Florida Senate - 2009 COMMITTEE AMENDMENT
Bill No. SB 462
Barcode 469286
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
03/04/2009 .
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The Committee on Health Regulation (Jones) recommended the
following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Section 893.055, Florida Statutes, is created to
6 read:
7 893.055 Prescription drug validation program.—
8 (1) As used in this section, the term:
9 (a) “Advisory report” means information provided by the
10 department in writing to a prescriber, dispenser, pharmacy, or
11 patient concerning the dispensing of controlled substances. All
12 advisory reports are for informational purposes only and impose
13 no obligations of any nature or any legal duty on a prescriber,
14 dispenser, pharmacy, or patient. The advisory reports issued by
15 the department are not subject to discovery or introduction into
16 evidence in any civil or administrative action against a
17 prescriber, dispenser, pharmacy, or patient arising out of the
18 matters that are the subject of the report, and no person who
19 participates in preparing an advisory report is permitted or
20 required to testify in any such civil action as to any findings,
21 recommendations, evaluations, opinions, or other actions taken
22 in connection with preparing such a report.
23 (b) “Controlled substance” means a controlled substance
24 listed in Schedule II, Schedule III, or Schedule IV in s.
25 893.03.
26 (c) “Department” means the Department of Health.
27 (d) “Dispenser” means a dispensing pharmacist or dispensing
28 health care practitioner.
29 (e) “Health care practitioner” or “practitioner” means any
30 practitioner subject to licensure or regulation by the
31 department under chapter 458, chapter 459, chapter 461, or
32 chapter 466.
33 (f) “Health care regulatory board” means any board that
34 licenses a practitioner or health care practitioner who is
35 regulated by the department.
36 (g) “Pharmacy” means any pharmacy subject to licensure or
37 regulation by the department under chapter 465 which dispenses
38 or delivers a controlled substance to a patient in this state.
39 (h) “Prescriber” means a prescribing physician, prescribing
40 practitioner, or other prescribing health care practitioner.
41 (2)(a) By December 1, 2010, the department shall design and
42 establish a comprehensive electronic system that has controlled
43 substance prescriptions provided to it and that provides
44 prescription information to a patient’s health care practitioner
45 and, as determined by the department, may provide advisory
46 reports to authorized pharmacists, pharmacies, prescribing
47 practitioners, and dispensing health care practitioners. The
48 system shall be designed to provide information regarding
49 dispensed prescriptions of controlled substances in order to
50 prevent the inadvertent, improper, or illegal use of controlled
51 substances and shall not infringe upon the legitimate
52 prescribing of a controlled substance by a prescribing
53 practitioner, dispensing pharmacist, or dispensing practitioner
54 acting in good faith and in the course of professional practice.
55 The system shall be consistent with standards of the American
56 Society for Automation in Pharmacy for the validation of
57 prescribing and dispensing controlled substances to an
58 individual. The electronic system shall also comply with the
59 Health Insurance Portability and Accountability Act (HIPAA) as
60 it pertains to protected health information (PHI), electronic
61 protected health information (EPHI), and all other relevant
62 state and federal privacy and security laws and regulations. The
63 validating of prescribed controlled substances shall include a
64 dispensing transaction with a dispenser not located in this
65 state but which is otherwise subject to the jurisdiction of this
66 state as to that dispensing transaction.
67 (b) The department shall adopt rules concerning the
68 reporting, evaluation, management, and storage of information
69 within the system, including rules for when information is
70 provided to pharmacies, prescribers, health care practitioners,
71 health care regulatory boards, and law enforcement agencies, and
72 such rules shall be developed with a reasonable-person standard
73 for prescription drug dispensers, prescribers, and patients. The
74 department shall work with the professional health care
75 licensure boards, such as the Board of Medicine and the Board of
76 Pharmacy and other appropriate organizations, such as the
77 Florida Pharmacy Association and the Florida Medical
78 Association, including those relating to pain management, the
79 the Attorney General, the Department of Law Enforcement, and the
80 Agency for Health Care Administration, to develop the
81 reasonable-person standard for rules appropriate for the
82 prescription drug validation program.
83 (c) All dispensers and prescribers subject to such
84 reporting requirements shall be notified by the department of
85 the implementation date for such reporting requirements.
86 (3) The pharmacist in charge of each pharmacy, regarding
87 each controlled substance dispensed by a pharmacist under the
88 supervision of the pharmacist in charge, and each prescriber who
89 directly dispenses a controlled substance shall submit to the
90 electronic system, by a procedure and in a format established by
91 the department, the following minimum information for inclusion
92 in the database:
93 (a) The name of the prescribing practitioner and the
94 practitioner’s federal Drug Enforcement Administration
95 registration number, the practitioner’s National Provider
96 Identification (NPI) or other appropriate identifier, and the
97 date of the prescription.
98 (b) The date the prescription was filled and the method of
99 payment therefor, including cash. This paragraph does not
100 authorize the department to include individual credit card or
101 other account numbers in the database.
102 (c) The name, address, and date of birth of the person for
103 whom the prescription was written.
104 (d) The name, national drug code, quantity, and strength of
105 the controlled substance dispensed.
106 (e) The name and address of the pharmacy or other location
107 from which the controlled substance was dispensed.
108 (f) The name of the pharmacist or practitioner dispensing
109 the controlled substance, the practitioner’s National Provider
110 Identification (NPI), and other appropriate identifying
111 information as determined by department rule.
112 (4) Each time a controlled substance is dispensed to an
113 individual, the controlled substance shall be reported to the
114 department through the system as soon thereafter as possible,
115 but not more than 15 days after the date the controlled
116 substance is dispensed. A dispenser must meet the reporting
117 requirements of this section by providing the required
118 information concerning each controlled substance that it
119 dispensed in a department-approved, secure methodology and
120 format. Such approved formats may include, but are not limited
121 to, submission via the Internet, on a disc, or by use of regular
122 mail.
123 (5) The following are exempt from this section when
124 administering controlled substances:
125 (a) A health care practitioner administering a controlled
126 substance directly to a patient if the amount of the controlled
127 substance is adequate to treat the patient during that
128 particular treatment session.
129 (b) A pharmacist or health care practitioner administering
130 a controlled substance to a patient or resident receiving care
131 as an admitted patient at a hospital, nursing home, hospice, or
132 intermediate care facility for the developmentally disabled
133 which is licensed in this state.
134 (c) A person administering a controlled substance in the
135 health care system of the Department of Corrections.
136 (d) A person administering a controlled substance in the
137 emergency room of a licensed hospital.
138 (e) A pharmacist or health care practitioner administering
139 a controlled substance to a person under the age of 16.
140 (6) The department may establish when to suspend and when
141 to resume requirements for reporting dispensing information to
142 the electronic system of controlled prescription drugs during a
143 state-declared or nationally declared disaster.
144 (7)(a) A practitioner or pharmacist who dispenses a
145 controlled substance must submit the information required by
146 this section in an electronic or other format approved by rule
147 of the department. The cost to the dispenser in submitting the
148 information required by this section may not be material or
149 extraordinary. Costs not considered to be material or
150 extraordinary include, but are not limited to, regular postage,
151 electronic media, regular electronic mail, and facsimile
152 charges.
153 (b) A pharmacy, prescriber, or dispenser may access
154 information in the prescription drug validation program’s
155 electronic system which relates to a patient of that pharmacy,
156 prescriber, or dispenser for the purpose of reviewing the
157 patient’s controlled drug prescription history to ensure a
158 proper standard of care. Other access to the program’s
159 electronic system shall be limited to the program’s manager and
160 designated program staff, who may act only in the absence of the
161 program manager. Access by the program manager or such
162 designated staff is only for prescription drug management and
163 for management of the database. Confidential and exempt
164 information in the database shall be released only as provided
165 in s. 893.0551. The individual who requests his or her own
166 information, the attorney general, a health care regulatory
167 board, any law enforcement agency, or any criminal justice
168 agency may request this information from the program manager and
169 may not directly access the database for this information.
170 (c) All transmissions of data required by this section must
171 comply with relevant state and federal privacy and security laws
172 and regulations. However, any authorized agency or person
173 receiving such information may maintain the information received
174 for up to 24 months before purging it from his or her records or
175 maintain it for longer than 24 months if the information is
176 pertinent to an ongoing health care or active law enforcement
177 investigation or prosecution.
178 (8) To assist in fulfilling the program responsibilities,
179 performance measures shall be reported annually by the
180 department each December 1, beginning in 2011. Data that does
181 not contain patient, physician, health care practitioner, or
182 dispenser identifying information may be requested during the
183 year by department employees so that the department may
184 undertake public health care and safety initiatives that take
185 advantage of observed trends. Performance measures may include,
186 but are not limited to, efforts to achieve the following
187 outcomes:
188 (a) Reduction of the rate of inappropriate use of
189 prescription drugs through department education and safety
190 efforts.
191 (b) Reduction of the quantity of pharmaceutical controlled
192 substances obtained by individuals attempting to engage in fraud
193 and deceit.
194 (c) Increased coordination among prescription drug
195 validation program partners.
196 (d) Involvement of stakeholders in achieving improved
197 patient health care and reduction of prescription drug abuse and
198 prescription drug diversion.
199 (9) Any person who knowingly fails to report the dispensing
200 of a controlled substance as required by this section commits a
201 misdemeanor of the first degree, punishable as provided in s.
202 775.082 or s. 775.083.
203 (10) All costs incurred by the department in administering
204 the prescription drug validation program shall be reimbursed
205 through federal grants or private funding applied for or
206 received by the state. The department and state government shall
207 cooperate in seeking federal grant funds, other nonstate grant
208 funds, gifts, donations, or other private moneys for the
209 department so long as the costs of doing so are not considered
210 material. Nonmaterial costs for this purpose include, but are
211 not limited to, the costs of mailing and personnel assigned to
212 research or apply for a grant. Notwithstanding the exemptions to
213 competitive-solicitation requirements under s. 287.057(5)(f),
214 the Department of Health shall comply with the competitive
215 solicitation requirements for the procurement of any goods or
216 services required by this section.
217 (11) The Office of Drug Control, in coordination with the
218 department, may establish a direct-support organization that has
219 a board consisting of at least five members to provide
220 assistance, funding, and promotional support for the activities
221 authorized for the prescription drug validation program.
222 (a) As used in this subsection, the term “direct-support
223 organization” means an organization that is:
224 1. A Florida corporation not for profit incorporated under
225 chapter 617, exempted from filing fees, and approved by the
226 Department of State.
227 2. Organized and operated to conduct programs and
228 activities; raise funds; request and receive grants, gifts, and
229 bequests of money; acquire, receive, hold, and invest, in its
230 own name, securities, funds, objects of value, or other
231 property, either real or personal; and make expenditures to or
232 for the direct or indirect benefit of the department in the
233 furtherance of the prescription drug validation program.
234 (b) The direct-support organization is not considered a
235 lobbying firm within the meaning of s. 11.045.
236 (c) The director of the Office of Drug Control shall
237 appoint a board of directors for the direct-support
238 organization. The director may designate employees of the Office
239 of Drug Control; state employees other than state employees from
240 the Department of Health; members of provider associations, such
241 as the Florida Pharmacy Association or the Florida Medical
242 Association; and any other nonstate employees as appropriate, to
243 serve on such board. Members of the board shall serve at the
244 pleasure of the director of the Office of Drug Control.
245 (d) The direct-support organization may operate under
246 written contract with the Office of Drug Control. The contract
247 must provide for:
248 1. Approval of the articles of incorporation and bylaws of
249 the direct-support organization by the Office of Drug Control.
250 2. Submission of an annual budget for the approval of the
251 Office of Drug Control.
252 3. Certification by the Office of Drug Control in
253 consultation with the department that the direct-support
254 organization is complying with the terms of the contract in a
255 manner consistent with and in furtherance of the goals and
256 purposes of the prescription drug validation program and in the
257 best interest of the state. Such certification must be made
258 annually and reported in the official minutes of a meeting of
259 the direct-support organization.
260 4. The reversion, without penalty, to the Office of Drug
261 Control, or to the state if the Office of Drug Control ceases to
262 exist, of all moneys and property held in trust by the direct
263 support organization for the benefit of the prescription drug
264 validation program if the direct-support organization ceases to
265 exist or if the contract is terminated.
266 5. The fiscal year of the direct-support organization,
267 which must begin July 1 of each year and end June 30 of the
268 following year.
269 6. The disclosure of the material provisions of the
270 contract to donors of gifts, contributions, or bequests,
271 including such disclosure on all promotional and fundraising
272 publications, and an explanation to such donors of the
273 distinction between the Office of Drug Control and the direct
274 support organization.
275 (e) The direct-support organization is specifically
276 authorized to collect and expend funds to be used for the
277 functions of the direct-support organization’s board of
278 directors, as necessary; establishing and administering the
279 prescription drug validation program’s electronic database,
280 including hardware, software, and personnel; conducting studies
281 on the efficiency and effectiveness of the program; providing
282 funds for future enhancements of the program within the intent
283 of this section; providing health care practitioner education,
284 including distribution of materials to promote public awareness
285 and education and conducting workshops or other meetings; travel
286 expenses; administrative costs, including personnel, audits,
287 facilities, and equipment; and all other requirements necessary
288 to establish the program as outlined in this section.
289 (f) The activities of the direct-support organization must
290 be consistent with the goals and mission of the Office of Drug
291 Control, as determined by the office in consultation with the
292 department, and in the best interests of the state. The direct
293 support organization must obtain a written approval from the
294 director of the Office of Drug Control for any activities in
295 support of the prescription drug validation program before
296 undertaking those activities.
297 (g) The Office of Drug Control, in consultation with the
298 department, may permit, without charge, appropriate use of
299 administrative services, property, and facilities of the Office
300 of Drug Control and the department by the direct-support
301 organization, subject to this section. The use must be directly
302 in keeping with the approved purposes of the direct-support
303 organization and may not be made at times or places that would
304 unreasonably interfere with opportunities for the public to use
305 such facilities for established purposes. Any moneys received
306 from rentals of facilities and properties managed by the Office
307 of Drug Control and the department may be held by the Office of
308 Drug Control or in a separate depository account in the name of
309 the direct-support organization and subject to the provisions of
310 the letter of agreement with the Office of Drug Control. The
311 letter of agreement must provide that any funds held in the
312 separate depository account in the name of the direct-support
313 organization must revert to the Office of Drug Control if the
314 direct-support organization is no longer approved by the Office
315 of Drug Control to operate in the best interests of the state.
316 (h) The Office of Drug Control, in consultation with the
317 department, may adopt requirements with which a direct-support
318 organization must comply in order to use department and Office
319 of Drug Control administrative services, property, or
320 facilities.
321 (i) The Office of Drug Control may not permit the use of
322 any administrative services, property, or facilities of the
323 state by a direct-support organization if that organization does
324 not provide equal membership and employment opportunities to all
325 persons regardless of race, color, religion, gender, age, or
326 national origin.
327 (j) The direct-support organization shall provide for an
328 independent annual financial audit in accordance with s.
329 215.981. Copies of the audit shall be provided to the Office of
330 Drug Control and the Office of Policy and Budget in the
331 Executive Office of the Governor.
332 (k) The direct-support organization may not exercise any
333 power under s. 617.0302(12) or (16).
334 (12) A prescriber or dispenser is authorized access to the
335 information under this section for his or her patient for his or
336 her review of the patient’s controlled drug prescription history
337 to ensure a proper standard of care. A prescriber or dispenser
338 acting in good faith is immune from any civil, criminal, or
339 administrative liability that might otherwise be incurred or
340 imposed for receiving or using information from the prescription
341 drug validation program. This subsection does not create a
342 private cause of action, and a person may not recover damages
343 against a prescriber or dispenser authorized to access
344 information under this subsection for accessing or failing to
345 access such information.
346 (13) To the extent that funding is provided for such
347 purpose through federal or private grants or gifts and other
348 types of available moneys, the department, in collaboration with
349 the Office of Drug Control, shall study the feasibility of
350 enhancing the prescription drug validation program for the
351 purposes of public health initiatives and statistical reporting
352 that respects the privacy of the patient, the prescriber, and
353 the dispenser. Such a study shall be conducted in order to
354 further improve the quality of health care services and safety
355 by improving prescription drug prescribing practices, taking
356 advantage of advances in technology, reducing duplicative
357 prescriptions and the overprescribing of prescription drugs, and
358 reducing drug abuse. In addition, the direct-support
359 organization shall provide funding for the department, in
360 collaboration with the Office of Drug Control, to conduct
361 training for health care practitioners and other appropriate
362 persons in using the program to support the program
363 enhancements.
364 (14) A pharmacist, pharmacy, or dispensing health care
365 practitioner or his or her agent, prior to releasing a
366 controlled substance to any person not known to such dispenser,
367 shall require the person purchasing, receiving, or otherwise
368 acquiring the controlled substance to present valid photographic
369 identification or other verification of his or her identity to
370 the dispenser. If the person does not have proper
371 identification, the dispenser may verify the validity of the
372 prescription and the identity of the patient with the prescriber
373 or his or her authorized agent, or by a method determined by the
374 department, before dispensing the controlled substance. The
375 person purchasing, receiving, or otherwise acquiring the
376 controlled substance does not have to be the specific patient to
377 whom the prescription is prescribed. A record shall be
378 maintained for 2 years of the person acquiring the controlled
379 substance, which record shall include the person’s name and
380 signature using the proper identification. This subsection does
381 not apply in an institutional setting or to a long-term care
382 facility, including, but not limited to, an assisted living
383 facility or a hospital to which patients are admitted. As used
384 in this subsection, the term “proper identification” means a
385 government-issued identification containing the person’s
386 picture, printed name, and signature.
387 (15) The Agency for Health Care Administration shall
388 continue the implementation of electronic prescribing by health
389 care practitioners, health care facilities, and pharmacies under
390 s. 408.061 and the electronic prescribing clearinghouse
391 collaboration with the private sector under s. 408.0611.
392 (16) By October 1, 2010, the department shall adopt rules
393 pursuant to ss. 120.536(1) and 120.54 to implement the
394 provisions of this section.
395 Section 2. (1) The Program Implementation and Oversight
396 Workgroup is created within the Executive Office of the
397 Governor. The director of the Office of Drug Control shall be a
398 nonvoting, ex officio member of the workgroup and shall act as
399 chair. The Office of Drug Control and the Department of Health
400 shall provide staff support for the workgroup.
401 (a) The following state officials shall serve on the
402 workgroup:
403 1. The Attorney General or his or her designee.
404 2. The Secretary of Children and Family Services or his or
405 her designee.
406 3. The Secretary of Health Care Administration or his or
407 her designee.
408 4. The State Surgeon General or his or her designee.
409 (b) In addition, the Governor shall appoint 10 members of
410 the public to serve on the workgroup. Of these 10 appointed
411 members, one member must have professional or occupational
412 expertise in computer security; one member must be a Florida
413 licensed, board-certified oncologist; two members must be
414 Florida-licensed, board-certified, fellowship-trained physicians
415 who have experience in pain management; one member must have
416 professional or occupational expertise in e-Prescribing or
417 prescription drug validation programs; one member must be a
418 Florida-licensed pharmacist; one member must have professional
419 or occupational expertise in law enforcement with experience in
420 prescription drug investigations; one member must have
421 professional or occupational expertise as an epidemiologist with
422 a background in tracking and analyzing drug trends; and two
423 members must have professional or occupational expertise as
424 providers of substance abuse treatment, with priority given to a
425 member who is a former substance abuser.
426 (c) Members appointed by the Governor shall be appointed to
427 a term of 3 years each. Any vacancy on the workgroup shall be
428 filled in the same manner as the original appointment, and any
429 member appointed to fill a vacancy shall serve only for the
430 unexpired term of the member’s predecessor.
431 (d) Members of the workgroup and members of subcommittees
432 appointed under subsection (4) shall serve without compensation,
433 but are entitled to reimbursement for per diem and travel
434 expenses as provided in s. 112.061, Florida Statutes.
435 (e) The workgroup shall meet at least quarterly or upon the
436 call of the chair.
437 (2) The purpose of the workgroup is to monitor the
438 implementation and safeguarding of the electronic system
439 established for the prescription drug validation program under
440 s. 893.055, Florida Statutes, and to ensure privacy, protection
441 of individual medication history, and the electronic system’s
442 appropriate use by physicians, dispensers, pharmacies, law
443 enforcement agencies, and those authorized to request
444 information from the electronic system.
445 (3) The Office of Drug Control shall submit a report to the
446 Governor, the President of the Senate, and the Speaker of the
447 House of Representatives by December 1 of each year which
448 contains a summary of the work of the workgroup during that year
449 and the recommendations developed in accordance with the
450 workgroup’s purpose as provided in subsection (2). Interim
451 reports may be submitted at the discretion of the chair.
452 (4) The chair of the workgroup shall appoint subcommittees
453 that include members of state agencies that are not represented
454 on the workgroup for the purpose of soliciting input and
455 recommendations from those state agencies as needed by the
456 workgroup to accomplish its purposes. In addition, the chair may
457 appoint subcommittees as necessary from among the members of the
458 workgroup in order to efficiently address specific issues. If a
459 state agency is to be represented on any subcommittee, the
460 representative shall be the head of the agency or his or her
461 designee. The chair may designate lead and contributing agencies
462 within a subcommittee.
463 (5) The workgroup shall provide a final report in
464 accordance with the workgroup’s purpose as provided in
465 subsection (2) on July 1, 2012, to the Governor, the President
466 of the Senate, and the Speaker of the House of Representatives.
467 Such report shall be prepared using only data that does not
468 identify a patient or dispenser. The workgroup shall expire and
469 this section is repealed on that date.
470 Section 3. Subsections (4) and (5) are added to section
471 458.309, Florida Statutes, to read:
472 458.309 Rulemaking authority.—
473 (4) Each physician who practices in a privately owned pain
474 management facility that primarily engages in the treatment of
475 pain by prescribing narcotic medications shall register the
476 facility with the department unless it is licensed as a facility
477 under chapter 395. The department shall inspect the facility
478 annually to ensure that it complies with board rules adopted
479 pursuant to s. 458.309(4) and (5) unless the facility is
480 accredited by a nationally recognized accrediting agency
481 approved by the board. The actual costs for registration and
482 inspection or accreditation shall be paid by the physician
483 seeking to register the facility.
484 (5) The board shall adopt rules setting forth standards of
485 practice for physicians practicing in privately owned pain
486 management facilities that primarily engage in the treatment of
487 pain by prescribing controlled substance medications. These
488 rules shall address, but need not be limited to, the following
489 subjects:
490 (a) Facility operations;
491 (b) Physical operations;
492 (c) Infection control requirements;
493 (d) Health and safety requirements;
494 (e) Quality assurance requirements;
495 (f) Patient records;
496 (g) Training requirements for all facility health care
497 practitioners; and
498 (h) Inspections.
499
500 A physician is primarily engaged in the treatment of pain by
501 prescribing narcotic medications when the majority of the
502 patients seen on any day the facility is open are issued
503 narcotic prescriptions for the treatment of nonmalignant pain.
504 Section 4. This act shall take effect July 1, 2009.
505
506 ================= T I T L E A M E N D M E N T ================
507 And the title is amended as follows:
508 Delete everything before the enacting clause
509 and insert:
510 A bill to be entitled
511 An act relating to a prescription drug validation
512 program (PDVP); creating s. 893.055, F.S.; providing
513 definitions; requiring the Department of Health to
514 establish a comprehensive electronic system to
515 validate the prescribing and dispensing of certain
516 controlled substances; requiring specified prescribing
517 and dispensing information to be reported to the
518 electronic system; requiring the department, in
519 conjunction with specified organizations, to adopt by
520 rule a reasonable-person standard appropriate for the
521 prescription drug validation program; providing a
522 reporting period; providing for implementation of a
523 shorter reporting period; providing exemptions from
524 participation in the system; authorizing the
525 Department of Health to establish when to suspend and
526 when to resume requirements for reporting dispensing
527 information during declared emergencies; requiring all
528 nonexempt pharmacists, pharmacies, dispensing
529 physicians, or prescribing and dispensing health care
530 practitioners to submit information in a specified
531 format; providing that the cost to the dispenser in
532 submitting the required information may not be
533 material or extraordinary; providing that specified
534 costs are not material or extraordinary; limiting
535 access to the system; providing for the use of data
536 for specified purposes; requiring compliance with
537 state and federal privacy and security laws;
538 authorizing an agency or person to maintain the data
539 for a specified period if the data is pertinent to an
540 ongoing health care or active law enforcement
541 investigation or prosecution; requiring the reporting
542 of certain performance measures; providing criminal
543 penalties for violations; requiring that all costs
544 incurred by the department for the program be paid
545 through a federal grant or through available private
546 funding sources; authorizing the Office of Drug
547 Control, in coordination with the Department of
548 Health, to establish a direct-support organization;
549 providing a definition; providing for a board of
550 directors appointed by the director of the Office of
551 Drug Control; authorizing the direct-support
552 organization to operate under written contract with
553 the Office of Drug Control; authorizing certain
554 activities and expenditures of the direct-support
555 organization; providing requirements for the use of
556 certain facilities and services; providing for audits;
557 prohibiting the direct-support organization from
558 exercising certain powers; establishing that a
559 prescribing health care practitioner, dispensing
560 physician, or pharmacist is not liable for use of the
561 department-provided controlled substances prescription
562 information of a patient; requiring a study of the
563 feasibility of enhancing the prescription drug
564 validation program for specified purposes; requiring
565 certain persons to present specified identification to
566 obtain prescriptions; providing for recordkeeping for
567 certain transactions; requiring the Agency for Health
568 Care Administration to continue implementation of
569 electronic prescribing and an electronic prescribing
570 clearinghouse; requiring the Department of Health to
571 adopt rules; establishing a Program Implementation and
572 Oversight Workgroup; providing for membership;
573 providing for reimbursement of certain member
574 expenses; providing for meetings; providing purposes;
575 requiring reports; providing for the creation,
576 membership, and duties of subcommittees; providing for
577 a final report and termination of the workgroup;
578 amending s. 458.309, F.S.; requiring certain
579 physicians who engage in pain management to register
580 their facility with the department; requiring the
581 department to inspect the facility; requiring the
582 Board of Medicine to adopt rules setting forth
583 standards of practice for certain physicians who
584 engage in pain management; providing criteria for the
585 rules; providing an effective date.
586
587 WHEREAS, as has been advocated by numerous pain management
588 experts, addiction medicine experts, pharmacists, and law
589 enforcement personnel, a prescription drug validation program
590 that provides for reporting and advisory information is
591 established pursuant to this act to serve as a means to promote
592 the public health and welfare and to detect and prevent
593 controlled substance abuse and diversion, and
594 WHEREAS, while the importance and necessity of the proper
595 prescribing, dispensing, and monitoring of controlled
596 substances, particularly pain medication, have been established,
597 controlled prescription drugs are too often diverted in this
598 state, often through fraudulent means, including outright theft,
599 phony pharmacy fronts, loose Internet medical evaluations, and
600 inappropriate importation; in addition, there is a criminal
601 element that facilitates the prescription drug abuse epidemic
602 through illegal profitmaking from the diversion of certain
603 controlled substances that are prescribed or dispensed by
604 physicians, health care practitioners, and pharmacists, and
605 WHEREAS, in 2007, 8,620 drug-related deaths occurred in
606 this state, 3,159 of which were caused by prescription drugs, an
607 average of nearly 9 Floridians dying each day from prescription
608 drugs; Schedule IV benzodiazepines, such as Xanax and Valium,
609 were found to be present in more drug-related deaths than
610 cocaine; and opiate pain medications contribute to increasing
611 numbers of drug-related deaths, and
612 WHEREAS, pharmaceutical drug diversion hurts this state
613 significantly in terms of lost lives, increased crime, human
614 misery from addiction, and ballooning health care costs
615 connected to treatment, medical expenses, and Medicaid fraud
616 that all Floridians ultimately bear, and
617 WHEREAS, the intent of this act is not to interfere with
618 the legitimate medical use of controlled substances; however,
619 the people of this state are in need of and will benefit from a
620 secure and privacy-protected statewide electronic system of
621 specified prescription drug medication information created
622 primarily to encourage safer controlled substance prescription
623 decisions that reduce the number of prescription drug overdoses
624 and the number of drug overdose deaths; to educate and inform
625 health care practitioners and provide an added tool in patient
626 care, including appropriate treatment for patients who have
627 become addicted; to guide public health initiatives to educate
628 the population on the dangers of misusing prescription drugs; to
629 prevent the abuse or diversion of prescribed controlled
630 substances; and to ensure that those who need prescribed
631 controlled substances receive them in a manner that protects
632 patient confidentiality, and
633 WHEREAS, while certain medicines are very helpful if
634 properly prescribed to a patient in need and then used as
635 prescribed, they may be dangerous or even deadly if improperly
636 dispensed, misused, or diverted, and
637 WHEREAS, it is the intent of the Legislature to encourage
638 patient safety, responsible pain management, and proper access
639 to useful prescription drugs that are prescribed by a
640 knowledgeable, properly licensed health care practitioner who
641 dispenses prescription drugs and that are dispensed by a
642 pharmacist who is made aware of the patient’s prescription drug
643 medication history, thus preventing, in some cases, an abuse or
644 addiction problem from developing or worsening, making such a
645 problem possible or easier to identify, and facilitating the
646 order of appropriate medical treatment or referral, and
647 WHEREAS, such an electronic system will also aid
648 administrative and law enforcement agencies in an active and
649 ongoing controlled drug-related investigation, maintaining such
650 information for any such investigation with a reasonable, good
651 faith anticipation of securing an arrest or prosecution in the
652 foreseeable future, and
653 WHEREAS, a Program Implementation and Oversight Workgroup
654 will provide information to the Governor and Legislature
655 regarding the implementation of the program and ensure that
656 privacy and confidentiality of the patient’s prescription
657 history is respected, NOW, THEREFORE,