The Board proposes the rule amendment for a comprehensive review and to update continuing education related to Validation of Prescriptions for Controlled Substances to add course content related to prescriptions for opioids.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-27.831Standards of Practice for the Filling of Controlled Substance Prescriptions; Electronic Prescribing; Mandatory Continuing Education

PURPOSE AND EFFECT: The Board proposes the rule amendment for a comprehensive review and to update continuing education related to Validation of Prescriptions for Controlled Substances to add course content related to prescriptions for opioids.

SUMMARY: The amendment will update continuing education related to Validation of Prescriptions for Controlled Substances to add course content related to prescriptions for opioids.

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: 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.

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: C. Erica White, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-27.831 Standards of Practice for the Filling of Controlled Substance Prescriptions; Electronic Prescribing; Mandatory Continuing Education.

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) through (5) No change.

(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) through (c) No change.

(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.

(f) Proper disposal of unused 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

4. section 381.887, F.S., Emergency treatment for suspected opioid overdoses and the State Surgeon General’s Statewide Standing Order for Naloxone.  

(h) Pharmacist initiated counseling of patients with opioid prescriptions; and

(i)  Available treatment resources for opioid physical dependence, addiction, misuse, or abuse.

(7) All licensed pharmacists shall complete the required course during the biennium ending on September 30, 2019. 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. A licensee who completed the mandated Validation of Prescription for Controlled Substances course between October 1, 2017 and May 1, 2018, shall be deemed to have complied with this subsection for the biennium ending on September 30, 2019. 

(8)(7) No change.

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,                         .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Pharmacy

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: February 6, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: January 11, 2018