Florida Regulations 64B16-27.831: Standards of Practice for the Filling of Controlled Substance Prescriptions; Electronic Prescribing; Mandatory Continuing Education
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The Board of Pharmacy recognizes that it is important for the patients of the State of Florida to be able to fill valid prescriptions for controlled substances. In filling these prescriptions, the Board does not expect pharmacists to take any specific action beyond exercising sound professional judgment. Pharmacists should not fear disciplinary action from the Board or other regulatory or enforcement agencies for dispensing controlled substances for a legitimate medical purpose in the usual course of professional practice. Every patient’s situation is unique and prescriptions for controlled substances shall be reviewed with each patient’s unique situation in mind. Pharmacists shall attempt to work with the patient and the prescriber to assist in determining the validity of the prescription.
(1) Definitions: For purposes of this rule the following definitions shall apply:
(a) Valid Prescription. A prescription is valid when it is based on a practitioner-patient relationship and when it has been issued for a legitimate medical purpose.
(b) Invalid Prescription. A prescription is invalid if the pharmacist knows or has reason to know that the prescription was not issued for a legitimate medical purpose.
(c) Validating a Prescription. Validating a prescription means the process implemented by the pharmacist to determine that the prescription was issued for a legitimate medical purpose.
(2) General Standards for Validating a Prescription: Each prescription may require a different validation process and no singular process can fit each situation that may be presented to the pharmacist. There are circumstances that may cause a pharmacist to question the validity of a prescription for a controlled substance; however, a concern with the validity of a prescription does not mean the prescription shall not be filled. Rather, when a pharmacist is presented with a prescription for a controlled substance, the pharmacist shall attempt to determine the validity of the prescription and shall attempt to resolve any concerns about the validity of the prescription by exercising his or her independent professional judgment.
(a) When validating a prescription, neither a person nor a licensee shall interfere with the exercise of the pharmacist’s independent professional judgment.
(b) When validating a prescription, the pharmacist shall ensure that all communication with the patient is not overheard by others.
(c) When validating a prescription, if at any time the pharmacist determines that in his or her professional judgment, concerns with the validity of the prescription cannot be resolved, the pharmacist shall refuse to fill or dispense the prescription.
(3) Minimum Standards Before Refusing to Fill a Prescription.
(a) Before a pharmacist can refuse to fill a prescription based solely upon a concern with the validity of the prescription, the pharmacist shall attempt to resolve those concerns and shall attempt to validate the prescription by performing the following:
1. Initiate communication with the patient or the patient’s representative to acquire information relevant to the concern with the validity of the prescription,
2. Initiate communication with the prescriber or the prescriber’s agent to acquire information relevant to the pharmacist’s concern with the validity of the prescription.
(b) In lieu of either subparagraph 1. or 2., but not both, the pharmacist may elect to access the Prescription Drug Monitoring Program’s Database to acquire information relevant to the pharmacist’s concern with the validity of the prescription.
(c) In the event that a pharmacist is unable to comply with paragraph (a), due to a refusal to cooperate with the pharmacist, the minimum standards for refusing to fill a prescription shall not be required.
(4) Duty to Report: If a pharmacist has reason to believe that a prescriber is involved in the diversion of controlled substances, the pharmacist shall report such prescriber to the Department of Health.
(5) Electronic Prescriptions: All controlled substances listed in Schedule II through V may be electronically prescribed pursuant to the provisions of Florida Statutes § 456.42(2), and pursuant to applicable federal law.
(6) Mandatory Continuing Education: All pharmacists shall complete a Board-approved 2-hour continuing education course on the Validation and Counseling of Prescriptions for Controlled Substances and Opioids. The course content shall include the following:
(a) Ensuring access to controlled substances for all patients with a valid prescription;
(b) Use of the Prescription Drug Monitoring Program’s Database;
(c) Assessment of prescriptions for appropriate therapeutic value;
(d) Detection of prescriptions not based on a legitimate medical purpose;
(e) The laws and rules related to the prescribing and dispensing of controlled substances.
(f) Proper patient storage and disposal of controlled substances;
(g) Protocols for addressing and resolving problems recognized during the drug utilization review to include but not limited to the following:
1. Drug/drug interactions;
2. Side effects;
3. High dose/low dose guidelines; and
(h) Education on the provision of Florida Statutes § 381.887, Emergency treatment for suspected opioid overdoses and on the State Surgeon General’s Statewide Standing Order for Naloxone (eff. May 19, 2017) for as long as the Order is valid and effective.
(i) Pharmacist initiated counseling of patients with opioid prescriptions; and
(j) Available treatment resources for opioid physical dependence, addiction, misuse, or abuse.
(7) All licensed pharmacists shall complete the required 2-hour course every biennium. The course shall count towards the mandatory 30 hours of CE required for licensure renewal. All newly licensed pharmacists must complete the required course before the end of the first biennial renewal period.
(8) Summary Record: Every pharmacy permit holder shall maintain a computerized record of controlled substance prescriptions dispensed. A hard copy printout summary of such record, covering the previous 60 day period, shall be made available within 72 hours following a request for it by any law enforcement personnel entitled to request such summary under authority of Florida Statutes § 893.07(4) Such summary shall include information from which it is possible to determine the volume and identity of controlled substances being dispensed under the prescription of a specific prescriber, and the volume and identity of controlled substances being dispensed to a specific patient.
Rulemaking Authority 456.013, 465.005, 465.0155, 465.009, 465.022(12) FS. Law Implemented 456.013, 456.42, 456.43, 465.0155, 465.003, 465.009, 465.016(1)(i), (s), 465.017, 465.022(12), 893.04 FS. History-New 8-29-02, Amended 2-24-03, 11-18-07, 12-24-15, 6-14-18, 4-5-23.
(1) Definitions: For purposes of this rule the following definitions shall apply:
(a) Valid Prescription. A prescription is valid when it is based on a practitioner-patient relationship and when it has been issued for a legitimate medical purpose.
(b) Invalid Prescription. A prescription is invalid if the pharmacist knows or has reason to know that the prescription was not issued for a legitimate medical purpose.
(c) Validating a Prescription. Validating a prescription means the process implemented by the pharmacist to determine that the prescription was issued for a legitimate medical purpose.
(2) General Standards for Validating a Prescription: Each prescription may require a different validation process and no singular process can fit each situation that may be presented to the pharmacist. There are circumstances that may cause a pharmacist to question the validity of a prescription for a controlled substance; however, a concern with the validity of a prescription does not mean the prescription shall not be filled. Rather, when a pharmacist is presented with a prescription for a controlled substance, the pharmacist shall attempt to determine the validity of the prescription and shall attempt to resolve any concerns about the validity of the prescription by exercising his or her independent professional judgment.
(a) When validating a prescription, neither a person nor a licensee shall interfere with the exercise of the pharmacist’s independent professional judgment.
(b) When validating a prescription, the pharmacist shall ensure that all communication with the patient is not overheard by others.
(c) When validating a prescription, if at any time the pharmacist determines that in his or her professional judgment, concerns with the validity of the prescription cannot be resolved, the pharmacist shall refuse to fill or dispense the prescription.
(3) Minimum Standards Before Refusing to Fill a Prescription.
(a) Before a pharmacist can refuse to fill a prescription based solely upon a concern with the validity of the prescription, the pharmacist shall attempt to resolve those concerns and shall attempt to validate the prescription by performing the following:
1. Initiate communication with the patient or the patient’s representative to acquire information relevant to the concern with the validity of the prescription,
2. Initiate communication with the prescriber or the prescriber’s agent to acquire information relevant to the pharmacist’s concern with the validity of the prescription.
(b) In lieu of either subparagraph 1. or 2., but not both, the pharmacist may elect to access the Prescription Drug Monitoring Program’s Database to acquire information relevant to the pharmacist’s concern with the validity of the prescription.
(c) In the event that a pharmacist is unable to comply with paragraph (a), due to a refusal to cooperate with the pharmacist, the minimum standards for refusing to fill a prescription shall not be required.
(4) Duty to Report: If a pharmacist has reason to believe that a prescriber is involved in the diversion of controlled substances, the pharmacist shall report such prescriber to the Department of Health.
(5) Electronic Prescriptions: All controlled substances listed in Schedule II through V may be electronically prescribed pursuant to the provisions of Florida Statutes § 456.42(2), and pursuant to applicable federal law.
(6) Mandatory Continuing Education: All pharmacists shall complete a Board-approved 2-hour continuing education course on the Validation and Counseling of Prescriptions for Controlled Substances and Opioids. The course content shall include the following:
(a) Ensuring access to controlled substances for all patients with a valid prescription;
(b) Use of the Prescription Drug Monitoring Program’s Database;
(c) Assessment of prescriptions for appropriate therapeutic value;
(d) Detection of prescriptions not based on a legitimate medical purpose;
(e) The laws and rules related to the prescribing and dispensing of controlled substances.
(f) Proper patient storage and disposal of controlled substances;
(g) Protocols for addressing and resolving problems recognized during the drug utilization review to include but not limited to the following:
1. Drug/drug interactions;
2. Side effects;
3. High dose/low dose guidelines; and
(h) Education on the provision of Florida Statutes § 381.887, Emergency treatment for suspected opioid overdoses and on the State Surgeon General’s Statewide Standing Order for Naloxone (eff. May 19, 2017) for as long as the Order is valid and effective.
(i) Pharmacist initiated counseling of patients with opioid prescriptions; and
(j) Available treatment resources for opioid physical dependence, addiction, misuse, or abuse.
(7) All licensed pharmacists shall complete the required 2-hour course every biennium. The course shall count towards the mandatory 30 hours of CE required for licensure renewal. All newly licensed pharmacists must complete the required course before the end of the first biennial renewal period.
(8) Summary Record: Every pharmacy permit holder shall maintain a computerized record of controlled substance prescriptions dispensed. A hard copy printout summary of such record, covering the previous 60 day period, shall be made available within 72 hours following a request for it by any law enforcement personnel entitled to request such summary under authority of Florida Statutes § 893.07(4) Such summary shall include information from which it is possible to determine the volume and identity of controlled substances being dispensed under the prescription of a specific prescriber, and the volume and identity of controlled substances being dispensed to a specific patient.
Rulemaking Authority 456.013, 465.005, 465.0155, 465.009, 465.022(12) FS. Law Implemented 456.013, 456.42, 456.43, 465.0155, 465.003, 465.009, 465.016(1)(i), (s), 465.017, 465.022(12), 893.04 FS. History-New 8-29-02, Amended 2-24-03, 11-18-07, 12-24-15, 6-14-18, 4-5-23.