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