Full Text of HB1077 095th General Assembly
HB1077eng 95TH GENERAL ASSEMBLY
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LRB095 03803 RAS 23834 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 Medical Practice Act of 1987 is amended by | 5 |
| changing Section 54.5 as follows:
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| (225 ILCS 60/54.5)
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| (Section scheduled to be repealed on December 31, 2008)
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| Sec. 54.5. Physician delegation of authority.
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| (a) Physicians licensed to practice medicine in all its
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| branches may delegate care and treatment responsibilities to a
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| physician assistant under guidelines in accordance with the
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| requirements of the Physician Assistant Practice Act of
1987. A | 13 |
| physician licensed to practice medicine in all its
branches may | 14 |
| enter into supervising physician agreements with
no more than 2 | 15 |
| physician assistants.
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| (b) A physician licensed to practice medicine in all its
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| branches in active clinical practice may collaborate with an | 18 |
| advanced practice
nurse in accordance with the requirements of | 19 |
| Title 15 of
the Nursing and Advanced Practice Nursing Act. | 20 |
| Collaboration
is for the purpose of providing medical | 21 |
| direction,
and no employment relationship is required. A
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| written collaborative agreement shall
conform to the | 23 |
| requirements of Sections 15-15 and 15-20
of the Nursing and
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| Advanced Practice Nursing Act. The written collaborative | 2 |
| agreement shall
be for
services the collaborating physician | 3 |
| generally provides to
his or her patients in the normal course | 4 |
| of clinical medical practice.
Physician medical direction | 5 |
| shall be adequate with respect to collaboration
with certified | 6 |
| nurse practitioners, certified nurse midwives, and clinical
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| nurse
specialists if a collaborating physician:
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| (1) participates in the joint formulation and joint | 9 |
| approval of orders or
guidelines with the advanced practice | 10 |
| nurse and periodically reviews such
orders and the services
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| provided patients under such orders in accordance with | 12 |
| accepted standards of
medical practice and advanced | 13 |
| practice nursing practice;
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| (2) is on site at least once a month to provide medical | 15 |
| direction and
consultation; and
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| (3) is available through telecommunications for | 17 |
| consultation on medical
problems, complications, or | 18 |
| emergencies or patient referral.
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| (b-1) A physician licensed to practice medicine in all its | 20 |
| branches in active clinical practice may collaborate with a | 21 |
| pharmacist for the purposes of emergency contraception drug | 22 |
| therapy initiation, in accordance with the requirements of | 23 |
| Section 22b of the Pharmacy Practice Act of 1987.
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| (b-5) An anesthesiologist or physician licensed to | 25 |
| practice medicine in
all its branches may collaborate with a | 26 |
| certified registered nurse anesthetist
in accordance with |
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| Section 15-25 of the Nursing and Advanced Practice Nursing
Act. | 2 |
| Medical direction for a certified registered nurse anesthetist | 3 |
| shall be
adequate if:
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| (1) an anesthesiologist or a physician
participates in | 5 |
| the joint formulation and joint approval of orders or
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| guidelines and periodically reviews such orders and the | 7 |
| services provided
patients under such orders; and
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| (2) for anesthesia services, the anesthesiologist
or | 9 |
| physician participates through discussion of and agreement | 10 |
| with the
anesthesia plan and is physically present and | 11 |
| available on the premises during
the delivery of anesthesia | 12 |
| services for
diagnosis, consultation, and treatment of | 13 |
| emergency medical conditions.
Anesthesia services in a | 14 |
| hospital shall be conducted in accordance with
Section 10.7 | 15 |
| of the Hospital Licensing Act and in an ambulatory surgical
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| treatment center in accordance with Section 6.5 of the | 17 |
| Ambulatory Surgical
Treatment Center Act.
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| (b-10) The anesthesiologist or operating physician must | 19 |
| agree with the
anesthesia plan prior to the delivery of | 20 |
| services.
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| (c) The supervising physician shall have access to the
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| medical records of all patients attended by a physician
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| assistant. The collaborating physician shall have access to
the | 24 |
| medical records of all patients attended to by an
advanced | 25 |
| practice nurse.
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| (d) Nothing in this Act
shall be construed to limit the |
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| delegation of
tasks or duties by a physician licensed to | 2 |
| practice medicine
in all its branches to a licensed practical | 3 |
| nurse, a registered professional
nurse, or other personnel.
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| (e) A physician shall not be liable for the acts or
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| omissions of a physician assistant or advanced practice
nurse | 6 |
| solely on the basis of having signed a
supervision agreement or | 7 |
| guidelines or a collaborative
agreement, an order, a standing | 8 |
| medical order, a
standing delegation order, or other order or | 9 |
| guideline
authorizing a physician assistant or advanced | 10 |
| practice
nurse to perform acts, unless the physician has
reason | 11 |
| to believe the physician assistant or advanced
practice nurse | 12 |
| lacked the competency to perform
the act or acts or commits | 13 |
| willful and wanton misconduct.
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| (Source: P.A. 90-742, eff. 8-13-98; 91-414, eff. 8-6-99 .)
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| Section 10. The Pharmacy Practice Act of 1987 is amended by | 16 |
| adding Section 22b as follows: | 17 |
| (225 ILCS 85/22b new) | 18 |
| Sec. 22b. Emergency contraception drug therapy. | 19 |
| (a) The General Assembly finds the following: | 20 |
| (1) Unintended pregnancies are a major public health | 21 |
| concern affecting individuals and society in general. Each | 22 |
| year, about 3,500,000 unintended pregnancies occur in this | 23 |
| country, half of which result from contraceptive failure or | 24 |
| inadequate contraceptive technique. |
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| (2) Emergency contraception is a highly cost-effective | 2 |
| method of reducing unintended pregnancies and is most | 3 |
| effective the earlier it is used. However, there are often | 4 |
| significant barriers to women obtaining emergency | 5 |
| contraception in a timely manner. | 6 |
| (3) The American College of Obstetricians and | 7 |
| Gynecologists, the American Academy of Pediatrics, the | 8 |
| American Medical Association, the American Public Health | 9 |
| Association, and more than 50 other national organizations | 10 |
| support increased access to emergency contraception. | 11 |
| The purpose of this Section is to establish collaborative | 12 |
| practice between pharmacists and authorized prescribers that | 13 |
| will enable pharmacists with appropriate training and who are | 14 |
| working in collaboration with an authorized prescriber to | 15 |
| initiate emergency contraception drug therapy in order to | 16 |
| increase timely access to emergency contraception. | 17 |
| (b) For the purposes of this Section: | 18 |
| "Authorized prescriber" means a "prescriber", as that | 19 |
| term is defined in Section 102 of the Illinois Controlled | 20 |
| Substances Act, who is authorized by the laws of this State | 21 |
| to prescribe drugs. | 22 |
| "Collaborative agreement" means an arrangement between | 23 |
| a pharmacist and an authorized prescriber that authorizes | 24 |
| the pharmacist to dispense emergency contraception to | 25 |
| either the patients of the authorized prescriber or | 26 |
| individuals who are not the patients of the authorized |
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| prescriber. | 2 |
| "Emergency contraception" means a drug that is (i) used | 3 |
| after intercourse; (ii) an elevated dose of hormones used | 4 |
| to prevent pregnancy; (iii) approved by the United States | 5 |
| Food and Drug Administration; and (iv) requires a | 6 |
| prescription. | 7 |
| "Protocol" means a written agreement between a pharmacist | 8 |
| or group of pharmacists and a licensed physician or group of | 9 |
| physicians that delegates prescriptive authority. | 10 |
| "Initiate" means to dispense emergency contraception under | 11 |
| a collaborative practice as outlined in this Section. | 12 |
| (c) Notwithstanding any other provision of law, a licensed | 13 |
| pharmacist who has completed the training required in this | 14 |
| Section may initiate emergency contraception drug therapy in | 15 |
| accordance with protocols developed by the pharmacist and an | 16 |
| authorized prescriber. Nothing in this Section shall be | 17 |
| construed to authorize collaborative practice between a | 18 |
| pharmacist and an authorized prescriber for any drugs other | 19 |
| than emergency contraception. Collaboration is for the purpose | 20 |
| of providing medical direction, and no employment relationship | 21 |
| is required. | 22 |
| (d) A pharmacist planning to initiate emergency | 23 |
| contraception drug therapy in his or her practice shall have on | 24 |
| file at his or her place of practice written protocol. The | 25 |
| protocol shall authorize a pharmacist to initiate emergency | 26 |
| contraception drug therapy and shall be established and |
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| approved by an authorized prescriber in accordance with rules | 2 |
| adopted by the Department. A copy of the written protocol shall | 3 |
| be on file with the Department. | 4 |
| (e) The protocol required by subsection (d) of this Section | 5 |
| shall include all of the following: | 6 |
| (1) A statement identifying the authorized prescriber | 7 |
| and the pharmacist who are parties to the protocol. | 8 |
| (2) A statement that the protocol is limited to the | 9 |
| initiation of emergency contraception drug therapy. | 10 |
| (3) A general statement of the procedures, decision | 11 |
| criteria, or plan the pharmacist is to follow when | 12 |
| initiating emergency contraception drug therapy. | 13 |
| (4) A statement of the activities the pharmacist is to | 14 |
| follow in the course of initiating emergency contraception | 15 |
| drug therapy, including documentation of decisions made | 16 |
| and a plan for communication or feedback to the licensed | 17 |
| physician concerning specific decisions made. | 18 |
| Documentation may occur on the prescriptive record, | 19 |
| patient profile, patient medical chart, or in a separate | 20 |
| log book. | 21 |
| (5) A statement that describes appropriate mechanisms | 22 |
| for reporting to the authorized prescriber monitoring | 23 |
| activities and results. | 24 |
| (6) A statement that describes how the licensed | 25 |
| physician will review the documentation and records made by | 26 |
| the pharmacist and that such review shall occur at least |
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| once every 3 months. | 2 |
| (7) A time period, not to exceed 2 years, during which | 3 |
| the written protocol will be in effect. | 4 |
| (f) Documentation related to the protocol must be | 5 |
| maintained for at least 3 years. | 6 |
| (g) The authorized prescriber shall review the | 7 |
| documentation and records made by the pharmacist and this | 8 |
| review shall occur at least once every 3 months during the time | 9 |
| in which the protocol is in effect. | 10 |
| (h) The protocol may be terminated upon written notice by | 11 |
| the authorized prescriber or pharmacist. The pharmacist shall | 12 |
| notify the Department in writing within 30 days after such | 13 |
| termination. | 14 |
| (i) The protocol shall be limited in duration to not more | 15 |
| than 2 years but shall be renewable pursuant to agreement | 16 |
| between the authorized prescriber and the pharmacist. | 17 |
| (j) Any modification to the protocol must be approved by | 18 |
| the Department as required by this Section for new protocols. | 19 |
| (k) The pharmacist must successfully complete a course of | 20 |
| training in the subject area of emergency contraception drug | 21 |
| therapy provided by (i) the Department of Public Health, (ii) | 22 |
| the American Council on Pharmaceutical Education (ACPE), or | 23 |
| (iii) a similar health authority, community organization, or | 24 |
| professional body approved by the Department. | 25 |
| Training must include study materials and instruction in | 26 |
| the following content areas: |
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| (1) current standards for prescribing emergency | 2 |
| contraception drug therapy; | 3 |
| (2) indications for the use of emergency contraception | 4 |
| drug therapy; | 5 |
| (3) interviewing the patient to establish need for | 6 |
| emergency contraception drug therapy, including sensitive | 7 |
| communication with the patient; | 8 |
| (4) patient counseling regarding the safety, efficacy, | 9 |
| and potential adverse effects of emergency contraception; | 10 |
| (5) referring patient for follow-up care with a health | 11 |
| care provider; | 12 |
| (6) informed consent; | 13 |
| (7) documentation and record management; and | 14 |
| (8) management of adverse events, including | 15 |
| identification, appropriate response, documentation, and | 16 |
| reporting. | 17 |
| (l) Any pharmacist initiating emergency contraception drug | 18 |
| therapy shall complete approved continuing education related | 19 |
| to emergency contraception drug therapy every 2 years. | 20 |
| (m) For each emergency contraception drug therapy | 21 |
| initiated pursuant to this Section, the pharmacist shall | 22 |
| provide the recipient of the emergency contraceptive drugs with | 23 |
| a standardized fact sheet developed by the Department that | 24 |
| includes, but is not limited to, the indications for use of the | 25 |
| drug, the appropriate method for using the drug, the need for | 26 |
| medical follow-up and referral information, information on |
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| sexual assault and referral information, and other appropriate | 2 |
| information. | 3 |
| In developing the fact sheet required in this subsection, | 4 |
| the Department shall consult with and solicit input from the | 5 |
| Department of Public Health, the American College of | 6 |
| Obstetricians and Gynecologists, Illinois Pharmacists | 7 |
| Association, Planned Parenthood, and other relevant health | 8 |
| care or professional organizations. After this consultation | 9 |
| and review, the Department may use, as its standardized fact | 10 |
| sheet, an existing publication developed by nationally | 11 |
| recognized medical organizations. | 12 |
| The Department may post the standardized fact sheet on its | 13 |
| web site for use by pharmacists who initiate emergency | 14 |
| contraception drug therapy. | 15 |
| (n) The pharmacy shall keep accurate patient profiles or | 16 |
| medication administration records showing all emergency | 17 |
| contraception drugs initiated to patients for at least 3 years. | 18 |
| (o) The pharmacist shall obtain written informed consent | 19 |
| from the patient and document the informed consent in | 20 |
| accordance with the approved protocol for emergency | 21 |
| contraception drug therapy. A record of such consent must be | 22 |
| maintained by the pharmacy for a period of at least 3 years. | 23 |
| (p) Nothing in this Section may be construed to affect any | 24 |
| provision of law relating to the confidentiality of medical | 25 |
| records. | 26 |
| (q) Nothing in this Section may be construed as creating a |
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| duty for any pharmacist to enter into a collaborative agreement | 2 |
| to initiate emergency contraception drug therapy with an | 3 |
| authorized prescriber, nor creating a duty for any authorized | 4 |
| prescriber to enter into a collaborative agreement with a | 5 |
| pharmacist to initiate emergency contraception drug therapy. | 6 |
| (r) The Department shall adopt rules for the administration | 7 |
| of this Section within 60 days after the effective date of this | 8 |
| amendatory Act of the 95th General Assembly.
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| Section 15. The Illinois Food, Drug and Cosmetic Act is | 10 |
| amended by changing Section 3.21 as follows:
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| (410 ILCS 620/3.21) (from Ch. 56 1/2, par. 503.21)
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| Sec. 3.21. Except as authorized by this Act, the Controlled | 13 |
| Substances
Act, the Pharmacy Practice Act of 1987, the Dental | 14 |
| Practice Act, the Medical
Practice Act of 1987, the Veterinary | 15 |
| Medicine and Surgery Practice Act of
2004, or the Podiatric | 16 |
| Medical Practice Act of 1987, to sell or dispense a
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| prescription drug without a prescription. | 18 |
| Nothing in this Section shall be construed to prohibit a | 19 |
| pharmacist from initiating emergency contraception drug | 20 |
| therapy in accordance with Section 22b of the Pharmacy Practice | 21 |
| Act of 1987.
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| (Source: P.A. 93-281, eff. 12-31-03.)
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| Section 99. Effective date. This Act takes effect upon | 24 |
| becoming law.
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