Florida Administrative code part IB Flashcards
what are the responsibilities of the prescription department manager?
-Continuous Quality Improvement Programs & Documentation
-policies and procedures
-recordkeeping
-automation
-closing
-inspections
-compliance with the law
what must be done before a community or internet pharmacy can be issued ?
a licensed pharmacist must be designated as a prescription department manager
what do applications for permits for a special parenteral and enteral, special closed system, or nuclear pharmacy require?
supervising licensed pharmacist be designated as the prescription department manager
what do applications for a special sterile compounding permit require
supervising licensed pharmacist or consultant pharmacist be designated as the prescription department manager or the consultant pharmacist of records
what happens id the PDM changes
no later tha 10days or 30 days for internet pharmacy , the BOP must be notified via a form of the change and the identity of the new PDM
can a registered pharmacist serve as a PDM at more than one pharmacy location ?
no unless approved by the board
how may a tech assist a pharmacist
in executing or carrying out the practice of the profession of pharmacy, but shall never themselves engage in the practice of the profession of pharmacy
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.
What must a tech not do?
- Receive new verbal prescriptions or any change in drug, strength, or directions of an existing prescription
-Interpret a prescription or medication order for therapeutic acceptability and appropriateness
-Engage in prospective drug review
-Provide patient counseling
-Monitor prescription usage
-Override clinical alerts without first notifying the pharmacist
-Conduct a final check of dosage and directions
-Transfer prescriptions
-Engage in patient counseling
-Prepare a copy of a prescription or read a prescription to any person to provide reference concerning treatment of the person or animal for whom the prescription was written
-In nuclear pharmacies, techs may receive diagnostic orders, but not therapy or blood product procedure orders
-Engage in any other act that requires the exercise of a pharmacist’s professional judgment.
what are delegable task for techs
-data entry
-labeling of prescription
retrieval of pt and rx files and profiles and records
-clarify select components w prescriber
-authorization for rx renewal
-
what can a tech both clarify and confirm on a prescription?
quantity
Pharmacists or registered interns acting under direct supervision of a pharmacist must:
Supervise and be responsible for the controlled substance inventory
Receive verbal prescriptions from a practitioner Interpret and identify prescription contents
Engage in consultation with a practitioner regarding interpretation of the prescription and date in patient profile
Engage in professional communication with practitioners, nurses or other health professionals
Advise or consult with a patient, both as to the prescription and the patient profile record
termination of enrollment in an intern program, or withdrawal of registration or attendance in an accredited school or college of pharmacy
Within thirty (30) days report such change in enrollment, registration or attendance to the Board office.
Tech registration
- must be at least 17
-Board approved training program (min 160 hr) - renewall: 20 hrs of CE required biennially
what is the ratio for any pharmacy engaged in sterile compounding
3:1
what is the ratio for pharmacy not engaged in sterile compounding
6:1
what is the ratio for a non dispensing pharmacy
8;1
pharmacist/ tech immunizing ratio
5:1
how must practicing pharmacist, interns, and register pharmacy techs maintain proof of current licensure
- readily available
- retrievable upon requires by DOH or member of the pub
- at secondary sit:\e: proof of wallet license
what may the pharmacy display
-license or registration of each pharmacy employee or
- a notice easily accessible to the public, available upon request
how must a pharmacist, intern and registered tech be clearly identifiable
- clearly visible ID badge
- or monogrammed smock showing their name
How must a pharmacist not advertise drugs nd prices ?
- must not be false, misleading, or deceptive
-may not advertise controlled substances
-may only solicit, accept, or dispense from pharmacy location w permit - not shady deal, no kickbacks
what drugs cab not be ordered by pharmacist
- no injectables
- no oral drugs for preganat or nursing mothers
- dosages exceeding manufactures recommendation
-should not be more than 34 day supply
maintain records for 4 years
Formulary of drugs Pharmacist may order
-oral analgesics (mild-mod pain): minor 6 day supply
- urinary analgesics
- otic analgesics
-antinausea preparations - antihistamines and decongestions
- topical antifungal/ antibacterial
- topical anti-inflammatory
-otic antifungal/antibacterial - keratolytics
- vitamins with fluoride
- ophthalmics
-h2 agonist - acne products
- topical antiviral
rule for schedule II and non control rx
- no prescription may be filled or refilled in execcess of 1 year
- ## no prescription for a controlled substance listed in schedule II may be refilled
rule for schedule III,IV, V rx
- may be filled or refilled more than 5 times within a 6 mine period after date on prescription
what is CQI program
ne that contains standards and procedures that can be used to identify and evaluate quality related events and improve patient care
what are quality related events
inappropriate dispensing or administration of a prescribed medication
- Quarterly review of quality related events (at least every 3 months)
A CQI program must also have:
-procedures for reviewing quality related events
- process to record, measure, assed, and improve quality of pt care
-document
- maintain summaries for 4 years
what is the negative drug formulary
List of drugs determined by the Board of Pharmacy and the Board of Medicine to demonstrate clinically significant biological or therapeutic inequivalence and should not be generically substituted as they can pose adverse clinical effects and threaten the health and safety of patients
what are the drugs that may not be substituted
1) Digitoxin
(2) ConjugatedEstrogen
(3) Dicumarol
(4) Chlorpromazine(SolidOralDosageForms)
(5) Theophylline(ControlledRelease)
(6) Pancrelipase(OralDosageForms)
what should pharmacist do when a substitution was made
-must notify patients when they perform generic substitutions
-Prior to delivery of prescription, pharmacist must inform patient of generic substitution, price difference, and of patient’s right to refuse the substitution
when us drug samples allowed in pharmacy
-Community pharmacies (non health care entities) may NOT store or be in possession of drug samples
– May possess sample drugs listed in pharmacist formulary
Can community pharmacies that are pharmacies of health care entities possess sample medicinal drugs?
- they may
- upon written request of the prescribing practitioner
what does health care entity mean?
a closed pharmacy or any person, organization, or business entity that provides diagnostic, medical, surgical, or dental treatment or care, or chronic or rehabilitative care
what should be done for every new or refill prescription?
-pharmacist shall ensure that an offer to counsel is made verbally and a printed offer
- OBRA Law
- delivery: offer written and shall provide toll free telephone
- counseling not required for inpatients
- not required if patient refuses
What is a valid Prescription?
based on a practitioner-patient relationship and when it has been issued for a legitimate medical purpose.
What is a invalid Prescription?
if the pharmacist knows or has reason to know that the prescription was not issued for a legitimate medical purpose.
what us validating a prescription?
the process implemented by the pharmacist to determine that the prescription was issued for a legitimate medical purpose.
what are general standards for validating a prescription?
- different process no singular process
- a concern with the validity of a prescription does not mean the prescription shall not be filled.
-the pharmacist shall attempt to determine the validity of the prescription and shall attempt to resolve any concerns about the validity of the prescription by exercising his or her independent professional judgment.
-concerns with the validity of the prescription cannot be resolved, the pharmacist shall refuse to fill or dispense the prescription.
what are the minimum standards before refusing to fill a prescription
the pharmacist shall attempt to resolve those concerns and shall attempt to validate the prescription
duty to report
If a pharmacist has reason to believe that a prescriber is involved in the diversion of controlled substances, the pharmacist shall report such prescriber to the Department of Health.
can schedule II through V be electronically prescribed
yes
how many hours of CE on the validation of rx for controlled substances must be completed
2 hours
mandetory
what is the record summary for controlled substance prescriptions
A hard copy printout summary of such record, covering the previous 60 day period, shall be made available within 72 hours following a request for it by any law enforcement personnel entitled to request such summary.
