Full Text of HB5890 96th General Assembly
HB5890enr 96TH GENERAL ASSEMBLY
|
|
|
HB5890 Enrolled |
|
LRB096 18739 ASK 34124 b |
|
| 1 |
| AN ACT concerning regulation.
| 2 |
| Be it enacted by the People of the State of Illinois,
| 3 |
| represented in the General Assembly:
| 4 |
| Section 5. The Pharmacy Practice Act is amended by changing | 5 |
| Section 3 as follows:
| 6 |
| (225 ILCS 85/3)
| 7 |
| (Text of Section before amendment by P.A. 96-339 ) | 8 |
| (Section scheduled to be repealed on January 1, 2018)
| 9 |
| Sec. 3. Definitions. For the purpose of this Act, except | 10 |
| where otherwise
limited therein:
| 11 |
| (a) "Pharmacy" or "drugstore" means and includes every | 12 |
| store, shop,
pharmacy department, or other place where | 13 |
| pharmacist
care is
provided
by a pharmacist (1) where drugs, | 14 |
| medicines, or poisons are
dispensed, sold or
offered for sale | 15 |
| at retail, or displayed for sale at retail; or
(2)
where
| 16 |
| prescriptions of physicians, dentists, advanced practice | 17 |
| nurses, physician assistants, veterinarians, podiatrists, or
| 18 |
| optometrists, within the limits of their
licenses, are
| 19 |
| compounded, filled, or dispensed; or (3) which has upon it or
| 20 |
| displayed within
it, or affixed to or used in connection with | 21 |
| it, a sign bearing the word or
words "Pharmacist", "Druggist", | 22 |
| "Pharmacy", "Pharmaceutical
Care", "Apothecary", "Drugstore",
| 23 |
| "Medicine Store", "Prescriptions", "Drugs", "Dispensary", |
|
|
|
HB5890 Enrolled |
- 2 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| "Medicines", or any word
or words of similar or like import, | 2 |
| either in the English language
or any other language; or (4) | 3 |
| where the characteristic prescription
sign (Rx) or similar | 4 |
| design is exhibited; or (5) any store, or
shop,
or other place | 5 |
| with respect to which any of the above words, objects,
signs or | 6 |
| designs are used in any advertisement.
| 7 |
| (b) "Drugs" means and includes (l) articles recognized
in | 8 |
| the official United States Pharmacopoeia/National Formulary | 9 |
| (USP/NF),
or any supplement thereto and being intended for and | 10 |
| having for their
main use the diagnosis, cure, mitigation, | 11 |
| treatment or prevention of
disease in man or other animals, as | 12 |
| approved by the United States Food and
Drug Administration, but | 13 |
| does not include devices or their components, parts,
or | 14 |
| accessories; and (2) all other articles intended
for and having | 15 |
| for their main use the diagnosis, cure, mitigation,
treatment | 16 |
| or prevention of disease in man or other animals, as approved
| 17 |
| by the United States Food and Drug Administration, but does not | 18 |
| include
devices or their components, parts, or accessories; and | 19 |
| (3) articles
(other than food) having for their main use and | 20 |
| intended
to affect the structure or any function of the body of | 21 |
| man or other
animals; and (4) articles having for their main | 22 |
| use and intended
for use as a component or any articles | 23 |
| specified in clause (l), (2)
or (3); but does not include | 24 |
| devices or their components, parts or
accessories.
| 25 |
| (c) "Medicines" means and includes all drugs intended for
| 26 |
| human or veterinary use approved by the United States Food and |
|
|
|
HB5890 Enrolled |
- 3 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| Drug
Administration.
| 2 |
| (d) "Practice of pharmacy" means (1) the interpretation and | 3 |
| the provision of assistance in the monitoring, evaluation, and | 4 |
| implementation of prescription drug orders; (2) the dispensing | 5 |
| of prescription drug orders; (3) participation in drug and | 6 |
| device selection; (4) drug administration limited to the | 7 |
| administration of oral, topical, injectable, and inhalation as | 8 |
| follows: in the context of patient education on the proper use | 9 |
| or delivery of medications; vaccination of patients 14 years of | 10 |
| age and older pursuant to a valid prescription or standing | 11 |
| order, by a physician licensed to practice medicine in all its | 12 |
| branches, upon completion of appropriate training, including | 13 |
| how to address contraindications and adverse reactions set | 14 |
| forth by rule, with notification to the patient's physician and | 15 |
| appropriate record retention, or pursuant to hospital pharmacy | 16 |
| and therapeutics committee policies and procedures; (5) drug | 17 |
| regimen review; (6) drug or drug-related research; (7) the | 18 |
| provision of patient counseling; (8) the practice of | 19 |
| telepharmacy; (9) the provision of those acts or services | 20 |
| necessary to provide pharmacist care; (10) medication therapy | 21 |
| management; and (11) the responsibility for compounding and | 22 |
| labeling of drugs and devices (except labeling by a | 23 |
| manufacturer, repackager, or distributor of non-prescription | 24 |
| drugs and commercially packaged legend drugs and devices), | 25 |
| proper and safe storage of drugs and devices, and maintenance | 26 |
| of required records. A pharmacist who performs any of the acts |
|
|
|
HB5890 Enrolled |
- 4 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| defined as the practice of pharmacy in this State must be | 2 |
| actively licensed as a pharmacist under this Act.
| 3 |
| (e) "Prescription" means and includes any written, oral, | 4 |
| facsimile, or
electronically transmitted order for drugs
or | 5 |
| medical devices, issued by a physician licensed to practice | 6 |
| medicine in
all its branches, dentist, veterinarian, or | 7 |
| podiatrist, or
optometrist, within the
limits of their | 8 |
| licenses, by a physician assistant in accordance with
| 9 |
| subsection (f) of Section 4, or by an advanced practice nurse | 10 |
| in
accordance with subsection (g) of Section 4, containing the
| 11 |
| following: (l) name
of the patient; (2) date when prescription | 12 |
| was issued; (3) name
and strength of drug or description of the | 13 |
| medical device prescribed;
and (4) quantity ; , (5) directions | 14 |
| for use ; , (6) prescriber's name,
address ,
and signature ; , and | 15 |
| (7) DEA number where required, for controlled
substances . The | 16 |
| prescription may, but is not required to, list the illness, | 17 |
| disease, or condition for which the drug or device is being | 18 |
| prescribed .
DEA numbers shall not be required on inpatient drug | 19 |
| orders.
| 20 |
| (f) "Person" means and includes a natural person, | 21 |
| copartnership,
association, corporation, government entity, or | 22 |
| any other legal
entity.
| 23 |
| (g) "Department" means the Department of Financial and
| 24 |
| Professional Regulation.
| 25 |
| (h) "Board of Pharmacy" or "Board" means the State Board
of | 26 |
| Pharmacy of the Department of Financial and Professional |
|
|
|
HB5890 Enrolled |
- 5 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| Regulation.
| 2 |
| (i) "Secretary"
means the Secretary
of Financial and | 3 |
| Professional Regulation.
| 4 |
| (j) "Drug product selection" means the interchange for a
| 5 |
| prescribed pharmaceutical product in accordance with Section | 6 |
| 25 of
this Act and Section 3.14 of the Illinois Food, Drug and | 7 |
| Cosmetic Act.
| 8 |
| (k) "Inpatient drug order" means an order issued by an | 9 |
| authorized
prescriber for a resident or patient of a facility | 10 |
| licensed under the
Nursing Home Care Act or the Hospital | 11 |
| Licensing Act, or "An Act in relation to
the founding and | 12 |
| operation of the University of Illinois Hospital and the
| 13 |
| conduct of University of Illinois health care programs", | 14 |
| approved July 3, 1931,
as amended, or a facility which is | 15 |
| operated by the Department of Human
Services (as successor to | 16 |
| the Department of Mental Health
and Developmental | 17 |
| Disabilities) or the Department of Corrections.
| 18 |
| (k-5) "Pharmacist" means an individual health care | 19 |
| professional and
provider currently licensed by this State to | 20 |
| engage in the practice of
pharmacy.
| 21 |
| (l) "Pharmacist in charge" means the licensed pharmacist | 22 |
| whose name appears
on a pharmacy license and who is responsible | 23 |
| for all aspects of the
operation related to the practice of | 24 |
| pharmacy.
| 25 |
| (m) "Dispense" or "dispensing" means the interpretation, | 26 |
| evaluation, and implementation of a prescription drug order, |
|
|
|
HB5890 Enrolled |
- 6 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| including the preparation and delivery of a drug or device to a | 2 |
| patient or patient's agent in a suitable container | 3 |
| appropriately labeled for subsequent administration to or use | 4 |
| by a patient in accordance with applicable State and federal | 5 |
| laws and regulations.
"Dispense" or "dispensing" does not mean | 6 |
| the physical delivery to a patient or a
patient's | 7 |
| representative in a home or institution by a designee of a | 8 |
| pharmacist
or by common carrier. "Dispense" or "dispensing" | 9 |
| also does not mean the physical delivery
of a drug or medical | 10 |
| device to a patient or patient's representative by a
| 11 |
| pharmacist's designee within a pharmacy or drugstore while the | 12 |
| pharmacist is
on duty and the pharmacy is open.
| 13 |
| (n) "Nonresident pharmacy"
means a pharmacy that is located | 14 |
| in a state, commonwealth, or territory
of the United States, | 15 |
| other than Illinois, that delivers, dispenses, or
distributes, | 16 |
| through the United States Postal Service, commercially | 17 |
| acceptable parcel delivery service, or other common
carrier, to | 18 |
| Illinois residents, any substance which requires a | 19 |
| prescription.
| 20 |
| (o) "Compounding" means the preparation and mixing of | 21 |
| components, excluding flavorings, (1) as the result of a | 22 |
| prescriber's prescription drug order or initiative based on the | 23 |
| prescriber-patient-pharmacist relationship in the course of | 24 |
| professional practice or (2) for the purpose of, or incident | 25 |
| to, research, teaching, or chemical analysis and not for sale | 26 |
| or dispensing. "Compounding" includes the preparation of drugs |
|
|
|
HB5890 Enrolled |
- 7 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| or devices in anticipation of receiving prescription drug | 2 |
| orders based on routine, regularly observed dispensing | 3 |
| patterns. Commercially available products may be compounded | 4 |
| for dispensing to individual patients only if all of the | 5 |
| following conditions are met: (i) the commercial product is not | 6 |
| reasonably available from normal distribution channels in a | 7 |
| timely manner to meet the patient's needs and (ii) the | 8 |
| prescribing practitioner has requested that the drug be | 9 |
| compounded.
| 10 |
| (p) (Blank).
| 11 |
| (q) (Blank).
| 12 |
| (r) "Patient counseling" means the communication between a | 13 |
| pharmacist or a student pharmacist under the supervision of a | 14 |
| pharmacist and a patient or the patient's representative about | 15 |
| the patient's medication or device for the purpose of | 16 |
| optimizing proper use of prescription medications or devices. | 17 |
| "Patient counseling" may include without limitation (1) | 18 |
| obtaining a medication history; (2) acquiring a patient's | 19 |
| allergies and health conditions; (3) facilitation of the | 20 |
| patient's understanding of the intended use of the medication; | 21 |
| (4) proper directions for use; (5) significant potential | 22 |
| adverse events; (6) potential food-drug interactions; and (7) | 23 |
| the need to be compliant with the medication therapy. A | 24 |
| pharmacy technician may only participate in the following | 25 |
| aspects of patient counseling under the supervision of a | 26 |
| pharmacist: (1) obtaining medication history; (2) providing |
|
|
|
HB5890 Enrolled |
- 8 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| the offer for counseling by a pharmacist or student pharmacist; | 2 |
| and (3) acquiring a patient's allergies and health conditions.
| 3 |
| (s) "Patient profiles" or "patient drug therapy record" | 4 |
| means the
obtaining, recording, and maintenance of patient | 5 |
| prescription
information, including prescriptions for | 6 |
| controlled substances, and
personal information.
| 7 |
| (t) (Blank).
| 8 |
| (u) "Medical device" means an instrument, apparatus, | 9 |
| implement, machine,
contrivance, implant, in vitro reagent, or | 10 |
| other similar or related article,
including any component part | 11 |
| or accessory, required under federal law to
bear the label | 12 |
| "Caution: Federal law requires dispensing by or on the order
of | 13 |
| a physician". A seller of goods and services who, only for the | 14 |
| purpose of
retail sales, compounds, sells, rents, or leases | 15 |
| medical devices shall not,
by reasons thereof, be required to | 16 |
| be a licensed pharmacy.
| 17 |
| (v) "Unique identifier" means an electronic signature, | 18 |
| handwritten
signature or initials, thumb print, or other | 19 |
| acceptable biometric
or electronic identification process as | 20 |
| approved by the Department.
| 21 |
| (w) "Current usual and customary retail price" means the | 22 |
| price that a pharmacy charges to a non-third-party payor.
| 23 |
| (x) "Automated pharmacy system" means a mechanical system | 24 |
| located within the confines of the pharmacy or remote location | 25 |
| that performs operations or activities, other than compounding | 26 |
| or administration, relative to storage, packaging, dispensing, |
|
|
|
HB5890 Enrolled |
- 9 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| or distribution of medication, and which collects, controls, | 2 |
| and maintains all transaction information. | 3 |
| (y) "Drug regimen review" means and includes the evaluation | 4 |
| of prescription drug orders and patient records for (1)
known | 5 |
| allergies; (2) drug or potential therapy contraindications;
| 6 |
| (3) reasonable dose, duration of use, and route of | 7 |
| administration, taking into consideration factors such as age, | 8 |
| gender, and contraindications; (4) reasonable directions for | 9 |
| use; (5) potential or actual adverse drug reactions; (6) | 10 |
| drug-drug interactions; (7) drug-food interactions; (8) | 11 |
| drug-disease contraindications; (9) therapeutic duplication; | 12 |
| (10) patient laboratory values when authorized and available; | 13 |
| (11) proper utilization (including over or under utilization) | 14 |
| and optimum therapeutic outcomes; and (12) abuse and misuse.
| 15 |
| (z) "Electronic transmission prescription" means any | 16 |
| prescription order for which a facsimile or electronic image of | 17 |
| the order is electronically transmitted from a licensed | 18 |
| prescriber to a pharmacy. "Electronic transmission | 19 |
| prescription" includes both data and image prescriptions.
| 20 |
| (aa) "Medication therapy management services" means a | 21 |
| distinct service or group of services offered by licensed | 22 |
| pharmacists, physicians licensed to practice medicine in all | 23 |
| its branches, advanced practice nurses authorized in a written | 24 |
| agreement with a physician licensed to practice medicine in all | 25 |
| its branches, or physician assistants authorized in guidelines | 26 |
| by a supervising physician that optimize therapeutic outcomes |
|
|
|
HB5890 Enrolled |
- 10 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| for individual patients through improved medication use. In a | 2 |
| retail or other non-hospital pharmacy, medication therapy | 3 |
| management services shall consist of the evaluation of | 4 |
| prescription drug orders and patient medication records to | 5 |
| resolve conflicts with the following: | 6 |
| (1) known allergies; | 7 |
| (2) drug or potential therapy contraindications; | 8 |
| (3) reasonable dose, duration of use, and route of | 9 |
| administration, taking into consideration factors such as | 10 |
| age, gender, and contraindications; | 11 |
| (4) reasonable directions for use; | 12 |
| (5) potential or actual adverse drug reactions; | 13 |
| (6) drug-drug interactions; | 14 |
| (7) drug-food interactions; | 15 |
| (8) drug-disease contraindications; | 16 |
| (9) identification of therapeutic duplication; | 17 |
| (10) patient laboratory values when authorized and | 18 |
| available; | 19 |
| (11) proper utilization (including over or under | 20 |
| utilization) and optimum therapeutic outcomes; and | 21 |
| (12) drug abuse and misuse. | 22 |
| "Medication therapy management services" includes the | 23 |
| following: | 24 |
| (1) documenting the services delivered and | 25 |
| communicating the information provided to patients' | 26 |
| prescribers within an appropriate time frame, not to exceed |
|
|
|
HB5890 Enrolled |
- 11 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| 48 hours; | 2 |
| (2) providing patient counseling designed to enhance a | 3 |
| patient's understanding and the appropriate use of his or | 4 |
| her medications; and | 5 |
| (3) providing information, support services, and | 6 |
| resources designed to enhance a patient's adherence with | 7 |
| his or her prescribed therapeutic regimens.
| 8 |
| "Medication therapy management services" may also include | 9 |
| patient care functions authorized by a physician licensed to | 10 |
| practice medicine in all its branches for his or her identified | 11 |
| patient or groups of patients under specified conditions or | 12 |
| limitations in a standing order from the physician. | 13 |
| "Medication therapy management services" in a licensed | 14 |
| hospital may also include the following: | 15 |
| (1) reviewing assessments of the patient's health | 16 |
| status; and | 17 |
| (2) following protocols of a hospital pharmacy and | 18 |
| therapeutics committee with respect to the fulfillment of | 19 |
| medication orders.
| 20 |
| (bb) "Pharmacist care" means the provision by a pharmacist | 21 |
| of medication therapy management services, with or without the | 22 |
| dispensing of drugs or devices, intended to achieve outcomes | 23 |
| that improve patient health, quality of life, and comfort and | 24 |
| enhance patient safety.
| 25 |
| (cc) "Protected health information" means individually | 26 |
| identifiable health information that, except as otherwise |
|
|
|
HB5890 Enrolled |
- 12 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| provided, is:
| 2 |
| (1) transmitted by electronic media; | 3 |
| (2) maintained in any medium set forth in the | 4 |
| definition of "electronic media" in the federal Health | 5 |
| Insurance Portability and Accountability Act; or | 6 |
| (3) transmitted or maintained in any other form or | 7 |
| medium. | 8 |
| "Protected health information" does not include individually | 9 |
| identifiable health information found in: | 10 |
| (1) education records covered by the federal Family | 11 |
| Educational Right and Privacy Act; or | 12 |
| (2) employment records held by a licensee in its role | 13 |
| as an employer. | 14 |
| (dd) "Standing order" means a specific order for a patient | 15 |
| or group of patients issued by a physician licensed to practice | 16 |
| medicine in all its branches in Illinois. | 17 |
| (ee) "Address of record" means the address recorded by the | 18 |
| Department in the applicant's or licensee's application file or | 19 |
| license file, as maintained by the Department's licensure | 20 |
| maintenance unit. | 21 |
| (ff) "Home pharmacy" means the location of a pharmacy's | 22 |
| primary operations.
| 23 |
| (Source: P.A. 95-689, eff. 10-29-07; 96-673, eff. 1-1-10.) | 24 |
| (Text of Section after amendment by P.A. 96-339 )
| 25 |
| (Section scheduled to be repealed on January 1, 2018)
|
|
|
|
HB5890 Enrolled |
- 13 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| Sec. 3. Definitions. For the purpose of this Act, except | 2 |
| where otherwise
limited therein:
| 3 |
| (a) "Pharmacy" or "drugstore" means and includes every | 4 |
| store, shop,
pharmacy department, or other place where | 5 |
| pharmacist
care is
provided
by a pharmacist (1) where drugs, | 6 |
| medicines, or poisons are
dispensed, sold or
offered for sale | 7 |
| at retail, or displayed for sale at retail; or
(2)
where
| 8 |
| prescriptions of physicians, dentists, advanced practice | 9 |
| nurses, physician assistants, veterinarians, podiatrists, or
| 10 |
| optometrists, within the limits of their
licenses, are
| 11 |
| compounded, filled, or dispensed; or (3) which has upon it or
| 12 |
| displayed within
it, or affixed to or used in connection with | 13 |
| it, a sign bearing the word or
words "Pharmacist", "Druggist", | 14 |
| "Pharmacy", "Pharmaceutical
Care", "Apothecary", "Drugstore",
| 15 |
| "Medicine Store", "Prescriptions", "Drugs", "Dispensary", | 16 |
| "Medicines", or any word
or words of similar or like import, | 17 |
| either in the English language
or any other language; or (4) | 18 |
| where the characteristic prescription
sign (Rx) or similar | 19 |
| design is exhibited; or (5) any store, or
shop,
or other place | 20 |
| with respect to which any of the above words, objects,
signs or | 21 |
| designs are used in any advertisement.
| 22 |
| (b) "Drugs" means and includes (l) articles recognized
in | 23 |
| the official United States Pharmacopoeia/National Formulary | 24 |
| (USP/NF),
or any supplement thereto and being intended for and | 25 |
| having for their
main use the diagnosis, cure, mitigation, | 26 |
| treatment or prevention of
disease in man or other animals, as |
|
|
|
HB5890 Enrolled |
- 14 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| approved by the United States Food and
Drug Administration, but | 2 |
| does not include devices or their components, parts,
or | 3 |
| accessories; and (2) all other articles intended
for and having | 4 |
| for their main use the diagnosis, cure, mitigation,
treatment | 5 |
| or prevention of disease in man or other animals, as approved
| 6 |
| by the United States Food and Drug Administration, but does not | 7 |
| include
devices or their components, parts, or accessories; and | 8 |
| (3) articles
(other than food) having for their main use and | 9 |
| intended
to affect the structure or any function of the body of | 10 |
| man or other
animals; and (4) articles having for their main | 11 |
| use and intended
for use as a component or any articles | 12 |
| specified in clause (l), (2)
or (3); but does not include | 13 |
| devices or their components, parts or
accessories.
| 14 |
| (c) "Medicines" means and includes all drugs intended for
| 15 |
| human or veterinary use approved by the United States Food and | 16 |
| Drug
Administration.
| 17 |
| (d) "Practice of pharmacy" means (1) the interpretation and | 18 |
| the provision of assistance in the monitoring, evaluation, and | 19 |
| implementation of prescription drug orders; (2) the dispensing | 20 |
| of prescription drug orders; (3) participation in drug and | 21 |
| device selection; (4) drug administration limited to the | 22 |
| administration of oral, topical, injectable, and inhalation as | 23 |
| follows: in the context of patient education on the proper use | 24 |
| or delivery of medications; vaccination of patients 14 years of | 25 |
| age and older pursuant to a valid prescription or standing | 26 |
| order, by a physician licensed to practice medicine in all its |
|
|
|
HB5890 Enrolled |
- 15 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| branches, upon completion of appropriate training, including | 2 |
| how to address contraindications and adverse reactions set | 3 |
| forth by rule, with notification to the patient's physician and | 4 |
| appropriate record retention, or pursuant to hospital pharmacy | 5 |
| and therapeutics committee policies and procedures; (5) drug | 6 |
| regimen review; (6) drug or drug-related research; (7) the | 7 |
| provision of patient counseling; (8) the practice of | 8 |
| telepharmacy; (9) the provision of those acts or services | 9 |
| necessary to provide pharmacist care; (10) medication therapy | 10 |
| management; and (11) the responsibility for compounding and | 11 |
| labeling of drugs and devices (except labeling by a | 12 |
| manufacturer, repackager, or distributor of non-prescription | 13 |
| drugs and commercially packaged legend drugs and devices), | 14 |
| proper and safe storage of drugs and devices, and maintenance | 15 |
| of required records. A pharmacist who performs any of the acts | 16 |
| defined as the practice of pharmacy in this State must be | 17 |
| actively licensed as a pharmacist under this Act.
| 18 |
| (e) "Prescription" means and includes any written, oral, | 19 |
| facsimile, or
electronically transmitted order for drugs
or | 20 |
| medical devices, issued by a physician licensed to practice | 21 |
| medicine in
all its branches, dentist, veterinarian, or | 22 |
| podiatrist, or
optometrist, within the
limits of their | 23 |
| licenses, by a physician assistant in accordance with
| 24 |
| subsection (f) of Section 4, or by an advanced practice nurse | 25 |
| in
accordance with subsection (g) of Section 4, containing the
| 26 |
| following: (l) name
of the patient; (2) date when prescription |
|
|
|
HB5890 Enrolled |
- 16 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| was issued; (3) name
and strength of drug or description of the | 2 |
| medical device prescribed;
and (4) quantity ; , (5) directions | 3 |
| for use ; , (6) prescriber's name,
address ,
and signature ; , and | 4 |
| (7) DEA number where required, for controlled
substances.
The | 5 |
| prescription may, but is not required to, list the illness, | 6 |
| disease, or condition for which the drug or device is being | 7 |
| prescribed. DEA numbers shall not be required on inpatient drug | 8 |
| orders.
| 9 |
| (f) "Person" means and includes a natural person, | 10 |
| copartnership,
association, corporation, government entity, or | 11 |
| any other legal
entity.
| 12 |
| (g) "Department" means the Department of Financial and
| 13 |
| Professional Regulation.
| 14 |
| (h) "Board of Pharmacy" or "Board" means the State Board
of | 15 |
| Pharmacy of the Department of Financial and Professional | 16 |
| Regulation.
| 17 |
| (i) "Secretary"
means the Secretary
of Financial and | 18 |
| Professional Regulation.
| 19 |
| (j) "Drug product selection" means the interchange for a
| 20 |
| prescribed pharmaceutical product in accordance with Section | 21 |
| 25 of
this Act and Section 3.14 of the Illinois Food, Drug and | 22 |
| Cosmetic Act.
| 23 |
| (k) "Inpatient drug order" means an order issued by an | 24 |
| authorized
prescriber for a resident or patient of a facility | 25 |
| licensed under the
Nursing Home Care Act, the MR/DD Community | 26 |
| Care Act, or the Hospital Licensing Act, or "An Act in relation |
|
|
|
HB5890 Enrolled |
- 17 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| to
the founding and operation of the University of Illinois | 2 |
| Hospital and the
conduct of University of Illinois health care | 3 |
| programs", approved July 3, 1931,
as amended, or a facility | 4 |
| which is operated by the Department of Human
Services (as | 5 |
| successor to the Department of Mental Health
and Developmental | 6 |
| Disabilities) or the Department of Corrections.
| 7 |
| (k-5) "Pharmacist" means an individual health care | 8 |
| professional and
provider currently licensed by this State to | 9 |
| engage in the practice of
pharmacy.
| 10 |
| (l) "Pharmacist in charge" means the licensed pharmacist | 11 |
| whose name appears
on a pharmacy license and who is responsible | 12 |
| for all aspects of the
operation related to the practice of | 13 |
| pharmacy.
| 14 |
| (m) "Dispense" or "dispensing" means the interpretation, | 15 |
| evaluation, and implementation of a prescription drug order, | 16 |
| including the preparation and delivery of a drug or device to a | 17 |
| patient or patient's agent in a suitable container | 18 |
| appropriately labeled for subsequent administration to or use | 19 |
| by a patient in accordance with applicable State and federal | 20 |
| laws and regulations.
"Dispense" or "dispensing" does not mean | 21 |
| the physical delivery to a patient or a
patient's | 22 |
| representative in a home or institution by a designee of a | 23 |
| pharmacist
or by common carrier. "Dispense" or "dispensing" | 24 |
| also does not mean the physical delivery
of a drug or medical | 25 |
| device to a patient or patient's representative by a
| 26 |
| pharmacist's designee within a pharmacy or drugstore while the |
|
|
|
HB5890 Enrolled |
- 18 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| pharmacist is
on duty and the pharmacy is open.
| 2 |
| (n) "Nonresident pharmacy"
means a pharmacy that is located | 3 |
| in a state, commonwealth, or territory
of the United States, | 4 |
| other than Illinois, that delivers, dispenses, or
distributes, | 5 |
| through the United States Postal Service, commercially | 6 |
| acceptable parcel delivery service, or other common
carrier, to | 7 |
| Illinois residents, any substance which requires a | 8 |
| prescription.
| 9 |
| (o) "Compounding" means the preparation and mixing of | 10 |
| components, excluding flavorings, (1) as the result of a | 11 |
| prescriber's prescription drug order or initiative based on the | 12 |
| prescriber-patient-pharmacist relationship in the course of | 13 |
| professional practice or (2) for the purpose of, or incident | 14 |
| to, research, teaching, or chemical analysis and not for sale | 15 |
| or dispensing. "Compounding" includes the preparation of drugs | 16 |
| or devices in anticipation of receiving prescription drug | 17 |
| orders based on routine, regularly observed dispensing | 18 |
| patterns. Commercially available products may be compounded | 19 |
| for dispensing to individual patients only if all of the | 20 |
| following conditions are met: (i) the commercial product is not | 21 |
| reasonably available from normal distribution channels in a | 22 |
| timely manner to meet the patient's needs and (ii) the | 23 |
| prescribing practitioner has requested that the drug be | 24 |
| compounded.
| 25 |
| (p) (Blank).
| 26 |
| (q) (Blank).
|
|
|
|
HB5890 Enrolled |
- 19 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| (r) "Patient counseling" means the communication between a | 2 |
| pharmacist or a student pharmacist under the supervision of a | 3 |
| pharmacist and a patient or the patient's representative about | 4 |
| the patient's medication or device for the purpose of | 5 |
| optimizing proper use of prescription medications or devices. | 6 |
| "Patient counseling" may include without limitation (1) | 7 |
| obtaining a medication history; (2) acquiring a patient's | 8 |
| allergies and health conditions; (3) facilitation of the | 9 |
| patient's understanding of the intended use of the medication; | 10 |
| (4) proper directions for use; (5) significant potential | 11 |
| adverse events; (6) potential food-drug interactions; and (7) | 12 |
| the need to be compliant with the medication therapy. A | 13 |
| pharmacy technician may only participate in the following | 14 |
| aspects of patient counseling under the supervision of a | 15 |
| pharmacist: (1) obtaining medication history; (2) providing | 16 |
| the offer for counseling by a pharmacist or student pharmacist; | 17 |
| and (3) acquiring a patient's allergies and health conditions.
| 18 |
| (s) "Patient profiles" or "patient drug therapy record" | 19 |
| means the
obtaining, recording, and maintenance of patient | 20 |
| prescription
information, including prescriptions for | 21 |
| controlled substances, and
personal information.
| 22 |
| (t) (Blank).
| 23 |
| (u) "Medical device" means an instrument, apparatus, | 24 |
| implement, machine,
contrivance, implant, in vitro reagent, or | 25 |
| other similar or related article,
including any component part | 26 |
| or accessory, required under federal law to
bear the label |
|
|
|
HB5890 Enrolled |
- 20 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| "Caution: Federal law requires dispensing by or on the order
of | 2 |
| a physician". A seller of goods and services who, only for the | 3 |
| purpose of
retail sales, compounds, sells, rents, or leases | 4 |
| medical devices shall not,
by reasons thereof, be required to | 5 |
| be a licensed pharmacy.
| 6 |
| (v) "Unique identifier" means an electronic signature, | 7 |
| handwritten
signature or initials, thumb print, or other | 8 |
| acceptable biometric
or electronic identification process as | 9 |
| approved by the Department.
| 10 |
| (w) "Current usual and customary retail price" means the | 11 |
| price that a pharmacy charges to a non-third-party payor.
| 12 |
| (x) "Automated pharmacy system" means a mechanical system | 13 |
| located within the confines of the pharmacy or remote location | 14 |
| that performs operations or activities, other than compounding | 15 |
| or administration, relative to storage, packaging, dispensing, | 16 |
| or distribution of medication, and which collects, controls, | 17 |
| and maintains all transaction information. | 18 |
| (y) "Drug regimen review" means and includes the evaluation | 19 |
| of prescription drug orders and patient records for (1)
known | 20 |
| allergies; (2) drug or potential therapy contraindications;
| 21 |
| (3) reasonable dose, duration of use, and route of | 22 |
| administration, taking into consideration factors such as age, | 23 |
| gender, and contraindications; (4) reasonable directions for | 24 |
| use; (5) potential or actual adverse drug reactions; (6) | 25 |
| drug-drug interactions; (7) drug-food interactions; (8) | 26 |
| drug-disease contraindications; (9) therapeutic duplication; |
|
|
|
HB5890 Enrolled |
- 21 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| (10) patient laboratory values when authorized and available; | 2 |
| (11) proper utilization (including over or under utilization) | 3 |
| and optimum therapeutic outcomes; and (12) abuse and misuse.
| 4 |
| (z) "Electronic transmission prescription" means any | 5 |
| prescription order for which a facsimile or electronic image of | 6 |
| the order is electronically transmitted from a licensed | 7 |
| prescriber to a pharmacy. "Electronic transmission | 8 |
| prescription" includes both data and image prescriptions.
| 9 |
| (aa) "Medication therapy management services" means a | 10 |
| distinct service or group of services offered by licensed | 11 |
| pharmacists, physicians licensed to practice medicine in all | 12 |
| its branches, advanced practice nurses authorized in a written | 13 |
| agreement with a physician licensed to practice medicine in all | 14 |
| its branches, or physician assistants authorized in guidelines | 15 |
| by a supervising physician that optimize therapeutic outcomes | 16 |
| for individual patients through improved medication use. In a | 17 |
| retail or other non-hospital pharmacy, medication therapy | 18 |
| management services shall consist of the evaluation of | 19 |
| prescription drug orders and patient medication records to | 20 |
| resolve conflicts with the following: | 21 |
| (1) known allergies; | 22 |
| (2) drug or potential therapy contraindications; | 23 |
| (3) reasonable dose, duration of use, and route of | 24 |
| administration, taking into consideration factors such as | 25 |
| age, gender, and contraindications; | 26 |
| (4) reasonable directions for use; |
|
|
|
HB5890 Enrolled |
- 22 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| (5) potential or actual adverse drug reactions; | 2 |
| (6) drug-drug interactions; | 3 |
| (7) drug-food interactions; | 4 |
| (8) drug-disease contraindications; | 5 |
| (9) identification of therapeutic duplication; | 6 |
| (10) patient laboratory values when authorized and | 7 |
| available; | 8 |
| (11) proper utilization (including over or under | 9 |
| utilization) and optimum therapeutic outcomes; and | 10 |
| (12) drug abuse and misuse. | 11 |
| "Medication therapy management services" includes the | 12 |
| following: | 13 |
| (1) documenting the services delivered and | 14 |
| communicating the information provided to patients' | 15 |
| prescribers within an appropriate time frame, not to exceed | 16 |
| 48 hours; | 17 |
| (2) providing patient counseling designed to enhance a | 18 |
| patient's understanding and the appropriate use of his or | 19 |
| her medications; and | 20 |
| (3) providing information, support services, and | 21 |
| resources designed to enhance a patient's adherence with | 22 |
| his or her prescribed therapeutic regimens.
| 23 |
| "Medication therapy management services" may also include | 24 |
| patient care functions authorized by a physician licensed to | 25 |
| practice medicine in all its branches for his or her identified | 26 |
| patient or groups of patients under specified conditions or |
|
|
|
HB5890 Enrolled |
- 23 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| limitations in a standing order from the physician. | 2 |
| "Medication therapy management services" in a licensed | 3 |
| hospital may also include the following: | 4 |
| (1) reviewing assessments of the patient's health | 5 |
| status; and | 6 |
| (2) following protocols of a hospital pharmacy and | 7 |
| therapeutics committee with respect to the fulfillment of | 8 |
| medication orders.
| 9 |
| (bb) "Pharmacist care" means the provision by a pharmacist | 10 |
| of medication therapy management services, with or without the | 11 |
| dispensing of drugs or devices, intended to achieve outcomes | 12 |
| that improve patient health, quality of life, and comfort and | 13 |
| enhance patient safety.
| 14 |
| (cc) "Protected health information" means individually | 15 |
| identifiable health information that, except as otherwise | 16 |
| provided, is:
| 17 |
| (1) transmitted by electronic media; | 18 |
| (2) maintained in any medium set forth in the | 19 |
| definition of "electronic media" in the federal Health | 20 |
| Insurance Portability and Accountability Act; or | 21 |
| (3) transmitted or maintained in any other form or | 22 |
| medium. | 23 |
| "Protected health information" does not include individually | 24 |
| identifiable health information found in: | 25 |
| (1) education records covered by the federal Family | 26 |
| Educational Right and Privacy Act; or |
|
|
|
HB5890 Enrolled |
- 24 - |
LRB096 18739 ASK 34124 b |
|
| 1 |
| (2) employment records held by a licensee in its role | 2 |
| as an employer. | 3 |
| (dd) "Standing order" means a specific order for a patient | 4 |
| or group of patients issued by a physician licensed to practice | 5 |
| medicine in all its branches in Illinois. | 6 |
| (ee) "Address of record" means the address recorded by the | 7 |
| Department in the applicant's or licensee's application file or | 8 |
| license file, as maintained by the Department's licensure | 9 |
| maintenance unit. | 10 |
| (ff) "Home pharmacy" means the location of a pharmacy's | 11 |
| primary operations.
| 12 |
| (Source: P.A. 95-689, eff. 10-29-07; 96-339, eff. 7-1-10; | 13 |
| 96-673, eff. 1-1-10; revised 10-1-09.)
| 14 |
| Section 99. Effective date. This Act takes effect upon | 15 |
| becoming law.
|
|