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Epp5 Fall 2020 The Practice of Pharmacy in Florida - Laws Rules - Alvarez Student Version 3 Slides
Epp5 Fall 2020 The Practice of Pharmacy in Florida - Laws Rules - Alvarez Student Version 3 Slides
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NPI# ME29634561
DATE: 08/08/2020
N A M E : JA N E D O E DOB 8/06/1952
A D D R E S S : 1 0 0 0 H A P P Y D R , D AV I E , F L 3 2 5 1 4
RX
AMBI E N 10MG # 90 ( NI NE TY)
SI G : TAKE 1 TABL E T P O TI D
REFILL: 2
JOHN SMITH_________________________________________
SIGNATURE
Despite expiration of their term, board members may continue to serve at “the
pleasure of the Governor” until they are replaced.
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Licensing
• You need a license to practice pharmacy
◦ The type of license depends on what you are going to do
• You need (added) special training / certification to do certain things (ex: immunize)
465.007-465.014
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Discussion of
Community Pharmacy Practice
Scenarios
(prescription transfers)
Discussion
Discussion
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Transferring prescriptions
• Legend drugs
• Controlled substances:
• C2
• C3 – C5
• Other jurisdiction
• Common database
• Must sign written job description / policies & procedures within 90 days of hire
enumerating non-delegable tasks
Tech Supervision
https://www.youtube.com/watch?v=IGQmdoK_ZfY
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Responsibility
• Tech: 0% (?)
• Pharmacist: 100%
Standards of Practice
(pharmacist Scope of practice)
• 465.0155 – Standards of Practice
◦ The Board shall adopt rules relating to the practice of pharmacy
• 64B16-27.1001
◦ Practice of Pharmacy reserved to pharmacist or intern under direct and immediate supervision of
a licensed pharmacist
Standards of Practice
(pharmacist Scope of practice)
Pharmacist Must:
• Supervise & be responsible for controlled substances inventory
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Standards of Practice
(pharmacist Scope of practice)
• Pharmacist Must:
◦ For compounding: interpret & identify all orders, mix or be physically present, physically
examine & certify the finished product (assuming full responsibility), create records in a
manner that pharmacist responsibility can be easily traced
Standards of Practice
(pharmacist Scope of practice)
• Order labs by Pharm.D. or Consultant pharmacist in nursing home or home health agency (64B16-
27.120)
◦ Authorized by medical director (nursing home) or practitioner in home health
◦ May order (prescribe) and dispense medications (64B16-27.210)
◦ No injectables
◦ Not to pregnant / nursing patients
◦ Not to exceed 34 day supply
◦ Pursuant to Rule 64B16-27.220 – Medicinal Drugs Which may be Ordered by Pharmacists
• May enter in Collaborative Practice Agreements (64B16-27.830)
◦ A) Order and interpret labs, B) execute drug therapy
• May enter in Collaborative Practice Agreements (465.1865) effective 7/2020
• Initiate, modify and d/c drug therapy for chronic health conditions
◦ Order and interpret clinical labs and / or perform CLIA waived tests
◦ Must report certain conditions of public health concern to DOH
• Test and treat minor health conditions as defined in 465.1865 or by Board rule (effective 7/2020)
CQI
Continuous Quality Improvement (CQI)
• Identification & evaluation of quality related events (QREs) & improve patient care
• QRE means
◦ Inappropriate dispensing, compounding or administration
◦ Variation from prescribers’ order (ex: wrong drug, wrong patient, wrong strength,
etc.)
◦ Failure to identify and manage pharmacotherapy (ex: interactions, contraindications,
over/under utilization, clinical abuse/misuse, therapeutic duplications, etc.)
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• Assess and improve quality – QRE identification & resolution via “root-cause analysis”
Case
https://www.youtube.com/watch?v=_V_vAxoI6U8
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Pharmacist Responsibilities
• Must be licensed to practice (see licensing criteria)
• Dispense, compound, and administer vaccinations and other medications authorized by law or
rule: (465.003(6)) – interpret and assess Rx for medication related problems & using professional
judgement shall certify and counsel as appropriate
Pharmacist Responsibilities
• Patient Safety: Check each patient’s medication record every time he or she gets a new or refill a
prescription to prevent potential medication related problems
Pharmacist Responsibilities
• Documentation: Document care, interventions, prescriber consultations, patient consultations, etc.
• Perform Administrative Tasks: keep patient files up to date, conduct inventory management, make sure
needed products are stocked
• Staff Management: oversee the work of pharmacy technicians, student interns, and residents; enforce
workplace policies.
◦ Ratios and identification of staff
◦ Supervision (direct = on premises) and not more than YOU can personally supervise
◦ Non-delegable tasks
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Patient Counseling
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Pharmacist Responsibilities
OBRA 90: Including prospective drug utilization (pro-DUR), offer to counsel
◦ Perform Pro-DUR (check patient profile) for therapeutic appropriateness
◦ (a) Over-utilization or under-utilization
◦ (b) Therapeutic duplication
◦ (c) Drug-disease contraindications
◦ (d) Drug-drug interactions
◦ (e) Incorrect drug dosage or duration of drug treatment
◦ (f) Drug-allergy interactions
◦ (g) Clinical abuse/misuse
Discussion
Discussion
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Discussion
Discussion
Display of Licensure
People need to know that you are licensed
◦ Posting of licenses or immediately available
◦ Identification of personnel (badge/monogram)
◦ Tech – identify self (verbally in person, phone and correspondence)
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Institutional Pharmacy
• http://www.floridahealth.gov/licensing-and-regulation/enforcement/inspection-
program/_documents/classii-institutional-rx.pdf
Pharmacy requirements
(64B16-27, 28 and sections of FS465)
• Rx dept is clean and safe, sink with running water, refrigerator, temp logs (if vaccines)
• Expired meds removed
• Certified (signed) daily Rx log
• Maintain copy of current laws/rules, other references
• Techs and interns properly identified and supervised (ID and ratios)
• Tech Policy (non-delegable and # of positions – 90 days of hire)
• Tech training documentation on duties enumerated in JD
• Pharmacist on duty at all times that pharmacy is OPEN
◦ Padlock if pharmacist is not present
• Policy of preventing dispensing of fraudulent Rxs
◦ Reporting to law enforcement within 24 hrs
• CQI policy and meeting summarizations (min qtrly)
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Misc. Requirements
• Offer to counsel
• Duty to warn
• Pedigree
• Central Fill
◦ Contract with Central Fill Pharmacy (if not under common ownership)
◦ Originating and central fill pharmacies identified on label
◦ If controlled substance “central fill” to appear on face of original Rx
◦ Originating pharmacy maintains record of date of receipt and date of delivery
◦ Toll free number provided to patient for consultation purposes
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Prescribing Authority
• Medical/Osteopathic physicians
• Optometrists
◦ Topical eye medications – FL (NOW expanded)
• Podiatrists
• Veterinarians
• Dentists
*Scope of practice
Prescribing Authority
Florida HB 423 – ARNP/PA Controlled Substance Prescribing
• Prescriptions for Schedule II controlled substances are limited to a 7-day supply, except for
psychiatric medications prescribed by a psychiatric nurse.
◦ Up to 30 days
• Psychiatric medications for patients younger than 18 years old may only be prescribed by a
psychiatric nurse.
Prescribing Authority
• Nurse practitioners and physician assistants
◦ Dependent
• Chiropractors
◦ NO PRESCRIBING RIGHTS
• Pharmacists
◦ Independent
◦ Limited formulary in state of Florida
◦ Under CPA
◦ Under Test and Treat protocol (effective 7/2020)
64B16-27.220
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RX
PHENTERMINE 30MG #30 (THIRTY)
SIG: TAKE 1 CAPSULE PO QD
REFILL: 3
JOHN SMITH________________________________________________
S I G N AT U R E
RX
ALBUTEROL INHALER
SIG: ONE INHALATION EVERY 6 HOURS IF NEEDED FOR SOB
REFILL: PRN
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Methods of communicating Rx
information
• From prescriber to dispenser by any means of communication
• Written Rxs
◦ Written by prescriber or agent of prescriber and must bear all requirements of valid Rx (ex: prescriber name,
address, patient name, drug name, etc.)
◦ Must be dated and signed by prescriber
◦ If CS (tamper proof Rx pad)
• Verbal / Oral Rxs
◦ From prescriber or agent of prescriber to pharmacist or intern (under supervision of pharmacist)
◦ Promptly reduced to writing by pharmacist/intern
◦ No CII
◦ Except in emergency (as defined in regs) – max. 72 hr supply
◦ Pharmacist must receive original Rx within 7 days or report to DEA (attach emergency oral Rx to
original Rx)
• No initial weight control Rx
Methods of communicating Rx
information
Faxed Rxs
• From individual (patient) to pharmacist
◦ Pharmacist must possess original Rx prior to dispensing
• From prescribers’ office to pharmacy
◦ Legend and CIII-CV
◦ CII only in following cases:
◦ In emergency – (max 72 hr supply) Pharmacist must notify DEA if does not receive original Rx from prescriber within 7 days
◦ Home infusion / IV pain therapy
◦ Patients in LTC
◦ Hospice
E-Prescriptions
• All medications including CS (CII-CV)
◦ Now required unless practitioner has a waiver from DOH - 2021
Rx Requirements
• Patient name • Directions (SIG)
• Date Rx issued • Amount
• Route
• Prescriber name and address
• Frequency
• Medication prescribed • Route of administration
◦ Name • Clear and concise
◦ Strength
◦ Dosage form • Prescriber signature
◦ Quantity • Stamped signature
• Written signature
• Refills • Electronic signature (e-scripts)
• Non-controlled Rx • (Hard-copy of e-script must be
• C II: not allowed signed)
• C III-V: maximum of 5 refills within 6 months from
date of issue
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Rx Requirements
• Controlled Substance
◦ Patient’s address
◦ Date prescribed (alpha)
◦ Qty (alpha and numeric)
◦ Prescriber’s DEA #
◦ Pharmacist initials
◦ Date dispensed
◦ ALL OF THE ABOVE ON THE “FACE OF THE RX”
◦ If C II – written Rx with some exceptions
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Auxiliary Labels
Prescription Refills
• No refills in excess of 1 year from date Rx written (legend Rx)
• No refills on CII
64B16-27.211
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◦ Meds for chronic conditions & those pharmacist deems necessary (professional
judgement)
◦ Pharmacist creates written order (with elements required in FS499 & FS893) &
signs order
◦ Advises physician of emergency dispensing within reasonable time
NPI# ME29634561
DATE: 08/08/2020
RX
PE RCOCE T 5/325MG #60 ( SIXTY )
SIG: TA KE 1 TA BL E T PO Q 6 HOU RS PRN PA IN
JOHN SMITH________________________________________________
SIGNATURE
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Substitution of Drugs
• Pharmacist shall substitute for less expensive generic drug
◦ Unless “medically necessary” indicated on face of Rx or verbally to pharmacist
◦ Biosimilars considered in same manner as “brand-generic”
◦ Shall notify patient of substitution
◦ Patient may request brand
• Sign posted:
◦ “consult your pharmacist concerning the availability of a less expensive generically equivalent
drug and the requirements of Florida law”
465.025
DAW 7
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Pharmacy Records
1. Vendor invoices 9. Prescriptions
2. Pedigree 10. Policies and Procedures
3. MSDS 11. Compounding records
4. Pharmacy permits 12. Control substance inventory (biennial)
5. CQI summarization records 13. Immunizations
6. Patient profiles 14. HIPAA
7. Patient charts 15. Others depending on license type (i.e.
wholesaler, institutional pharmacies, etc.)
8. Agreements (third party, collaborative
practice, protocols, standing orders)
Recordkeeping
Dispensing Record
• Prescription #
• Date dispensed
• Quantity dispensed
• ID of dispensing pharmacist
◦ If controlled substance (pharmacist initials and date dispensed on face of Rx)
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Compounding
Log Elements
Compounding Record
• Name and quantity of all ingredients • Calculations/quantities of ingredients made
at all steps
• Source of all ingredients
• Total amount made
◦ Manufacturer
• Specific procedure description (formula)
◦ Lot # • Beyond use date
◦ Expiration date ◦ Literature or formulated product data
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