Full Text of HB5747 100th General Assembly
HB5747 100TH GENERAL ASSEMBLY |
| | 100TH GENERAL ASSEMBLY
State of Illinois
2017 and 2018 HB5747 Introduced , by Rep. Michelle Mussman SYNOPSIS AS INTRODUCED: |
| 225 ILCS 85/3 | | 225 ILCS 85/19.7 new | |
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Amends the Pharmacy Practice Act. Provides that "practice of pharmacy" includes the prescribing and dispensing of hormonal contraceptive patches and self-administered oral hormonal contraceptives. Defines "hormonal contraceptive patch" as a transdermal patch applied to the skin of a patient, by the patient or by a practitioner, that releases a drug composed of a combination of hormones that is approved by the United States Food and Drug Administration to prevent pregnancy and "self-administered oral hormonal contraceptive" as a drug composed of a combination of hormones that is approved by the United States Food and Drug Administration to prevent pregnancy and that the patient to whom the drug is prescribed may take orally. Allows pharmacists to prescribe and dispense contraceptives to a person over 18 years of age and a person under 18 years of age only if the person has evidence of a previous prescription from a primary care or a women's health care practitioner. Requires the Department of Financial and Professional Regulation to adopt rules to establish standard procedures for pharmacists to prescribe contraceptives. Provides requirements for the rules to be adopted by the Department. Provides that all State and federal laws governing insurance coverage of contraceptive drugs and products shall apply to the provisions.
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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 and by adding Section 19.7 as follows:
| 6 | | (225 ILCS 85/3)
| 7 | | (Section scheduled to be repealed on January 1, 2020)
| 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 | | registered nurses, physician assistants, veterinarians, | 17 | | podiatric physicians, or
optometrists, within the limits of | 18 | | their
licenses, are
compounded, filled, or dispensed; or (3) | 19 | | which has upon it or
displayed within
it, or affixed to or used | 20 | | in connection with it, a sign bearing the word or
words | 21 | | "Pharmacist", "Druggist", "Pharmacy", "Pharmaceutical
Care", | 22 | | "Apothecary", "Drugstore",
"Medicine Store", "Prescriptions", | 23 | | "Drugs", "Dispensary", "Medicines", or any word
or words of |
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| 1 | | similar or like import, either in the English language
or any | 2 | | other language; or (4) where the characteristic prescription
| 3 | | sign (Rx) or similar design is exhibited; or (5) any store, or
| 4 | | shop,
or other place with respect to which any of the above | 5 | | words, objects,
signs or designs are used in any advertisement.
| 6 | | (b) "Drugs" means and includes (1) 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 (1), (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: | 2 | | (1) the interpretation and the provision of assistance | 3 | | in the monitoring, evaluation, and implementation of | 4 | | prescription drug orders; | 5 | | (2) the dispensing of prescription drug orders; | 6 | | (3) participation in drug and device selection; | 7 | | (4) drug administration limited to the administration | 8 | | of oral, topical, injectable, and inhalation as follows: | 9 | | (A) in the context of patient education on the | 10 | | proper use or delivery of medications; | 11 | | (B) vaccination of patients 14 years of age and | 12 | | older pursuant to a valid prescription or standing | 13 | | order, by a physician licensed to practice medicine in | 14 | | all its branches, upon completion of appropriate | 15 | | training, including how to address contraindications | 16 | | and adverse reactions set forth by rule, with | 17 | | notification to the patient's physician and | 18 | | appropriate record retention, or pursuant to hospital | 19 | | pharmacy and therapeutics committee policies and | 20 | | procedures; and | 21 | | (C) administration of injections of | 22 | | alpha-hydroxyprogesterone caproate, pursuant to a | 23 | | valid prescription, by a physician licensed to | 24 | | practice medicine in all its branches, upon completion | 25 | | of appropriate training, including how to address | 26 | | contraindications and adverse reactions set forth by |
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| 1 | | rule, with notification to the patient's physician and | 2 | | appropriate record retention, or pursuant to hospital | 3 | | pharmacy and therapeutics committee policies and | 4 | | procedures; | 5 | | (5) vaccination of patients ages 10 through 13 limited | 6 | | to the Influenza (inactivated influenza vaccine and live | 7 | | attenuated influenza intranasal vaccine) and Tdap (defined | 8 | | as tetanus, diphtheria, acellular pertussis) vaccines, | 9 | | pursuant to a valid prescription or standing order, by a | 10 | | physician licensed to practice medicine in all its | 11 | | branches, upon completion of appropriate training, | 12 | | including how to address contraindications and adverse | 13 | | reactions set forth by rule, with notification to the | 14 | | patient's physician and appropriate record retention, or | 15 | | pursuant to hospital pharmacy and therapeutics committee | 16 | | policies and procedures; | 17 | | (6) drug regimen review; | 18 | | (7) drug or drug-related research; | 19 | | (8) the provision of patient counseling; | 20 | | (9) the practice of telepharmacy; | 21 | | (10) the provision of those acts or services necessary | 22 | | to provide pharmacist care; | 23 | | (11) medication therapy management; and | 24 | | (12) the responsibility for compounding and labeling | 25 | | of drugs and devices (except labeling by a manufacturer, | 26 | | repackager, or distributor of non-prescription drugs and |
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| 1 | | commercially packaged legend drugs and devices), proper | 2 | | and safe storage of drugs and devices, and maintenance of | 3 | | required records ; and . | 4 | | (13) the prescribing and dispensing of hormonal | 5 | | contraceptive patches and self-administered oral hormonal | 6 | | contraceptives. | 7 | | A pharmacist who performs any of the acts defined as the | 8 | | practice of pharmacy in this State must be actively licensed as | 9 | | a pharmacist under this Act.
| 10 | | (e) "Prescription" means and includes any written, oral, | 11 | | facsimile, or
electronically transmitted order for drugs
or | 12 | | medical devices, issued by a physician licensed to practice | 13 | | medicine in
all its branches, dentist, veterinarian, podiatric | 14 | | physician, or
optometrist, within the
limits of his or her | 15 | | license their licenses , by a physician assistant in accordance | 16 | | with
subsection (f) of Section 4, or by an advanced practice | 17 | | registered nurse in
accordance with subsection (g) of Section | 18 | | 4, containing the
following: (1) name
of the patient; (2) date | 19 | | when prescription was issued; (3) name
and strength of drug or | 20 | | description of the medical device prescribed;
and (4) quantity; | 21 | | (5) directions for use; (6) prescriber's name,
address,
and | 22 | | signature; and (7) DEA registration number where required, for | 23 | | controlled
substances.
The prescription may, but is not | 24 | | required to, list the illness, disease, or condition for which | 25 | | the drug or device is being prescribed. DEA registration | 26 | | numbers shall not be required on inpatient drug orders.
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| 1 | | (f) "Person" means and includes a natural person, | 2 | | partnership,
association, corporation, government entity, or | 3 | | any other legal
entity.
| 4 | | (g) "Department" means the Department of Financial and
| 5 | | Professional Regulation.
| 6 | | (h) "Board of Pharmacy" or "Board" means the State Board
of | 7 | | Pharmacy of the Department of Financial and Professional | 8 | | Regulation.
| 9 | | (i) "Secretary"
means the Secretary
of Financial and | 10 | | Professional Regulation.
| 11 | | (j) "Drug product selection" means the interchange for a
| 12 | | prescribed pharmaceutical product in accordance with Section | 13 | | 25 of
this Act and Section 3.14 of the Illinois Food, Drug and | 14 | | Cosmetic Act.
| 15 | | (k) "Inpatient drug order" means an order issued by an | 16 | | authorized
prescriber for a resident or patient of a facility | 17 | | licensed under the
Nursing Home Care Act, the ID/DD Community | 18 | | Care Act, the MC/DD Act, the Specialized Mental Health | 19 | | Rehabilitation Act of 2013, the Hospital Licensing Act, or the | 20 | | University of Illinois Hospital Act "An Act in relation to
the | 21 | | founding and operation of the University of Illinois Hospital | 22 | | 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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| 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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| 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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| 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" or "device" means an instrument, | 18 | | apparatus, implement, machine,
contrivance, implant, in vitro | 19 | | reagent, or other similar or related article,
including any | 20 | | component part or accessory, required under federal law to
bear | 21 | | the label "Caution: Federal law requires dispensing by or on | 22 | | the order
of a physician". A seller of goods and services who, | 23 | | only for the purpose of
retail sales, compounds, sells, rents, | 24 | | or leases medical devices shall not,
by reasons thereof, be | 25 | | required to be a licensed pharmacy.
| 26 | | (v) "Unique identifier" means an electronic signature, |
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| 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) "Electronically transmitted prescription" means a | 25 | | prescription that is created, recorded, or stored by electronic | 26 | | means; issued and validated with an electronic signature; and |
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| 1 | | transmitted by electronic means directly from the prescriber to | 2 | | a pharmacy. An electronic prescription is not an image of a | 3 | | physical prescription that is transferred by electronic means | 4 | | from computer to computer, facsimile to facsimile, or facsimile | 5 | | to computer.
| 6 | | (aa) "Medication therapy management services" means a | 7 | | distinct service or group of services offered by licensed | 8 | | pharmacists, physicians licensed to practice medicine in all | 9 | | its branches, advanced practice registered nurses authorized | 10 | | in a written agreement with a physician licensed to practice | 11 | | medicine in all its branches, or physician assistants | 12 | | authorized in guidelines by a supervising physician that | 13 | | optimize therapeutic outcomes for individual patients through | 14 | | improved medication use. In a retail or other non-hospital | 15 | | pharmacy, medication therapy management services shall consist | 16 | | of the evaluation of prescription drug orders and patient | 17 | | medication records to resolve conflicts with the following: | 18 | | (1) known allergies; | 19 | | (2) drug or potential therapy contraindications; | 20 | | (3) reasonable dose, duration of use, and route of | 21 | | administration, taking into consideration factors such as | 22 | | age, gender, and contraindications; | 23 | | (4) reasonable directions for use; | 24 | | (5) potential or actual adverse drug reactions; | 25 | | (6) drug-drug interactions; | 26 | | (7) drug-food interactions; |
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| 1 | | (8) drug-disease contraindications; | 2 | | (9) identification of therapeutic duplication; | 3 | | (10) patient laboratory values when authorized and | 4 | | available; | 5 | | (11) proper utilization (including over or under | 6 | | utilization) and optimum therapeutic outcomes; and | 7 | | (12) drug abuse and misuse. | 8 | | "Medication therapy management services" includes the | 9 | | following: | 10 | | (1) documenting the services delivered and | 11 | | communicating the information provided to patients' | 12 | | prescribers within an appropriate time frame, not to exceed | 13 | | 48 hours; | 14 | | (2) providing patient counseling designed to enhance a | 15 | | patient's understanding and the appropriate use of his or | 16 | | her medications; and | 17 | | (3) providing information, support services, and | 18 | | resources designed to enhance a patient's adherence with | 19 | | his or her prescribed therapeutic regimens. | 20 | | "Medication therapy management services" may also include | 21 | | patient care functions authorized by a physician licensed to | 22 | | practice medicine in all its branches for his or her identified | 23 | | patient or groups of patients under specified conditions or | 24 | | limitations in a standing order from the physician. | 25 | | "Medication therapy management services" in a licensed | 26 | | hospital may also include the following: |
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| 1 | | (1) reviewing assessments of the patient's health | 2 | | status; and | 3 | | (2) following protocols of a hospital pharmacy and | 4 | | therapeutics committee with respect to the fulfillment of | 5 | | medication orders.
| 6 | | (bb) "Pharmacist care" means the provision by a pharmacist | 7 | | of medication therapy management services, with or without the | 8 | | dispensing of drugs or devices, intended to achieve outcomes | 9 | | that improve patient health, quality of life, and comfort and | 10 | | enhance patient safety.
| 11 | | (cc) "Protected health information" means individually | 12 | | identifiable health information that, except as otherwise | 13 | | provided, is:
| 14 | | (1) transmitted by electronic media; | 15 | | (2) maintained in any medium set forth in the | 16 | | definition of "electronic media" in the federal Health | 17 | | Insurance Portability and Accountability Act; or | 18 | | (3) transmitted or maintained in any other form or | 19 | | medium. | 20 | | "Protected health information" does not include | 21 | | individually identifiable health information found in: | 22 | | (1) education records covered by the federal Family | 23 | | Educational Right and Privacy Act; or | 24 | | (2) employment records held by a licensee in its role | 25 | | as an employer. | 26 | | (dd) "Standing order" means a specific order for a patient |
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| 1 | | or group of patients issued by a physician licensed to practice | 2 | | medicine in all its branches in Illinois. | 3 | | (ee) "Address of record" means the designated address | 4 | | recorded by the Department in the applicant's application file | 5 | | or licensee's license file maintained by the Department's | 6 | | licensure maintenance unit. | 7 | | (ff) "Home pharmacy" means the location of a pharmacy's | 8 | | primary operations.
| 9 | | (gg) "Email address of record" means the designated email | 10 | | address recorded by the Department in the applicant's | 11 | | application file or the licensee's license file, as maintained | 12 | | by the Department's licensure maintenance unit. | 13 | | (Source: P.A. 99-180, eff. 7-29-15; 100-208, eff. 1-1-18; | 14 | | 100-497, eff. 9-8-17; 100-513, eff. 1-1-18; revised 9-29-17.) | 15 | | (225 ILCS 85/19.7 new) | 16 | | Sec. 19.7. Contraceptive drugs and products. | 17 | | (a) As used in this Section: | 18 | | "Hormonal contraceptive patch" means a transdermal patch | 19 | | applied to the skin of a patient, by the patient or by a | 20 | | practitioner, that releases a drug composed of a combination of | 21 | | hormones that is approved by the United States Food and Drug | 22 | | Administration to prevent pregnancy. | 23 | | "Self-administered oral hormonal contraceptives" means a | 24 | | drug composed of a combination of hormones that is approved by | 25 | | the United States Food and Drug Administration to prevent |
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| 1 | | pregnancy and that the patient to whom the drug is prescribed | 2 | | may take orally. | 3 | | (b) A pharmacist may prescribe and dispense hormonal | 4 | | contraceptive patches and self-administered oral hormonal | 5 | | contraceptives to a person who is: | 6 | | (1) at least 18 years of age, regardless of whether the | 7 | | person has evidence of a previous prescription from a | 8 | | primary care practitioner or a women's health care | 9 | | practitioner for a hormonal contraceptive patch or | 10 | | self-administered oral hormonal contraceptive; or | 11 | | (2) under 18 years of age only if the person has | 12 | | evidence of a previous prescription from a primary care | 13 | | practitioner or a women's health care practitioner for a | 14 | | hormonal contraceptive patch or self-administered oral | 15 | | hormonal contraceptive. | 16 | | (c) The Department shall adopt rules to establish, in | 17 | | consideration of guidelines established by the American | 18 | | Congress of Obstetricians and Gynecologists, standard | 19 | | procedures for the prescribing of hormonal contraceptive | 20 | | patches and self-administered oral hormonal contraceptives by | 21 | | pharmacists. | 22 | | (d) The rules adopted under this Section must require a | 23 | | pharmacist to: | 24 | | (1) complete a training program approved by the | 25 | | Department that is related to prescribing hormonal | 26 | | contraceptive patches and self-administered oral hormonal |
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| 1 | | contraceptives; | 2 | | (2) provide a self-screening risk assessment tool that | 3 | | the patient must use prior to the pharmacist's prescribing | 4 | | the hormonal contraceptive patch or self-administered oral | 5 | | hormonal contraceptive; | 6 | | (3) refer the patient to the patient's primary care | 7 | | practitioner or women's health care practitioner upon | 8 | | prescribing and dispensing the hormonal contraceptive | 9 | | patch or self-administered oral hormonal contraceptive; | 10 | | (4) provide the patient with a written record of the | 11 | | hormonal contraceptive patch or self-administered oral | 12 | | hormonal contraceptive prescribed and dispensed and advise | 13 | | the patient to consult with a primary care practitioner or | 14 | | women's health care practitioner; and | 15 | | (5) dispense the hormonal contraceptive patch or | 16 | | self-administered oral hormonal contraceptive to the | 17 | | patient as soon as practicable after the pharmacist issues | 18 | | the prescription. | 19 | | (e) The rules adopted under this Section must prohibit a | 20 | | pharmacist from: | 21 | | (1) requiring a patient to schedule an appointment with | 22 | | the pharmacist for the prescribing or dispensing of a | 23 | | hormonal contraceptive patch or self-administered oral | 24 | | hormonal contraceptive; and | 25 | | (2) prescribing and dispensing a hormonal | 26 | | contraceptive patch or self-administered oral hormonal |
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| 1 | | contraceptive to a patient who does not have evidence of a | 2 | | clinical visit for women's health within the 3 years | 3 | | immediately following the initial prescription and | 4 | | dispensation of a hormonal contraceptive patch or | 5 | | self-administered oral hormonal contraceptive by a | 6 | | pharmacist to the patient. | 7 | | (f) All State and federal laws governing insurance coverage | 8 | | of contraceptive drugs, devices, products, and services shall | 9 | | apply to hormonal contraceptive patches and self-administered | 10 | | oral hormonal contraceptives prescribed by a pharmacist under | 11 | | this Section.
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