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1 | AN ACT concerning regulation.
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2 | Be it enacted by the People of the State of Illinois,
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3 | represented in the General Assembly:
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4 | Section 5. The Medical Practice Act of 1987 is amended by | ||||||
5 | changing Section 54.5 as follows:
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6 | (225 ILCS 60/54.5)
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7 | (Section scheduled to be repealed on December 31, 2008)
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8 | Sec. 54.5. Physician delegation of authority.
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9 | (a) Physicians licensed to practice medicine in all its
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10 | branches may delegate care and treatment responsibilities to a
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11 | physician assistant under guidelines in accordance with the
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12 | 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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16 | (b) A physician licensed to practice medicine in all its
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17 | 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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22 | written collaborative agreement shall
conform to the | ||||||
23 | requirements of Sections 15-15 and 15-20
of the Nursing and
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1 | 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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7 | nurse
specialists if a collaborating physician:
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8 | (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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11 | provided patients under such orders in accordance with | ||||||
12 | accepted standards of
medical practice and advanced | ||||||
13 | practice nursing practice;
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14 | (2) is on site at least once a month to provide medical | ||||||
15 | direction and
consultation; and
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16 | (3) is available through telecommunications for | ||||||
17 | consultation on medical
problems, complications, or | ||||||
18 | emergencies or patient referral.
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19 | (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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24 | (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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1 | 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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4 | (1) an anesthesiologist or a physician
participates in | ||||||
5 | the joint formulation and joint approval of orders or
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6 | guidelines and periodically reviews such orders and the | ||||||
7 | services provided
patients under such orders; and
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8 | (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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16 | treatment center in accordance with Section 6.5 of the | ||||||
17 | Ambulatory Surgical
Treatment Center Act.
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18 | (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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21 | (c) The supervising physician shall have access to the
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22 | medical records of all patients attended by a physician
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23 | 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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26 | (d) Nothing in this Act
shall be construed to limit the |
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1 | 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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4 | (e) A physician shall not be liable for the acts or
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5 | 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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14 | (Source: P.A. 90-742, eff. 8-13-98; 91-414, eff. 8-6-99 .)
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15 | 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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1 | (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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1 | 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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1 | 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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1 | 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 | (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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1 | 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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1 | 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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9 | Section 15. The Illinois Food, Drug and Cosmetic Act is | ||||||
10 | amended by changing Section 3.21 as follows:
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11 | (410 ILCS 620/3.21) (from Ch. 56 1/2, par. 503.21)
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12 | 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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17 | 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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22 | (Source: P.A. 93-281, eff. 12-31-03.)
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23 | Section 99. Effective date. This Act takes effect upon | ||||||
24 | becoming law.
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