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5 | 5 | | 2025 -- S 0692 |
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6 | 6 | | ======== |
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7 | 7 | | LC002231 |
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8 | 8 | | ======== |
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9 | 9 | | S T A T E O F R H O D E I S L A N D |
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10 | 10 | | IN GENERAL ASSEMBLY |
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11 | 11 | | JANUARY SESSION, A.D. 2025 |
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12 | 12 | | ____________ |
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13 | 13 | | |
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14 | 14 | | A N A C T |
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15 | 15 | | RELATING TO BUSINESSES AND PROFESSIONS -- PHARMACIES |
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16 | 16 | | Introduced By: Senator Melissa A. Murray |
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17 | 17 | | Date Introduced: March 07, 2025 |
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18 | 18 | | Referred To: Senate Health & Human Services |
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19 | 19 | | |
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20 | 20 | | |
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21 | 21 | | It is enacted by the General Assembly as follows: |
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22 | 22 | | SECTION 1. Chapter 5-19.1 of the General Laws entitled "Pharmacies" is hereby amended 1 |
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23 | 23 | | by adding thereto the following section: 2 |
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24 | 24 | | 5-19.1-37. Pharmacy technicians -- Scope of practice -- Pharmacy technician 3 |
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25 | 25 | | dispensing process validation within institutional pharmacies. 4 |
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26 | 26 | | (a) In accordance with chapter 19.1 of title 5 and adopted by the state board of pharmacy, 5 |
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27 | 27 | | a pharmacy technician or pharmacy intern may perform technology-assisted dispensing process 6 |
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28 | 28 | | validation for medications prepared for distribution by another pharmacy technician or intern 7 |
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29 | 29 | | within an institutional pharmacy. 8 |
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30 | 30 | | (b) Definitions. For purposes of this section, the following words and terms shall have the 9 |
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31 | 31 | | following meanings: 10 |
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32 | 32 | | (1) “Automated storage and distribution devices” means a mechanical device that delivers 11 |
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33 | 33 | | drugs other than by administration, and uses automated data processing technology to: 12 |
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34 | 34 | | (i) Provide effective storage and security of drugs contained in the device; 13 |
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35 | 35 | | (ii) Limit access to authorized individuals; 14 |
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36 | 36 | | (iii) Record the identity of all personnel who access the drugs stored within the device; 15 |
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37 | 37 | | (iv) Provide documentation of storage and removal of contents; 16 |
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38 | 38 | | (v) Provide ongoing documentation that monitors proper delivery of drugs to ensure patient 17 |
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39 | 39 | | safety; and 18 |
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40 | 40 | | (iv) Comply with all relevant statutes, rules and regulations. 19 |
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41 | 41 | | |
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42 | 42 | | |
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43 | 43 | | LC002231 - Page 2 of 4 |
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44 | 44 | | (2) “Controlled substance" means a drug or substance, or an immediate precursor of such 1 |
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45 | 45 | | drug or substance, so designated under or pursuant to the provisions of chapter 28 of title 21. 2 |
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46 | 46 | | (3) “Dispensing process validation” means the physical verification that ensures the drug, 3 |
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47 | 47 | | drug dosage, and drug form selected is the correct drug, drug dosage, and drug form for the purpose 4 |
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48 | 48 | | for which it was selected. When applicable, dispensing process validation is subject to, and occurs 5 |
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49 | 49 | | after, licensed pharmacist drug utilization review and clinical conflict resolution. 6 |
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50 | 50 | | (4) “Institutional pharmacy” means any pharmacy that is located within or off-site, and 7 |
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51 | 51 | | contracted with, any hospital, clinic or dispensary in which drugs are compounded or dispensed to 8 |
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52 | 52 | | its patients or patients of another licensed in-patient healthcare facility with whom it has a contract. 9 |
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53 | 53 | | (5) “Supervision” means oversight and control by a licensed pharmacist who is responsible 10 |
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54 | 54 | | for work performed by pharmacy technicians and pharmacy interns. 11 |
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55 | 55 | | (6) “Technology” means an electronic system designed to achieve accuracy in drug product 12 |
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56 | 56 | | identity verification including, but not limited to, barcode scanning and radio frequency 13 |
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57 | 57 | | identification (RFID). 14 |
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58 | 58 | | (c)(1) With regard to activities authorized, acting in compliance with this section, a licensed 15 |
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59 | 59 | | pharmacist may delegate, and a pharmacy technician or pharmacy intern may perform under the 16 |
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60 | 60 | | supervision of the pharmacist, technology-assisted dispensing process validation of medications 17 |
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61 | 61 | | prepared for distribution by another pharmacy technician or pharmacy intern when such medication 18 |
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62 | 62 | | will be administered to the patient by a licensed health care professional, including: 19 |
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63 | 63 | | (i) Patient-specific medication orders; 20 |
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64 | 64 | | (ii) Automated storage and distribution devices stock; 21 |
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65 | 65 | | (iii) Repackaged medication from bulk to unit-of-use doses; and 22 |
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66 | 66 | | (iv) Emergency kits. 23 |
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67 | 67 | | (2) Acting in compliance with this section, a licensed pharmacist shall not delegate 24 |
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68 | 68 | | dispensing process validation for: 25 |
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69 | 69 | | (i) Controlled substances; or 26 |
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70 | 70 | | (ii) Compounded products (whether sterile or non-sterile) unless the compounded products 27 |
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71 | 71 | | have been previously verified by a licensed pharmacist (e.g., previously batched compounded 28 |
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72 | 72 | | product). 29 |
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73 | 73 | | (3) In delegating activities under this section, a licensed pharmacist shall use reasonable 30 |
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74 | 74 | | professional judgment and shall ensure that authorized activities do not require the exercise of 31 |
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75 | 75 | | discretion or clinical judgment by the pharmacy technician or pharmacy intern. 32 |
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76 | 76 | | (d) (1) With regard to quality and control, the institutional pharmacy where activities 33 |
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77 | 77 | | authorized in this section are conducted shall: 34 |
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78 | 78 | | |
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79 | 79 | | |
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80 | 80 | | LC002231 - Page 3 of 4 |
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81 | 81 | | (i) Document a pharmacy technician or pharmacy intern dispensing process validation 1 |
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82 | 82 | | policy and procedure; 2 |
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83 | 83 | | (ii) Maintain an institutional pharmacy-specific training program including a record of 3 |
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84 | 84 | | pharmacy technicians and/or pharmacy interns trained; and 4 |
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85 | 85 | | (iii) Maintain a continuous quality assessment system to periodically verify the accuracy 5 |
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86 | 86 | | of the pharmacy technician or pharmacy intern dispensing process validation, including: 6 |
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87 | 87 | | (A) Recording any errors which reach the patient; 7 |
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88 | 88 | | (B) Recording any quality related events; and 8 |
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89 | 89 | | (C) Specific limits of acceptable quality related event levels before reassessment. 9 |
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90 | 90 | | (2) No pharmacy technician or pharmacy intern shall engage in authorized activities 10 |
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91 | 91 | | without documentation of training. 11 |
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92 | 92 | | (e) With regards to rules and regulations, the board of pharmacy shall make, adopt, amend, 12 |
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93 | 93 | | and repeal such rules and regulations as may be deemed necessary by the board from time to time 13 |
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94 | 94 | | for the proper administration and enforcement of this section. Such rules and regulations shall be 14 |
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95 | 95 | | promulgated in accordance with the procedures specified in chapter 35 of title 42 ("administrative 15 |
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96 | 96 | | procedures"). 16 |
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97 | 97 | | SECTION 2. This act shall take effect upon passage. 17 |
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99 | 99 | | LC002231 |
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101 | 101 | | |
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102 | 102 | | |
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103 | 103 | | LC002231 - Page 4 of 4 |
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104 | 104 | | EXPLANATION |
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105 | 105 | | BY THE LEGISLATIVE COUNCIL |
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106 | 106 | | OF |
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107 | 107 | | A N A C T |
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108 | 108 | | RELATING TO BUSINESSES AND PROFESSIONS -- PHARMACIES |
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109 | 109 | | *** |
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110 | 110 | | This act would authorize a pharmacy technician or pharmacy intern to perform technology-1 |
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111 | 111 | | assisted dispensing process validation for medications prepared for distribution by another 2 |
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112 | 112 | | pharmacy technician or intern within an institutional pharmacy. 3 |
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113 | 113 | | This act would take effect upon passage. 4 |
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115 | 115 | | LC002231 |
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