96TH GENERAL ASSEMBLY
State of Illinois
2009 and 2010
SB3270

 

Introduced 2/9/2010, by Sen. Donne E. Trotter

 

SYNOPSIS AS INTRODUCED:
 
225 ILCS 85/3

    Amends the Pharmacy Practice Act. Makes a technical change in a Section concerning definitions.


LRB096 16561 ASK 31834 b

 

 

A BILL FOR

 

SB3270 LRB096 16561 ASK 31834 b

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 changing
5 Section 3 as follows:
 
6     (225 ILCS 85/3)
7     (Text of Section before amendment by P.A. 96-339)
8     (Section scheduled to be repealed on January 1, 2018)
9     Sec. 3. Definitions. For the the purpose of this Act,
10 except where otherwise limited therein:
11     (a) "Pharmacy" or "drugstore" means and includes every
12 store, shop, pharmacy department, or other place where
13 pharmacist care is provided by a pharmacist (1) where drugs,
14 medicines, or poisons are dispensed, sold or offered for sale
15 at retail, or displayed for sale at retail; or (2) where
16 prescriptions of physicians, dentists, advanced practice
17 nurses, physician assistants, veterinarians, podiatrists, or
18 optometrists, within the limits of their licenses, are
19 compounded, filled, or dispensed; or (3) which has upon it or
20 displayed within it, or affixed to or used in connection with
21 it, a sign bearing the word or words "Pharmacist", "Druggist",
22 "Pharmacy", "Pharmaceutical Care", "Apothecary", "Drugstore",
23 "Medicine Store", "Prescriptions", "Drugs", "Dispensary",

 

 

SB3270 - 2 - LRB096 16561 ASK 31834 b

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

 

 

SB3270 - 3 - LRB096 16561 ASK 31834 b

1 Drug Administration.
2     (d) "Practice of pharmacy" means (1) the interpretation and
3 the provision of assistance in the monitoring, evaluation, and
4 implementation of prescription drug orders; (2) the dispensing
5 of prescription drug orders; (3) participation in drug and
6 device selection; (4) drug administration limited to the
7 administration of oral, topical, injectable, and inhalation as
8 follows: in the context of patient education on the proper use
9 or delivery of medications; vaccination of patients 14 years of
10 age and older pursuant to a valid prescription or standing
11 order, by a physician licensed to practice medicine in all its
12 branches, upon completion of appropriate training, including
13 how to address contraindications and adverse reactions set
14 forth by rule, with notification to the patient's physician and
15 appropriate record retention, or pursuant to hospital pharmacy
16 and therapeutics committee policies and procedures; (5) drug
17 regimen review; (6) drug or drug-related research; (7) the
18 provision of patient counseling; (8) the practice of
19 telepharmacy; (9) the provision of those acts or services
20 necessary to provide pharmacist care; (10) medication therapy
21 management; and (11) the responsibility for compounding and
22 labeling of drugs and devices (except labeling by a
23 manufacturer, repackager, or distributor of non-prescription
24 drugs and commercially packaged legend drugs and devices),
25 proper and safe storage of drugs and devices, and maintenance
26 of required records. A pharmacist who performs any of the acts

 

 

SB3270 - 4 - LRB096 16561 ASK 31834 b

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

 

 

SB3270 - 5 - LRB096 16561 ASK 31834 b

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

 

 

SB3270 - 6 - LRB096 16561 ASK 31834 b

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

 

 

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

 

 

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

 

 

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

 

 

SB3270 - 10 - LRB096 16561 ASK 31834 b

1 prescription drug orders and patient medication records to
2 resolve conflicts with the following:
3         (1) known allergies;
4         (2) drug or potential therapy contraindications;
5         (3) reasonable dose, duration of use, and route of
6     administration, taking into consideration factors such as
7     age, gender, and contraindications;
8         (4) reasonable directions for use;
9         (5) potential or actual adverse drug reactions;
10         (6) drug-drug interactions;
11         (7) drug-food interactions;
12         (8) drug-disease contraindications;
13         (9) identification of therapeutic duplication;
14         (10) patient laboratory values when authorized and
15     available;
16         (11) proper utilization (including over or under
17     utilization) and optimum therapeutic outcomes; and
18         (12) drug abuse and misuse.
19 "Medication therapy management services" includes the
20 following:
21         (1) documenting the services delivered and
22     communicating the information provided to patients'
23     prescribers within an appropriate time frame, not to exceed
24     48 hours;
25         (2) providing patient counseling designed to enhance a
26     patient's understanding and the appropriate use of his or

 

 

SB3270 - 11 - LRB096 16561 ASK 31834 b

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

 

 

SB3270 - 12 - LRB096 16561 ASK 31834 b

1     definition of "electronic media" in the federal Health
2     Insurance Portability and Accountability Act; or
3         (3) transmitted or maintained in any other form or
4     medium.
5 "Protected health information" does not include individually
6 identifiable health information found in:
7         (1) education records covered by the federal Family
8     Educational Right and Privacy Act; or
9         (2) employment records held by a licensee in its role
10     as an employer.
11     (dd) "Standing order" means a specific order for a patient
12 or group of patients issued by a physician licensed to practice
13 medicine in all its branches in Illinois.
14     (ee) "Address of record" means the address recorded by the
15 Department in the applicant's or licensee's application file or
16 license file, as maintained by the Department's licensure
17 maintenance unit.
18     (ff) "Home pharmacy" means the location of a pharmacy's
19 primary operations.
20 (Source: P.A. 95-689, eff. 10-29-07; 96-673, eff. 1-1-10.)
 
21     (Text of Section after amendment by P.A. 96-339)
22     (Section scheduled to be repealed on January 1, 2018)
23     Sec. 3. Definitions. For the the purpose of this Act,
24 except where otherwise limited therein:
25     (a) "Pharmacy" or "drugstore" means and includes every

 

 

SB3270 - 13 - LRB096 16561 ASK 31834 b

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

 

 

SB3270 - 14 - LRB096 16561 ASK 31834 b

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

 

 

SB3270 - 15 - LRB096 16561 ASK 31834 b

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

 

 

SB3270 - 16 - LRB096 16561 ASK 31834 b

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

 

 

SB3270 - 17 - LRB096 16561 ASK 31834 b

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 responsible
6 for all aspects of the operation related to the practice of
7 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 located
23 in a state, commonwealth, or territory of the United States,
24 other than Illinois, that delivers, dispenses, or distributes,
25 through the United States Postal Service, commercially
26 acceptable parcel delivery service, or other common carrier, to

 

 

SB3270 - 18 - LRB096 16561 ASK 31834 b

1 Illinois residents, any substance which requires a
2 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 the
6 prescriber-patient-pharmacist relationship in the course of
7 professional practice or (2) for the purpose of, or incident
8 to, research, teaching, or chemical analysis and not for sale
9 or dispensing. "Compounding" includes the preparation of drugs
10 or devices in anticipation of receiving prescription drug
11 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 not
15 reasonably available from normal distribution channels in a
16 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)

 

 

SB3270 - 19 - LRB096 16561 ASK 31834 b

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 pharmacist;
11 and (3) acquiring a patient's allergies and health conditions.
12     (s) "Patient profiles" or "patient drug therapy record"
13 means the obtaining, recording, and maintenance of patient
14 prescription information, including prescriptions for
15 controlled substances, and personal information.
16     (t) (Blank).
17     (u) "Medical device" means an instrument, apparatus,
18 implement, machine, contrivance, implant, in vitro reagent, or
19 other similar or related article, including any component part
20 or accessory, required under federal law to bear the label
21 "Caution: Federal law requires dispensing by or on the order of
22 a physician". A seller of goods and services who, only for the
23 purpose of retail sales, compounds, sells, rents, or leases
24 medical devices shall not, by reasons thereof, be required to
25 be a licensed pharmacy.
26     (v) "Unique identifier" means an electronic signature,

 

 

SB3270 - 20 - LRB096 16561 ASK 31834 b

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

 

 

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

 

 

SB3270 - 22 - LRB096 16561 ASK 31834 b

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

 

 

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

 

 

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1 Department in the applicant's or licensee's application file or
2 license file, as maintained by the Department's licensure
3 maintenance unit.
4     (ff) "Home pharmacy" means the location of a pharmacy's
5 primary operations.
6 (Source: P.A. 95-689, eff. 10-29-07; 96-339, eff. 7-1-10;
7 96-673, eff. 1-1-10; revised 10-1-09.)