103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB4822 Introduced 2/6/2024, by Rep. Natalie A. Manley SYNOPSIS AS INTRODUCED: 215 ILCS 5/356z.63225 ILCS 85/3 Amends the Pharmacy Practice Act and the Illinois Insurance Code. In the definition of "practice of pharmacy", includes the ordering of testing, screening, and treatment (rather than the ordering and administration of tests and screenings) for influenza. Makes conforming changes. Effective January 1, 2025. LRB103 37464 RTM 67587 b A BILL FOR 103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB4822 Introduced 2/6/2024, by Rep. Natalie A. Manley SYNOPSIS AS INTRODUCED: 215 ILCS 5/356z.63225 ILCS 85/3 215 ILCS 5/356z.63 225 ILCS 85/3 Amends the Pharmacy Practice Act and the Illinois Insurance Code. In the definition of "practice of pharmacy", includes the ordering of testing, screening, and treatment (rather than the ordering and administration of tests and screenings) for influenza. Makes conforming changes. Effective January 1, 2025. LRB103 37464 RTM 67587 b LRB103 37464 RTM 67587 b A BILL FOR
103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB4822 Introduced 2/6/2024, by Rep. Natalie A. Manley SYNOPSIS AS INTRODUCED:
215 ILCS 5/356z.63225 ILCS 85/3 215 ILCS 5/356z.63 225 ILCS 85/3
215 ILCS 5/356z.63
225 ILCS 85/3
Amends the Pharmacy Practice Act and the Illinois Insurance Code. In the definition of "practice of pharmacy", includes the ordering of testing, screening, and treatment (rather than the ordering and administration of tests and screenings) for influenza. Makes conforming changes. Effective January 1, 2025.
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A BILL FOR
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1 AN ACT concerning regulation.
2 Be it enacted by the People of the State of Illinois,
3 represented in the General Assembly:
4 Section 5. The Illinois Insurance Code is amended by
5 changing Section 356z.63 as follows:
6 (215 ILCS 5/356z.63)
7 Sec. 356z.63 356z.61. Coverage of pharmacy testing,
8 screening, vaccinations, and treatment. A group or individual
9 policy of accident and health insurance or a managed care plan
10 that is amended, delivered, issued, or renewed on or after
11 January 1, 2025 shall provide coverage for health care or
12 patient care services provided by a pharmacist if:
13 (1) the pharmacist meets the requirements and scope of
14 practice described in paragraph (15), (16), or (17), or
15 (18) of subsection (d) of Section 3 of the Pharmacy
16 Practice Act;
17 (2) the health plan provides coverage for the same
18 service provided by a licensed physician, an advanced
19 practice registered nurse, or a physician assistant;
20 (3) the pharmacist is included in the health benefit
21 plan's network of participating providers; and
22 (4) reimbursement has been successfully negotiated in
23 good faith between the pharmacist and the health plan.
103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB4822 Introduced 2/6/2024, by Rep. Natalie A. Manley SYNOPSIS AS INTRODUCED:
215 ILCS 5/356z.63225 ILCS 85/3 215 ILCS 5/356z.63 225 ILCS 85/3
215 ILCS 5/356z.63
225 ILCS 85/3
Amends the Pharmacy Practice Act and the Illinois Insurance Code. In the definition of "practice of pharmacy", includes the ordering of testing, screening, and treatment (rather than the ordering and administration of tests and screenings) for influenza. Makes conforming changes. Effective January 1, 2025.
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A BILL FOR
215 ILCS 5/356z.63
225 ILCS 85/3
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1 (Source: P.A. 103-1, eff. 4-27-23; revised 8-29-23.)
2 Section 10. The Pharmacy Practice Act is amended by
3 changing Section 3 as follows:
4 (225 ILCS 85/3)
5 (Section scheduled to be repealed on January 1, 2028)
6 Sec. 3. Definitions. For the purpose of this Act, except
7 where otherwise limited therein:
8 (a) "Pharmacy" or "drugstore" means and includes every
9 store, shop, pharmacy department, or other place where
10 pharmacist care is provided by a pharmacist (1) where drugs,
11 medicines, or poisons are dispensed, sold or offered for sale
12 at retail, or displayed for sale at retail; or (2) where
13 prescriptions of physicians, dentists, advanced practice
14 registered nurses, physician assistants, veterinarians,
15 podiatric physicians, or optometrists, within the limits of
16 their licenses, are compounded, filled, or dispensed; or (3)
17 which has upon it or displayed within it, or affixed to or used
18 in connection with it, a sign bearing the word or words
19 "Pharmacist", "Druggist", "Pharmacy", "Pharmaceutical Care",
20 "Apothecary", "Drugstore", "Medicine Store", "Prescriptions",
21 "Drugs", "Dispensary", "Medicines", or any word or words of
22 similar or like import, either in the English language or any
23 other language; or (4) where the characteristic prescription
24 sign (Rx) or similar design is exhibited; or (5) any store, or
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1 shop, or other place with respect to which any of the above
2 words, objects, signs or designs are used in any
3 advertisement.
4 (b) "Drugs" means and includes (1) articles recognized in
5 the official United States Pharmacopoeia/National Formulary
6 (USP/NF), or any supplement thereto and being intended for and
7 having for their main use the diagnosis, cure, mitigation,
8 treatment or prevention of disease in man or other animals, as
9 approved by the United States Food and Drug Administration,
10 but does not include devices or their components, parts, or
11 accessories; and (2) all other articles intended for and
12 having for their main use the diagnosis, cure, mitigation,
13 treatment or prevention of disease in man or other animals, as
14 approved by the United States Food and Drug Administration,
15 but does not include devices or their components, parts, or
16 accessories; and (3) articles (other than food) having for
17 their main use and intended to affect the structure or any
18 function of the body of man or other animals; and (4) articles
19 having for their main use and intended for use as a component
20 or any articles specified in clause (1), (2) or (3); but does
21 not include devices or their components, parts or accessories.
22 (c) "Medicines" means and includes all drugs intended for
23 human or veterinary use approved by the United States Food and
24 Drug Administration.
25 (d) "Practice of pharmacy" means:
26 (1) the interpretation and the provision of assistance
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1 in the monitoring, evaluation, and implementation of
2 prescription drug orders;
3 (2) the dispensing of prescription drug orders;
4 (3) participation in drug and device selection;
5 (4) drug administration limited to the administration
6 of oral, topical, injectable, and inhalation as follows:
7 (A) in the context of patient education on the
8 proper use or delivery of medications;
9 (B) vaccination of patients 7 years of age and
10 older pursuant to a valid prescription or standing
11 order, by a physician licensed to practice medicine in
12 all its branches, except for vaccinations covered by
13 paragraph (15), upon completion of appropriate
14 training, including how to address contraindications
15 and adverse reactions set forth by rule, with
16 notification to the patient's physician and
17 appropriate record retention, or pursuant to hospital
18 pharmacy and therapeutics committee policies and
19 procedures. Eligible vaccines are those listed on the
20 U.S. Centers for Disease Control and Prevention (CDC)
21 Recommended Immunization Schedule, the CDC's Health
22 Information for International Travel, or the U.S. Food
23 and Drug Administration's Vaccines Licensed and
24 Authorized for Use in the United States. As applicable
25 to the State's Medicaid program and other payers,
26 vaccines ordered and administered in accordance with
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1 this subsection shall be covered and reimbursed at no
2 less than the rate that the vaccine is reimbursed when
3 ordered and administered by a physician;
4 (B-5) following the initial administration of
5 long-acting or extended-release form opioid
6 antagonists by a physician licensed to practice
7 medicine in all its branches, administration of
8 injections of long-acting or extended-release form
9 opioid antagonists for the treatment of substance use
10 disorder, pursuant to a valid prescription by a
11 physician licensed to practice medicine in all its
12 branches, upon completion of appropriate training,
13 including how to address contraindications and adverse
14 reactions, including, but not limited to, respiratory
15 depression and the performance of cardiopulmonary
16 resuscitation, set forth by rule, with notification to
17 the patient's physician and appropriate record
18 retention, or pursuant to hospital pharmacy and
19 therapeutics committee policies and procedures;
20 (C) administration of injections of
21 alpha-hydroxyprogesterone caproate, pursuant to a
22 valid prescription, by a physician licensed to
23 practice medicine in all its branches, upon completion
24 of appropriate training, including how to address
25 contraindications and adverse reactions set forth by
26 rule, with notification to the patient's physician and
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1 appropriate record retention, or pursuant to hospital
2 pharmacy and therapeutics committee policies and
3 procedures; and
4 (D) administration of injections of long-term
5 antipsychotic medications pursuant to a valid
6 prescription by a physician licensed to practice
7 medicine in all its branches, upon completion of
8 appropriate training conducted by an Accreditation
9 Council of Pharmaceutical Education accredited
10 provider, including how to address contraindications
11 and adverse reactions set forth by rule, with
12 notification to the patient's physician and
13 appropriate record retention, or pursuant to hospital
14 pharmacy and therapeutics committee policies and
15 procedures.
16 (5) (blank);
17 (6) drug regimen review;
18 (7) drug or drug-related research;
19 (8) the provision of patient counseling;
20 (9) the practice of telepharmacy;
21 (10) the provision of those acts or services necessary
22 to provide pharmacist care;
23 (11) medication therapy management;
24 (12) the responsibility for compounding and labeling
25 of drugs and devices (except labeling by a manufacturer,
26 repackager, or distributor of non-prescription drugs and
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1 commercially packaged legend drugs and devices), proper
2 and safe storage of drugs and devices, and maintenance of
3 required records;
4 (13) the assessment and consultation of patients and
5 dispensing of hormonal contraceptives;
6 (14) the initiation, dispensing, or administration of
7 drugs, laboratory tests, assessments, referrals, and
8 consultations for human immunodeficiency virus
9 pre-exposure prophylaxis and human immunodeficiency virus
10 post-exposure prophylaxis under Section 43.5;
11 (15) vaccination of patients 7 years of age and older
12 for COVID-19 or influenza subcutaneously, intramuscularly,
13 or orally as authorized, approved, or licensed by the
14 United States Food and Drug Administration, pursuant to
15 the following conditions:
16 (A) the vaccine must be authorized or licensed by
17 the United States Food and Drug Administration;
18 (B) the vaccine must be ordered and administered
19 according to the Advisory Committee on Immunization
20 Practices standard immunization schedule;
21 (C) the pharmacist must complete a course of
22 training accredited by the Accreditation Council on
23 Pharmacy Education or a similar health authority or
24 professional body approved by the Division of
25 Professional Regulation;
26 (D) the pharmacist must have a current certificate
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1 in basic cardiopulmonary resuscitation;
2 (E) the pharmacist must complete, during each
3 State licensing period, a minimum of 2 hours of
4 immunization-related continuing pharmacy education
5 approved by the Accreditation Council on Pharmacy
6 Education;
7 (F) the pharmacist must comply with recordkeeping
8 and reporting requirements of the jurisdiction in
9 which the pharmacist administers vaccines, including
10 informing the patient's primary-care provider, when
11 available, and complying with requirements whereby the
12 person administering a vaccine must review the vaccine
13 registry or other vaccination records prior to
14 administering the vaccine; and
15 (G) the pharmacist must inform the pharmacist's
16 patients who are less than 18 years old, as well as the
17 adult caregiver accompanying the child, of the
18 importance of a well-child visit with a pediatrician
19 or other licensed primary-care provider and must refer
20 patients as appropriate;
21 (16) the ordering and administration of COVID-19
22 therapeutics subcutaneously, intramuscularly, or orally
23 with notification to the patient's physician and
24 appropriate record retention or pursuant to hospital
25 pharmacy and therapeutics committee policies and
26 procedures. Eligible therapeutics are those approved,
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1 authorized, or licensed by the United States Food and Drug
2 Administration and must be administered subcutaneously,
3 intramuscularly, or orally in accordance with that
4 approval, authorization, or licensing; and
5 (17) the ordering and administration of tests and
6 screenings for SARS-CoV-2
(i) influenza, (ii) SARS-COV 2,
7 and (iii) health conditions identified by a statewide
8 public health emergency, as defined in the Illinois
9 Emergency Management Agency Act, with notification to the
10 patient's physician and appropriate record retention or
11 pursuant to hospital pharmacy and therapeutics committee
12 policies and procedures. Eligible tests and screenings are
13 those approved, authorized, or licensed by the United
14 States Food and Drug Administration and must be
15 administered in accordance with that approval,
16 authorization, or licensing; and .
17 (18) the ordering of testing, screening, and treatment
18 for influenza.
19 A pharmacist who orders testing, screening, or treatments
20 or administers tests or screenings for health conditions
21 described in paragraphs (17) and (18) this paragraph may use a
22 test that may guide clinical decision-making for the health
23 condition that is waived under the federal Clinical Laboratory
24 Improvement Amendments of 1988 and regulations promulgated
25 thereunder or any established screening procedure that is
26 established under a statewide protocol.
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1 A pharmacist may delegate the administrative and technical
2 tasks of performing a test for the health conditions described
3 in paragraphs (17) and (18) this paragraph to a registered
4 pharmacy technician or student pharmacist acting under the
5 supervision of the pharmacist.
6 A pharmacist who performs any of the acts defined as the
7 practice of pharmacy in this State must be actively licensed
8 as a pharmacist under this Act.
9 (e) "Prescription" means and includes any written, oral,
10 facsimile, or electronically transmitted order for drugs or
11 medical devices, issued by a physician licensed to practice
12 medicine in all its branches, dentist, veterinarian, podiatric
13 physician, or optometrist, within the limits of his or her
14 license, by a physician assistant in accordance with
15 subsection (f) of Section 4, or by an advanced practice
16 registered nurse in accordance with subsection (g) of Section
17 4, containing the following: (1) name of the patient; (2) date
18 when prescription was issued; (3) name and strength of drug or
19 description of the medical device prescribed; and (4)
20 quantity; (5) directions for use; (6) prescriber's name,
21 address, and signature; and (7) DEA registration number where
22 required, for controlled substances. The prescription may, but
23 is not required to, list the illness, disease, or condition
24 for which the drug or device is being prescribed. DEA
25 registration numbers shall not be required on inpatient drug
26 orders. A prescription for medication other than controlled
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1 substances shall be valid for up to 15 months from the date
2 issued for the purpose of refills, unless the prescription
3 states otherwise.
4 (f) "Person" means and includes a natural person,
5 partnership, association, corporation, government entity, or
6 any other legal entity.
7 (g) "Department" means the Department of Financial and
8 Professional Regulation.
9 (h) "Board of Pharmacy" or "Board" means the State Board
10 of Pharmacy of the Department of Financial and Professional
11 Regulation.
12 (i) "Secretary" means the Secretary of Financial and
13 Professional Regulation.
14 (j) "Drug product selection" means the interchange for a
15 prescribed pharmaceutical product in accordance with Section
16 25 of this Act and Section 3.14 of the Illinois Food, Drug and
17 Cosmetic Act.
18 (k) "Inpatient drug order" means an order issued by an
19 authorized prescriber for a resident or patient of a facility
20 licensed under the Nursing Home Care Act, the ID/DD Community
21 Care Act, the MC/DD Act, the Specialized Mental Health
22 Rehabilitation Act of 2013, the Hospital Licensing Act, or the
23 University of Illinois Hospital Act, or a facility which is
24 operated by the Department of Human Services (as successor to
25 the Department of Mental Health and Developmental
26 Disabilities) or the Department of Corrections.
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1 (k-5) "Pharmacist" means an individual health care
2 professional and provider currently licensed by this State to
3 engage in the practice of pharmacy.
4 (l) "Pharmacist in charge" means the licensed pharmacist
5 whose name appears on a pharmacy license and who is
6 responsible for all aspects of the operation related to the
7 practice of pharmacy.
8 (m) "Dispense" or "dispensing" means the interpretation,
9 evaluation, and implementation of a prescription drug order,
10 including the preparation and delivery of a drug or device to a
11 patient or patient's agent in a suitable container
12 appropriately labeled for subsequent administration to or use
13 by a patient in accordance with applicable State and federal
14 laws and regulations. "Dispense" or "dispensing" does not mean
15 the physical delivery to a patient or a patient's
16 representative in a home or institution by a designee of a
17 pharmacist or by common carrier. "Dispense" or "dispensing"
18 also does not mean the physical delivery of a drug or medical
19 device to a patient or patient's representative by a
20 pharmacist's designee within a pharmacy or drugstore while the
21 pharmacist is on duty and the pharmacy is open.
22 (n) "Nonresident pharmacy" means a pharmacy that is
23 located in a state, commonwealth, or territory of the United
24 States, other than Illinois, that delivers, dispenses, or
25 distributes, through the United States Postal Service,
26 commercially acceptable parcel delivery service, or other
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1 common carrier, to Illinois residents, any substance which
2 requires a prescription.
3 (o) "Compounding" means the preparation and mixing of
4 components, excluding flavorings, (1) as the result of a
5 prescriber's prescription drug order or initiative based on
6 the prescriber-patient-pharmacist relationship in the course
7 of professional practice or (2) for the purpose of, or
8 incident to, research, teaching, or chemical analysis and not
9 for sale or dispensing. "Compounding" includes the preparation
10 of drugs or devices in anticipation of receiving prescription
11 drug orders based on routine, regularly observed dispensing
12 patterns. Commercially available products may be compounded
13 for dispensing to individual patients only if all of the
14 following conditions are met: (i) the commercial product is
15 not reasonably available from normal distribution channels in
16 a timely manner to meet the patient's needs and (ii) the
17 prescribing practitioner has requested that the drug be
18 compounded.
19 (p) (Blank).
20 (q) (Blank).
21 (r) "Patient counseling" means the communication between a
22 pharmacist or a student pharmacist under the supervision of a
23 pharmacist and a patient or the patient's representative about
24 the patient's medication or device for the purpose of
25 optimizing proper use of prescription medications or devices.
26 "Patient counseling" may include without limitation (1)
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1 obtaining a medication history; (2) acquiring a patient's
2 allergies and health conditions; (3) facilitation of the
3 patient's understanding of the intended use of the medication;
4 (4) proper directions for use; (5) significant potential
5 adverse events; (6) potential food-drug interactions; and (7)
6 the need to be compliant with the medication therapy. A
7 pharmacy technician may only participate in the following
8 aspects of patient counseling under the supervision of a
9 pharmacist: (1) obtaining medication history; (2) providing
10 the offer for counseling by a pharmacist or student
11 pharmacist; and (3) acquiring a patient's allergies and health
12 conditions.
13 (s) "Patient profiles" or "patient drug therapy record"
14 means the obtaining, recording, and maintenance of patient
15 prescription information, including prescriptions for
16 controlled substances, and personal information.
17 (t) (Blank).
18 (u) "Medical device" or "device" means an instrument,
19 apparatus, implement, machine, contrivance, implant, in vitro
20 reagent, or other similar or related article, including any
21 component part or accessory, required under federal law to
22 bear the label "Caution: Federal law requires dispensing by or
23 on the order of a physician". A seller of goods and services
24 who, only for the purpose of retail sales, compounds, sells,
25 rents, or leases medical devices shall not, by reasons
26 thereof, be required to be a licensed pharmacy.
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1 (v) "Unique identifier" means an electronic signature,
2 handwritten signature or initials, thumb print, or other
3 acceptable biometric or electronic identification process as
4 approved by the Department.
5 (w) "Current usual and customary retail price" means the
6 price that a pharmacy charges to a non-third-party payor.
7 (x) "Automated pharmacy system" means a mechanical system
8 located within the confines of the pharmacy or remote location
9 that performs operations or activities, other than compounding
10 or administration, relative to storage, packaging, dispensing,
11 or distribution of medication, and which collects, controls,
12 and maintains all transaction information.
13 (y) "Drug regimen review" means and includes the
14 evaluation of prescription drug orders and patient records for
15 (1) known allergies; (2) drug or potential therapy
16 contraindications; (3) reasonable dose, duration of use, and
17 route of administration, taking into consideration factors
18 such as age, gender, and contraindications; (4) reasonable
19 directions for use; (5) potential or actual adverse drug
20 reactions; (6) drug-drug interactions; (7) drug-food
21 interactions; (8) drug-disease contraindications; (9)
22 therapeutic duplication; (10) patient laboratory values when
23 authorized and available; (11) proper utilization (including
24 over or under utilization) and optimum therapeutic outcomes;
25 and (12) abuse and misuse.
26 (z) "Electronically transmitted prescription" means a
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1 prescription that is created, recorded, or stored by
2 electronic means; issued and validated with an electronic
3 signature; and transmitted by electronic means directly from
4 the prescriber to a pharmacy. An electronic prescription is
5 not an image of a physical prescription that is transferred by
6 electronic means from computer to computer, facsimile to
7 facsimile, or facsimile to computer.
8 (aa) "Medication therapy management services" means a
9 distinct service or group of services offered by licensed
10 pharmacists, physicians licensed to practice medicine in all
11 its branches, advanced practice registered nurses authorized
12 in a written agreement with a physician licensed to practice
13 medicine in all its branches, or physician assistants
14 authorized in guidelines by a supervising physician that
15 optimize therapeutic outcomes for individual patients through
16 improved medication use. In a retail or other non-hospital
17 pharmacy, medication therapy management services shall consist
18 of the evaluation of prescription drug orders and patient
19 medication records to resolve conflicts with the following:
20 (1) known allergies;
21 (2) drug or potential therapy contraindications;
22 (3) reasonable dose, duration of use, and route of
23 administration, taking into consideration factors such as
24 age, gender, and contraindications;
25 (4) reasonable directions for use;
26 (5) potential or actual adverse drug reactions;
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1 (6) drug-drug interactions;
2 (7) drug-food interactions;
3 (8) drug-disease contraindications;
4 (9) identification of therapeutic duplication;
5 (10) patient laboratory values when authorized and
6 available;
7 (11) proper utilization (including over or under
8 utilization) and optimum therapeutic outcomes; and
9 (12) drug abuse and misuse.
10 "Medication therapy management services" includes the
11 following:
12 (1) documenting the services delivered and
13 communicating the information provided to patients'
14 prescribers within an appropriate time frame, not to
15 exceed 48 hours;
16 (2) providing patient counseling designed to enhance a
17 patient's understanding and the appropriate use of his or
18 her medications; and
19 (3) providing information, support services, and
20 resources designed to enhance a patient's adherence with
21 his or her prescribed therapeutic regimens.
22 "Medication therapy management services" may also include
23 patient care functions authorized by a physician licensed to
24 practice medicine in all its branches for his or her
25 identified patient or groups of patients under specified
26 conditions or limitations in a standing order from the
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1 physician.
2 "Medication therapy management services" in a licensed
3 hospital may also include the following:
4 (1) reviewing assessments of the patient's health
5 status; and
6 (2) following protocols of a hospital pharmacy and
7 therapeutics committee with respect to the fulfillment of
8 medication orders.
9 (bb) "Pharmacist care" means the provision by a pharmacist
10 of medication therapy management services, with or without the
11 dispensing of drugs or devices, intended to achieve outcomes
12 that improve patient health, quality of life, and comfort and
13 enhance patient safety.
14 (cc) "Protected health information" means individually
15 identifiable health information that, except as otherwise
16 provided, is:
17 (1) transmitted by electronic media;
18 (2) maintained in any medium set forth in the
19 definition of "electronic media" in the federal Health
20 Insurance Portability and Accountability Act; or
21 (3) transmitted or maintained in any other form or
22 medium.
23 "Protected health information" does not include
24 individually identifiable health information found in:
25 (1) education records covered by the federal Family
26 Educational Right and Privacy Act; or
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1 (2) employment records held by a licensee in its role
2 as an employer.
3 (dd) "Standing order" means a specific order for a patient
4 or group of patients issued by a physician licensed to
5 practice medicine in all its branches in Illinois.
6 (ee) "Address of record" means the designated address
7 recorded by the Department in the applicant's application file
8 or licensee's license file maintained by the Department's
9 licensure maintenance unit.
10 (ff) "Home pharmacy" means the location of a pharmacy's
11 primary operations.
12 (gg) "Email address of record" means the designated email
13 address recorded by the Department in the applicant's
14 application file or the licensee's license file, as maintained
15 by the Department's licensure maintenance unit.
16 (Source: P.A. 102-16, eff. 6-17-21; 102-103, eff. 1-1-22;
17 102-558, eff. 8-20-21; 102-813, eff. 5-13-22; 102-1051, eff.
18 1-1-23; 103-1, eff. 4-27-23.)
HB4822 - 19 - LRB103 37464 RTM 67587 b