1 | 1 | | SENATE . . . . . . . . . . . . . . No. 2480 |
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2 | 2 | | The Commonwealth of Massachusetts |
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3 | 3 | | _______________ |
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4 | 4 | | In the One Hundred and Ninety-Third General Court |
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5 | 5 | | (2023-2024) |
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6 | 6 | | _______________ |
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7 | 7 | | SENATE, October 19, 2023. |
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8 | 8 | | The committee on Senate Ways and Means, to whom was referred the Senate Bill |
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9 | 9 | | enabling pharmacists to prescribe, dispense and administer PrEP (Senate, No. 1353),- reports, |
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10 | 10 | | recommending that the same ought to pass with an amendment substituting a new draft with the |
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11 | 11 | | same title (Senate, No. 2480). |
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12 | 12 | | For the committee, |
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13 | 13 | | Michael J. Rodrigues 1 of 4 |
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14 | 14 | | FILED ON: 10/19/2023 |
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15 | 15 | | SENATE . . . . . . . . . . . . . . No. 2480 |
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16 | 16 | | The Commonwealth of Massachusetts |
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17 | 17 | | _______________ |
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18 | 18 | | In the One Hundred and Ninety-Third General Court |
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19 | 19 | | (2023-2024) |
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20 | 20 | | _______________ |
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21 | 21 | | An Act enabling pharmacists to prescribe, dispense and administer PrEP. |
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22 | 22 | | Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority |
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23 | 23 | | of the same, as follows: |
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24 | 24 | | 1 SECTION 1. Section 1 of chapter 94C of the General Laws, as appearing in the 2022 |
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25 | 25 | | 2Official Edition, is hereby amended by inserting after the definition of “Extended-release long- |
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26 | 26 | | 3acting opioid in a non-abuse deterrent form” the following 2 definitions:- |
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27 | 27 | | 4 “HIV”, human immunodeficiency virus. |
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28 | 28 | | 5 “HIV prevention drug”, a drug approved by the United States Food and Drug |
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29 | 29 | | 6Administration for the prevention of HIV, including, but not limited to, pre-exposure |
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30 | 30 | | 7prophylaxis. |
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31 | 31 | | 8 SECTION 2. Said section 1 of said chapter 94C, as so appearing, is hereby further |
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32 | 32 | | 9amended by inserting after the definition of “Practitioner” the following definition:- |
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33 | 33 | | 10 “Pre-exposure prophylaxis”, a drug or drug combination that is taken or administered to |
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34 | 34 | | 11reduce the risk of HIV contraction and meets the same clinical eligibility recommendations |
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35 | 35 | | 12provided in current guidelines of the federal Centers for Disease Control and Prevention. 2 of 4 |
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36 | 36 | | 13 SECTION 3. Said chapter 94C is hereby further amended by inserting after section 21B |
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37 | 37 | | 14the following section:- |
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38 | 38 | | 15 Section 21C. (a) A licensed pharmacist may prescribe, dispense or administer HIV |
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39 | 39 | | 16prevention drugs in accordance with regulations promulgated by the department and United |
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40 | 40 | | 17States Food and Drug Administration guidance and product labeling; provided, however, that a |
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41 | 41 | | 18pharmacist shall not furnish a 60-day supply of pre-exposure prophylaxis to a single patient more |
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42 | 42 | | 19than once every 2 years; and provided further, that the patient: |
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43 | 43 | | 20 (i) is HIV negative, as documented by a negative HIV test result obtained within the |
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44 | 44 | | 21previous 7 days from an HIV antigen and antibody test or antibody-only test or from a rapid, |
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45 | 45 | | 22point-of-care fingerstick blood test approved by the United States Food and Drug |
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46 | 46 | | 23Administration; provided, however, that if the patient does not provide evidence of a negative |
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47 | 47 | | 24HIV test in accordance with this clause, the pharmacist may order an HIV test prior to |
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48 | 48 | | 25prescribing, dispensing or administering the drugs; provided further, that if the test results are not |
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49 | 49 | | 26transmitted directly to the pharmacist, the pharmacist shall verify the test results to the |
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50 | 50 | | 27pharmacist’s satisfaction prior to prescribing, dispensing or administering the drugs; and |
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51 | 51 | | 28provided further, that if the patient tests positive for HIV infection, the pharmacist or person |
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52 | 52 | | 29administering the test shall direct the patient to a primary care provider and provide the patient |
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53 | 53 | | 30with a list of providers and clinics in the region; |
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54 | 54 | | 31 (ii) does not report any signs or symptoms of acute HIV infection on a self-reported |
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55 | 55 | | 32checklist of acute HIV infection signs and symptoms; and |
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56 | 56 | | 33 (iii) does not report taking any contraindicated medication. 3 of 4 |
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57 | 57 | | 34 (c) A licensed pharmacist that prescribes, dispenses or administers HIV prevention drugs |
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58 | 58 | | 35shall: |
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59 | 59 | | 36 (i) provide counseling to the patient on the ongoing use of pre-exposure prophylaxis, |
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60 | 60 | | 37which may include education about side effects, safety during pregnancy and breastfeeding, |
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61 | 61 | | 38adherence to recommended dosing and the importance of timely testing and treatment, as |
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62 | 62 | | 39applicable, for HIV, renal function, hepatitis B, hepatitis C, sexually transmitted infections and |
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63 | 63 | | 40pregnancy for individuals of child-bearing capacity; |
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64 | 64 | | 41 (ii) notify the patient that the patient is required to be seen by a primary care provider to |
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65 | 65 | | 42receive subsequent prescriptions for pre-exposure prophylaxis; |
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66 | 66 | | 43 (iii) document, to the extent possible, the services provided to the patient by the |
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67 | 67 | | 44pharmacist in the patient’s record in the record system maintained by the pharmacy and maintain |
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68 | 68 | | 45records of pre-exposure prophylaxis furnished to each patient; and |
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69 | 69 | | 46 (iv) notify the patient’s primary care provider that the pharmacist completed the |
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70 | 70 | | 47requirements specified in this subsection; provided, however, that if the patient does not have a |
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71 | 71 | | 48primary care provider or refuses consent to notify the patient’s primary care provider, the |
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72 | 72 | | 49pharmacist shall provide the patient a list of physicians and surgeons, clinics or other health care |
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73 | 73 | | 50service providers to contact regarding ongoing care for pre-exposure prophylaxis. |
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74 | 74 | | 51 SECTION 4. Not later than 6 months after the effective date of this act, the department of |
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75 | 75 | | 52public health shall promulgate regulations to establish statewide drug therapy protocols for |
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76 | 76 | | 53prescribing, dispensing and administering pre-exposure prophylaxis and other HIV prevention |
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77 | 77 | | 54drugs approved by the United States Food and Drug Administration that are consistent with |
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78 | 78 | | 55federal Centers for Disease Control and Prevention guidelines. The regulations shall include, but 4 of 4 |
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79 | 79 | | 56not be limited to, rules stating that a pharmacist shall not furnish a 60-day supply of pre-exposure |
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80 | 80 | | 57prophylaxis to a single patient more than once every 2 years. |
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