General Terms and Conditions to Be Followed by a Pharmacist When Ordering and Dispensing Approved Medicinal Drug Products, Standards of Practice - Continuous Quality Improvement Program, Requirement for Patient Records, Record-Keeping for Orthotics ...

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NOS.RULE TITLES:

64B16-27.210General Terms and Conditions to Be Followed by a Pharmacist When Ordering and Dispensing Approved Medicinal Drug Products

64B16-27.300Standards of Practice - Continuous Quality Improvement Program

64B16-27.800Requirement for Patient Records

64B16-27.851Record-Keeping for Orthotics and Pedorthics

NOTICE OF CHANGE

Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 40 No. 59, March 26, 2014 issue of the Florida Administrative Register.

The change is in response to written comments submitted by the staff of the Joint Administrative Procedures Committee and comments received at a public hearing on the rule.  The changes are as follows:

1. The Summary of Statement of Estimated Regulatory Costs and Legislative Ratification shall now read as follows:

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, with input from the public, determined that there would not be an adverse effect on small business to maintain the records for 4 years, and that there would not be a regulatory cost of $200,000 in the aggregate to any entity, because any additional economic impact that additional storage might have, would be more than offset by savings in employee time managing numerous kinds of records with different retention times. These savings will consist primarily of reduced labor costs, reduced work hours spent on records management, and reduced decision making time, as well as reduced document destruction costs.

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.

2. For Rule 64B16-27.300, subsection (5) shall now read as follows:

(5) Records maintained as a component of a pharmacy Continuous Quality Improvement Program are confidential under the Health Insurance Portability and Accountability Act and are exempt from discovery pursuant to provisions of Section 766.101, F.S. In order to determine compliance the Department may review the policy and procedures and a Summarization of Quality-Related Events. The summarization document shall analyze remedial measures undertaken following a Quality-Related Event. No patient name or employee name shall be included in this summarization. The summarization shall be maintained for four (4) two years. Records are considered peer-review documents and are not subject to discovery in civil litigation or administrative actions.

3. For Rule 64B16-27.851, sections 468.802 and 468.812(3) F.S., shall be removed from both the Rulemaking Authority and the Law Implemented. 

4. For Rule 64B16-27.851, section 465.1901, F.S. shall be added to the Rulemaking Authority. Section 456.057(17) F.S., shall be added to the Law Implemented, while section 456.057(16) F.S., shall be removed from the Law Implemented.

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