Consultant Pharmacist of Record; Initial Designation; Change.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16ER20-21Consultant Pharmacist of Record; Initial Designation; Change.

SPECIFIC REASONS FOR FINDING AN IMMEDIATE DANGER TO THE PUBLIC HEALTH, SAFETY OR WELFARE: The Board of Pharmacy (hereinafter the “Board”) is statutorily mandated to promulgate rules necessary to regulate the practice of consultant pharmacists. Pursuant to this authority, the Board has promulgated rules setting forth the practice requirements for consultant pharmacists in the State of Florida. Pursuant to Rule 64B16-28.501(3), Florida Administrative Code, the consultant pharmacist of record for a Class I, Class II, Modified Class II, or Class III Institutional permit shall inspect the facility and prepare a written report to be filed at the permitted facility at least monthly. Rules 64B16-28.702(2)(b), (c), and (d) F.A.C., require consultant pharmacists to “provide on-site consultations not less than once every month, unless otherwise directed by the Board after review of the policy and procedure manual” for the Modified Class II Institutional Pharmacies that are under their supervision and control. Rule 64B16-28.850(16), F.A.C., also requires consultant pharmacists to inspect permitted ESSRD pharmacies under their supervision on a monthly basis. Further, Rules 64B16-28.870(3)(c) and (d), F.A.C., require consultant pharmacists of Special Assisted Living Facilities (“ALF”) permits to “inspect the facility and prepare a written report to be filed at the permitted facility at least monthly”.

On March 1, 2020, Florida Governor Ron DeSantis issued Executive Order Number 20-51 which directed the State Health Officer and Surgeon General, Dr. Scott Rivkees, to declare a public health emergency pursuant to the spread of the Coronavirus Disease 2019 (“COVID-19”). On March 9, 2020, Governor DeSantis issued Executive Order Number 20-52 (Emergency Management - COVID-19 Public Health Emergency) and officially declared that a state of emergency exists in the State of Florida. On March 16, 2020, Dr. Rivkees issued Emergency Order DOH 20-002 in order to prepare for, respond to, and mitigate any effect of COVID-19 in the State of Florida.

COVID-19 is a severe acute respiratory illness that can spread among humans through respiratory transmission and presents with symptoms similar to those of influenza. As of March 19, 2020, there are 360 confirmed cases of COVID-19 in Florida residents. The Center for Disease Control (“CDC”) recommends mitigation measures to combat the spread of COVID-19 such as staying home when sick, keeping away from others who are sick, and staying home when a household member is sick with respiratory disease symptoms. The CDC also recommends those who are at a higher risk, such as older adults and those who have serious chronic medical conditions, should avoid non-essential air travel and avoid crowds as much as possible.

Due to the concerns surrounding the spread of COVID-19, several consultant pharmacists have reached out to the Board staff with concerns regarding the performance of in-person inspections pursuant to the aforementioned rules. At least one pharmacist was not allowed to enter an ALF permit holder where he was serving as the consultant pharmacist due to COVID-19 concerns. Other practitioners have expressed concerns regarding the potential unintentional spread of the virus to facilities housing high risk individuals if they were to comply with the provisions requiring in-person inspections.

Ensuring that Florida’s consultant pharmacists are not unnecessarily put at risk is essential during this healthcare emergency. Further, ensuring facilities that house large portions of high-risk individuals are not exposed to COVID-19 is of utmost concern. Healthcare providers such as consultant pharmacists have an increased likelihood of being exposed to COVID-19 due to the number of health care facilities they visit during the performance of duties. Considering the spread of COVID-19, requiring consultant pharmacists to perform in-person inspections at permitted institutional pharmacies increases the risk of exposure of the medical providers and the facilities’ patients to COVID-19.

Accordingly, the Board, by emergency rule, hereby waives the requirement that off-site consultant pharmacists conduct monthly inspections as required by Rule 64B16-28.501(3), F.A.C.; Rules 64B16-28.702(2)(b), (c), and (d) F.A.C.; Rule 64B16-28.850(16), F.A.C., and Rules 64B16-28.870(3)(c) and (d), F.A.C. The Board finds that these actions are a measured regulatory approach that helps protect the patients of consultant pharmacists and the pharmacists themselves from exposure to COVID-19. This emergency rule shall not be interpreted in any way that would alleviate the obligations to perform drug regimen reviews pursuant to State and Federal law.

REASON FOR CONCLUDING THAT THE PROCEDURE IS FAIR UNDER THE CIRCUMSTANCES: Given the recently declared emergency in the State of Florida and the recent guidance from the CDC, the Board finds that requiring off-site consultant pharmacists to conduct in person inspections of permitted pharmacies under their supervision would constitute an immediate danger to the public health, safety, or welfare and necessitates immediate action regarding this issue. Notice of this emergency meeting was published in the Florida Administrative Register on March 18, 2020. Further, notice of the Board’s emergency meeting and an agenda outlining the topic for the meeting was posted on the Board’s official website on March 17, 2020.

SUMMARY: The proposed emergency rule waives the requirement that off-site consultant pharmacists conduct in-person inspections pursuant to Rule 64B16-28.501(3), F.A.C.; Rules 64B16-28.702(2)(b), (c), and (d) F.A.C.; Rule 64B16-28.850(16), F.A.C., and Rules 64B16-28.870(3)(c) and (d), F.A.C..

THE PERSON TO BE CONTACTED REGARDING THE EMERGENCY RULE IS: Jessica L. Sapp, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin # C-08, Tallahassee, Florida 32399-1708.

 

THE FULL TEXT OF THE EMERGENCY RULE IS:

 

64B16ER20-21(64B16-28.501) Consultant Pharmacist of Record; Initial Designation; Change.

(1) through (4) No change.

(5) Off-site consultant pharmacists of record shall not be required to perform inspections and on-site consultations at permitted institutional pharmacies as referenced in Rules 64B16-28.501(3), F.A.C.; Rules 64B16-28.702(2)(b), (c), and (d) F.A.C.; Rule 64B16-28.850(16), F.A.C., and Rules 64B16-28.870(3)(c) and (d), F.A.C., when the consultant pharmacist of record is not regularly present at the location. This rule shall in no way modify any obligations stemming from State or Federal laws requiring drug regimen reviews.

Rulemaking Authority 465.005, 465.0125, 465.022 FS. Law Implemented 465.0125, 465.019, 465.022, 465.0266 FS. History-New 7-18-94, Formerly 61F10-28.501, 59X-28.501, Amended 1-2-02, 12-30-07, 11-5-17, 6-5-18, 9-27-18.

 

THIS RULE TAKES EFFECT UPON BEING FILED WITH THE DEPARTMENT OF STATE UNLESS A LATER TIME AND DATE IS SPECIFIED IN THE RULE.

EFFECTIVE DATE: March 19, 2020