99TH GENERAL ASSEMBLY
State of Illinois
2015 and 2016
SB3336

 

Introduced 2/19/2016, by Sen. Dale A. Righter

 

SYNOPSIS AS INTRODUCED:
 
225 ILCS 85/18a new

    Amends the Pharmacy Practice Act. Requires pharmacies to establish and maintain a quality assurance program designed to prevent dispensing errors as well as a process designed to detect and identify dispensing errors. Requires pharmacies to commence an investigation into any detected dispensing errors within 2 days after the date the dispensing error is discovered. Requires that if an investigation into a dispensing error indicates that the dispensing error is attributable, in whole or in part, to the pharmacy or its personnel, that a quality assurance review be performed. Provides requirements for the quality assurance review and its records. Provides that the records of the quality assurance review shall not be subject to discovery in any arbitration, civil, or other proceeding, except in certain circumstances. Effective 12 months after becoming law.


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A BILL FOR

 

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1    AN ACT concerning regulation.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 5. The Pharmacy Practice Act is amended by adding
5Section 18a as follows:
 
6    (225 ILCS 85/18a new)
7    Sec. 18a. Quality assurance program.
8    (a) For purposes of this Section:
9    "Dispensing error" means any preventable event that may
10cause or lead to inappropriate medication use or patient harm.
11Such events may be related to professional practice, health
12care products, procedures, and systems, including:
13prescribing; order communication; product labeling, packaging,
14and nomenclature; compounding; dispensing; distribution;
15administration; education; monitoring; and use. "Dispensing
16error" does not include any act or omission that is corrected
17prior to furnishing the drug to the patient or the patient's
18agent.
19    "Essential cause examination" means a process for
20identifying the basic or causal factors that underlie the
21occurrence or possible occurrence of a dispensing error. An
22essential cause examination focuses primarily on systems and
23processes, not individual performance. It progresses from

 

 

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1special causes in the dispensing process to common causes in
2organizational processes and identifies potential improvements
3in processes or systems that would tend to decrease the
4likelihood of such events in the future or determines, after
5analysis, that no such opportunities for improvement exist.
6    (b) Each pharmacy shall establish and maintain a quality
7assurance program designed to prevent dispensing errors.
8    (c) Each quality assurance program shall be described in
9written policies and procedures maintained in the pharmacy and
10shall be reviewed by the licensee and revised, if necessary,
11prior to application for renewal of the pharmacy's license. The
12policies and procedures shall include directions for
13communicating the details of the dispensing error to the
14patient, caregiver, prescriber, and other members of the health
15care team as appropriate. This communication shall also
16describe methods for correcting the dispensing error and
17reducing its negative impact on the patient.
18    (d) Each quality assurance program shall include a process
19designed to detect and identify dispensing errors. An
20investigation of each dispensing error shall commence as soon
21as is reasonably possible, but no later than 2 business days
22after the date the dispensing error is discovered. If the
23investigation indicates that the dispensing error is
24attributable, in whole or in part, to the pharmacy or its
25personnel, a quality assurance review shall be performed.
26    (e) The quality assurance review shall include

 

 

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1investigation of the dispensing error and completion of an
2essential cause examination of the dispensing error. A written
3record of the quality assurance review shall be retained in the
4pharmacy. The written record shall contain at least the
5following:
6        (1) the date of, location of, and participants in the
7    quality assurance review conducted;
8        (2) the record of the facts relating to the dispensing
9    error;
10        (3) the essential cause examination;
11        (4) the findings and determinations generated by the
12    quality assurance review;
13        (5) changes to pharmacy policy or procedure made
14    pursuant to the quality assurance review, if any; and
15        (6) activities undertaken with the patient or health
16    care providers to mitigate the dispensing error.
17    The pharmacy shall inform all pharmacy personnel of any
18changes in pharmacy policy or procedure made pursuant to a
19quality assurance review.
20    (f) Records relating to activities undertaken as part of a
21quality assurance review for dispensing errors that occurred in
22the pharmacy, including, but not limited to, investigation or
23confirmation of a dispensing error, shall be maintained and
24immediately accessible in the pharmacy for at least 5 years
25from the date those records were created. The Department may
26review quality assurance records in an individual pharmacy as

 

 

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1necessary to protect the public health and safety, as
2determined by the Department, or if fraud is alleged by a
3government agency with jurisdiction over the pharmacy.
4    (g) Neither the proceedings nor records of a pharmacy's
5quality assurance program shall be subject to discovery in any
6arbitration, civil, or other proceeding, except as provided in
7subsection (f) of this Section. No person in attendance at a
8meeting of a pharmacy's quality assurance committee shall be
9required to testify in any arbitration, civil, or other
10proceeding, except as provided in subsection (f) of this
11Section, as to what transpired at that meeting.
12    (h) The pharmacy's compliance with this Section may be
13considered by the Department as a mitigating factor in the
14investigation and evaluation of a dispensing error.
15    (i) Nothing in this Section shall be construed to prevent a
16pharmacy from contracting or otherwise arranging for the
17provision of personnel or other resources by a third party or
18administrative offices with such skill or expertise as the
19pharmacy believes to be necessary to satisfy the requirements
20of this Section.
 
21    Section 99. Effective date. This Act takes effect 12 months
22after becoming law.