Illinois General Assembly - Full Text of SB0317
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Full Text of SB0317  100th General Assembly

SB0317sam001 100TH GENERAL ASSEMBLY

Sen. John G. Mulroe

Filed: 3/23/2017

 

 


 

 


 
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1
AMENDMENT TO SENATE BILL 317

2    AMENDMENT NO. ______. Amend Senate Bill 317 by replacing
3everything after the enacting clause with the following:
 
4    "Section 5. The Pharmacy Practice Act is amended by
5changing Section 3 as follows:
 
6    (225 ILCS 85/3)
7    (Section scheduled to be repealed on January 1, 2018)
8    Sec. 3. Definitions. For the purpose of this Act, except
9where otherwise limited therein:
10    (a) "Pharmacy" or "drugstore" means and includes every
11store, shop, pharmacy department, or other place where
12pharmacist care is provided by a pharmacist (1) where drugs,
13medicines, or poisons are dispensed, sold or offered for sale
14at retail, or displayed for sale at retail; or (2) where
15prescriptions of physicians, dentists, advanced practice
16nurses, physician assistants, veterinarians, podiatric

 

 

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1physicians, or optometrists, within the limits of their
2licenses, are compounded, filled, or dispensed; or (3) which
3has upon it or displayed within it, or affixed to or used in
4connection with it, a sign bearing the word or words
5"Pharmacist", "Druggist", "Pharmacy", "Pharmaceutical Care",
6"Apothecary", "Drugstore", "Medicine Store", "Prescriptions",
7"Drugs", "Dispensary", "Medicines", or any word or words of
8similar or like import, either in the English language or any
9other language; or (4) where the characteristic prescription
10sign (Rx) or similar design is exhibited; or (5) any store, or
11shop, or other place with respect to which any of the above
12words, objects, signs or designs are used in any advertisement.
13    (b) "Drugs" means and includes (1) articles recognized in
14the official United States Pharmacopoeia/National Formulary
15(USP/NF), or any supplement thereto and being intended for and
16having for their main use the diagnosis, cure, mitigation,
17treatment or prevention of disease in man or other animals, as
18approved by the United States Food and Drug Administration, but
19does not include devices or their components, parts, or
20accessories; and (2) all other articles intended for and having
21for their main use the diagnosis, cure, mitigation, treatment
22or prevention of disease in man or other animals, as approved
23by the United States Food and Drug Administration, but does not
24include devices or their components, parts, or accessories; and
25(3) articles (other than food) having for their main use and
26intended to affect the structure or any function of the body of

 

 

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1man or other animals; and (4) articles having for their main
2use and intended for use as a component or any articles
3specified in clause (1), (2) or (3); but does not include
4devices or their components, parts or accessories.
5    (c) "Medicines" means and includes all drugs intended for
6human or veterinary use approved by the United States Food and
7Drug Administration.
8    (d) "Practice of pharmacy" means:
9        (1) the interpretation and the provision of assistance
10    in the monitoring, evaluation, and implementation of
11    prescription drug orders;
12        (2) the dispensing of prescription drug orders;
13        (3) participation in drug and device selection;
14        (4) drug administration limited to the administration
15    of oral, topical, injectable, and inhalation as follows:
16            (A) in the context of patient education on the
17        proper use or delivery of medications;
18            (B) vaccination of patients 14 years of age and
19        older pursuant to a valid prescription or standing
20        order, by a physician licensed to practice medicine in
21        all its branches, upon completion of appropriate
22        training, including how to address contraindications
23        and adverse reactions set forth by rule, with
24        notification to the patient's physician and
25        appropriate record retention, or pursuant to hospital
26        pharmacy and therapeutics committee policies and

 

 

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1        procedures; and
2            (C) administration of injections of
3        hydroxyprogesterone caproate and medroxyprogesterone
4        acetate, pursuant to a valid prescription, by a
5        physician licensed to practice medicine in all its
6        branches, upon completion of appropriate training,
7        including how to address contraindications and adverse
8        reactions set forth by rule, with notification to the
9        patient's physician and appropriate record retention,
10        or pursuant to hospital pharmacy and therapeutics
11        committee policies and procedures;
12        (5) vaccination of patients ages 10 through 13 limited
13    to the Influenza (inactivated influenza vaccine and live
14    attenuated influenza intranasal vaccine) and Tdap (defined
15    as tetanus, diphtheria, acellular pertussis) vaccines,
16    pursuant to a valid prescription or standing order, by a
17    physician licensed to practice medicine in all its
18    branches, upon completion of appropriate training,
19    including how to address contraindications and adverse
20    reactions set forth by rule, with notification to the
21    patient's physician and appropriate record retention, or
22    pursuant to hospital pharmacy and therapeutics committee
23    policies and procedures;
24        (6) drug regimen review;
25        (7) drug or drug-related research;
26        (8) the provision of patient counseling;

 

 

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1        (9) the practice of telepharmacy;
2        (10) the provision of those acts or services necessary
3    to provide pharmacist care;
4        (11) medication therapy management; and
5        (12) the responsibility for compounding and labeling
6    of drugs and devices (except labeling by a manufacturer,
7    repackager, or distributor of non-prescription drugs and
8    commercially packaged legend drugs and devices), proper
9    and safe storage of drugs and devices, and maintenance of
10    required records.
11    A pharmacist who performs any of the acts defined as the
12practice of pharmacy in this State must be actively licensed as
13a pharmacist under this Act.
14    (e) "Prescription" means and includes any written, oral,
15facsimile, or electronically transmitted order for drugs or
16medical devices, issued by a physician licensed to practice
17medicine in all its branches, dentist, veterinarian, podiatric
18physician, or optometrist, within the limits of their licenses,
19by a physician assistant in accordance with subsection (f) of
20Section 4, or by an advanced practice nurse in accordance with
21subsection (g) of Section 4, containing the following: (1) name
22of the patient; (2) date when prescription was issued; (3) name
23and strength of drug or description of the medical device
24prescribed; and (4) quantity; (5) directions for use; (6)
25prescriber's name, address, and signature; and (7) DEA number
26where required, for controlled substances. The prescription

 

 

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1may, but is not required to, list the illness, disease, or
2condition for which the drug or device is being prescribed. DEA
3numbers shall not be required on inpatient drug orders.
4    (f) "Person" means and includes a natural person,
5copartnership, association, corporation, government entity, or
6any other legal entity.
7    (g) "Department" means the Department of Financial and
8Professional Regulation.
9    (h) "Board of Pharmacy" or "Board" means the State Board of
10Pharmacy of the Department of Financial and Professional
11Regulation.
12    (i) "Secretary" means the Secretary of Financial and
13Professional Regulation.
14    (j) "Drug product selection" means the interchange for a
15prescribed pharmaceutical product in accordance with Section
1625 of this Act and Section 3.14 of the Illinois Food, Drug and
17Cosmetic Act.
18    (k) "Inpatient drug order" means an order issued by an
19authorized prescriber for a resident or patient of a facility
20licensed under the Nursing Home Care Act, the ID/DD Community
21Care Act, the MC/DD Act, the Specialized Mental Health
22Rehabilitation Act of 2013, or the Hospital Licensing Act, or
23"An Act in relation to the founding and operation of the
24University of Illinois Hospital and the conduct of University
25of Illinois health care programs", approved July 3, 1931, as
26amended, or a facility which is operated by the Department of

 

 

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1Human Services (as successor to the Department of Mental Health
2and Developmental Disabilities) or the Department of
3Corrections.
4    (k-5) "Pharmacist" means an individual health care
5professional and provider currently licensed by this State to
6engage in the practice of pharmacy.
7    (l) "Pharmacist in charge" means the licensed pharmacist
8whose name appears on a pharmacy license and who is responsible
9for all aspects of the operation related to the practice of
10pharmacy.
11    (m) "Dispense" or "dispensing" means the interpretation,
12evaluation, and implementation of a prescription drug order,
13including the preparation and delivery of a drug or device to a
14patient or patient's agent in a suitable container
15appropriately labeled for subsequent administration to or use
16by a patient in accordance with applicable State and federal
17laws and regulations. "Dispense" or "dispensing" does not mean
18the physical delivery to a patient or a patient's
19representative in a home or institution by a designee of a
20pharmacist or by common carrier. "Dispense" or "dispensing"
21also does not mean the physical delivery of a drug or medical
22device to a patient or patient's representative by a
23pharmacist's designee within a pharmacy or drugstore while the
24pharmacist is on duty and the pharmacy is open.
25    (n) "Nonresident pharmacy" means a pharmacy that is located
26in a state, commonwealth, or territory of the United States,

 

 

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1other than Illinois, that delivers, dispenses, or distributes,
2through the United States Postal Service, commercially
3acceptable parcel delivery service, or other common carrier, to
4Illinois residents, any substance which requires a
5prescription.
6    (o) "Compounding" means the preparation and mixing of
7components, excluding flavorings, (1) as the result of a
8prescriber's prescription drug order or initiative based on the
9prescriber-patient-pharmacist relationship in the course of
10professional practice or (2) for the purpose of, or incident
11to, research, teaching, or chemical analysis and not for sale
12or dispensing. "Compounding" includes the preparation of drugs
13or devices in anticipation of receiving prescription drug
14orders based on routine, regularly observed dispensing
15patterns. Commercially available products may be compounded
16for dispensing to individual patients only if all of the
17following conditions are met: (i) the commercial product is not
18reasonably available from normal distribution channels in a
19timely manner to meet the patient's needs and (ii) the
20prescribing practitioner has requested that the drug be
21compounded.
22    (p) (Blank).
23    (q) (Blank).
24    (r) "Patient counseling" means the communication between a
25pharmacist or a student pharmacist under the supervision of a
26pharmacist and a patient or the patient's representative about

 

 

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1the patient's medication or device for the purpose of
2optimizing proper use of prescription medications or devices.
3"Patient counseling" may include without limitation (1)
4obtaining a medication history; (2) acquiring a patient's
5allergies and health conditions; (3) facilitation of the
6patient's understanding of the intended use of the medication;
7(4) proper directions for use; (5) significant potential
8adverse events; (6) potential food-drug interactions; and (7)
9the need to be compliant with the medication therapy. A
10pharmacy technician may only participate in the following
11aspects of patient counseling under the supervision of a
12pharmacist: (1) obtaining medication history; (2) providing
13the offer for counseling by a pharmacist or student pharmacist;
14and (3) acquiring a patient's allergies and health conditions.
15    (s) "Patient profiles" or "patient drug therapy record"
16means the obtaining, recording, and maintenance of patient
17prescription information, including prescriptions for
18controlled substances, and personal information.
19    (t) (Blank).
20    (u) "Medical device" means an instrument, apparatus,
21implement, machine, contrivance, implant, in vitro reagent, or
22other similar or related article, including any component part
23or accessory, required under federal law to bear the label
24"Caution: Federal law requires dispensing by or on the order of
25a physician". A seller of goods and services who, only for the
26purpose of retail sales, compounds, sells, rents, or leases

 

 

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1medical devices shall not, by reasons thereof, be required to
2be a licensed pharmacy.
3    (v) "Unique identifier" means an electronic signature,
4handwritten signature or initials, thumb print, or other
5acceptable biometric or electronic identification process as
6approved by the Department.
7    (w) "Current usual and customary retail price" means the
8price that a pharmacy charges to a non-third-party payor.
9    (x) "Automated pharmacy system" means a mechanical system
10located within the confines of the pharmacy or remote location
11that performs operations or activities, other than compounding
12or administration, relative to storage, packaging, dispensing,
13or distribution of medication, and which collects, controls,
14and maintains all transaction information.
15    (y) "Drug regimen review" means and includes the evaluation
16of prescription drug orders and patient records for (1) known
17allergies; (2) drug or potential therapy contraindications;
18(3) reasonable dose, duration of use, and route of
19administration, taking into consideration factors such as age,
20gender, and contraindications; (4) reasonable directions for
21use; (5) potential or actual adverse drug reactions; (6)
22drug-drug interactions; (7) drug-food interactions; (8)
23drug-disease contraindications; (9) therapeutic duplication;
24(10) patient laboratory values when authorized and available;
25(11) proper utilization (including over or under utilization)
26and optimum therapeutic outcomes; and (12) abuse and misuse.

 

 

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1    (z) "Electronic transmission prescription" means any
2prescription order for which a facsimile or electronic image of
3the order is electronically transmitted from a licensed
4prescriber to a pharmacy. "Electronic transmission
5prescription" includes both data and image prescriptions.
6    (aa) "Medication therapy management services" means a
7distinct service or group of services offered by licensed
8pharmacists, physicians licensed to practice medicine in all
9its branches, advanced practice nurses authorized in a written
10agreement with a physician licensed to practice medicine in all
11its branches, or physician assistants authorized in guidelines
12by a supervising physician that optimize therapeutic outcomes
13for individual patients through improved medication use. In a
14retail or other non-hospital pharmacy, medication therapy
15management services shall consist of the evaluation of
16prescription drug orders and patient medication records to
17resolve conflicts with the following:
18        (1) known allergies;
19        (2) drug or potential therapy contraindications;
20        (3) reasonable dose, duration of use, and route of
21    administration, taking into consideration factors such as
22    age, gender, and contraindications;
23        (4) reasonable directions for use;
24        (5) potential or actual adverse drug reactions;
25        (6) drug-drug interactions;
26        (7) drug-food interactions;

 

 

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1        (8) drug-disease contraindications;
2        (9) identification of therapeutic duplication;
3        (10) patient laboratory values when authorized and
4    available;
5        (11) proper utilization (including over or under
6    utilization) and optimum therapeutic outcomes; and
7        (12) drug abuse and misuse.
8    "Medication therapy management services" includes the
9following:
10        (1) documenting the services delivered and
11    communicating the information provided to patients'
12    prescribers within an appropriate time frame, not to exceed
13    48 hours;
14        (2) providing patient counseling designed to enhance a
15    patient's understanding and the appropriate use of his or
16    her medications; and
17        (3) providing information, support services, and
18    resources designed to enhance a patient's adherence with
19    his or her prescribed therapeutic regimens.
20    "Medication therapy management services" may also include
21patient care functions authorized by a physician licensed to
22practice medicine in all its branches for his or her identified
23patient or groups of patients under specified conditions or
24limitations in a standing order from the physician.
25    "Medication therapy management services" in a licensed
26hospital may also include the following:

 

 

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1        (1) reviewing assessments of the patient's health
2    status; and
3        (2) following protocols of a hospital pharmacy and
4    therapeutics committee with respect to the fulfillment of
5    medication orders.
6    (bb) "Pharmacist care" means the provision by a pharmacist
7of medication therapy management services, with or without the
8dispensing of drugs or devices, intended to achieve outcomes
9that improve patient health, quality of life, and comfort and
10enhance patient safety.
11    (cc) "Protected health information" means individually
12identifiable health information that, except as otherwise
13provided, is:
14        (1) transmitted by electronic media;
15        (2) maintained in any medium set forth in the
16    definition of "electronic media" in the federal Health
17    Insurance Portability and Accountability Act; or
18        (3) transmitted or maintained in any other form or
19    medium.
20    "Protected health information" does not include
21individually identifiable health information found in:
22        (1) education records covered by the federal Family
23    Educational Right and Privacy Act; or
24        (2) employment records held by a licensee in its role
25    as an employer.
26    (dd) "Standing order" means a specific order for a patient

 

 

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1or group of patients issued by a physician licensed to practice
2medicine in all its branches in Illinois.
3    (ee) "Address of record" means the address recorded by the
4Department in the applicant's or licensee's application file or
5license file, as maintained by the Department's licensure
6maintenance unit.
7    (ff) "Home pharmacy" means the location of a pharmacy's
8primary operations.
9(Source: P.A. 98-104, eff. 7-22-13; 98-214, eff. 8-9-13;
1098-756, eff. 7-16-14; 99-180, eff. 7-29-15.)".