Full Text of SB3270 96th General Assembly
SB3270 96TH GENERAL ASSEMBLY
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96TH GENERAL ASSEMBLY
State of Illinois
2009 and 2010 SB3270
Introduced 2/9/2010, by Sen. Donne E. Trotter SYNOPSIS AS INTRODUCED: |
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Amends the Pharmacy Practice Act. Makes a technical change in a Section concerning definitions.
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A BILL FOR
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SB3270 |
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LRB096 16561 ASK 31834 b |
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| AN ACT concerning regulation.
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| Be it enacted by the People of the State of Illinois,
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| represented in the General Assembly:
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| Section 5. The Pharmacy Practice Act is amended by changing | 5 |
| Section 3 as follows:
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| (225 ILCS 85/3)
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| (Text of Section before amendment by P.A. 96-339 ) | 8 |
| (Section scheduled to be repealed on January 1, 2018)
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| Sec. 3. Definitions. For the the purpose of this Act, | 10 |
| except where otherwise
limited therein:
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| (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
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| prescriptions of physicians, dentists, advanced practice | 17 |
| nurses, physician assistants, veterinarians, podiatrists, or
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| optometrists, within the limits of their
licenses, are
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| compounded, filled, or dispensed; or (3) which has upon it or
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| 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",
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| "Medicine Store", "Prescriptions", "Drugs", "Dispensary", |
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LRB096 16561 ASK 31834 b |
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| "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.
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| (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
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| 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.
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| (c) "Medicines" means and includes all drugs intended for
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| human or veterinary use approved by the United States Food and |
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| Drug
Administration.
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| (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 |
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LRB096 16561 ASK 31834 b |
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| defined as the practice of pharmacy in this State must be | 2 |
| actively licensed as a pharmacist under this Act.
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| (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
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| subsection (f) of Section 4, or by an advanced practice nurse | 10 |
| in
accordance with subsection (g) of Section 4, containing the
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| 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.
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| (f) "Person" means and includes a natural person, | 18 |
| copartnership,
association, corporation, government entity, or | 19 |
| any other legal
entity.
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| (g) "Department" means the Department of Financial and
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| Professional Regulation.
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| (h) "Board of Pharmacy" or "Board" means the State Board
of | 23 |
| Pharmacy of the Department of Financial and Professional | 24 |
| Regulation.
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| (i) "Secretary"
means the Secretary
of Financial and | 26 |
| Professional Regulation.
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| (j) "Drug product selection" means the interchange for a
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| 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.
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| (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
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| 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.
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| (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.
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| (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.
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| (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 |
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LRB096 16561 ASK 31834 b |
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| 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
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| pharmacist's designee within a pharmacy or drugstore while the | 9 |
| pharmacist is
on duty and the pharmacy is open.
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| (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.
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| (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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LRB096 16561 ASK 31834 b |
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| 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.
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| (p) (Blank).
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| (q) (Blank).
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| (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.
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| (s) "Patient profiles" or "patient drug therapy record" |
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| means the
obtaining, recording, and maintenance of patient | 2 |
| prescription
information, including prescriptions for | 3 |
| controlled substances, and
personal information.
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| (t) (Blank).
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| (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.
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| (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.
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| (w) "Current usual and customary retail price" means the | 19 |
| price that a pharmacy charges to a non-third-party payor.
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| (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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| of prescription drug orders and patient records for (1)
known | 2 |
| allergies; (2) drug or potential therapy contraindications;
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| (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.
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| (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.
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| (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 |
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| 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 |
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SB3270 |
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LRB096 16561 ASK 31834 b |
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| 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.
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| "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.
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| (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.
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| (cc) "Protected health information" means individually | 23 |
| identifiable health information that, except as otherwise | 24 |
| provided, is:
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| (1) transmitted by electronic media; | 26 |
| (2) maintained in any medium set forth in the |
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SB3270 |
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LRB096 16561 ASK 31834 b |
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| 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.
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| (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)
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| 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 |
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SB3270 |
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LRB096 16561 ASK 31834 b |
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| 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 |
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SB3270 |
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LRB096 16561 ASK 31834 b |
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| 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 |
|
|
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SB3270 |
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LRB096 16561 ASK 31834 b |
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| 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 |
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SB3270 |
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LRB096 16561 ASK 31834 b |
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| 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.
|
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SB3270 |
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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 |
|
|
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SB3270 |
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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) |
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|
SB3270 |
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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, |
|
|
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SB3270 |
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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 |
|
|
|
SB3270 |
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LRB096 16561 ASK 31834 b |
|
| 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 |
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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 |
|
|
|
SB3270 |
- 23 - |
LRB096 16561 ASK 31834 b |
|
| 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 |
|
|
|
SB3270 |
- 24 - |
LRB096 16561 ASK 31834 b |
|
| 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.)
|
|