House Bill 0319

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    Florida House of Representatives - 1999                 HB 319

        By Representative Gay






  1                      A bill to be entitled

  2         An act relating to pharmacy practice; amending

  3         s. 465.003, F.S.; defining the term "data

  4         communication device"; revising the definition

  5         of the term "practice of the profession of

  6         pharmacy"; amending s. 465.016, F.S.;

  7         authorizing the redispensing of unused or

  8         returned unit-dose medication by correctional

  9         facilities under certain conditions; providing

10         a ground for which a pharmacist may be subject

11         to discipline by the Board of Pharmacy;

12         amending s. 465.017, F.S.; providing additional

13         persons to whom and entities to which records

14         relating to the filling of prescriptions and

15         the dispensing of medicinal drugs that are

16         maintained by a pharmacy may be furnished;

17         specifying authorized uses of patient records

18         by pharmacy owners; providing restrictions on

19         such records when transmitted through a data

20         communication device; amending ss. 465.014,

21         465.015, 465.0196, 468.812, and 499.003, F.S.;

22         correcting cross references, to conform;

23         amending s. 499.012, F.S.; redefining the term

24         "wholesale distribution," relating to the

25         distribution of prescription drugs, to provide

26         for the exclusion of certain activities;

27         creating s. 499.072, F.S.; creating the Drug

28         Regulation Advisory Group; providing

29         membership; providing terms of office;

30         providing for meetings, for reimbursement of

31         expenses, and for purposes and duties of the

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  1         group; authorizing the Department of Health to

  2         publish compliance policy guidelines that

  3         include recommendations of the group; providing

  4         effective dates.

  5

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

  7

  8         Section 1.  Subsection (12) of section 465.003, Florida

  9  Statutes, is amended, subsections (4) through (14) are

10  renumbered as subsections (5) through (15), respectively, and

11  a new subsection (4) is added to said section, to read:

12         465.003  Definitions.--As used in this chapter, the

13  term:

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

15  device that receives electronic information from one source

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

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

18         (13)(12)  "Practice of the profession of pharmacy"

19  includes compounding, dispensing, and consulting concerning

20  contents, therapeutic values, and uses of any medicinal drug;

21  and consulting concerning therapeutic values and interactions

22  of patent or proprietary preparations, whether pursuant to

23  prescriptions or in the absence and entirely independent of

24  such prescriptions or orders; and other pharmaceutical

25  services.  For purposes of this subsection, "other

26  pharmaceutical services" means evaluation and monitoring of

27  the patient's health as it relates to drug therapy and

28  assisting the patient in the management of his or her drug

29  therapy, and includes review of the patient's drug therapy and

30  communication with the patient and the patient's prescribing

31  health care provider as licensed under chapter 458, chapter

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  1  459, chapter 461, or chapter 466, or similar statutory

  2  provision in another jurisdiction, or such provider's agent or

  3  such other persons as specifically authorized by the patient,

  4  regarding the drug therapy.  However, nothing in this

  5  subsection may be interpreted to permit an alteration of a

  6  prescriber's directions, unless otherwise permitted by law.

  7  "Practice of the profession of pharmacy" The phrase also

  8  includes any other act, service, operation, research, or

  9  transaction incidental to, or forming a part of, any of the

10  foregoing acts, requiring, involving, or employing the science

11  or art of any branch of the pharmaceutical profession, study,

12  or training, and shall expressly permit a pharmacist to

13  transmit information from persons authorized to prescribe

14  medicinal drugs to their patients.  "Practice of the

15  profession of pharmacy" also includes the administering of

16  immunizations by a pharmacist within the framework of an

17  established protocol under a supervisory practitioner who is a

18  physician licensed under chapter 458 or chapter 459 or by

19  written agreement with a county health department.  Each

20  protocol must contain specific procedures to address any

21  unforeseen allergic reaction to an immunization.  A pharmacist

22  may not enter into a protocol unless he or she maintains at

23  least $200,000 of professional liability insurance, and not

24  until the pharmacist has completed training in immunizations

25  as may be required by the board.  The decision by a

26  supervisory practitioner to enter into such a protocol is a

27  professional decision of the practitioner, and no person may

28  interfere with a supervisory practitioner's decision as to

29  whether to enter into such a protocol.  A pharmacist may not

30  enter into a protocol that is to be performed while acting as

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  1  an employee without the written approval of the owner of the

  2  pharmacy.

  3         Section 2.  Effective upon this act becoming a law,

  4  paragraph (l) of subsection (1) of section 465.016, Florida

  5  Statutes, is amended to read:

  6         465.016  Disciplinary actions.--

  7         (1)  The following acts shall be grounds for

  8  disciplinary action set forth in this section:

  9         (l)  Placing in the stock of any pharmacy any part of

10  any prescription compounded or dispensed which is returned by

11  a patient; however, in a hospital, nursing home, correctional

12  facility, or extended care facility in which unit-dose

13  medication is dispensed to inpatients, each dose being

14  individually sealed and the individual unit dose or unit-dose

15  system labeled with the name of the drug, dosage strength,

16  manufacturer's control number, and expiration date, if any,

17  the unused unit dose of medication may be returned to the

18  pharmacy for redispensing.  Each pharmacist shall maintain

19  appropriate records for any unused or returned medicinal

20  drugs.

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

22  section 465.016, Florida Statutes, to read:

23         465.016  Disciplinary actions.--

24         (1)  The following acts shall be grounds for

25  disciplinary action set forth in this section:

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

27  authorized by this chapter and chapter 455.

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

29  Statutes, is amended to read:

30         465.017  Authority to inspect.--

31

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

  2  406, 409, 455, 499, and 893, records maintained by in a

  3  pharmacy relating to the filling of prescriptions and the

  4  dispensing of medicinal drugs shall not be furnished, except

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

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

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

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

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

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

11  practitioners and pharmacists consulting with or dispensing to

12  the patient; or to insurance carriers or other payors

13  authorized by the patient to receive such records.  For

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

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

16  owner may use such records in the aggregate without patient

17  identification data, regardless of where such records are

18  held, for purposes reasonably related to the business and

19  practice of pharmacy except upon the written authorization of

20  such patient.  Such records may be furnished in any civil or

21  criminal proceeding, upon the issuance of a subpoena from a

22  court of competent jurisdiction and proper notice to the

23  patient or her or his legal representative by the party

24  seeking such records.  Such records or any part thereof, if

25  transmitted through a data communication device and not

26  directly between a pharmacy and a treating practitioner, may

27  not be accessed, used, or maintained by the operator or owner

28  of the data communication device unless specifically

29  authorized by this section.  It is the intent of this

30  subsection to allow the use and sharing of such records to

31  improve patient care, provided the pharmacist acts in the best

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  1  interests of her or his patient.  Nothing in this subsection

  2  may be construed to authorize or expand solicitation or

  3  marketing to patients or potential patients in any manner not

  4  otherwise specifically authorized by law.

  5         Section 5.  Section 465.014, Florida Statutes, is

  6  amended to read:

  7         465.014  Pharmacy technician.--No person other than a

  8  licensed pharmacist or pharmacy intern may engage in the

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

10  pharmacist may delegate to nonlicensed pharmacy technicians

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

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

13  shall be performed under the direct supervision of a licensed

14  pharmacist who shall be responsible for all such acts

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

16  technician, under the supervision of a pharmacist, may

17  initiate or receive communications with a practitioner or his

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

19  authorization requests.  No licensed pharmacist shall

20  supervise more than one pharmacy technician unless otherwise

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

22  shall establish guidelines to be followed by licensees or

23  permittees in determining the circumstances under which a

24  licensed pharmacist may supervise more than one but not more

25  than three pharmacy technicians.

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

27  465.015, Florida Statutes, is amended to read:

28         465.015  Violations and penalties.--

29         (2)  It is unlawful for any person:

30

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

  2  465.003(8)(7) without first being furnished with a

  3  prescription.

  4         Section 7.  Section 465.0196, Florida Statutes, is

  5  amended to read:

  6         465.0196  Special pharmacy permits.--Any person

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

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

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

10  pharmacy permit.  If the board certifies that the application

11  complies with the applicable laws and rules of the board

12  governing the practice of the profession of pharmacy, the

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

14  unless a licensed pharmacist is designated to undertake the

15  professional supervision of the compounding and dispensing of

16  all drugs dispensed by the pharmacy.  The licensed pharmacist

17  shall be responsible for maintaining all drug records and for

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

19  which the compounding, storing, and dispensing of medicinal

20  drugs occurs.  The permittee shall notify the department

21  within 10 days of any change of the licensed pharmacist

22  responsible for such duties.

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

24  Statutes, is amended to read:

25         468.812  Exemptions from licensure.--

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

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

28  any person acting under the supervision of a licensed

29  pharmacist.  The practice of orthotics or pedorthics by a

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

31  the supervision of a pharmacist shall be construed to be

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

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

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

  4  practice.  The Board of Pharmacy shall develop rules regarding

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

  6  pharmacist or person under the supervision of a pharmacist

  7  engaged in the practice of orthotics or pedorthics shall not

  8  be precluded from continuing that practice pending adoption of

  9  these rules.

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

11  Statutes, is amended to read:

12         499.003  Definitions of terms used in ss.

13  499.001-499.081.--As used in ss. 499.001-499.081, the term:

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

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

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

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

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

19  or (c).

20         Section 10.  Paragraph (a) of subsection (1) and

21  subsection (5) of section 499.012, Florida Statutes, 1998

22  Supplement, are amended to read:

23         499.012  Wholesale distribution; definitions; permits;

24  general requirements.--

25         (1)  As used in this section, the term:

26         (a)  "Wholesale distribution" means distribution of

27  prescription drugs to persons other than a consumer or

28  patient, but does not include:

29         1.  Any of the following activities, which is not a

30  violation of s. 499.005(21) if such activity is conducted in

31  accordance with s. 499.014:

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  1         a.  The purchase or other acquisition by a hospital or

  2  other health care entity that is a member of a group

  3  purchasing organization of a prescription drug for its own use

  4  from the group purchasing organization or from other hospitals

  5  or health care entities that are members of that organization.

  6         b.  The sale, purchase, or trade of a prescription drug

  7  or an offer to sell, purchase, or trade a prescription drug by

  8  a charitable organization described in s. 501(c)(3) of the

  9  Internal Revenue Code of 1986, as amended and revised, to a

10  nonprofit affiliate of the organization to the extent

11  otherwise permitted by law.

12         c.  The sale, purchase, or trade of a prescription drug

13  or an offer to sell, purchase, or trade a prescription drug

14  among hospitals or other health care entities that are under

15  common control. For purposes of this section, "common control"

16  means the power to direct or cause the direction of the

17  management and policies of a person or an organization,

18  whether by ownership of stock, by voting rights, by contract,

19  or otherwise.

20         2.  Any of the following activities, which is not a

21  violation of s. 499.005(21) if such activity is conducted in

22  accordance with rules established by the department:

23         a.  The sale, purchase, or trade of a prescription drug

24  among federal, state, or local government health care entities

25  that are under common control and are authorized to purchase

26  such prescription drug.

27         b.  The sale, purchase, trade, or other transfer of a

28  prescription drug from or for any federal, state, or local

29  government agency or any entity eligible to purchase

30  prescription drugs at public health services prices pursuant

31  to s. 602 of Pub. L. No. 102-585 to a contract provider or its

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  1  subcontractor for eligible patients of the agency or entity

  2  under the following conditions:

  3         (I)  The agency or entity must obtain written

  4  authorization for the sale, purchase, trade, or other transfer

  5  of a prescription drug under this sub-subparagraph from the

  6  Secretary of Health.  This written authorization must be based

  7  on a favorable recommendation by the Drug Regulation Advisory

  8  Group after the group has reviewed the agency's or entity's

  9  submission to the department of a detailed plan and

10  justification for the sale, purchase, trade, or other transfer

11  of a prescription drug under this sub-subparagraph and must

12  enhance the public's health by improving needed access,

13  quality, or safety because current patient drug delivery

14  systems are inadequate.

15         (II)  The contract provider or subcontractor must be

16  authorized by law to administer or dispense prescription

17  drugs.

18         (III)  In the case of a subcontractor, the agency or

19  entity must be a party to and execute the subcontract.

20         (IV)  A contract provider or subcontractor must

21  maintain separate and apart from other prescription drug

22  inventory any prescription drugs of the agency or entity in

23  its possession.

24         (V)  The contract provider and subcontractor must

25  maintain and produce immediately for inspection all records of

26  movement or transfer of all the prescription drugs belonging

27  to the agency or entity, including, but not limited to, the

28  records of receipt and disposition of prescription drugs.

29  Each contractor and subcontractor dispensing or administering

30  these drugs must maintain and produce records documenting the

31  dispensing or administration.  Records that are required to be

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  1  maintained include, but are not limited to, a perpetual

  2  inventory itemizing drugs received and drugs dispensed by

  3  prescription number or administered by patient identifier,

  4  which must be submitted to the agency or entity monthly.

  5         (VI)  The contract provider or subcontractor may

  6  administer or dispense the prescription drugs only to the

  7  eligible patients of the agency or entity or must return the

  8  prescription drugs for or to the agency or entity.  The

  9  contract provider or subcontractor must require proof from

10  each person seeking to fill a prescription or obtain treatment

11  that the person is an eligible patient of the agency or entity

12  and must, at a minimum, maintain a copy of this proof as part

13  of the records of the contractor or subcontractor required

14  under sub-sub-subparagraph (V).

15         (VII)  The prescription drugs transferred pursuant to

16  this sub-subparagraph may not be billed to Medicaid.

17         (VIII)  In addition to the departmental inspection

18  authority set forth in s. 499.051, the establishment of the

19  contract provider and subcontractor and all records pertaining

20  to prescription drugs subject to this sub-subparagraph shall

21  be subject to inspection by the agency or entity.  All records

22  relating to prescription drugs of a manufacturer under this

23  sub-subparagraph shall be subject to audit by the manufacturer

24  of those drugs, without identifying individual patient

25  information.

26         c.b.  The sale, purchase, or trade of a prescription

27  drug or an offer to sell, purchase, or trade a prescription

28  drug for emergency medical reasons.;  For purposes of this

29  sub-subparagraph subparagraph, the term "emergency medical

30  reasons" includes transfers of prescription drugs by a retail

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  1  pharmacy to another retail pharmacy to alleviate a temporary

  2  shortage.

  3         d.c.  The transfer purchase or acquisition of a

  4  prescription drug acquired by a medical director on behalf of

  5  a licensed an emergency medical services provider to that

  6  medical director for use by emergency medical services

  7  provider and its transport vehicles for use in accordance with

  8  the provider's license under providers acting within the scope

  9  of their professional practice pursuant to chapter 401.

10         e.d.  The revocation of a sale or the return of a

11  prescription drug to the person's prescription drug wholesale

12  supplier.

13         f.e.  The donation of a prescription drug by a health

14  care entity to a charitable organization that has been granted

15  an exemption under s. 501(c)(3) of the Internal Revenue Code

16  of 1986, as amended, and that is authorized to possess

17  prescription drugs.

18         g.f.  The transfer of a prescription drug by a person

19  authorized to purchase or receive prescription drugs to a

20  person licensed or permitted to handle reverse distributions

21  or destruction under the laws of the jurisdiction in which the

22  person handling the reverse distribution or destruction

23  receives the drug.

24         3.  The dispensing of a prescription drug pursuant to a

25  prescription;

26         h.4.  The distribution of prescription drug samples by

27  manufacturers' representatives or distributors'

28  representatives conducted in accordance with s. 499.028.; or

29         i.5.  The sale, purchase, or trade of blood and blood

30  components intended for transfusion.  As used in this

31  sub-subparagraph section, the term "blood" means whole blood

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  1  collected from a single donor and processed either for

  2  transfusion or further manufacturing, and the term "blood

  3  components" means that part of the blood separated by physical

  4  or mechanical means.

  5         3.  The lawful dispensing of a prescription drug in

  6  accordance with chapter 465.

  7         (5)  The department may adopt rules governing the

  8  recordkeeping, storage, and handling with respect to each of

  9  the distributions of prescription drugs specified in

10  subparagraphs (1)(a)1. and, 2., 4., and 5.

11         Section 11.  Section 499.072, Florida Statutes, is

12  created to read:

13         499.072  Drug Regulation Advisory Group.--

14         (1)  There is created the Drug Regulation Advisory

15  Group, which is an independent advisory group composed of at

16  least 13 members appointed by the Secretary of Health and

17  including:

18         (a)  One member representing the prescription drug

19  wholesale industry in this state.

20         (b)  One member representing pharmaceutical

21  manufacturers, who may represent pharmaceutical manufacturers

22  nationwide.

23         (c)  One member who is a practicing pharmacist.

24         (d)  One member representing the Agency for Health Care

25  Administration.

26         (e)  One member who is a physician licensed under

27  chapter 458 or chapter 459.

28         (f)  One consumer representative.

29         (g)  One member representing the cosmetic industry.

30         (h)  One member representing the compressed medical gas

31  industry.

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  1         (i)  One member representing the medical device

  2  manufacturing industry.

  3         (j)  The Executive Director of the Board of Pharmacy,

  4  who shall be an ex officio member.

  5         (k)  One member representing the department, who shall

  6  chair group meetings.

  7         (l)  One member representing hospitals.

  8         (m)  One member representing the long-term care

  9  industry.

10         (2)  Members shall be appointed for terms of 4 years,

11  except for the Executive Director of the Board of Pharmacy and

12  the departmental representative, who may serve indefinitely.

13  Members of the group may be reappointed.  A vacancy in

14  membership that occurs before the expiration of a term shall

15  be filled by a member appointed by the Secretary of Health for

16  a full term.

17         (3)  The group shall meet upon request of the

18  department, but no more than four times a year.  Members of

19  the group shall serve without compensation, but may be

20  reimbursed for per diem and travel expenses as provided in s.

21  112.061.

22         (4)  The purposes and duties of the Drug Regulation

23  Advisory Group include, but are not limited to:

24         (a)  Making recommendations to the Secretary of Health

25  regarding authorizations for the sale, purchase, trade, or

26  other transfer of a prescription drug under s. 499.012(1)(a)2.

27         (b)  Making recommendations to the department regarding

28  enforcement priorities under this chapter.

29         (c)  Briefing the department on industry trends that

30  affect this chapter.

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  1         (d)  Providing information and guidance on issues

  2  submitted by the department to the group.

  3         (e)  Facilitating the dissemination of relevant

  4  information concerning current issues affecting the public

  5  health within the scope and responsibility of this chapter.

  6         (5)  The department may publish compliance policy

  7  guidelines that set forth enforcement priorities or other

  8  recommendations of the Drug Regulation Advisory Group when

  9  that is in the best interests of the public health.

10         Section 12.  Except as otherwise provided herein, this

11  act shall take effect July 1, 1999.

12

13            *****************************************

14                          HOUSE SUMMARY

15
      Defines the term "data communication device" and expands
16    the definition of "practice of the profession of
      pharmacy" to include other pharmaceutical services
17    relating to drug therapy and administration of
      immunizations under certain circumstances.  Authorizes
18    the redispensing of unused or returned unit-dose
      medication by correctional facilities under certain
19    conditions.  Provides that using or releasing a patient's
      records except as authorized by chapter 465 or chapter
20    455, F.S., constitutes a ground for disciplinary action
      against a pharmacist.  Provides additional persons to
21    whom and entities to which records relating to the
      filling of prescriptions and the dispensing of medicinal
22    drugs that are maintained by a pharmacy may be furnished.
      Specifies authorized uses of patient records by pharmacy
23    owners.  Provides restrictions on such records when
      transmitted through a data communication device.
24    Redefines the term "wholesale distribution," relating to
      the distribution of prescription drugs, to provide for
25    the exclusion of certain activities.  Creates the Drug
      Regulation Advisory Group and provides for its members
26    and their terms of office.  Provides for meetings, for
      reimbursement of expenses, and for purposes and duties of
27    the group.  Authorizing the Department of Health to
      publish compliance policy guidelines that include
28    recommendations of the group.  See bill for details.

29

30

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