Iowa Admin. Code r. 657-37.2

Current through Register Vol. 47, No.14, January 8, 2025
Rule 657-37.2 - Definitions

For the purposes of this chapter, the following definitions shall apply.

"Administer" means to provide or apply a controlled substance to a patient for immediate use within the prescribing practitioner's practice location. Administration does not include dispensing.

"Board" means the Iowa board of pharmacy.

"Client" means the owner, owner's designee, or other person responsible for an animal patient.

"Controlled substance" means a drug in Schedules II through V set forth in Iowa Code chapter 124, division II.

"Council" means the PMP advisory council established pursuant to Iowa Code section 124.555 to provide oversight and to co-manage PMP activities with the board.

"CSA registration" means registration with the board under the Iowa uniform controlled substances Act pursuant to 657-Chapter 10.

"DEA number" means the registration number issued to an individual or pharmacy by the U.S. Department of Justice, Drug Enforcement Administration (DEA), authorizing the individual or pharmacy to engage in the prescribing, dispensing, distributing, or procuring of a controlled substance.

"Dispense" means to provide a controlled substance to a patient for self-use outside of the prescribing practitioner's practice location. Dispensing does not include administration.

"Dispenser" means a pharmacy or prescriber, regardless of location, who delivers to the ultimate user a substance required to be reported to the PMP. "Dispenser" does not include a person exempt from reporting pursuant to subrule 37.7(2).

"First responder" means an emergency medical care provider, a registered nurse staffing an authorized service program under Iowa Code section 147A.12, a physician assistant staffing an authorized service program under Iowa Code section 147A.13, a firefighter, or a peace officer as defined in Iowa Code section 801.4, who is trained and authorized to administer an opioid antagonist.

"Health care facility" means a residential care facility, a nursing facility, an intermediate care facility for persons with mental illness, or an intermediate care facility for persons with an intellectual disability.

"Health care professional" means a person who, by certification, registration, or licensure, is qualified to provide and is engaged in providing health care to patients. "Health care professional" does not include clerical or administrative staff. A health care professional shall be credentialed in a manner that permits verification and regulation of the health care professional's credentials.

"Health care system" means an organization that includes at least one hospital or at least one group of practitioners that provides comprehensive care that are connected with each other through common ownership or management.

"HIPAA" means the Health Insurance Portability and Accountability Act.

"Law enforcement" means an entity or agency with jurisdiction to investigate or prosecute violations of criminal law. "Law enforcement" includes, but is not limited to, such agencies as police departments, United States attorneys, the DEA, county attorneys, and the Medicaid fraud control unit.

"Licensing authority" means an agency that licenses or registers health care professionals and has jurisdiction to enforce governing laws over those individuals who are licensed or registered. "Licensing authority" includes, but is not limited to, professional licensing boards and the DEA.

"NarxCare" means an analytics tool and care management platform that helps practitioners analyze real-time data from the PMP. The platform analyzes patient data and history to provide a patient risk score and usage patterns to help practitioners identify potential risk factors.

"NDC number" means the universal product identifier used in the United States to identify a specific human drug.

"Opioid antagonist" means a drug that binds to opioid receptors and blocks or inhibits the effects of opioids acting on those receptors with the intention to reverse overdose, including but not limited to naloxone hydrochloride or any other similarly acting drug approved by the United States Food and Drug Administration.

"Patient" means a person or animal to whom a prescription is prescribed or dispensed.

"PMP administrator" means staff persons designated to manage and administer the PMP under the direction and oversight of the board and the council.

"Practitioner" means a prescriber or a pharmacist.

"Practitioner's delegate" means a health care professional who is under the supervision of a PMP-registered practitioner and who is authorized by the practitioner to access PMP information on the practitioner's behalf.

"Prescriber" means an individual with an active CSA registration who has the authority to prescribe controlled substances. For the purposes of this chapter, "prescriber" does not include a licensed veterinarian.

"Prescription monitoring program" or "PMP" means the program established pursuant to these rules for the collection and maintenance of PMP information and for the provision of PMP information to authorized individuals.

"Reportable prescription" means the record of a controlled substance administered or dispensed by a practitioner and the record of an opioid antagonist dispensed by a practitioner or administered by a first responder. "Reportable prescription" shall not include records identified in subrule 37.7(1). "Reportable prescription" shall include, but not be limited to:

1. The dispensing of a controlled substance to an emergency department patient;
2. The administration of a controlled substance to a patient at the discretion of the treating practitioner
3. The administration or dispensing of an opioid antagonist to an emergency department patient;
4. The dispensing of a controlled substance sample;
5. The dispensing of a controlled substance or opioid antagonist to a patient upon discharge from a hospital or care facility; and
6. The dispensing of a Schedule V controlled substance without a prescription pursuant to rule 657-10.33 (124,155A).

Iowa Admin. Code r. 657-37.2

ARC 7903B, IAB 7/1/09, effective 8/5/09; ARC 0056C, IAB 4/4/12, effective 7/1/12; ARC 0242C, IAB 8/8/12, effective 1/1/2013
Amended by IAB April 10, 2019/Volume XLI, Number 21, effective 5/15/2019
Amended by IAB April 7, 2021/Volume XLIII, Number 21, effective 5/12/2021
Amended by IAB February 8, 2023/Volume XLV, Number 16, effective 3/15/2023