Iowa Admin. Code r. 657-8.19

Current through Register Vol. 47, No. 11, December 11, 2024

Rule 657-8.19 - Manner of issuance of a prescription drug or medication order

A prescription drug order or medication order that is issued prior to January 1, 2020, or that is exempt from the electronic prescription mandate pursuant to rule 657-21.8 (124,155A) may be transmitted from a prescriber or a prescriber's agent to a pharmacy in written form, orally including telephone voice communication, by facsimile transmission as provided in rule 657-21.7 (124,155A), or by electronic transmission in accordance with applicable federal and state laws, rules, and regulations. Any prescription drug order or medication order provided to a patient in written or printed form shall include the original, handwritten signature of the prescriber except as provided in rule 657-21.6 (124,155A).

(1)Requirements for a prescription. A valid prescription drug order shall be based on a valid patient-prescriber relationship except as provided in subrule 8.19(7) for epinephrine auto-injectors, subrule 8.19(8) for opioid antagonists, or subrule 8.19(10) for bronchodilator canisters or bronchodilator canisters and spacers.

a.Written, electronic, or facsimile prescription. In addition to the electronic prescription application and pharmacy prescription application requirements of this rule, a written, electronic, or facsimile prescription shall include:

(1) The date issued.

(2) The name and address of the patient except as provided in subrule 8.19(7) for epinephrine auto-injectors, subrule 8.19(8) for opioid antagonists, subrule 8.19(9) for expedited partner therapy, or subrule 8.19(10) for bronchodilator canisters or bronchodilator canisters and spacers.

(3) The name, strength, and quantity of the drug or device prescribed.

(4) The name and address of the prescriber and, if the prescription is for a controlled substance, the prescriber's DEA registration number.

(5) The written or electronic signature of the prescriber.

b.Written prescription. In addition to the requirements of paragraph 8.19(1)"a," a written prescription shall be manually signed, with ink or indelible pencil, by the prescriber. The requirement for manual signature shall not apply when an electronically prepared and signed prescription for a noncontrolled substance is printed on security paper as provided in 657-paragraph 21.6(2)"b."

c.Facsimile prescription. In addition to the requirements of paragraph 8.19(1)"a," a prescription transmitted via facsimile shall include:

(1) The identification number of the facsimile machine used to transmit the prescription to the pharmacy.

(2) The time and date of transmission of the prescription.

(3) The name, address, telephone number, and facsimile number of the pharmacy to which the prescription is being transmitted.

(4) If the prescription is for a controlled substance and in compliance with DEA regulations, the manual signature of the prescriber.

d.Electronic prescription. In addition to the requirements of paragraph 8.19(1)"a," an electronically prepared prescription for a controlled or noncontrolled prescription drug or device that is electronically transmitted to a pharmacy shall include the prescriber's electronic signature, except as provided herein.

(1) An electronically prepared prescription for a controlled substance that is printed out or faxed by the prescriber or the prescriber's agent shall be manually signed by the prescriber.

(2) The prescriber shall ensure that the electronic prescription application used to prepare and transmit the electronic prescription complies with applicable state and federal laws, rules, and regulations regarding electronic prescriptions.

(3) The prescriber or the prescriber's agent shall provide verbal verification of an electronic prescription upon the request of the pharmacy.

(4) An electronic prescription for a noncontrolled prescription drug or device that is transmitted by an authorized agent shall not be required to contain the prescriber's electronic signature.

(2)Verification. The pharmacist shall exercise professional judgment regarding the accuracy, validity, and authenticity of any prescription drug order or medication order consistent with federal and state laws, rules, and regulations. In exercising professional judgment, the prescriber and the pharmacist shall take adequate measures to guard against the diversion of prescription drugs and controlled substances through prescription forgeries.

(3)Transmitting agent. The prescriber may authorize an agent to transmit to the pharmacy a prescription drug order or medication order orally, by facsimile transmission, or by electronic transmission provided that the first and last names and title of the transmitting agent are included in the order.

a.New order. A new written or electronically prepared and transmitted prescription drug or medication order shall be manually or electronically signed by the prescriber, except as provided in paragraph 8.19(1)"d." If transmitted by the prescriber's agent, the first and last names and title of the transmitting agent shall be included in the order. If the prescription is for a controlled substance and is written or printed from an electronic prescription application, the prescription shall be manually signed by the prescriber. An electronically prepared prescription shall not be electronically transmitted to the pharmacy if the prescription has been printed prior to the electronic transmission. An electronically prepared and electronically transmitted prescription that is printed following the electronic transmission shall be clearly labeled as a copy, not valid for dispensing.

b.Refill order or renewal order. An authorization to refill a prescription drug or medication order, or to renew or continue an existing drug therapy, may be transmitted to professional pharmacy staff through oral communication, in writing, by facsimile transmission, or by electronic transmission initiated by or directed by the prescriber.

(1) If the transmission is completed by the prescriber's agent and the first and last names and title of the transmitting agent are included in the order, the prescriber's signature is not required on the fax or alternate electronic transmission.

(2) If the order differs in any manner from the original order, such as a change of the drug strength, dosage form, or directions for use, the prescriber shall sign the order as provided by paragraph 8.19(3)"a."

(4)Receiving agent. Regardless of the means of transmission to a pharmacy, only professional pharmacy staff shall be authorized to receive a new prescription drug or medication order from a prescriber or the prescriber's agent. A technician trainee may receive a refill or renewal order from a prescriber or the prescriber's agent only if the technician's supervising pharmacist has authorized that function.

(5)Legitimate purpose. The pharmacy and professional pharmacy staff shall ensure that the prescription drug or medication order, regardless of the means of transmission, has been issued for a legitimate medical purpose by a prescriber acting in the usual course of the prescriber's professional practice. A pharmacist shall not dispense a prescription drug if the pharmacist knows or should have known that the prescription was issued solely on the basis of an Internet-based questionnaire.

(6)Refills. A refill is one or more dispensings of a prescription drug or device that result in the patient's receipt of the quantity authorized by the prescriber for a single fill as indicated on the prescription drug order.

a.Noncontrolled prescription drug or device. A prescription for a prescription drug or device that is not a controlled substance may authorize no more than 12 refills within 18 months following the date on which the prescription is issued.

b.Controlled substance. A prescription for a Schedule III, IV, or V controlled substance may authorize no more than 5 refills within 6 months following the date on which the prescription is issued.

(7)Epinephrine auto-injector prescription issued to school or facility. A physician, an advanced registered nurse practitioner, or a physician assistant may issue a prescription for one or more epinephrine auto-injectors in the name of a facility as defined in Iowa Code subsection 135.185(1), a school district, oran accredited nonpublic school. The prescription shall comply with all requirements of subrule 8.19(1) as applicable to the form of the prescription except that the prescription shall be issued in the name and address of the facility, the school district, or the accredited nonpublic school in lieu of the name and address of a patient. Provisions requiring a preexisting patient-prescriber relationship shall not apply to a prescription issued pursuant to this subrule.

a. The pharmacy's patient profile and record of dispensing of a prescription issued pursuant to this subrule shall be maintained in the name of the facility, school district, or accredited nonpublic school to which the prescription was issued and the drug was dispensed.

b. The label affixed to an epinephrine auto-injector dispensed pursuant to this subrule shall identify the name of the facility, school district, or accredited nonpublic school to which the prescription is dispensed.

(8)Opioid antagonist prescription issued to law enforcement, fire department, service program, or school district. A physician, an advanced registered nurse practitioner, or a physician assistant may issue a prescription for one or more opioid antagonists in the name of a law enforcement agency, fire department, or service program pursuant to Iowa Code section 147A.18 and rule 657-39.7 (135,147A), or in the name ofa school district pursuant to Iowa Code section 135.190 and rule 657-39.7 (135,147A). The prescription shall comply with all requirements of subrule 8.19(1) as applicable to the form of the prescription except that the prescription shall be issued in the name and address of the law enforcement agency, fire department, service program, or school district in lieu of the name and address of a patient. Provisions requiring a preexisting patient-prescriber relationship shall not apply to a prescription issued pursuant to this subrule.

a. The pharmacy's patient profile and record of dispensing ofan opioid antagonist pursuant to this subrule shall be maintained in the name of the law enforcement agency, fire department, service program, or school district to which the prescription was issued and the drug was dispensed.

b. The label affixed to an opioid antagonist dispensed pursuant to this subrule shall identify the name of the law enforcement agency, fire department, service program, or school district to which the prescription is dispensed and shall be affixed such that the expiration date of the drug is not rendered illegible.

(9)Expedited partner therapy. Pursuant to Iowa Code section 139A.41, a physician, physician assistant, or advanced registered nurse practitioner may issue a prescription to one or more sexual partners of an infected patient for an oral antibiotic intended to treat a sexually transmitted chlamydia or gonorrhea infection. The prescription shall comply with all requirements of subrule 8.19(1) as applicable to the form of the prescription except that the prescription shall not be required to contain the patient name and address. The prescription shall indicate the antibiotic is being issued for the purpose of expedited partner therapy. Provisions requiring a preexisting patient-prescriber relationship shall not apply to a prescription issued pursuant to this subrule.

(10)Bronchodilator canister or bronchodilator canister and spacer prescription issued to a school district or accredited nonpublic school. A physician, an advanced registered nurse practitioner, or a physician assistant may issue a prescription for one or more bronchodilator canisters or bronchodilator canisters and spacers in the name of a school district or accredited nonpublic school pursuant to Iowa Code section 280.16A. The prescription shall comply with all requirements of subrule 8.19(1) as applicable to the form of the prescription except that the prescription shall be issued in the name and address of the school district or accredited nonpublic school in lieu of the name and address of a patient. Provisions requiring a preexisting patient-prescriber relationship shall not apply to a prescription issued pursuant to this subrule.

a. The pharmacy's patient profile and record of dispensing of a bronchodilator canister or bronchodilator canister and spacer pursuant to this subrule shall be maintained in the name of the school district or accredited nonpublic school to which the prescription was issued and the drug was dispensed.

b. The label affixed to a bronchodilator canister or bronchodilator canister and spacer dispensed pursuant to this subrule shall identify the name of the school district or accredited nonpublic school to which the prescription is dispensed and shall be affixed such that the expiration date of the drug is not rendered illegible.

Iowa Admin. Code r. 657-8.19

ARC 8171B, IAB 9/23/09, effective 10/28/09; ARC 9912B, IAB 12/14/11, effective 1/18/12

Amended by IAB February 17, 2016/Volume XXXVIII, Number 17, effective 3/23/2016

Amended by IAB November 23, 2016/Volume XXXIX, Number 11, effective 11/3/2016

Amended by IAB June 20, 2018/Volume XL, Number 26, effective 7/25/2018

Amended by IAB July 31, 2019/Volume XLII, Number 3, effective 9/4/2019

Amended by IAB February 12, 2020/Volume XLII, Number 17, effective 3/18/2020

Amended by IAB March 22, 2023/Volume XLV, Number 19, effective 4/26/2023