2016 Board of Pharmacy Regulatory Update Goar Alvarez, Pharm.D.,C.Ph. Assistant Dean Nova Southeastern University College of Pharmacy Past President – Florida Pharmacy Association Member, Florida Board of Pharmacy
Disclosures I have no conflicts of interest to disclose concerning todays’ presentation
Learning Objectives • Discuss regulatory activities and the rule making process • Summarize recent regulatory changes of significance to Florida pharmacists and technicians • Discuss proposed language changes to BOP rules being considered • Discuss select disciplinary case studies
Background • the Board of Pharmacy exists to protect the health and safety of the public…. not the licenses of pharmacists or pharmacies • The Board of Pharmacy is given regulatory authority by the State Legislature
Why we create Rules? • “Protect Health and Safety of the Public”
How Rules are created • State legislature passes a statute (law) mandating rulemaking • BOP rules must be created within 180 days of Statute passing • Board indentifies rules that need to be updated or created to protect public health • Public comment during rules committee
How we create Rules? • The rules committee meets with each board meeting and more often if needed • Rules are opened by the rules committee and are considered “open for rule development” • These get published and are listed on the BOP agenda
How we create Rules? • The Rules Committee 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 published with the Florida Register for 21 days for public comment before becoming effective • Found on Florida Administrative code website www.flrules.org
HB 323 Pharmacist to Tech Ratio • Effective July 1, 2014 • Maintained 1:1 ratio • Allowed expansion depending on practice • Removed Rx requirement for shingles vaccine • Allows the date for a controlled substance to be in numeric month/day/year format, abbreviated month written out, or have the month written out in whole Referenced 465.004 F.S., 465.014 F.S., 465.189 F.S., 456.42 F.S.
HB 323 Pharmacist to Tech Ratio • Legislature required the Board to write or update rules surrounding the tech ratio component of HB323 • 64B16-27.4001 Delegation to and Supervision of Pharmacy Technicians; Responsibility of Supervising Pharmacist • 64B16-27.410 Registered Pharmacy Technician to Pharmacist Ratio • 64B16-27.420 Registered Pharmacy Technician Responsibilities
64B16-27.4001 Delegation to and Supervision of Pharmacy Technicians; Responsibility of Supervising Pharmacist • 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 64B16-27.420, F.A.C., to the following types of pharmacy technicians • Defines Registered Pharmacy Technician and Pharmacy Technician in Training
64B16-27.4001 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
64B16-27.4001 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. • “On the premises” – remains a requirement
64B16-27.410 Registered Pharmacy Technician to Pharmacist Ratio • Effective 1/7/15 • Sterile Compounding 3:1 • Community 4:1 • Does not dispense medicinal drugs 6:1 • 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
64B16-27.420 Delegable and Non- Delegable Tasks • Effective 2/27/15 • Delegable Tasks • tasks performed pursuant to a pharmacist’s direction • without the exercise of the pharmacy technician’s own judgment and discretion • pharmacy technician may not exercise the independent professional judgment that is the foundation of the practice of the profession of pharmacy. • Data Entry, Labeling, counting, weighing, measuring, pouring, initiating communication for and accepting refill authorizations
64B16-27.420 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
HB7077 Non resident Sterile Compounding Permit • Needed regulatory authority to inspect and license Non Resident Pharmacies shipping into Florida • Needed to re-define Compounding • 64B16-27.700 • Standards of Practice for Compounding Sterile Products • 64B16-27.797 • Update Sterile Products and Special Parenteral/Enteral Compounding • 64B16-28.820
Definition of Compounding 64B16-27.700 • (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 • 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 clarified
Sterile Compounding 64B16-27.797 • 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. • Held statewide Sterile Compounding meetings and workshops
64B16-28.820 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 in or shipped into the State of Florida without one of these new 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
Miscellaneous Rules • 64B16-28.810 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.
HB279 Vaccine Administration by Pharmacists • Expand Chapter 465.189, F.S. to allow: • a registered intern under supervision of a pharmacist to administer vaccines to an adult after completion of a 20 hour of Board-approved coursework • administration of all immunizations or vaccines recommended by the U.S. Centers for Disease Control and for international travel (adult) – Feb 2015 • administration of vaccines during a State of Emergency • supervising pharmacist must be a certified immunizing pharmacist • A 1:1 pharmacist to intern ratio be observed for this activity
HB279 Vaccine Administration by Pharmacists (cont.) • 64B16-26.1032 – • Language clarified to waive pharmacy interns immunization registration fee
64B16-27.831 Standards of Practice for the Filling of Controlled Substance Prescriptions • 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.
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