2
3
4
5
6
7 LONG TITLE
8 General Description:
9 This bill authorizes a pharmacist to dispense HIV post-exposure prophylaxis pursuant
10 to a standing prescription drug order issued by a physician.
11 Highlighted Provisions:
12 This bill:
13 ▸ provides definitions;
14 ▸ specifies that this bill does not create a duty or standard of care for a person to
15 prescribe or dispense HIV post-exposure prophylaxis;
16 ▸ authorizes a pharmacist to dispense HIV post-exposure prophylaxis pursuant to a
17 standing prescription drug order issued by a physician;
18 ▸ specifies the conditions under which certain physicians may issue a standing
19 prescription drug order authorizing the dispensing of HIV post-exposure
20 prophylaxis;
21 ▸ specifies requirements for dispensing HIV post-exposure prophylaxis;
22 ▸ requires rulemaking; and
23 ▸ creates an exemption from civil liability.
24 Money Appropriated in this Bill:
25 None
26 Other Special Clauses:
27 None
28 Utah Code Sections Affected:
29 ENACTS:
30 26-67-101, Utah Code Annotated 1953
31 26-67-102, Utah Code Annotated 1953
32 26-67-103, Utah Code Annotated 1953
33 26-67-104, Utah Code Annotated 1953
34 26-67-105, Utah Code Annotated 1953
35 26-67-106, Utah Code Annotated 1953
36 26-67-107, Utah Code Annotated 1953
37 26-67-108, Utah Code Annotated 1953
38
39 Be it enacted by the Legislature of the state of Utah:
40 Section 1. Section 26-67-101 is enacted to read:
41
42 26-67-101. Title.
43 This chapter is known as "HIV Post-Exposure Prophylaxis Access Act."
44 Section 2. Section 26-67-102 is enacted to read:
45 26-67-102. Definitions.
46 As used in this chapter:
47 (1) "CDC guidelines" means "Updated Guidelines for Antiretroviral Postexposure
48 Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to
49 HIV-United States, 2016," published by the Centers for Disease Control and Prevention.
50 (2) "Dispense" means the same as that term is defined in Section 58-17b-102.
51 (3) "Division" means the Division of Occupational and Professional Licensing created
52 in Section 58-1-103.
53 (4) "HIV" means human immunodeficiency virus.
54 (5) "HIV post-exposure prophylaxis" means:
55 (a) tenofovir disoproxil fumarate (300 mg) with emtricitabine (200 mg), taken once
56 daily and used in combination with:
57 (i) raltegravir (400 mg), taken twice daily; or
58 (ii) dolutegravir (50 mg), taken once daily;
59 (b) tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg), taken once
60 daily and used in combination with:
61 (i) darunavir (800 mg), taken once daily; and
62 (ii) ritonavir (100 mg), taken once daily; or
63 (c) a drug or drug combination that:
64 (i) complies with CDC guidelines; and
65 (ii) is approved by the division under Section 26-67-107.
66 (6) "HIV test" means a test:
67 (a) for exposure to HIV; and
68 (b) classified as waived under 42 U.S.C. Sec. 263a.
69 (7) "Local health department" means:
70 (a) a local health department, as defined in Section 26A-1-102; or
71 (b) a multicounty local health department, as defined in Section 26A-1-102.
72 (8) "Patient counseling" means the same as that term is defined in Section 58-17b-102.
73 (9) "Pharmacist" means the same as that term is defined in Section 58-17b-102.
74 (10) "Pharmacy intern" means the same as that term is defined in Section 58-17b-102.
75 (11) "Physician" means the same as that term is defined in Section 58-67-102.
76 (12) "Prescribe" means the same as that term is defined in Section 58-17b-102.
77 Section 3. Section 26-67-103 is enacted to read:
78 26-67-103. Voluntary participation.
79 This chapter does not create a duty or standard of care for a person to prescribe or
80 dispense HIV post-exposure prophylaxis.
81 Section 4. Section 26-67-104 is enacted to read:
82 26-67-104. Authorization to dispense HIV post-exposure prophylaxis.
83 Notwithstanding any other provision of law, an individual licensed to dispense HIV
84 post-exposure prophylaxis under Title 58, Chapter 17b, Pharmacy Practice Act, may dispense
85 HIV post-exposure prophylaxis:
86 (1) to a patient who is 18 years old or older;
87 (2) under a standing prescription drug order made in accordance with Section
88 26-67-105;
89 (3) without any other prescription drug order from an individual licensed to prescribe
90 HIV post-exposure prophylaxis; and
91 (4) in accordance with the dispensing guidelines in Section 26-67-106.
92 Section 5. Section 26-67-105 is enacted to read:
93 26-67-105. Standing prescription drug orders for HIV post-exposure prophylaxis.
94 A physician who is licensed to prescribe HIV post-exposure prophylaxis, including a
95 physician acting in the physician's capacity as an employee of the department or as the medical
96 director of a local health department, may issue a standing prescription drug order authorizing
97 the dispensing of HIV post-exposure prophylaxis in accordance with a protocol that:
98 (1) requires the physician to specify the individuals, by professional license number,
99 authorized to dispense HIV post-exposure prophylaxis;
100 (2) requires the physician to review at least annually the dispensing practices of each
101 individual authorized by the physician to dispense HIV post-exposure prophylaxis;
102 (3) requires an individual authorized by the physician to dispense HIV post-exposure
103 prophylaxis to make and retain a record of each patient to whom HIV post-exposure
104 prophylaxis is dispensed, including:
105 (a) the name of the patient;
106 (b) the drug dispensed to the patient; and
107 (c) other relevant information regarding the drug or the patient; and
108 (4) is approved by the division under Section 26-67-107.
109 Section 6. Section 26-67-106 is enacted to read:
110 26-67-106. Requirements for dispensing HIV post-exposure prophylaxis.
111 (1) A pharmacist or a pharmacy intern who is authorized under Section 26-67-104 to
112 dispense HIV post-exposure prophylaxis may not dispense HIV post-exposure prophylaxis
113 under Section 26-67-104 unless:
114 (a) the patient completes a self-screening risk assessment questionnaire that is
115 approved by the division under Section 26-67-107;
116 (b) the results of the questionnaire in Subsection (1)(a) indicate that the patient is not a
117 high-risk patient;
118 (c) (i) the patient submits to an HIV test provided to the patient by the pharmacist or
119 pharmacy intern; or
120 (ii) the patient expresses a willingness to submit to an HIV test at a future date and
121 report the results to the patient's health care provider; and
122 (d) the pharmacist or pharmacy intern dispenses a 28-day supply to the patient.
123 (2) A pharmacist or a pharmacy intern may not dispense HIV post-exposure
124 prophylaxis under Section 26-67-104 more than one time to each patient in a 12-month period.
125 (3) If a pharmacist or pharmacy intern dispenses HIV post-exposure prophylaxis to a
126 patient under Section 26-67-104, the pharmacist or pharmacy intern shall:
127 (a) provide patient counseling that is consistent with CDC guidelines, including
128 information regarding:
129 (i) the appropriate administration and storage of the HIV post-exposure prophylaxis;
130 (ii) the potential side effects and risks of the HIV post-exposure prophylaxis, including,
131 as appropriate, during pregnancy or breastfeeding;
132 (iii) when to seek emergency medical attention;
133 (iv) as appropriate, the importance of timely testing and treatment, for HIV and
134 sexually transmitted diseases;
135 (v) the importance of consulting a physician for follow-up care; and
136 (vi) the availability of HIV pre-exposure prophylaxis for individuals who are at
137 substantial risk of acquiring HIV;
138 (b) provide the patient with:
139 (i) written information regarding the importance of the patient visiting the patient's
140 primary care practitioner for follow-up care; and
141 (ii) a copy of the record of the encounter with the patient that includes:
142 (A) the patient's completed self-screening risk assessment questionnaire;
143 (B) the results of an HIV test completed under Subsection (1)(c)(i); and
144 (C) a description of the HIV post-exposure prophylaxis dispensed; and
145 (c) (i) if the patient consents, notify the patient's primary care practitioner that the
146 pharmacist has dispensed HIV post-exposure prophylaxis to the patient; and
147 (ii) if the patient does not consent or the patient does not have a primary care
148 practitioner, provide the patient with a list of health care providers who are able to provide the
149 patient with follow-up care for HIV post-exposure prophylaxis.
150 (4) A patient may not waive the patient counseling required in Subsection (3)(a).
151 (5) If a pharmacist or pharmacy intern refuses to dispense HIV post-exposure
152 prophylaxis to a patient under Section 26-67-104, the pharmacist or pharmacy intern shall
153 explain to the patient the reason for the refusal.
154 Section 7. Section 26-67-107 is enacted to read:
155 26-67-107. Rulemaking.
156 The division shall make rules in accordance with Title 63G, Chapter 3, Utah
157 Administrative Rulemaking Act, regarding:
158 (1) additional drugs or drug combinations that comply with CDC guidelines;
159 (2) a standing prescription drug order protocol for use under Section 26-67-105; and
160 (3) a self-screening risk assessment questionnaire that includes a question regarding
161 whether the patient:
162 (a) was exposed to HIV within the previous 72 hours; and
163 (b) satisfies the criteria for HIV post-exposure prophylaxis described in CDC
164 guidelines.
165 Section 8. Section 26-67-108 is enacted to read:
166 26-67-108. Limited civil liability.
167 A physician who issues a standing prescription drug order in accordance with Section
168 26-67-105 is not liable for any civil damages for acts or omissions resulting from the
169 dispensing of HIV post-exposure prophylaxis under this chapter.