BILL NUMBER: SB 644 CHAPTERED 09/29/05 CHAPTER 417 FILED WITH SECRETARY OF STATE SEPTEMBER 29, 2005 APPROVED BY GOVERNOR SEPTEMBER 29, 2005 PASSED THE SENATE SEPTEMBER 8, 2005 PASSED THE ASSEMBLY SEPTEMBER 7, 2005 AMENDED IN ASSEMBLY SEPTEMBER 1, 2005 AMENDED IN ASSEMBLY AUGUST 25, 2005 AMENDED IN ASSEMBLY JULY 5, 2005 AMENDED IN SENATE MAY 18, 2005 AMENDED IN SENATE MAY 4, 2005 AMENDED IN SENATE APRIL 7, 2005 INTRODUCED BY Senator Ortiz (Principal coauthor: Assembly Member Levine) (Coauthors: Senators Alquist, Figueroa, Kuehl, and Romero) (Coauthors: Assembly Members Berg, Cohn, Frommer, Goldberg, Jones, Klehs, Koretz, Laird, Leno, Liu, Nation, and Nava) FEBRUARY 22, 2005 An act to amend Sections 4314 and 4315 of, and to add Section 733 to, the Business and Professions Code, relating to healing arts. LEGISLATIVE COUNSEL'S DIGEST SB 644, Ortiz Dispensing prescription drugs and devices. (1) Existing law makes certain actions by a health care professional unprofessional conduct subject to disciplinary action by the licensing board regulating the health care professional. Under existing law, the California State Board of Pharmacy is authorized to issue a citation for the violation of the Pharmacy Law or regulations adopted pursuant to it, and the board's executive officer is authorized to issue a letter of admonishment for the violation of those provisions. This bill would prohibit a health care licentiate from obstructing a patient in obtaining a prescription drug or device and would require the licentiate to dispense drugs and devices pursuant to a lawful prescription or order except in specified circumstances, including on ethical, moral, or religious grounds asserted by the licentiate. The bill would authorize the licentiate to decline to dispense the prescription or order on that basis only if the licentiate notified his or her employer of the objection and it can be reasonably accommodated. The bill would require the licentiate's employer in those circumstances to establish protocols to ensure a patient's timely access to the prescribed drug or device. The bill would authorize the California State Board of Pharmacy to issue a citation for a violation of these provisions and would authorize its executive officer to issue a letter of admonishment for their violation. (2) The bill would incorporate additional changes to Section 4315 of the Business and Professions Code made by this bill and SB 1111 to take effect if both bills are enacted and this bill is enacted last. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. It is the intent of the Legislature that health care professionals dispense prescription drugs and devices in a timely way or provide appropriate referrals for patients to obtain the necessary prescription drugs and devices, despite the health care professional's objection to dispensing the drugs or devices on ethical, moral, or religious grounds. SEC. 2 Section 733 is added to the Business and Professions Code, to read: 733. (a) No licentiate shall obstruct a patient in obtaining a prescription drug or device that has been legally prescribed or ordered for that patient. A violation of this section constitutes unprofessional conduct by the licentiate and shall subject the licentiate to disciplinary or administrative action by his or her licensing agency. (b) Notwithstanding any other provision of law, a licentiate shall dispense drugs and devices, as described in subdivision (a) of Section 4024, pursuant to a lawful order or prescription unless one of the following circumstances exists: (1) Based solely on the licentiate's professional training and judgment, dispensing pursuant to the order or the prescription is contrary to law, or the licentiate determines that the prescribed drug or device would cause a harmful drug interaction or would otherwise adversely affect the patient's medical condition. (2) The prescription drug or device is not in stock. If an order, other than an order described in Section 4019, or prescription cannot be dispensed because the drug or device is not in stock, the licentiate shall take one of the following actions: (A) Immediately notify the patient and arrange for the drug or device to be delivered to the site or directly to the patient in a timely manner. (B) Promptly transfer the prescription to another pharmacy known to stock the prescription drug or device that is near enough to the site from which the prescription or order is transferred, to ensure the patient has timely access to the drug or device. (C) Return the prescription to the patient and refer the patient . The licentiate shall make a reasonable effort to refer the patient to a pharmacy that stocks the prescription drug or device that is near enough to the referring site to ensure that the patient has timely access to the drug or device. (3) The licentiate refuses on ethical, moral, or religious grounds to dispense a drug or device pursuant to an order or prescription. A licentiate may decline to dispense a prescription drug or device on this basis only if the licentiate has previously notified his or her employer, in writing, of the drug or class of drugs to which he or she objects, and the licentiate's employer can, without creating undue hardship, provide a reasonable accommodation of the licentiate' s objection. The licentiate's employer shall establish protocols that ensure that the patient has timely access to the prescribed drug or device despite the licentiate's refusal to dispense the prescription or order. For purposes of this section, "reasonable accommodation" and "undue hardship" shall have the same meaning as applied to those terms pursuant to subdivision (l) of Section 12940 of the Government Code. (c) For the purposes of this section, "prescription drug or device" has the same meaning as the definition in Section 4022. (d) The provisions of this section shall apply to the drug therapy described in paragraph (8) of subdivision (a) of Section 4052. (e) This section imposes no duty on a licentiate to dispense a drug or device pursuant to a prescription or order without payment for the drug or device, including payment directly by the patient or through a third party payer accepted by the licentiate or payment of any required copayment by the patient. SEC. 3. Section 4314 of the Business and Professions Code is amended to read: 4314. (a) The board may issue citations containing fines and orders of abatement for any violation of Section 733 or for any violation of this chapter or regulations adopted pursuant to this chapter, in accordance with Sections 125.9, 148, and 4005 and the regulations adopted pursuant to those sections. (b) Where appropriate, a citation issued by the board, as specified in this section, may subject the person or entity to whom the citation is issued to an administrative fine. (c) Notwithstanding any other provision of law, where appropriate, a citation issued by the board may contain an order of abatement. The order of abatement shall fix a reasonable time for abatement of the violation. It may also require the person or entity to whom the citation is issued to demonstrate how future compliance with the Pharmacy Law, and the regulations adopted pursuant thereto, will be accomplished. A demonstration may include, but is not limited to, submission of a corrective action plan, and requiring completion of up to six hours of continuing education courses in the subject matter specified in the order of abatement. Any continuing education courses required by the order of abatement shall be in addition to those required for license renewal. (d) Nothing in this section shall in any way limit the board from issuing a citation, fine, and order of abatement pursuant to Section 4067 or Section 56.36 of the Civil Code, and the regulations adopted pursuant to those sections. SEC. 4. Section 4315 of the Business and Professions Code is amended to read: 4315. (a) The executive officer, or his or her designee, may issue a letter of admonishment to a licensee for failure to comply with Section 733 or for failure to comply with this chapter or regulations adopted pursuant to this chapter, directing the licensee to come into compliance. (b) The letter of admonishment shall be in writing and shall describe in detail the nature and facts of the violation, including a reference to the statutes or regulations violated. (c) The letter of admonishment shall inform the licensee that within 30 days of service of the order of admonishment the licensee may do either of the following: (1) Submit a written request for an office conference to the executive officer of the board to contest the letter of admonishment. (A) Upon a timely request, the executive officer, or his or her designee, shall hold an office conference with the licensee or the licensee's legal counsel or authorized representative. Unless so authorized by the executive officer, or his or her designee, no individual other than the legal counsel or authorized representative of the licensee may accompany the licensee to the office conference. (B) Prior to or at the office conference, the licensee may submit to the executive officer declarations and documents pertinent to the subject matter of the letter of admonishment. (C) The office conference is intended to be an informal proceeding and shall not be subject to the provisions of the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340), Chapter 4 (commencing with Section 11370), Chapter 4.5 (commencing with Section 11400), and Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code). (D) The executive officer, or his or her designee, may affirm, modify, or withdraw the letter of admonishment. Within 14 calendar days from the date of the office conference, the executive officer, or his or her designee, shall personally serve or send by certified mail to the licensee's address of record with the board a written decision. This decision shall be deemed the final administrative decision concerning the letter of admonishment. (E) Judicial review of the decision may be had by filing a petition for a writ of mandate in accordance with the provisions of Section 1094.5 of the Code of Civil Procedure within 30 days of the date the decision was personally served or sent by certified mail. The judicial review shall extend to the question of whether or not there was a prejudicial abuse of discretion in the issuance of the letter of admonishment. (2) Comply with the letter of admonishment and submit a written corrective action plan to the executive officer documenting compliance. If an office conference is not requested pursuant to this section, compliance with the letter of admonishment shall not constitute an admission of the violation noted in the letter of admonishment. (d) The letter of admonishment shall be served upon the licensee personally or by certified mail at the licensee's address of record with the board. If the licensee is served by certified mail, service shall be effective upon deposit in the United States mail. (e) The licensee shall maintain and have readily available on the pharmacy premises a copy of the letter of admonishment and corrective action plan for at least three years from the date of issuance of the letter of admonishment. (f) Nothing in this section shall in any way limit the board's authority or ability to do either of the following: (1) Issue a citation pursuant to Section 125.9, 148, or 4067 or pursuant to Section 1775 of Title 16 of the California Code of Regulations. (2) Institute disciplinary proceedings pursuant to Article 19 (commencing with Section 4300). SEC. 5. Section 4315 of the Business and Professions Code is amended to read: 4315. (a) The executive officer, or his or her designee, may issue a letter of admonishment to a licensee for failure to comply with Section 733 or for failure to comply with this chapter or regulations adopted pursuant to this chapter, directing the licensee to come into compliance. (b) The letter of admonishment shall be in writing and shall describe in detail the nature and facts of the violation, including a reference to the statutes or regulations violated. (c) The letter of admonishment shall inform the licensee that within 30 days of service of the order of admonishment the licensee may do either of the following: (1) Submit a written request for an office conference to the executive officer of the board to contest the letter of admonishment. (A) Upon a timely request, the executive officer, or his or her designee, shall hold an office conference with the licensee or the licensee's legal counsel or authorized representative. Unless so authorized by the executive officer, or his or her designee, no individual other than the legal counsel or authorized representative of the licensee may accompany the licensee to the office conference. (B) Prior to or at the office conference the licensee may submit to the executive officer declarations and documents pertinent to the subject matter of the letter of admonishment. (C) The office conference is intended to be an informal proceeding and shall not be subject to the provisions of the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340), Chapter 4 (commencing with Section 11370), Chapter 4.5 (commencing with Section 11400), and Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code). (D) The executive officer, or his or her designee, may affirm, modify, or withdraw the letter of admonishment. Within 14 calendar days from the date of the office conference, the executive officer, or his or her designee, shall personally serve or send by certified mail to the licensee's address of record with the board a written decision. This decision shall be deemed the final administrative decision concerning the letter of admonishment. (E) Judicial review of the decision may be had by filing a petition for a writ of mandate in accordance with the provisions of Section 1094.5 of the Code of Civil Procedure within 30 days of the date the decision was personally served or sent by certified mail. The judicial review shall extend to the question of whether or not there was a prejudicial abuse of discretion in the issuance of the letter of admonishment. (2) Comply with the letter of admonishment and submit a written corrective action plan to the executive officer documenting compliance. If an office conference is not requested pursuant to this section, compliance with the letter of admonishment shall not constitute an admission of the violation noted in the letter of admonishment. (d) The letter of admonishment shall be served upon the licensee personally or by certified mail at the licensee's address of record with the board. If the licensee is served by certified mail, service shall be effective upon deposit in the United States mail. (e) The licensee shall maintain and have readily available a copy of the letter of admonishment and corrective action plan, if any, for at least three years from the date of issuance of the letter of admonishment. (f) Nothing in this section shall in any way limit the board's authority or ability to do either of the following: (1) Issue a citation pursuant to Section 125.9, 148, or 4067 or pursuant to Section 1775 of Title 16 of the California Code of Regulations. (2) Institute disciplinary proceedings pursuant to Article 19 (commencing with Section 4300). SEC. 6. Section 5 of this bill incorporates amendments to Section 4315 of the Business and Professions Code proposed by both this bill and Senate Bill 1111. It shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2006, (2) each bill amends Section 4315 of the Business and Professions Code, and (3) this bill is enacted after Senate Bill 1111, in which case Section 4 of this bill shall not become operative.