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SB-1442 Pharmacies: staffing.(2017-2018)

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Date Published: 06/11/2018 09:00 PM
SB1442:v96#DOCUMENT

Amended  IN  Assembly  June 11, 2018
Amended  IN  Senate  May 03, 2018
Amended  IN  Senate  April 02, 2018

CALIFORNIA LEGISLATURE— 2017–2018 REGULAR SESSION

Senate Bill No. 1442


Introduced by Senator Wiener
(Coauthor: Senator Galgiani)(Coauthors: Senators Galgiani and Stone)

February 16, 2018


An act to add Section 4113.5 to the Business and Professions Code, relating to healing arts.


LEGISLATIVE COUNSEL'S DIGEST


SB 1442, as amended, Wiener. Pharmacies: staffing.
Under the Pharmacy Law, the California State Board of Pharmacy licenses and regulates the practice of pharmacy and the conduct of a pharmacy in this state. A knowing violation of that law is a crime.
This bill would prohibit a pharmacy from requiring a pharmacist to engage in the practice of pharmacy at any time the pharmacy is open to the public, unless the pharmacist is assisted at all times by either another employee of the pharmacy or, if the pharmacy is located within another establishment, an employee of the establishment within which the pharmacy is located. The bill would exempt certain pharmacies from its provisions certain pharmacies that are owned and operated primarily by pharmacists, as specified. provisions. By imposing a new requirement on pharmacies, the knowing violation of which would be a 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.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: YES  

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


SECTION 1.

 The Legislature finds and declares as follows:
(a) Licensed pharmacists are health care professionals whose training and experience play a vital role in protecting public health.
(b) Pharmacists are legally and ethically bound to advise their patients, physicians, and other health practitioners on the selection, dosages, interactions, and side effects of medications as well as monitor the health and progress of those patients to ensure that they are using their medications safely and effectively.
(c) Pursuant to Section 4001.1 of the Business and Professions Code, the highest priority for the regulation of pharmacists is protection of the public.
(d) The duties of a pharmacist include preventing the abuse of prescription opioids. In August 2013, the California State Board of Pharmacy revoked the licenses of both a pharmacy and its pharmacist because the pharmacist failed to comply with corresponding responsibility requirements in the distribution of opioid drugs. Four patients died as a result of the pharmacist’s actions.
(e) The California State Board of Pharmacy’s decision and order in that case identifies “red flags” that pharmacists are legally obligated to watch for before filling such a prescription. These “red flags” include:
(1) Irregularities on the face of the prescription itself.
(2) Nervous patient demeanor.
(3) The age or presentation of patient (e.g., youthful patients seeking chronic pain medications).
(4) Multiple patients all with the same address.
(5) Multiple prescriptions for the same patient for duplicate therapy.
(6) Requests for early refills of prescriptions.
(7) Prescriptions written for an unusually large quantity of drugs.
(8) Prescriptions written for duplicative drug therapy.
(9) Initial prescriptions written for strong opiates.
(10) Long distances traveled from the patient’s home to the prescriber’s office or to the pharmacy.
(11) Irregularities in the prescriber’s qualifications in relation to the type of medications prescribed.
(12) Prescriptions that are written outside of the prescriber’s medical specialty.
(13) Prescriptions for medications with no logical connection to an illness or condition.
(f) In 2013, the Governor signed legislation that significantly expanded the scope of practice of pharmacists. Pharmacists are now, without a prescription from a physician, permitted to vaccinate their patients, aid them in the administration of self-administered hormonal contraception, and provide nicotine replacement products. The California State Board of Pharmacy has by regulation promulgated extensive protocols governing each of these new duties.
(g) For self-administered hormonal contraception, the California Code of Regulations requires a pharmacist to complete the following steps:
(1) Ask the patient to use and complete the self-screening tool.
(2) Review the self-screening answers and clarify responses if needed.
(3) Measure and record the patient’s seated blood pressure if combined hormonal contraceptives are requested or recommended.
(4) Before furnishing self-administered hormonal contraception, ensure that the patient is appropriately trained in administration of the requested or recommended contraceptive medication.
(5) When a self-administered hormonal contraceptive is furnished, provide the patient with appropriate counseling and information on the product furnished, including:
(A) Dosage.
(B) Effectiveness.
(C) Potential side effects.
(D) Safety.
(E) The importance of receiving recommended preventative health screenings.
(F) That self-administered hormonal contraception does not protect against sexually transmitted infections.
(h) For nicotine replacement products, the California Code of Regulations requires a pharmacist to complete the following steps:
(1) Review the patient’s current tobacco use and past quit attempts.
(2) Ask the patient screening questions related to pregnancy, heart attacks, history of heart ailments, chest pain, or nasal allergies.
(3) Review the instructions for use with every patient using a nicotine replacement product.
(i) For vaccines, Section 1746.4 of Title 16 of the California Code of Regulations requires a pharmacist to notify each patient’s primary care provider of any vaccine administered to the patient, or enter the appropriate information in a patient record system shared with the primary care provider, as permitted by the primary care provider.
(j) Notwithstanding the number, complexity, and importance of a pharmacist’s duties, including those new obligations described above, the Legislature has heard uncontradicted testimony that licensed pharmacists are left alone for indeterminate periods of time in the pharmacy and are, simultaneously, required by such establishments to perform nonpharmacist functions such as staffing cash registers and assisting consumers in purchasing prescriptions, groceries, and other nonpharmacy goods. Survey information of pharmacists working in pharmacies reinforces the testimony.
(k) Staffing inadequacies like these interfere with the professional responsibilities of licensed pharmacists, including those requiring time and professional judgment listed above, and pose a risk to the public health because it leaves licensed pharmacists an insufficient amount of time to perform their licensed functions safely and lawfully, exercise their professional discretion, and comply with their legal and ethical obligations to protect the health and well-being of patients.

SEC. 2.

 Section 4113.5 is added to the Business and Professions Code, to read:

4113.5.
 (a) A pharmacy shall not require a pharmacist employee to engage in the practice of pharmacy at any time the pharmacy is open to the public, unless the pharmacist is assisted at all times by either another employee of the pharmacy or, if the pharmacy is located within another establishment, an employee of the establishment within which the pharmacy is located. This section shall not be construed to permit an employee who is not licensed under this chapter to engage in any act for which a license is required under this chapter.
(b) This section shall not apply to any of the following:
(1) A hospital pharmacy, as defined in Section 4029.
(2) A pharmacy owned or operated by a federal, state, local, or tribal government entity, including, but not limited to, a correctional pharmacy or a University of California pharmacy.
(3) Any other pharmacy from which controlled substances, dangerous drugs, or dangerous devices are not furnished, sold, or dispensed at retail.
(c) A pharmacy that permits patients to receive medications at a drive-through window shall not be required to comply with this section if both of the following conditions are met:
(1) A pharmacist is working during the times when patients may only receive medication at the drive-through window.
(2) The pharmacist’s employer does not require the pharmacist to retrieve items for sale to patients if the items are located outside the pharmacy. These items include, but are not limited to, items for which a prescription is not required.

(b)

(d) This section shall not apply to a pharmacy that meets both of the following criteria:
(1) Is owned and operated by at least one or more pharmacists, as defined in Section 4036, who control the majority of the beneficial interest in, as well as have exclusive management and control over, the operation.
(2) Where the pharmacist or pharmacists with the beneficial interest, management, and control, as described in paragraph (1), have management and control of no more than four pharmacies collectively.
(e) This section shall not be construed to permit an employee who is not licensed under this chapter to engage in any act for which a license is required under this chapter.

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.