Existing law, the Pharmacy Law, a knowing violation of which is a misdemeanor, provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. Existing A knowing violation of that law is a misdemeanor. That law requires a pharmacist to inform a patient orally or in writing of the harmful effects of a drug dispensed by prescription under specified circumstances, and requires a pharmacist to use professional judgment to provide a patient with directions for use that enhance the patients understanding of those directions. Existing regulatory law requires a pharmacist to provide oral consultation to a patient upon the patients request or whenever the pharmacist, in his or her professional judgment, deems it warranted.

This bill bill, except as specified, would require a pharmacist pharmacist, on dispensing any opioid medication to a patient or the patients agent for the first time, to provide oral consultation to a patient or the patients agent before dispensing any opioid medication the medication, in accordance with regulations to be adopted by the board, except as specified. board. The bill would prohibit the pharmacist from dispensing the medication if the patient or the patients agent declines the consultation. Because a knowing violation of the bills provisions would be a crime, the 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 Pharmacy Law, a knowing violation of which is a misdemeanor, provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. Existing law requires a pharmacist to inform a patient orally or in writing of the harmful effects of a drug dispensed by prescription under specified circumstances, and requires a pharmacist to use professional judgment to provide a patient with directions for use that enhance the patients understanding of those directions. Existing regulatory law requires a pharmacist to provide oral consultation to a patient upon the patients request or whenever the pharmacist, in his or her professional judgment, deems it warranted.

This bill would require a pharmacist to provide oral consultation to a patient or the patients agent before dispensing any opioid medication in accordance with regulations adopted by the board. board, except as specified. Because a knowing violation of the bills provisions would be a crime, the 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 Pharmacy Law, a knowing violation of which is a misdemeanor, provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. Existing law requires a pharmacist to inform a patient orally or in writing of the harmful effects of a drug dispensed by prescription under specified circumstances, and requires a pharmacist to use professional judgment to provide a patient with directions for use that enhance the patients understanding of those directions. Existing regulatory law requires a pharmacist to provide oral consultation to a patient upon the patients request or whenever the pharmacist, in his or her professional judgment, deems it warranted.

This bill would require a pharmacist to provide oral consultation to a patient or the patients agent before dispensing any opioid medication in accordance with regulations adopted by the board. Because a knowing violation of the bills provisions would be a crime, the 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

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Jerry Hill, Chair

2017 - 2018 Regular

Bill No: SB 1229 Hearing Date: April 23, 2018

Subject: Pharmacists: opioid medications: consultation

SUMMARY:

Requires a pharmacist, when 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 specifies that the initial consultation shall be a condition of obtaining the opioid medication and that the pharmacist shall not dispense the medication if the patient or the patient’s agent declines the consultation.

Existing law:

1. Establishes the Board of Pharmacy (BOP) to administer and regulate the Pharmacy Law. (Business and Professions Code (BPC) § 4001)
2. Authorizes BOP to adopt rules and regulations, not inconsistent with the laws of California, as may be necessary for the protection of the public pertaining to the practice of pharmacy; pertaining to establishments wherein any drug or device is compounded, prepared, furnished, or dispensed; and providing for standards of minimum equipment for licensed establishments. (BPC § 4005(a))
   
3. Provides that a pharmacist may provide consultation, training and education to patients about drug therapy, disease management, and disease prevention.
   (BPC § 4052 (a) (8))
   
4. Provides that a pharmacist shall use professional judgement to provide a patient with directions for use of a prescription drug that enhance the patient’s understanding of those directions and are consistent with the prescriber’s instructions. (BPC § 4076 (e))
   
5. Requires that in every pharmacy there shall be prominently posted in a place conspicuous to, and readable by, prescription drug consumers a notice provided by BOP concerning the availability of prescription price information, the possibility of generic drug product selection, the type of services provided by the pharmacies, and a statement describing patient’s rights relative to the requirements imposed on pharmacists to not obstruct a patient in obtaining a prescription drug or device that has been legally prescribed or ordered for that patient, except as specified.
   (BPC §§ 4122, 733)

Existing Pharmacy Regulations (Duty to Consult):

1. Requires a pharmacist to provide oral consultation to his or her patient or the patient’s agent in all care settings upon request, or whenever a pharmacist deems it warranted in the exercise of his or her professional judgment. (California Code of Regulations (CCR) § 1707.2 (a))
   
2. Requires that in addition to the obligation to consult in Item # 1 above, a pharmacist shall provide oral consultation to his or her patient or the patient’s agent in any care setting in which the agent is present whenever the prescription drug has not previously been dispensed to a patient, or whenever a prescription drug is dispensed by a pharmacy that has not been previously dispensed to a patient in the same dosage form, strength, or with the same written directions. (CCR § 1707.2 (b)(1))
   
3. Specifies that when the patient or agent is not present (including, but not limited, in a case where a prescription drug is shipped by mail), a pharmacy shall ensure that the patient receives written notice of his or her right to consultation, and a telephone number from which the patient may obtain oral consultation from a pharmacist who has ready access to the patient’s records. (CCR § 1707.2 (b)(2))
   
4. Provides that the oral consultation provided shall at least include directions for the use and storage, the importance of compliance with directions and precautions, and relevant warnings, including common severe side of adverse effects or interactions that may be encountered. (CCR § 1707.2 (c))
   
5. Provides that whenever a pharmacist deems it warranted in the exercise of his or her professional judgment, the oral consultation shall include additional information as specified. (CCR § 1707.2 (d))
   
6. Specifies that a pharmacist is not required to provide oral consultation when a patient or the patient’s agent refuses such consultation. (CCR § 1707.2 (e))
   
7. Requires that prior to consultation a pharmacist shall review a patient’s drug therapy and medication record before each prescription drug is delivered and the review shall include screening for severe potential drug therapy problems. (CCR § 1707.3)

This bill:

1. Requires a pharmacist, when 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 specifies that the initial consultation shall be a condition of obtaining the opioid medication and the pharmacist shall not dispense the medication if the patient of the patient’s agent declines the consultation.
   
2. Provides that a pharmacist at a hospital pharmacy, as defined, is not required to provide oral consultation before dispensing an opioid medication to a patient who has been admitted to the hospital.
   
3. Requires BOP to adopt regulations to implement this requirement of consultation before dispensing an opioid medication and can establish matters required to be to be discussed in the consultation.

FISCAL EFFECT:

Unknown. This bill is keyed “fiscal” by Legislative Counsel.

COMMENTS:

1. Purpose. This measure is sponsored by the Author. According to the Author, “the American Society of Addiction Medicine found that in 2012, 259 million prescriptions were written for opioids. They also found that four in five heroin users started by misusing prescription painkillers. Currently a pharmacist is not required to consult a patient when dispensing an opioid as the patient can waive the consult. The Author states, “if patients were required to be consulted by a pharmacist they would be alerted about the risks and better equipped to avoid misuse and thereby avoid a deadly addiction.”
   
   The Author indicates that this bill originated from talks with various law enforcement and healthcare professionals about their experiences with the increasing threat of opioid addiction and misuse that they have noticed in and around their communities.
2. 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 alone, more than 1,700 young adults died from prescription drug (mainly opioid) overdoses, which is more than died from overdoses of any other drug, including heroin and cocaine combined, and many more young adults 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 five percent of persons age 26 or older have 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 and 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 four-fold increase from 1999, when nearly five persons died 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 that the mortality gap between men and women is closing.
2. Related Legislation This Year. SB 1109 (Bates) would require prescribers to take continuing education courses on the risks of addiction associated with the use of Schedule II controlled substances; would require additional warning labeling on all Schedule II controlled substance vials or prescription bottles about the risks of addiction and overdose when using opioids; would require 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 would require prescribers to discuss risks and dangers of opioids and opioid addiction prior to prescribing minors controlled substances for the first time, unless the treatment is in an emergency or emergency surgery or the minor is undergoing addiction treatment or treatment for intractable pain. (Status: This bill passed out of this Committee by a vote of 8-0 on April 16, 2018 and is currently pending before the Senate Health Committee.)

SCR 115 (McGuire and Gaines) would recognize the impact opioid-related deaths have had on California communities, encourage the state to increase funding for support and other programs in rural areas facing the epidemic, and support groups and organizations working in California to combat the epidemic.
(Status: The bill is pending on the Senate Floor.)

AB 1998 (Rodriguez) would prohibit a prescriber from prescribing certain opioids in an amount greater that the patient needs for a three-day period unless the 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. (Status: The bill is pending in the Assembly Committee on Health.)

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 Assembly 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: The bill is pending in the Assembly Committee on Appropriations.)

AB 2741 (Burke) would limit 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. (Status: The bill is pending in the Assembly Committee on Health.)

AB 2760 (Wood) would require certain prescriptions for opioids to also include a co-prescription for naloxone. (Status: The bill is pending in the Assembly Committee on Health.)

AB 2859 (Caballero) would require a community pharmacy that dispenses Schedule II, III, or IV controlled substances to display safe storage products, as defined, for sale within the pharmacy department. (Status: The bill is pending in the Assembly Committee on Appropriations.)

AB 2741 (Waldron) would require 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.)

1. Prior Related Legislation. SCR 68 (Bates and Hill, Chapter 157, Statutes of 2017) designated the month of September 2017 as Opioid, Heroin, Fentanyl, and Prescription Drug Abuse Awareness Month, as specified.

AB 182 (Waldron) would have established the Heroin and Opioid Public Education (Hope) Act (Hope Program) and required DPH to develop, coordinate, implement, and oversee a public awareness campaign, as specified, upon appropriation or receipt of adequate state or federal funds, to educate targeted audiences about the growing heroin use and opioid medication abuse epidemic, as well as the importance and availability of services to avert addiction and to treat substance use disorders. (Status: Held under submission in Senate Appropriations Committee.)

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 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.)

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 Opposition. The California Medical Association (CMA) is opposed to this measure and argues that it is unnecessary, uncollaborative, and may likely result in delays for patients who have been prescribed critical medications by their physicians. As indicated by the CMA, pharmacists already have a professional duty to provide consultations to patients. Requiring a patient or patient’s agent who has been briefed by their physician and who may have an ongoing prescription for a chronic disease to sit through an unnecessary consultation my result in pointless delays in receiving medication for the patient. The CMA also states that this bill deviates from the historically collaborative relationship between the Medical Board of California and BOP. “For example, prior scope expansions proposals for pharmacists have included collaborative efforts between the two boards. Whether it was expanding access to immunizations, self-administered hormonal contraceptives, or nicotine replace products, the boards have partnered to promulgate the appropriate regulations and guidelines. SB 1229 leaves this important task to the Board of Pharmacy only.”
   
   The California Pharmacists Association (CPhA) and the California Retailers Association (CRA) also oppose this measure and writes that “[w]hile CPhA and CRA appreciate the author’s desire to address the opioid abuse plaguing our state, the provisions in SB 1129 mandates a consultation to occur even if the patient expressly declines to consult, as allowed in current law. This could put both the pharmacist and the patient in a very awkward position when the patients is picking up their needed medication and the pharmacist now has to act as a law enforcement type. Also, current regulations already provide the patient with information on opioids and the potential for addiction when the prescription is dispensed, known as patient packet inserts (PPI). For example, the PPI for the opioid OxyContin states, ‘A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly, as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.’”
   
   The American College of Obstetricians and Gynecologists is opposed to this measure and argues that “SB 1229 requires an additional, yet vague, consultation be performed by a pharmacist prior to dispensing an opioid, but it fails to include the prescribing physician in any decision-making to determine the details of the consultation. This requirement of pharmacists could interfere with the physician and patient relationship regarding the proper course of treatment and potentially delay the patient’s access to important medication.”

1. Is This Measure Necessary? Pharmacists are required to provide consultation to a patient or the patient's agent in all care settings upon request, or whenever the pharmacist deems it warranted in the exercise of his or her professional judgment.  The oral consultation provided by a pharmacist includes information like the importance of compliance with directions and precautions and relevant warnings, including common severe side or adverse effects or interactions that may be encountered.  A pharmacist is also authorized to include additional information whenever a pharmacist deems it warranted in the exercise of his or her professional judgment. 

The pharmacist’s broad authority and responsibility regarding providing consultation on any prescription medication, even those that are considered as more dangerous than others, would seem to be sufficient under these circumstances and requiring consultation even when refused does not seem necessary, if in the professional judgment of the pharmacists it is not warranted.

BOP has even made consultation for opioid drugs a priority in its enforcement actions. For example, in August 2013, the BOP made a 2012 license revocation case a "precedential decision."  In this case, BOP revoked the licenses of both a Huntington Beach pharmacy and its pharmacist because the pharmacist failed to comply with corresponding responsibility requirements in the distribution of opioid drugs.  The Decision and Order concluded that a pharmacist must inquire whenever a pharmacist believes that a prescription may not have been written for a legitimate medical purpose, and that the pharmacist must not fill the prescription when the results of a reasonable inquiry do not overcome concern about a prescription being written for a legitimate medical purpose.

SUPPORT AND OPPOSITION:

Support:

None on file as of April 17, 2018.

Opposition:

American College of Obstetricians and Gynecologists.

California Medical Association

California Pharmacists Association

California Retailers Association

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