97TH GENERAL ASSEMBLY
State of Illinois
2011 and 2012
HB2028

 

Introduced , by Rep. Dan Reitz

 

SYNOPSIS AS INTRODUCED:
 
225 ILCS 85/3
225 ILCS 85/5.7
225 ILCS 85/9.8 new
225 ILCS 85/23  from Ch. 111, par. 4143

    Amends the Pharmacy Practice Act. Defines "pharmacist clinician", "prescriptive authority" and "appropriately trained". Provides that a pharmacist clinician shall have on file at his or her place of practice written guidelines and protocols authorizing prescriptive authority. Provides that the guidelines and protocols authorizing prescriptive authority shall include a statement (i) identifying the practitioner authorized to prescribe and the pharmacist clinician who is a party to the guidelines or protocol, (ii) of the types of decisions a pharmacist clinician is authorize to make, (iii) of the activities the pharmacist clinician is to follow in the course of exercising prescriptive authority, and (iv) that describes appropriate mechanisms for reporting to the practitioner monitoring activities and results. Provides that claims of professional superiority in filling prescriptions or in any manner implying professional superiority that may reduce the public confidence in the ability, character, or integrity of other pharmacies or pharmacists are unlawful. Provides restrictions in advertising. Makes other changes. Effective immediately.


LRB097 06516 CEL 46600 b

 

 

A BILL FOR

 

HB2028LRB097 06516 CEL 46600 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
5Sections 3, 5.7, and 23 and by adding Sections 9.8 and 26.5 as
6follows:
 
7    (225 ILCS 85/3)
8    (Section scheduled to be repealed on January 1, 2018)
9    Sec. 3. Definitions. For the purpose of this Act, except
10where otherwise limited therein:
11    (a) "Pharmacy" or "drugstore" means and includes every
12store, shop, pharmacy department, or other place where
13pharmacist care is provided by a pharmacist (1) where drugs,
14medicines, or poisons are dispensed, sold or offered for sale
15at retail, or displayed for sale at retail; or (2) where
16prescriptions of physicians, dentists, advanced practice
17nurses, physician assistants, veterinarians, podiatrists, or
18optometrists, within the limits of their licenses, are
19compounded, filled, or dispensed; or (3) which has upon it or
20displayed within it, or affixed to or used in connection with
21it, a sign bearing the word or words "Pharmacist", "Druggist",
22"Pharmacy", "Pharmaceutical Care", "Apothecary", "Drugstore",
23"Medicine Store", "Prescriptions", "Drugs", "Dispensary",

 

 

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

 

 

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

 

 

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

 

 

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1    (g) "Department" means the Department of Financial and
2Professional Regulation.
3    (h) "Board of Pharmacy" or "Board" means the State Board of
4Pharmacy of the Department of Financial and Professional
5Regulation.
6    (i) "Secretary" means the Secretary of Financial and
7Professional Regulation.
8    (j) "Drug product selection" means the interchange for a
9prescribed pharmaceutical product in accordance with Section
1025 of this Act and Section 3.14 of the Illinois Food, Drug and
11Cosmetic Act.
12    (k) "Inpatient drug order" means an order issued by an
13authorized prescriber for a resident or patient of a facility
14licensed under the Nursing Home Care Act, the MR/DD Community
15Care Act, or the Hospital Licensing Act, or "An Act in relation
16to the founding and operation of the University of Illinois
17Hospital and the conduct of University of Illinois health care
18programs", approved July 3, 1931, as amended, or a facility
19which is operated by the Department of Human Services (as
20successor to the Department of Mental Health and Developmental
21Disabilities) or the Department of Corrections.
22    (k-5) "Pharmacist" means an individual health care
23professional and provider currently licensed by this State to
24engage in the practice of pharmacy.
25    (l) "Pharmacist in charge" means the licensed pharmacist
26whose name appears on a pharmacy license and who is responsible

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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1following:
2        (1) documenting the services delivered and
3    communicating the information provided to patients'
4    prescribers within an appropriate time frame, not to exceed
5    48 hours;
6        (2) providing patient counseling designed to enhance a
7    patient's understanding and the appropriate use of his or
8    her medications; and
9        (3) providing information, support services, and
10    resources designed to enhance a patient's adherence with
11    his or her prescribed therapeutic regimens.
12"Medication therapy management services" may also include
13patient care functions authorized by a physician licensed to
14practice medicine in all its branches for his or her identified
15patient or groups of patients under specified conditions or
16limitations in a standing order from the physician.
17"Medication therapy management services" in a licensed
18hospital may also include the following:
19        (1) reviewing assessments of the patient's health
20    status; and
21        (2) following protocols of a hospital pharmacy and
22    therapeutics committee with respect to the fulfillment of
23    medication orders.
24    (bb) "Pharmacist care" means the provision by a pharmacist
25of medication therapy management services, with or without the
26dispensing of drugs or devices, intended to achieve outcomes

 

 

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1that improve patient health, quality of life, and comfort and
2enhance patient safety.
3    (cc) "Protected health information" means individually
4identifiable health information that, except as otherwise
5provided, is:
6        (1) transmitted by electronic media;
7        (2) maintained in any medium set forth in the
8    definition of "electronic media" in the federal Health
9    Insurance Portability and Accountability Act; or
10        (3) transmitted or maintained in any other form or
11    medium.
12"Protected health information" does not include individually
13identifiable health information found in:
14        (1) education records covered by the federal Family
15    Educational Right and Privacy Act; or
16        (2) employment records held by a licensee in its role
17    as an employer.
18    (dd) "Standing order" means a specific order for a patient
19or group of patients issued by a physician licensed to practice
20medicine in all its branches in Illinois.
21    (ee) "Address of record" means the address recorded by the
22Department in the applicant's or licensee's application file or
23license file, as maintained by the Department's licensure
24maintenance unit.
25    (ff) "Home pharmacy" means the location of a pharmacy's
26primary operations.

 

 

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1    (gg) "Pharmacist clinician" means a pharmacist who is
2recognized as a licensed health care provider with additional
3training who exercises prescriptive authority in accordance
4with authority granted under a properly executed standing order
5as set forth in this Act.
6    (hh) "Prescriptive authority" means the authority to
7initiate, manage, or modify a drug or drug therapies as
8specified in a standing order with a valid licensed prescriber.
9    (ii) "Appropriately trained" means the satisfactory
10completion of one of the following: (i) a course of study that
11covers fitting and patient management of therapeutic diabetic
12shoes and inserts that is approved by the National Commission
13of Orthotic and Prosthetic Education (N.C.O.P.E.), (ii) an
14appropriate manufacturer's training course consisting of
15fitting of therapeutic shoes with assessment to be completed to
16prove success, or (iii) a course of study that covers fitting
17and patient management of therapeutic diabetic shoes and
18inserts that are approved by a nationally recognized orthotic
19and prosthetic certification or accreditation organization
20that has its certification or accreditation programs
21recognized by the National Commission for Certifying Agencies.
22    (jj) "Therapeutic diabetic shoes and inserts" means any of
23the Healthcare Common Procedure Coding System (HCPCS) codes
24A5500, A5510, A5512, or A5513.
25(Source: P.A. 95-689, eff. 10-29-07; 96-339, eff. 7-1-10;
2696-673, eff. 1-1-10; 96-1000, eff. 7-2-10; 96-1353, eff.

 

 

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17-28-10.)
 
2    (225 ILCS 85/5.7)
3    (Section scheduled to be repealed on January 1, 2018)
4    Sec. 5.7. Advertising services.
5    (a) A licensee shall include in every advertisement for
6services regulated under this Act his or her title as it
7appears on the license or the initials authorized under this
8Act.
9    (b) The claiming of professional superiority in the filling
10of prescriptions or in any manner implying the professional
11superiority that may reduce the public confidence in the
12ability, character, or integrity of another pharmacy or
13pharmacist is unlawful. It shall be unlawful for a pharmacist
14or pharmacy to do any of the following:
15        (1) use testimonials or claims of superior quality of
16    product or care to entice the public;
17        (2) advertise in any way that misleads or presents
18    information that is intended to mislead the public;
19        (3) advertise or offer gifts as an inducement or offer
20    prescription medications without costs or without co-pays;
21    and
22        (4) offer or provide prescription pads with
23    promotional information such as directions to specific
24    pharmacies or disclose or direct patients by recommending
25    pricing information.

 

 

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1(Source: P.A. 91-310, eff. 1-1-00.)
 
2    (225 ILCS 85/9.8 new)
3    Sec. 9.8. Pharmacist clinician prescriptive authority.
4    (a) A pharmacist clinician planning to exercise
5prescriptive authority in his or her practice shall have on
6file at his or her place of practice written guidelines or
7protocol. The guidelines or protocol shall authorize a
8pharmacist clinician to exercise prescriptive authority and
9shall be established and approved by a practitioner in
10accordance with regulations adopted by the Board. The duly
11licensed practitioner who is a party to the standing order
12shall be in active practice and the prescriptive authority that
13he or she grants to a pharmacist clinician shall be within the
14scope of the practitioner's current practice.
15    (b) The guidelines or protocol required by subsection (a)
16shall include:
17        (1) a statement identifying the practitioner
18    authorized to prescribe and the pharmacist clinician who is
19    a party to the guidelines or protocol;
20        (2) a statement of the types of prescriptive authority
21    decisions that the pharmacist clinician is authorized to
22    make that may include:
23            (A) a statement of the types of diseases, dangerous
24        drugs, or dangerous drug categories involved and the
25        type of prescriptive authority authorized in each

 

 

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1        case; and
2            (B) a general statement of the procedures,
3        decision criteria, or plan the pharmacist clinician is
4        to follow when exercising prescriptive authority.
5        (3) a statement of the activities the pharmacist
6    clinician is to follow in the course of exercising
7    prescriptive authority, including documentation of
8    decisions made and a plan for communication or feedback to
9    the authorizing practitioner concerning specific decisions
10    made; documentation may occur on the prescriptive record,
11    patient profile, patient medical chart, or in a separate
12    log book; and
13        (4) a statement that describes appropriate mechanisms
14    for reporting to the practitioner monitoring activities
15    and results.
16    (c) The written guidelines or protocol shall be reviewed
17and shall be revised every 2 years if necessary.
18    (d) A pharmacist clinician planning to exercise
19prescriptive authority in his or her practice shall be
20authorized to monitor dangerous drug therapy.
 
21    (225 ILCS 85/23)  (from Ch. 111, par. 4143)
22    (Section scheduled to be repealed on January 1, 2018)
23    Sec. 23. It is unlawful for a pharmacist or pharmacy to pay
24or promise to pay to any person who owns, operates, manages or
25is an employee of a hospital, nursing home or other health care

 

 

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1facility or to any person authorized by law to prescribe drugs
2or to any entity in which a person authorized by law to
3prescribe drugs holds an interest, any rebate, refund,
4discount, commission or other valuable consideration for, on
5account of, or based upon income received or resulting from the
6sale or furnishing by any such pharmacy of drugs or devices,
7prescriptions or any other service to patients of the above
8specified persons, organizations or facilities.
9    This shall not be deemed to include rent or other
10remunerations paid to an individual, partnership, or
11corporation by a pharmacist or pharmacy for the lease, rental,
12or use of space, owned or controlled, by the individual,
13partnership or corporation.
14    It is unlawful for any licensed pharmacist, pharmacy, or
15registered licensee to engage in the offering, use, or
16distribution of any premiums, coupons, rebates, inducements,
17or any kind of economic incentive to transfer prescriptions.
18(Source: P.A. 85-796.)
 
19    Section 99. Effective date. This Act takes effect upon
20becoming law.