RULE NO.: RULE TITLE:
64K-1.001: Patient Advisory Alerts and Reports
64K-1.003: Accessing Database
64K-1.004: Management and Operation of Database
64K-1.005: Storage and Security of Information
64K-1.006: Program Evaluation and Other
64K-1.001 Patient Advisory Alerts and Reports.
(1) A patient An advisory report is a document in an electronic or paper format screen containing information related to the dispensing of regarding a patient based on controlled substances listed in Schedules II through IV in Section 893.03, F.S. The patient advisory report is created from dispensing information substance information that has been reported to the Prescription Drug Monitoring Program (Program) database by pharmacies and dispensing practitioners. The advisory report will be accessible online to the practitioner or the pharmacist. The Program will update the advisory reports at least once a week and the information on the reports shall be removed when older than 60 days. Advisory reports will be issued in accordance with Section 893.13(7)(a)8., F.S. when recommended by law enforcement or by a board governing health care practitioners.
(2) A patient An advisory report alert available only upon request in accordance with Section 893.055(2)(a), F.S., will indicate to a health care practitioner when a is a report containing information that indicates that a patient may have been prescribed or received controlled substances from multiple health care practitioners in a strength, amount, or at a frequency that may be contrary to law of concern to the patient or to any involved pharmacies and practitioners. When an alert is issued, the screen or report shall contain the phrase “ADVISORY ALERT” in distinguishing or colored font. The alert report shall be retained for a minimum of six months and until at least six months have passed during which time the patient has not been prescribed or received controlled substances in a strength, amount, or at a frequency that may be of concern to the patient or to any involved pharmacies and practitioners.
(3) An advisory report will only be provided to the practitioner, pharmacy, pharmacist, or patient upon request. When an alert report is created, a confidential alert notification will be e-mailed to the referenced practitioner or pharmacy with instructions on how to request and access the alert report.
64K-1.003 Accessing Database.
(1) The following entities have direct access to the information contained in the Program central database:
(a) A pharmacist pharmacy, prescriber, or dispenser if the information relates to a patient of that pharmacy, prescriber, or dispenser for purposes of reviewing the patient’s controlled substance prescription history. Those entities who are authorized to prescribe or dispense controlled substances, Schedules II-IV, and are licensed in the State of registered in the Program system, may access the database through the secure web portal to request and receive information electronically, or may submit a written request to the Program manager if information must be received by an alternate means.
(b) The Program manager and designated Program support staff acting at the direction of or as authorized by the Program manager for purposes of management of the Program database and in furtherance of the Program.
(2) The following entities do not have direct access to the information in the database, but may request access from the Program manager or authorized staff:
(a) The Department or the heath care regulatory boards in subparagraph 893.005(7)(c)1., F.S., when involved in a specific controlled substance investigation involving a designated person for one or more prescribed controlled substances.
(b) The Attorney General or designee for Medicaid Fraud cases involving prescribed controlled substances.
(c) A law enforcement agency during an active investigation regarding potential criminal activity, fraud, or theft relating to prescribed controlled substances.
(d) A patient or the legal guardian or designated health care surrogate of an incapacitated patient as described in Section s. 893.0551, F.S., who, for the purpose of verifying the accuracy of the database information, contacts the Prescription Drug Monitoring Program at 4052 Bald Cypress Way, Bin #C-16, Tallahassee, FL 32399-3254 or by telephone at (850)245-4797 to request form DH 2143 “Patient Information Request,” effective December, 2010, which is incorporated by reference and located at ________submits a notarized request on a form authorized by the Program. To receive the requested information, the patient or other authorized person representative must make an appointment, appear in person at the Program office, and produce proof of representation if not the patient as well as a valid government issued identification, which includes a photograph photographic proof of identity.
(3) The Program manager or designated staff must ensure that the entity requesting access to information is permitted by law to receive access and must document steps taken take every reasonable precaution to verify the request as authentic.
64K-1.004 Management and Operation of Database.
(1) All entities that dispense controlled substances, Schedules II-IV, are required to report to the Program central database. These entities include:
(a) Any pharmacy with a permit issued under Chapter Ch. 465, F.S., that dispenses controlled substances, whether located in or out of the State of Florida, including mail order or Internet pharmacies.
(b) Any health care practitioner, practicing in
(c) Exemptions from reporting are as stated in Section s. 893.055(5), F.S.
(2) All entities that dispense controlled substances, Schedules II-IV, must register with the Program prior to submitting data.
(2)(3) All dispensers will electronically submit report data to the Program’s database as soon thereafter as possible, but not more than 7 15 days after the controlled substance is dispensed to an individual according to a schedule developed and published by the Program. Extensions of the time within which a dispenser must report the dispensing of a controlled substance shall be granted for no more than 30 days upon request to the Program by any dispenser unable to submit data by electronic means for good cause if the dispenser provides evidence of having suffered a mechanical or electronic failure or cannot report for reasons beyond the control of the dispenser or if the central database is unable to receive submissions.
(3)(4) Data not accepted by the database system due to a substantial number of errors or omissions shall be corrected and resubmitted to the database by the reporting dispenser within ten business five days of receiving written notice that the submitted data was unacceptable.
(4)(5) Failure to report the dispensing of Schedules II-IV controlled substances will result in the Program filing a complaint with the Department for investigation by the Department and a referral to law enforcement.
(5)(6) All information from the database disseminated in any form by the Program to any entity is considered protected health information and the use of it is governed by any and all applicable federal and state laws. Authorized entities receiving such information shall maintain the information for up to 24 months before purging it from the records or shall maintain it for longer than 24 months if advised that the information is pertinent to an ongoing disciplinary or law enforcement investigation or prosecution.
(6)(7)(a) A patient, health care provider, prescriber, or dispenser is authorized to submit to the Program an electronic request for the correction of erroneous information in the database. The request shall include:
1. A statement explaining in detail the basis for the requested correction;
2. The precise change requested;
3. Documentation establishing the error and the correct information;
4. The requester’s name, address, telephone number, and license number if licensed as a health care provider in
(b) The Program manager or designated staff will review all requests to correct information in the database and will contact the entity that provided the data under review. If the reporter of the data concurs that the data should be corrected as requested, the reporter Program will make the correction. If the reporter does not agree, the reporter correction will not enter the correction be entered. The entity or person requesting the correction will be notified of whether the correction has been made the Program’s determination.
64K-1.005 Storage and Security of Information.
Breaches in database security discovered by the Program manager or designated staff must be reported to the Department and to law enforcement within one business day of discovery of the breach. System users who become aware of a breach in security must report the suspected breach to the Program manager or designated staff Department as soon as possible, but or no later than one business day after its discovery.
64K-1.006 Program Evaluation and Other.
Beginning in October 2011, the Department shall evaluate the Program to prepare a report to the Legislature and Governor by December 1 of each year using the performance measures specified in Section s. 893.055(8), F.S.