|
|
|
HB1077 Engrossed |
- 2 - |
LRB095 03803 RAS 23834 b |
|
|
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
|
7 |
| nurse
specialists if a collaborating physician:
|
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
|
11 |
| provided patients under such orders in accordance with |
12 |
| accepted standards of
medical practice and advanced |
13 |
| practice nursing practice;
|
14 |
| (2) is on site at least once a month to provide medical |
15 |
| direction and
consultation; and
|
16 |
| (3) is available through telecommunications for |
17 |
| consultation on medical
problems, complications, or |
18 |
| emergencies or patient referral.
|
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.
|
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 |
|
|
|
HB1077 Engrossed |
- 3 - |
LRB095 03803 RAS 23834 b |
|
|
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:
|
4 |
| (1) an anesthesiologist or a physician
participates in |
5 |
| the joint formulation and joint approval of orders or
|
6 |
| guidelines and periodically reviews such orders and the |
7 |
| services provided
patients under such orders; and
|
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
|
16 |
| treatment center in accordance with Section 6.5 of the |
17 |
| Ambulatory Surgical
Treatment Center Act.
|
18 |
| (b-10) The anesthesiologist or operating physician must |
19 |
| agree with the
anesthesia plan prior to the delivery of |
20 |
| services.
|
21 |
| (c) The supervising physician shall have access to the
|
22 |
| medical records of all patients attended by a physician
|
23 |
| assistant. The collaborating physician shall have access to
the |
24 |
| medical records of all patients attended to by an
advanced |
25 |
| practice nurse.
|
26 |
| (d) Nothing in this Act
shall be construed to limit the |
|
|
|
HB1077 Engrossed |
- 4 - |
LRB095 03803 RAS 23834 b |
|
|
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.
|
4 |
| (e) A physician shall not be liable for the acts or
|
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.
|
14 |
| (Source: P.A. 90-742, eff. 8-13-98; 91-414, eff. 8-6-99 .)
|
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. |
|
|
|
HB1077 Engrossed |
- 5 - |
LRB095 03803 RAS 23834 b |
|
|
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 |
|
|
|
HB1077 Engrossed |
- 6 - |
LRB095 03803 RAS 23834 b |
|
|
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 |
|
|
|
HB1077 Engrossed |
- 7 - |
LRB095 03803 RAS 23834 b |
|
|
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 |
|
|
|
HB1077 Engrossed |
- 8 - |
LRB095 03803 RAS 23834 b |
|
|
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: |
|
|
|
HB1077 Engrossed |
- 9 - |
LRB095 03803 RAS 23834 b |
|
|
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 |
|
|
|
HB1077 Engrossed |
- 10 - |
LRB095 03803 RAS 23834 b |
|
|
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 |
|
|
|
HB1077 Engrossed |
- 11 - |
LRB095 03803 RAS 23834 b |
|
|
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.
|
9 |
| Section 15. The Illinois Food, Drug and Cosmetic Act is |
10 |
| amended by changing Section 3.21 as follows:
|
11 |
| (410 ILCS 620/3.21) (from Ch. 56 1/2, par. 503.21)
|
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
|
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.
|
22 |
| (Source: P.A. 93-281, eff. 12-31-03.)
|
23 |
| Section 99. Effective date. This Act takes effect upon |
24 |
| becoming law.
|