(1) As used in this section, the term:
(a) “Active investigation” means an investigation that is being conducted with a reasonable, good faith belief that it could lead to the filing of administrative, civil, or criminal proceedings, or that is ongoing and continuing and for which there is a reasonable, good faith anticipation of securing an arrest or prosecution in the foreseeable future.
Terms Used In Florida Statutes 893.055
- administration: means the direct application of a controlled substance, whether by injection, inhalation, ingestion, or any other means, to the body of a person or animal. See Florida Statutes 893.02
- Arrest: Taking physical custody of a person by lawful authority.
- Contract: A legal written agreement that becomes binding when signed.
- Controlled substance: means any substance named or described in Schedules I-V of…. See Florida Statutes 893.02
- Corporation: A legal entity owned by the holders of shares of stock that have been issued, and that can own, receive, and transfer property, and carry on business in its own name.
- Damages: Money paid by defendants to successful plaintiffs in civil cases to compensate the plaintiffs for their injuries.
- delivery: means the actual, constructive, or attempted transfer from one person to another of a controlled substance, whether or not there is an agency relationship. See Florida Statutes 893.02
- Department: means the Department of Health. See Florida Statutes 893.02
- Discovery: Lawyers' examination, before trial, of facts and documents in possession of the opponents to help the lawyers prepare for trial.
- Dispense: means the transfer of possession of one or more doses of a medicinal drug by a pharmacist or other licensed practitioner to the ultimate consumer thereof or to one who represents that it is his or her intention not to consume or use the same but to transfer the same to the ultimate consumer or user for consumption by the ultimate consumer or user. See Florida Statutes 893.02
- Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
- Fiscal year: The fiscal year is the accounting period for the government. For the federal government, this begins on October 1 and ends on September 30. The fiscal year is designated by the calendar year in which it ends; for example, fiscal year 2006 begins on October 1, 2005 and ends on September 30, 2006.
- Fraud: Intentional deception resulting in injury to another.
- Guardian: A person legally empowered and charged with the duty of taking care of and managing the property of another person who because of age, intellect, or health, is incapable of managing his (her) own affairs.
- Litigation: A case, controversy, or lawsuit. Participants (plaintiffs and defendants) in lawsuits are called litigants.
- Manufacturer: means and includes every person who prepares, derives, produces, compounds, or repackages any drug as defined by the Florida Drug and Cosmetic Act. See Florida Statutes 893.02
- Misdemeanor: Usually a petty offense, a less serious crime than a felony, punishable by less than a year of confinement.
- Patient: means an individual to whom a controlled substance is lawfully dispensed or administered pursuant to the provisions of this chapter. See Florida Statutes 893.02
- person: includes individuals, children, firms, associations, joint adventures, partnerships, estates, trusts, business trusts, syndicates, fiduciaries, corporations, and all other groups or combinations. See Florida Statutes 1.01
- Pharmacist: means a person who is licensed pursuant to chapter 465 to practice the profession of pharmacy in this state. See Florida Statutes 893.02
- Possession: includes temporary possession for the purpose of verification or testing, irrespective of dominion or control. See Florida Statutes 893.02
- Practitioner: means a physician licensed under chapter 458, a dentist licensed under chapter 466, a veterinarian licensed under chapter 474, an osteopathic physician licensed under chapter 459, an advanced practice registered nurse licensed under chapter 464, a naturopath licensed under chapter 462, a certified optometrist licensed under chapter 463, a psychiatric nurse as defined in…. See Florida Statutes 893.02
- Prescription: includes any order for drugs or medicinal supplies which is written or transmitted by any means of communication by a licensed practitioner authorized by the laws of this state to prescribe such drugs or medicinal supplies, is issued in good faith and in the course of professional practice, is intended to be dispensed by a person authorized by the laws of this state to do so, and meets the requirements of…. See Florida Statutes 893.02
- Settlement: Parties to a lawsuit resolve their difference without having a trial. Settlements often involve the payment of compensation by one party in satisfaction of the other party's claims.
- Testify: Answer questions in court.
- Trial: A hearing that takes place when the defendant pleads "not guilty" and witnesses are required to come to court to give evidence.
- writing: includes handwriting, printing, typewriting, and all other methods and means of forming letters and characters upon paper, stone, wood, or other materials. See Florida Statutes 1.01
(b) “Administration” means the obtaining and giving of a single dose of a controlled substance by a legally authorized person to a patient for her or his consumption.
(c) “Controlled substance” means a controlled substance listed in Schedule II, Schedule III, Schedule IV, or Schedule V of s. 893.03 or 21 U.S.C. s. 812.
(d) “Dispense” means the transfer of possession of one or more doses of a controlled substance by a dispenser to the ultimate consumer or to his or her agent.
(e) “Dispenser” means a dispensing health care practitioner, pharmacy, or pharmacist licensed to dispense controlled substances in or into this state.
1(f) “Electronic health recordkeeping system” means an electronic or computer-based information system used by health care practitioners or providers to create, collect, store, manipulate, exchange, or make available personal health information for the delivery of patient care.
(g) “Health care practitioner” or “practitioner” means any practitioner licensed under chapter 458, chapter 459, chapter 461, chapter 463, chapter 464, chapter 465, or chapter 466.
(h) “Health care regulatory board” has the same meaning as in s. 456.001(1).
(i) “Law enforcement agency” means the Department of Law Enforcement, a sheriff’s office in this state, a police department in this state, or a law enforcement agency of the Federal Government which enforces the laws of this state or the United States relating to controlled substances and whose agents and officers are empowered by law to conduct criminal investigations and make arrests.
(j) “Pharmacy” includes a community pharmacy, an institutional pharmacy, a nuclear pharmacy, a special pharmacy, or an Internet pharmacy that is licensed by the department under chapter 465 and that dispenses or delivers controlled substances to an individual or address in this state.
(k) “Prescriber” means a prescribing physician, prescribing practitioner, or other prescribing health care practitioner authorized by the laws of this state to order controlled substances.
(l) “Program manager” means an employee of or a person contracted by the department who is designated to ensure the integrity of the prescription drug monitoring program in accordance with the requirements established in this section.
(2)(a) The department shall maintain an electronic system to collect and store controlled substance dispensing information and shall release the information as authorized in this section and s. 893.0551. The electronic system must:
1. Not infringe upon the legitimate prescribing or dispensing of a controlled substance by a prescriber or dispenser acting in good faith and in the course of professional practice.
2. Be consistent with standards of the American Society for Automation in Pharmacy.
3. Comply with the Health Insurance Portability and Accountability Act as it pertains to protected health information, electronic protected health information, and all other relevant state and federal privacy and security laws and regulations.
4. Purge or cause to be purged information in the database that is more than 4 years old.
1(b) To protect personally identifiable information, the department shall assign a unique identifier to each patient for whom a record exists in the system. Such identifier may not identify or provide a reasonable basis to identify a patient by any person not authorized under this section to access personally identifiable information in the system.
(c) The department may collaborate with professional health care regulatory boards, appropriate organizations, and other state agencies to identify indicators of controlled substance abuse.
(3)(a) For each controlled substance dispensed to a patient in this state, the following information must be reported by the dispenser to the system as soon thereafter as possible but no later than the close of the next business day after the day the controlled substance is dispensed unless an extension or exemption is approved by the department:
1. The name of the prescribing practitioner, the practitioner’s federal Drug Enforcement Administration registration number, the practitioner’s National Provider Identification or other appropriate identifier, and the date of the prescription.
2. The date the prescription was filled and the method of payment, such as cash by an individual, insurance coverage through a third party, or Medicaid payment. This paragraph does not authorize the department to include individual credit card numbers or other account numbers in the system.
3. The full name, address, telephone number, and date of birth of the person for whom the prescription was written.
4. The name, national drug code, quantity, and strength of the controlled substance dispensed.
5. The full name, federal Drug Enforcement Administration registration number, State of Florida Department of Health issued pharmacy permit number, and address of the pharmacy or other location from which the controlled substance was dispensed. If the controlled substance was dispensed by a practitioner other than a pharmacist, the practitioner’s full name, address, federal Drug Enforcement Administration registration number, State of Florida Department of Health issued license number, and National Provider Identification.
6. Whether the drug was dispensed as an initial prescription or a refill, and the number of refills ordered.
7. The name of the individual picking up the controlled substance prescription and type and issuer of the identification provided.
8. Other appropriate identifying information as determined by department rule.
(b) The following acts of administration or dispensing are exempt from the reporting requirements of this subsection:
1. All acts of administration of a controlled substance.
2. The dispensing of a controlled substance in the health care system of the Department of Corrections.
3. The dispensing of a controlled substance to a person under the age of 16.
(4) The following persons must be provided direct access to information in the system:
(a) A prescriber or dispenser or his or her designee.
(b) An employee of the United States Department of Veterans Affairs, the United States Department of Defense, or the Indian Health Service who provides health care services pursuant to such employment and who has the authority to prescribe or dispense controlled substances shall have access to the information in the program’s system upon verification of employment.
(c) The program manager or designated program and support staff to administer the system.
1. In order to calculate performance measures pursuant to subsection (14), the program manager or program and support staff members who have been directed by the program manager to calculate performance measures may have direct access to information that contains no identifying information of any patient, physician, health care practitioner, prescriber, or dispenser.
2. The program manager or designated program and support staff must provide the department, upon request, data that does not contain patient, physician, health care practitioner, prescriber, or dispenser identifying information for public health care and safety initiatives purposes.
3. The program manager, upon determining a pattern consistent with the department’s rules established under subsection (16), may provide relevant information to the prescriber and dispenser.
4. The program manager, upon determining a pattern consistent with the rules established under subsection (16) and having cause to believe a violation of s. 893.13(7)(a)8., (8)(a), or (8)(b) has occurred, may provide relevant information to the applicable law enforcement agency.
The program manager and designated program and support staff must complete a level II background screening.
(5) The following entities may not directly access information in the system, but may request information from the program manager or designated program and support staff:
(a) The department and its health care regulatory boards, as appropriate, for investigations involving licensees authorized to prescribe or dispense controlled substances.
1(b) The Attorney General for:
1. Medicaid fraud cases involving prescribed controlled substances.
2. An active investigation or pending civil or criminal litigation involving prescribed controlled substances, other than Medicaid fraud cases, upon the granting of a petition or motion by a trial court which specifically identifies the active or pending matter. The Attorney General shall ensure that information obtained under this subparagraph is not used for any purpose other than the specific matter stated in the petition or motion. Notice to any party regarding such petition or motion is not required, except in cases of pending civil litigation. The trial court shall grant the petition or motion and authorize release of information when the information appears reasonably calculated to lead to the discovery of admissible evidence. The department may not release any patient information pursuant to this subparagraph other than the patient’s unique identifier assigned pursuant to paragraph (2)(b), year of birth, and the county, city, and zip code where the patient resides, consistent with the provisions of the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations. The Attorney General shall maintain a log of each person with whom the information is shared to document the chain of custody, execute a confidentiality agreement or an agreement bound by a protective order with each such person, ensure that the information is maintained in a secure manner, and require each such person to return all information or certify its destruction under penalty of perjury to the Attorney General upon the final resolution of the matter for which the information was requested.
(c) A law enforcement agency during active investigations of potential criminal activity, fraud, or theft regarding prescribed controlled substances.
(d) A medical examiner when conducting an authorized investigation under s. 406.11, to determine the cause of death of an individual.
(e) An impaired practitioner consultant who is retained by the department under s. 456.076 to review the system information of an impaired practitioner program participant or a referral who has agreed to be evaluated or monitored through the program and who has separately agreed in writing to the consultant’s access to and review of such information.
(f) A patient or the legal guardian or designated health care surrogate of an incapacitated patient who submits a written and notarized request that includes the patient’s full name, address, phone number, date of birth, and a copy of a government-issued photo identification.
(6) The department may enter into one or more reciprocal agreements or contracts to share prescription drug monitoring information with other states, districts, territories, the United States Department of Veterans Affairs, the United States Department of Defense, or the Indian Health Service if the prescription drug monitoring programs of such other states, districts, territories, the United States Department of Veterans Affairs, the United States Department of Defense, or the Indian Health Service are compatible with the Florida program.
(a) In determining compatibility, the department shall consider:
1. The safeguards for privacy of patient records and the success of the program in protecting patient privacy.
2. The persons authorized to view the data collected by the program. Comparable entities and licensed health care practitioners in other states, districts, or territories of the United States; law enforcement agencies; the Attorney General’s Medicaid Fraud Control Unit; medical regulatory boards; the United States Department of Veterans Affairs; the United States Department of Defense; the Indian Health Service; and, as needed, management staff who have similar duties as management staff who work with the prescription drug monitoring program as authorized in s. 893.0551 are authorized access upon approval by the department.
3. The schedules of the controlled substances that are monitored by the program.
4. The data reported to or included in the program’s system.
5. Any implementing criteria deemed essential for a thorough comparison.
6. The costs and benefits to the state of sharing prescription information.
(b) The department shall assess the prescription drug monitoring program’s continued compatibility every 4 years with programs from other states, districts, territories, the United States Department of Veterans Affairs, the United States Department of Defense, or the Indian Health Service.
(c) Any agreements or contracts for sharing of prescription drug monitoring information between the department and other states, districts, territories, the United States Department of Veterans Affairs, the United States Department of Defense, or the Indian Health Service shall contain the same restrictions and requirements as this section or s. 893.0551, and the information must be provided according to the department’s determination of compatibility.
(7) The department may enter into agreements or contracts to establish secure connections between the system and a prescribing or dispensing health care practitioner’s electronic health recordkeeping system. The electronic health recordkeeping system owner or license holder will be responsible for ensuring that only authorized individuals have access to prescription drug monitoring program information.
(8) A prescriber or dispenser or a designee of a prescriber or dispenser must consult the system to review a patient’s controlled substance dispensing history before prescribing or dispensing a controlled substance for a patient age 16 or older. This requirement does not apply when prescribing or dispensing a nonopioid controlled substance listed in Schedule V of s. 893.03 or 21 U.S.C. 812 or prescribing or dispensing a controlled substance to a patient who has been admitted to hospice pursuant to s. 400.6095. For purposes of this subsection, a “nonopioid controlled substance” is a controlled substance that does not contain any amount of a substance listed as an opioid in s. 893.03 or 21 U.S.C. 812.
(a) The duty to consult the system does not apply when the system:
1. Is determined by the department to be nonoperational; or
2. Cannot be accessed by the prescriber or dispenser or a designee of the prescriber or dispenser because of a temporary technological or electrical failure.
(b) A prescriber or dispenser or designee of a prescriber or dispenser who does not consult the system under this subsection shall document the reason he or she did not consult the system in the patient’s medical record or prescription record and shall not prescribe or dispense greater than a 3-day supply of a controlled substance to the patient.
(c) The department shall issue a nondisciplinary citation to any prescriber or dispenser who fails to consult the system as required by this subsection for an initial offense. Each subsequent offense is subject to disciplinary action pursuant to s. 456.073.
(9) A person who willfully and knowingly fails to report the dispensing of a controlled substance as required by this section commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083.
1(10) Information in the prescription drug monitoring program’s system may be released only as provided in this section and s. 893.0551.
(a) Except as provided in paragraph (b), the content of the system is intended to be informational only. Information in the system is not subject to discovery or introduction into evidence in any civil or administrative action against a prescriber, dispenser, pharmacy, or patient arising out of matters that are the subject of information in the system. The program manager and authorized persons who participate in preparing, reviewing, issuing, or any other activity related to management of the system may not be permitted or required to testify in any such civil or administrative action as to any findings, recommendations, evaluations, opinions, or other actions taken in connection with management of the system.
(b) The Attorney General may introduce information from the system released pursuant to subparagraph (5)(b)2. as evidence in a civil, criminal, or administrative action against a dispenser, manufacturer, or a pharmacy. The program manager and authorized persons who participate in preparing, reviewing, issuing, or any other activity related to the management of the system may testify for purposes of authenticating the records introduced into evidence pursuant to this paragraph.
(11) A prescriber or dispenser, or his or her designee, may have access to the information under this section which relates to a patient of that prescriber or dispenser as needed for the purpose of reviewing the patient’s controlled drug prescription history. A prescriber or dispenser acting in good faith is immune from any civil, criminal, or administrative liability that might otherwise be incurred or imposed for receiving or using information from the prescription drug monitoring program. This subsection does not create a private cause of action, and a person may not recover damages against a prescriber or dispenser authorized to access information under this subsection for accessing or failing to access such information.
(12)(a) All costs incurred by the department in administering the prescription drug monitoring program shall be funded through federal grants, private funding applied for or received by the state, or state funds appropriated in the General Appropriations Act. The department may not:
1. Commit funds for the monitoring program without ensuring funding is available; or
2. Use funds provided, directly or indirectly, by prescription drug manufacturers to implement the program.
(b) The department shall cooperate with the direct-support organization established under subsection (15) in seeking federal grant funds, other nonstate grant funds, gifts, donations, or other private moneys for the department if the costs of doing so are immaterial. Immaterial costs include, but are not limited to, the costs of mailing and personnel assigned to research or apply for a grant. The department may competitively procure and contract pursuant to s. 287.057 for any goods and services required by this section.
(13) The department shall conduct or participate in studies to examine the feasibility of enhancing the prescription drug monitoring program for the purposes of public health initiatives and statistical reporting. Such studies shall respect the privacy of the patient, the prescriber, and the dispenser. Such studies may be conducted by the department or a contracted vendor in order to:
(a) Improve the quality of health care services and safety by improving prescribing and dispensing practices for controlled substances;
(b) Take advantage of advances in technology;
(c) Reduce duplicative prescriptions and the overprescribing of controlled substances; and
(d) Reduce drug abuse.
(14) The department shall annually report on performance measures to the Governor, the President of the Senate, and the Speaker of the House of Representatives by December 1. Performance measures may include, but are not limited to, the following outcomes:
(a) Reduction of the rate of inappropriate use of controlled substances through department education and safety efforts.
(b) Reduction of the quantity of controlled substances obtained by individuals attempting to engage in fraud and deceit.
(c) Increased coordination among partners participating in the prescription drug monitoring program.
(d) Involvement of stakeholders in achieving improved patient health care and safety and reduction of controlled substance abuse and controlled substance diversion.
(15) The department may establish a direct-support organization to provide assistance, funding, and promotional support for the activities authorized for the prescription drug monitoring program.
(a) As used in this subsection, the term “direct-support organization” means an organization that is:
1. A Florida corporation not for profit incorporated under chapter 617, exempted from filing fees, and approved by the Department of State.
2. Organized and operated to conduct programs and activities; raise funds; request and receive grants, gifts, and bequests of money; acquire, receive, hold, and invest, in its own name, securities, funds, objects of value, or other property, either real or personal; and make expenditures or provide funding to or for the direct or indirect benefit of the department in the furtherance of the prescription drug monitoring program.
(b) The State Surgeon General shall appoint a board of directors for the direct-support organization.
1. The board of directors shall consist of no fewer than five members who shall serve at the pleasure of the State Surgeon General.
2. The State Surgeon General shall provide guidance to members of the board to ensure that moneys received by the direct-support organization are not received from inappropriate sources. Inappropriate sources include, but are not limited to, donors, grantors, persons, prescription drug manufacturers, or organizations that may monetarily or substantively benefit from the purchase of goods or services by the department in furtherance of the prescription drug monitoring program.
(c) The direct-support organization shall operate under written contract with the department. The contract must, at a minimum, provide for:
1. Approval of the articles of incorporation and bylaws of the direct-support organization by the department.
2. Submission of an annual budget for the approval of the department.
3. The reversion, without penalty, to the department’s grants and donations trust fund for the administration of the prescription drug monitoring program of all moneys and property held in trust by the direct-support organization for the benefit of the prescription drug monitoring program if the direct-support organization ceases to exist or if the contract is terminated.
4. The fiscal year of the direct-support organization, which must begin July 1 of each year and end June 30 of the following year.
5. The disclosure of the material provisions of the contract to donors of gifts, contributions, or bequests, including such disclosure on all promotional and fundraising publications, and an explanation to such donors of the distinction between the department and the direct-support organization.
6. The direct-support organization’s collecting, expending, and providing of funds to the department for the development, implementation, and operation of the prescription drug monitoring program as described in this section. The direct-support organization may collect and expend funds to be used for the functions of the direct-support organization’s board of directors, as necessary and approved by the department. In addition, the direct-support organization may collect and provide funding to the department in furtherance of the prescription drug monitoring program by:
a. Establishing and administering the prescription drug monitoring program’s electronic system, including hardware and software.
b. Conducting studies on the efficiency and effectiveness of the program to include feasibility studies as described in subsection (13).
c. Providing funds for future enhancements of the program within the intent of this section.
d. Providing user training of the prescription drug monitoring program, including distribution of materials to promote public awareness and education and conducting workshops or other meetings for health care practitioners, pharmacists, and others as appropriate.
e. Providing funds for travel expenses.
f. Providing funds for administrative costs, including personnel, audits, facilities, and equipment.
g. Fulfilling all other requirements necessary to implement and operate the program as outlined in this section.
7. Certification by the department that the direct-support organization is complying with the terms of the contract in a manner consistent with and in furtherance of the goals and purposes of the prescription drug monitoring program and in the best interests of the state. Such certification must be made annually and reported in the official minutes of a meeting of the direct-support organization.
(d) The activities of the direct-support organization must be consistent with the goals and mission of the department, as determined by the department, and in the best interests of the state. The direct-support organization must obtain written approval from the department for any activities in support of the prescription drug monitoring program before undertaking those activities.
(e) The direct-support organization shall provide for an independent annual financial audit in accordance with s. 215.981. Copies of the audit shall be provided to the department and the Office of Policy and Budget in the Executive Office of the Governor.
(f) The direct-support organization may not exercise any power under s. 617.0302(12) or (16).
(g) The direct-support organization is not considered a lobbying firm within the meaning of s. 11.045.
(h) The department may permit, without charge, appropriate use of administrative services, property, and facilities of the department by the direct-support organization, subject to this section. The use must be directly in keeping with the approved purposes of the direct-support organization and may not be made at times or places that would unreasonably interfere with opportunities for the public to use such facilities for established purposes. Any moneys received from rentals of facilities and properties managed by the department may be held in a separate depository account in the name of the direct-support organization and subject to the provisions of the letter of agreement with the department. The letter of agreement must provide that any funds held in the separate depository account in the name of the direct-support organization must revert to the department if the direct-support organization is no longer approved by the department to operate in the best interests of the state.
(i) The department may adopt rules under s. 120.54 to govern the use of administrative services, property, or facilities of the department or office by the direct-support organization.
(j) The department may not permit the use of any administrative services, property, or facilities of the state by a direct-support organization if that organization does not provide equal membership and employment opportunities to all persons regardless of race, color, religion, gender, age, or national origin.
(k) This subsection is repealed October 1, 2027, unless reviewed and saved from repeal by the Legislature.
(16) The department shall adopt rules necessary to implement this section.
2(17) For the 2020-2021 fiscal year only, neither the Attorney General nor the department may use funds received as part of a settlement agreement to administer the prescription drug monitoring program. This subsection expires July 1, 2021.