Bill Text: IA SSB3074 | 2017-2018 | 87th General Assembly | Introduced


Bill Title: A bill for an act relating to the electronic prescribing of prescription drugs including controlled substances, making penalties applicable, and providing penalties.

Spectrum: Committee Bill

Status: (N/A - Dead) 2018-02-07 - Subcommittee recommends amendment and passage. [SSB3074 Detail]

Download: Iowa-2017-SSB3074-Introduced.html
Senate Study Bill 3074 - Introduced SENATE/HOUSE FILE _____ BY (PROPOSED BOARD OF PHARMACY BILL) 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 5304DP (12) 87 ss/rh
S.F. _____ H.F. _____ 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 July 1, 2019, 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 5304DP (12) 87 ss/rh 1/ 9
S.F. _____ H.F. _____ (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 or 7 electronic failure at the prescriber’s or pharmacy’s location. 8 (9) A prescription issued in an emergency situation 9 pursuant to federal law and regulation rules of the board. 10 d. A practitioner, as defined in section 124.101, subsection 11 27, paragraph “a” , who violates paragraph “a” is subject 12 to an administrative penalty of two hundred fifty dollars 13 per violation, up to a maximum of five thousand dollars per 14 calendar year. The assessment of an administrative penalty 15 pursuant to this paragraph by the appropriate licensing board 16 of the practitioner alleged to have violated paragraph “a” 17 shall not be considered a disciplinary action and shall not be 18 released or reported as discipline. A practitioner may appeal 19 the assessment of an administrative penalty pursuant to this 20 paragraph, which shall initiate a contested case proceeding 21 under chapter 17A. A penalty collected pursuant to this 22 paragraph shall be deposited into the drug information program 23 fund established pursuant to section 124.557. The board shall 24 be notified of any administrative penalties assessed by the 25 appropriate professional licensing board and deposited into the 26 drug information program fund under this paragraph. 27 3. A prescription issued prior to July 1, 2019, or a 28 prescription that is exempt from the electronic prescription 29 requirement in subsection 2, paragraph “c” , may be transmitted 30 by a practitioner or the practitioner’s authorized agent to a 31 pharmacy in any of the following ways: 32 a. Electronically, if transmitted in accordance with 33 the requirements for electronic prescriptions pursuant to 34 subsection 2. 35 -2- LSB 5304DP (12) 87 ss/rh 2/ 9
S.F. _____ H.F. _____ b. By facsimile for a schedule III, IV, or V controlled 1 substance, or for a schedule II controlled substance only 2 pursuant to federal law and regulation and rules of the board. 3 c. Orally for a schedule III, IV, or V controlled substance, 4 or for a schedule II controlled substance only in an emergency 5 situation pursuant to federal regulation and rules of the 6 board. 7 d. By providing an original signed prescription to a patient 8 or a patient’s authorized representative. 9 4. If permitted by federal law and in accordance with 10 federal requirements, an electronic or facsimile prescription 11 shall serve as the original signed prescription and the 12 practitioner shall not provide a patient, a patient’s 13 authorized representative, or the dispensing pharmacy with a 14 signed, written prescription. An original signed prescription 15 shall be retained for a minimum of two years from the date of 16 the latest dispensing or refill of the prescription. 17 5. A prescription for a schedule II controlled substance 18 shall not be filled more than six months after the date 19 of issuance. A prescription for a schedule II controlled 20 substance shall not be refilled. 21 6. A prescription for a schedule III, IV, or V controlled 22 substance shall not be filled or refilled more than six months 23 after the date on which the prescription was issued or be 24 refilled more than five times. 25 7. A controlled substance shall not be distributed or 26 dispensed other than for a medical purpose. 27 8. A practitioner, medical group, or pharmacy that is unable 28 to timely comply with the electronic prescribing requirements 29 in subsection 2, paragraph “b” , may petition the board for an 30 exemption from the requirements based upon economic hardship, 31 technical limitations that the practitioner, medical group, or 32 pharmacy cannot control, or other exceptional circumstances. 33 The board shall adopt rules establishing the form and specific 34 information to be included in a request for an exemption 35 -3- LSB 5304DP (12) 87 ss/rh 3/ 9
S.F. _____ H.F. _____ and the specific criteria to be considered by the board in 1 determining whether to approve a request for an exemption. The 2 board may approve an exemption for a period of time determined 3 by the board not to exceed one year from the date of approval, 4 and may be renewed annually upon request subject to board 5 approval. 6 Sec. 2. Section 155A.27, Code 2018, is amended by striking 7 the section and inserting in lieu thereof the following: 8 155A.27 Requirements for prescription. 9 1. Except when dispensed directly by a prescriber to an 10 ultimate user, a prescription drug shall not be dispensed 11 without a prescription, authorized by a prescriber, and based 12 on a valid patient-prescriber relationship. 13 2. a. Beginning July 1, 2019, every prescription issued for 14 a prescription drug shall be transmitted electronically as an 15 electronic prescription to a pharmacy by a prescriber or the 16 prescriber’s authorized agent unless exempt under paragraph 17 “b” . 18 b. Paragraph “a” shall not apply to any of the following: 19 (1) A prescription for a patient residing in a nursing home, 20 long-term care facility, correctional facility, or jail. 21 (2) A prescription authorized by a licensed veterinarian. 22 (3) A prescription for a device. 23 (4) A prescription dispensed by a department of veterans 24 affairs pharmacy. 25 (5) A prescription requiring information that makes 26 electronic transmission impractical, such as complicated or 27 lengthy directions for use or attachments. 28 (6) A prescription for a compounded preparation containing 29 two or more components. 30 (7) A prescription issued in response to a public health 31 emergency in a situation where a non-patient specific 32 prescription would be permitted. 33 (8) A prescription issued for an opioid antagonist pursuant 34 to section 135.190 or a prescription issued for epinephrine 35 -4- LSB 5304DP (12) 87 ss/rh 4/ 9
S.F. _____ H.F. _____ pursuant to section 135.185. 1 (9) A prescription issued during a temporary technical 2 or electronic failure at the location of the prescriber or 3 pharmacy. 4 (10) A prescription issued pursuant to an established and 5 valid collaborative practice agreement, standing order, or drug 6 research protocol. 7 (11) A prescription issued in an emergency situation 8 pursuant to federal law and regulation and rules of the board. 9 c. A practitioner, as defined in section 124.101, subsection 10 27, paragraph “a” , who violates paragraph “a” is subject 11 to an administrative penalty of two hundred fifty dollars 12 per violation, up to a maximum of five thousand dollars per 13 calendar year. The assessment of an administrative penalty 14 pursuant to this paragraph by the appropriate licensing board 15 of the practitioner alleged to have violated paragraph “a” 16 shall not be considered a disciplinary action and shall not be 17 released or reported as discipline. A practitioner may appeal 18 the assessment of an administrative penalty pursuant to this 19 paragraph, which shall initiate a contested case proceeding 20 under chapter 17A. A penalty collected pursuant to this 21 paragraph shall be deposited into the drug information program 22 fund established pursuant to section 124.557. The board shall 23 be notified of any administrative penalties assessed by the 24 appropriate professional licensing board and deposited into the 25 drug information program fund under this paragraph. 26 3. For prescriptions issued prior to July 1, 2019, or 27 for prescriptions exempt from the electronic prescription 28 requirement in subsection 2, paragraph “b” , a prescriber or the 29 prescriber’s authorized agent may transmit a prescription for a 30 prescription drug to a pharmacy by any of the following means: 31 a. Electronically. 32 b. By facsimile. 33 c. Orally. 34 d. By providing an original signed prescription to a patient 35 -5- LSB 5304DP (12) 87 ss/rh 5/ 9
S.F. _____ H.F. _____ or a patient’s authorized representative. 1 4. A prescription shall be issued in compliance with 2 this subsection. Regardless of the means of transmission, a 3 prescriber shall provide verbal verification of a prescription 4 upon request of the pharmacy. 5 a. If written, electronic, or facsimile, each prescription 6 shall contain all of the following: 7 (1) The date of issue. 8 (2) The name and address of the patient for whom, or the 9 owner of the animal for which, the drug is dispensed. 10 (3) The name, strength, and quantity of the drug prescribed. 11 (4) The directions for use of the drug, medicine, or device 12 prescribed. 13 (5) The name, address, and written or electronic signature 14 of the prescriber issuing the prescription. 15 (6) The federal drug enforcement administration number, if 16 required under chapter 124. 17 b. If electronic, each prescription shall comply with all 18 of the following: 19 (1) The prescriber shall ensure that the electronic system 20 used to transmit the electronic prescription has adequate 21 security and safeguards designed to prevent and detect 22 unauthorized access, modification, or manipulation of the 23 prescription. 24 (2) Notwithstanding paragraph “a” , subparagraph (5), 25 for prescriptions that are not controlled substances, if 26 transmitted by an authorized agent, the electronic prescription 27 shall not require the written or electronic signature of the 28 prescriber issuing the prescription. 29 c. If facsimile, in addition to the requirements of 30 paragraph “a” , each prescription shall contain all of the 31 following: 32 (1) The identification number of the facsimile machine 33 which is used to transmit the prescription. 34 (2) The date and time of transmission of the prescription. 35 -6- LSB 5304DP (12) 87 ss/rh 6/ 9
S.F. _____ H.F. _____ (3) The name, address, telephone number, and facsimile 1 number of the pharmacy to which the prescription is being 2 transmitted. 3 d. If oral, the prescriber issuing the prescription 4 shall furnish the same information required for a written 5 prescription, except for the written signature and address 6 of the prescriber. Upon receipt of an oral prescription, 7 the recipient shall promptly reduce the oral prescription to 8 a written format by recording the information required in a 9 written prescription. 10 e. A prescription transmitted by electronic, facsimile, 11 or oral means by a prescriber’s agent shall also include 12 the name and title of the prescriber’s agent completing the 13 transmission. 14 5. An electronic, facsimile, or oral prescription 15 shall serve as the original signed prescription and the 16 prescriber shall not provide a patient, a patient’s authorized 17 representative, or the dispensing pharmacist with a signed 18 written prescription. Prescription records shall be retained 19 pursuant to rules of the board. 20 6. This section shall not prohibit a pharmacist, 21 in exercising the pharmacist’s professional judgment, 22 from dispensing, at one time, additional quantities of a 23 prescription drug, with the exception of a prescription drug 24 that is a controlled substance as defined in section 124.101, 25 up to the total number of dosage units authorized by the 26 prescriber on the original prescription and any refills of 27 the prescription, not to exceed a ninety-day supply of the 28 prescription drug as specified on the prescription. 29 7. A prescriber, medical group, institution, or pharmacy 30 that is unable to timely comply with the electronic prescribing 31 requirements in subsection 2, paragraph “a” , may petition 32 the board for an exemption from the requirements based upon 33 economic hardship, technical limitations that the prescriber, 34 medical group, institution, or pharmacy cannot control, or 35 -7- LSB 5304DP (12) 87 ss/rh 7/ 9
S.F. _____ H.F. _____ other exceptional circumstances. The board shall adopt rules 1 establishing the form and specific information to be included 2 in a request for an exemption and the specific criteria to be 3 considered by the board in determining whether to approve a 4 request for an exemption. The board may approve an exemption 5 for a period of time determined by the board, not to exceed one 6 year from the date of approval, and may be annually renewed 7 subject to board approval upon request. 8 Sec. 3. Section 155A.29, subsection 4, Code 2018, is amended 9 to read as follows: 10 4. An authorization to refill a prescription drug order may 11 shall be transmitted to a pharmacist pharmacy by a prescriber 12 or the prescriber’s authorized agent through word of mouth, 13 note, telephone, facsimile, or other means of communication 14 initiated by or directed by the practitioner. The transmission 15 shall include the information required pursuant to section 16 155A.27 , except that prescription drug orders for controlled 17 substances shall be transmitted pursuant to section 124.308, 18 and, if not transmitted directly by the practitioner, 19 shall identify by also include the name and title of the 20 practitioner’s agent completing the transmission. 21 EXPLANATION 22 The inclusion of this explanation does not constitute agreement with 23 the explanation’s substance by the members of the general assembly. 24 This bill relates to the electronic prescribing of 25 prescription drugs, including controlled substances. The 26 bill requires all prescriptions for prescription drugs to 27 transmitted to a pharmacy electronically, effective July 1, 28 2019. The bill also requires prescriptions for controlled 29 substances that are issued electronically to comply with 30 federal law for the electronic transmittal of prescriptions 31 for controlled substances. The bill provides exemptions 32 from this requirement in certain circumstances and provides 33 alternative methods for the transmittal of prescriptions in 34 those circumstances and for prescriptions transmitted prior to 35 -8- LSB 5304DP (12) 87 ss/rh 8/ 9
S.F. _____ H.F. _____ July 1, 2019. The bill also allows a person subject to the 1 requirements of the bill to petition the board of pharmacy 2 for exemption from the requirements of the bill based on 3 economic hardship, technical limitations, or other exceptional 4 circumstances. The bill requires refills for prescription 5 drugs and controlled substances to be transmitted in the same 6 manner as required for initial prescriptions. 7 A practitioner who does not transmit a prescription 8 drug order electronically as required by the bill shall be 9 subject to an administrative penalty of $250 per violation, 10 up to a maximum of $5,000 per calendar year. Such a penalty 11 shall be assessed by the professional licensing board of the 12 practitioner alleged to have committed the violation. A 13 practitioner may contest such penalty, which shall initiate a 14 contested case proceeding under Code chapter 17A. Any such 15 penalty collected by a professional licensing board shall be 16 deposited into the drug information program fund and reported 17 to the board. 18 A person who does not comply with Code section 124.308 19 is guilty of an aggravated misdemeanor pursuant to Code 20 section 124.402. An aggravated misdemeanor is punishable by 21 confinement for no more than two years and a fine of at least 22 $625 but not more than $6,250. 23 -9- LSB 5304DP (12) 87 ss/rh 9/ 9
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