103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB5530 Introduced , by Rep. Maurice A. West, II SYNOPSIS AS INTRODUCED: 225 ILCS 85/3 Amends the Pharmacy Practice Act. In the definition of "practice of pharmacy": provides for the administration of long-acting injectables for mental health or substance use disorders (rather than injections of long-term antipsychotic medications); and removes language providing that the definition includes administration of injections of long-acting or extended-release form opioid antagonists for the treatment of a substance use disorder following the initial administration of long-acting or extended-release form opioid antagonists by a physician licensed to practice medicine in all its branches. LRB103 37122 RTM 67241 b A BILL FOR 103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB5530 Introduced , by Rep. Maurice A. West, II SYNOPSIS AS INTRODUCED: 225 ILCS 85/3 225 ILCS 85/3 Amends the Pharmacy Practice Act. In the definition of "practice of pharmacy": provides for the administration of long-acting injectables for mental health or substance use disorders (rather than injections of long-term antipsychotic medications); and removes language providing that the definition includes administration of injections of long-acting or extended-release form opioid antagonists for the treatment of a substance use disorder following the initial administration of long-acting or extended-release form opioid antagonists by a physician licensed to practice medicine in all its branches. LRB103 37122 RTM 67241 b LRB103 37122 RTM 67241 b A BILL FOR
103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB5530 Introduced , by Rep. Maurice A. West, II SYNOPSIS AS INTRODUCED:
225 ILCS 85/3 225 ILCS 85/3
225 ILCS 85/3
Amends the Pharmacy Practice Act. In the definition of "practice of pharmacy": provides for the administration of long-acting injectables for mental health or substance use disorders (rather than injections of long-term antipsychotic medications); and removes language providing that the definition includes administration of injections of long-acting or extended-release form opioid antagonists for the treatment of a substance use disorder following the initial administration of long-acting or extended-release form opioid antagonists by a physician licensed to practice medicine in all its branches.
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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 Pharmacy Practice Act is amended by
5 changing Section 3 as follows:
6 (225 ILCS 85/3)
7 (Section scheduled to be repealed on January 1, 2028)
8 Sec. 3. Definitions. For the purpose of this Act, except
9 where otherwise limited therein:
10 (a) "Pharmacy" or "drugstore" means and includes every
11 store, shop, pharmacy department, or other place where
12 pharmacist care is provided by a pharmacist (1) where drugs,
13 medicines, or poisons are dispensed, sold or offered for sale
14 at retail, or displayed for sale at retail; or (2) where
15 prescriptions of physicians, dentists, advanced practice
16 registered nurses, physician assistants, veterinarians,
17 podiatric physicians, or optometrists, within the limits of
18 their licenses, are compounded, filled, or dispensed; or (3)
19 which has upon it or displayed within it, or affixed to or used
20 in connection with it, a sign bearing the word or words
21 "Pharmacist", "Druggist", "Pharmacy", "Pharmaceutical Care",
22 "Apothecary", "Drugstore", "Medicine Store", "Prescriptions",
23 "Drugs", "Dispensary", "Medicines", or any word or words of
103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB5530 Introduced , by Rep. Maurice A. West, II SYNOPSIS AS INTRODUCED:
225 ILCS 85/3 225 ILCS 85/3
225 ILCS 85/3
Amends the Pharmacy Practice Act. In the definition of "practice of pharmacy": provides for the administration of long-acting injectables for mental health or substance use disorders (rather than injections of long-term antipsychotic medications); and removes language providing that the definition includes administration of injections of long-acting or extended-release form opioid antagonists for the treatment of a substance use disorder following the initial administration of long-acting or extended-release form opioid antagonists by a physician licensed to practice medicine in all its branches.
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A BILL FOR
225 ILCS 85/3
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1 similar or like import, either in the English language or any
2 other language; or (4) where the characteristic prescription
3 sign (Rx) or similar design is exhibited; or (5) any store, or
4 shop, or other place with respect to which any of the above
5 words, objects, signs or designs are used in any
6 advertisement.
7 (b) "Drugs" means and includes (1) articles recognized in
8 the official United States Pharmacopoeia/National Formulary
9 (USP/NF), or any supplement thereto and being intended for and
10 having for their main use the diagnosis, cure, mitigation,
11 treatment or prevention of disease in man or other animals, as
12 approved by the United States Food and Drug Administration,
13 but does not include devices or their components, parts, or
14 accessories; and (2) all other articles intended for and
15 having for their main use the diagnosis, cure, mitigation,
16 treatment or prevention of disease in man or other animals, as
17 approved by the United States Food and Drug Administration,
18 but does not include devices or their components, parts, or
19 accessories; and (3) articles (other than food) having for
20 their main use and intended to affect the structure or any
21 function of the body of man or other animals; and (4) articles
22 having for their main use and intended for use as a component
23 or any articles specified in clause (1), (2) or (3); but does
24 not include devices or their components, parts or accessories.
25 (c) "Medicines" means and includes all drugs intended for
26 human or veterinary use approved by the United States Food and
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1 Drug Administration.
2 (d) "Practice of pharmacy" means:
3 (1) the interpretation and the provision of assistance
4 in the monitoring, evaluation, and implementation of
5 prescription drug orders;
6 (2) the dispensing of prescription drug orders;
7 (3) participation in drug and device selection;
8 (4) drug administration limited to the administration
9 of oral, topical, injectable, and inhalation as follows:
10 (A) in the context of patient education on the
11 proper use or delivery of medications;
12 (B) vaccination of patients 7 years of age and
13 older pursuant to a valid prescription or standing
14 order, by a physician licensed to practice medicine in
15 all its branches, except for vaccinations covered by
16 paragraph (15), upon completion of appropriate
17 training, including how to address contraindications
18 and adverse reactions set forth by rule, with
19 notification to the patient's physician and
20 appropriate record retention, or pursuant to hospital
21 pharmacy and therapeutics committee policies and
22 procedures. Eligible vaccines are those listed on the
23 U.S. Centers for Disease Control and Prevention (CDC)
24 Recommended Immunization Schedule, the CDC's Health
25 Information for International Travel, or the U.S. Food
26 and Drug Administration's Vaccines Licensed and
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1 Authorized for Use in the United States. As applicable
2 to the State's Medicaid program and other payers,
3 vaccines ordered and administered in accordance with
4 this subsection shall be covered and reimbursed at no
5 less than the rate that the vaccine is reimbursed when
6 ordered and administered by a physician;
7 (B-5) (blank); following the initial
8 administration of long-acting or extended-release form
9 opioid antagonists by a physician licensed to practice
10 medicine in all its branches, administration of
11 injections of long-acting or extended-release form
12 opioid antagonists for the treatment of substance use
13 disorder, pursuant to a valid prescription by a
14 physician licensed to practice medicine in all its
15 branches, upon completion of appropriate training,
16 including how to address contraindications and adverse
17 reactions, including, but not limited to, respiratory
18 depression and the performance of cardiopulmonary
19 resuscitation, set forth by rule, with notification to
20 the patient's physician and appropriate record
21 retention, or pursuant to hospital pharmacy and
22 therapeutics committee policies and procedures;
23 (C) administration of injections of
24 alpha-hydroxyprogesterone caproate, pursuant to a
25 valid prescription, by a physician licensed to
26 practice medicine in all its branches, upon completion
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1 of appropriate training, including how to address
2 contraindications and adverse reactions set forth by
3 rule, with notification to the patient's physician and
4 appropriate record retention, or pursuant to hospital
5 pharmacy and therapeutics committee policies and
6 procedures; and
7 (D) administration of long-acting injectables for
8 mental health or substance use disorders injections of
9 long-term antipsychotic medications pursuant to a
10 valid prescription by a physician licensed to practice
11 medicine in all its branches, upon completion of
12 appropriate training conducted by an Accreditation
13 Council of Pharmaceutical Education accredited
14 provider, 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.
20 (5) (blank);
21 (6) drug regimen review;
22 (7) drug or drug-related research;
23 (8) the provision of patient counseling;
24 (9) the practice of telepharmacy;
25 (10) the provision of those acts or services necessary
26 to provide pharmacist care;
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1 (11) medication therapy management;
2 (12) the responsibility for compounding and labeling
3 of drugs and devices (except labeling by a manufacturer,
4 repackager, or distributor of non-prescription drugs and
5 commercially packaged legend drugs and devices), proper
6 and safe storage of drugs and devices, and maintenance of
7 required records;
8 (13) the assessment and consultation of patients and
9 dispensing of hormonal contraceptives;
10 (14) the initiation, dispensing, or administration of
11 drugs, laboratory tests, assessments, referrals, and
12 consultations for human immunodeficiency virus
13 pre-exposure prophylaxis and human immunodeficiency virus
14 post-exposure prophylaxis under Section 43.5;
15 (15) vaccination of patients 7 years of age and older
16 for COVID-19 or influenza subcutaneously, intramuscularly,
17 or orally as authorized, approved, or licensed by the
18 United States Food and Drug Administration, pursuant to
19 the following conditions:
20 (A) the vaccine must be authorized or licensed by
21 the United States Food and Drug Administration;
22 (B) the vaccine must be ordered and administered
23 according to the Advisory Committee on Immunization
24 Practices standard immunization schedule;
25 (C) the pharmacist must complete a course of
26 training accredited by the Accreditation Council on
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1 Pharmacy Education or a similar health authority or
2 professional body approved by the Division of
3 Professional Regulation;
4 (D) the pharmacist must have a current certificate
5 in basic cardiopulmonary resuscitation;
6 (E) the pharmacist must complete, during each
7 State licensing period, a minimum of 2 hours of
8 immunization-related continuing pharmacy education
9 approved by the Accreditation Council on Pharmacy
10 Education;
11 (F) the pharmacist must comply with recordkeeping
12 and reporting requirements of the jurisdiction in
13 which the pharmacist administers vaccines, including
14 informing the patient's primary-care provider, when
15 available, and complying with requirements whereby the
16 person administering a vaccine must review the vaccine
17 registry or other vaccination records prior to
18 administering the vaccine; and
19 (G) the pharmacist must inform the pharmacist's
20 patients who are less than 18 years old, as well as the
21 adult caregiver accompanying the child, of the
22 importance of a well-child visit with a pediatrician
23 or other licensed primary-care provider and must refer
24 patients as appropriate;
25 (16) the ordering and administration of COVID-19
26 therapeutics subcutaneously, intramuscularly, or orally
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1 with notification to the patient's physician and
2 appropriate record retention or pursuant to hospital
3 pharmacy and therapeutics committee policies and
4 procedures. Eligible therapeutics are those approved,
5 authorized, or licensed by the United States Food and Drug
6 Administration and must be administered subcutaneously,
7 intramuscularly, or orally in accordance with that
8 approval, authorization, or licensing; and
9 (17) the ordering and administration of tests and
10 screenings for (i) influenza, (ii) SARS-COV 2, and (iii)
11 health conditions identified by a statewide public health
12 emergency, as defined in the Illinois Emergency Management
13 Agency Act, with notification to the patient's physician
14 and appropriate record retention or pursuant to hospital
15 pharmacy and therapeutics committee policies and
16 procedures. Eligible tests and screenings are those
17 approved, authorized, or licensed by the United States
18 Food and Drug Administration and must be administered in
19 accordance with that approval, authorization, or
20 licensing.
21 A pharmacist who orders or administers tests or
22 screenings for health conditions described in this
23 paragraph may use a test that may guide clinical
24 decision-making for the health condition that is waived
25 under the federal Clinical Laboratory Improvement
26 Amendments of 1988 and regulations promulgated thereunder
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1 or any established screening procedure that is established
2 under a statewide protocol.
3 A pharmacist may delegate the administrative and
4 technical tasks of performing a test for the health
5 conditions described in this paragraph to a registered
6 pharmacy technician or student pharmacist acting under the
7 supervision of the pharmacist.
8 A pharmacist who performs any of the acts defined as the
9 practice of pharmacy in this State must be actively licensed
10 as a pharmacist under this Act.
11 (e) "Prescription" means and includes any written, oral,
12 facsimile, or electronically transmitted order for drugs or
13 medical devices, issued by a physician licensed to practice
14 medicine in all its branches, dentist, veterinarian, podiatric
15 physician, or optometrist, within the limits of his or her
16 license, by a physician assistant in accordance with
17 subsection (f) of Section 4, or by an advanced practice
18 registered nurse in accordance with subsection (g) of Section
19 4, containing the following: (1) name of the patient; (2) date
20 when prescription was issued; (3) name and strength of drug or
21 description of the medical device prescribed; and (4)
22 quantity; (5) directions for use; (6) prescriber's name,
23 address, and signature; and (7) DEA registration number where
24 required, for controlled substances. The prescription may, but
25 is not required to, list the illness, disease, or condition
26 for which the drug or device is being prescribed. DEA
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1 registration numbers shall not be required on inpatient drug
2 orders. A prescription for medication other than controlled
3 substances shall be valid for up to 15 months from the date
4 issued for the purpose of refills, unless the prescription
5 states otherwise.
6 (f) "Person" means and includes a natural person,
7 partnership, association, corporation, government entity, or
8 any other legal entity.
9 (g) "Department" means the Department of Financial and
10 Professional Regulation.
11 (h) "Board of Pharmacy" or "Board" means the State Board
12 of Pharmacy of the Department of Financial and Professional
13 Regulation.
14 (i) "Secretary" means the Secretary of Financial and
15 Professional Regulation.
16 (j) "Drug product selection" means the interchange for a
17 prescribed pharmaceutical product in accordance with Section
18 25 of this Act and Section 3.14 of the Illinois Food, Drug and
19 Cosmetic Act.
20 (k) "Inpatient drug order" means an order issued by an
21 authorized prescriber for a resident or patient of a facility
22 licensed under the Nursing Home Care Act, the ID/DD Community
23 Care Act, the MC/DD Act, the Specialized Mental Health
24 Rehabilitation Act of 2013, the Hospital Licensing Act, or the
25 University of Illinois Hospital Act, or a facility which is
26 operated by the Department of Human Services (as successor to
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1 the Department of Mental Health and Developmental
2 Disabilities) or the Department of Corrections.
3 (k-5) "Pharmacist" means an individual health care
4 professional and provider currently licensed by this State to
5 engage in the practice of pharmacy.
6 (l) "Pharmacist in charge" means the licensed pharmacist
7 whose name appears on a pharmacy license and who is
8 responsible for all aspects of the operation related to the
9 practice of pharmacy.
10 (m) "Dispense" or "dispensing" means the interpretation,
11 evaluation, and implementation of a prescription drug order,
12 including the preparation and delivery of a drug or device to a
13 patient or patient's agent in a suitable container
14 appropriately labeled for subsequent administration to or use
15 by a patient in accordance with applicable State and federal
16 laws and regulations. "Dispense" or "dispensing" does not mean
17 the physical delivery to a patient or a patient's
18 representative in a home or institution by a designee of a
19 pharmacist or by common carrier. "Dispense" or "dispensing"
20 also does not mean the physical delivery of a drug or medical
21 device to a patient or patient's representative by a
22 pharmacist's designee within a pharmacy or drugstore while the
23 pharmacist is on duty and the pharmacy is open.
24 (n) "Nonresident pharmacy" means a pharmacy that is
25 located in a state, commonwealth, or territory of the United
26 States, other than Illinois, that delivers, dispenses, or
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1 distributes, through the United States Postal Service,
2 commercially acceptable parcel delivery service, or other
3 common carrier, to Illinois residents, any substance which
4 requires a prescription.
5 (o) "Compounding" means the preparation and mixing of
6 components, excluding flavorings, (1) as the result of a
7 prescriber's prescription drug order or initiative based on
8 the prescriber-patient-pharmacist relationship in the course
9 of professional practice or (2) for the purpose of, or
10 incident to, research, teaching, or chemical analysis and not
11 for sale or dispensing. "Compounding" includes the preparation
12 of drugs or devices in anticipation of receiving prescription
13 drug orders based on routine, regularly observed dispensing
14 patterns. Commercially available products may be compounded
15 for dispensing to individual patients only if all of the
16 following conditions are met: (i) the commercial product is
17 not reasonably available from normal distribution channels in
18 a timely manner to meet the patient's needs and (ii) the
19 prescribing practitioner has requested that the drug be
20 compounded.
21 (p) (Blank).
22 (q) (Blank).
23 (r) "Patient counseling" means the communication between a
24 pharmacist or a student pharmacist under the supervision of a
25 pharmacist and a patient or the patient's representative about
26 the patient's medication or device for the purpose of
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1 optimizing proper use of prescription medications or devices.
2 "Patient counseling" may include without limitation (1)
3 obtaining a medication history; (2) acquiring a patient's
4 allergies and health conditions; (3) facilitation of the
5 patient's understanding of the intended use of the medication;
6 (4) proper directions for use; (5) significant potential
7 adverse events; (6) potential food-drug interactions; and (7)
8 the need to be compliant with the medication therapy. A
9 pharmacy technician may only participate in the following
10 aspects of patient counseling under the supervision of a
11 pharmacist: (1) obtaining medication history; (2) providing
12 the offer for counseling by a pharmacist or student
13 pharmacist; and (3) acquiring a patient's allergies and health
14 conditions.
15 (s) "Patient profiles" or "patient drug therapy record"
16 means the obtaining, recording, and maintenance of patient
17 prescription information, including prescriptions for
18 controlled substances, and personal information.
19 (t) (Blank).
20 (u) "Medical device" or "device" means an instrument,
21 apparatus, implement, machine, contrivance, implant, in vitro
22 reagent, or other similar or related article, including any
23 component part or accessory, required under federal law to
24 bear the label "Caution: Federal law requires dispensing by or
25 on the order of a physician". A seller of goods and services
26 who, only for the purpose of retail sales, compounds, sells,
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1 rents, or leases medical devices shall not, by reasons
2 thereof, be required to be a licensed pharmacy.
3 (v) "Unique identifier" means an electronic signature,
4 handwritten signature or initials, thumb print, or other
5 acceptable biometric or electronic identification process as
6 approved by the Department.
7 (w) "Current usual and customary retail price" means the
8 price that a pharmacy charges to a non-third-party payor.
9 (x) "Automated pharmacy system" means a mechanical system
10 located within the confines of the pharmacy or remote location
11 that performs operations or activities, other than compounding
12 or administration, relative to storage, packaging, dispensing,
13 or distribution of medication, and which collects, controls,
14 and maintains all transaction information.
15 (y) "Drug regimen review" means and includes the
16 evaluation of prescription drug orders and patient records for
17 (1) known allergies; (2) drug or potential therapy
18 contraindications; (3) reasonable dose, duration of use, and
19 route of administration, taking into consideration factors
20 such as age, gender, and contraindications; (4) reasonable
21 directions for use; (5) potential or actual adverse drug
22 reactions; (6) drug-drug interactions; (7) drug-food
23 interactions; (8) drug-disease contraindications; (9)
24 therapeutic duplication; (10) patient laboratory values when
25 authorized and available; (11) proper utilization (including
26 over or under utilization) and optimum therapeutic outcomes;
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1 and (12) abuse and misuse.
2 (z) "Electronically transmitted prescription" means a
3 prescription that is created, recorded, or stored by
4 electronic means; issued and validated with an electronic
5 signature; and transmitted by electronic means directly from
6 the prescriber to a pharmacy. An electronic prescription is
7 not an image of a physical prescription that is transferred by
8 electronic means from computer to computer, facsimile to
9 facsimile, or facsimile to computer.
10 (aa) "Medication therapy management services" means a
11 distinct service or group of services offered by licensed
12 pharmacists, physicians licensed to practice medicine in all
13 its branches, advanced practice registered nurses authorized
14 in a written agreement with a physician licensed to practice
15 medicine in all its branches, or physician assistants
16 authorized in guidelines by a supervising physician that
17 optimize therapeutic outcomes for individual patients through
18 improved medication use. In a retail or other non-hospital
19 pharmacy, medication therapy management services shall consist
20 of the evaluation of prescription drug orders and patient
21 medication records to resolve conflicts with the following:
22 (1) known allergies;
23 (2) drug or potential therapy contraindications;
24 (3) reasonable dose, duration of use, and route of
25 administration, taking into consideration factors such as
26 age, gender, and contraindications;
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1 (4) reasonable directions for use;
2 (5) potential or actual adverse drug reactions;
3 (6) drug-drug interactions;
4 (7) drug-food interactions;
5 (8) drug-disease contraindications;
6 (9) identification of therapeutic duplication;
7 (10) patient laboratory values when authorized and
8 available;
9 (11) proper utilization (including over or under
10 utilization) and optimum therapeutic outcomes; and
11 (12) drug abuse and misuse.
12 "Medication therapy management services" includes the
13 following:
14 (1) documenting the services delivered and
15 communicating the information provided to patients'
16 prescribers within an appropriate time frame, not to
17 exceed 48 hours;
18 (2) providing patient counseling designed to enhance a
19 patient's understanding and the appropriate use of his or
20 her medications; and
21 (3) providing information, support services, and
22 resources designed to enhance a patient's adherence with
23 his or her prescribed therapeutic regimens.
24 "Medication therapy management services" may also include
25 patient care functions authorized by a physician licensed to
26 practice medicine in all its branches for his or her
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1 identified patient or groups of patients under specified
2 conditions or limitations in a standing order from the
3 physician.
4 "Medication therapy management services" in a licensed
5 hospital may also include the following:
6 (1) reviewing assessments of the patient's health
7 status; and
8 (2) following protocols of a hospital pharmacy and
9 therapeutics committee with respect to the fulfillment of
10 medication orders.
11 (bb) "Pharmacist care" means the provision by a pharmacist
12 of medication therapy management services, with or without the
13 dispensing of drugs or devices, intended to achieve outcomes
14 that improve patient health, quality of life, and comfort and
15 enhance patient safety.
16 (cc) "Protected health information" means individually
17 identifiable health information that, except as otherwise
18 provided, is:
19 (1) transmitted by electronic media;
20 (2) maintained in any medium set forth in the
21 definition of "electronic media" in the federal Health
22 Insurance Portability and Accountability Act; or
23 (3) transmitted or maintained in any other form or
24 medium.
25 "Protected health information" does not include
26 individually identifiable health information found in:
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