Full Text of SB3513 97th General Assembly
SB3513 97TH GENERAL ASSEMBLY |
| | 97TH GENERAL ASSEMBLY
State of Illinois
2011 and 2012 SB3513 Introduced 2/8/2012, by Sen. Iris Y. Martinez SYNOPSIS AS INTRODUCED: |
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Amends the Pharmacy Practice Act. Changes the definition of "practice of pharmacy" to permit a pharmacist to vaccinate a patient 7 years (instead of 14 years) of age and older pursuant to a valid prescription or standing order. Effective immediately.
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| | A BILL FOR |
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| 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| 7 | | (Section scheduled to be repealed on January 1, 2018)
| 8 | | Sec. 3. Definitions. For the purpose of this Act, except | 9 | | where otherwise
limited therein:
| 10 | | (a) "Pharmacy" or "drugstore" means and includes every | 11 | | store, shop,
pharmacy department, or other place where | 12 | | pharmacist
care is
provided
by a pharmacist (1) where drugs, | 13 | | medicines, or poisons are
dispensed, sold or
offered for sale | 14 | | at retail, or displayed for sale at retail; or
(2)
where
| 15 | | prescriptions of physicians, dentists, advanced practice | 16 | | nurses, physician assistants, veterinarians, podiatrists, or
| 17 | | optometrists, within the limits of their
licenses, are
| 18 | | compounded, filled, or dispensed; or (3) which has upon it or
| 19 | | displayed within
it, or affixed to or used in connection with | 20 | | it, a sign bearing the word or
words "Pharmacist", "Druggist", | 21 | | "Pharmacy", "Pharmaceutical
Care", "Apothecary", "Drugstore",
| 22 | | "Medicine Store", "Prescriptions", "Drugs", "Dispensary", | 23 | | "Medicines", or any word
or words of similar or like import, |
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| 1 | | either in the English language
or any other language; or (4) | 2 | | where the characteristic prescription
sign (Rx) or similar | 3 | | design is exhibited; or (5) any store, or
shop,
or other place | 4 | | with respect to which any of the above words, objects,
signs or | 5 | | designs are used in any advertisement.
| 6 | | (b) "Drugs" means and includes (l) articles recognized
in | 7 | | the official United States Pharmacopoeia/National Formulary | 8 | | (USP/NF),
or any supplement thereto and being intended for and | 9 | | having for their
main use the diagnosis, cure, mitigation, | 10 | | treatment or prevention of
disease in man or other animals, as | 11 | | approved by the United States Food and
Drug Administration, but | 12 | | does not include devices or their components, parts,
or | 13 | | accessories; and (2) all other articles intended
for and having | 14 | | for their main use the diagnosis, cure, mitigation,
treatment | 15 | | or prevention of disease in man or other animals, as approved
| 16 | | by the United States Food and Drug Administration, but does not | 17 | | include
devices or their components, parts, or accessories; and | 18 | | (3) articles
(other than food) having for their main use and | 19 | | intended
to affect the structure or any function of the body of | 20 | | man or other
animals; and (4) articles having for their main | 21 | | use and intended
for use as a component or any articles | 22 | | specified in clause (l), (2)
or (3); but does not include | 23 | | devices or their components, parts or
accessories.
| 24 | | (c) "Medicines" means and includes all drugs intended for
| 25 | | human or veterinary use approved by the United States Food and | 26 | | Drug
Administration.
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| 1 | | (d) "Practice of pharmacy" means (1) the interpretation and | 2 | | the provision of assistance in the monitoring, evaluation, and | 3 | | implementation of prescription drug orders; (2) the dispensing | 4 | | of prescription drug orders; (3) participation in drug and | 5 | | device selection; (4) drug administration limited to the | 6 | | administration of oral, topical, injectable, and inhalation as | 7 | | follows: in the context of patient education on the proper use | 8 | | or delivery of medications; vaccination of patients 7 14 years | 9 | | of age and older pursuant to a valid prescription or standing | 10 | | order, by a physician licensed to practice medicine in all its | 11 | | branches, upon completion of appropriate training, including | 12 | | how to address contraindications and adverse reactions set | 13 | | forth by rule, with notification to the patient's physician and | 14 | | appropriate record retention, or pursuant to hospital pharmacy | 15 | | and therapeutics committee policies and procedures; (5) drug | 16 | | regimen review; (6) drug or drug-related research; (7) the | 17 | | provision of patient counseling; (8) the practice of | 18 | | telepharmacy; (9) the provision of those acts or services | 19 | | necessary to provide pharmacist care; (10) medication therapy | 20 | | management; and (11) the responsibility for compounding and | 21 | | labeling of drugs and devices (except labeling by a | 22 | | manufacturer, repackager, or distributor of non-prescription | 23 | | drugs and commercially packaged legend drugs and devices), | 24 | | proper and safe storage of drugs and devices, and maintenance | 25 | | of required records. A pharmacist who performs any of the acts | 26 | | defined as the practice of pharmacy in this State must be |
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| 1 | | actively licensed as a pharmacist under this Act.
| 2 | | (e) "Prescription" means and includes any written, oral, | 3 | | facsimile, or
electronically transmitted order for drugs
or | 4 | | medical devices, issued by a physician licensed to practice | 5 | | medicine in
all its branches, dentist, veterinarian, or | 6 | | podiatrist, or
optometrist, within the
limits of their | 7 | | licenses, by a physician assistant in accordance with
| 8 | | subsection (f) of Section 4, or by an advanced practice nurse | 9 | | in
accordance with subsection (g) of Section 4, containing the
| 10 | | following: (l) name
of the patient; (2) date when prescription | 11 | | was issued; (3) name
and strength of drug or description of the | 12 | | medical device prescribed;
and (4) quantity; (5) directions for | 13 | | use; (6) prescriber's name,
address,
and signature; and (7) DEA | 14 | | number where required, for controlled
substances.
The | 15 | | prescription may, but is not required to, list the illness, | 16 | | disease, or condition for which the drug or device is being | 17 | | prescribed. DEA numbers shall not be required on inpatient drug | 18 | | orders.
| 19 | | (f) "Person" means and includes a natural person, | 20 | | copartnership,
association, corporation, government entity, or | 21 | | any other legal
entity.
| 22 | | (g) "Department" means the Department of Financial and
| 23 | | Professional Regulation.
| 24 | | (h) "Board of Pharmacy" or "Board" means the State Board
of | 25 | | Pharmacy of the Department of Financial and Professional | 26 | | Regulation.
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| 1 | | (i) "Secretary"
means the Secretary
of Financial and | 2 | | Professional Regulation.
| 3 | | (j) "Drug product selection" means the interchange for a
| 4 | | prescribed pharmaceutical product in accordance with Section | 5 | | 25 of
this Act and Section 3.14 of the Illinois Food, Drug and | 6 | | Cosmetic Act.
| 7 | | (k) "Inpatient drug order" means an order issued by an | 8 | | authorized
prescriber for a resident or patient of a facility | 9 | | licensed under the
Nursing Home Care Act, the ID/DD Community | 10 | | Care Act, the Specialized Mental Health Rehabilitation Act, or | 11 | | the Hospital Licensing Act, or "An Act in relation to
the | 12 | | founding and operation of the University of Illinois Hospital | 13 | | and the
conduct of University of Illinois health care | 14 | | programs", approved July 3, 1931,
as amended, or a facility | 15 | | which is operated by the Department of Human
Services (as | 16 | | successor to 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, |
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| 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 |
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| 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 |
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| 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, |
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| 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 |
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| 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 |
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| 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 |
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| 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. 96-339, eff. 7-1-10; 96-673, eff. 1-1-10; | 24 | | 96-1000, eff. 7-2-10; 96-1353, eff. 7-28-10; 97-38, eff. | 25 | | 6-28-11; 97-227, eff. 1-1-12; revised 10-4-11.)
| 26 | | Section 99. Effective date. This Act takes effect upon |
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| 1 | | becoming law.
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