97TH GENERAL ASSEMBLY
State of Illinois
2011 and 2012
SB3513

 

Introduced 2/8/2012, by Sen. Iris Y. Martinez

 

SYNOPSIS AS INTRODUCED:
 
225 ILCS 85/3

    Amends the Pharmacy Practice Act. Changes the definition of "practice of pharmacy" to permit a pharmacist to vaccinate a patient 7 years (instead of 14 years) of age and older pursuant to a valid prescription or standing order. Effective immediately.


LRB097 17615 CEL 62822 b

 

 

A BILL FOR

 

SB3513LRB097 17615 CEL 62822 b

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7    (Section scheduled to be repealed on January 1, 2018)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, podiatrists, or
17optometrists, within the limits of their licenses, are
18compounded, filled, or dispensed; or (3) which has upon it or
19displayed within it, or affixed to or used in connection with
20it, a sign bearing the word or words "Pharmacist", "Druggist",
21"Pharmacy", "Pharmaceutical Care", "Apothecary", "Drugstore",
22"Medicine Store", "Prescriptions", "Drugs", "Dispensary",
23"Medicines", or any word or words of similar or like import,

 

 

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1either in the English language or any other language; or (4)
2where the characteristic prescription sign (Rx) or similar
3design is exhibited; or (5) any store, or shop, or other place
4with respect to which any of the above words, objects, signs or
5designs 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 as
7follows: in the context of patient education on the proper use
8or delivery of medications; vaccination of patients 7 14 years
9of age and older pursuant to a valid prescription or standing
10order, by a physician licensed to practice medicine in all its
11branches, upon completion of appropriate training, including
12how to address contraindications and adverse reactions set
13forth by rule, with notification to the patient's physician and
14appropriate record retention, or pursuant to hospital pharmacy
15and therapeutics committee policies and procedures; (5) drug
16regimen review; (6) drug or drug-related research; (7) the
17provision of patient counseling; (8) the practice of
18telepharmacy; (9) the provision of those acts or services
19necessary to provide pharmacist care; (10) medication therapy
20management; and (11) the responsibility for compounding and
21labeling of drugs and devices (except labeling by a
22manufacturer, repackager, or distributor of non-prescription
23drugs and commercially packaged legend drugs and devices),
24proper and safe storage of drugs and devices, and maintenance
25of required records. A pharmacist who performs any of the acts
26defined as the practice of pharmacy in this State must be

 

 

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1actively licensed as a pharmacist under this Act.
2    (e) "Prescription" means and includes any written, oral,
3facsimile, or electronically transmitted order for drugs or
4medical devices, issued by a physician licensed to practice
5medicine in all its branches, dentist, veterinarian, or
6podiatrist, or optometrist, within the limits of their
7licenses, by a physician assistant in accordance with
8subsection (f) of Section 4, or by an advanced practice nurse
9in accordance with subsection (g) of Section 4, containing the
10following: (l) name of the patient; (2) date when prescription
11was issued; (3) name and strength of drug or description of the
12medical device prescribed; and (4) quantity; (5) directions for
13use; (6) prescriber's name, address, and signature; and (7) DEA
14number where required, for controlled substances. The
15prescription may, but is not required to, list the illness,
16disease, or condition for which the drug or device is being
17prescribed. DEA numbers shall not be required on inpatient drug
18orders.
19    (f) "Person" means and includes a natural person,
20copartnership, association, corporation, government entity, or
21any other legal entity.
22    (g) "Department" means the Department of Financial and
23Professional Regulation.
24    (h) "Board of Pharmacy" or "Board" means the State Board of
25Pharmacy of the Department of Financial and Professional
26Regulation.

 

 

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1    (i) "Secretary" means the Secretary of Financial and
2Professional Regulation.
3    (j) "Drug product selection" means the interchange for a
4prescribed pharmaceutical product in accordance with Section
525 of this Act and Section 3.14 of the Illinois Food, Drug and
6Cosmetic Act.
7    (k) "Inpatient drug order" means an order issued by an
8authorized prescriber for a resident or patient of a facility
9licensed under the Nursing Home Care Act, the ID/DD Community
10Care Act, the Specialized Mental Health Rehabilitation Act, or
11the Hospital Licensing Act, or "An Act in relation to the
12founding and operation of the University of Illinois Hospital
13and the conduct of University of Illinois health care
14programs", approved July 3, 1931, as amended, or a facility
15which is operated by the Department of Human Services (as
16successor to the Department of Mental Health and Developmental
17Disabilities) or the Department of Corrections.
18    (k-5) "Pharmacist" means an individual health care
19professional and provider currently licensed by this State to
20engage in the practice of pharmacy.
21    (l) "Pharmacist in charge" means the licensed pharmacist
22whose name appears on a pharmacy license and who is responsible
23for all aspects of the operation related to the practice of
24pharmacy.
25    (m) "Dispense" or "dispensing" means the interpretation,
26evaluation, and implementation of a prescription drug order,

 

 

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1including the preparation and delivery of a drug or device to a
2patient or patient's agent in a suitable container
3appropriately labeled for subsequent administration to or use
4by a patient in accordance with applicable State and federal
5laws and regulations. "Dispense" or "dispensing" does not mean
6the physical delivery to a patient or a patient's
7representative in a home or institution by a designee of a
8pharmacist or by common carrier. "Dispense" or "dispensing"
9also does not mean the physical delivery of a drug or medical
10device to a patient or patient's representative by a
11pharmacist's designee within a pharmacy or drugstore while the
12pharmacist is on duty and the pharmacy is open.
13    (n) "Nonresident pharmacy" means a pharmacy that is located
14in a state, commonwealth, or territory of the United States,
15other than Illinois, that delivers, dispenses, or distributes,
16through the United States Postal Service, commercially
17acceptable parcel delivery service, or other common carrier, to
18Illinois residents, any substance which requires a
19prescription.
20    (o) "Compounding" means the preparation and mixing of
21components, excluding flavorings, (1) as the result of a
22prescriber's prescription drug order or initiative based on the
23prescriber-patient-pharmacist relationship in the course of
24professional practice or (2) for the purpose of, or incident
25to, research, teaching, or chemical analysis and not for sale
26or dispensing. "Compounding" includes the preparation of drugs

 

 

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1or devices in anticipation of receiving prescription drug
2orders based on routine, regularly observed dispensing
3patterns. Commercially available products may be compounded
4for dispensing to individual patients only if all of the
5following conditions are met: (i) the commercial product is not
6reasonably available from normal distribution channels in a
7timely manner to meet the patient's needs and (ii) the
8prescribing practitioner has requested that the drug be
9compounded.
10    (p) (Blank).
11    (q) (Blank).
12    (r) "Patient counseling" means the communication between a
13pharmacist or a student pharmacist under the supervision of a
14pharmacist and a patient or the patient's representative about
15the patient's medication or device for the purpose of
16optimizing proper use of prescription medications or devices.
17"Patient counseling" may include without limitation (1)
18obtaining a medication history; (2) acquiring a patient's
19allergies and health conditions; (3) facilitation of the
20patient's understanding of the intended use of the medication;
21(4) proper directions for use; (5) significant potential
22adverse events; (6) potential food-drug interactions; and (7)
23the need to be compliant with the medication therapy. A
24pharmacy technician may only participate in the following
25aspects of patient counseling under the supervision of a
26pharmacist: (1) obtaining medication history; (2) providing

 

 

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1the offer for counseling by a pharmacist or student pharmacist;
2and (3) acquiring a patient's allergies and health conditions.
3    (s) "Patient profiles" or "patient drug therapy record"
4means the obtaining, recording, and maintenance of patient
5prescription information, including prescriptions for
6controlled substances, and personal information.
7    (t) (Blank).
8    (u) "Medical device" means an instrument, apparatus,
9implement, machine, contrivance, implant, in vitro reagent, or
10other similar or related article, including any component part
11or accessory, required under federal law to bear the label
12"Caution: Federal law requires dispensing by or on the order of
13a physician". A seller of goods and services who, only for the
14purpose of retail sales, compounds, sells, rents, or leases
15medical devices shall not, by reasons thereof, be required to
16be a licensed pharmacy.
17    (v) "Unique identifier" means an electronic signature,
18handwritten signature or initials, thumb print, or other
19acceptable biometric or electronic identification process as
20approved by the Department.
21    (w) "Current usual and customary retail price" means the
22price that a pharmacy charges to a non-third-party payor.
23    (x) "Automated pharmacy system" means a mechanical system
24located within the confines of the pharmacy or remote location
25that performs operations or activities, other than compounding
26or administration, relative to storage, packaging, dispensing,

 

 

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1or distribution of medication, and which collects, controls,
2and maintains all transaction information.
3    (y) "Drug regimen review" means and includes the evaluation
4of prescription drug orders and patient records for (1) known
5allergies; (2) drug or potential therapy contraindications;
6(3) reasonable dose, duration of use, and route of
7administration, taking into consideration factors such as age,
8gender, and contraindications; (4) reasonable directions for
9use; (5) potential or actual adverse drug reactions; (6)
10drug-drug interactions; (7) drug-food interactions; (8)
11drug-disease contraindications; (9) therapeutic duplication;
12(10) patient laboratory values when authorized and available;
13(11) proper utilization (including over or under utilization)
14and optimum therapeutic outcomes; and (12) abuse and misuse.
15    (z) "Electronic transmission prescription" means any
16prescription order for which a facsimile or electronic image of
17the order is electronically transmitted from a licensed
18prescriber to a pharmacy. "Electronic transmission
19prescription" includes both data and image prescriptions.
20    (aa) "Medication therapy management services" means a
21distinct service or group of services offered by licensed
22pharmacists, physicians licensed to practice medicine in all
23its branches, advanced practice nurses authorized in a written
24agreement with a physician licensed to practice medicine in all
25its branches, or physician assistants authorized in guidelines
26by a supervising physician that optimize therapeutic outcomes

 

 

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1for individual patients through improved medication use. In a
2retail or other non-hospital pharmacy, medication therapy
3management services shall consist of the evaluation of
4prescription drug orders and patient medication records to
5resolve conflicts with the following:
6        (1) known allergies;
7        (2) drug or potential therapy contraindications;
8        (3) reasonable dose, duration of use, and route of
9    administration, taking into consideration factors such as
10    age, gender, and contraindications;
11        (4) reasonable directions for use;
12        (5) potential or actual adverse drug reactions;
13        (6) drug-drug interactions;
14        (7) drug-food interactions;
15        (8) drug-disease contraindications;
16        (9) identification of therapeutic duplication;
17        (10) patient laboratory values when authorized and
18    available;
19        (11) proper utilization (including over or under
20    utilization) and optimum therapeutic outcomes; and
21        (12) drug abuse and misuse.
22"Medication therapy management services" includes the
23following:
24        (1) documenting the services delivered and
25    communicating the information provided to patients'
26    prescribers within an appropriate time frame, not to exceed

 

 

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1    48 hours;
2        (2) providing patient counseling designed to enhance a
3    patient's understanding and the appropriate use of his or
4    her medications; and
5        (3) providing information, support services, and
6    resources designed to enhance a patient's adherence with
7    his or her prescribed therapeutic regimens.
8"Medication therapy management services" may also include
9patient care functions authorized by a physician licensed to
10practice medicine in all its branches for his or her identified
11patient or groups of patients under specified conditions or
12limitations in a standing order from the physician.
13"Medication therapy management services" in a licensed
14hospital may also include the following:
15        (1) reviewing assessments of the patient's health
16    status; and
17        (2) following protocols of a hospital pharmacy and
18    therapeutics committee with respect to the fulfillment of
19    medication orders.
20    (bb) "Pharmacist care" means the provision by a pharmacist
21of medication therapy management services, with or without the
22dispensing of drugs or devices, intended to achieve outcomes
23that improve patient health, quality of life, and comfort and
24enhance patient safety.
25    (cc) "Protected health information" means individually
26identifiable health information that, except as otherwise

 

 

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1provided, is:
2        (1) transmitted by electronic media;
3        (2) maintained in any medium set forth in the
4    definition of "electronic media" in the federal Health
5    Insurance Portability and Accountability Act; or
6        (3) transmitted or maintained in any other form or
7    medium.
8"Protected health information" does not include individually
9identifiable health information found in:
10        (1) education records covered by the federal Family
11    Educational Right and Privacy Act; or
12        (2) employment records held by a licensee in its role
13    as an employer.
14    (dd) "Standing order" means a specific order for a patient
15or group of patients issued by a physician licensed to practice
16medicine in all its branches in Illinois.
17    (ee) "Address of record" means the address recorded by the
18Department in the applicant's or licensee's application file or
19license file, as maintained by the Department's licensure
20maintenance unit.
21    (ff) "Home pharmacy" means the location of a pharmacy's
22primary operations.
23(Source: P.A. 96-339, eff. 7-1-10; 96-673, eff. 1-1-10;
2496-1000, eff. 7-2-10; 96-1353, eff. 7-28-10; 97-38, eff.
256-28-11; 97-227, eff. 1-1-12; revised 10-4-11.)
 
26    Section 99. Effective date. This Act takes effect upon

 

 

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1becoming law.