Senate Bill 1016c1

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    Florida Senate - 1999                           CS for SB 1016

    By the Committee on Health, Aging and Long-Term Care; and
    Senators Sebesta, Lee and Sullivan




    317-2119A-99

  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         s. 465.015, F.S.; providing penalties for

20         unauthorized use of pharmacy records when

21         transmitted through a data communication

22         device; conforming cross-references; amending

23         ss. 465.014, 465.0196, 468.812, 499.003, F.S.;

24         conforming cross-references; providing an

25         effective date.

26

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

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

30  Patient Privacy Act of 1999."

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    Florida Senate - 1999                           CS for SB 1016
    317-2119A-99




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

  2  section 465.003, Florida Statutes, are renumbered as

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

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

  5         465.003  Definitions.--As used in this chapter, the

  6  term:

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

  8  device that receives electronic information from one source

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

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

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

12  section 465.016, Florida Statutes, to read:

13         465.016  Disciplinary actions.--

14         (1)  The following acts shall be grounds for

15  disciplinary action set forth in this section:

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

17  authorized by this chapter and chapter 455.

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

19  Statutes, is amended to read:

20         465.017  Authority to inspect.--

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

22  406, 409, 455, 499, and 893, records maintained by in a

23  pharmacy relating to the filling of prescriptions and the

24  dispensing of medicinal drugs shall not be furnished, except

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

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

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

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

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

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

31  practitioners and pharmacists consulting with or dispensing to

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    Florida Senate - 1999                           CS for SB 1016
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  1  the patient; or to insurance carriers or other payors

  2  authorized by the patient to receive such records.  For

  3  purposes of this section, the pharmacy permitholder shall be

  4  considered the custodian of records maintained in a pharmacy.

  5  The pharmacy owner may use such records internally in the

  6  aggregate without patient identification data, regardless of

  7  where such records are held, for purposes reasonably related

  8  to the business and practice of only that pharmacy except upon

  9  the written authorization of such patient.  Such records may

10  be furnished in any civil or criminal proceeding, upon the

11  issuance of a subpoena from a court of competent jurisdiction

12  and proper notice to the patient or her or his legal

13  representative by the party seeking such records.  Such

14  records or any part thereof, if transmitted through a data

15  communication device not under the control or ownership of a

16  pharmacy or affiliated company or not directly between a

17  pharmacy and a treating practitioner, may not be accessed,

18  used, or maintained by the operator or owner of the data

19  communication device unless specifically authorized by this

20  section.  It is the intent of this subsection to allow the use

21  and sharing of such records to improve patient care, provided

22  the pharmacist acts in the best interests of her or his

23  patient.  Nothing in this subsection may be construed to

24  authorize or expand solicitation or marketing to patients or

25  potential patients in any manner not otherwise specifically

26  authorized by law.

27         Section 5.  Section 465.014, Florida Statutes, is

28  amended to read:

29         465.014  Pharmacy technician.--No person other than a

30  licensed pharmacist or pharmacy intern may engage in the

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

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    Florida Senate - 1999                           CS for SB 1016
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  1  pharmacist may delegate to nonlicensed pharmacy technicians

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

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

  4  shall be performed under the direct supervision of a licensed

  5  pharmacist who shall be responsible for all such acts

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

  7  technician, under the supervision of a pharmacist, may

  8  initiate or receive communications with a practitioner or his

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

10  authorization requests.  No licensed pharmacist shall

11  supervise more than one pharmacy technician unless otherwise

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

13  shall establish guidelines to be followed by licensees or

14  permittees in determining the circumstances under which a

15  licensed pharmacist may supervise more than one but not more

16  than three pharmacy technicians.

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

18  465.015, Florida Statutes, is amended, present subsection (4)

19  of that section is redesignated as subsection (5) and amended,

20  and a new subsection (4) is added to that section, to read:

21         465.015  Violations and penalties.--

22         (2)  It is unlawful for any person:

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

24  465.003(8)(7) without first being furnished with a

25  prescription.

26         (4)  It is unlawful for records maintained by a

27  pharmacy relating to the filling of prescriptions and the

28  dispensing of medicinal drugs, if transmitted through a

29  data-communication device not under the control or ownership

30  of a pharmacy or affiliated company or not transmitted

31  directly between a pharmacy and a treating practitioner, to be

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    Florida Senate - 1999                           CS for SB 1016
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  1  accessed, used, or maintained by the operator or owner of the

  2  data-communication device unless specifically authorized by s.

  3  465.017.

  4         (5)(4)  Any person who violates any provision of

  5  subsection (1), or subsection (3), or subsection (4) is guilty

  6  of a misdemeanor of the first degree, punishable as provided

  7  in s. 775.082 or s. 775.083. Any person who violates any

  8  provision of subsection (2) is guilty of a felony of the third

  9  degree, punishable as provided in s. 775.082, s. 775.083, or

10  s. 775.084. In any warrant, information, or indictment, it

11  shall not be necessary to negative any exceptions, and the

12  burden of any exception shall be upon the defendant.

13         Section 7.  Section 465.0196, Florida Statutes, is

14  amended to read:

15         465.0196  Special pharmacy permits.--Any person

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

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

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

19  pharmacy permit.  If the board certifies that the application

20  complies with the applicable laws and rules of the board

21  governing the practice of the profession of pharmacy, the

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

23  unless a licensed pharmacist is designated to undertake the

24  professional supervision of the compounding and dispensing of

25  all drugs dispensed by the pharmacy.  The licensed pharmacist

26  shall be responsible for maintaining all drug records and for

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

28  which the compounding, storing, and dispensing of medicinal

29  drugs occurs.  The permittee shall notify the department

30  within 10 days of any change of the licensed pharmacist

31  responsible for such duties.

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    Florida Senate - 1999                           CS for SB 1016
    317-2119A-99




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

  2  Statutes, is amended to read:

  3         468.812  Exemptions from licensure.--

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

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

  6  any person acting under the supervision of a licensed

  7  pharmacist.  The practice of orthotics or pedorthics by a

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

  9  the supervision of a pharmacist shall be construed to be

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

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

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

13  practice.  The Board of Pharmacy shall develop rules regarding

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

15  pharmacist or person under the supervision of a pharmacist

16  engaged in the practice of orthotics or pedorthics shall not

17  be precluded from continuing that practice pending adoption of

18  these rules.

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

20  Statutes, is amended to read:

21         499.003  Definitions of terms used in ss.

22  499.001-499.081.--As used in ss. 499.001-499.081, the term:

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

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

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

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

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

28  or (c).

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

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    Florida Senate - 1999                           CS for SB 1016
    317-2119A-99




  1          STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
                       COMMITTEE SUBSTITUTE FOR
  2                         Senate Bill 1016

  3

  4  The bill clarifies that the pharmacy permitholder shall be
    considered the custodian of records maintained in a pharmacy.
  5  The bill provides a criminal penalty for the unauthorized use
    of pharmacy records when transmitted through a data
  6  communication device by any person who operates or owns a data
    communication device and who accesses, uses, or maintains
  7  pharmacy records in violation of the provisions of the bill.

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