Senate File 2312 - Introduced SENATE FILE 2312 BY COMMITTEE ON HUMAN RESOURCES (SUCCESSOR TO SSB 3074) A BILL FOR An Act relating to the electronic prescribing of prescription 1 drugs including controlled substances, making penalties 2 applicable, and providing penalties. 3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 4 TLSB 5304SV (2) 87 ss/rh
S.F. 2312 Section 1. Section 124.308, Code 2018, is amended by 1 striking the section and inserting in lieu thereof the 2 following: 3 124.308 Prescriptions. 4 1. Except when dispensed directly by a practitioner to an 5 ultimate user, a prescription drug as defined in section 155A.3 6 that is a controlled substance shall not be dispensed without 7 a prescription, unless such prescription is authorized by a 8 practitioner and complies with this section, section 155A.27, 9 applicable federal law and regulation, and rules of the board. 10 2. a. Beginning January 1, 2020, every prescription issued 11 for a controlled substance shall be transmitted electronically 12 as an electronic prescription pursuant to the requirements in 13 subsection 2, paragraph “b” , unless exempt under subsection 2, 14 paragraph “c” . 15 b. Except for prescriptions identified in paragraph “c” , 16 a prescription that is transmitted pursuant to paragraph “a” 17 shall be transmitted to a pharmacy by a practitioner or the 18 practitioner’s authorized agent in compliance with federal 19 law and regulation for electronic prescriptions of controlled 20 substances. The practitioner’s electronic prescription system 21 and the receiving pharmacy’s dispensing system shall comply 22 with federal law and regulation for electronic prescriptions of 23 controlled substances. 24 c. Paragraph “b” shall not apply to any of the following: 25 (1) A prescription for a patient residing in a nursing home, 26 long-term care facility, correctional facility, or jail. 27 (2) A prescription authorized by a licensed veterinarian. 28 (3) A prescription dispensed by a department of veterans 29 affairs pharmacy. 30 (4) A prescription requiring information that makes 31 electronic submission impractical, such as complicated or 32 lengthy directions for use or attachments. 33 (5) A prescription for a compounded preparation containing 34 two or more components. 35 -1- LSB 5304SV (2) 87 ss/rh 1/ 10
S.F. 2312 (6) A prescription issued in response to a public health 1 emergency in a situation where a non-patient specific 2 prescription would be permitted. 3 (7) A prescription issued pursuant to an established and 4 valid collaborative practice agreement, standing order, or drug 5 research protocol. 6 (8) A prescription issued during a temporary technical 7 or electronic failure at the practitioner’s or pharmacy’s 8 location, provided that a prescription issued pursuant to 9 this subparagraph shall indicate on the prescription that the 10 practitioner or pharmacy is experiencing a temporary technical 11 or electronic failure. 12 (9) A prescription issued in an emergency situation 13 pursuant to federal law and regulation rules of the board. 14 d. A practitioner, as defined in section 124.101, subsection 15 27, paragraph “a” , who violates paragraph “a” is subject 16 to an administrative penalty of two hundred fifty dollars 17 per violation, up to a maximum of five thousand dollars per 18 calendar year. The assessment of an administrative penalty 19 pursuant to this paragraph by the appropriate licensing board 20 of the practitioner alleged to have violated paragraph “a” 21 shall not be considered a disciplinary action or reported 22 as discipline. A practitioner may appeal the assessment of 23 an administrative penalty pursuant to this paragraph, which 24 shall initiate a contested case proceeding under chapter 25 17A. A penalty collected pursuant to this paragraph shall be 26 deposited into the drug information program fund established 27 pursuant to section 124.557. The board shall be notified 28 of any administrative penalties assessed by the appropriate 29 professional licensing board and deposited into the drug 30 information program fund under this paragraph. 31 e. A pharmacist who receives a written, oral, or facsimile 32 prescription shall not be required to verify that the 33 prescription is subject to an exception under paragraph “c” 34 and may dispense a prescription drug pursuant to an otherwise 35 -2- LSB 5304SV (2) 87 ss/rh 2/ 10
S.F. 2312 valid written, oral, or facsimile prescription. However, a 1 pharmacist shall exercise professional judgment in identifying 2 and reporting suspected violations of this section to the 3 board or the appropriate professional licensing board of the 4 practitioner. 5 3. A prescription issued prior to January 1, 2020, or a 6 prescription that is exempt from the electronic prescription 7 requirement in subsection 2, paragraph “c” , may be transmitted 8 by a practitioner or the practitioner’s authorized agent to a 9 pharmacy in any of the following ways: 10 a. Electronically, if transmitted in accordance with 11 the requirements for electronic prescriptions pursuant to 12 subsection 2. 13 b. By facsimile for a schedule III, IV, or V controlled 14 substance, or for a schedule II controlled substance only 15 pursuant to federal law and regulation and rules of the board. 16 c. Orally for a schedule III, IV, or V controlled substance, 17 or for a schedule II controlled substance only in an emergency 18 situation pursuant to federal regulation and rules of the 19 board. 20 d. By providing an original signed prescription to a patient 21 or a patient’s authorized representative. 22 4. If permitted by federal law and in accordance with 23 federal requirements, an electronic or facsimile prescription 24 shall serve as the original signed prescription and the 25 practitioner shall not provide a patient, a patient’s 26 authorized representative, or the dispensing pharmacy with a 27 signed, written prescription. An original signed prescription 28 shall be retained for a minimum of two years from the date of 29 the latest dispensing or refill of the prescription. 30 5. A prescription for a schedule II controlled substance 31 shall not be filled more than six months after the date 32 of issuance. A prescription for a schedule II controlled 33 substance shall not be refilled. 34 6. A prescription for a schedule III, IV, or V controlled 35 -3- LSB 5304SV (2) 87 ss/rh 3/ 10
S.F. 2312 substance shall not be filled or refilled more than six months 1 after the date on which the prescription was issued or be 2 refilled more than five times. 3 7. A controlled substance shall not be distributed or 4 dispensed other than for a medical purpose. 5 8. A practitioner, medical group, or pharmacy that is unable 6 to timely comply with the electronic prescribing requirements 7 in subsection 2, paragraph “b” , may petition the board for an 8 exemption from the requirements based upon economic hardship, 9 technical limitations that the practitioner, medical group, or 10 pharmacy cannot control, or other exceptional circumstances. 11 The board shall adopt rules establishing the form and specific 12 information to be included in a request for an exemption 13 and the specific criteria to be considered by the board in 14 determining whether to approve a request for an exemption. The 15 board may approve an exemption for a period of time determined 16 by the board not to exceed one year from the date of approval, 17 and may be renewed annually upon request subject to board 18 approval. 19 Sec. 2. Section 155A.27, Code 2018, is amended by striking 20 the section and inserting in lieu thereof the following: 21 155A.27 Requirements for prescription. 22 1. Except when dispensed directly by a prescriber to an 23 ultimate user, a prescription drug shall not be dispensed 24 without a prescription, authorized by a prescriber, and based 25 on a valid patient-prescriber relationship. 26 2. a. Beginning January 1, 2020, every prescription issued 27 for a prescription drug shall be transmitted electronically as 28 an electronic prescription to a pharmacy by a prescriber or the 29 prescriber’s authorized agent unless exempt under paragraph 30 “b” . 31 b. Paragraph “a” shall not apply to any of the following: 32 (1) A prescription for a patient residing in a nursing home, 33 long-term care facility, correctional facility, or jail. 34 (2) A prescription authorized by a licensed veterinarian. 35 -4- LSB 5304SV (2) 87 ss/rh 4/ 10
S.F. 2312 (3) A prescription for a device. 1 (4) A prescription dispensed by a department of veterans 2 affairs pharmacy. 3 (5) A prescription requiring information that makes 4 electronic transmission impractical, such as complicated or 5 lengthy directions for use or attachments. 6 (6) A prescription for a compounded preparation containing 7 two or more components. 8 (7) A prescription issued in response to a public health 9 emergency in a situation where a non-patient specific 10 prescription would be permitted. 11 (8) A prescription issued for an opioid antagonist pursuant 12 to section 135.190 or a prescription issued for epinephrine 13 pursuant to section 135.185. 14 (9) A prescription issued during a temporary technical 15 or electronic failure at the location of the prescriber or 16 pharmacy, provided that a prescription issued pursuant to 17 this subparagraph shall indicate on the prescription that the 18 prescriber or pharmacy is experiencing a temporary technical 19 or electronic failure. 20 (10) A prescription issued pursuant to an established and 21 valid collaborative practice agreement, standing order, or drug 22 research protocol. 23 (11) A prescription issued in an emergency situation 24 pursuant to federal law and regulation and rules of the board. 25 c. A practitioner, as defined in section 124.101, subsection 26 27, paragraph “a” , who violates paragraph “a” is subject 27 to an administrative penalty of two hundred fifty dollars 28 per violation, up to a maximum of five thousand dollars per 29 calendar year. The assessment of an administrative penalty 30 pursuant to this paragraph by the appropriate licensing board 31 of the practitioner alleged to have violated paragraph “a” 32 shall not be considered a disciplinary action and shall not be 33 released or reported as discipline. A practitioner may appeal 34 the assessment of an administrative penalty pursuant to this 35 -5- LSB 5304SV (2) 87 ss/rh 5/ 10
S.F. 2312 paragraph, which shall initiate a contested case proceeding 1 under chapter 17A. A penalty collected pursuant to this 2 paragraph shall be deposited into the drug information program 3 fund established pursuant to section 124.557. The board shall 4 be notified of any administrative penalties assessed by the 5 appropriate professional licensing board and deposited into the 6 drug information program fund under this paragraph. 7 d. A pharmacist who receives a written, oral, or facsimile 8 prescription shall not be required to verify that the 9 prescription is subject to an exception under paragraph “b” 10 and may dispense a prescription drug pursuant to an otherwise 11 valid written, oral, or facsimile prescription. However, a 12 pharmacist shall exercise professional judgment in identifying 13 and reporting suspected violations of this section to the 14 board or the appropriate professional licensing board of the 15 prescriber. 16 3. For prescriptions issued prior to January 1, 2020, 17 or for prescriptions exempt from the electronic prescription 18 requirement in subsection 2, paragraph “b” , a prescriber or the 19 prescriber’s authorized agent may transmit a prescription for a 20 prescription drug to a pharmacy by any of the following means: 21 a. Electronically. 22 b. By facsimile. 23 c. Orally. 24 d. By providing an original signed prescription to a patient 25 or a patient’s authorized representative. 26 4. A prescription shall be issued in compliance with 27 this subsection. Regardless of the means of transmission, a 28 prescriber shall provide verbal verification of a prescription 29 upon request of the pharmacy. 30 a. If written, electronic, or facsimile, each prescription 31 shall contain all of the following: 32 (1) The date of issue. 33 (2) The name and address of the patient for whom, or the 34 owner of the animal for which, the drug is dispensed. 35 -6- LSB 5304SV (2) 87 ss/rh 6/ 10
S.F. 2312 (3) The name, strength, and quantity of the drug prescribed. 1 (4) The directions for use of the drug, medicine, or device 2 prescribed. 3 (5) The name, address, and written or electronic signature 4 of the prescriber issuing the prescription. 5 (6) The federal drug enforcement administration number, if 6 required under chapter 124. 7 b. If electronic, each prescription shall comply with all 8 of the following: 9 (1) The prescriber shall ensure that the electronic system 10 used to transmit the electronic prescription has adequate 11 security and safeguards designed to prevent and detect 12 unauthorized access, modification, or manipulation of the 13 prescription. 14 (2) Notwithstanding paragraph “a” , subparagraph (5), 15 for prescriptions that are not controlled substances, if 16 transmitted by an authorized agent, the electronic prescription 17 shall not require the written or electronic signature of the 18 prescriber issuing the prescription. 19 c. If facsimile, in addition to the requirements of 20 paragraph “a” , each prescription shall contain all of the 21 following: 22 (1) The identification number of the facsimile machine 23 which is used to transmit the prescription. 24 (2) The date and time of transmission of the prescription. 25 (3) The name, address, telephone number, and facsimile 26 number of the pharmacy to which the prescription is being 27 transmitted. 28 d. If oral, the prescriber issuing the prescription 29 shall furnish the same information required for a written 30 prescription, except for the written signature and address 31 of the prescriber. Upon receipt of an oral prescription, 32 the recipient shall promptly reduce the oral prescription to 33 a written format by recording the information required in a 34 written prescription. 35 -7- LSB 5304SV (2) 87 ss/rh 7/ 10
S.F. 2312 e. A prescription transmitted by electronic, facsimile, 1 or oral means by a prescriber’s agent shall also include 2 the name and title of the prescriber’s agent completing the 3 transmission. 4 5. An electronic, facsimile, or oral prescription 5 shall serve as the original signed prescription and the 6 prescriber shall not provide a patient, a patient’s authorized 7 representative, or the dispensing pharmacist with a signed 8 written prescription. Prescription records shall be retained 9 pursuant to rules of the board. 10 6. This section shall not prohibit a pharmacist, 11 in exercising the pharmacist’s professional judgment, 12 from dispensing, at one time, additional quantities of a 13 prescription drug, with the exception of a prescription drug 14 that is a controlled substance as defined in section 124.101, 15 up to the total number of dosage units authorized by the 16 prescriber on the original prescription and any refills of 17 the prescription, not to exceed a ninety-day supply of the 18 prescription drug as specified on the prescription. 19 7. A prescriber, medical group, institution, or pharmacy 20 that is unable to timely comply with the electronic prescribing 21 requirements in subsection 2, paragraph “a” , may petition 22 the board for an exemption from the requirements based upon 23 economic hardship, technical limitations that the prescriber, 24 medical group, institution, or pharmacy cannot control, or 25 other exceptional circumstances. The board shall adopt rules 26 establishing the form and specific information to be included 27 in a request for an exemption and the specific criteria to be 28 considered by the board in determining whether to approve a 29 request for an exemption. The board may approve an exemption 30 for a period of time determined by the board, not to exceed one 31 year from the date of approval, and may be annually renewed 32 subject to board approval upon request. 33 Sec. 3. Section 155A.29, subsection 4, Code 2018, is amended 34 to read as follows: 35 -8- LSB 5304SV (2) 87 ss/rh 8/ 10
S.F. 2312 4. An authorization to refill a prescription drug order may 1 shall be transmitted to a pharmacist pharmacy by a prescriber 2 or the prescriber’s authorized agent through word of mouth, 3 note, telephone, facsimile, or other means of communication 4 initiated by or directed by the practitioner. The transmission 5 shall include the information required pursuant to section 6 155A.27 , except that prescription drug orders for controlled 7 substances shall be transmitted pursuant to section 124.308, 8 and, if not transmitted directly by the practitioner, 9 shall identify by also include the name and title of the 10 practitioner’s agent completing the transmission. 11 EXPLANATION 12 The inclusion of this explanation does not constitute agreement with 13 the explanation’s substance by the members of the general assembly. 14 This bill relates to the electronic prescribing of 15 prescription drugs, including controlled substances. The 16 bill requires all prescriptions for prescription drugs to 17 transmitted to a pharmacy electronically, effective January 18 1, 2020. The bill also requires prescriptions for controlled 19 substances that are issued electronically to comply with 20 federal law for the electronic transmittal of prescriptions 21 for controlled substances. The bill provides exemptions 22 from this requirement in certain circumstances and provides 23 alternative methods for the transmittal of prescriptions in 24 those circumstances and for prescriptions transmitted prior 25 to January 1, 2020. The bill also allows a person subject to 26 the requirements of the bill to petition the board of pharmacy 27 for exemption from the requirements of the bill based on 28 economic hardship, technical limitations, or other exceptional 29 circumstances. The bill requires refills for prescription 30 drugs and controlled substances to be transmitted in the same 31 manner as required for initial prescriptions. The bill does 32 not require that a pharmacist who receives a prescription in 33 other than an electronic format to verify that the prescription 34 is subject to an exception. However, the bill directs 35 -9- LSB 5304SV (2) 87 ss/rh 9/ 10
S.F. 2312 pharmacists to use their professional judgment in identifying 1 violations. 2 A practitioner who does not transmit a prescription 3 drug order electronically as required by the bill shall be 4 subject to an administrative penalty of $250 per violation, 5 up to a maximum of $5,000 per calendar year. Such a penalty 6 shall be assessed by the professional licensing board of the 7 practitioner alleged to have committed the violation. A 8 practitioner may contest such penalty, which shall initiate a 9 contested case proceeding under Code chapter 17A. Any such 10 penalty collected by a professional licensing board shall be 11 deposited into the drug information program fund and reported 12 to the board. 13 A person who does not comply with Code section 124.308 14 is guilty of an aggravated misdemeanor pursuant to Code 15 section 124.402. An aggravated misdemeanor is punishable by 16 confinement for no more than two years and a fine of at least 17 $625 but not more than $6,250. 18 -10- LSB 5304SV (2) 87 ss/rh 10/ 10