The Board proposes the rule amendment to update standards of practice for the dispensing of controlled substances.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-27.831Standards of Practice for the Dispensing of Controlled Substances for Treatment of Pain

PURPOSE AND EFFECT: The Board proposes the rule amendment to update standards of practice for the dispensing of controlled substances.

SUMMARY: The standards of practice for the dispensing of controlled substances will be updated.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of this rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 465.005, 465.0155 FS.

LAW IMPLEMENTED: 456.072(1)(i), 465.0155, 465.016(1)(i), (o) FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Allison Dudley, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

(Substantial rewording of Rule 64B16-27.831, F.A.C. follows. See Florida Administrative Code for present text.)

 

64B16-27.831 Standards of Practice for the Dispensing of Controlled Substances.

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 state regulatory or enforcement agencies for dispensing controlled substances for a legitimate medical purpose in the usual course of professional practice. The Board recognizes that every patient’s situation is unique and prescriptions for controlled substances shall be reviewed with each patient’s unique situation in mind. The Board encourages pharmacists to work with the patient and the prescriber to assist in determining the validity of the prescription.

(1) 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. A prescription shall be deemed invalid if the pharmacist knows or has reason to know that the prescription was not issued for a legitimate medical purpose.

(2) Prescription Validation - Validating a prescription means the process and steps implemented by the pharmacist to determine that the prescription was issued for a legitimate medical purpose. During the validation process, when the pharmacist is communicating with the patient or the prescriber, the pharmacist shall ensure that the communication cannot be overheard by others in the prescription dispensing area of the pharmacy. Neither a person nor a licensee shall interfere with the independent professional judgment of the pharmacist who is responsible for determining that the prescription is valid.

(3) Filling and Dispensing – 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 through a prescription validation process deemed appropriate under the specific circumstances. If at any time during the validation process a pharmacist determines that in his or her independent professional judgment that the doubts or concerns about the validity of the prescription cannot be resolved, the pharmacist shall refuse to fill or dispense the prescription.

(a) There are certain circumstances that may cause a pharmacist to question the validity of a prescription for a controlled substance. In the pharmacy community, these concerns are often referred to as “red flags.”  A concern with the validity of a prescription does not mean the prescription shall not or cannot be filled. Rather, when a pharmacist has a concern with the validity of a prescription, a pharmacist shall attempt to resolve any concerns.

(b) Neither pharmacists nor pharmacies may refuse to fill a prescription for a controlled substance based ONLY on a concern or doubt about whether the prescription was issued for a legitimate medical purpose without first attempting to resolve the concerns and doubts through the following minimum validation process steps:

1. The pharmacist shall first verify or attempt to verify the identity of the  person who presented the prescription to the pharmacy through proper identification issued by a state or the Federal Government that contains a photograph and a printed name with a signature or through a document as recognized in s. 893.055(14), Fla. Stat. (2015).

2. If the pharmacist has doubts or concerns about the validity of the prescription, the pharmacist may attempt to resolve concerns with the validity of the prescription by accessing the Prescription Drug Monitoring Database (PDMP). 

3. If accessing the PDMP does not resolve the doubts or concerns with the validity of the prescription, the pharmacist must then attempt to validate the prescription with the prescriber or his or her agent prior to refusing to fill the prescription.

(4) Mandatory Continuing Education – All pharmacists shall complete a Board-approved 2-hour continuing education course on the Validation of Prescriptions for Controlled Substances. 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 Database (PDMP);

(c) Assessment of prescriptions for appropriate therapeutic value;

(d) Detection of prescriptions not based on a legitimate medical purpose; and

(e) The laws and rules related to the prescribing and dispensing of controlled substances.

All licensed pharmacists shall complete the required course during the biennium ending on September 30, 2017. A 2-hour course shall be taken every biennium thereafter. 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.

(5) Electronic Prescriptions – All controlled substances listed in Schedule II through V may be electronically prescribed pursuant to the provisions of  s.456.42(2), Fla. Stat. (2015), and pursuant to applicable federal law.

(6) 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 Section 465.017, F.S. Such summary shall include information from which it is possible to determine the volume and identity of controlled substance medications being dispensed under the prescription of a specific prescriber, and the volume and identity of controlled substance medications being dispensed to a specific patient.

(7) Any pharmacist who has reason to believe that a prescriber of controlled substances is involved in the diversion of controlled substances shall report such prescriber to the Department of Health.

Rulemaking Specific Authority 456.013, 465.005, 465.0155, 465.009, 465.022(12) FS. Law Implemented 456.013, 456.42, 456.43, 456.072(1)(i), 465.0155, 465.003, 465.009, 465.016(1)(i), (s)(o), 465.017(2), 465.022(12), 893.04 FS. History–New 8-29-02, Amended 2-24-03, 11-18-07,                             .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Pharmacy and Controlled Substance Standards Committee

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Pharmacy

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: October 7, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: August 3, 2015