Bill Text: IL SB3277 | 2013-2014 | 98th General Assembly | Amended


Bill Title: Amends the Pharmacy Practice Act. Adds the administration of the Meningococcal vaccine to patients 10 through 13 years of age to the definition of "practice of pharmacy".

Spectrum: Slight Partisan Bill (Democrat 3-1)

Status: (Failed) 2015-01-13 - Session Sine Die [SB3277 Detail]

Download: Illinois-2013-SB3277-Amended.html

Sen. Pamela J. Althoff

Filed: 3/14/2014

09800SB3277sam001LRB098 18970 ZMM 56945 a
1
AMENDMENT TO SENATE BILL 3277
2 AMENDMENT NO. ______. Amend Senate Bill 3277 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7 (Section scheduled to be repealed on January 1, 2018)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, podiatric

09800SB3277sam001- 2 -LRB098 18970 ZMM 56945 a
1physicians, or optometrists, within the limits of their
2licenses, are compounded, filled, or dispensed; or (3) which
3has upon it or displayed within it, or affixed to or used in
4connection with it, a sign bearing the word or words
5"Pharmacist", "Druggist", "Pharmacy", "Pharmaceutical Care",
6"Apothecary", "Drugstore", "Medicine Store", "Prescriptions",
7"Drugs", "Dispensary", "Medicines", or any word or words of
8similar or like import, either in the English language or any
9other language; or (4) where the characteristic prescription
10sign (Rx) or similar design is exhibited; or (5) any store, or
11shop, or other place with respect to which any of the above
12words, objects, signs or designs 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

09800SB3277sam001- 3 -LRB098 18970 ZMM 56945 a
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 10 through 13 limited to the
24Influenza (inactivated influenza vaccine and live attenuated
25influenza intranasal vaccine), and Tdap (defined as tetanus,
26diphtheria, acellular pertussis), and Meningococcal vaccines,

09800SB3277sam001- 4 -LRB098 18970 ZMM 56945 a
1pursuant to a valid prescription or standing order, by a
2physician licensed to practice medicine in all its branches,
3upon completion of appropriate training, including how to
4address contraindications and adverse reactions set forth by
5rule, with notification to the patient's physician and
6appropriate record retention, or pursuant to hospital pharmacy
7and therapeutics committee policies and procedures; (6) drug
8regimen review; (7) drug or drug-related research; (8) the
9provision of patient counseling; (9) the practice of
10telepharmacy; (10) the provision of those acts or services
11necessary to provide pharmacist care; (11) medication therapy
12management; and (12) the responsibility for compounding and
13labeling of drugs and devices (except labeling by a
14manufacturer, repackager, or distributor of non-prescription
15drugs and commercially packaged legend drugs and devices),
16proper and safe storage of drugs and devices, and maintenance
17of required records. A pharmacist who performs any of the acts
18defined as the practice of pharmacy in this State must be
19actively licensed as a pharmacist under this Act. A pharmacist
20who administers a vaccination to a patient under the age of 18
21years shall notify the patient's physician, if one is
22identified by the patient or the patient's guardian, and shall
23record the vaccination in the Illinois Comprehensive Automated
24Immunization Registry (I-CARE) within a reasonable amount of
25time after administering the vaccination.
26 (e) "Prescription" means and includes any written, oral,

09800SB3277sam001- 5 -LRB098 18970 ZMM 56945 a
1facsimile, or electronically transmitted order for drugs or
2medical devices, issued by a physician licensed to practice
3medicine in all its branches, dentist, veterinarian, or
4podiatric physician, or optometrist, within the limits of their
5licenses, by a physician assistant in accordance with
6subsection (f) of Section 4, or by an advanced practice nurse
7in accordance with subsection (g) of Section 4, containing the
8following: (l) name of the patient; (2) date when prescription
9was issued; (3) name and strength of drug or description of the
10medical device prescribed; and (4) quantity; (5) directions for
11use; (6) prescriber's name, address, and signature; and (7) DEA
12number where required, for controlled substances. The
13prescription may, but is not required to, list the illness,
14disease, or condition for which the drug or device is being
15prescribed. DEA numbers shall not be required on inpatient drug
16orders.
17 (f) "Person" means and includes a natural person,
18copartnership, association, corporation, government entity, or
19any other legal entity.
20 (g) "Department" means the Department of Financial and
21Professional Regulation.
22 (h) "Board of Pharmacy" or "Board" means the State Board of
23Pharmacy of the Department of Financial and Professional
24Regulation.
25 (i) "Secretary" means the Secretary of Financial and
26Professional Regulation.

09800SB3277sam001- 6 -LRB098 18970 ZMM 56945 a
1 (j) "Drug product selection" means the interchange for a
2prescribed pharmaceutical product in accordance with Section
325 of this Act and Section 3.14 of the Illinois Food, Drug and
4Cosmetic Act.
5 (k) "Inpatient drug order" means an order issued by an
6authorized prescriber for a resident or patient of a facility
7licensed under the Nursing Home Care Act, the ID/DD Community
8Care Act, the Specialized Mental Health Rehabilitation Act of
92013, or the Hospital Licensing Act, or "An Act in relation to
10the founding and operation of the University of Illinois
11Hospital and the conduct of University of Illinois health care
12programs", approved July 3, 1931, as amended, or a facility
13which is operated by the Department of Human Services (as
14successor to the Department of Mental Health and Developmental
15Disabilities) or the Department of Corrections.
16 (k-5) "Pharmacist" means an individual health care
17professional and provider currently licensed by this State to
18engage in the practice of pharmacy.
19 (l) "Pharmacist in charge" means the licensed pharmacist
20whose name appears on a pharmacy license and who is responsible
21for all aspects of the operation related to the practice of
22pharmacy.
23 (m) "Dispense" or "dispensing" means the interpretation,
24evaluation, and implementation of a prescription drug order,
25including the preparation and delivery of a drug or device to a
26patient or patient's agent in a suitable container

09800SB3277sam001- 7 -LRB098 18970 ZMM 56945 a
1appropriately labeled for subsequent administration to or use
2by a patient in accordance with applicable State and federal
3laws and regulations. "Dispense" or "dispensing" does not mean
4the physical delivery to a patient or a patient's
5representative in a home or institution by a designee of a
6pharmacist or by common carrier. "Dispense" or "dispensing"
7also does not mean the physical delivery of a drug or medical
8device to a patient or patient's representative by a
9pharmacist's designee within a pharmacy or drugstore while the
10pharmacist is on duty and the pharmacy is open.
11 (n) "Nonresident pharmacy" means a pharmacy that is located
12in a state, commonwealth, or territory of the United States,
13other than Illinois, that delivers, dispenses, or distributes,
14through the United States Postal Service, commercially
15acceptable parcel delivery service, or other common carrier, to
16Illinois residents, any substance which requires a
17prescription.
18 (o) "Compounding" means the preparation and mixing of
19components, excluding flavorings, (1) as the result of a
20prescriber's prescription drug order or initiative based on the
21prescriber-patient-pharmacist relationship in the course of
22professional practice or (2) for the purpose of, or incident
23to, research, teaching, or chemical analysis and not for sale
24or dispensing. "Compounding" includes the preparation of drugs
25or devices in anticipation of receiving prescription drug
26orders based on routine, regularly observed dispensing

09800SB3277sam001- 8 -LRB098 18970 ZMM 56945 a
1patterns. Commercially available products may be compounded
2for dispensing to individual patients only if all of the
3following conditions are met: (i) the commercial product is not
4reasonably available from normal distribution channels in a
5timely manner to meet the patient's needs and (ii) the
6prescribing practitioner has requested that the drug be
7compounded.
8 (p) (Blank).
9 (q) (Blank).
10 (r) "Patient counseling" means the communication between a
11pharmacist or a student pharmacist under the supervision of a
12pharmacist and a patient or the patient's representative about
13the patient's medication or device for the purpose of
14optimizing proper use of prescription medications or devices.
15"Patient counseling" may include without limitation (1)
16obtaining a medication history; (2) acquiring a patient's
17allergies and health conditions; (3) facilitation of the
18patient's understanding of the intended use of the medication;
19(4) proper directions for use; (5) significant potential
20adverse events; (6) potential food-drug interactions; and (7)
21the need to be compliant with the medication therapy. A
22pharmacy technician may only participate in the following
23aspects of patient counseling under the supervision of a
24pharmacist: (1) obtaining medication history; (2) providing
25the offer for counseling by a pharmacist or student pharmacist;
26and (3) acquiring a patient's allergies and health conditions.

09800SB3277sam001- 9 -LRB098 18970 ZMM 56945 a
1 (s) "Patient profiles" or "patient drug therapy record"
2means the obtaining, recording, and maintenance of patient
3prescription information, including prescriptions for
4controlled substances, and personal information.
5 (t) (Blank).
6 (u) "Medical device" means an instrument, apparatus,
7implement, machine, contrivance, implant, in vitro reagent, or
8other similar or related article, including any component part
9or accessory, required under federal law to bear the label
10"Caution: Federal law requires dispensing by or on the order of
11a physician". A seller of goods and services who, only for the
12purpose of retail sales, compounds, sells, rents, or leases
13medical devices shall not, by reasons thereof, be required to
14be a licensed pharmacy.
15 (v) "Unique identifier" means an electronic signature,
16handwritten signature or initials, thumb print, or other
17acceptable biometric or electronic identification process as
18approved by the Department.
19 (w) "Current usual and customary retail price" means the
20price that a pharmacy charges to a non-third-party payor.
21 (x) "Automated pharmacy system" means a mechanical system
22located within the confines of the pharmacy or remote location
23that performs operations or activities, other than compounding
24or administration, relative to storage, packaging, dispensing,
25or distribution of medication, and which collects, controls,
26and maintains all transaction information.

09800SB3277sam001- 10 -LRB098 18970 ZMM 56945 a
1 (y) "Drug regimen review" means and includes the evaluation
2of prescription drug orders and patient records for (1) known
3allergies; (2) drug or potential therapy contraindications;
4(3) reasonable dose, duration of use, and route of
5administration, taking into consideration factors such as age,
6gender, and contraindications; (4) reasonable directions for
7use; (5) potential or actual adverse drug reactions; (6)
8drug-drug interactions; (7) drug-food interactions; (8)
9drug-disease contraindications; (9) therapeutic duplication;
10(10) patient laboratory values when authorized and available;
11(11) proper utilization (including over or under utilization)
12and optimum therapeutic outcomes; and (12) abuse and misuse.
13 (z) "Electronic transmission prescription" means any
14prescription order for which a facsimile or electronic image of
15the order is electronically transmitted from a licensed
16prescriber to a pharmacy. "Electronic transmission
17prescription" includes both data and image prescriptions.
18 (aa) "Medication therapy management services" means a
19distinct service or group of services offered by licensed
20pharmacists, physicians licensed to practice medicine in all
21its branches, advanced practice nurses authorized in a written
22agreement with a physician licensed to practice medicine in all
23its branches, or physician assistants authorized in guidelines
24by a supervising physician that optimize therapeutic outcomes
25for individual patients through improved medication use. In a
26retail or other non-hospital pharmacy, medication therapy

09800SB3277sam001- 11 -LRB098 18970 ZMM 56945 a
1management services shall consist of the evaluation of
2prescription drug orders and patient medication records to
3resolve conflicts with the following:
4 (1) known allergies;
5 (2) drug or potential therapy contraindications;
6 (3) reasonable dose, duration of use, and route of
7 administration, taking into consideration factors such as
8 age, gender, and contraindications;
9 (4) reasonable directions for use;
10 (5) potential or actual adverse drug reactions;
11 (6) drug-drug interactions;
12 (7) drug-food interactions;
13 (8) drug-disease contraindications;
14 (9) identification of therapeutic duplication;
15 (10) patient laboratory values when authorized and
16 available;
17 (11) proper utilization (including over or under
18 utilization) and optimum therapeutic outcomes; and
19 (12) drug abuse and misuse.
20 "Medication therapy management services" includes the
21following:
22 (1) documenting the services delivered and
23 communicating the information provided to patients'
24 prescribers within an appropriate time frame, not to exceed
25 48 hours;
26 (2) providing patient counseling designed to enhance a

09800SB3277sam001- 12 -LRB098 18970 ZMM 56945 a
1 patient's understanding and the appropriate use of his or
2 her medications; and
3 (3) providing information, support services, and
4 resources designed to enhance a patient's adherence with
5 his or her prescribed therapeutic regimens.
6 "Medication therapy management services" may also include
7patient care functions authorized by a physician licensed to
8practice medicine in all its branches for his or her identified
9patient or groups of patients under specified conditions or
10limitations in a standing order from the physician.
11 "Medication therapy management services" in a licensed
12hospital may also include the following:
13 (1) reviewing assessments of the patient's health
14 status; and
15 (2) following protocols of a hospital pharmacy and
16 therapeutics committee with respect to the fulfillment of
17 medication orders.
18 (bb) "Pharmacist care" means the provision by a pharmacist
19of medication therapy management services, with or without the
20dispensing of drugs or devices, intended to achieve outcomes
21that improve patient health, quality of life, and comfort and
22enhance patient safety.
23 (cc) "Protected health information" means individually
24identifiable health information that, except as otherwise
25provided, is:
26 (1) transmitted by electronic media;

09800SB3277sam001- 13 -LRB098 18970 ZMM 56945 a
1 (2) maintained in any medium set forth in the
2 definition of "electronic media" in the federal Health
3 Insurance Portability and Accountability Act; or
4 (3) transmitted or maintained in any other form or
5 medium.
6 "Protected health information" does not include
7individually identifiable health information found in:
8 (1) education records covered by the federal Family
9 Educational Right and Privacy Act; or
10 (2) employment records held by a licensee in its role
11 as an employer.
12 (dd) "Standing order" means a specific order for a patient
13or group of patients issued by a physician licensed to practice
14medicine in all its branches in Illinois.
15 (ee) "Address of record" means the address recorded by the
16Department in the applicant's or licensee's application file or
17license file, as maintained by the Department's licensure
18maintenance unit.
19 (ff) "Home pharmacy" means the location of a pharmacy's
20primary operations.
21(Source: P.A. 97-38, eff. 6-28-11; 97-227, eff. 1-1-12; 97-813,
22eff. 7-13-12; 97-1043, eff. 8-21-12; 98-104, eff. 7-22-13;
2398-214, eff. 8-9-13; revised 9-24-13.)".
feedback