Senate Bill sb0636c1

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    Florida Senate - 2002                            CS for SB 636

    By the Committee on Health, Aging and Long-Term Care; and
    Senator Burt




    317-1775A-02

  1                      A bill to be entitled

  2         An act relating to controlled substances;

  3         providing for specified licensing boards to

  4         adopt rules governing the prescribing of

  5         controlled substances; requiring certain health

  6         care providers to complete education courses

  7         relating to the prescription of controlled

  8         substances; providing penalties and requiring a

  9         report; providing for the emergency suspension

10         of certain licenses for prescribing violations;

11         requiring the Department of Health and the

12         Department of Law Enforcement to share certain

13         information regarding health care

14         practitioners; requiring a report; requiring

15         the Department of Legal Affairs to establish an

16         electronic system to monitor the prescribing of

17         certain controlled substances; establishing an

18         advisory council and providing for its

19         membership, duties, staff, and compensation;

20         amending s. 456.033, F.S.; eliminating certain

21         requirements for HIV and AIDS education

22         courses; amending s. 456.072, F.S., revising

23         penalties; amending s. 458.345, F.S.; requiring

24         certain resident physicians, interns, and

25         fellows to complete an educational course in

26         prescribing controlled substances; amending s.

27         461.013, F.S.; prohibiting the presigning of

28         blank prescription forms and providing

29         penalties; amending s. 893.04, F.S.; providing

30         additional requirements for pharmacists

31         regarding the identification of persons to whom

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  1         controlled substances are dispensed;

  2         prohibiting certain prescribing practitioners

  3         from possessing, administering, dispensing, or

  4         prescribing controlled substances; creating s.

  5         893.065, F.S.; establishing protocols requiring

  6         prescriptions for certain controlled substances

  7         to be issued on special forms developed by the

  8         Department of Legal Affairs; establishing

  9         requirements for the design, issuance, and

10         control of such forms; providing record-keeping

11         requirements; providing other requirements for

12         the use of such forms; providing an effective

13         date.

14

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

16

17         Section 1.  Physicians; rules establishing prescribing

18  guidelines.--To minimize the diversion and resultant abuse of

19  controlled substances, the Board of Medicine and the Board of

20  Osteopathic Medicine shall adopt rules to establish guidelines

21  for prescribing controlled substances to patients in

22  emergency-department settings. Such guidelines must allow

23  physicians to provide legitimate medical treatment of acute

24  and chronic pain and require them to recognize and prevent

25  abuse of pain medications prescribed in emergency-department

26  settings. The guidelines must also consider requirements of

27  state and federal law and of the Joint Commission on the

28  Accreditation of Healthcare Organizations. Each board shall

29  consult with the Florida College of Emergency Physicians in

30  developing these guidelines.

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  1         Section 2.  Instruction required for certain licensees

  2  in prescribing and pharmacology.--

  3         (1)  The appropriate professional licensing board shall

  4  require each person licensed under chapter 458, chapter 459,

  5  chapter 461, chapter 462, or chapter 466, Florida Statutes, to

  6  complete a 1-hour educational course, approved by the board,

  7  on appropriate prescribing and pharmacology of controlled

  8  substances, as part of the licensee's initial license renewal

  9  after January 1, 2003. The course shall provide education in

10  the state and federal laws and rules governing the prescribing

11  and dispensing of controlled substances; in appropriate

12  evaluation of patients for any risk of drug diversion and the

13  resulting abuse of controlled substances; in the use of

14  informed consent and other protocols, such as discussing the

15  risks and benefits of using controlled substances, with

16  patients to prevent drug diversion; in the need to keep

17  accurate and complete medical records to justify treatment

18  with controlled substances; in addiction and substance-abuse

19  issues with respect to patients; in the appropriate use of

20  recognized pain-management guidelines; and in the need for

21  consultation and referral of patients who are at risk for

22  misuse of medication or diversion of controlled substances,

23  when appropriate.

24         (2)  The board may approve additional equivalent

25  courses that satisfy the requirements of subsection (1). Each

26  licensing board that requires a licensee to complete an

27  educational course pursuant to this section shall include the

28  hours required to complete the course in the total required

29  continuing educational requirements.

30         (3)  Any person who holds two or more licenses subject

31  to this section may satisfy the requirements of this section

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  1  by taking only one such board-approved course for relicensure

  2  of all such licenses.

  3         (4)  A licensee who fails to comply with this section

  4  is subject to disciplinary action under each respective

  5  practice act and section 456.072(1)(k), Florida Statutes. In

  6  addition to discipline by the board, the licensee must

  7  complete the course.

  8         (5)  The board shall require, as a condition of

  9  granting a license under the chapter specified in subsection

10  (1), that an applicant for initial licensure complete an

11  educational course set forth in subsection (1). An applicant

12  who has not taken a course at the time of licensure shall be

13  allowed 6 months within which to complete this requirement.

14         (6)  The board may adopt rules necessary to administer

15  this section.

16         Section 3.  Emergency suspension orders; controlled

17  substances.--Upon receipt of sufficient evidence from any

18  agency authorized to enforce chapter 893, Florida Statutes,

19  regarding a violation of section 458.331(1)(q), section

20  458.331(1)(r), section 458.331(1)(aa), section 459.015(1)(t),

21  section 459.015(1)(u), section 459.015(1)(ee), section

22  461.013(1)(o), section 461.013(1)(p), section 461.013(1)(dd),

23  section 462.14(1)(q), section 462.14(1)(r), section

24  462.14(1)(aa), section 464.018(1)(i), section 465.016(1)(e),

25  section 465.016(1)(i), section 466.028(1)(p), section

26  466.028(1)(q), section 466.028(1)(r), or section

27  466.028(1)(dd) or of chapter 893, Florida Statutes, by a

28  licensed health care practitioner who is authorized to

29  prescribe, dispense, or administer controlled substances, the

30  Department of Health shall review the case and if the

31  practitioner is a danger to the public health, safety, or

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  1  welfare of the public as set forth in section 120.60(6),

  2  Florida Statutes, recommend the suspension or restriction of

  3  the practitioner's license to the Secretary of Health within

  4  10 working days after receiving such evidence. The Secretary

  5  of Health may suspend or restrict the license of the

  6  practitioner in accordance with section 120.60(6), Florida

  7  Statutes.

  8         Section 4.  Sharing of arrest and other information

  9  regarding certain health care practitioners.--In order to

10  facilitate the efficiency of the Department of Health's

11  investigation of applicable violations involving the diversion

12  of controlled substances by such practitioners, the Department

13  of Law Enforcement shall, when practicable, notify and provide

14  investigative information to the Department of Health

15  regarding the arrest of any licensed health care practitioner

16  who is authorized to prescribe, dispense, or administer

17  controlled substances.

18         (1)  The Medical Examiner's Commission within the

19  Department of Law Enforcement shall report quarterly to the

20  Department of Health any deaths attributed to the abuse of

21  controlled substances, based on autopsy reports completed

22  within this state, and any other public information that may

23  facilitate that department's expeditious investigation of the

24  information to determine whether any of the deaths have

25  involved conduct by a licensed health care practitioner which

26  is subject to disciplinary action under section 456.073,

27  Florida Statutes. The Department of Health or the board having

28  regulatory authority over the practitioner shall investigate

29  any information received by the department or the board when

30  it has reasonable grounds to believe that the practitioner has

31  violated any law relating to the practitioner's practice.

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  1         (2)  To help the Department of Health and regulatory

  2  boards control the diversion and resultant abuse of controlled

  3  substances, the Department of Health and the Department of Law

  4  Enforcement shall study the feasibility of expanding the

  5  electronic exchange of information to facilitate the transfer

  6  to the Department of Health of criminal history information

  7  involving licensed health care practitioners who are

  8  authorized to prescribe, administer, or dispense controlled

  9  substances. The Department of Law Enforcement shall

10  investigate the feasibility of the electronic transmission of

11  information from medical examiners within this state to the

12  Department of Health regarding autopsies and other public

13  reports that attribute death to controlled-substance abuse.

14  The Department of Law Enforcement, in consultation with the

15  Department of Health, must submit a report of its findings to

16  the Legislature by November 1, 2002.

17         Section 5.  Electronic monitoring system for

18  prescriptions.--

19         (1)  By July 1, 2003, the Department of Legal Affairs

20  shall design and establish an electronic system consistent

21  with the National Council of Prescription Drug Programs

22  (NCPDP) standards to monitor the prescribing of Schedule II

23  controlled substances, other drugs designated by rule by the

24  Attorney General under this section, and codeine, hydrocodone,

25  dihydrocodeine, ethylmorphine, and morphine, as scheduled in

26  Schedule II and Schedule III, by health care practitioners

27  within the state or the dispensing of such controlled

28  substances to an address within the state by a pharmacy

29  permitted or registered by the Board of Pharmacy.

30         (2)  All Schedule II controlled substances, and codeine

31  hydrocodone, dihydrocodeine, ethylmorphine, and morphine as

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  1  scheduled in Schedule II and Schedule III, and any other drug

  2  designated by the Attorney General under this section shall be

  3  included in the electronic monitoring system. The Attorney

  4  General may, by rule, designate any other drug for inclusion

  5  in such system after making a determination that the drug is a

  6  drug of abuse. The Attorney General must consider the

  7  recommendations of the prescription-monitoring advisory

  8  council created by this section before designating a drug of

  9  abuse for inclusion in the electronic monitoring system and

10  only after he or she determines that the current level of

11  regulation over the prescribing and dispensing of such drug is

12  inadequate and that the drug has a high potential for abuse or

13  is being excessively misused, abused, or diverted into illicit

14  drug trafficking.

15         (3)  Each controlled substance or drug subject to this

16  section which is dispensed in this state must be timely

17  reported to the Department of Legal Affairs. Such data must be

18  reported each time that:

19         (a)  A Schedule II controlled substance is dispensed;

20         (b)  A drug that is designated by the Attorney General

21  under subsection (2) is dispensed; or

22         (c)  Codeine, hydrocodone, dihydrocodeine,

23  ethylmorphine, or morphine as scheduled in Schedule II and

24  Schedule III is dispensed.

25         (4)  This section does not apply to controlled

26  substances or drugs:

27         (a)  Ordered from an institutional pharmacy licensed

28  under section 465.019(2), Florida Statutes, in accordance with

29  the institutional policy for such controlled substances or

30  drugs; or

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  1         (b)  Administered by a health care practitioner to a

  2  patient or resident receiving care from a hospital, nursing

  3  home, assisted living facility, home health agency, hospice,

  4  or intermediate care facility for the developmentally disabled

  5  which is licensed in this state.

  6         (5)  The data required under this section includes:

  7         (a)  The patient's name.

  8         (b)  The patient's address.

  9         (c)  The national drug code number of the substance

10  dispensed.

11         (d)  The date that the substance is dispensed.

12         (e)  The quantity of substance dispensed.

13         (f)  The dispenser's National Association of Board's of

14  Pharmacy (NABP) number.

15         (g)  The prescribing practitioner's United States Drug

16  Enforcement Administration Number.

17         (6)  The information must be reported within 30 days

18  after the date the controlled substance or drug is dispensed.

19         (7)  A dispenser must transmit the information required

20  by this section in an electronic format approved by rule of

21  the Board of Pharmacy after consultation with the advisory

22  council and the Department of Legal Affairs unless a specific

23  waiver is granted to that dispenser by the Department of Legal

24  Affairs.

25         (8)  The Department of Legal Affairs shall establish a

26  13-member prescription-monitoring program advisory council to

27  assist it in identifying drugs of abuse for inclusion in the

28  monitoring system and in implementing the system.

29         (a)  The Governor shall appoint members to serve on the

30  advisory council. The members of the council shall include the

31  Attorney General or his or her designee who shall serve as the

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  1  chairperson; the Secretary of Health or his or her designee;

  2  the executive director of the Department of Law Enforcement or

  3  his or her designee; the director of the Office of Drug

  4  Control within the Executive Office of Governor or his or her

  5  designee; a physician who is licensed in this state under

  6  chapter 458, Florida Statutes, who is recommended by the

  7  Florida Medical Association; a physician who is licensed in

  8  this state under chapter 459, Florida Statutes, who is

  9  recommended by the Florida Osteopathic Medical Association; a

10  podiatric physician who is licensed in this state under

11  chapter 461, Florida Statutes, who is recommended by the

12  Florida Podiatric Medical Association; a pharmacist who is

13  licensed in this state under chapter 465, Florida Statutes,

14  who is recommended by the Florida Pharmacy Association; a

15  pharmacist who is licensed in this state under chapter 465,

16  Florida Statutes, who is recommended by the Florida Retail

17  Federation; a pharmacist who is licensed in this state under

18  chapter 465, Florida Statutes, who is recommended by the

19  National Community Pharmacy Association; a dentist who is

20  licensed in this state under chapter 466, Florida Statutes,

21  who is recommended by the Florida Dental Association; a

22  veterinarian who is licensed in this state under chapter 474,

23  Florida Statutes, who is recommended by the Florida Veterinary

24  Medical Association; and a prosecutor who has expertise in the

25  criminal prosecution of drug-diversion cases.

26         (b)  The advisory council members shall meet no more

27  often than quarterly at the call of the chairperson, and serve

28  without compensation. However, such members may receive

29  reimbursement, as provided in section 112.061, Florida

30  Statutes, for per diem and travel expenses incurred in the

31  performance of their official duties.

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  1         (c)  The Department of Legal Affairs shall provide

  2  staff and other administrative assistance that is reasonably

  3  necessary to assist the advisory council in carrying out its

  4  responsibilities.

  5         (9)  The Department of Legal Affairs shall adopt rules

  6  pursuant to section 120.536(1) and section 120.574, Florida

  7  Statutes, necessary to administer this section.

  8         Section 6.  Subsections (1) and (9) of section 456.033,

  9  Florida Statutes, are amended to read:

10         456.033  Requirement for instruction for certain

11  licensees on HIV and AIDS.--

12         (1)  The appropriate board shall require each person

13  licensed or certified under chapter 457; chapter 458; chapter

14  459; chapter 460; chapter 461; chapter 463; part I of chapter

15  464; chapter 465; chapter 466; part II, part III, part V, or

16  part X of chapter 468; or chapter 486 to complete a continuing

17  educational course, approved by the board, on human

18  immunodeficiency virus and acquired immune deficiency syndrome

19  as part of biennial relicensure or recertification. The course

20  shall consist of education on the modes of transmission,

21  infection control procedures, clinical management, and

22  prevention of human immunodeficiency virus and acquired immune

23  deficiency syndrome. Such course shall include information on

24  current Florida law on acquired immune deficiency syndrome and

25  its impact on testing, confidentiality of test results,

26  treatment of patients, and any protocols and procedures

27  applicable to human immunodeficiency virus counseling and

28  testing, reporting, the offering of HIV testing to pregnant

29  women, and partner notification issues pursuant to ss. 381.004

30  and 384.25.

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  1         (9)(a)  In lieu of completing a course as required in

  2  subsection (1), the licensee may complete a course in

  3  end-of-life care and palliative health care, so long as the

  4  licensee completed an approved AIDS/HIV course in the

  5  immediately preceding biennium.

  6         (b)  In lieu of completing a course as required by

  7  subsection (1), a person licensed under chapter 466 who has

  8  completed an approved AIDS/HIV course in the immediately

  9  preceding 2 years may complete a course approved by the Board

10  of Dentistry.

11         Section 7.  Paragraph (d) of subsection (2) of section

12  456.072, Florida Statutes, is amended to read:

13         456.072  Grounds for discipline; penalties;

14  enforcement.--

15         (2)  When the board, or the department when there is no

16  board, finds any person guilty of the grounds set forth in

17  subsection (1) or of any grounds set forth in the applicable

18  practice act, including conduct constituting a substantial

19  violation of subsection (1) or a violation of the applicable

20  practice act which occurred prior to obtaining a license, it

21  may enter an order imposing one or more of the following

22  penalties:

23         (d)  Imposition of an administrative fine not to exceed

24  $25,000 $10,000 for each count or separate offense. If the

25  violation is for fraud or making a false or fraudulent

26  representation, the board, or the department if there is no

27  board, must impose a fine of $10,000 per count or offense.

28         Section 8.  Paragraph (d) is added to subsection (1) of

29  section 458.345, Florida Statutes, to read:

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  1         458.345  Registration of resident physicians, interns,

  2  and fellows; list of hospital employees; prescribing of

  3  medicinal drugs; penalty.--

  4         (1)  Any person desiring to practice as a resident

  5  physician, assistant resident physician, house physician,

  6  intern, or fellow in fellowship training which leads to

  7  subspecialty board certification in this state, or any person

  8  desiring to practice as a resident physician, assistant

  9  resident physician, house physician, intern, or fellow in

10  fellowship training in a teaching hospital in this state as

11  defined in s. 408.07(44) or s. 395.805(2), who does not hold a

12  valid, active license issued under this chapter shall apply to

13  the department to be registered and shall remit a fee not to

14  exceed $300 as set by the board.  The department shall

15  register any applicant the board certifies has met the

16  following requirements:

17         (d)  Has completed, upon initial registration, the

18  1-hour educational course in the prescribing of controlled

19  substances as set forth in section 2 of this act. An applicant

20  who has not taken a course at the time of registration shall

21  be allowed up to 6 months within which to complete this

22  requirement.

23         Section 9.  Paragraph (dd) is added to subsection (1)

24  of section 461.013, Florida Statutes, to read:

25         461.013  Grounds for disciplinary action; action by the

26  board; investigations by department.--

27         (1)  The following acts constitute grounds for denial

28  of a license or disciplinary action, as specified in s.

29  456.072(2):

30         (dd)  Presigning blank prescription forms.

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  1         Section 10.  Paragraphs (h), (i), (j), (k), and (l) are

  2  added to subsection (1) of section 893.04, Florida Statutes,

  3  to read:

  4         893.04  Pharmacist and practitioner.--

  5         (1)  A pharmacist, in good faith and in the course of

  6  professional practice only, may dispense controlled substances

  7  upon a written or oral prescription of a practitioner, under

  8  the following conditions:

  9         (h)  A pharmacist may not dispense a Schedule II

10  controlled substance; codeine, hydrocodone, dihydrocodeine,

11  ethylmorphine, or morphine, as scheduled in Schedule II and

12  Schedule III; or drug of abuse designated by the Attorney

13  General by rule under the prescription-monitoring system to

14  any individual not personally known to the pharmacist, without

15  first obtaining suitable identification and documenting, by

16  signature on a log book kept by the pharmacist, the identity

17  of the individual obtaining the controlled substance. If the

18  individual does not have suitable identification or it is

19  impracticable to obtain such identification, the pharmacist

20  must verify the validity of the prescription and identity of

21  the patient with the prescribing practitioner, or the

22  prescribing practitioner's authorized agent, before dispensing

23  the controlled substance or drug as provided by rule of the

24  Board of Pharmacy. The Board of Pharmacy must adopt, by rule,

25  procedures for a pharmacist to verify the validity of a

26  prescription for a Schedule II controlled substance; other

27  drug designated by the Attorney General under this section; or

28  codeine, hydrocodone, dihydrocodeine, ethylmorphine, or

29  morphine, as scheduled in Schedule II and Schedule III, for

30  circumstances when it is otherwise impracticable for the

31  pharmacist or dispensing practitioner to obtain suitable

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  1  identification from the patient or the patient's agent. For

  2  purposes of this section, identification is suitable only if

  3  it contains the photograph, the printed name, and the

  4  signature of the individual obtaining the Schedule II

  5  controlled substance or drug of abuse under the

  6  prescription-monitoring system.

  7         (i)  Any pharmacist that dispenses a Schedule II

  8  controlled substance or drug subject to the requirements of

  9  this section when dispensed by mail shall be exempt from the

10  requirements to obtain suitable identification.

11         (j)  All prescriptions issued for a Schedule II

12  controlled substance; codeine, hydrocodone, dihydrocodeine,

13  ethylmorphine, or morphine, as scheduled in Schedule II and

14  Schedule III; or a drug of abuse under the

15  prescription-monitoring system which has been designated by

16  the Attorney General by rule, must include both a written and

17  numerical notation of quantity on the face of the

18  prescription.

19         (k)  A pharmacist may not dispense more than a 30-day

20  supply of a controlled substance listed in Schedule III upon

21  an oral prescription.

22         (l)  A pharmacist may not knowingly fill a prescription

23  that has been mutilated or forged for a Schedule II controlled

24  substance; codeine, hydrocodone, dihydrocodeine,

25  ethylmorphine, and morphine, as scheduled in Schedule II and

26  Schedule III; or a drug of abuse under the

27  prescription-monitoring system which has been designated by

28  the Attorney General by rule.

29         Section 11.  Section 893.065, Florida Statutes, is

30  created to read:

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  1         893.065  Prescriptions required for certain controlled

  2  substances.--

  3         (1)  On or after July 1, 2002, a person may not issue a

  4  prescription for a Schedule II controlled substance; codeine,

  5  hydrocodone, dihydrocodeine, ethylmorphine, or morphine, as

  6  scheduled in Schedule II and Schedule III; or any drug

  7  included as a drug of abuse under the prescription-monitoring

  8  system which has been designated by the Attorney General by

  9  rule, unless the prescription meets the requirements of this

10  section.

11         (2)  The Department of Legal Affairs shall develop a

12  counterfeit-proof prescription blank for use by practitioners

13  who prescribe controlled substances classified in:

14         (a)  Schedule II;

15         (b)  Any drug that is designated by the Attorney

16  General by rule under subsection (1).

17         (c)  Schedule II or Schedule III as codeine,

18  hydrocodone, dihydrocodeine, ethylmorphine, or morphine.

19         (3)  Prescription blanks shall be issued by the

20  Department of Legal Affairs to such practitioners. The

21  prescription blanks must be printed on distinctive paper and

22  must bear the preprinted full name, address, and category of

23  professional licensure of the practitioner to whom they are

24  issued and that practitioner's federal registry number for

25  controlled substances. The prescription blanks may not be

26  transferred.

27         (4)  The Department of Legal Affairs must cover all

28  costs for the electronic prescription-monitoring program,

29  including the department's actual costs of preparing, issuing,

30  and tracking prescription blanks.

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  1         (5)  Notwithstanding s. 893.04(1)(a)-(d), a person may

  2  not prescribe a Schedule II controlled substance; codeine,

  3  hydrocodone, dihydrocodeine, ethylmorphine, or morphine, as

  4  scheduled in Schedule II and Schedule III; or any drug which

  5  has been designated by the Attorney General by rule under

  6  subsection (1), nor may any person fill, compound, or dispense

  7  such a prescription, unless it complies with this section.

  8         (a)  The signature on each such prescription form must

  9  be wholly written in ink or indelible pencil in the

10  handwriting of the prescribing practitioner. Each prescription

11  must be prepared, dated, and signed by the prescribing

12  practitioner on the day when issued, and must contain,

13  typewritten or handwritten by the physician or an employee of

14  the physician, the full name and address of the person for

15  whom, or the owner of the animal for which, the controlled

16  substance is prescribed; the name, quantity, and strength of

17  the controlled substance; directions for use; and the address,

18  category of professional licensure, and federal controlled

19  substance registration number of the prescribing practitioner.

20  If the prescription is for an animal, the prescription must

21  state the species of animal for which it is prescribed. If the

22  prescribing practitioner does not specify the address of the

23  person for whom, or animal for which, the prescription is

24  prescribed, the pharmacist filling the prescription or an

25  employee acting under the direction of the pharmacist must

26  write or type the address on the prescription or maintain the

27  information in a readily retrievable form in the pharmacy.

28         (b)  The original of the prescription must be delivered

29  to the pharmacist filling the prescription. The original must

30  be retained on file by the proprietor of the pharmacy in which

31  it is filled for a period of 2 years, properly endorsed by the

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  1  pharmacist with the name and address of the pharmacy, the

  2  pharmacy's state permit number, the date that the prescription

  3  was filled, and the signature of the pharmacist, and a copy

  4  must be available for inspection by the Department of Legal

  5  Affairs. Notwithstanding any provision of this section, the

  6  prescribing practitioner's address, category of professional

  7  licensure, or federal controlled substances registration

  8  number need not appear on the prescription if that information

  9  is readily retrievable in the pharmacy.

10         (c)  All prescriptions issued for a Schedule II

11  controlled substance; codeine, hydrocodone, dihydrocodeine,

12  ethylmorphine, or morphine, as scheduled in Schedule II and

13  Schedule III; or any drug which has been designated by the

14  Attorney General by rule under subsection (1), must include

15  both a written and numerical notation of quantity on the face

16  of the prescription.

17         (d)  A pharmacist may not dispense more than a 30-day

18  supply of a controlled substance listed in Schedule III upon

19  an oral prescription.

20         (e)  A pharmacist may not knowingly fill a prescription

21  that has been mutilated or forged for a Schedule II controlled

22  substance; codeine, hydrocodone, dihydrocodeine,

23  ethylmorphine, or morphine, as scheduled in Schedule II and

24  Schedule III; or any drug which has been designated by the

25  Attorney General by rule under subsection (1).

26         (f)  Any controlled substance listed in Schedule III;

27  codeine, hydrocodone, dihydrocodeine, ethylmorphine, or

28  morphine, as scheduled in Schedule II and Schedule III; or any

29  drug which has been designated by the Attorney General by rule

30  under subsection (1), may be dispensed by a pharmacist upon an

31  oral prescription, if before filling the prescription, the

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    Florida Senate - 2002                            CS for SB 636
    317-1775A-02




  1  pharmacist reduces it to writing in ink or indelible pencil in

  2  the handwriting of the pharmacist, upon an official form

  3  issued by the Department of Legal Affairs for that purpose.

  4  Such prescriptions must contain the date of the oral

  5  authorization and the information required by paragraph (a).

  6         (6)  Any pharmacist that dispenses a Schedule II

  7  controlled substance or drug subject to the requirements of

  8  this section when dispensed by mail shall be exempt from the

  9  requirements to use the required prescription blanks.

10         Section 12.  This act shall take effect July 1, 2002.

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    Florida Senate - 2002                            CS for SB 636
    317-1775A-02




  1          STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
                       COMMITTEE SUBSTITUTE FOR
  2                         Senate Bill 636

  3

  4  The Committee Substitute for SB 636 revises requirements for
    an electronic prescription monitoring system in Florida for
  5  controlled substances to limit the drugs covered by the system
    to controlled substances in Schedule II; codeine, hydrocodone,
  6  dihydrocodeine, ethylmorphine, and morphine, as scheduled in
    Schedule II and Schedule III; and other drugs as designated by
  7  the Attorney General, by rule. The Attorney General may, by
    rule, designate any other drug for inclusion in the system
  8  after making a determination that the drug is a drug of abuse
    and the consideration of specified criteria.
  9
    An exemption to the reporting requirements of the prescription
10  monitoring system is created for controlled substances or
    drugs that: (1) are ordered from an institutional pharmacy
11  licensed under s. 465.19(2), F.S., in accordance with
    institutional policy for such controlled substances or drugs;
12  or (2) are administered by a health care practitioner to a
    patient or resident receiving care from a hospital, nursing
13  home, assisted living facility, home health agency, hospice or
    intermediate care facility for the developmentally disabled
14  which is licensed in Florida.

15  The bill revises the requirements for special prescription
    blanks to require only a single-copy counterfeit-proof
16  prescription blank and limits the scope of drugs to be covered
    by the blanks to those covered by the electronic prescription
17  monitoring system. An exemption to the requirements for the
    prescription blanks is created for drugs dispensed through the
18  mail in Florida.

19  The bill revises the membership and duties of the prescription
    monitoring program advisory council.
20
    The bill deletes provisions that require the Department of
21  Health or boards to impose a mandatory $25,000 fine per count
    or offense if the violation is for inappropriate or excessive
22  prescribing of any controlled substance.

23  The bill deletes a procedure for the surrender of serialized
    prescription blanks in the event of a criminal proceeding when
24  a practitioner is named in a warrant of arrest or is charged
    with a felony violation of chapter 499, Florida Statutes,
25  relating to drugs, devices and household products or chapter
    893, Florida Statutes, relating to controlled substances.
26
    The bill revises the requirements for pharmacists to obtain
27  suitable identification prior to dispensing certain drugs and
    provides exemptions for drugs dispensed through the mail.
28
    The bill specifies that the Department of Legal Affairs must
29  bear the costs of the prescription monitoring program.

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