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Board Rules on Pharmacist Services on Final ApproachThis week the Florida Board of Pharmacy met and completed their work in preparation for the final adoption of test and treat rules as well as regulations related to pharmacist collaborative practice. These new rules will take effect on October 28, 2020. The genesis behind this effort came from adoption of House bill 389 that allows pharmacists to manage patients with chronic and non-chronic medical conditions. These rules which are being created within a totally new chapter began its development in June. This is one of the fastest trips we can recall in agency rulemaking. Generally complex regulations of this type take 12 to 18 months to complete. These rules will be final at the end of this month. During the Board meeting it was mentioned that some revisions will be considered at a future meeting of the Board. A listing of these new rules are below:
EDITOR’S NOTE: Members should be reminded that prior to starting these programs in your pharmacy, you will need to complete an initial 20 hour Board approved certification training program on collaborative practice and a 20 hour certification training program on testing and treating patients with non-chronic conditions. More will be discussed on these new changes in laws and rules at our December law and regulatory conference.
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Florida Consultant Pharmacist Rules Under ReviewThe Board has begun efforts to revise rule 64B16-26.300 and 64B16-26.301 related to consultant pharmacists. This rule is being opened to address language adopted under House bill 599 that was signed into law by Governor DeSantis during the 2020 legislative session. HB599 allows consultant pharmacists in institutions to modify or discontinue prescription drug therapy, order and evaluate laboratory tests and conduct patient assessments as appropriate to evaluate and monitor drug therapy. Included in the Board’s discussions were ideas to remove the 40 hour period of assessment and evaluation under the supervision of a preceptor. The Board’s review of this issue included acknowledgement of the advanced training of today’s pharmacist and some concerns over availability of training sites.
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Report Theft or Loss of Controlled SubstancesMembers should be reminded that there is a requirement to report to your local sheriff’s office or chief law enforcement agency upon learning of any instance in which a person obtained or attempted to obtain a controlled substance through fraudulent means. The reporting needs to be done within 24 hours or by the next business day whichever is later. (See F.S. 465.015) Prescription department managers also must make sure that you have procedures in place on the handling of fraudulent prescriptions as well as notifying the Board of Pharmacy whenever there is a theft or significant loss of controlled substances. This notification must be done within one business day. (See F.S. 465.022)
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FDA Approves Treatment for EbolaYesterday, the U.S. Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients. The most common symptoms experienced while receiving Inmazeb included: fever, chills, tachycardia (fast heart rate), tachypnea (fast breathing), and vomiting; however, these are also common symptoms of Ebola virus infection. Patients who receive Inmazeb should avoid the concurrent administration of a live vaccine due to the treatment’s potential to inhibit replication of a live vaccine virus indicated for prevention of Ebola virus infection and possibly reduce the vaccine’s efficacy. Hypersensitivity, including infusion-related events, can occur in patients taking Inmazeb, and treatment should be discontinued in the event of a hypersensitivity reaction.
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FDA Considering Restrictions on cBHTThe FDA has commissioned a study on compounding of hormorne therapy. It is possible that there will be an effort to restrict this practice by pharmacists. The Alliance for Pharmacy Compounding has weighed in on this issue and asking that members of Congress be contacted and encouraged to sign a joint letter raising concerns about the NASEM study.
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