Board of Pharmacy Legislative Update Allison M. Dudley, J.D. Executive Director Board of Pharmacy. Disclosure. Objectives 9/9/2015

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1 Board of Pharmacy Legislative Update Allison M. Dudley, J.D. Executive Director Board of Pharmacy Disclosure I have nothing to disclose and further, I was not paid an honorarium or travel reimbursement for participating in today s presentation Objectives Summarize Rule changes for The Florida Board of Pharmacy Discuss how these changes will change the scope of Pharmacy practice Identify how the changes will affect Pharmacist and Technicians 1

2 Background We are here today to discuss the regulatory and legislative changes that occurred during Remember that the Board of Pharmacy is in place to protect the health and safety of the public. Not the licenses of pharmacists or pharmacy permits Background The Board of Pharmacy is given regulatory authority under the State Legislature and is restricted to the rule making we can create by Chapter 465 We cannot creates rules unless granted that privilege by the legislature and sometimes we are mandated to create rules by Legislation Why we create Rules? It goes back to our initial mission Protect Health and Safety of the Public 2

3 Which Rules? State legislation passes a statute mandating rulemaking These rules must be created within 180 days Board indentifies rules that need to be updated or posses a public threat Public comment during rules committee How we create Rules? The rules committee meets with each board meeting and sometimes in between if needed Rules are opened by the rules committee and are considered open for rule development These gets published and are listed on the agenda How we create Rules? The Rules Committee then updates and changes the rule This can take several meetings The rule is then forwarded to the full board for approval or denial If approved it is then published for 21 days public comment before becoming effective with the Florida Register Can be found on Florida Administrative code website 3

4 HB 323 Pharmacist to Tech Ratio Effective July 1 st, 2014 Gave authority to the Board to allow pharmacists to supervise more than 1 technician i and removed the cap of 3 Revised composition of the Board to increase to 2 in institutional and community Gave ability to administer meningococcal and shingles vaccine HB 323 Pharmacist to Tech Ratio Require the date for a controlled substance to be in a numeric month/day/year format, have the abbreviated month written out, or have the month written out in whole Referenced F.S., F.S., F.S., F.S. HB 323 Pharmacist to Tech Ratio Require the date for a controlled substance to be in a numeric month/day/year format, have the abbreviated month written out, or have the month written out in whole Referenced F.S., F.S., F.S., F.S. 4

5 HB 323 Pharmacist to Tech Ratio Only the Pharmacist to Tech ratio required action from the board It required updating of 3 rules to be compliant with statute t t 64B Delegation to and Supervision of Pharmacy Technicians; Responsibility of Supervising Pharmacist 64B Registered Pharmacy Technician to Pharmacist Ratio 64B Registered Pharmacy Technician Responsibilities 64B Delegation to and Supervision of Pharmacy Technicians; Responsibility of Supervising Pharmacist Published 9/24/14 Effective 12/31/14 Creates several definitions Delegation: A pharmacist shall not delegate more tasks than he or she can personally supervise and ensure compliance with this rule. A pharmacist may delegate those non-discretionary delegable tasks enumerated in Rule 64B , F.A.C., to the following types of pharmacy technicians Defines Registered Pharmacy Technician and Pharmacy Technician in Training 64B Delegation to and Supervision of Pharmacy Technicians; Responsibility of Supervising Pharmacist Supervision: Delegated tasks must be performed under the direct supervision of a pharmacist and pursuant to the following definitions and requirements Direct Supervision: means supervision by a pharmacist who is on the premises at all times the delegated tasks are being performed; who is aware of delegated tasks being performed; and who is readily available to provide personal assistance, direction and approval throughout the time the delegated tasks are being performed 5

6 64B Delegation to and Supervision of Pharmacy Technicians; Responsibility of Supervising Pharmacist Use of Technology: A pharmacist, as an adjunct to assist in the direct supervision of the pharmacy technician, may employ technological means to communicate with or observe the pharmacy technician. A pharmacist shall make certain all applicable state and federal laws, including, but not limited to confidentiality, are fully observed when employing technological means of communication and observation. 64B Registered Pharmacy Technician to Pharmacist Ratio Published 12/18/14 Effective 1/7/15 Resets Ratios from 1:1 Sterile Compounding 3:1 Retail 4:1 Does not dispense medicinal drugs 6:1 Variances? Exemptions? Very Specific Written Policy and Procedure Manual Techs must sign they have reviewed P&P manual P&P must be maintained on site where the tech performs their duties Traveling techs 72 hours to produce to Inspector 64B Delegable and Non- Delegable Tasks Published 12/9/14 Effective 2/27/15 Definition of Delegable Tasks Delegable tasks are those tasks that are performed pursuant to a pharmacist s direction, without the exercise of the pharmacy technician s own judgment and discretion, and which do not require the pharmacy technician to exercise the independent professional judgment that is the foundation of the practice of the profession of pharmacy. Data Entry, Labeling, counting, weighing, measuring, pouring, initiation communication for clarifications, accept refill authorizations, 6

7 64B Delegable and Non- Delegable Tasks Non-Delegable Tasks New Verbal Orders or Changes Assess Prescriptions for Therapeutic Appropriateness Final Verification Prospective Drug Review Override Clinical Alerts Transfer Prescriptions Prepare copy of Prescriptions Patient counseling Exercise Pharmacist Professional Judgment House Bill 7077 Non resident Sterile Compounding Permit Needed regulatory authority to inspect and license Non Resident Pharmacies shipping into Florida Needed to Define Compounding 64B Standards d of Practice for Compounding Sterile Products 64B Update Sterile Products and Special Parenteral/Enteral Compounding 64B Definition of Compounding 64B (g) In the case of compounded sterile products intended for human use, the pharmacy must be in full compliance with 21 U.S.C. 353b, including being registered as an Outsourcing Facility. 21 U.S.C. 353b (eff. Nov. 27, 2013) is hereby adopted and incorporated by reference. This is to be in compliance with Federal laws regarding definition of compounding and 503A Patient Specific vs 503B Outsourcing Facilities It is important to note the wording of human use Veterinary use? 7

8 Sterile Compounding 64B Effective 10/1/14 The rule amendment incorporates, and sets as the minimum standards to follow when compounding sterile products, chapters 797, 71, 85, 731 of the United States Pharmacopeia, and the rule was substantially reworded. Removed 1160 Pharmaceutical Calculations Removed 1231 Water for Pharmaceutical Use Held statewide Sterile Compounding Meeting and workshops 64B Sterile Products and Special Parenteral/Enteral Compounding This was no longer needed with the creation of the Sterile Compounding Permit This new permit went into effect on March 21 st 2014 On October 1 st 2014 Non-resident Sterile Compounding went into effect No Compounded Sterile product can be made or shipped into the State of Florida without one of these licenses Record Retention For the following rules, the amendments require consistent periods of record retention, from two years to four years. This ensures the records retention schedule is compatible with the biennial inspection period by the Department of Health The Board has been going through and updating all record retention requirements on all applicable rules 8

9 Destruction of Controlled Substances A document must be completed showing the name and quantity of the drug, strength and dosage form, patient s name, prescription number and name of the institution. This documentation, at the time of destruction, shall be witnessed and signed by the consultant pharmacist, director of nursing, and the administrator or his/her designee, which may include a licensed physician, midlevel practitioner, nurse, another pharmacist, or a sworn law enforcement officer. 64B & 64B Miscellaneous Rules 64B Centralized Prescription Filling, Delivering and Returning Cleaned up verbiage and deleted duplicate sections Added d Class II Institutional Pharmacies 64B Automated Filling Systems within a Pharmacy This new rule address the procedures and care required of licensees and permittees who choose to use automated fill equipment within a pharmacy. The rule defines the process of automated fill and sets forth the procedures for using automated fill equipment within a pharmacy. Miscellaneous Rules 64B Special Pharmacy - Limited Community The rule amendment allows a class II institutional pharmacy to obtain a limited community permit to dispense multi-dose medicinal drugs under a doctor's order to patients being discharged from the hospital. This allows for continued use of the multi-dose medicine originally prescribed while the patient was in the hospital. 9

10 Questions 10

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