Current through Reg. 50, No. 244; December 17, 2024
Section 64K-1.003 - Accessing Database(1) Definitions: (a) "Authenticate, Authenticated, or Authentication" means a confirmation of the authorized user's credentials by the prescription drug monitoring program of a state, district or territory.(b) "Designee" means a person, preferably a licensed or certified health care professional, appointed to act as an agent of a prescriber or dispenser for the purposes of requesting or receiving information from the Prescription Drug Monitoring Program database, E-FORCSE®.(c) "E-FORCSE®" is the comprehensive electronic database system established by the Department of Health that has controlled substance prescribing and dispensing information reported to it and that provides the information to persons and entities allowed by law to access, request and receive this information.(d) "Electronic health record" is an electronic or digital version of a patient's medical history, maintained over time and may include all of the key administrative clinical data relevant to that person's medical care under a particular provider, including demographics, progress notes, problems, medications, vital signs, past medical history, immunizations, laboratory data and radiology reports. The electronic health record uses computer hardware and software for the storage, retrieval, sharing and use of health care information and data.(e) "Impaired practitioner consultant" means an impaired practitioner program designated by the department through contract with a consultant to evaluate, refer and monitor impaired practitioners. The department has designated the Intervention Project for Nurses (IPN) and Professionals Resource Network (PRN) as the Approved Impaired Practitioner Programs.(f) "Order" means a written, transmitted or oral direction from a prescriber for a controlled substance to be administered to a patient.(g) "Prescribe" means the act of a prescriber issuing, writing or transmitting a direction to a pharmacist to dispense a specified controlled substance to a specified patient.(2) Pharmacists, prescribers and dispensers, or their designees, are required to access and consult E-FORCSE® to review a patient's controlled substance dispensing history each time a controlled substance, other than a nonopioid drug listed on Schedule V, is prescribed or dispensed, but not ordered, for a patient age 16 or older unless a statutory exception applies.(3)(a) Pharmacists, prescribers and dispensers licensed in Florida may directly access the information in E-FORCSE® by registering at https://florida.pmpaware.net/login. A pharmacist, prescriber or dispenser must review the "PMP AWARxE® Requestor User Support Manual, Florida Prescription Drug Monitoring Program, Version 3.0" DH8009-PDMP, effective 5/2022, which is incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-15670, prior to registering. Registration denials, stating the reason for denial, will be emailed to the unsuccessful registrant.(b) A prescriber or dispenser licensed to practice in the state of Florida may request and receive information from E-FORCSE® using a secure recordkeeping system integration associated with his or her electronic health record. If the user is authenticated, E-FORCSE® will return query results to the authorized user's electronic health record.(c) Prescribers and dispensers licensed in states, districts or territories other than Florida, may directly access information in E-FORCSE® using an approved secure recordkeeping system integration associated with his or her electronic health record if:1. The prescribers and dispensers are practicing in a state, district or territory where the Department has entered into a reciprocal interstate data sharing agreement, and;2. The prescriber or dispenser, is accessing the information through an approved secure recordkeeping system integration associated with his or her electronic health record or pharmacy management system which authenticates the user's credentials by the prescription drug monitoring program.(4)(a) A designee of a prescriber or dispenser may directly access the information in E-FORCSE® by registering at https://florida.pmpaware.net/login. A designee must review the "PMP AWARxE® Requestor User Support Manual" prior to registration.(b) A registered designee will not have access to E-FORCSE® until the designating prescriber or dispenser affirmatively accepts responsibility for the designee and links the designee to a pharmacy, prescriber or dispenser E-FORCSE® account as described in the "PMP AWARxE® Requestor User Support Manual." The linking process will require the prescriber or dispenser to certify that the designee has reviewed the "PMP AWARxE® Requestor User Support Manual".(c) Registered designees who do not access E-FORCSE® for a period in excess of one year will be deactivated. Deactivated designees may request activation by sending a request to e-forcse@flhealth.gov.(5) Prescribers and dispensers and their designees employed by the United States Department of Veterans Affairs (DVA), United States Department of Defense (DOD), and the Indian Health Service (IHS) who are authorized to prescribe or dispense controlled substance and are not licensed in Florida but provide health care services to patients in this state pursuant to such employment, may directly access E-FORCSE® by registering at https://florida.pmpaware.net/login. An employee of the DVA, DOD and IHS must review the "PMP AWARxE Requestor User Support Manual" prior to registering. Registration denials, stating the reason for the denial, will be emailed to the unsuccessful registrant. (a) A registered employee of the DVA, DOD, and IHS will not have access to E-FORCSE® until his or her employment is verified.(b) Direct access to the information in E-FORCSE® is limited to the information that relates to a patient of such employee and may be accessed only for the purpose of reviewing that patient's controlled substance prescription history.(c) A prescriber or dispenser or designee employed by the DVA, DOD or IHS that is an authorized E-FORCSE® user must notify E-FORSCE® within 30 days of termination of employment.(6)(a) Law enforcement and other agencies that do not have direct access to E-FORSCE® may request information from the program manager by having the agency head or a person appointed by the agency head for this purpose execute an "Agency User Agreement, " DH8017-PDMP, effective 3/2023, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-15671. If approved, the program manager will execute and return the agreement to the agency.(b) After approval of the "Agency User Agreement, " each agency head or person appointed by the agency head for this purpose shall appoint an agency administrator with an "Agency Administrator Appointment Form," DH8010-PDMP, effective 5/2019, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-11368. The agency administrator may register at https://florida.pmpaware.net/login. Prior to registration, each agency administrator must review the "PMP AWARxE[TM] Law Enforcement and Regulatory User Support Manual, " DH8012-PDMP, effective 7/2021, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-15672 and the "E-FORCSE® Information Security and Privacy Training Course, " (Florida Department of Law Enforcement, 2014) available at https://www.flrules.org/Gateway/reference.asp?No=Ref-15675 or https://360.articulate.com/review/content/af6873e1-d7e7-4f35-b68d-ce2f0d834d52/review, and complete the "Authorized User Certification Form", DH8025-PDMP, effective 7/2019, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-11370. The agency administrator shall maintain the "Authorized User Certification Form" for the duration of the appointment and make it available for examination upon request of the program manager. Upon registration, the agency administrator will upload the "Agency User Agreement" and the "Agency Administrator Appointment Form." Registration denials, stating the reason for the denial, will be emailed to the unsuccessful registrant.(c) Each agency head or person appointed by the agency head for this purpose shall immediately notify the program manager or support staff of a change in the agency administrator. Authority to request and receive information from E-FORCSE® shall be suspended during an agency administrator vacancy.(d) A designee of an agency administrator may register at https://florida.pmpaware.net/login. A registered designee will not have access to E-FORCSE® until the agency administrator affirmatively accepts responsibility for the designee and links the designee to the agency administrator's account as described in the "PMP AWARxE Law Enforcement and Regulatory User Support Manual." The linking process will require the agency administrator to certify that the designee has reviewed the "PMP AWARxE Law Enforcement and Regulatory User Support Manual" and the "E-FORCSE® Information Security and Privacy Training Course." The designee must provide a printed copy of the "Authorized User Certification Form" to the agency administrator who shall maintain it for the duration of the appointment and make it available for examination upon request of the program manager. Registration denials, stating the reason for the denial, will be emailed to the unsuccessful registrant.(e) An authorized law enforcement user must have actual knowledge of an active investigation as defined by Section 893.055(1)(a), F.S., prior to submitting a request and is prohibited from requesting information on behalf of another law enforcement agency or entity.(f) Each agency administrator shall immediately update user access permissions upon separation or reassignment of users and immediately update user access permissions upon discovery of negligence, improper or unauthorized use or dissemination of information and promptly notify the program manager or support staff by email.(g) Prior to the release of information in active investigations or pending civil or criminal litigation involving prescribed controlled substances, the Attorney General or his or her designee must upload evidence of the trial court granting the petition or motion which specifically identifies the active or pending matter leading to the discovery of admissible evidence.(7)(a) Impaired practitioner consultants do not have direct access to E-FORCSE® but may request and review information relating to persons referred to or participating in the approved impaired practitioner programs by having the Medical Director or Executive Director of the impaired practitioner program execute an "Impaired Practitioner Consultant User Agreement, " DH8020-PDMP, effective 3/2023, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-15673. If approved, the program manager will execute and return the agreement to the Medical Director or Executive Director of the impaired practitioner program.(b) The impaired practitioner consultant shall immediately notify the program manager or support staff of a change of Medical Director or Executive Director. Authority to request and receive information from E-FORCSE® shall be suspended while the position of Medical Director or Executive Director is vacant.(c) Upon approval of the impaired practitioner consultant user agreement, the Medical Director or Executive Director of the approved practitioner program may appoint up to three (3) authorized users who are employees of the impaired practitioner consultant to request and receive information on behalf of the impaired practitioner program using an "Impaired Practitioner Program Authorized User Appointment Form, " DH8022-PDMP, effective 7/2016, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-07633. Prior to appointment, each authorized user must review the "Training Guide for Impaired Practitioner Consultants, " DH8021-PDMP, effective 7/2018, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-10122. Certification of this review is required before registration can be completed. The authorized user must provide a printed copy of this certification to the Medical Director or Executive Director of the impaired practitioner program who shall maintain them for the duration of the appointment and make them available for examination upon request of the program manager. Approved authorized users will be notified by email and provided with instructions for requesting and receiving information from E-FORCSE®. Registration denials, stating the reason for the denial, will be emailed to the Medical Director or Executive Director.(d) The Medical Director or Executive Director of the impaired practitioner consultant shall immediately notify the program manager or support staff by email of authorized user changes.(e) The person referred to or participating in the impaired practitioner program must provide written authorization for the impaired practitioner consultant to request and review information from E-FORCSE® relating to that person. The referred or participating person shall use the "Authorization for Impaired Practitioner Consultant Access, " Form DH8023-PDMP, effective 7/2016, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-07635, to provide this authorization. The impaired practitioner consultant or authorized user must upload the executed authorization form with the request for information from E-FORCSE® relating to the referred or participating person. Each access for a referred person requires a new authorization form. Authorizations for impaired practitioner program participants can be in effect no longer than the duration of the monitoring contract with the impaired practitioner program. If approved, the program manager will return the information on the referred or participating person from E-FORCSE® to the impaired practitioner consultant or authorized user. If denied, the program manager will notify the impaired practitioner consultant or authorized user with the reason for the denial.(f) Impaired practitioner program consultants and authorized users may only query information relating to the referred or participating person who has given authorization to access the information, and not any prescriber or dispenser. An impaired practitioner program consultant may make a notation of the query in the impaired practitioner program file.(g) Information in E-FORCSE® relating to referred and participating persons accessed by impaired practitioner consultants and authorized users is confidential and exempt and shall not be disclosed or transmitted to any other person, program or entity, including the Department. To prevent inadvertent disclosure, the information should not be included in the referred or participating person's impaired practitioner program file, downloaded or printed.(8) A patient or the legal guardian or designated health care surrogate of an incapacitated patient may request information from E-FORCSE® to verify the accuracy of the information by contacting the Prescription Drug Monitoring Program by mail at 4052 Bald Cypress Way, Bin #C-16, Tallahassee, FL 32399-3254, or by telephone at (850)245-4797 and submitting form DH 2143, "Patient Information Request, " effective 7/2018, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-10123.Fla. Admin. Code Ann. R. 64K-1.003
Rulemaking Authority, 893.055 FS. Law Implemented 893.055, 893.0551 FS.
New 11-24-11, Amended by Florida Register Volume 42, Number 021, February 02, 2016 effective 2/17/2016, Amended by Florida Register Volume 43, Number 020, January 31, 2017 effective 2/14/2017, Amended by Florida Register Volume 44, Number 234, December 4, 2018 effective 12/19/2018, Amended by Florida Register Volume 45, Number 230, November 26, 2019 effective 12/11/2019, Amended by Florida Register Volume 49, Number 143, July 25, 2023 effective 8/8/2023.New 11-24-11, Amended 2-17-16, 2-14-17, 12-19-18, 12-11-19, 8-8-23.