HB3627 99TH GENERAL ASSEMBLY

  
  

 


 
99TH GENERAL ASSEMBLY
State of Illinois
2015 and 2016
HB3627

 

Introduced , by Rep. Marcus C. Evans, Jr.

 

SYNOPSIS AS INTRODUCED:
 
225 ILCS 85/3

    Amends the Pharmacy Practice Act. Makes changes to the definition of "practice of pharmacy", including (ii) allowing for the vaccination of patients ages 10 through 13 pursuant to a valid prescription or standing order (was, limited to Influenza (inactivated influenza vaccine and live attenuated influenza intranasal vaccine) and Tdap (defined as tetanus, diphtheria, acellular pertussis) vaccines). Effective January 1, 2016.


LRB099 09519 AMC 29727 b

 

 

A BILL FOR

 

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1    AN ACT concerning regulation.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 5. The Pharmacy Practice Act is amended by changing
5Section 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7    (Section scheduled to be repealed on January 1, 2018)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
17physicians, or optometrists, within the limits of their
18licenses, are compounded, filled, or dispensed; or (3) which
19has upon it or displayed within it, or affixed to or used in
20connection 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

 

 

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1similar or like import, either in the English language or any
2other language; or (4) where the characteristic prescription
3sign (Rx) or similar design is exhibited; or (5) any store, or
4shop, or other place with respect to which any of the above
5words, objects, signs or designs are used in any advertisement.
6    (b) "Drugs" means and includes (l) articles recognized in
7the official United States Pharmacopoeia/National Formulary
8(USP/NF), or any supplement thereto and being intended for and
9having for their main use the diagnosis, cure, mitigation,
10treatment or prevention of disease in man or other animals, as
11approved by the United States Food and Drug Administration, but
12does not include devices or their components, parts, or
13accessories; and (2) all other articles intended for and having
14for their main use the diagnosis, cure, mitigation, treatment
15or prevention of disease in man or other animals, as approved
16by the United States Food and Drug Administration, but does not
17include devices or their components, parts, or accessories; and
18(3) articles (other than food) having for their main use and
19intended to affect the structure or any function of the body of
20man or other animals; and (4) articles having for their main
21use and intended for use as a component or any articles
22specified in clause (l), (2) or (3); but does not include
23devices or their components, parts or accessories.
24    (c) "Medicines" means and includes all drugs intended for
25human or veterinary use approved by the United States Food and
26Drug Administration.

 

 

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1    (d) "Practice of pharmacy" means (1) the interpretation and
2the provision of assistance in the monitoring, evaluation, and
3implementation of prescription drug orders; (2) the dispensing
4of prescription drug orders; (3) participation in drug and
5device selection; (4) drug administration limited to the
6administration of oral, topical, injectable, and inhalation,
7and as follows: in the context of patient education on the
8proper use or delivery of medications; vaccination of patients
910 14 years of age and older pursuant to a valid prescription
10or standing order, by a physician licensed to practice medicine
11in all its branches, upon completion of appropriate training,
12including how to address contraindications and adverse
13reactions set forth by rule, with notification to the patient's
14physician and appropriate record retention, or pursuant to
15hospital pharmacy and therapeutics committee policies and
16procedures; (5) vaccination of patients ages 10 through 13
17limited to the Influenza (inactivated influenza vaccine and
18live attenuated influenza intranasal vaccine) and Tdap
19(defined as tetanus, diphtheria, acellular pertussis)
20vaccines, pursuant to a valid prescription or standing order,
21by a physician licensed to practice medicine in all its
22branches, upon completion of appropriate training, including
23how to address contraindications and adverse reactions set
24forth by rule, with notification to the patient's physician and
25appropriate record retention, or pursuant to hospital pharmacy
26and therapeutics committee policies and procedures; (6) drug

 

 

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1regimen review; (6) (7) drug or drug-related research; (7) (8)
2the provision of patient counseling; (8) (9) the practice of
3telepharmacy; (9) (10) the provision of those acts or services
4necessary to provide pharmacist care; (10) (11) medication
5therapy management; and (11) (12) the responsibility for
6compounding and labeling of drugs and devices (except labeling
7by a manufacturer, repackager, or distributor of
8non-prescription drugs and commercially packaged legend drugs
9and devices), proper and safe storage of drugs and devices, and
10maintenance of required records. A pharmacist who performs any
11of the acts defined as the practice of pharmacy in this State
12must be actively licensed as a pharmacist under this Act.
13    (e) "Prescription" means and includes any written, oral,
14facsimile, or electronically transmitted order for drugs or
15medical devices, issued by a physician licensed to practice
16medicine in all its branches, dentist, veterinarian, podiatric
17physician, or optometrist, within the limits of their licenses,
18by a physician assistant in accordance with subsection (f) of
19Section 4, or by an advanced practice nurse in accordance with
20subsection (g) of Section 4, containing the following: (l) name
21of the patient; (2) date when prescription was issued; (3) name
22and strength of drug or description of the medical device
23prescribed; and (4) quantity; (5) directions for use; (6)
24prescriber's name, address, and signature; and (7) DEA number
25where required, for controlled substances. The prescription
26may, but is not required to, list the illness, disease, or

 

 

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1condition for which the drug or device is being prescribed. DEA
2numbers shall not be required on inpatient drug orders.
3    (f) "Person" means and includes a natural person,
4copartnership, association, corporation, government entity, or
5any other legal entity.
6    (g) "Department" means the Department of Financial and
7Professional Regulation.
8    (h) "Board of Pharmacy" or "Board" means the State Board of
9Pharmacy of the Department of Financial and Professional
10Regulation.
11    (i) "Secretary" means the Secretary of Financial and
12Professional Regulation.
13    (j) "Drug product selection" means the interchange for a
14prescribed pharmaceutical product in accordance with Section
1525 of this Act and Section 3.14 of the Illinois Food, Drug and
16Cosmetic Act.
17    (k) "Inpatient drug order" means an order issued by an
18authorized prescriber for a resident or patient of a facility
19licensed under the Nursing Home Care Act, the ID/DD Community
20Care Act, the Specialized Mental Health Rehabilitation Act of
212013, or the Hospital Licensing Act, or "An Act in relation to
22the founding and operation of the University of Illinois
23Hospital and the conduct of University of Illinois health care
24programs", approved July 3, 1931, as amended, or a facility
25which is operated by the Department of Human Services (as
26successor to the Department of Mental Health and Developmental

 

 

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

 

 

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

 

 

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

 

 

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1    (v) "Unique identifier" means an electronic signature,
2handwritten signature or initials, thumb print, or other
3acceptable biometric or electronic identification process as
4approved by the Department.
5    (w) "Current usual and customary retail price" means the
6price that a pharmacy charges to a non-third-party payor.
7    (x) "Automated pharmacy system" means a mechanical system
8located within the confines of the pharmacy or remote location
9that performs operations or activities, other than compounding
10or administration, relative to storage, packaging, dispensing,
11or distribution of medication, and which collects, controls,
12and maintains all transaction information.
13    (y) "Drug regimen review" means and includes the evaluation
14of prescription drug orders and patient records for (1) known
15allergies; (2) drug or potential therapy contraindications;
16(3) reasonable dose, duration of use, and route of
17administration, taking into consideration factors such as age,
18gender, and contraindications; (4) reasonable directions for
19use; (5) potential or actual adverse drug reactions; (6)
20drug-drug interactions; (7) drug-food interactions; (8)
21drug-disease contraindications; (9) therapeutic duplication;
22(10) patient laboratory values when authorized and available;
23(11) proper utilization (including over or under utilization)
24and optimum therapeutic outcomes; and (12) abuse and misuse.
25    (z) "Electronic transmission prescription" means any
26prescription order for which a facsimile or electronic image of

 

 

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

 

 

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

 

 

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

 

 

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1    (ee) "Address of record" means the address recorded by the
2Department in the applicant's or licensee's application file or
3license file, as maintained by the Department's licensure
4maintenance unit.
5    (ff) "Home pharmacy" means the location of a pharmacy's
6primary operations.
7(Source: P.A. 97-38, eff. 6-28-11; 97-227, eff. 1-1-12; 97-813,
8eff. 7-13-12; 97-1043, eff. 8-21-12; 98-104, eff. 7-22-13;
998-214, eff. 8-9-13; 98-756, eff. 7-16-14.)
 
10    Section 99. Effective date. This Act takes effect January
111, 2016.