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AB-2265 Pharmacy: dispensing controlled substances: lockable vials.(2021-2022)



Current Version: 04/06/22 - Amended Assembly

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AB2265:v97#DOCUMENT

Amended  IN  Assembly  April 06, 2022
Amended  IN  Assembly  March 30, 2022

CALIFORNIA LEGISLATURE— 2021–2022 REGULAR SESSION

Assembly Bill
No. 2265

Introduced by Assembly Member Arambula
(Principal coauthor: Senator Umberg)

February 16, 2022

An act to add Article 12.5 (commencing with Section 4178) to Chapter 9 of Division 2 of the Business and Professions Code, relating to healing arts.


LEGISLATIVE COUNSEL'S DIGEST


AB 2265, as amended, Arambula. Pharmacy: dispensing controlled substances: lockable vials.
Existing law, the Pharmacy Law, provides for the licensing and regulation of pharmacists by the California State Board of Pharmacy in the Department of Consumer Affairs. Existing law prohibits a person from possessing any controlled substance, with certain exceptions, including substances furnished to a person upon the prescription of a physician, dentist, podiatrist, optometrist, veterinarian, or another of specified healing arts licensees.
This bill would, commencing June 30, 2023, require a pharmacist, with certain exceptions, to dispense a Schedule II or Schedule IIN controlled substance in a lockable vial, as defined. The bill would require the pharmacist to also provide to a patient a specified opioid factsheet and the lockable vial vendor’s online assistance information or toll-free telephone number, which a vendor contracting with a pharmacy would be required to provide to the pharmacy. The bill would require the manufacturer of the controlled substance to reimburse the pharmacy within 30 days of receiving the pharmacy’s claim for reimbursement for the cost of the lockable vial, not to exceed $2 per vial, vial and for the pharmacy’s dispensing costs and services rendered, not to exceed $2.50 per vial. rendered. The bill would require the board, by October 1, 2023, to establish reasonable minimum and maximum amounts of reimbursement that include the cost of the lockable vial and services rendered and dispensing costs. The bill would make the manufacturer of a controlled substance subject to a civil penalty of $1,000 for each day the manufacturer is delinquent in reimbursing the pharmacy. The bill would, with certain exceptions, grant prescribers and pharmacists immunity from liability for adverse consequences resulting from a patient not being able to access their medication in a lockable vial or the failure of the lockable vial to prevent unauthorized access.
Existing law, when no other penalty is provided, makes a knowing violation of the Pharmacy Law a misdemeanor and, in all other instances, makes a violation punishable as an infraction.
This bill would exempt violations of the bill’s provisions from those criminal penalties. The bill would require the board to assess an unspecified fine, to be determined by the board, for a violation of the bill’s provisions by a pharmacist and would authorize the board to refrain from taking administrative action under certain circumstances, including a finding of financial hardship. The bill would exempt correctional pharmacies, correctional clinics, or patients of the Department of Corrections and Rehabilitation from the bill, and would authorize the board to adopt regulations to carry out its provisions. The bill would provide related findings and declarations of the Legislature.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: NO  

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


SECTION 1.

 (a) The Legislature finds and declares as follows:

(a)

(1) The federal Poison Prevention Packaging Act of 1970 (PPPA) requires child resistant caps for prescription medications, and these requirements have not been updated in the subsequent 50 years.

(b)

(2) After the PPPA was implemented, deaths in children five years of age and younger went down by 1.4 per million. This represented a reduction in the rate of fatalities, up to 45 percent, from projections of deaths without the presence of childproof packaging.

(c)

(3) Pilfering is the leading source of youth opioid abuse.

(d)

(4) Each year, nearly 600,000 children between 12 and 17 years of age initiate prescription drug abuse by pilfering medication from an adult in their home.

(e)

(5) Between 1999 and 2016, prescription and illicit drug poisonings saw an increased mortality rate of 268 percent.

(f)

(6) During the first year of the pandemic, opioid abuse in California rose 44.6 percent while in the nation as a whole it rose 30 percent.

(g)

(7) Locking pill vials have been shown to reduce or eliminate pilfering.

(h)

(8) Locking pill vials are inexpensive, costing less than $2 each, and the costs are expected to come down significantly.

(i)

(9) Long-term return on investment of locking pill vials in saved medical costs is anticipated to be over 80 percent.
(b) It is therefore the intent of the Legislature in enacting this act to do all of the following:
(1) Expand safety precautions for the administration of controlled substances in Schedule II and Schedule IIN of the federal Controlled Substances Act (21 U.S.C. Sec. 801 et seq.).
(2) Require a pharmacist who dispenses in solid oral dosage form a controlled substance in Schedule II or Schedule IIN of the federal Controlled Substances Act to dispense the substance in a lockable vial, except as specified.
(3) Require the manufacturer of a controlled substance covered by this act to reimburse a pharmacy for the cost of the vial and services rendered and dispensing costs.
(4) Require the California State Board of Pharmacy to establish reasonable minimum and maximum amounts of reimbursement to a pharmacy for the cost of the vial and services rendered and dispensing costs.
(5) Ensure that the cost of administering controlled substances in lockable vials does not increase costs to patients and insurers.

SEC. 2.

 Article 12.5 (commencing with Section 4178) is added to Chapter 9 of Division 2 of the Business and Professions Code, to read:
Article  12.5. California Safe Dispensing Act

4178.
 (a) This article shall be known, and may be cited, as the California Safe Dispensing Act.
(b) This article shall become operative on June 30, 2023.

4178.1.
 (a) As used in this article, “lockable vial” means a prescription locking vial that qualifies as a “safe storage product” as defined in paragraph (2) of subdivision (a) of Section 4106.5 that is made of materials classified as “generally recognized as safe” under Title 21 of the Code of Federal Regulations and meets the applicable standards specified in Part 1700 of Title 16 of the Code of Federal Regulations.
(b) Except as provided in subdivision (c), (d), a pharmacist who dispenses in solid oral dosage form a controlled substance in Schedule II or Schedule IIN of the federal Controlled Substances Act (21 U.S.C. Sec. 801 et seq.) shall do all of the following:
(1) Dispense the controlled substance in a lockable vial.
(2) Provide a copy of the Opioid Factsheet for Patients published by the federal Centers for Disease Control and Prevention.
(3) Provide the patient with information regarding the online assistance or toll-free telephone number made available by the vendor providing the lockable vial pursuant to subdivision (e). (f).

(A)

(c) (1) Except as provided in subparagraph (B), paragraph (2), a patient, the patient’s parent or legal guardian if the patient is a minor or otherwise unable to authorize medical care, or the conservator of the patient if the conservator has been given the power to make health care decisions for the patient, shall choose the code. code for the lockable vial.

(B)

(2) In the case of medications prescribed to a minor who may consent to services specified in Chapter 3 (commencing with Section 6920) of Part 4 of Division 11 of the Family Code, the minor shall choose the code. code for the lockable vial.

(c)

(d) (1) A pharmacist shall not dispense a controlled substance in Schedule II or Schedule IIN of the federal Controlled Substances Act in a lockable vial directly to a patient who, because of a physical or mental condition, to the pharmacist’s knowledge, would have difficulty opening the lockable vial.
(2) A pharmacist is not required to dispense a controlled substance in Schedule II or Schedule IIN of the federal Controlled Substances Act in a lockable vial in any of the following circumstances:
(A) The prescription, dispensation, and administration of the controlled substance occurs in a hospital or other inpatient care facility.
(B) The patient, including a patient who is a minor who may consent to services specified in Chapter 3 (commencing with Section 6920) of Part 4 of Division 11 of the Family Code, or the patient’s representative who is authorized pursuant to paragraph (3) of subdivision (b) (c) to choose the code for the lockable vial requests to their prescriber or the pharmacist that the patient’s medication not be dispensed in a lockable vial.
(C) The prescriber indicated on the prescription that the patient requested not to receive their medication in a lockable vial.

(d)

(e) (1) The manufacturer of a controlled substance covered by this section shall reimburse the pharmacy within 30 days of receiving a claim for the acquisition cost of lockable vials used by the pharmacy to dispense controlled substances covered by this section. The acquisition cost shall not exceed two dollars ($2) per lockable vial.
(2) The manufacturer of a controlled substance covered by this section shall compensate the pharmacy within 30 days of receiving the claim for dispensing costs and services rendered, including any patient consultation and instruction or any other professional services rendered to comply with this section. The board shall establish a reasonable rate of compensation that is not less than two dollars and fifty cents ($2.50) per lockable vial. A pharmacy technician or other pharmacy staff may complete all tasks in this section that are not otherwise prohibited by law.
(3) (A) A manufacturer of a controlled substance that fails to reimburse a pharmacy within the time period and for the amount specified in this subdivision is liable for a civil penalty of one thousand dollars ($1,000) per day for each day the manufacturer is delinquent in reimbursing the pharmacy.
(B) The civil penalty shall be assessed and recovered in a civil action brought by the board in the name of the people of the State of California.
(C) Assessment of a civil penalty, at the request of the manufacturer of the controlled substance that was assessed the penalty, may be reviewed on appeal and the penalty may be reduced or waived for good cause.
(4) By October 1, 2023, the board shall establish reasonable minimum and maximum amounts of reimbursement that include the cost of the vial and services rendered and dispensing costs.

(e)

(f) Any vendor that contracts with a pharmacy to provide a lockable vial shall make available at all times assistance online or through a toll-free telephone number for patient use.

(f)

(g) (1) A prescriber, or the prescriber’s professional corporation or other business entity, or a pharmacist or pharmacy corporation, who prescribes or dispenses a controlled substance dispensed in a lockable vial shall not be liable for any adverse consequences that result from either of the following:
(A) The failure of any lockable vial to prevent unauthorized access.
(B) A patient not being able to access medication in a lockable vial.
(2) This subdivision does not affect a person’s liability under existing law for damages caused by defective products, or as a result of willful or wanton misconduct, recklessness, or gross negligence.

(g)

(h) The board may adopt regulations to carry out this article.

(h)

(i) (1) The board shall assess a fine in an amount to be determined by the board for a violation of this section by a pharmacist.
(2) The board may choose not to take administrative action against a pharmacy if it determines that compliance with this section would create a financial hardship on the pharmacy or that the pharmacy was temporarily out of stock of lockable vials after taking reasonable steps to ensure an adequate supply for all dispensations of Schedule II or Schedule IIN controlled substances.

(i)

(j) Section 4321 shall not apply to a violation of this section.

4178.2.
 This article does not apply to correctional pharmacies, correctional clinics, or patients of the Department of Corrections and Rehabilitation.