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MPJE > MPJE > Flashcards

MPJE Flashcards

1
Q

When a pharmacist does not comply with the PPPA, what else is he violating?

A

PPPA (which the CPSC enforces) and it is also a misbranding violation of the FDCA that the FDA enforces

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2
Q

Specific prescription and non-prescription drug exemptions of PPPA act

A

a. oral contraceptives, conjugated estorgens, NE acetate in manufacturer’s dispenser package.

b. Medroxyprogesterone acetate tablets

c. SL NG and SL & chewable isosorbide dinitrate of 10 mg or less

d. ASA and ACETAMINOPHEN in effervesc tabs or granules

e. K supplements in unit-dose packaging

f. Na fluoride containing not more than 264 mg of Na fluoride per package

g. Anhydrous cholestyramine and colestipol packets

h. Erythromycin ethylsuccinate granules for oral suspension and oral suspensions in packages containing no more than 8 g of erythromycin

i. Eryth ethylsucc tablets in packages containing no more than 16g

j. prednisone tabs no more than 105 mg per package

k. methylprednisolone no more than 84mg

l. mabendazole tabs no more than 600 mg

m. betamethasone tabs no more than 12.6 mg per package

n. prep in aerosol containers intended for inhalation

o. pancrelipase preps

p. sucrose prep in solution of glycerol and water

q. hormone replacement therapy products that rely solely upon the activity of one or more progestogen or estrogen substances

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3
Q

concentration limits for codeine

A

C5 limit: 200 mg/100 ml
C3 limit: 1.8 g/100 ml and 90 mg/dosage unit. anything above this limit would be schedule 2

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4
Q

A pharmacist that has reason to believe a prescriber is involved in the diversion of controlled substances is required to report the prescriber to who?

A

The Florida Department of Health

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5
Q

Which of the following are considered “Red Flags” that must be resolved before filling a controlled substance prescription? Select All That Apply:
1- Patients travelling long distances to have prescriptions filled at a pharmacy

2- Patients paying cash for controlled substance prescriptions

3- prescriptions issued for a combination of a benzodiazepine, an opioid, and a muscle relaxant

4- Prescriptions for an opioid for more than a 7-day supply

A

Patients travelling long distances to have prescriptions filled at a pharmacy

Patients paying cash for controlled substance prescriptions

Prescriptions issued for a combination of a benzodiazepine, an opioid, and a muscle relaxant

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6
Q

A patient you have never encountered before comes to your pharmacy with a suspicious written prescription for what appears to be a 30-day supply of Vicodin. The name of the drug is misspelled and the prescriber’s signature appears to be forged. What must the pharmacist do?

A

Do not fill the prescription and notify the chief law enforcement agency of the county of this attempt to fill a fraudulent prescription within 24 hours.

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7
Q

Which of the following prescriptions based on a tele-health visit may be a valid prescription?

A prescription for Tylenol #3 issued by a dentist in South Carolina for an outpatient in Miami to treat an acute toothache.

A prescription for Hycodan issued by a physician in St. Petersburg for an outpatient in Tampa.

A prescription for Adderall issued by a physician in Orlando for an outpatient in Daytona Beach.

A prescription for a 30-day supply of Demerol tablets issued by a physician’s assistant in Sarasota for an outpatient in Sarasota.

A

A prescription for Adderall issued by a physician in Orlando for an outpatient in Daytona Beach.

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8
Q

Designated agents are authorized to

A

COMMUNICATE C 3 - C 5 controlled only

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9
Q

can you accept a verbal c3 rx?

A

florida says yes for only 30 day supply if verbal rx

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10
Q

Florida law requires that all written controlled rx have a :

A

RX NUMBER
INITIALS OF PHARMACIST FILLING
DATE FILLED

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11
Q

Can you take a verbal c2 rx order?

A

NO unless its an emergency

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12
Q

The background color of a written counter-proof prescription must be

A

blue or green

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13
Q

When a pharmacist fills a Schedule II prescription from a verbal order of a prescriber in an emergency, the pharmacy must receive a valid written or electronic prescription form the prescriber marked “Authorization for Emergency Dispensing” within

A

7 days

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14
Q

What must a prescriber indicate on a prescription for an opioid drug in Schedule II for acute pain in order for the pharmacist to dispense a 7-day supply?

A

Acute Pain Exception

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15
Q

Total quantity that may be sold to any one purchaser within 48h of C5

A

120 mg codeine (4 oz)
60 mg dihydrocodeine
30 mg ethyl morphine
240 mg of opium (8 oz)

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16
Q

Methadone can be dispensed to a narcotic-dependent person for a period of 30 days by who?

A

By a narcotic treatment facility.

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17
Q

The Florida statewide standing order issued by the state Surgeon General permits pharmacies to dispense naloxone to

A

Emergency responders.

18
Q

Which of the following may be grounds for finding a pharmacist unfit or incompetent to practice pharmacy? Select All That Apply

Misuse of any controlled substance

Habitual intoxication

Abnormal physical or mental condition which threatens the public health

Disability

A

all except disability

19
Q

A suspension of a pharmacy permit may not exceed

A

1 year

20
Q

Which of the following violations could lead to revocation of a pharmacist’s license even for a first-time offense?

Failure to report an attempt to obtain controlled substances from a fraudulent prescription.

Failure to have a Prescription Department Manager in a community pharmacy

Obtaining a license by misrepresentation or fraud

Failure to supervise a registered pharmacy technician

A

Obtaining a license by misrepresentation or fraud

21
Q

Who are the donors eligible under the “Prescription Drug Donation Repository Program”

A

1- Nursing homes facility with closed drug delivery system
2- Hospices that have maintained control of a patient’s rx drugs
3- Hospitals with closed drug delivery systems
4-Pharmacies
5- Drug manuf or wholesale distributors
6- medical device manufacturers or suppliers

cannot be made by patient under this program

22
Q

Who can participate as a repository?

A

1- healthcare practitioner’s office
2- pharmacy
3- hosp with closed drug delivery system
4-nursing home with closed…
5-free clinic or non-profit health clinic that is licensed or permitted to dispense medicinal drugs in florida
6- prescribers who receive rx drugs or supplies directly from drug manuf or wholesaler distrib or pharmacy

a pharmacist must inspect the donated drug

23
Q

ineligible drugs that cant be donated under the program:

A

-controlled substances
-cancer drugs
-rems
-drugs requiring storage other than room temp

24
Q

Outpatient Dispensing using an Automated Pharmacy System written policies and procedures what do they address?

A
  • community pharmacy must maintain written policies and procedures to ensure proper and safe functioning
  • review them ANNUALLY and maintain the records for minimum 4 years

They must address:
1- maintain system and e-verif in gd condition
2- ensure its integrity and ability to identify who’s responsible of making data entry
3- accurate filling, stocking, restocking, verif
4- ensure sanitary operation and prevent cross-contamination
5- test accuracy before first use, upon restarting and after modification of the system or e verif process which alters filling, stocking…
6- training persons authorized to access
7- conduct routine and prevent measures ex: calibration
8- removing expired, adulterated, misbranded, recall
9- prevent unauthoriz from access and modify security
10- identify & record person responsible for filling..
11- ensure compliance with state and federal (label/storage..)
12- maintain ongoing quality assurance program and tracking and documenting errors

25
Q

which otc is not required to be packaged in tamper evident packaging? (otc requirement under provisions of FDCA and federal regulations)

A

most otc are required to be packaged in tamper evident packaging
or else they would be considered ADULTERATED AND MISBRANDED

exceptions:
— dermatological
—- dentifrices
——insulins
——-lozenges

26
Q

A pharmacist that repackages OTC would be subject to which requirements? (otc requirement under provisions of FDCA and federal regulations)

A

cGMP and all additional manuf labeling and tamper evident packaging

27
Q

what are the types of CSOS (controlled substance ordering system) certificates?

A

administrative: digitally sign communication with DEA as well as other participants in the CSOS community.
signing: used for digitally signing controlled subst orders. issued to approved registrant and POA. approved coordinator applicants can have it if he holds POA and requests a signing certificate

28
Q

Ordering C3-5 must be documented by a pharmacy with an invoice provided by the wholesaler or manuf. what must the invoice contain?

A

1-Name of C
2- Dosage form & strength
3- # units per container
4- Qtty received (container)
5- date of receipt
6- name & address & dea# of registrant from where the C was received

29
Q

whats in a transaction info under the DSCSA?

A

name of rx drug, strength, dosage form, NDC, date of transaction, container size and number of containers, name & address of both parties, NSI

30
Q

What is transaction statement?

A

its under DSCSA, a paper or electronic statement by seller that the seller is authorized(licensed), received the product from an authorized (licensed), received transaction info and history from prior owner and did not knowingly ship a suspect or illegitimate product product, has systems and processes to comply with verification requirements and did not knowingly provide false transaction information

31
Q

Which of the following is required on an OTC drug label? Select all that apply.
Adequate information for use

Name and address of the manufacturer, packer, or distributor

Drug Facts panel

Adequate directions for safe and effective use

A

Name and address of the manufacturer, packer, or distributor

Drug Facts panel

Adequate directions for safe and effective use

32
Q

what is in the transaction data?

A

name, strength, dosage form, ndc, container size & how many, date of transaction, addrees & name of both parties, SNI

33
Q

Acetaminophen exemptions from child-resistant container

A

1- efferv tablets or granules containing < 10% acetam. with a median lethal dose >5g/kg of body weight that release at least 85 ml CO2 per grain when placed in water

2- unflav acetm containing powder form other than those intended for peds use, that are packaged in unit doses with no more than 13 grains of actem per unit dose and that contain no other substance subj to special packaging requirements

34
Q

to perform telehealth, out of state should register with:

A

florida department of Health

35
Q

what is under the Transfer of medicinal drugs; change of ownership florida rule?

A

must provide transfer info to board of pharmacy
complete inventory of C subst
transfer C2 using DEA 222

36
Q

Which pharmacy may be indicated on the label of a prescription that has been centrally filled using a code rather than by the pharmacy name and address?-

A

The central fill pharmacy

37
Q

whats in a collab practice 20 hour course?

A
  • performance of patient assessments
  • ordering, performing, interpreting clinical and lab tests related to collab pharmacy practice
  • evaluating and managing diseases and health conditions in collab
  • applicable laws and rules
  • no less than 8 out of the 20 should be live
    awarded 20 hours of general CE
    -course can be provided by ACPE… blabla
    -maintain 250K $ liability
  • FILE an application for PHARMACITS COLLAB PRACTICE CERTIFCATION available on the BOARD’S wesbsite
    -maintain records for 5 years
38
Q

A collab practice agreement must include:

A

name of physician’s patients

each chronic health condition

specific rx drugs to be managed for each patient

circumstances when pharmacist can order/perform/evaluate lab tests

when to notifiy physician and time frame

begin and end date of collab and procedure and transfer

statement that collab can be terminated by each party

(it ends in 2 years if not renewed) –> 8 additional CE hours to renew every 2 years.

keep this agreement with you two
addundem if need to change stuff(copy of addundum in initial agreement)

39
Q

COURSE of test and treat must address:

A

patient assessments; POC testing procedures; safe and effective treatment of minor nonchronic; identify CI ; laws and rules ; writing and entering into written protocol; 8 hours of the 20 should be live; 250k;

no renewal needed ; formulary includes all medicinal drugs approved by FDA; CLEA

40
Q

written protocol of test an treat:

A
  • specific categories of the patients authorized to be tested or screened
  • physician instructions (obrain medical history, treat base don age…)
  • process to notify

pharmacist should submit within 5 days the written protocl to the board online

41
Q
A

MPJE (1 decks)

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