House File 2377 H-8091 Amend House File 2377 as follows: 1 1. Page 1, line 29, before < shall > by inserting < or the 2 prescribing practitioner's designated agent > 3 2. Page 1, line 29, after < database > by inserting < prior to 4 issuing an opioid prescription > 5 3. Page 2, line 35, by striking < twenty-four > 6 4. Page 3, line 1, by striking < hours > and inserting < one 7 business day > 8 5. Page 4, line 32, by striking < program > and inserting 9 < department, and the department to report to the program, > 10 6. By striking page 5, line 7, through page 12, line 27, and 11 inserting: 12 < Sec. ___. Section 124.308, Code 2018, is amended by 13 striking the section and inserting in lieu thereof the 14 following: 15 124.308 Prescriptions. 16 1. Except when dispensed directly by a practitioner to an 17 ultimate user, a prescription drug as defined in section 155A.3 18 that is a controlled substance shall not be dispensed without 19 a prescription, unless such prescription is authorized by a 20 practitioner and complies with this section, section 155A.27, 21 applicable federal law and regulation, and rules of the board. 22 2. a. Beginning January 1, 2020, every prescription issued 23 for a controlled substance shall be transmitted electronically 24 as an electronic prescription pursuant to the requirements in 25 subsection 2, paragraph “b” , unless exempt under subsection 2, 26 paragraph “c” . 27 b. Except for prescriptions identified in paragraph “c” , 28 a prescription that is transmitted pursuant to paragraph “a” 29 shall be transmitted to a pharmacy by a practitioner or the 30 practitioner’s authorized agent in compliance with federal 31 law and regulation for electronic prescriptions of controlled 32 substances. The practitioner’s electronic prescription system 33 and the receiving pharmacy’s dispensing system shall comply 34 with federal law and regulation for electronic prescriptions of 35 -1- HF2377.3666 (1) 87 ss/rh 1/ 10 #1. #2. #3. #4. #5. #6.
controlled substances. 1 c. Paragraph “b” shall not apply to any of the following: 2 (1) A prescription for a patient residing in a nursing home, 3 long-term care facility, correctional facility, or jail. 4 (2) A prescription authorized by a licensed veterinarian. 5 (3) A prescription dispensed by a department of veterans 6 affairs pharmacy. 7 (4) A prescription requiring information that makes 8 electronic submission impractical, such as complicated or 9 lengthy directions for use or attachments. 10 (5) A prescription for a compounded preparation containing 11 two or more components. 12 (6) A prescription issued in response to a public health 13 emergency in a situation where a non-patient specific 14 prescription would be permitted. 15 (7) A prescription issued pursuant to an established and 16 valid collaborative practice agreement, standing order, or drug 17 research protocol. 18 (8) A prescription issued during a temporary technical 19 or electronic failure at the practitioner’s or pharmacy’s 20 location, provided that a prescription issued pursuant to 21 this subparagraph shall indicate on the prescription that the 22 practitioner or pharmacy is experiencing a temporary technical 23 or electronic failure. 24 (9) A prescription issued in an emergency situation 25 pursuant to federal law and regulation rules of the board. 26 d. A practitioner, as defined in section 124.101, subsection 27 27, paragraph “a” , who violates paragraph “a” is subject 28 to an administrative penalty of two hundred fifty dollars 29 per violation, up to a maximum of five thousand dollars per 30 calendar year. The assessment of an administrative penalty 31 pursuant to this paragraph by the appropriate licensing board 32 of the practitioner alleged to have violated paragraph “a” 33 shall not be considered a disciplinary action or reported 34 as discipline. A practitioner may appeal the assessment of 35 -2- HF2377.3666 (1) 87 ss/rh 2/ 10
an administrative penalty pursuant to this paragraph, which 1 shall initiate a contested case proceeding under chapter 2 17A. A penalty collected pursuant to this paragraph shall be 3 deposited into the drug information program fund established 4 pursuant to section 124.557. The board shall be notified 5 of any administrative penalties assessed by the appropriate 6 professional licensing board and deposited into the drug 7 information program fund under this paragraph. 8 e. A pharmacist who receives a written, oral, or facsimile 9 prescription shall not be required to verify that the 10 prescription is subject to an exception under paragraph “c” 11 and may dispense a prescription drug pursuant to an otherwise 12 valid written, oral, or facsimile prescription. However, a 13 pharmacist shall exercise professional judgment in identifying 14 and reporting suspected violations of this section to the 15 board or the appropriate professional licensing board of the 16 practitioner. 17 3. A prescription issued prior to January 1, 2020, or a 18 prescription that is exempt from the electronic prescription 19 requirement in subsection 2, paragraph “c” , may be transmitted 20 by a practitioner or the practitioner’s authorized agent to a 21 pharmacy in any of the following ways: 22 a. Electronically, if transmitted in accordance with 23 the requirements for electronic prescriptions pursuant to 24 subsection 2. 25 b. By facsimile for a schedule III, IV, or V controlled 26 substance, or for a schedule II controlled substance only 27 pursuant to federal law and regulation and rules of the board. 28 c. Orally for a schedule III, IV, or V controlled substance, 29 or for a schedule II controlled substance only in an emergency 30 situation pursuant to federal regulation and rules of the 31 board. 32 d. By providing an original signed prescription to a patient 33 or a patient’s authorized representative. 34 4. If permitted by federal law and in accordance with 35 -3- HF2377.3666 (1) 87 ss/rh 3/ 10
federal requirements, an electronic or facsimile prescription 1 shall serve as the original signed prescription and the 2 practitioner shall not provide a patient, a patient’s 3 authorized representative, or the dispensing pharmacy with a 4 signed, written prescription. An original signed prescription 5 shall be retained for a minimum of two years from the date of 6 the latest dispensing or refill of the prescription. 7 5. A prescription for a schedule II controlled substance 8 shall not be filled more than six months after the date 9 of issuance. A prescription for a schedule II controlled 10 substance shall not be refilled. 11 6. A prescription for a schedule III, IV, or V controlled 12 substance shall not be filled or refilled more than six months 13 after the date on which the prescription was issued or be 14 refilled more than five times. 15 7. A controlled substance shall not be distributed or 16 dispensed other than for a medical purpose. 17 8. A practitioner, medical group, or pharmacy that is unable 18 to timely comply with the electronic prescribing requirements 19 in subsection 2, paragraph “b” , may petition the board for an 20 exemption from the requirements based upon economic hardship, 21 technical limitations that the practitioner, medical group, or 22 pharmacy cannot control, or other exceptional circumstances. 23 The board shall adopt rules establishing the form and specific 24 information to be included in a request for an exemption 25 and the specific criteria to be considered by the board in 26 determining whether to approve a request for an exemption. The 27 board may approve an exemption for a period of time determined 28 by the board not to exceed one year from the date of approval, 29 and may be renewed annually upon request subject to board 30 approval. 31 Sec. ___. Section 155A.27, Code 2018, is amended by striking 32 the section and inserting in lieu thereof the following: 33 155A.27 Requirements for prescription. 34 1. Except when dispensed directly by a prescriber to an 35 -4- HF2377.3666 (1) 87 ss/rh 4/ 10
ultimate user, a prescription drug shall not be dispensed 1 without a prescription, authorized by a prescriber, and based 2 on a valid patient-prescriber relationship. 3 2. a. Beginning January 1, 2020, every prescription issued 4 for a prescription drug shall be transmitted electronically as 5 an electronic prescription to a pharmacy by a prescriber or the 6 prescriber’s authorized agent unless exempt under paragraph 7 “b” . 8 b. Paragraph “a” shall not apply to any of the following: 9 (1) A prescription for a patient residing in a nursing home, 10 long-term care facility, correctional facility, or jail. 11 (2) A prescription authorized by a licensed veterinarian. 12 (3) A prescription for a device. 13 (4) A prescription dispensed by a department of veterans 14 affairs pharmacy. 15 (5) A prescription requiring information that makes 16 electronic transmission impractical, such as complicated or 17 lengthy directions for use or attachments. 18 (6) A prescription for a compounded preparation containing 19 two or more components. 20 (7) A prescription issued in response to a public health 21 emergency in a situation where a non-patient specific 22 prescription would be permitted. 23 (8) A prescription issued for an opioid antagonist pursuant 24 to section 135.190 or a prescription issued for epinephrine 25 pursuant to section 135.185. 26 (9) A prescription issued during a temporary technical 27 or electronic failure at the location of the prescriber or 28 pharmacy, provided that a prescription issued pursuant to 29 this subparagraph shall indicate on the prescription that the 30 prescriber or pharmacy is experiencing a temporary technical 31 or electronic failure. 32 (10) A prescription issued pursuant to an established and 33 valid collaborative practice agreement, standing order, or drug 34 research protocol. 35 -5- HF2377.3666 (1) 87 ss/rh 5/ 10
(11) A prescription issued in an emergency situation 1 pursuant to federal law and regulation and rules of the board. 2 c. A practitioner, as defined in section 124.101, subsection 3 27, paragraph “a” , who violates paragraph “a” is subject 4 to an administrative penalty of two hundred fifty dollars 5 per violation, up to a maximum of five thousand dollars per 6 calendar year. The assessment of an administrative penalty 7 pursuant to this paragraph by the appropriate licensing board 8 of the practitioner alleged to have violated paragraph “a” 9 shall not be considered a disciplinary action or reported 10 as discipline. A practitioner may appeal the assessment of 11 an administrative penalty pursuant to this paragraph, which 12 shall initiate a contested case proceeding under chapter 13 17A. A penalty collected pursuant to this paragraph shall be 14 deposited into the drug information program fund established 15 pursuant to section 124.557. The board shall be notified 16 of any administrative penalties assessed by the appropriate 17 professional licensing board and deposited into the drug 18 information program fund under this paragraph. 19 d. A pharmacist who receives a written, oral, or facsimile 20 prescription shall not be required to verify that the 21 prescription is subject to an exception under paragraph “b” 22 and may dispense a prescription drug pursuant to an otherwise 23 valid written, oral, or facsimile prescription. However, a 24 pharmacist shall exercise professional judgment in identifying 25 and reporting suspected violations of this section to the 26 board or the appropriate professional licensing board of the 27 prescriber. 28 3. For prescriptions issued prior to January 1, 2020, 29 or for prescriptions exempt from the electronic prescription 30 requirement in subsection 2, paragraph “b” , a prescriber or the 31 prescriber’s authorized agent may transmit a prescription for a 32 prescription drug to a pharmacy by any of the following means: 33 a. Electronically. 34 b. By facsimile. 35 -6- HF2377.3666 (1) 87 ss/rh 6/ 10
c. Orally. 1 d. By providing an original signed prescription to a patient 2 or a patient’s authorized representative. 3 4. A prescription shall be issued in compliance with 4 this subsection. Regardless of the means of transmission, a 5 prescriber shall provide verbal verification of a prescription 6 upon request of the pharmacy. 7 a. If written, electronic, or facsimile, each prescription 8 shall contain all of the following: 9 (1) The date of issue. 10 (2) The name and address of the patient for whom, or the 11 owner of the animal for which, the drug is dispensed. 12 (3) The name, strength, and quantity of the drug prescribed. 13 (4) The directions for use of the drug, medicine, or device 14 prescribed. 15 (5) The name, address, and written or electronic signature 16 of the prescriber issuing the prescription. 17 (6) The federal drug enforcement administration number, if 18 required under chapter 124. 19 b. If electronic, each prescription shall comply with all 20 of the following: 21 (1) The prescriber shall ensure that the electronic system 22 used to transmit the electronic prescription has adequate 23 security and safeguards designed to prevent and detect 24 unauthorized access, modification, or manipulation of the 25 prescription. 26 (2) Notwithstanding paragraph “a” , subparagraph (5), 27 for prescriptions that are not controlled substances, if 28 transmitted by an authorized agent, the electronic prescription 29 shall not require the written or electronic signature of the 30 prescriber issuing the prescription. 31 c. If facsimile, in addition to the requirements of 32 paragraph “a” , each prescription shall contain all of the 33 following: 34 (1) The identification number of the facsimile machine 35 -7- HF2377.3666 (1) 87 ss/rh 7/ 10
which is used to transmit the prescription. 1 (2) The date and time of transmission of the prescription. 2 (3) The name, address, telephone number, and facsimile 3 number of the pharmacy to which the prescription is being 4 transmitted. 5 d. If oral, the prescriber issuing the prescription 6 shall furnish the same information required for a written 7 prescription, except for the written signature and address 8 of the prescriber. Upon receipt of an oral prescription, 9 the recipient shall promptly reduce the oral prescription to 10 a written format by recording the information required in a 11 written prescription. 12 e. A prescription transmitted by electronic, facsimile, 13 or oral means by a prescriber’s agent shall also include 14 the name and title of the prescriber’s agent completing the 15 transmission. 16 5. An electronic, facsimile, or oral prescription 17 shall serve as the original signed prescription and the 18 prescriber shall not provide a patient, a patient’s authorized 19 representative, or the dispensing pharmacist with a signed 20 written prescription. Prescription records shall be retained 21 pursuant to rules of the board. 22 6. This section shall not prohibit a pharmacist, 23 in exercising the pharmacist’s professional judgment, 24 from dispensing, at one time, additional quantities of a 25 prescription drug, with the exception of a prescription drug 26 that is a controlled substance as defined in section 124.101, 27 up to the total number of dosage units authorized by the 28 prescriber on the original prescription and any refills of 29 the prescription, not to exceed a ninety-day supply of the 30 prescription drug as specified on the prescription. 31 7. A prescriber, medical group, institution, or pharmacy 32 that is unable to timely comply with the electronic prescribing 33 requirements in subsection 2, paragraph “a” , may petition 34 the board for an exemption from the requirements based upon 35 -8- HF2377.3666 (1) 87 ss/rh 8/ 10
economic hardship, technical limitations that the prescriber, 1 medical group, institution, or pharmacy cannot control, or 2 other exceptional circumstances. The board shall adopt rules 3 establishing the form and specific information to be included 4 in a request for an exemption and the specific criteria to be 5 considered by the board in determining whether to approve a 6 request for an exemption. The board may approve an exemption 7 for a period of time determined by the board, not to exceed one 8 year from the date of approval, and may be annually renewed 9 subject to board approval upon request. 10 Sec. ___. Section 155A.29, subsection 4, Code 2018, is 11 amended to read as follows: 12 4. An authorization to refill a prescription drug order may 13 shall be transmitted to a pharmacist pharmacy by a prescriber 14 or the prescriber’s authorized agent through word of mouth, 15 note, telephone, facsimile, or other means of communication 16 initiated by or directed by the practitioner. The transmission 17 shall include the information required pursuant to section 18 155A.27 , except that prescription drug orders for controlled 19 substances shall be transmitted pursuant to section 124.308, 20 and, if not transmitted directly by the practitioner, 21 shall identify by also include the name and title of the 22 practitioner’s agent completing the transmission. > 23 7. Page 13, by striking line 14. 24 8. Page 21, after line 25 by inserting: 25 < (f) Medical assistance was not sought during the execution 26 of an arrest warrant, search warrant, or other lawful search. > 27 9. Page 22, by striking lines 10 through 12 and inserting: 28 < 5. Nothing in this section shall do any of the following: 29 a. Preclude or prevent an investigation by law enforcement 30 of the drug-related overdose where medical assistance was 31 provided. 32 b. Be construed to limit or bar the use or admissibility 33 of any evidence or information obtained in connection with the 34 investigation of the drug-related overdose in the investigation 35 -9- HF2377.3666 (1) 87 ss/rh 9/ 10 #7. #8. #9.
or prosecution of other crimes or violations which do not 1 qualify for immunity under this section and which are committed 2 by any person, including the overdose patient or overdose 3 reporter. 4 c. Preclude the investigation or prosecution of any person 5 on the basis of evidence obtained from sources other than the 6 specific drug-related overdose where medical assistance was 7 provided. > 8 10. By renumbering, redesignating, and correcting internal 9 references as necessary. 10 ______________________________ LUNDGREN of Dubuque -10- HF2377.3666 (1) 87 ss/rh 10/ 10 #10.