a minor and his or her guardian prior to prescribing, prohibited a subsequent prescription to be made until the minor is evaluated by a pain management specialist or pediatrician, and required review and verification by a pharmacist of documents memorializing the education provided to a minor and guardian. SB 419 was amended to deal with a different subject.

AB 40 (Santiago, Chapter 607, Statutes of 2017) authorized an entity that operates a health information technology system to establish integration with, and submit queries to CURES on either a user-initiated basis or automated basis, according to certain requirements.

AB 182 (Waldron of 2017) was substantially similar to AB 2174. AB 182 was held on the Senate Appropriations Committee suspense file.

AB 715 (Wood of 2017) would have required DPH to convene a workgroup to review existing prescription guidelines and develop a recommended statewide guideline addressing best practices for prescribing opioid pain relievers. AB 715 was vetoed by the Governor, who referenced the CDC and MBC guidelines in stating the bill was unnecessary.

SB 482 (Lara, Chapter 708, Statutes of 2016) required a health care provider authorized to prescribe, order, administer, or furnish a controlled substance to consult 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 patient’s treatment. Provides exemptions from the responsibility to consult CURES, 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 CURES.

AB 623 (Wood of 2015) would have prohibited a health plan or health insurer from requiring the use of opioid drug products that have no abuse-deterrent properties in order to access abuse-deterrent opioid drug products; would have required pharmacists to provide a patient receiving an opioid drug product information about proper storage and disposal of the drug; and, would have mandated that a plan and insurer may not prevent a provider from prescribing a less than 30-day supply of opioids analgesic drugs and to provide coverage, if otherwise covered, for the less than 30-day prescription. AB 623 was held on the Assembly Appropriations Committee suspense file.

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 workers compensation, specialists in pharmacology and specialists in addiction medicine to the entities the MBC may consult with in developing the standards. SB 500 was amended to deal with another 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. SB 1258 was held on the Senate Appropriations Committee suspense file.

AB 831 (Bloom of 2013) would have required the California Health and Human Services Agency (CHHSA) to convene a temporary working group to develop a state plan to reduce the rate of fatal drug overdoses and appropriated $500,000 from the General Fund to CHHSA to provide grants to local agencies to implement drug overdose prevention and response programs. AB 831 was held on the Assembly Appropriations Committee suspense file.

1. Support. The California Council of Community Behavioral Health Agencies (CBHA) writes that the Legislature has passed several bills to address the opioid crisis in California, including reducing “doctor shopping” that increase a patient’s access to opioid prescriptions; increasing access to medications such as Naloxone to reverse opioid overdoses; and codifying federal standards to allow nurses and PAs to administer Buprenorphine, a drug that reduces opioid dependence. However, these measures are reactive in that they deal with addiction after it has occurred. CBHA states that the Legislature must pass legislation aimed at prevention in order to effectively combat the opioid epidemic, and a proven method is to address a major contributor – opioid overprescribing. America’s Physician Groups states that in recognition of the opioid crisis, they developed a tool for prescribers based on CDC guidelines for prescribing opioids for chronic pain and they continue to work with numerous stakeholders and public health officials in addressing this public health problem, and this bill mirrors much of this work to provide prescribers clinically-based and patient focused policies relating to chronic pain management. The California Association of Joint Powers Authorities writes that their members have experienced countless workers’ compensation claims involving opioid abuse and applauds the bill’s requirement that prescribers adopt, maintain and adhere to safe opioid prescribing policies, with the goal of reducing the overall prescription, ordering, administration, or furnishing of opioids to the lowest effective dose and the shortest duration necessary to treat the patient.
2. Support if amended. The Osteopathic Physicians and Surgeons of California states that they are supportive in concept but would want to have the Medical Board’s current guidelines incorporated to ensure that physicians are able to reference existing guidelines.   
3. Opposition. The California Chapter of the American College of Emergency Physicians writes that guidelines are intended to be guidelines, and provide a framework for prescribing and a general expectation for patients who may be shopping for opioids but are not meant to be one size fits all rules that substitute for physician clinical judgement. California ACEP states that this bill makes a physician subject to administrative sanctions if they do not strictly adhere to clinical guidelines, regardless of the reason, and therefore ignores the very value of administering guidelines. The California Academy of Family Physicians states that it supports the goal of this bill, but believes that the establishment of prescribing policies should be left up to the individual physician and/or physician group, not dictated in statute.
4. Amendments. The author is requesting the Committee approve the following amendments to address drafting errors and stakeholder concerns:
   1. On page 5, line 21 insert “palliative care” after “hospice”
   2. On page 3, line 9 insert “This section shall not apply to veterinarians licensed pursuant to 4800 of the Business and Professions Code”
   3. On page 4, line 19 insert “equivalents” after “milligrams”
   4. On page 3, line 10 delete “orders” and line 29 delete “ordering”
   5. On page 5, delete lines 10-15

SUPPORT AND OPPOSITION:

Support: America’s Physician Groups

California Association of Code Enforcement Officers

California Chiropractic Association

California College and University Police Chiefs Association

California Council of Community Behavioral Health Agencies

California Association of Joint Powers Authorities

California Narcotic Officers Association

Los Angeles County Professional Peace Officers Association

Oppose: California Academy of Family Physicians

California Chapter of the American College of Emergency Physicians

-- END --

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Jerry Hill, Chair

2017 - 2018 Regular

Bill No: Hearing Date: June 18, 2018

Subject:

SUMMARY: Requires every healthcare practitioner authorized to prescribe Schedule II and Schedule III opioids to adopt a safe prescribing policy.

Existing law:

1. Establishes various practice acts in the Business and Professions Code (BPC) governed by various boards within the Department of Consumer Affairs (DCA) which provide for the licensing and regulation of health care professionals including: physicians and surgeons (under the Medical Practice Act), dentists (under the Dental Practice Act), veterinarians (under the Veterinary Medicine Practice Act); registered nurses, nurse practitioners (NP) and certified nurse-midwives (CNM) (under the Nursing Practice Act); physician assistants (PA) (under the Physician Assistant Practice Act); osteopathic physicians and surgeons (under the Osteopathic Medical Practice Act); naturopathic doctors (ND) (under the Naturopathic Doctors Act); optometrists (under the Optometry Practice Act); doctors of podiatric medicine (under the Podiatric Act) and; pharmacies, pharmacists and wholesalers of dangerous drugs or devices (under the Pharmacy Law).
   (Business and Professions Code (BPC) §§ 500 et seq.)
2. Provides that a physician and surgeon may not prescribe, dispense, or administer dangerous drugs or controlled substances to a person he or she knows or reasonably believes is using or will use the drugs or substances for a nonmedical purpose. (BPC § 2241)
3. Authorizes a physician and surgeon to prescribe for, or dispense or administer to, a person under his or her treatment for a medical condition dangerous drugs or prescription controlled substances for the treatment of pain or a condition causing pain, including, but not limited to, intractable pain. Provides that a physician and surgeon shall not be subject to disciplinary action for prescribing, dispensing, or administering dangerous drugs or prescription controlled substances according to certain requirements. Authorizes MBC to take any action against a physician and surgeon who violates laws related to inappropriate prescribing. Provides that a physician and surgeon shall exercise reasonable care in determining whether a particular patient or condition, or the complexity of a patient’s treatment, including, but not limited to, a current or recent pattern of drug abuse, requires consultation with, or referral to, a more qualified specialist. (BPC § 2241.5)
4. Requires the Division of Medical Quality (DMQ) within MBC, to develop standards before June 1, 2002 to ensure competent review in cases concerning the management, including, but not limited to, the undertreatment, undermedication, and overmedication of a patient’s pain. (BPC § 2241.6)
5. Authorizes DMQ to consult with entities such as the American Pain Society, the American Academy of Pain Medicine, the California Society of Anesthesiologists, the California Chapter of the American College of Emergency Physicians, and any other medical entity specializing in pain control therapies to develop the standards utilizing, to the extent they are applicable, current authoritative clinical practice guidelines. (BPC § 2241.6)
6. Establishes the Uniform Controlled Substances Act which regulates controlled substances and 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)
7. Classifies controlled substances in five schedules according to their danger and potential for abuse. (HSC § 11054-11058)
8. Prohibits any person other than a physician, dentist, podiatrist, veterinarian, ND (according to certain supervision and protocol requirements), pharmacist (according to certain authorizations, policies and procedures), CNM (if furnished or ordered incidentally to the provision of family planning services, routine health care or perinatal care, or care rendered consistent with the CNM’s practice; occurs under physician and surgeon supervision; and is in accordance with standardized procedures or protocols as specified), NP (if it is consistent with a NP’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); a pharmacist or registered nurse or PA 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. (Health and Safety Code (HSC) § 11150)
9. 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)
10. 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))
    

This bill:

1. States findings and declarations that the opioid epidemic is a public health crisis; that over 80 percent of opioid prescriptions originated from physician offices; and that opioid prescriptions declined by an average of three percent between 2014 and 2017.
2. States Legislative intent that opioid prescriptions in California for Schedule II and Schedule III drugs continue in a year-over-year downward trend consistent with the average trend established between 2014 and 2017.
3. Requires, by July 1, 2019, every health care practitioner who prescribes, orders, administers, or furnishes Schedule II and Schedule III to establish or adopt a safe opioid prescribing policy (Policy). Authorizes a group of practitioners to adopt a Policy that applies to all parties as part of a business affiliation or contract with an organized provider group.
4. States that a health care practitioner or group of practitioners is deemed to have satisfied the Policy adoption requirement by adopting a nationally recognized guideline for the use of opioids for managing pain if the guideline meets the criteria in Item #5) below.
5. Requires the Policy to be a written document promoting the appropriate dosage and duration of opioid prescriptions for patients, with the goal of reducing the overall prescription, ordering, administration, or furnishing of opioids to the lowest effective dose and the shortest duration necessary to treat the patient. Requires the policy to address, but not be limited to:
6. The appropriate dose and duration of prescriptions for adult patients experiencing acute pain.
7. The appropriate dose and duration of prescriptions for pediatric patients experiencing acute pain.
8. Alternatives to opioid treatment, including nonpharmacological treatment options and referral to specialty care, as appropriate.
9. Recommendations for assessing patients’ continued use of opioids for pain management.
10. Concurrent prescription of opioid antagonists to at-risk patients according to certain criteria.
11. Recommendations for counseling patients on overdose and addiction risk and response.
12. Requires the development of a Policy to include review and consideration of evidence-based science, literature, research, and guidelines, including relevant recommendations and research from academia and consideration of existing guidelines and recommendations from groups including, but not limited to, the federal Centers for Disease Control and Prevention (CDC), the federal Centers for Medicare and Medicaid Services, the Medical Board of California (MBC), and the American Society of Addiction Medicine. Requires the Policy to be reviewed periodically and updated according to applicable scientific studies and available data.
13. Requires a prescriber who determines, based on his or her professional judgment, that the Policy is not appropriate for a specific patient’s treatment, to provide adequate documentation in the patient’s record to support the treatment decision.
14. Specifies that the Policy shall not place limitations on the prescription, ordering, administration, or furnishing of opioids to patients undergoing treatment for chronic pain, cancer, substance-use disorder, sickle cell disease with acute intermittent porphyria, hospice, or end-of-life care.
15. Requires a health care practitioner who fails to establish or adopt a Policy to be referred to the appropriate state professional licensing board solely for administrative sanctions, as deemed appropriate by that board.
16. Specifies that these provisions do not create a private right of action against a health care practitioner and do not limit a health care practitioner’s liability for the negligent failure to diagnose or treat a patient.
17. Requires the State Department of Public Health (DPH), by July 1, 2024, to submit a report to the Legislature and made available to the public that addresses: data about the number of opioid prescriptions and dosage of those prescriptions by prescribing license type, the year-by-year change in opioid prescription rates and dosages for prescriptions; the progress made toward reducing the over-prescription of opioids; recommendations for whether further reduction of opioid prescription is needed; and information, if available, on opioid prescriptions by geographic location. Requires data from the state’s prescription drug monitoring program, CURES, to be used in preparing the report and authorizes and encourages DPH to contract with an independent academic entity, including the University of California, to prepare the report.

FISCAL EFFECT: This bill is keyed fiscal by Legislative Counsel. According to the Assembly Committee on Appropriations analysis dated May 9, 2018, this bill will result in minor costs for DPH to monitor and report to the Legislature on reductions in opioid prescriptions; minor enforcement and information technology costs to health care boards that license prescribers and unknown General Fund costs, potentially in excess of $150,000, to the California Department of Corrections and Rehabilitation Division of Juvenile Justice and the Department of State Hospitals to develop compliant protocols.

COMMENTS:

1. Purpose. The Author is the Sponsor of this bill. According to the Author, “The California Office of Statewide Health Planning and Development reported that nearly 4,000 ER visits in California were due to opioid overdoses in 2016, a year which had 23 million opioid prescriptions in California alone – in a state with a population of 40 million residents. The Author cites a nationwide study conducted by the University of Southern California that found “a high-risk user obtains 87.8 percent of their opioid prescriptions from a doctor’s office. More than 80 percent of the chronic and high-strength dosage prescriptions were from doctor office settings. Additionally, about 83.45 percent of opioid prescriptions originated from physician offices, while emergency departments were responsible for only 4.38 percent of opioid prescriptions in 2012.

According to the Author, “this bill is needed to curb opioid abuse and over prescribing of opioids. An estimate of 115 people die in the United States daily due to opioids and, according to the Centers for Disease Control and Prevention,
40 percent of all opioid overdose deaths in the country involved a prescription opioid.

Rural communities are among the most affected by the opioid epidemic and subject to drug abuse and dependency. According to the California Department of Public Health, Trinity County, a territory of an estimated 13,628 residents, had filled prescriptions of opioids 18,439 times, vastly exceeding the state’s average of prescription drug use (603.4 per 1,000 residents) and death rates (4.9 per 100,000 residents). According to the American Society of Addiction Medicine, there were 52,404 lethal drug overdoses in 2015, with 20,101 of those deaths being related to prescription pain relievers and 12,990 of those deaths being heroin-related.

AB 1998 stops short of a mandate and allows providers the opportunity to police themselves and make a serious effort to reduce unnecessary opioid prescriptions.”

The Author states that “the language of this bill holds providers accountable while also providing flexibility for providers to determine a policy that works best for them or their practice.”

1. 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 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).

1. 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. Results from the 2016 National Survey on Drug Use and Health found that 11.8 million people age 12 or older misused opioids in the past year, the vast majority of whom misused prescription pain relievers. Among people 12 or older who misused pain relievers in the past year, about half (53 percent) indicated that they obtained the last pain relievers they misused from a friend or relative.

The National Institute on Drug Abuse (NIDA) reports young adults (age 18 to 25) are the biggest abusers of prescription opioid pain relievers, ADHD stimulants, and anti-anxiety drugs. In 2014, more than 1,700 young adults died from prescription drug (mainly opioid) overdoses, more than died from overdoses of any other drug, including heroin and cocaine combined, and many more needed emergency treatment. The nonmedical use of prescription drugs is highest among young adults. Six percent of 12- to 17- year-olds, 12 percent of 18- to 25- year-olds and 5 percent of persons age 26 or older used prescription drugs nonmedically 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.

1. Prescription Drug Deaths. Prescription opioids continue to be involved in more overdose deaths than any other drug. NIDA reports that more than 1,700 young adults died from prescription drug overdose in 2014, a 4-fold increase from 1999, nearly 5 persons per day. According to the Centers for Disease Control (CDC), overdose deaths involving prescription opioids have quadrupled since 1999. CDC found that from 1999 to 2015, more than 183,000 people died in the U.S. from overdoses related to prescription opioids. CDC notes that the most common drugs involved in prescription opioid overdose deaths are methadone, oxycodone and hydrocodone. According to the CDC, among those who died from prescription opioid overdose between 1999 and 2014, overdose rates were highest among people aged 25 to 54, overdose rates were higher among non-Hispanic whites and American Indian or Alaskan Natives, compared to non-Hispanic blacks and Hispanics and men were more likely to die from overdose, but the mortality gap between men and women is closing.

1. Guidelines for Prescribing Controlled Substances. For certain types of medication, and certain types of medication prescribed to certain types of patients, guidelines on appropriate and safe prescribing practices can serve as a helpful tools for providers, patients and regulatory boards alike.
   

In 2016, CDC issued a Guideline for Prescribing Opioids for Chronic Pain. According to CDC, the Guideline addresses patient-centered clinical practices including conducting thorough assessments, considering all possible treatments, closely monitoring risks, and safely discontinuing opioids. The three main focus areas in the Guideline include:

• Determining when to initiate or continue opioids for chronic pain (Selection of non-pharmacologic therapy, nonopioid pharmacologic therapy, opioid therapy; Establishment of treatment goals; Discussion of risks and benefits of therapy with patients)
• Opioid selection, dosage, duration, follow-up, and discontinuation (Selection of immediate-release or extended-release and long-acting opioids; Dosage considerations; Duration of treatment; Considerations for follow-up and discontinuation of opioid therapy)
• Assessing risk and addressing harms of opioid use (Evaluation of risk factors for opioid-related harms and ways to mitigate patient risk; Review of prescription drug monitoring program (PDMP) data; Use of urine drug testing; Considerations for co-prescribing benzodiazepines; Arrangement of treatment for opioid use disorder)

In 1994, MBC unanimously adopted a policy statement entitled “Prescribing Controlled Substances for Pain.” Stemming from studies and discussions about controlled substances, this policy statement was designed to provide guidance to improve prescriber standards for pain management, while simultaneously undermining opportunities for drug diversion and abuse. The guidelines outlined appropriate steps related to a patient’s examination, treatment plan, informed consent, periodic review, consultation, records, and compliance with controlled substances laws. Subsequent to MBC’s 1994 action, legislation that took effect in 2002 (AB 487, Aroner, Chapter 518, Statutes of 2001) created a task force to revisit the 1994 guidelines to develop standards assuring competent review in cases concerning the under-treatment and under-medication of a patient's pain and also required CE courses for physicians in the subjects of pain management and the treatment of terminally ill and dying patients. The passage of AB 2198 in 2006 (Houston, Chapter 350, Statutes of 2006) updated California law governing the use of drugs to treat pain by clarifying that health care professionals with a medical basis, including the treatment of pain, for prescribing, furnishing, dispensing, or administering dangerous drugs or prescription controlled substances, may do so without being subject to disciplinary action or prosecution.

MBC currently encourages all licensees to consult the policy statement and Guidelines for Prescribing Controlled Substances for Pain which were updated in 2014 based on input from a MBC Prescribing Task Force that held multiple meetings to identify best practices. According to the MBC website, “The board strongly urges physicians and surgeons to view effective pain management as a high priority in all patients, including children, the elderly, and patients who are terminally ill. Pain should be assessed and treated promptly, effectively and for as long as pain persists. The medical management of pain should be based on up-to-date knowledge about pain, pain assessment and pain treatment. Pain treatment may involve the use of several medications and non-pharmacological treatment modalities, often in combination. For some types of pain, the use of medications is emphasized and should be pursued vigorously; for other types, the use of medications is better de-emphasized in favor of other therapeutic modalities. Physicians and surgeons should have sufficient knowledge or utilize consultations to make such judgments for their patients. Medications, in particular opioid analgesics, are considered the cornerstone of treatment for pain associated with trauma, surgery, medical procedures, or cancer.” MBC intends for the guidelines to educate physicians on effective pain management in California by avoiding under treatment, overtreatment, or other inappropriate treatment of a patient’s pain. Reduction of prescription overdose deaths is also an objective of the updated guidelines.

In 2015, the Osteopathic Medical Board of California, which licenses and oversees osteopathic physicians and surgeons, adopted the 2014 MBC guidelines.

1. Related Legislation This Year. Prescription medicine used to treat pain has been the focus of ongoing discussions in the Legislature, as California and the nation face an epidemic of prescription drug abuse and related overdose deaths.

SB 1109 (Bates) requires prescribers to take continuing education courses on the risks of addiction associated with the use of Schedule II controlled substances; requires additional warning labeling about the risks of addiction and overdose for opioid prescriptions; requires school districts, charter schools, and private schools that offer athletics programs, as well as youth sports organizations, to provide an information sheet to participants about the risk of opioid addiction that parents have to sign and return; and requires prescribers to discuss risks and dangers of opioids and opioid addiction with minors and their parents or guardians.  (Status:  This bill is pending in the Assembly Committee on Health.)​

AB 2174 (Waldron) requires the Department of Public Health (DPH), upon appropriation by the Legislature or receipt of adequate state or federal grant funding, and in consultation with stakeholders as appropriate, to develop, coordinate, implement and oversee a comprehensive multicultural public awareness campaign, designed to combat the growing heroin and opioid medication epidemic in the state. (Status: The measure is pending in the Assembly Committee on Appropriations.)

AB 2486 (McCarty) would establish the Opioid Prevention and Rehabilitation Program Fund to treat opioid addiction by providing existing programs the additional funding. (Status: The bill is pending in the Senate Committee on Health.)

AB 2487 (McCarty) would add opioid addiction training as a CME requirement for certain physicians to increase the availability of buprenorphine treatment. (Status: This bill is also pending in this committee.)

AB 2741 (Burke) would limit all opioid prescriptions for minors to a maximum of 5 days, with exceptions, and require a prescriber to discuss risks related to opioid medication with the minor and the minor’s parent or guardian and obtain written consent prior to writing the prescription. (Status: This bill is also pending in this committee.)

AB 2760 (Wood) would require certain prescriptions for opioids to also include a co-prescription for naloxone. (Status: This bill is also pending in this committee.)

1. Prior Related Legislation. SB 419 (Portantino) contained similar language to provisions of AB 2741 and SB 1109 above related to prescriber notification of and discussions with minor patients about opioid use when it was heard in this committee in 2017. (Status: The measure was amended to deal with a different subject.)

AB 182 (Waldron) of 2017 was substantially similar to the Author’s AB 2174 above. (Status: The measure was held under submission in the Senate Committee on Appropriations.)

AB 715 (Wood) of 2017 would have required DPH to convene a workgroup to review existing prescription guidelines and develop a recommended statewide guideline addressing best practices for prescribing opioid pain relievers. (Status: The bill was vetoed by the Governor who referenced the CDC and MBC guidelines in stating the bill was unnecessary.)

AB 1512 (McCarty) of 2017 would have imposed a tax of one cent ($0.01) per milligram on the distribution of opioids and required the amounts collected to be used for addiction prevention and rehabilitation programs. (Status: The bill was held in Assembly Committee on Revenue and Taxation).

AB 1977 (Wood) of 2016 would have established the Opioid Abuse Task Force to develop recommendations to the Legislature regarding the abuse and misuse of opioids in California. (Status: The measure was amended to deal with a different subject.)

AB 623 (Wood) of 2015 would have prohibited a health care service plan or health insurer from requiring the use of opioid drug products that have no abuse-deterrent properties in order to access abuse-deterrent opioid drug products; would have required pharmacists to provide a patient receiving an opioid drug product information about proper storage and disposal of the drug; and, would have mandated that a plan and insurer may not prevent a provider from prescribing a less than 30-day supply of opioids analgesic drugs and to provide coverage, if otherwise covered, for the less than 30-day prescription. (Status: The bill was held under submission in the Assembly Committee on Appropriations.)

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 workers compensation, 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 the 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.)

AB 831 (Bloom) of 2013 would have required the California Health and Human Services Agency (CHHSA) to convene a temporary working group to develop a state plan to reduce the rate of fatal drug overdoses and appropriated $500,000 from the General Fund to CHHSA to provide grants to local agencies to implement drug overdose prevention and response programs. (Status: The bill was held under submission in the Assembly Committee on Appropriations.)

1. Arguments in Support. America’s Physician Groups California Access Coalition, California Association of Code Enforcement Officers, California College and University Police Chiefs Association, California Council of Community Behavioral Agencies, California Narcotic Officers Association, Depression and Bipolar Support Alliance, and the Los Angeles County Professional Peace Officers Association write in support and note that this bill would address opioid overprescribing by requiring every health care practitioner authorized to prescribe opioids to adopt a safe prescribing protocol and would allow prescribes to use professional judgement to determine when a protocol is not appropriate.

The Osteopathic Physicians and Surgeons of California supports this bill if it is amended to incorporate prescriber guidelines for controlled substances endorsed by the MBC and the Osteopathic Medical Board of California.

1. Arguments in Opposition. The California Academy of Family Physicians and the

California Chapter of the American College of Emergency Physicians write in opposition and note that prescribing guidelines have been an important tool in combatting overprescribing; however, there are many reasons why a physician may need to deviate from a guideline and should not be face with administrative sanctions for doing so.

The California Medical Association (CMA) states that the concept of the bill, the adoption of a Policy, is one the organization has worked with the Author to develop into a more detailed policy which provides consistency in opioid prescribing with evidence-based guidelines developed by nationally and professionally recognized leaders in patient care. According to CMA, it is paramount that the bill “be something that, if signed, our members are able to actually and confidently implement.” CMA is requesting an amendment to clarify the applicability of the Policy adoption requirement in this bill.

1. Proposed Author’s Amendments. In response to concerns raised by interested parties and opponents above and in order to further clarify the intent of the bill, the Author has proposed the following changes to the bill (as outlined in the mockup below):
2. Clarify that a hospital pharmacy and therapeutics committee is included in the group of practitioners authorized to adopt a Policy.
3. Include professionally recognized guidelines or those established by a state licensing board or commission that were updated on or after January 1, 2015 as those which a practitioner or group of practitioners may adopt in order to comply with the Policy adoption requirement set forth in this bill.
4. Clarify that the requirement for a Policy to consider the appropriate dosage for adults and children is applicable to practitioners providing care for those populations.
5. Delete the requirement for a Policy to address concurrent prescription of opioid antagonists to at-risk patients according to certain criteria and instead require every Policy to include a requirement that the prescriber offer a prescription for naloxone hydrochloride or another drug approved by the United States Food and Drug Administration for the complete or partial reversal of opioid depression to a patient under certain conditions.

NOTE:

Double-referral to Senate Health Committee, second.

SUPPORT AND OPPOSITION:

Support:

America’s Physician Groups

California Access Coalition

California Association of Code Enforcement Officers

California College and University Police Chiefs Association

California Council of Community Behavioral Agencies

California Narcotic Officers Association

Depression and Bipolar Support Alliance

Los Angeles County Professional Peace Officers Association

Osteopathic Physicians and Surgeons of California

Opposition:

California Academy of Family Physicians

California Chapter of the American College of Emergency Physicians

-- END –

Mockup of AB 1998 as proposed to be amended

The people of the State of California do enact as follows:

SECTION 1. The Legislature finds and declares all of the following:

(a) The opioid epidemic is a public health crisis affecting not only the State of California, but the entire country.

(b) According to the federal Centers for Disease Control and Prevention, 66 percent of the drug overdose deaths in the United States involve an opioid.

(c) In 2016, there were almost 2,000 overdose deaths due to opioids alone, and nearly 4,000 emergency room visits due to opioid overdoses.

(d) According to a 2018 University of Southern California study, about 83.45 percent of opioid prescriptions originated from physician offices.

(e) In 2016, there were 23 million opioid prescriptions in California, a state that has nearly 40 million residents.

(f) According to data from the State Department of Public Health, opioid prescriptions declined by an average of three percent between 2014 and 2017.

SEC. 2. Section 11153.1 is added to the Health and Safety Code, to read:

11153.1. (a) It is the intent of the Legislature that, from July 1, 2019, to July 1, 2023, inclusive, opioid prescriptions in California for Schedule II and Schedule III, as defined in Sections 11055 and 11056 respectively, continue in a year-over-year downward trend consistent with the average trend established between 2014 and 2017.

(b) By July 1, 2019, every health care practitioner who prescribes, orders, administers, or furnishes opioids classified as Schedule II and Schedule III pursuant to Sections 11055 and 11056, respectively, shall establish or adopt a safe opioid prescribing policy, as described in subsection (d). A group of practitioners, including a hospital pharmacy and therapeutics committee, may adopt a safe opioid prescribing policy that applies to all parties as part of a business affiliation or contract with an organized provider group.

(c) A health care practitioner or group of practitioners, including a hospital pharmacy and therapeutics committee, is deemed to have satisfied this section by adopting a nationally or professionally recognized guideline, or guidelines established by a state licensing board or commission that were updated on or after January 1, 2015, for the use of opioids for managing pain if the guideline meets the requirements detailed in subsection (d).

(d) The safe opioid prescribing policy shall be a written document promoting the appropriate dosage and duration of opioid prescriptions for patients, with the goal of reducing the overall prescription, ordering, administration, or furnishing of opioids to the lowest effective dose and the shortest duration necessary to treat the patient. The policy shall address, but not be limited to, all of the following:

(1) The appropriate dose and duration of prescriptions for adult patients as applicable experiencing acute pain.

(2) The appropriate dose and duration of prescriptions for pediatric patients as applicable experiencing acute pain.

(3) Alternatives to opioid treatment, including nonpharmacological treatment options and referral to specialty care, as appropriate.

(4) Recommendations for assessing patients’ continued use of opioids for pain management.

(5) Concurrent prescription of opioid antagonists to at-risk patients, including, but not limited to, patients who meet any of the following criteria:

(A) An opioid dosage of 90 morphine milligrams or more per day.

(B) Patients who are prescribed benzodiazepines.

(C) Patients with a history of substance use disorder.

(5) Recommendations for counseling patients on overdose and addiction risk and response.

(e) In addition to the policy described in (d), every policy shall include a requirement that the prescriber offer a prescription for naloxone hydrochloride or another drug approved by the United States Food and Drug Administration (FDA) for the complete or partial reversal of opioid depression to a patient when one or more of the following conditions are present:

1. The prescription dosage for the patient is 90 morphine milligrams or more of an opioid medication per day.
2. An opioid medication is prescribed concurrently with a prescription for benzodiazepine.
3. The patient presents with an increased risk for overdose, including a patient with a history of overdose, a patient with a history of substance use disorder, or a patient at risk of returning to a high dose of opioid medication to which the patient is no longer tolerant.

(ef) The development of a safe opioid prescribing policy shall include review and consideration of evidence-based science, literature, research, and guidelines, including relevant recommendations and research from academia and consideration of existing guidelines and recommendations from groups including, but not limited to, the federal Centers for Disease Control and Prevention, the federal Centers for Medicare and Medicaid Services, the Medical Board of California, and the American Society of Addiction Medicine.

(fg) The safe opioid prescribing policy shall be reviewed periodically and updated according to applicable scientific studies and available data.

(gh) When a prescriber determines, based on his or her professional judgment, that the safe prescribing policy is not appropriate for a specific patient’s treatment, the health care practitioner shall provide adequate documentation in the patient’s record to support the treatment decision.

(i) A health care practitioner who prescribes, orders, administers, or furnishes opioids classified as Schedule II and Schedule III pursuant to Sections 11055 and 11056, respectively, to a hospital patient shall follow the guidelines or policy of that hospital’s pharmacy and therapeutics committee adopted pursuant to subdivision (d).

(hj) The safe opioid prescribing policy shall not place limitations on the prescription, ordering, administration, or furnishing of opioids to patients undergoing treatment for chronic pain, cancer, substance use disorder, sickle cell disease with acute intermittent porphyria, hospice, palliative care or end-of-life care.

(ik) (1) A health care practitioner who fails to establish or adopt a safe opioid prescribing policy, as required by subdivision (b), shall be referred to the appropriate state professional licensing board solely for administrative sanctions, as deemed appropriate by that board.

(2) This section does not create a private right of action against a health care practitioner. This section does not limit a health care practitioner’s liability for the negligent failure to diagnose or treat a patient.

(jl) (1) By July 1, 2024, the State Department of Public Health shall submit a report to the Legislature and publish to the public, using data from the CURES database, detailing progress toward the goal stated in subdivision (a). The department may, and is encouraged to, contract with an independent academic entity, including the University of California, to prepare the report. The report shall address, but not be limited to, all of the following:

(A) The overall number of opioid prescriptions, rates of opioid prescription per 1,000 persons, and morphine milligram equivalents per year in the years 2019 to 2023, inclusive. This information shall be provided in total, and by prescribing license.

(B) The overall year-by-year change in opioid prescriptions, rates of opioid prescription per 1,000 persons, and morphine milligram equivalents from the years 2019 to 2023, inclusive.

(C) The progress made toward reducing the over-prescription of opioids.

(D) Recommendations for whether further reduction of opioid prescription is needed.

(E) Information, if available, on opioid prescriptions by geographic location.

(2) Before publishing the final report, the department shall provide an opportunity for feedback on the draft report by relevant stakeholders.

(3) The report submitted pursuant to this subdivision shall be submitted in compliance with Section 9795 of the Government Code.

(4) The requirement for submitting a report imposed under this subdivision is inoperative on July 1, 2028, pursuant to Section 10231.5 of the Government Code.

SEC. 3. No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.

ASSEMBLY THIRD READING

ATR Bill Id:AB 1998

Author:(Rodriguez)

As Amended Ver:May 25, 2018

Majority vote

SUMMARY: Requires every healthcare practitioner authorized to prescribe opioids classified as Schedule II and Schedule III to adopt a safe prescribing policy (SPP), as specified. Specifically this bill:

1. Allows for a group of practitioners to adopt a SPP that applies to all parties as part of a business affiliation or contract with an organized provider group.
2. Establishes it is the intent of the Legislature that by July 1, 2023, there will be a continued decline on a year-over-year downward trend consistent with the average trend established between the years 2014 and 2017 (3% per year).
3. Requires the California Department of Public Health (DPH) by July 1, 2024, to submit to the legislature and publish to the public, using data from the Controlled Substance Utilization, Review and Evaluation System (CURES) database, a report detailing progress toward the stated goal. Encourages DPH to contract with an independent academic entity to prepare the report.

FISCAL EFFECT: According to the Assembly Appropriations Committee:

1. Minor costs to CDPH to monitor and report to the Legislature on reductions in opioid prescriptions.
2. Potential minor enforcement costs, as well as minor information technology costs to add new enforcement codes, to health care boards within the Department of Consumer Affairs (DCA) that license prescribers, including the Medical Board of California, the Osteopathic Medical Board of California, the Board of Registered Nursing, and Physician Assistant Board (various fee-supported special funds).
3. Unknown General Fund costs, potentially in excess of $150,000, to the California Department of Corrections and Rehabilitation Division of Juvenile Justice and the Department of State Hospitals to develop compliant protocols.

COMMENTS: According to the author, California is experiencing an opioid epidemic. Excessive prescriptions are a significant factor in the amount of opioid overdoses and deaths in the state. Currently, there is no regulation on the quantity or supply of opioid prescriptions a doctor can prescribe. The author believes that the lack of such regulations directly contributes to excessive prescriptions. According to a 2018 University of Southern California study, about 83.45% of opioid prescriptions originated from physician offices, while emergency departments were responsible for only 4.38% of opioid prescriptions in 2012. The author contends, that when coupled with 2016 statistics from the DPH, which reveal that there were 1,925 opioid overdose deaths and 3,935 opioid overdose emergency visits, it becomes clear that over-prescription of opioids coming from physician offices is one of the biggest factors contributing to the opioid epidemic. The author concludes that the cause of over-prescribing is a direct result of the lack of regulation in existing law.

The America’s Physician Groups (APG) in support of this bill state that the providers at APG take this public health crisis very seriously and is committed to working in addressing this terrible crisis impacting patients, their families and the communities they live in. In recognition of this crisis, APG developed a tool for prescribers to use in prescribing opioids. This bill mirrors much of this work to provide prescribers clinically-based and patient focused protocols relating to chronic pain management. The California Council of Community Behavioral Health Agencies also in support states that this bill would address opioid overprescribing by requiring every health care practitioner to adopt a safe prescribing protocol. This bill is a vital measure in preventing opioid abuse before it can take place.

There is no known opposition to the current version of this bill.

Analysis Prepared by: Judith Babcock / HEALTH / (916) 319-2097 FN: 0003339

Date of Hearing: May 9, 2018

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez Fletcher, Chair

ABPCA Bill Id:AB 1998

Author:(Rodriguez) – As Amended Ver:April 11, 2018

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

SUMMARY:

This bill requires health care practitioners authorized to prescribe specified opioid drugs to adopt a safe prescribing protocol and establishes an unspecified goal for a percentage reduction in opiate prescriptions that must be monitored and reported on by the California Department of Public Health (CDPH) by January 1, 2022.

FISCAL EFFECT:

1. Minor costs to CDPH to monitor and report to the Legislature on reductions in opioid prescriptions.
2. Minor enforcement costs, as well as minor information technology costs to add new enforcement codes, to health care boards within the Department of Consumer Affairs (DCA) that license prescribers, including the Medical Board of California, the Osteopathic Medical Board of California, the Board of Registered Nursing, and Physician Assistant Board (various fee-supported special funds).
3. Unknown GF costs, potentially in excess of $150,000, to the California Department of Corrections and Rehabilitation Division of Juvenile Justice and the Department of State Hospitals to develop compliant protocols.

COMMENTS:

1. Purpose. This bill is intended to combat over-prescribing of opiates by requiring development of and adherence to evidence-based protocols.
2. Background. Most opioid analgesics (pain relief drugs) are Schedule II drugs—drugs with a recognized medical use, but with a high potential for abuse, that may lead to severe psychological or physical dependence. A number of prescribing guidelines exist, but adoption is not universal among health care providers. Over 2,000 people died due to opioid overdoes in California in 2016. Public health professionals have pointed to opiate overprescribing as one reason the crisis has grown.
3. Staff Comment. Some of the protocols seem too specific to be enshrined in statute—for instance, a protocol implying providers should co-prescribe opioid antagonists to patients with an opioid dosage of 90 morphine milligrams or more per day. Because medical science changes, the author may wish to avoid referencing specific dosages and medications in favor of more general requirements.

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

Date of Hearing: April 24, 2018

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Evan Low, Chair

ABPCA Bill Id:AB 1998

Author:(Rodriguez) – As Amended Ver:April 11, 2018

SUBJECT: Opioids: safe prescribing protocol.

SUMMARY: Beginning June 1, 2019, requires every health care practitioner authorized to prescribe opioids classified as Schedule II and Schedule III to adopt a safe prescribing protocol (SPP); additionally requires the State Department of Public Health to utilize data from the CURES prescription drug monitoring program to report on progress toward to-be-specified opioid prescription reduction objectives to be met by January 1, 2022.

EXISTING LAW:

1. Allows only a physician, dentist, podiatrist, veterinarian, naturopathic doctor, registered nurse, certified nurse-midwife, optometrist, or out-of-state prescriber to write or issue a prescription. (Health and Safety Code (HSC) § 11150)
2. States that a prescription for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice, and that the responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. (HSC § 11153)
3. Prohibits medical professionals from prescribing, administering, or dispensing a controlled substance to an addict, as defined. (HSC § 11156)
4. Establishes the Controlled Substance Utilization Review and Evaluation System (CURES), a PDMP maintained by the California Department of Justice (DOJ) for the purposes of collecting records of dispensed controlled substances for review by licensed prescribers and dispensers, regulatory investigators, law enforcement, and statistical researchers. (HSC § 11165)
5. Requires pharmacists and other dispensers to report information to CURES within 7 days relating to prescriptions of Schedule II, III, and IV controlled substances. (Id.)
6. Authorizes the use of deidentified data from CURES for statistical analysis, education, and research. (Id.)
7. Requires health care practitioners in receipt of a federal Drug Enforcement Administration (DEA) registration providing authorization to prescribe controlled substances, as well as pharmacists, to register for access to the CURES database. (HSC § 11165.1(a))
8. Pending certification of readiness by the DOJ, requires certain health care practitioners 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 once every four months thereafter if the substance remains part of the treatment of the patient, with certain exceptions. (HSC § 11165.4)
9. Prohibits any person from obtaining or attempting to obtain a prescription for controlled substances, by fraud, deceit, misrepresentation, subterfuge, or the concealment of a material fact. (HSC § 11173)
10. Enables security printers and prescribers to report stolen or lost prescription pads to the DOJ through CURES. (HSC § 11165.3)

THIS BILL:

1. States that it is the intent of the Legislature that by January 1, 2022, there shall be a to-be-specified reduction in the number of prescriptions issued in California for opioids classified as Schedule II and Schedule III, as well as the quantify of doses for these prescriptions.
2. Requires, beginning June 1, 2019, that every health care practitioner authorized to prescribe opioids classified as Schedule II and Schedule III adopt a safe prescribing protocol.
3. Allows a group of practitioners to adopt a safe prescribing protocol that applies to all parties as part of a business affiliation or contract with an organized provider group.
4. Defines “safe prescribing protocol” as a written document promoting the appropriate and optimal selection, dosage, and duration of opioid prescriptions for patients, with the goal of reducing the misuse of opioids.
5. Requires a safe prescribing protocol to include, at a minimum, the following:
   1. The maximum dose and duration of prescriptions for adult patients experiencing acute pain.
   2. The maximum dose and duration of prescriptions for pediatric patients experiencing acute pain.
   3. Alternatives to opioid treatment, including nonpharmacological treatment options.
   4. Refill authorization practices.
   5. Coprescription of opioid antagonists to specified at-risk patients.
   6. Referral guidelines and policies between primary care and specialty care, including, but not limited to, pain specialists.
   7. Mechanisms for prescriber peer-to-peer review and cooperation.
   8. Procedures for periodic review of the protocol for effectiveness in reducing opioid prescription.
   9. Procedures for updating the protocol, as appropriate.
   10. Mechanisms for patient education on the side effects of opioids, including the risk of addiction and overdose.
6. Requires that the development of a safe prescribing protocol shall include review and consideration of evidence-based science, literature, research, and guidelines.
7. States a health care practitioner or a group of practitioners may adopt the federal Centers for Medicare and Medicaid Services opioid prescribing guidelines as the safe prescribing protocol.
8. States that if, in the health care practitioner’s professional judgment, adherence to the safe prescribing protocol is not appropriate for a patient’s condition, the practitioner shall note in the patient’s medical record the reason the protocol was not followed.
9. Specifies that these requirements do not apply to a health care practitioner who is authorized to prescribe opioids if the prescription of those opioids is limited to patients undergoing treatment for chronic pain, cancer, substance use disorder, or hospice or end-of-life care.
10. States that failure to develop or adhere to the protocol is unprofessional conduct and enforceable by the health care practitioner’s licensing board.
11. Requires the State Department of Public Health, utilizing data from the CURES database for the year ending December 31, 2016, to monitor progress toward the Legislature’s opioid prescription reduction goal and report this information to the Legislature annually.

FISCAL EFFECT: Unknown; this bill is keyed fiscal by the Legislative Counsel.

COMMENTS:

Purpose. This bill is sponsored by the author. According to the author:

As an Emergency Medical Technician for over 3 decades, I have responded to far too many fatal overdose incidents which destroy families and communities. Given that almost half of opioid related overdose deaths come from prescriptions, it is time that we ensure excessive prescriptions are limited while providing physicians the flexibility to properly care for patients. The opioid crisis is real and as more potent drugs are being added to the market, something must be done to save lives from addiction, or worse.

Background. Overview of the Opioid Crisis. In October of 2017, the White House declared the opioid crisis a public health emergency, formally recognizing what had long been understood to be a growing epidemic responsible for devastation in communities across the country. According to the Centers for Disease Control and Prevention, as many as 50,000 Americans died of an opioid overdose in 2016, representing a 28 percent increase over the previous year. Additionally, the number of Americans who died of an overdose of fentanyl and other opioids more than doubled during that time with nearly 20,000 deaths. These death rates compare to, and potentially exceed, those at the height of the AIDS epidemic.

Opioids are a class of drugs prescribed and administered by health professionals to manage pain. Modern use of the term “opioid” typically describes both naturally occurring opiates derived from the opium poppy as well as their manufactured synthetics. Common examples of prescription opioids include oxycodone (OxyContin, Percocet); hydrocodone (Vicodin, Norco, Lorcet); codeine; morphine; and fentanyl. Heroin is also an opioid.

In addition to providing pain relief, opioids can be used as a cough suppressant, an antidiarrheal, a method of sedation, and a treatment for shortness of breath. The majority of pharmaceutical opioids are Schedule II drugs under the federal Controlled Substances Act, considered by the federal Drug Enforcement Agency (DEA) to have a high potential for abuse that may lead to severe psychological or physical dependence. However, combination drugs containing lower doses of opioids combined with other active ingredients are typically less restricted; for example, cough syrups containing low doses of codeine are frequently classified Schedule V medications.

The abuse of prescription drugs was historically viewed as a criminal concern analogous to street narcotics cases regularly investigated by law enforcement. In recent years, however, an expert consensus has evolved around the opinion that the opioid crisis must be addressed through the lens of public health policy. This belief is supported by research demonstrating how health professionals may have inadvertently contributed to the origins of the crisis. It is widely accepted that health professionals will play a critical role in any meaningful solutions.

In the opioid crisis’s broader national context, there has been a persistent perception that California represents a relatively minor segment of an epidemic more typically identified with states like New Hampshire and West Virginia. However, there is substantial evidence that communities in California have been much harder hit than may be generally believed. For example, in 2015, several rural counties in California saw as many or more drug overdose deaths per 100,000 residents than some Midwestern states. It has been reported than some small counties had more opioid prescriptions than residents. In total, the California Department of Public Health estimates that nearly 2,000 Californians died of an opioid overdose in 2016.

In February of 2018, a bipartisan coalition of California State Assemblymembers announced a package of legislation aimed at combating the opioid crisis. The bills have been presented as representing a diversity of approaches to curbing overprescription, encouraging treatment, and preventing diversion. The potential of each proposed measure to effectively address the epidemic of prescription drug abuse must be evaluated in proportion to any added burden to those health professionals who remain tasked with ensuring that legitimate treatment continues to be provided to patients with pain management needs.

CURES Database. CURES was first established in 1996 as a “technologically sophisticated” database containing prescription records collected through California’s Triplicate Prescription Program, which provided the DOJ with copies of all Schedule II drug prescriptions. Subsequent legislation made CURES the state’s sole prescription record repository and added Schedule III and IV drugs to the database. In 2008, CURES was upgraded to function as a PDMP, allowing health professionals, regulators, and law enforcement to conduct web-based searches of the system to inform prescribing practices and support investigations.

Every dispenser of controlled substances and every health practitioner authorized by the DEA to prescribe controlled substances is required to obtain a login for access to CURES. For each dispensed Schedule II, III, or IV drug, pharmacists are required to report basic information about the patient and their prescription within 7 days. This information is then made available to other system users in a variety of possible contexts. For example, physicians may query a patient’s prescription history prior to writing a new prescription; pharmacists can check the system before agreeing to fill a prescription for a controlled substance; regulators may review a licensee’s prescribing practices as part of a disciplinary investigation; and law enforcement can incorporate a search of the system into a potential criminal case of drug diversion.

Over 50 million prescription records have been uploaded into the system by dispensing pharmacists since the beginning of the CURES program. As of January 1, 2018, 170,422 users had been approved for access to the system. Last year, close to 10 million activity reports had been processed by practitioners, pharmacists, law enforcement, and regulatory users. The vast majority of these searches (over 99%) were queries made by prescribers and dispensers seeking to review a patient’s prescription history as a component of exercising informed clinical judgment before providing access to opioids or other controlled substances.

Access to CURES is limited by a number of state and federal privacy laws. This includes the Health Insurance Portability and Accountability Act (HIPAA), the California Medical Information Act, and the Information Practices Act. Whether law enforcement use of the system implicates the Fourth Amendment’s protections against unreasonable searches remains a topic of debate. In 2017, the Supreme Court of California ruled in Lewis v. Superior Court that privacy interests are justified by the state’s interest in preventing drug diversion and protecting patients.

CURES data, once deidentified, is authorized by statute to be provided to academic and public health institutions for research purposes. The data is currently utilized by the State Department of Public Health to populate a statewide dashboard relating to opioid prescription and overdose statistics. This dashboard is the result of a partnership between the State Department of Public Health and the California Department of Justice, in addition to other entities.

Prescription Limitations. Because of the role overprescription has played in exacerbating the opioid crisis, some health experts have suggested capping the number of days a drug can be prescribed for at a time. In July of 2017, the Center for Disease Control released updated guidelines that recommended no more than a 3-day prescription for acute pain management. This bill no longer directly limits how many days an opioid may be prescribed for, but merely requires that prescribers utilize safe prescribing protocols as a way of reducing overall prescriptions.

Current Related Legislation. AB 1751 (Low) would provide a framework for the CURES PDMP to connect with other states that comply with California’s patient privacy and data security standards.

AB 1752 (Low) would add Schedule V drugs to the CURES database and change the requirement for pharmacists to report dispensed prescriptions from seven days to the following business day.

AB 1753 (Low) would limit the number of security printers authorized to manufacture prescription pads and linking uniquely serialized pads with CURES.

AB 2741 (Burke) would limit all opioid prescriptions for minors to a maximum of 5 days, with exceptions, and require a prescriber to discuss risks related to opioid medication with the minor and the minor’s parent or guardian and obtain written consent prior to writing the prescription.

AB 2384 (Arambula) would remove barriers to medication-assisted treatment, such as prior authorization requirements and limits on coverage.

AB 2859 (Caballero) would increase safe storage practices among parents to prevent access to prescription drugs in the home by children and adolescents.

AB 2086 (Gallagher) would allow prescribers of controlled substances to review a list of patients for whom they are listed as being the prescriber.

AB 2487 (McCarty) would add opioid addiction training as a continuing medical education requirement for certain physicians to increase the availability of buprenorphine treatment.

AB 2486 (McCarty) would establish the Opioid Prevention and Rehabilitation Program Fund to treat opioid addiction by providing existing programs the additional funding.

AB 2783 (O’Donnell) would reconcile discrepancies between California’s controlled substance schedules and the corresponding federal controlled substance schedules.

AB 1963 (Waldron) would incentivize medical providers to become certified prescribers of medication-assisted treatment by increasing the reimbursement rates for providers who prescribe these drug treatments.

AB 2789 (Wood) would require that prescriptions be submitted electronically, with limited exceptions.

AB 2760 (Wood) would require certain prescriptions for opioids to also include a co-prescription for naloxone.

Prior Related Legislation. AB 1048 (Arambula, Chapter 615, Statutes of 2017) authorized a pharmacist to dispense a Schedule II controlled substance as a partial fill if requested by the patient or the prescriber.

SB 482 (Lara, Chapter 708, Statutes of 2016) mandated that health practitioners consult a patient’s history in CURES prior to prescribing them a Schedule II, III, or IV controlled substance for the first time and then at least once every four months as long as the prescription continued to be renewed.

REGISTERED SUPPORT:

None on file.

REGISTERED OPPOSITION:

None on file.

Analysis Prepared by: Robert Sumner / B. & P. / (916) 319-3301

Date of Hearing: April 17, 2018

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 1998

Author:(Rodriguez) – As Amended Ver:April 11, 2018

SUBJECT: Opioids: safe prescribing protocol.

SUMMARY: Requires every healthcare practitioner authorized to prescribe opioids classified as Schedule II and Schedule III to adopt a safe prescribing protocol (SPP), as specified. Establishes it is the intent of the Legislature that by January 1, 2022, there will be an, as yet, undetermined percentage reduction in the number of prescriptions issued in California classified as Schedule II and Schedule III and an, as yet, undetermined percentage reduction in the quantity of doses authorized in prescriptions for opioids classified as Schedule II and Schedule III. Specifically, this bill:

1. Establishes Legislative intent that by January 1, 2022, there will be:
   1. An, as yet, undetermined percentage reduction in the number of prescriptions issued in California for opioids classified as Schedule II and Schedule III, respectively; and,
   2. An, as yet, undetermined percentage reduction in the quantity of doses authorized by prescriptions for opioids classified as Schedule II and Schedule III.
2. Requires by June 1, 2019, every healthcare practitioner authorized to prescribe opioids classified as Schedule II and Schedule II respectively, to adopt a SPP. Allows a group of practitioners to adopt a SPP that applies to all parties as part of a business affiliation or contract with an organized provider group.
3. Requires the SPP to be a written document promoting the appropriate and optimal selection, dosage, and duration of opioid prescriptions for patients, with the goal of reducing the misuse of opioids. Requires the protocol to include, but not be limited to, all of the following:
   1. The maximum dose and duration of prescriptions for adult patients experiencing acute pain;
   2. The maximum dose and duration of prescriptions for pediatric patients experiencing acute pain;
   3. Alternatives to opioid treatment, including nonpharmacological treatment options;
   4. Refill authorization practices;
   5. Co-prescription of opioid antagonists to at-risk patients, including, but not limited to patients who meet any of the following criteria:
      1. An opioid dosage of 90 morphine milligrams equivalents (mme) or more per day;
      2. Patients who are prescribed benzodiazepines; and,
      3. Patients with a history of substance use disorder.
   6. Referral guidelines and policies between primary care and specialty care, including, but not limited to, pain specialists;
   7. Mechanisms for prescriber peer-to-peer review and cooperation;
   8. Procedures for periodic review of the protocol of effectiveness in reducing opioid prescriptions;
   9. Procedures for updating the protocol; and,
   10. Mechanisms for patient education on the side effects of opioids, including the risk of addiction and overdose.
4. Requires development of the SPP to include review and consideration of evidence-based science, literature, research, and guidelines, including relevant recommendations and research from academia and consideration of existing guidelines and recommendations from groups including, but not limited to the Federal Centers for Disease Control and Prevention (CDC), the federal Centers for Medicare and Medicaid Services (CMS), the Medical Board of California (MBC), and the American Society of Addiction Medicine.
5. Provides for a healthcare practitioner or a group of practitioners to adopt the CMS opioid prescribing guidelines as the SPP.
6. Provides that if, in the healthcare practitioner’s professional judgment, adherence to the SPP is not appropriate for a patient’s condition, the practitioner to note in the patient’s medical record the reason the protocol was not followed.
7. Exempts the prescribing of opioids to patients undergoing treatment for chronic pain, cancer, substance use disorder, or hospice or end-of-life care from the requirements of this bill.
8. Establishes failure to develop or adhere to the protocol established as a result of this bill, except at provided in 6) above to be unprofessional conduct and enforceable by the healthcare practitioner’s respective licensing board.
9. Requires the Department of Public Health (DPH) using data from the Controlled Substance Utilization Review and Evaluation System database for year ending December 31, 2016, to monitor progress toward the goals stated in 1) above and to report annually to the Legislature.

EXISTING LAW:

1. Provides for the licensure, registration, certification, regulation and oversight of various prescribing healthcare providers by licensing boards, including the MBC, the Dental Board of California, the Board of Registered Nursing, the Osteopathic Medical Board of California, and others.
2. Authorizes healthcare providers such as Physicians and Surgeons, Dentists, and Osteopathic Doctors to prescribe medications, including controlled substances listed in Schedules II-V of the California Uniform Controlled Substances Act (CUCSA).
3. Authorizes Nurse Practitioners, Certified Nurse Midwives, and Physician Assistants, under certain limitations to prescribe medications, including controlled substances listed in Schedules II-V of the CUCSA.
4. Authorizes Naturopathic Doctors, under certain limitations to prescribe medications, including controlled substances listed in Schedules III-V of the CUCSA.
5. Requires prescription drugs to be ordered and dispensed in accordance with the Pharmacy Law.
6. Makes repeated acts of clearly excessive prescribing or administering of drugs or treatment unprofessional conduct for certain health care practitioners.

7) Authorizes a pharmacist to dispense a Schedule II controlled substance as a partial fill if requested by the patient or the prescriber.

FISCAL EFFECT: This bill has not yet been analyzed by a fiscal committee.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, California is experiencing an opioid epidemic. Excessive prescriptions are a significant factor in the amount of opioid overdoses and deaths in the state. Currently, there is no regulation on the quantity or supply of opioid prescriptions a doctor can prescribe. The author believes that the lack of such regulations directly contributes to excessive prescriptions. According to a 2018 University of Southern California study, about 83.45% of opioid prescriptions originated from physician offices, while emergency departments (ED) were responsible for only 4.38% of opioid prescriptions in 2012. The author contends, that when coupled with 2016 statistics from the DPH, which reveal that there were 1,925 opioid overdose deaths and 3,935 opioid overdose emergency visits, it becomes clear that over-prescription of opioids coming from physician offices is one of the biggest factors contributing to the opioid epidemic. The author concludes that the cause of over-prescribing is a direct result of the lack of regulation in existing law.
2. BACKGROUND.
   1. Opioids. Opioids are a class of narcotic drugs that include medications such as hydrocodone, oxycodone, morphine, codeine, and other related drugs. Most opioid analgesics are classified at Schedule II drugs in the California Uniform Controlled Substances Act (CUCSA), in that they have a recognized medical use, but also have a high potential for abuse that may lead to severe psychological and/or physical dependence. According to the DPH, in the past prescription opioids were prescribed for relieving short-tem (acute) pain. Today, they are increasingly being used for long-term (chronic) pain management. As a result, sales of opioid pain relievers have quadrupled in the past 10 years. Taken as prescribed, opioids can be used to manage pain safely and effectively. However, opioids may also produce other effects including euphoric response since these drugs affect the regions of the brain involving reward response. The National Institute on Drug Abuse states that those who abuse opioids may seek to intensify their experience by taking the drug in ways other than those prescribed such as snorting or injecting, thereby increasing their risk for serious medical complications, including overdose. Prescription opioid misuse can lead to long-term health problems, trouble breathing, overdose and death.
      
      The opioid crisis has been declared a public health emergency by the White House in that nationally; the opioid crisis is credited with the deaths of more than 50,000 Americans in 2016. In 2016 DPH reported 2,031 opioid deaths in California with 4,623 ED visits for all opioids (excluding heroin). Also, in 2016, deaths as a result of Fentanyl increased to 237 and there were more than 23.6 million opioid prescriptions issued in the State of California.
   2. Federal Controlled Substances Act. Certain drugs are classified under the federal Controlled Substances Act of 1970 (CSA) into one of five schedules. Placement in a given schedule depends on whether a drug has a currently accepted medical use, its relative abuse potential, and its likelihood of causing either addiction or physical dependency when abused. Most opioid analgesics are schedule II drugs, in that they have a recognized medical use, but also have a high potential for abuse that may lead to severe psychological dependence or severe physical dependence. The CSA places a number of restrictions on prescribers and pharmacies that dispense controlled substances such as opioids. For example, refills are not permitted and a new written prescription must be presented each time the drug is dispensed.
   3. Prescribing Guidelines. Over the past decade there has been a proliferation of opioid prescribing guidelines Whether a practitioner follows a set of guidelines or not and which set of guidelines they choose to follow, if any, has been largely left to the practitioner’s discretion. The guidelines are all different with varying recommendations and nuances. For example:
      1. CDC Guidelines for Prescribing Opioids for Chronic Pain (CDC Guidelines). CDC Guidelines recommend: “When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to 50 morphine milligram equivalents (MME)/ per day, and should avoid increasing dosage to more than 90 MME/day or carefully justify a decision to titrate dosage to more than 90 MME/day. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.” 
      2. MBC Guidelines for Prescribing Controlled Substances for Pain. Released in November 2014, the MBC guidelines were primarily intended to address the use of opioids in the long-term treatment of chronic pain, the guidelines briefly discussed opioid use for acute pain and stated: “Opioid medications should only be used for treatment of acute pain when the severity of the pain warrants that choice and after determining that other non-opioid pain medications or therapies likely will not provide adequate pain relief. When opioid medications are prescribed for treatment of acute pain, the number dispensed should be for a short duration and no more than the number of doses needed based on the usual duration of pain severe enough to require opioids for that condition. Long and intermediate duration-of-action opioids or extended-release/long-acting opioids should not be used for treatment of acute pain, including post-operative pain, except in situations where monitoring and assessment for adverse effects can be conducted.”
   4. California HealthCare Foundation Issue Brief (CHCF Brief). In June of 2016, the CHCF released a brief, entitled, “Case Studies: Three California Health Plans Take Action against Opioid Overuse.” The Brief describes the success these health plans experienced when they decided to initiate major programs aimed at opioid reduction within their health care plans. Each program was different, yet focused on similar themes, many of which can be replicated in individual or group practices through careful deliberation and development of SPPs. The three health plans, Partnership HealthPlan of California, a Medi-Cal plan serving 14 Northern California counties, Blue Shield of California, a commercial nonprofit health plan and Kaiser Permanente Southern California (KPSC), an integrated plan and delivery system, all reported significant reductions in opioid prescriptions and dosage when their respective programs were implemented. Programs and particulars all varied but results were reported as follows:
      1. Partnership Health Plan. “In the first 21 months of their program, Partnership dropped its total opioid prescriptions per member and total number of pills prescribed by 50% across the population; the number of members per 1,000 on high-dose daily opioids (greater than 120 mme) dropped by 50% as well. These numbers range from 9% to 66% depending on the county.”
      2. Blue Shield of California. “Within six months of implementation, Blue Shield noted the following changes: 25% reduction in new opioid uses progressing to chronic use of daily opioids, 33% reduction in prescribing of oxycodone extended release products, half of which came from reducing prescriptions for the highest-strength tables (80mg), a 10% reduction in the number of patients on the highest opioid doses (in excess of 500 mme per day), and a 19% reduction in total prescription volume per 10,000 members per month for all opioids.”
      3. KPSC. “Since starting its program in 2010, KPSC has seen a more than a 85% reduction in the prescribing of a brand name oxycodone, and a reduction in the prescribing of opioid/acetaminophen combinations of greater than 200 tablets by 98%. Prescribing of the combination of opioid plus benzodiazepine plus carisoprodol has decreased by 84%. Also between 2013 and 2015, KPSC has decreased the number of patients on high opioid doses (more than 120 MME per day) by 31%.”
   5. Other States Opioid Limitations. Twenty-nine states have adopted prescription limitations for opioid prescribing. For adults, the limitation is often for acute pain, leaving chronic, palliative and hospice care unlimited. Some limitations are for initial prescriptions only; however, in the case of children the dose limits are not restricted to initial prescriptions. The most restrictive limitation is Kentucky with a three-day limit for initial prescriptions for both adults and children. Most “limits” allow prescribers to prescribe more days/dosage if, in their professional judgment, it is warranted and the prescriber documents the exception in the patient’s health record.
3. SUPPORT. The AIDS Healthcare Foundation (AHF) in support of a prior version of this bill states that one of the well-known causes of risky sexual behavior is the use of drugs that reduce inhibitions and leads to less-cautious decisions about sexual activity. The CDC has called attention to the fact that prescription opioids are correlative to increase human immunodeficiency virus and sexually transmitted disease rates. AHF stated that regardless of nominal improvements in the opioid epidemic in California, it remains persistent and widespread, resulting in far too many deaths and far too great an impact on the public health. AHF points out that the consequences of uncontrolled opioid use suggests that limitations on prescriptions are warranted and necessary.
4. OPPOSITION. The California Medical Association (CMA) state in opposition to a prior version of this bill that this bill is unnecessary, arbitrary, burdensome to patients and physicians, and places the government between a patient and his or her physician. CMA further states that the determination that more than 3 days’ worth of medication is excessive, regardless of the patient diagnosis or any other pertinent factors, is not data-drive, nor evidence-based. CMA opposes this bill as it attempts to legislate the practice of medicine without any evidence-based or data-drive methods, but by arbitrarily limiting the dosage allowed to be prescribed by a physician regardless of the patient’s needs.
5. RELATED LEGISLATION.
   1. AB 1963 (Waldron) increases Medi-Cal reimbursement rates for providers who prescribe medication assisted drug treatments. AB 1963 is pending in the Assembly Appropriations Committee.
   2. AB 2086 (Gallagher) allows prescribers of controlled substances to access the Controlled Substances Utilization Review and Evaluation System database and review a list of patients for whom the prescriber is listed as being the prescriber. AB 2086 is pending in the Assembly Appropriations Committee.
   3. AB 2256 (Santiago) authorizes a pharmacy or wholesaler to furnish naloxone hydrochloride or other opioid antagonists to law enforcement agencies, under specified conditions. AB 2256 is pending in the Assembly Public Safety Committee.
   4. AB 2384 (Arambula) requires that drug formularies maintained by healthcare service plans, including Medi-Cal, or health insurers include specified prescription drugs for medication assisted treatment (MAT) and provides that MAT is presumed to be medically necessary and not subject to specified requirements including prior authorization and an annual or lifetime dollar limit. AB 2384 is pending in the Assembly Health Committee.
   5. AB 2741 (Burke) limits all opioid prescriptions for minors to a maximum of five days and requires a prescriber to discuss risks related to opioid medication with the minor and the minor’s parent or guardian and obtain written consent prior to writing the prescription. AB 2741 is pending in the Assembly Health Committee.
   6. AB 2760 (Wood) requires prescribers to co-prescribe naloxone when prescribed to patients who are identified to be in risk categories as defined. AB 2760 is pending in the Assembly Health Committee.
   7. AB 2783 (O’Donnell) reclassifies specified hydrocodone combination products as Schedule II controlled substances. AB 2783 is pending in the Assembly Public Safety Committee.
   8. AB 2789 (Wood) requires that by January 1, 2020 health care practitioners authorized to issue prescriptions will have the capability to transmit electronic data transmission prescriptions and requires that by January 1, 2021, health care practitioners issue prescriptions as an electronic data transmission. AB 2789 is pending in the Assembly Appropriations Committee.
   9. SB 1109 (Bates) requires: i) existing continuing education courses for all prescribers to include the risks of addiction and overdose; ii) a warning label on all Schedule II controlled substances prescription bottles on the associated addiction and overdose risks; iii) a minor’s and a parent’s or guardian’s signature after a required consultation with a prescriber for any minor receiving an initial opioid prescription; and, iv) an information sheet on the risks of opioids to be signed by a minor athlete and the minor athlete’s parent or guardian before participation in organized team sports. SB 1109 is pending in the Senate Business, Professions and Economic Development Committee.
6. PREVIOUS LEGISLATION.
   1. AB 1048 (Arambula), Chapter 615, Statutes of 2017, authorized a pharmacist to dispense a Schedule II controlled substance as a partial fill if requested by the patient or the prescriber.
   2. AB 715 (Wood) of 2017 would have required DPH to convene a workgroup for the purpose of reviewing existing guidelines and developing a recommended statewide guideline regarding the prescribing of opioid pain relievers for instances of acute, short-term pain, as specified. AB 715 was vetoed by Governor Edmund G. Brown, Jr., who stated:

“Since 2014, the Department of Public Health has led the Prescription Opioid Misuse and Overdose Prevention Workgroup which is comprised of state and local agencies as well as medical and patient organization committed to reducing opioid overdose rates in California.”

• 1. SB 419 (Portantino) would have prohibited a person from prescribing oxycodone to a patient under 21 years of age, except as specified. SB 419 was held at the Assembly Desk.
  2. AB 1977 (Wood) of 2016 would have established the Opioid Abuse Task Force to develop recommendations to the Legislature regarding the abuse and misuse of opioids in California. AB 1977 was amended and language pertaining to the Opioid Abuse Task Force was deleted.
  3. AB 623 (Wood) of 2015 would have prohibited health care service plans or health insurers from requiring the use of opioids that have no abuse-deterrent properties; would have required pharmacists to provide patients receiving an opioid product information about proper storage and disposal; and, would have authorized providers to prescribe less than 30-day supplies of opioids. AB 623 was held in the Assembly Appropriations Committee.
  4. AB 831 (Bloom) of 2013 would have required the California Health and Human Services Agency (CHHSA) to convene a temporary working group to develop a state plan to reduce the rate of fatal drug overdoses and would have appropriated $500,000 from the General Fund to CHHSA to provide grants to local agencies to implement drug overdose prevention and response programs. AB 831 was held in the Assembly Appropriations Committee.
  5. 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. SB 500 was amended and language pertaining to pain management was deleted.

7) DOUBLE-REFERRAL. This bill has been double-referred; upon passage of this committee, it will be referred to the Assembly Business and Professions Committee.

REGISTERED SUPPORT / OPPOSITION:

Support (Previous Version of Bill)

AIDS Healthcare Foundation

California Access Coalition

California Association of Joint Powers Authorities

Consumer Attorneys of California

Opposition (Previous Version of Bill)

American College of Obstetricians and Gynecologists

America’s Physician Groups

California Academy of Family Physicians

California Chapter of the American College of Emergency Physicians (California ACEP)

California Chronic Care Coalition

California Medical Association

California Pharmacists Association

California Rheumatology Alliance

National Health Law Program (NHeLP)

Analysis Prepared by: Judith Babcock / HEALTH / (916) 319-2097