Sen. Iris Y. Martinez

Filed: 3/2/2012

 

 


 

 


 
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1
AMENDMENT TO SENATE BILL 3513

2    AMENDMENT NO. ______. Amend Senate Bill 3513 by replacing
3everything after the enacting clause with the following:
 
4    "Section 5. The Pharmacy Practice Act is amended by
5changing Section 3 as follows:
 
6    (225 ILCS 85/3)
7    (Section scheduled to be repealed on January 1, 2018)
8    Sec. 3. Definitions. For the purpose of this Act, except
9where otherwise limited therein:
10    (a) "Pharmacy" or "drugstore" means and includes every
11store, shop, pharmacy department, or other place where
12pharmacist care is provided by a pharmacist (1) where drugs,
13medicines, or poisons are dispensed, sold or offered for sale
14at retail, or displayed for sale at retail; or (2) where
15prescriptions of physicians, dentists, advanced practice
16nurses, physician assistants, veterinarians, podiatrists, or

 

 

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

 

 

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1man or other animals; and (4) articles having for their main
2use and intended for use as a component or any articles
3specified in clause (l), (2) or (3); but does not include
4devices or their components, parts or accessories.
5    (c) "Medicines" means and includes all drugs intended for
6human or veterinary use approved by the United States Food and
7Drug Administration.
8    (d) "Practice of pharmacy" means (1) the interpretation and
9the provision of assistance in the monitoring, evaluation, and
10implementation of prescription drug orders; (2) the dispensing
11of prescription drug orders; (3) participation in drug and
12device selection; (4) drug administration limited to the
13administration of oral, topical, injectable, and inhalation as
14follows: in the context of patient education on the proper use
15or delivery of medications; vaccination of patients 14 years of
16age and older pursuant to a valid prescription or standing
17order, by a physician licensed to practice medicine in all its
18branches, upon completion of appropriate training, including
19how to address contraindications and adverse reactions set
20forth by rule, with notification to the patient's physician and
21appropriate record retention, or pursuant to hospital pharmacy
22and therapeutics committee policies and procedures; (5)
23vaccination of patients ages 9 through 13 limited to the
24Influenza (inactivated influenza vaccine and live attenuated
25influenza intranasal vaccine), Meningitis (defined as MCV4
26Meningococcal and MSV4 Meningococcal), Td (defined as Tetanus

 

 

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1and Diphtheria), and Tdap (defined as tetanus, diphtheria,
2acellular pertussis) vaccines, pursuant to a valid
3prescription or standing order, by a physician licensed to
4practice medicine in all its branches, upon completion of
5appropriate training, including how to address
6contraindications and adverse reactions set forth by rule, with
7notification to the patient's physician and appropriate record
8retention, or pursuant to hospital pharmacy and therapeutics
9committee policies and procedures; (6) drug regimen review; (7)
10(6) drug or drug-related research; (8) (7) the provision of
11patient counseling; (9) (8) the practice of telepharmacy; (10)
12(9) the provision of those acts or services necessary to
13provide pharmacist care; (11) (10) medication therapy
14management; and (12) (11) the responsibility for compounding
15and labeling of drugs and devices (except labeling by a
16manufacturer, repackager, or distributor of non-prescription
17drugs and commercially packaged legend drugs and devices),
18proper and safe storage of drugs and devices, and maintenance
19of required records. A pharmacist who performs any of the acts
20defined as the practice of pharmacy in this State must be
21actively licensed as a pharmacist under this Act.
22    (e) "Prescription" means and includes any written, oral,
23facsimile, or electronically transmitted order for drugs or
24medical devices, issued by a physician licensed to practice
25medicine in all its branches, dentist, veterinarian, or
26podiatrist, or optometrist, within the limits of their

 

 

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1licenses, by a physician assistant in accordance with
2subsection (f) of Section 4, or by an advanced practice nurse
3in accordance with subsection (g) of Section 4, containing the
4following: (l) name of the patient; (2) date when prescription
5was issued; (3) name and strength of drug or description of the
6medical device prescribed; and (4) quantity; (5) directions for
7use; (6) prescriber's name, address, and signature; and (7) DEA
8number where required, for controlled substances. The
9prescription may, but is not required to, list the illness,
10disease, or condition for which the drug or device is being
11prescribed. DEA numbers shall not be required on inpatient drug
12orders.
13    (f) "Person" means and includes a natural person,
14copartnership, association, corporation, government entity, or
15any other legal entity.
16    (g) "Department" means the Department of Financial and
17Professional Regulation.
18    (h) "Board of Pharmacy" or "Board" means the State Board of
19Pharmacy of the Department of Financial and Professional
20Regulation.
21    (i) "Secretary" means the Secretary of Financial and
22Professional Regulation.
23    (j) "Drug product selection" means the interchange for a
24prescribed pharmaceutical product in accordance with Section
2525 of this Act and Section 3.14 of the Illinois Food, Drug and
26Cosmetic Act.

 

 

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1    (k) "Inpatient drug order" means an order issued by an
2authorized prescriber for a resident or patient of a facility
3licensed under the Nursing Home Care Act, the ID/DD Community
4Care Act, the Specialized Mental Health Rehabilitation Act, or
5the Hospital Licensing Act, or "An Act in relation to the
6founding and operation of the University of Illinois Hospital
7and the conduct of University of Illinois health care
8programs", approved July 3, 1931, as amended, or a facility
9which is operated by the Department of Human Services (as
10successor to the Department of Mental Health and Developmental
11Disabilities) or the Department of Corrections.
12    (k-5) "Pharmacist" means an individual health care
13professional and provider currently licensed by this State to
14engage in the practice of pharmacy.
15    (l) "Pharmacist in charge" means the licensed pharmacist
16whose name appears on a pharmacy license and who is responsible
17for all aspects of the operation related to the practice of
18pharmacy.
19    (m) "Dispense" or "dispensing" means the interpretation,
20evaluation, and implementation of a prescription drug order,
21including the preparation and delivery of a drug or device to a
22patient or patient's agent in a suitable container
23appropriately labeled for subsequent administration to or use
24by a patient in accordance with applicable State and federal
25laws and regulations. "Dispense" or "dispensing" does not mean
26the physical delivery to a patient or a patient's

 

 

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

 

 

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1timely manner to meet the patient's needs and (ii) the
2prescribing practitioner has requested that the drug be
3compounded.
4    (p) (Blank).
5    (q) (Blank).
6    (r) "Patient counseling" means the communication between a
7pharmacist or a student pharmacist under the supervision of a
8pharmacist and a patient or the patient's representative about
9the patient's medication or device for the purpose of
10optimizing proper use of prescription medications or devices.
11"Patient counseling" may include without limitation (1)
12obtaining a medication history; (2) acquiring a patient's
13allergies and health conditions; (3) facilitation of the
14patient's understanding of the intended use of the medication;
15(4) proper directions for use; (5) significant potential
16adverse events; (6) potential food-drug interactions; and (7)
17the need to be compliant with the medication therapy. A
18pharmacy technician may only participate in the following
19aspects of patient counseling under the supervision of a
20pharmacist: (1) obtaining medication history; (2) providing
21the offer for counseling by a pharmacist or student pharmacist;
22and (3) acquiring a patient's allergies and health conditions.
23    (s) "Patient profiles" or "patient drug therapy record"
24means the obtaining, recording, and maintenance of patient
25prescription information, including prescriptions for
26controlled substances, and personal information.

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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1    medium.
2"Protected health information" does not include individually
3identifiable health information found in:
4        (1) education records covered by the federal Family
5    Educational Right and Privacy Act; or
6        (2) employment records held by a licensee in its role
7    as an employer.
8    (dd) "Standing order" means a specific order for a patient
9or group of patients issued by a physician licensed to practice
10medicine in all its branches in Illinois.
11    (ee) "Address of record" means the address recorded by the
12Department in the applicant's or licensee's application file or
13license file, as maintained by the Department's licensure
14maintenance unit.
15    (ff) "Home pharmacy" means the location of a pharmacy's
16primary operations.
17(Source: P.A. 96-339, eff. 7-1-10; 96-673, eff. 1-1-10;
1896-1000, eff. 7-2-10; 96-1353, eff. 7-28-10; 97-38, eff.
196-28-11; 97-227, eff. 1-1-12; revised 10-4-11.)
 
20    Section 99. Effective date. This Act takes effect upon
21becoming law.".