96TH GENERAL ASSEMBLY
State of Illinois
2009 and 2010
HB0535

 

Introduced 2/4/2009, by Rep. Charles E. Jefferson

 

SYNOPSIS AS INTRODUCED:
 
225 ILCS 25/50.5 new
225 ILCS 60/33   from Ch. 111, par. 4400-33
225 ILCS 65/65-40  was 225 ILCS 65/15-20
225 ILCS 80/6   from Ch. 111, par. 3906
225 ILCS 85/18   from Ch. 111, par. 4138
225 ILCS 95/7.5
225 ILCS 100/20.10 new
225 ILCS 120/50.5 new

    Amends the Illinois Dental Practice Act, the Medical Practice Act of 1987, the Nurse Practice Act, the Illinois Optometric Practice Act of 1987, the Pharmacy Practice Act, the Physician Assistant Practice Act of 1987, and the Podiatric Medical Practice Act of 1987. Provides that no licensee or registrant under the Acts shall be compelled to release his or her prescription records to any person or entity licensed under the Wholesale Drug Distribution Licensing Act or any other pharmaceutical sales company and may take all acceptable measures necessary to safeguard these records from unwanted release. Prohibits licensees or registrants under the Acts from releasing any prescription record to a person or entity licensed under the Wholesale Drug Distribution Licensing Act or any other pharmaceutical sales company, unless the licensee or registrant has obtained a release waiver from the patient for whom the prescription was initiated or the patient's authorized agent. Amends the Wholesale Drug Distribution Licensing Act to prohibit the compulsion of the release of prescription records from a licensee or registrant and the receipt of prescription records without the provision of proof of a patient waiver.


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FISCAL NOTE ACT MAY APPLY

 

 

A BILL FOR

 

HB0535 LRB096 05766 ASK 15841 b

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 Illinois Dental Practice Act is amended by
5 adding Section 50.5 as follows:
 
6     (225 ILCS 25/50.5 new)
7     (Section scheduled to be repealed on January 1, 2016)
8     Sec. 50.5. Prescription record release prohibited. No
9 dentist shall be compelled to release his or her prescription
10 records to any person or entity licensed under the Wholesale
11 Drug Distribution Licensing Act or any other pharmaceutical
12 sales company and may take all measures necessary and deemed
13 acceptable by the Department to safeguard these records from
14 unwanted release. A dentist is prohibited from releasing any
15 prescription record to a person or entity licensed under the
16 Wholesale Drug Distribution Licensing Act or any other
17 pharmaceutical sales company, unless the dentist has obtained a
18 release waiver from the patient for whom the prescription was
19 initiated or the patient's authorized agent.
 
20     Section 10. The Medical Practice Act of 1987 is amended by
21 changing Section 33 as follows:
 

 

 

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1     (225 ILCS 60/33)  (from Ch. 111, par. 4400-33)
2     (Section scheduled to be repealed on December 31, 2010)
3     Sec. 33. Any person licensed under this Act to practice
4 medicine in all of its branches shall be authorized to purchase
5 legend drugs requiring an order of a person authorized to
6 prescribe drugs, and to dispense such legend drugs in the
7 regular course of practicing medicine. The dispensing of such
8 legend drugs shall be the personal act of the person licensed
9 under this Act and may not be delegated to any other person not
10 licensed under this Act or the Pharmacy Practice Act unless
11 such delegated dispensing functions are under the direct
12 supervision of the physician authorized to dispense legend
13 drugs. Except when dispensing manufacturers' samples or other
14 legend drugs in a maximum 72 hour supply, persons licensed
15 under this Act shall maintain a book or file of prescriptions
16 as required in the Pharmacy Practice Act. No licensee shall be
17 compelled to release his or her prescription records to any
18 person or entity licensed under the Wholesale Drug Distribution
19 Licensing Act or any other pharmaceutical sales company and may
20 take all measures necessary and deemed acceptable by the
21 Department to safeguard these records from unwanted release. A
22 licensee is prohibited from releasing any prescription record
23 to a person or entity licensed under the Wholesale Drug
24 Distribution Licensing Act or any other pharmaceutical sales
25 company, unless the licensee has obtained a release waiver from
26 the patient for whom the prescription was initiated or the

 

 

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1 patient's authorized agent. Any person licensed under this Act
2 who dispenses any drug or medicine shall dispense such drug or
3 medicine in good faith and shall affix to the box, bottle,
4 vessel or package containing the same a label indicating (a)
5 the date on which such drug or medicine is dispensed; (b) the
6 name of the patient; (c) the last name of the person dispensing
7 such drug or medicine; (d) the directions for use thereof; and
8 (e) the proprietary name or names or, if there are none, the
9 established name or names of the drug or medicine, the dosage
10 and quantity, except as otherwise authorized by regulation of
11 the Department of Professional Regulation. The foregoing
12 labeling requirements shall not apply to drugs or medicines in
13 a package which bears a label of the manufacturer containing
14 information describing its contents which is in compliance with
15 requirements of the Federal Food, Drug, and Cosmetic Act and
16 the Illinois Food, Drug, and Cosmetic Act. "Drug" and
17 "medicine" have the meaning ascribed to them in the Pharmacy
18 Practice Act, as now or hereafter amended; "good faith" has the
19 meaning ascribed to it in subsection (v) of Section 102 of the
20 "Illinois Controlled Substances Act", approved August 16,
21 1971, as amended.
22     Prior to dispensing a prescription to a patient, the
23 physician shall offer a written prescription to the patient
24 which the patient may elect to have filled by the physician or
25 any licensed pharmacy.
26     A violation of any provision of this Section shall

 

 

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1 constitute a violation of this Act and shall be grounds for
2 disciplinary action provided for in this Act.
3 (Source: P.A. 95-689, eff. 10-29-07.)
 
4     Section 15. The Nurse Practice Act is amended by changing
5 Section 65-40 as follows:
 
6     (225 ILCS 65/65-40)   (was 225 ILCS 65/15-20)
7     (Section scheduled to be repealed on January 1, 2018)
8     Sec. 65-40. Prescriptive authority.
9     (a) A collaborating physician or podiatrist may, but is not
10 required to, delegate prescriptive authority to an advanced
11 practice nurse as part of a written collaborative agreement.
12 This authority may, but is not required to, include
13 prescription of, selection of, orders for, administration of,
14 storage of, acceptance of samples of, and dispensing over the
15 counter medications, legend drugs, medical gases, and
16 controlled substances categorized as Schedule III, III-N, IV,
17 or V controlled substances, as defined in Article II of the
18 Illinois Controlled Substances Act, and other preparations,
19 including, but not limited to, botanical and herbal remedies.
20 The collaborating physician or podiatrist must have a valid
21 current Illinois controlled substance license and federal
22 registration to delegate authority to prescribe delegated
23 controlled substances.
24     (b) To prescribe controlled substances under this Section,

 

 

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1 an advanced practice nurse must obtain a mid-level practitioner
2 controlled substance license. Medication orders shall be
3 reviewed periodically by the collaborating physician or
4 podiatrist.
5     (c) The collaborating physician or podiatrist shall file
6 with the Department notice of delegation of prescriptive
7 authority and termination of such delegation, in accordance
8 with rules of the Department. Upon receipt of this notice
9 delegating authority to prescribe Schedule III, III-N, IV, or V
10 controlled substances, the licensed advanced practice nurse
11 shall be eligible to register for a mid-level practitioner
12 controlled substance license under Section 303.05 of the
13 Illinois Controlled Substances Act.
14     (d) In addition to the requirements of subsections (a),
15 (b), and (c) of this Section, a collaborating physician may,
16 but is not required to, delegate authority to an advanced
17 practice nurse to prescribe Schedule II or II-N controlled
18 substances, if all of the following conditions apply:
19         (1) No more than 5 Schedule II or II-N controlled
20     substances by oral dosage may be delegated.
21         (2) Any delegation must be controlled substances that
22     the collaborating physician prescribes.
23         (3) Any prescription must be limited to no more than a
24     30-day oral dosage, with any continuation authorized only
25     after prior approval of the collaborating physician.
26         (4) The advanced practice nurse must discuss the

 

 

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1     condition of any patients for whom a controlled substance
2     is prescribed monthly with the delegating physician.
3     (e) Nothing in this Act shall be construed to limit the
4 delegation of tasks or duties by a physician to a licensed
5 practical nurse, a registered professional nurse, or other
6 persons.
7     (f) No advanced practice nurse with prescriptive authority
8 shall be compelled to release his or her prescription records
9 to any person or entity licensed under the Wholesale Drug
10 Distribution Licensing Act or any other pharmaceutical sales
11 company and may take all measures necessary and deemed
12 acceptable by the Department to safeguard these records from
13 unwanted release. An advanced practice nurse with prescriptive
14 authority is prohibited from releasing any prescription record
15 to a person or entity licensed under the Wholesale Drug
16 Distribution Licensing Act or any other pharmaceutical sales
17 company, unless the advanced practice nurse has obtained a
18 release waiver from the patient for whom the prescription was
19 initiated or the patient's authorized agent.
20 (Source: P.A. 95-639, eff. 10-5-07.)
 
21     Section 20. The Illinois Optometric Practice Act of 1987 is
22 amended by changing Section 6 as follows:
 
23     (225 ILCS 80/6)  (from Ch. 111, par. 3906)
24     (Section scheduled to be repealed on January 1, 2017)

 

 

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1     Sec. 6. Display of license; change of address; record of
2 examinations and prescriptions. Every holder of a license under
3 this Act shall display such license on a conspicuous place in
4 the office or offices wherein such holder practices optometry
5 and every holder shall, whenever requested, exhibit such
6 license to any representative of the Department, and shall
7 notify the Department of the address or addresses and of every
8 change thereof, where such holder shall practice optometry.
9     Every licensed optometrist shall keep a record of
10 examinations made and prescriptions issued, which record shall
11 include the names of persons examined and for whom
12 prescriptions were prepared, and shall be signed by the
13 licensed optometrist and retained by him in the office in which
14 such professional service was rendered. Such records shall be
15 preserved by the optometrist for a period designated by the
16 Department. A copy of such records shall be provided, upon
17 written request, to the person examined, or his or her
18 designee. No licensed optometrist shall be compelled to release
19 his or her prescription records to any person or entity
20 licensed under the Wholesale Drug Distribution Licensing Act or
21 any other pharmaceutical sales company and may take all
22 measures necessary and deemed acceptable by the Department to
23 safeguard these records from unwanted release. A licensed
24 optometrist is prohibited from releasing any prescription
25 record to a person or entity licensed under the Wholesale Drug
26 Distribution Licensing Act or any other pharmaceutical sales

 

 

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1 company, unless the optometrist has obtained a release waiver
2 from the patient for whom the prescription was initiated or the
3 patient's authorized agent.
4 (Source: P.A. 94-787, eff. 5-19-06.)
 
5     Section 25. The Pharmacy Practice Act is amended by
6 changing Section 18 as follows:
 
7     (225 ILCS 85/18)  (from Ch. 111, par. 4138)
8     (Section scheduled to be repealed on January 1, 2018)
9     Sec. 18. Record retention. Except as provided in subsection
10 (b), there shall be kept in every drugstore or pharmacy a
11 suitable book, file, or electronic record keeping system in
12 which shall be preserved for a period of not less than 5 years
13 the original, or an exact, unalterable image, of every written
14 prescription and the original transcript or copy of every
15 verbal prescription filled, compounded, or dispensed, in such
16 pharmacy; and such book or file of prescriptions shall at all
17 reasonable times be open to inspection to the pharmacy
18 coordinator and the duly authorized agents or employees of the
19 Department.
20     Every prescription filled or refilled shall contain the
21 unique identifiers of the persons authorized to practice
22 pharmacy under the provision of this Act who fills or refills
23 the prescription.
24     Records kept pursuant to this Section may be maintained in

 

 

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1 an alternative data retention system, such as a direct digital
2 imaging system, provided that:
3         (1) the records maintained in the alternative data
4     retention system contain all of the information required in
5     a manual record;
6         (2) the data processing system is capable of producing
7     a hard copy of the electronic record on the request of the
8     Board, its representative, or other authorized local,
9     State, or federal law enforcement or regulatory agency;
10         (3) the digital images are recorded and stored only by
11     means of a technology that does not allow subsequent
12     revision or replacement of the images; and
13         (4) the prescriptions may be retained in written form
14     or recorded in a data processing system, provided that such
15     order can be produced in printed form upon lawful request.
16     As used in this Section, "digital imaging system" means a
17 system, including people, machines, methods of organization,
18 and procedures, that provides input, storage, processing,
19 communications, output, and control functions for digitized
20 representations of original prescription records.
21     Inpatient drug orders may be maintained within an
22 institution in a manner approved by the Department.
23     No licensee or registrant shall be compelled to release
24 prescription records to any person or entity licensed under the
25 Wholesale Drug Distribution Licensing Act or any other
26 pharmaceutical sales company and may take all measures

 

 

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1 necessary and deemed acceptable by the Department to safeguard
2 these records from unwanted release. A licensee or registrant
3 is prohibited from releasing any prescription record to a
4 person or entity licensed under the Wholesale Drug Distribution
5 Licensing Act or any other pharmaceutical sales company, unless
6 the licensee or registrant has obtained a release waiver from
7 the patient for whom the prescription was initiated or the
8 patient's authorized agent.
9 (Source: P.A. 94-84, eff. 6-28-05; 95-689, eff. 10-29-07.)
 
10     Section 30. The Physician Assistant Practice Act of 1987 is
11 amended by changing Section 7.5 as follows:
 
12     (225 ILCS 95/7.5)
13     (Section scheduled to be repealed on January 1, 2018)
14     Sec. 7.5. Prescriptions. A supervising physician may
15 delegate limited prescriptive authority to a physician
16 assistant. This authority may, but is not required to, include
17 prescription and dispensing of legend drugs and legend
18 controlled substances categorized as Schedule III, IV, or V
19 controlled substances, as defined in Article II of the Illinois
20 Controlled Substances Act, as delegated in the written
21 guidelines required by this Act. To prescribe Schedule III, IV,
22 or V controlled substances under this Section, a physician
23 assistant must obtain a mid-level practitioner controlled
24 substances license. Medication orders issued by a physician

 

 

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1 assistant shall be reviewed periodically by the supervising
2 physician. The supervising physician shall file with the
3 Department notice of delegation of prescriptive authority to a
4 physician assistant and termination of delegation, specifying
5 the authority delegated or terminated. Upon receipt of this
6 notice delegating authority to prescribe Schedule III, IV, or V
7 controlled substances, the physician assistant shall be
8 eligible to register for a mid-level practitioner controlled
9 substances license under Section 303.05 of the Illinois
10 Controlled Substances Act. Nothing in this Act shall be
11 construed to limit the delegation of tasks or duties by the
12 supervising physician to a nurse or other appropriately trained
13 personnel.
14     No physician assistant with prescriptive authority shall
15 be compelled to release his or her prescription records to any
16 person or entity licensed under the Wholesale Drug Distribution
17 Licensing Act or any other pharmaceutical sales company and may
18 take all measures necessary and deemed acceptable by the
19 Department to safeguard these records from unwanted release. A
20 physician assistant with prescriptive authority is prohibited
21 from releasing any prescription record to a person or entity
22 licensed under the Wholesale Drug Distribution Licensing Act or
23 any other pharmaceutical sales company, unless the physician
24 assistant has obtained a release waiver from the patient for
25 whom the prescription was initiated or the patient's authorized
26 agent.

 

 

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1     The Department shall establish by rule the minimum
2 requirements for written guidelines to be followed under this
3 Section.
4 (Source: P.A. 90-116, eff. 7-14-97; 90-818, eff. 3-23-99.)
 
5     Section 35. The Podiatric Medical Practice Act of 1987 is
6 amended by adding Section 20.10 as follows:
 
7     (225 ILCS 100/20.10 new)
8     (Section scheduled to be repealed on January 1, 2018)
9     Sec. 20.10. Prescription record release prohibited. No
10 licensee shall be compelled to release his or her prescription
11 records to any person or entity licensed under the Wholesale
12 Drug Distribution Licensing Act or any other pharmaceutical
13 sales company and may take all measures necessary and deemed
14 acceptable by the Department to safeguard these records from
15 unwanted release. A licensee is prohibited from releasing any
16 prescription record to a person or entity licensed under the
17 Wholesale Drug Distribution Licensing Act or any other
18 pharmaceutical sales company, unless the licensee has obtained
19 a release waiver from the patient for whom the prescription was
20 initiated or the patient's authorized agent.
 
21     Section 40. The Wholesale Drug Distribution Licensing Act
22 is amended by adding Section 50.5 as follows:
 

 

 

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1     (225 ILCS 120/50.5 new)
2     (Section scheduled to be repealed on January 1, 2013)
3     Sec. 50.5. Prescription record release prohibited. No
4 licensee under this Act shall compel or attempt to compel a
5 prescribing agent, as that term is defined by the Department,
6 to release prescription records. A licensee under this Act is
7 prohibited from receiving any prescription record from a
8 prescribing agent, unless that prescribing agent presents
9 proof that he or she has obtained a release waiver from the
10 patient for whom the prescription was initiated or the
11 patient's authorized agent.