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2 | 2 | | SENATE DOCKET, NO. 445 FILED ON: 1/15/2023 |
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3 | 3 | | SENATE . . . . . . . . . . . . . . No. 1353 |
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4 | 4 | | The Commonwealth of Massachusetts |
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5 | 5 | | _________________ |
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6 | 6 | | PRESENTED BY: |
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7 | 7 | | Julian Cyr |
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8 | 8 | | _________________ |
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9 | 9 | | To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General |
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10 | 10 | | Court assembled: |
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11 | 11 | | The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill: |
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12 | 12 | | An Act enabling pharmacists to prescribe, dispense and administer PrEP. |
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13 | 13 | | _______________ |
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14 | 14 | | PETITION OF: |
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15 | 15 | | NAME:DISTRICT/ADDRESS :Julian CyrCape and IslandsJack Patrick Lewis7th Middlesex1/23/2023Joanne M. ComerfordHampshire, Franklin and Worcester2/7/2023Susannah M. Whipps2nd Franklin2/7/2023Mark C. MontignySecond Bristol and Plymouth2/7/2023Rebecca L. RauschNorfolk, Worcester and Middlesex2/7/2023Vanna Howard17th Middlesex2/7/2023Patricia D. JehlenSecond Middlesex3/7/2023 1 of 4 |
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16 | 16 | | SENATE DOCKET, NO. 445 FILED ON: 1/15/2023 |
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17 | 17 | | SENATE . . . . . . . . . . . . . . No. 1353 |
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18 | 18 | | By Mr. Cyr, a petition (accompanied by bill, Senate, No. 1353) of Julian Cyr, Jack Patrick |
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19 | 19 | | Lewis, Joanne M. Comerford, Susannah M. Whipps and other members of the General Court for |
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20 | 20 | | legislation to enable pharmacists to prescribe, dispense and administer PrEP. Public Health. |
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21 | 21 | | [SIMILAR MATTER FILED IN PREVIOUS SESSION |
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22 | 22 | | SEE SENATE, NO. 2955 OF 2021-2022.] |
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23 | 23 | | The Commonwealth of Massachusetts |
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24 | 24 | | _______________ |
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25 | 25 | | In the One Hundred and Ninety-Third General Court |
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26 | 26 | | (2023-2024) |
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27 | 27 | | _______________ |
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28 | 28 | | An Act enabling pharmacists to prescribe, dispense and administer PrEP. |
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29 | 29 | | Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority |
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30 | 30 | | of the same, as follows: |
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31 | 31 | | 1 SECTION 1. Section 1 of chapter 94C, as appearing in the 2020 Official Edition, is |
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32 | 32 | | 2hereby amended by inserting after the definition of “Extended-release long-acting opioid in a |
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33 | 33 | | 3non-abuse deterrent form” the following 2 definitions:- |
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34 | 34 | | 4 “HIV”, human immunodeficiency virus. |
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35 | 35 | | 5 “HIV prevention drug”, a drug approved by the United States Food and Drug |
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36 | 36 | | 6Administration for the prevention of HIV, including, but not limited to, pre-exposure |
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37 | 37 | | 7prophylaxis. |
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38 | 38 | | 8 SECTION 2. Said section 1 of said chapter 94C, as so appearing, is hereby further |
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39 | 39 | | 9amended by inserting after the definition of “Practitioner” the following definition:- 2 of 4 |
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40 | 40 | | 10 “Pre-exposure prophylaxis”, a drug or drug combination that is taken or administered to |
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41 | 41 | | 11reduce the risk of HIV acquisition and meets the same clinical eligibility recommendations |
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42 | 42 | | 12provided in current guidelines of the federal Centers for Disease Control and Prevention. |
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43 | 43 | | 13 SECTION 3. Said chapter 94C is hereby further amended by inserting after section 21B |
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44 | 44 | | 14the following section:- |
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45 | 45 | | 15 Section 21C. (a) A licensed pharmacist may prescribe, dispense or administer HIV |
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46 | 46 | | 16prevention drugs in accordance with regulations promulgated by the department as set forth in |
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47 | 47 | | 17this section. |
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48 | 48 | | 18 (b) A licensed pharmacist may prescribe, dispense or administer HIV prevention drugs |
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49 | 49 | | 19according to United States Food and Drug Administration guidance and product labeling if the |
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50 | 50 | | 20patient: |
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51 | 51 | | 21 (i) is HIV negative, as documented by a negative HIV test result obtained within the |
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52 | 52 | | 22previous 7 days from an HIV antigen and antibody test or antibody-only test or from a rapid, |
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53 | 53 | | 23point-of-care fingerstick blood test approved by the United States Food and Drug |
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54 | 54 | | 24Administration; provided, however, that if the patient does not provide evidence of a negative |
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55 | 55 | | 25HIV test in accordance with this clause, the pharmacist may order an HIV test prior to |
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56 | 56 | | 26prescribing, dispensing or administering the drugs; provided further, that if the test results are not |
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57 | 57 | | 27transmitted directly to the pharmacist, the pharmacist shall verify the test results to the |
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58 | 58 | | 28pharmacist’s satisfaction prior to prescribing, dispensing or administering the drugs; and |
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59 | 59 | | 29provided further, that if the patient tests positive for HIV infection, the pharmacist or person |
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60 | 60 | | 30administering the test shall direct the patient to a primary care provider and provide the patient |
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61 | 61 | | 31with a list of providers and clinics in the region; 3 of 4 |
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62 | 62 | | 32 (ii) does not report any signs or symptoms of acute HIV infection on a self-reported |
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63 | 63 | | 33checklist of acute HIV infection signs and symptoms; and |
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64 | 64 | | 34 (iii) does not report taking any contraindicated medication. |
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65 | 65 | | 35 (c) A licensed pharmacist that prescribes, dispenses or administers HIV prevention drugs |
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66 | 66 | | 36shall: |
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67 | 67 | | 37 (i) provide counseling to the patient on the ongoing use of pre-exposure prophylaxis, |
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68 | 68 | | 38which may include education about side effects, safety during pregnancy and breastfeeding, |
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69 | 69 | | 39adherence to recommended dosing and the importance of timely testing and treatment, as |
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70 | 70 | | 40applicable, for HIV, renal function, hepatitis B, hepatitis C, sexually transmitted infections and |
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71 | 71 | | 41pregnancy for individuals of child-bearing capacity; |
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72 | 72 | | 42 (ii) notify the patient that the patient is required to be seen by a primary care provider to |
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73 | 73 | | 43receive subsequent prescriptions for pre-exposure prophylaxis and that a pharmacist shall not |
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74 | 74 | | 44furnish a 60-day supply of pre-exposure prophylaxis to a single patient more than once every 2 |
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75 | 75 | | 45years: |
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76 | 76 | | 46 (iii) document, to the extent possible, the services provided to the patient by the |
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77 | 77 | | 47pharmacist in the patient’s record in the record system maintained by the pharmacy and maintain |
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78 | 78 | | 48records of pre-exposure prophylaxis furnished to each patient; and |
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79 | 79 | | 49 (iv) notify the patient’s primary care provider that the pharmacist completed the |
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80 | 80 | | 50requirements specified in this subsection; provided, however, that if the patient does not have a |
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81 | 81 | | 51primary care provider or refuses consent to notify the patient’s primary care provider, the 4 of 4 |
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82 | 82 | | 52pharmacist shall provide the patient a list of physicians and surgeons, clinics or other health care |
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83 | 83 | | 53service providers to contact regarding ongoing care for pre-exposure prophylaxis. |
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84 | 84 | | 54 SECTION 4. The department of public health shall promulgate regulations to establish |
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85 | 85 | | 55statewide drug therapy protocols for prescribing, dispensing and administering pre-exposure |
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86 | 86 | | 56prophylaxis and other HIV prevention drugs approved by the United States Food and Drug |
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87 | 87 | | 57Administration that are consistent with federal Centers for Disease Control and Prevention |
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88 | 88 | | 58guidelines not later than 6 months after the effective date of this act. The regulations shall |
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89 | 89 | | 59include, but not be limited to, rules stating that a pharmacist shall not furnish a 60-day supply of |
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90 | 90 | | 60pre-exposure prophylaxis to a single patient more than once every 2 years. |
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