SB195: SB195 Pharmacies; pharmacists are authorized to dispense preexposure prophylaxis and postexposure prophylaxis under certain conditions; provide

26 LC 46 1376S Senate Bill 195 By: Senators Hufstetler of the 52nd, Kirkpatrick of the 32nd, Watson of the 1st, Parent of the 44th and Orrock of the 36th AS PASSED A BILL TO BE ENTITLED AN ACT To amend Article 6 of Chapter 4 of Title 26 of the Official Cod e of Georgia Annotated,1 relating to pharmacies, so as to provide that pharmacists are a uthorized to dispense 2 preexposure prophylaxis and postexposure prophylaxis under certain conditions; to amend3 Article 2 of Chapter 34 of Title 43 of the Official Code of Geo rgia Annotated, relating to4 medical practice, so as to provide for the approval or development of a training program for5 pharmacists by the State Board of Pharmacy; to require pharmaci sts to complete such6 training program before dispensing preexposure prophylaxis or postexposure prophylaxis;7 to provide for patient requirements; to provide for limitations and conditions; to provide for8 sanctions; to provide for definitions; to provide for related matters; to repeal conflicting laws;9 and for other purposes.10 BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:11 SECTION 1.12 Article 6 of Chapter 4 of Title 26 of the Official Code of Geor gia Annotated, relating to13 pharmacies, is amended by adding a new Code section to read as follows:14 "26-4-120.15 (a) As used in this Code section, the term:16 S. B. 195 - 1 - 26 LC 46 1376S (1) 'CLIA-waived' means a test system which is listed on the f ederal Food and Drug17 Administration's Clinical Laboratory Improvement Assessment program data base with18 a complexity rating of 'waived.'19 (2) 'Dispense' shall have the same meaning as set forth in paragraph (10) of Code Section20 26-4-5.21 (3) 'HIV' shall have the same meaning as set forth in paragrap h (10) of Code Section22 31-22-9.1.23 (4) 'HIV test' shall have the same meaning as set forth in paragraph (12) of Code Section24 31-22-9.1.25 (5) 'Licensed practitioner' means a physician licensed to practice medicine in this state26 or an advanced practice registered nurse or physician assistant acting pursuant to27 delegated authority by a physician in accordance with Code Section 43-34-23 or 43-34-2528 or subsection (e.1) of Code Section 43-34-103.29 (6) 'Pharmacist' means an individual licensed under Chapter 4 of Title 26 to engage in30 the practice of pharmacy in the State of Georgia, who is locate d and practicing in the31 State of Georgia.32 (7) 'Postexposure prophylaxis' means any HIV prevention drug o r drug combination33 determined by the State Board of Pharmacy to meet the same clin ical eligibility34 recommendations provided in the federal Centers for Disease Con trol and Prevention35 guidelines for postexposure prophylaxis for the prevention of H IV infection and other36 infections.37 (8) 'Preexposure prophylaxis' means any HIV prevention drug or drug combination38 determined by the State Board of Pharmacy to meet the same clin ical eligibility39 recommendations provided in the federal Centers for Disease Con trol and Prevention40 guidelines for preexposure prophyla xis for the prevention of HI V infection and other41 infections.42 S. B. 195 - 2 - 26 LC 46 1376S (b) Notwithstanding any other law to the contrary, a pharmacist, pursuant to a PEP or PrEP43 protocol agreement, is authorized to issue a PEP or PrEP order and to dispense and44 administer preexposure prophylaxis and postexposure prophylaxis pursuant to such PEP45 or PrEP order in accordance with this Code section and Code Section 43-34-26.2.46 (c) Before dispensing or administering preexposure prophylaxis or postexposure47 prophylaxis to a patient, a pharmacist shall complete a training program, accredited by the48 Accreditation Council for Pharmacy Education or a similar health authority or professional49 body and approved by the State Board of Pharmacy, on the use of preexposure prophylaxis50 and postexposure prophylaxis. Such training program shall be a pproved no later than51 January 1, 2027. The training program shall include, but is not limited to:52 (1) Pharmacology education of preexposure prophylaxis and postexposure prophylaxis;53 (2) Preexposure prophylaxis and postexposure prophylaxis and c ontraindicated54 medications;55 (3) Financial assistance programs for preexposure prophylaxis and postexposure56 prophylaxis; and57 (4) Relevant federal guidelines, including those issued by the federal Centers for Disease58 Control and Prevention, regarding preexposure prophylaxis and p ostexposure59 prophylaxis.60 (d) A pharmacist shall be authorized to dispense at least a 30 day supply and up to a 9061 day supply or administer a long-acting injectable of preexposure prophylaxis if:62 (1) The patient is HIV negative, as documented by a test result obtained by the patient63 within the previous seven days from an HIV antigen/antibody test or antibody-only test64 or from a rapid point-of-care fingerstick blood test approved b y the federal Food and65 Drug Administration; provided, however, that, if the patient does not provide such a test66 result, the pharmacist may order and administer a CLIA-waived HIV test. The results of67 any such test shall either be sent directly to the pharmacist or verified by the pharmacist68 prior to prescribing, dispensing, or administering the drugs;69 S. B. 195 - 3 - 26 LC 46 1376S (2) The patient does not report taking any contraindicated medications;70 (3) The pharmacist documents, to the extent possible, the serv ices provided by the71 pharmacist in the patient's record in the pharmacy's record system;72 (4) The pharmacist dispenses or administers preexposure prophylaxis to a single patient73 pursuant to the Centers for Disease Control and Prevention clinical practice guidelines74 for preexposure prophylaxis for the prevention of HIV infection or as directed otherwise75 by a licensed practitioner;76 (5) The pharmacist notifies the patient's primary care provide r of any actions taken or77 tests conducted under this subsection, or, if the patient does not have a primary care78 provider or refuses to consent to the notification of such prov ider, the pharmacist shall79 provide the patient with a list of physicians, clinics, or other healthcare service providers80 to contact regarding ongoing care for preexposure prophylaxis; and81 (6) The pharmacist is otherwise in compliance with the require ments of Code Section82 43-34-26.2.83 (e) A pharmacist shall be authorized to dispense or administer a 30 day supply of84 postexposure prophylaxis if:85 (1) The pharmacist, upon screening the patient, determines the patient meets the clinical86 criteria set forth in the Centers for Disease Control and Preve ntion guidelines for87 postexposure prophylaxis; and88 (2) The pharmacist notifies the patient's primary care provide r of the postexposure89 prophylaxis treatment, or, if the patient does not have a primary care provider or refuses90 to consent to the notification of such provider, the pharmacist shall provide the patient91 with a list of physicians, clinics, or other healthcare service providers to contact regarding92 follow-up care for postexposure prophylaxis."93 S. B. 195 - 4 - 26 LC 46 1376S SECTION 2.94 Article 2 of Chapter 34 of Title 43 of the Official Code of Geo rgia Annotated, relating to95 medical practice, is amended by adding a new Code section to read as follows:96 "43-34-26.2.97 (a) As used in this Code section, the term:98 (1) 'Administer' means the provision of a unit dose of a long-acting injectable for PEP99 or PrEP by a pharmacist or nurse pursuant to a PEP or PrEP order contained in a PEP or100 PrEP protocol agreement with a physician.101 (2) 'Adverse event' means an event that is a negative consequence of the administration102 of a long-acting injectable for PEP or PrEP that results in an unintended reaction, injury,103 or illness, which may or may not have been preventable.104 (3) 'PEP' means any HIV prevention drug or drug combination determined by the State105 Board of Pharmacy to meet the same clinical eligibility recommendations provided in the106 federal Centers for Disease Control and Prevention guidelines f or postexposure107 prophylaxis for the prevention of HIV infection and other infections.108 (4) 'PrEP' means any HIV prevention drug or drug combination determined by the State109 Board of Pharmacy to meet the same clinical eligibility recommendations provided in the110 federal Centers for Disease Control and Prevention guidelines f or preexposure111 prophylaxis for the prevention of HIV infection and other infections.112 (5) 'PEP or PrEP order' means a prescription drug order, issued by a pharmacist pursuant113 to authority delegated by a physician pursuant to a PEP or PrEP protocol agreement, for114 a long-acting injectable for PEP or PrEP to patients who meet certain criteria.115 (6) 'PEP or PrEP protocol agreement' means a written document mutually agreed upon116 and signed by a physician and a pharmacist, by which document the physician delegates117 prescriptive authority to the pharmacist to prescribe a long-acting injectable for PEP or118 PrEP to patients who meet certain criteria determined by the physician.119 S. B. 195 - 5 - 26 LC 46 1376S (7) 'Pharmacist' means an individual licensed under Chapter 4 of Title 26 to engage in120 the practice of pharmacy in the State of Georgia, who is located and practicing in the state121 of Georgia.122 (8) 'Pharmacy intern' means a pharmacy intern as defined in pa ragraph (19) of Code123 Section 26-4-5.124 (9) 'Physician' means an individual licensed to practice medicine and surgery pursuant125 to this article and whose principal place of practice is located in this state.126 (b) A physician engaged in the active practice of medicine may prescribe a long-acting127 injectable for PEP or PrEP for a group of patients via a PEP or PrEP order contained in a128 PEP or PrEP protocol agreement to be administered by a pharmaci st, provided that the129 physician resides in Georgia and the pharmacist holds current certification in Basic Cardiac130 Life Support.131 (c) A PEP or PrEP protocol agreement between a physician and a pharmacist pursuant to132 this Code section shall, without limitation:133 (1) Contain the current names, addresses, telephone numbers, and professional license134 numbers of the physician and the pharmacist;135 (2) Contain a provision for immediate consultation between the pharmacist and the136 physician. If the physician is not available, the physician fo r purposes of consultation137 may designate another physician who concurs with the terms of the PEP or PrEP protocol138 agreement;139 (3) Require the pharmacist to take an appropriate case history and determine whether the140 patient has had a physical examination within the past year and shall not administer a141 long-acting injectable for PEP or PrEP to a patient with any co ndition for which such142 long-acting injectable for PEP or PrEP is contraindicated;143 (4) Require the pharmacist to provide the recipient with the appropriate and current PEP144 or PrEP information;145 S. B. 195 - 6 - 26 LC 46 1376S (5) Require the pharmacist to provide written information to t he recipient to be146 developed by the Department of Public Health on the importance of having and147 periodically seeing a primary care physician;148 (6) Require the pharmacist or his or her employer to retain documentation of each dose149 of PEP or PrEP administered. Such documentation shall include, but not be limited to:150 (A) The administering pharmacist's name, address, telephone number, and professional151 license number;152 (B) The name, dose, manufacturer, and lot number of the long-a cting injectable for153 PEP or PrEP;154 (C) The recipient's name, address, date of birth, and telephone number;155 (D) The date of administration and injection site;156 (E) A signed and dated consent form by which the recipient con sents to the157 administration of the long-acting injectable for PEP or PrEP an d authorizes the158 pharmacy or nurse to notify the recipient's primary care provid er of the long-acting159 injectable for PEP or PrEP administered to the recipient; and160 (F) Any adverse events or complications that occur;161 (7) Require the pharmacist to make documented reasonable efforts to obtain the name162 of the recipient's primary care provider and to notify such primary care provider of the163 long-acting injectable for PEP or PrEP administered by the pharmacist within 72 hours164 of administration;165 (8) Require the pharmacist to administer the long-acting injectable for PEP or PrEP to166 a patient in a private room, area with a privacy screen, or other interior area in which the167 patient's privacy can be maintained. In no event shall a pharm acist administer a168 long-acting injectable for PEP or PrEP to a patient in a manner that is designed so that169 the patient can be served while remaining in his or her personal vehicle;170 (9) Require, as a condition of administration of the long-acti ng injectable for PEP or171 PrEP, the recipient to remain under the observation of a pharma cist for a period of not172 S. B. 195 - 7 - 26 LC 46 1376S less than 15 minutes immediately subsequent to the administrati on of the long-acting173 injectable for PEP or PrEP;174 (10) Contain procedures to follow up on the occurrence of an a dverse event or175 complication;176 (11) Require the pharmacist to maintain individual liability i nsurance coverage or be177 individually covered by his or her employer's liability insurance coverage in an amount178 not less than $250,000.00 to cover claims arising from administ ration of long-acting179 injectables for PEP or PrEP by the pharmacist pursuant to a PEP or PrEP protocol180 agreement and to provide proof of such coverage to the physician for submission to the181 board with the PEP or PrEP protocol agreement. The pharmacist shall also retain a copy182 of the proof of insurance coverage, including the name of the insurer and policy number,183 on site at his or her primary location in such form as it may b e readily accessible for184 inspection by the Georgia Drugs and Narcotics Agency, upon request;185 (12) Require the pharmacist to post proof of the PEP or PrEP p rotocol agreement in a186 conspicuous location within the pharmacy or other setting in wh ich the long-acting187 injectables for PEP or PrEP are being administered;188 (13) Require the pharmacist to submit a signed and notarized affidavit to the physician189 for submission to the board with the PEP or PrEP protocol agree ment attesting to the190 following:191 (A) Compliance with paragraph (11) of this subsection regardin g maintenance of192 liability insurance;193 (B) Verification that the pharmacist holds current certification in Basic Cardiac Life194 Support as required by subsection (b) of this Code section;195 (C) The pharmacist has a copy of the PEP or PrEP protocol agreement and agrees to196 comply with its requirements; and197 S. B. 195 - 8 - 26 LC 46 1376S (D) Identification of the pharmacist's location or locations in which he or she will be198 administering long-acting injectables for PEP or PrEP pursuant to the PEP or PrEP199 protocol agreement.200 The pharmacist shall keep a copy of the affidavit on site at his or her primary location for201 inspection by the State Board of Pharmacy or agents of the Georgia Drugs and Narcotics202 Agency, upon request. The State Board of Pharmacy shall have the authority to impose203 sanctions in accordance with subsection (n) of this Code sectio n on any pharmacist204 subject to the requirements of this paragraph who does not subm it the information205 required by this paragraph and to notify the delegating physici an and the applicable206 licensing board for such person of violations of this paragraph; and207 (14) Be renewed and, if necessary, revised or updated biennial ly by the physician and208 the pharmacist. A PEP or PrEP protocol agreement that is not renewed biennially shall209 expire.210 (d)(1) A pharmacist who is a party to a PEP or PrEP protocol agreement pursuant to this211 Code section shall not delegate the administration of a long-acting injectable for PEP or212 PrEP to any individual other than:213 (A) A pharmacy intern; or214 (B) A qualified pharmacy technician in accordance with paragra ph (2) of this215 subsection,216 under the direct supervision of the pharmacist whether or not any such other individual217 is under the supervision, direct or otherwise, of the pharmacist.218 (2) A pharmacist who is a party to a PEP or PrEP protocol agre ement pursuant to this219 Code section may authorize one or more qualified pharmacy techn icians to administer220 long-acting injectables for PEP or PrEP pursuant to Code Section 26-4-52 so long as:221 (A) The physician with whom the PEP or PrEP protocol agreement is entered into has222 approved such authorization; and223 S. B. 195 - 9 - 26 LC 46 1376S (B) Such authorization is included in the PEP or PrEP protocol agreement between the224 physician and pharmacist.225 (e) A pharmacist administering long-acting injectables for PEP or PrEP pursuant to a PEP226 or PrEP protocol agreement author ized by this Code section shal l maintain policies and227 procedures for the handling and disposal of used or contaminated equipment and supplies.228 (f) Nothing in this Code section shall be construed to authori ze a physician to prescribe229 any other drugs pursuant to a PEP or PrEP protocol agreement or a PEP or PrEP order230 other than those long-acting injectables for PEP or PrEP specif ically authorized in such231 PEP or PrEP protocol agreement or PEP or PrEP order.232 (g) A delegating physician may not enter into a PEP or PrEP pr otocol agreement with233 more than ten pharmacists at any one time.234 (h) It shall be unlawful for a physician who is employed by a pharmacist to enter into a235 PEP or PrEP protocol agreement or otherwise delegate medical ac ts to such pharmacist. 236 It shall be unlawful for a physician who is employed by a pharmacy to enter into a PEP or237 PrEP protocol agreement or otherwise delegate medical acts to a pharmacist who is also238 employed by such pharmacy.239 (i) The board shall have the authority to promulgate rules and regulations governing a240 physician who is a party to a PEP or PrEP protocol agreement in order to carry out the241 intent and purposes of this Code section. Further, the board shall:242 (1) Require that the PEP or PrEP protocol agreement, along wit h the affidavit by the243 pharmacist submitted pursuant to paragraph (13) of subsection (c) of this Code section244 and the proof of insurance required pursuant to paragraph (11) of subsection (c) of this245 Code section, be filed by the physician with the board and be made available by the board246 for public inspection; and247 (2) Promulgate by rule an approved standard protocol template that may be utilized as248 a PEP or PrEP protocol agreement and make such template availab le on the board's249 website.250 S. B. 195 - 10 - 26 LC 46 1376S (j) Nothing in this Code section shall be construed to require a physician to enter into a251 PEP or PrEP protocol agreement. A public or private managed care system, health plan,252 hospital, insurance company, or similar entity shall not require a physician, pharmacist, or253 nurse to enter into a PEP or PrEP protocol agreement as a condition for participation in or254 reimbursement from such entity.255 (k) No physician who complies with the provisions of this Code section shall be subject256 to criminal or civil liability or discipline for unprofessional conduct for:257 (1) Entering into a PEP or PrEP protocol agreement with a pharmacist;258 (2) The acts or omissions of a pharmacist to whom prescriptive authority has been259 delegated in the issuance of a PEP or PrEP order contained in a PEP or PrEP protocol260 agreement with a pharmacist; or261 (3) The acts or omissions of a pharmacist pursuant to a PEP or PrEP protocol agreement262 including the administration of a long-acting injectable for PEP or PrEP.263 Nothing in this subsection shall be interpreted as altering liability of an employer for acts264 of his or her employees.265 (l) This Code section shall not apply to any activities conducted by a hospital, physician's266 office, nursing home, or other healthcare facility designated by the Department of Public267 Health or conducted within any other facility or entity owned, operated, or leased by a268 hospital.269 (m) This Code section shall not be interpreted as limiting the authority of any authorized270 person to dispense or administer long-acting injectables for PEP or PrEP.271 (n)(1) A pharmacist who fails to comply with paragraph (11) of subsection (c) of this272 Code section may be assessed a fine of up to $2,500.00 by the State Board of Pharmacy.273 (2) A pharmacist who administers a long-acting injectable for PEP or PrEP without a274 PEP or PrEP protocol agreement as required by this Code section may be assessed a fine275 of up to $2,500.00 and may be prohibited from administering long-acting injectables for276 S. B. 195 - 11 - 26 LC 46 1376S PEP or PrEP pursuant to this Code section for up to one year as determined by the State277 Board of Pharmacy.278 (3) A pharmacist who fails to comply with paragraph (5) of subsection (c) of this Code279 section may be subject to any or all of the following sanctions by the State Board of280 Pharmacy:281 (A) The issuance of a written warning;282 (B) A fine of up to $500.00; and283 (C) Prohibition from administering long-acting injectables for PEP or PrEP pursuant284 to this Code section for up to one year.285 (4) A pharmacist who fails to comply with paragraph (12) of subsection (c) of this Code286 section may be subject to any or all of the following sanctions by the State Board of287 Pharmacy:288 (A) The issuance of a written warning; and289 (B) Prohibition from administering long-acting injectables for PEP or PrEP pursuant290 to this Code section for up to six months.291 (5) A pharmacist who fails to comply with paragraph (13) of subsection (c) of this Code292 section may be subject to any or all of the following sanctions by the State Board of293 Pharmacy:294 (A) The issuance of a written warning;295 (B) A fine of up to $5,000.00; and296 (C) Prohibition from administering long-acting injectables for PEP or PrEP pursuant297 to this Code section.298 (6) The sanctions contained in this subsection shall be supple mental to any other299 sanctions or penalties to which a pharmacist may otherwise be subject."300 SECTION 3.301 Al laws and parts of laws in conflict with this Act are repealed.302 S. B. 195 - 12 -