Florida Administrative code part IB

Question 1

what are the responsibilities of the prescription department manager?

Answer 1

-Continuous Quality Improvement Programs & Documentation
-policies and procedures
-recordkeeping
-automation
-closing
-inspections
-compliance with the law

Question 2

what must be done before a community or internet pharmacy can be issued ?

Answer 2

a licensed pharmacist must be designated as a prescription department manager

Question 3

what do applications for permits for a special parenteral and enteral, special closed system, or nuclear pharmacy require?

Answer 3

supervising licensed pharmacist be designated as the prescription department manager

Question 4

what do applications for a special sterile compounding permit require

Answer 4

supervising licensed pharmacist or consultant pharmacist be designated as the prescription department manager or the consultant pharmacist of records

Question 5

what happens id the PDM changes

Answer 5

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

Question 6

can a registered pharmacist serve as a PDM at more than one pharmacy location ?

Answer 6

no unless approved by the board

Question 7

how may a tech assist a pharmacist

Answer 7

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.

Question 8

What must a tech not do?

Answer 8

• 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.

Question 9

what are delegable task for techs

Answer 9

-data entry
-labeling of prescription
retrieval of pt and rx files and profiles and records
-clarify select components w prescriber
-authorization for rx renewal
-

Question 10

what can a tech both clarify and confirm on a prescription?

Answer 10

quantity

Question 11

Pharmacists or registered interns acting under direct supervision of a pharmacist must:

Answer 11

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

Question 12

termination of enrollment in an intern program, or withdrawal of registration or attendance in an accredited school or college of pharmacy

Answer 12

Within thirty (30) days report such change in enrollment, registration or attendance to the Board office.

Question 13

Tech registration

Answer 13

• must be at least 17
  -Board approved training program (min 160 hr)
• renewall: 20 hrs of CE required biennially

Question 14

what is the ratio for any pharmacy engaged in sterile compounding

Answer 14

3:1

Question 15

what is the ratio for pharmacy not engaged in sterile compounding

Answer 15

6:1

Question 16

what is the ratio for a non dispensing pharmacy

Answer 16

8;1

Question 17

pharmacist/ tech immunizing ratio

Answer 17

5:1

Question 18

how must practicing pharmacist, interns, and register pharmacy techs maintain proof of current licensure

Answer 18

• readily available
• retrievable upon requires by DOH or member of the pub
• at secondary sit:\e: proof of wallet license

Question 19

what may the pharmacy display

Answer 19

-license or registration of each pharmacy employee or
- a notice easily accessible to the public, available upon request

Question 20

how must a pharmacist, intern and registered tech be clearly identifiable

Answer 20

• clearly visible ID badge
• or monogrammed smock showing their name

Question 21

How must a pharmacist not advertise drugs nd prices ?

Answer 21

• 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

Question 22

what drugs cab not be ordered by pharmacist

Answer 22

• 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

Question 23

Formulary of drugs Pharmacist may order

Answer 23

-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

Question 24

rule for schedule II and non control rx

Answer 24

• 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

Question 25

rule for schedule III,IV, V rx

Answer 25

- may be filled or refilled more than 5 times within a 6 mine period after date on prescription

Question 25

what is CQI program

Answer 25

ne that contains standards and procedures that can be used to identify and evaluate quality related events and improve patient care

Question 26

what are quality related events

Answer 26

inappropriate dispensing or administration of a prescribed medication - Quarterly review of quality related events (at least every 3 months)

Question 27

A CQI program must also have:

Answer 27

-procedures for reviewing quality related events - process to record, measure, assed, and improve quality of pt care -document - maintain summaries for 4 years

Question 28

what is the negative drug formulary

Answer 28

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

Question 29

what are the drugs that may not be substituted

Answer 29

1) Digitoxin (2) ConjugatedEstrogen (3) Dicumarol (4) Chlorpromazine(SolidOralDosageForms) (5) Theophylline(ControlledRelease) (6) Pancrelipase(OralDosageForms)

Question 30

what should pharmacist do when a substitution was made

Answer 30

-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

Question 31

when us drug samples allowed in pharmacy

Answer 31

-Community pharmacies (non health care entities) may NOT store or be in possession of drug samples – May possess sample drugs listed in pharmacist formulary

Question 32

Can community pharmacies that are pharmacies of health care entities possess sample medicinal drugs?

Answer 32

- they may - upon written request of the prescribing practitioner

Question 33

what does health care entity mean?

Answer 33

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

Question 34

what should be done for every new or refill prescription?

Answer 34

-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

Question 35

What is a valid Prescription?

Answer 35

based on a practitioner-patient relationship and when it has been issued for a legitimate medical purpose.

Question 36

What is a invalid Prescription?

Answer 36

if the pharmacist knows or has reason to know that the prescription was not issued for a legitimate medical purpose.

Question 37

what us validating a prescription?

Answer 37

the process implemented by the pharmacist to determine that the prescription was issued for a legitimate medical purpose.

Question 38

what are general standards for validating a prescription?

Answer 38

- 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.

Question 39

what are the minimum standards before refusing to fill a prescription

Answer 39

the pharmacist shall attempt to resolve those concerns and shall attempt to validate the prescription

Question 40

duty to report

Answer 40

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.

Question 41

can schedule II through V be electronically prescribed

Answer 41

yes

Question 42

how many hours of CE on the validation of rx for controlled substances must be completed

Answer 42

2 hours mandetory

Question 43

what is the record summary for controlled substance prescriptions

Answer 43

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.