House Bill hb0813c1
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Florida House of Representatives - 2001 CS/HB 813
By the Committee on Health Regulation and Representative
Justice
1 A bill to be entitled
2 An act relating to pharmacists; providing a
3 short title; creating s. 465.0165, F.S.;
4 defining the term "pharmaceutical adverse
5 incident" and requiring that such incidents be
6 reported to the Department of Health; providing
7 that such incident reports are not discoverable
8 or admissible in any civil or administrative
9 action, except disciplinary proceedings;
10 requiring the department to review reported
11 incidents to determine if the incidents
12 potentially involve conduct by a health care
13 practitioner that is subject to disciplinary
14 action; specifying that any disciplinary action
15 shall be taken by the appropriate board;
16 providing for the adoption of rules and forms;
17 requiring the department to publish
18 pharmaceutical adverse incident information on
19 its website; providing exemptions from
20 reporting requirements; providing contingent
21 effective dates.
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23 Be It Enacted by the Legislature of the State of Florida:
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25 Section 1. This act may be cited as the "Ernest Belles
26 Act."
27 Section 2. Section 465.0165, Florida Statutes, is
28 created to read:
29 465.0165 Reports of pharmaceutical adverse
30 incidents.--
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Florida House of Representatives - 2001 CS/HB 813
601-197-01
1 (1) As used in this section, the term "pharmaceutical
2 adverse incident" means the dispensing of a different
3 medication, a different dose, or the correct medication in a
4 container with different instructions than that specified in
5 the prescription, which results in actual harm to the patient,
6 but does not include the dispensing of a generic equivalent
7 medication with the patient's consent.
8 (2)(a) A pharmacist licensed under chapter 465, or
9 other health care practitioner as defined in s. 456.001, who
10 becomes aware of a patient alleging that a pharmaceutical
11 adverse incident occurred which was caused by a health care
12 practitioner, must report such incident to the Department of
13 Health on forms provided by the department. The pharmaceutical
14 adverse incident report is not discoverable or admissible in
15 any civil or administrative action, except in disciplinary
16 proceedings by the department or the appropriate regulatory
17 board.
18 (b) This subsection shall take effect only upon the
19 effective date of legislation that makes any such information
20 provided to the department confidential and exempt from s.
21 119.07(1) and s. 24(a), Art. I of the State Constitution,
22 until 10 days after probable cause is found that a violation
23 of law occurred. Such legislation must also provide that
24 information may only be used by the department or the Board of
25 Pharmacy in a disciplinary proceeding brought against the
26 pharmacist or by the department in any study of adverse
27 incidents without identifying the patient, pharmacist,
28 pharmacy, office, or entity by name, location, or other
29 identifier.
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Florida House of Representatives - 2001 CS/HB 813
601-197-01
1 (3) The required notification to the department must
2 be submitted in writing by certified mail and postmarked
3 within 15 days after the occurrence of the adverse incident.
4 (4) Effective July 1, 2003, subject to subsequent act
5 of the Legislature and a specific appropriation sufficient to
6 cover the actual costs, the department shall review each
7 incident and determine whether it potentially involved conduct
8 by a pharmacist or health care practitioner who is subject to
9 disciplinary action, in which case s. 456.073 applies.
10 Disciplinary action, if any, shall be taken by the board under
11 which the pharmacist or health care practitioner is licensed.
12 (5) The department shall adopt forms and rules for
13 administering this section.
14 (6) The department shall publish on its website, no
15 less than quarterly, a summary and trend analysis of
16 pharmaceutical adverse incidents received pursuant to this
17 section, which shall not include information that would
18 identify the patients or the health care practitioners
19 involved. The purpose of the publication of the summary and
20 trend analysis is to promote the rapid dissemination of
21 information relating to adverse incidents to assist in the
22 avoidance of similar incidents and reduce patient harm.
23 (7) The provisions of this section shall not apply to:
24 (a) Pharmacists employed by pharmacies participating
25 in the reporting program provided by Rule 64B16-27.300,
26 Florida Administrative Code; or
27 (b) Pharmacists employed by pharmacies notifying the
28 Board of Pharmacy that they will establish a continuous
29 quality improvement program consistent with the requirements
30 of Rule 64B16-27.300, Florida Administrative Code.
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Florida House of Representatives - 2001 CS/HB 813
601-197-01
1 (8) Pharmacies located in facilities that are
2 operating medical review committees pursuant to s.
3 766.101(1)(a) shall be governed by the reporting requirements
4 in Rule 64B16-27.300, Florida Administrative Code, in lieu of
5 the requirements of this section.
6 Section 3. Except as otherwise provided herein, this
7 act shall take effect on the same date as, but not be
8 effective unless and until such time as, legislation amending
9 s. 766.101, Florida Statutes, to include a continuous quality
10 improvement committee of a pharmacy licensed pursuant to
11 chapter 465, Florida Statutes, within the provisions of s.
12 766.101(1), Florida Statutes, if such legislation is adopted
13 in the same legislative session or an extension thereof and
14 becomes a law.
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