Section 2080.20  Incorporation by Reference and Definitions

No incorporations by reference in this Part include any later amendments or editions.  The definitions that apply to this Part are those found in the Act.

"Act" means the Illinois Controlled Substances Act [720 ILCS 570].

"Account" refers to the clinical entity that is providing direct patient care and is registered with the ILPMP to have access to patient-specific data through the ILPMP.

"Birth Date" means the medication recipient's birth date.

"Central Repository" means a place designated by the Department where Schedule II-V drug data and other healthcare data are stored or housed.

"Certified Health IT Module" means any service, component, or a combination thereof that can meet the requirements of at least one certification criterion adopted under the Office of the National Coordinator for Health Information Technology (ONC), including, but not limited to, the 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications (available at https://www.federalregister.gov/documents/2015/10/16/2015-25597/2015-edition-health-information-technology-health-it-certification-criteria-2015-edition-base); https://www.healthit.gov; and NCPDP Protocols available to members at https://www.ncpdp.org/.

"Clinical Director" means a Department of Human Services administrative employee licensed to either prescribe or dispense controlled substances who shall run the clinical aspects of the Department of Human Services Prescription Monitoring Program [720 ILCS 570/102 (d-5)].

"Connecting Entity" or "Entity" means the health system, hospital, medical office, clinic, or practice that maintains the Electronic Health Record system or employs the professional making the ILPMP query.

"Controlled Substance" means a drug, substance, immediate precursor, or synthetic drug in the Schedules of Article II of the Illinois Controlled Substances Act or a drug or other substance, or immediate precursor, designated as a controlled substance by DHS through administrative rule.  The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in the Liquor Control Act of 1934 and the Tobacco Products Act of 1995 [720 ILCS 570/102(f)].

"DEA Number" means the United States Drug Enforcement Administration prescriber or dispenser registration number.

"Department" or "DHS" means the Illinois Department of Human Services or its successor agency.

"DFPR" means the Illinois Department of Financial and Professional Regulation.

"Dispense" means to deliver a controlled substance to an ultimate user or research subject by or pursuant to the lawful order of a prescriber, including the prescribing, administering, packaging, labeling or compounding necessary to prepare the substance for that delivery. [720 ILCS 570/102(p)]

"Dispenser" means a practitioner who dispenses a controlled substance [720 ILCS 570/102(p) and (q)].

"DoIT" means the Illinois Department of Innovation and Technology.

"DPH" means the Illinois Department of Public Health.

"EHR" means electronic health record for a Licensed Healthcare Entity.

"Electronic Integration" means the process by which ILPMP data is directly accessible within the EHR system.

"Freestanding Clinic" means urgent care operations or outpatient surgery centers and similar operations that do not provide overnight in-house stays.

"Gender" includes the social, psychological, cultural, and behavioral aspects of identifying as a man, woman, gender diverse, or other gender identity.

"ILPMP" means the Illinois Prescription Management Program.

"Illinois Healthcare License Number" means the license assigned by DPH to facilities designated to provide specific types or levels of healthcare.

"Initial CII Narcotics Prescription" means the initial CII narcotics prescription issued to a patient for the initialization of treatment, in accordance with 720 ILCS 570-314.5.

"Licensed Healthcare Entity" means those operations that are licensed to provide health services by either DPH or DFPR.

"Licensed Healthcare Provider" means any individual who meets the professional licensing requirements and follows the standards set forth by DFPR and is authorized to prescribe or dispense controlled substances within Illinois.

"Medication Shopping" means the conduct prohibited under Section 314.5(a) of the Act.

"Mid-level Practitioner" means:

a physician assistant who has been delegated authority to prescribe through a written delegation of authority by a physician licensed to practice medicine in all of its branches, in accordance with Section 7.5 of the Physician Assistant Practice Act of 1987 [225 ILCS 95];

an advanced practice registered nurse who has been delegated authority to prescribe through a written delegation of authority by a physician licensed to practice medicine in all of its branches or by a podiatrist, in accordance with Section 65-40 of the Nurse Practice Act [225 ILCS 65];

an advanced practice registered nurse certified as a nurse practitioner, nurse midwife, or clinical nurse specialist who has been granted authority to prescribe by a hospital affiliate in accordance with Section 65-45 of the Nurse Practice Act [225 ILCS 65]; or

an animal euthanasia agency [720 ILCS 570/102(t-5); or

a prescribing psychologist. [720 ILCS 570/102(z-10)]

"National Drug Code Identification Number" or "NDC Identification Number" means the number used to provide uniform product identification for all substances recognized as drugs in the United States Pharmacopoeia National Formulary, USP31-NF26 (US Pharmacopoeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland  20852 (2023)).

"NCPDP Protocol" means the computing standards implemented by the National Council for Prescription Drug Programs at https://standards.ncpdp.org/Access-to-Standards.aspx.

"One-to-One Secure Link" or "One-to-One Connection" means connecting a provider and the ILPMP through an EHR or a pharmacy management system.

"Patient ID" means the identification of the individual receiving the medication or the responsible individual obtaining the medication on behalf of the recipient or the owner of the animal.  The standards for establishing patient ID for proper filling of a prescription are established by Section 2080.70(d).

"Patient Location Code" means the location of the patient when receiving pharmacy services.

"Pharmacist-In-Charge" means the licensed pharmacist whose name appears on the pharmacy license and who is responsible for all aspects of the operation related to the practice of pharmacy.

"Pharmacy Shopping" means the conduct prohibited under Section 314.5(b) of the Act.

"PMIX Based Protocol" means industry and government standards used to facilitate and reduce the cost of participating and sharing the ILPMP information by requiring end-to-end security, standards-based exchange services, common exchange data and metadata, and hub-to-hub capability. PMIX-Based protocols can be found at https://www.pdmpassist.org/PMIX/Proposed Standards.

"ILPMP Administrator" means an employee of the Department with a background in computer and business processes who operates under the designated, specific authority of the Clinical Director.

"PMPnow" means the State of Illinois automated, one-to-one connection service that allows an ILPMP patient profile request to be generated directly within a Requester's EHR or pharmacy management system.

"Prescribed" means ordered by a prescriber verbally, electronically, or in writing.

"Prescriber" means the healthcare professional that is authorized to prescribe medications as set forth in the various professional practices of the State of Illinois.

"Prescription Monitoring Program" or "PMP" means the entity that collects, tracks, and stores reported data on controlled substances and select drugs pursuant to Section 316 of the Act  [720 ILCS 570/102(nn-5)].

"Prescription Monitoring Program Advisory Committee" or "PMPAC" means a committee consisting of licensed healthcare providers representing professions that are licensed to prescribe or dispense controlled substances.  The committee serves in a consultant context regarding longitudinal evaluations of compliance with evidence-based clinical practice and controlled substances.  The committee makes recommendations regarding the scheduling of controlled substances and recommendations concerning continuing education designed to improve the health and safety of the citizens of Illinois regarding pharmacotherapies of controlled substances.

"Provider" means the prescriber or dispenser acting in the direct care of the patient.

"Recipient's Name" means the given or common name of a person who is the intended user of a dispensed medication.  It may also mean the species or common name or common given name of an animal that is the intended user of a dispensed medication.  If an animal's name is entered, the owner's name is required also.

"Requester" means the prescriber, dispenser, or registered designee that is initiating a patient query of ILPMP data. A Requester must be authorized to access ILPMP data via a valid ILPMP registered website (www.ilpmp.org) user account.

"RESTful Based Web Service" means a computing architectural style, consisting of a coordinated set of components, connectors, and data elements within a distributed hypermedia system, in which the focus is on component roles and a specific set of interactions between data elements rather than implementation details.  Its purpose is to induce performance, scalability, simplicity, modifiability, visibility, portability, and reliability.

"Sample Trend Analysis" means the summary reports that look at utilization rates for specific classes of medications over time.

"Schedule Drug" means any substances listed in the federal Controlled Substances Act (21 U.S.C. 812) or the Illinois Controlled Substances Act [720 ILCS 570] or by the Department pursuant to its authority under Section 202 of the Illinois Controlled Substances Act [720 ILCS 570/202]. Schedule I-V substances are listed in section 812 of the federal Controlled Substances Act (21 U.S.C. 812(b)(2), (b)(3), (b)(4), (b)(5) and (c)) and Sections 204, 206, 208, 210 and 212 of the Illinois Controlled Substances Act [720 ILCS 570/204, 206, 208, 210 and 212].

"SOAP Based Web Service" means a messaging protocol that allows programs that run on disparate operating systems (e.g., Windows or Linux) to communicate using Hypertext Transfer Protocol (HTTP) and its Extensible Markup Language (XML).

"Vendor" means the company providing EHR, Certified Health IT Module, or pharmacy management software services to its connecting entity customers.

(Source:  Amended at 47 Ill. Reg. 13500, effective September 8, 2023)