Senate Bill 1016

CODING: Words stricken are deletions; words underlined are additions.


    Florida Senate - 1999                                  SB 1016

    By Senators Sebesta, Lee and Sullivan





    20-830-99                                               See HB

  1                      A bill to be entitled

  2         An act relating to pharmacy practice; providing

  3         a short title; amending s. 465.003, F.S.;

  4         defining the term "data communication device";

  5         amending s. 465.016, F.S.; providing that using

  6         or releasing a patient's records except as

  7         authorized by chapter 455 or chapter 465, F.S.,

  8         constitutes a ground for disciplinary action

  9         against a pharmacist, for which there are

10         penalties; amending s. 465.017, F.S.; providing

11         additional persons to whom and entities to

12         which records relating to the filling of

13         prescriptions and the dispensing of medicinal

14         drugs that are maintained by a pharmacy may be

15         furnished; specifying authorized uses of

16         patient records by pharmacy owners; providing

17         restrictions on such records when transmitted

18         through a data communication device; amending

19         ss. 465.014, 465.015, 465.0196, 468.812,

20         499.003, F.S.; conforming cross-references;

21         providing an effective date.

22

23  Be It Enacted by the Legislature of the State of Florida:

24

25         Section 1.  This act may be cited as the "Pharmacy

26  Patient Privacy Act of 1999."

27         Section 2.  Present subsections (4) through (14) of

28  section 465.003, Florida Statutes, are renumbered as

29  subsections (5) through (15), respectively, and a new

30  subsection (4) is added to that section to read:

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    Florida Senate - 1999                                  SB 1016
    20-830-99                                               See HB




  1         465.003  Definitions.--As used in this chapter, the

  2  term:

  3         (4)  "Data communication device" means an electronic

  4  device that receives electronic information from one source

  5  and transmits or routes it to another, including, but not

  6  limited to, any such bridge, router, switch, or gateway.

  7         Section 3.  Paragraph (q) is added to subsection (1) of

  8  section 465.016, Florida Statutes, to read:

  9         465.016  Disciplinary actions.--

10         (1)  The following acts shall be grounds for

11  disciplinary action set forth in this section:

12         (q)  Using or releasing a patient's records except as

13  authorized by this chapter and chapter 455.

14         Section 4.  Subsection (2) of section 465.017, Florida

15  Statutes, is amended to read:

16         465.017  Authority to inspect.--

17         (2)  Except as permitted by this chapter, and chapters

18  406, 409, 455, 499, and 893, records maintained by in a

19  pharmacy relating to the filling of prescriptions and the

20  dispensing of medicinal drugs shall not be furnished, except

21  upon the written authorization of the patient, to any person

22  other than to the patient for whom the drugs were dispensed,

23  or her or his legal representative, or to the department

24  pursuant to existing law, or, in the event that the patient is

25  incapacitated or unable to request such said records, her or

26  his spouse; to the department pursuant to law; to health care

27  practitioners and pharmacists consulting with or dispensing to

28  the patient; or to insurance carriers or other payors

29  authorized by the patient to receive such records.  For

30  purposes of this section, records held in a pharmacy shall be

31  considered owned by the owner of the pharmacy.  The pharmacy

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    Florida Senate - 1999                                  SB 1016
    20-830-99                                               See HB




  1  owner may use such records internally in the aggregate without

  2  patient identification data, regardless of where such records

  3  are held, for purposes reasonably related to the business and

  4  practice of only that pharmacy except upon the written

  5  authorization of such patient.  Such records may be furnished

  6  in any civil or criminal proceeding, upon the issuance of a

  7  subpoena from a court of competent jurisdiction and proper

  8  notice to the patient or her or his legal representative by

  9  the party seeking such records.  Such records or any part

10  thereof, if transmitted through a data communication device

11  not under the control or ownership of a pharmacy or affiliated

12  company or not directly between a pharmacy and a treating

13  practitioner, may not be accessed, used, or maintained by the

14  operator or owner of the data communication device unless

15  specifically authorized by this section.  It is the intent of

16  this subsection to allow the use and sharing of such records

17  to improve patient care, provided the pharmacist acts in the

18  best interests of her or his patient.  Nothing in this

19  subsection may be construed to authorize or expand

20  solicitation or marketing to patients or potential patients in

21  any manner not otherwise specifically authorized by law.

22         Section 5.  Section 465.014, Florida Statutes, is

23  amended to read:

24         465.014  Pharmacy technician.--No person other than a

25  licensed pharmacist or pharmacy intern may engage in the

26  practice of the profession of pharmacy, except that a licensed

27  pharmacist may delegate to nonlicensed pharmacy technicians

28  those duties, tasks, and functions which do not fall within

29  the purview of s. 465.003(13)(12).  All such delegated acts

30  shall be performed under the direct supervision of a licensed

31  pharmacist who shall be responsible for all such acts

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    Florida Senate - 1999                                  SB 1016
    20-830-99                                               See HB




  1  performed by persons under his or her supervision.  A pharmacy

  2  technician, under the supervision of a pharmacist, may

  3  initiate or receive communications with a practitioner or his

  4  or her agent, on behalf of a patient, regarding refill

  5  authorization requests.  No licensed pharmacist shall

  6  supervise more than one pharmacy technician unless otherwise

  7  permitted by the guidelines adopted by the board.  The board

  8  shall establish guidelines to be followed by licensees or

  9  permittees in determining the circumstances under which a

10  licensed pharmacist may supervise more than one but not more

11  than three pharmacy technicians.

12         Section 6.  Paragraph (c) of subsection (2) of section

13  465.015, Florida Statutes, is amended to read:

14         465.015  Violations and penalties.--

15         (2)  It is unlawful for any person:

16         (c)  To sell or dispense drugs as defined in s.

17  465.003(8)(7) without first being furnished with a

18  prescription.

19         Section 7.  Section 465.0196, Florida Statutes, is

20  amended to read:

21         465.0196  Special pharmacy permits.--Any person

22  desiring a permit to operate a pharmacy which does not fall

23  within the definitions set forth in s. 465.003(11)(10)(a)1.,

24  2., and 3. shall apply to the department for a special

25  pharmacy permit.  If the board certifies that the application

26  complies with the applicable laws and rules of the board

27  governing the practice of the profession of pharmacy, the

28  department shall issue the permit.  No permit shall be issued

29  unless a licensed pharmacist is designated to undertake the

30  professional supervision of the compounding and dispensing of

31  all drugs dispensed by the pharmacy.  The licensed pharmacist

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    Florida Senate - 1999                                  SB 1016
    20-830-99                                               See HB




  1  shall be responsible for maintaining all drug records and for

  2  providing for the security of the area in the facility in

  3  which the compounding, storing, and dispensing of medicinal

  4  drugs occurs.  The permittee shall notify the department

  5  within 10 days of any change of the licensed pharmacist

  6  responsible for such duties.

  7         Section 8.  Subsection (3) of section 468.812, Florida

  8  Statutes, is amended to read:

  9         468.812  Exemptions from licensure.--

10         (3)  The provisions of this act relating to orthotics

11  or pedorthics do not apply to any licensed pharmacist or to

12  any person acting under the supervision of a licensed

13  pharmacist.  The practice of orthotics or pedorthics by a

14  pharmacist or any of the pharmacist's employees acting under

15  the supervision of a pharmacist shall be construed to be

16  within the meaning of the term "practice of the profession of

17  pharmacy" as set forth in s. 465.003(13)(12), and shall be

18  subject to regulation in the same manner as any other pharmacy

19  practice.  The Board of Pharmacy shall develop rules regarding

20  the practice of orthotics and pedorthics by a pharmacist.  Any

21  pharmacist or person under the supervision of a pharmacist

22  engaged in the practice of orthotics or pedorthics shall not

23  be precluded from continuing that practice pending adoption of

24  these rules.

25         Section 9.  Subsection (19) of section 499.003, Florida

26  Statutes, is amended to read:

27         499.003  Definitions of terms used in ss.

28  499.001-499.081.--As used in ss. 499.001-499.081, the term:

29         (19)  "Legend drug," "prescription drug," or "medicinal

30  drug" means any drug, including, but not limited to, finished

31  dosage forms, or active ingredients subject to, defined by, or

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    Florida Senate - 1999                                  SB 1016
    20-830-99                                               See HB




  1  described by s. 503(b) of the Federal Food, Drug, and Cosmetic

  2  Act or s. 465.003(8)(7), s. 499.007(12), or s. 499.0122(1)(b)

  3  or (c).

  4         Section 10.  This act shall take effect July 1, 1999.

  5

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  7                       LEGISLATIVE SUMMARY

  8
      Creates the "Pharmacy Patient Privacy Act of 1999."
  9    Defines the term "data communication device."  Provides
      that using or releasing a patient's records except as
10    authorized by chapter 455 or chapter 465, F.S.,
      constitutes a ground for disciplinary action against a
11    pharmacist, for which there are penalties.  Provides
      additional persons to whom and entities to which records
12    relating to the filling of prescriptions and the
      dispensing of medicinal drugs that are maintained by a
13    pharmacy may be furnished.  Specifies authorized uses of
      patient records by pharmacy owners.  Provides
14    restrictions on such records when transmitted through a
      data communication device.
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