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P5 > LAW > Flashcards

LAW Flashcards

1
Q

A non-opiate prescription must be filled within ___________ of date of issue.

A

6 months

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1
Q

An opiate prescription must be filled within ____________ of date of issue.

A

14 days

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2
Q

The cutoff for refilling a dangerous drug (or C-V) prescription is __________.

A

One year

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3
Q

The cutoff for refilling a prescription for a C-III/C-IV is _________.

A

6 months

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4
Q

Maximum days supply for a “do not fill until” prescription?

A

90 days

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5
Q

Used to report destruction of controlled substance (natural causes)

A

DEA Form 41

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6
Q

Used to report lost/stolen controlled substances

A

DEA Form 106

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7
Q

Used to order C-I/C-II agents

A

DEA Form 222

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8
Q

Used to order medications if opening a new pharmacy or attempting to get a personal DEA#

A

DEA Form 224

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9
Q

The use of or exposure to will cause serious adverse health consequences or death

A

FDA Class I Recall

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10
Q

The use of or exposure to may cause temporary or medically reversible adverse health consequences; or the probability of serious health consequences is remote

A

FDA Class II Recall

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11
Q

The use of or exposure to is not likely to cause adverse health consequences

A

FDA Class III Recall

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12
Q

A drug that is filthy, putrid, or decomposed (expired) is considered:

A

Adulterated

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13
Q

A drug that is falsely labeled or is labeled in a misleading way:

A

Misbranded

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14
Q

The Ohio Law that constitutes Duty to Report:

A

OAC 4729:1-4-02

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15
Q

Duty to Report applies when:

A

An error is a result of reckless behavior/unprofessional conduct AND results in patient harm/death

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16
Q

T/F: Prescribing must be done in the usual course of professional practice & only within the scope of their employment

A

TRUE

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17
Q

In the old track/trace system of conducting recalls, entire lots had to be pulled from shelves. With serialization, recalls can be conducted on a ___________________.

A

Package level

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18
Q

Partial fills for C-II’s can take place if:

A
  1. Pt is terminally ill or in an ECF
  2. Fill is requested by pt/prescriber, total # doesn’t exceed total RX #, and total # remaining gets filled within 30 days of written date.
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19
Q

Things that must be documented on the back of a partial fill RX:

A
  1. Date dispensed
  2. # dispensed
  3. Remaining # authorized to be dispensed
  4. Prescription # (if different from original)
  5. Manual initials or other form of positive identification of dispensing pharmacy
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20
Q

Refill authorizations may be orally transferred by prescriber/agent to:

A
  1. Pharmacist
  2. Recording device
  3. Intern being supervised by RPh
  4. Certified technicians FOR NON-CONTROLS
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21
Q

Outpatient/Retail label must contain:

A
  1. Name/Address of pharmacy
  2. Full name of pt & prescriber
  3. Directions
  4. Date of dispense
  5. Cautions required by state/fed law
  6. Serial #
  7. Drug name & strength (or generic name & distributor)
  8. Quantity
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22
Q

Institutional drug order must contain:

A
  1. Patient name
  2. Name, strength, dosage form
  3. Directions (including route)
  4. Date prescribed
  5. Prescriber’s Positive ID
23
Q

Sterile compounding

A

USP 797

24
Q

Non-sterile compounding

A

USP 795

25
Q

Federal chapter that defines “outsourcing pharmacy compounding” enabling these entities to compound bulk, non-patient specific compounds

A

FDA 503b (cGMP)

26
Q

Must notify BoPh within ___________ for:
- Change of name
- Change of address
- Change of employer
- D/C of a terminal distributor’s license

A

30 days

27
Q

Must notify BoPh within _________ for:
- Change of RP

A

10 days

28
Q

Must notify BoPh _________ for:
- Suspected theft or loss of a dangerous drug

A

Immediately

29
Q

T/F: Every pharmacy must have a Responsible Person, who must be a pharmacist

A

TRUE

30
Q

Requirements of RP:

A
  • Supervision of dangerous drugs/records/security
  • Adequate safeguards are assured to prevent sale/distribution of dangerous drugs by anyone but a pharmacist
  • Must be physically present a sufficient amount of time to provide supervision
  • Take inventory of controlled substances when changing RPs
31
Q

Return to stock requirements:

A

-Pharmacy expiration label (1 year, unless manufacturer outdate sooner)
-Drug remains in container that it was meant to be dispensed in

32
Q

Pseudoephedrine Maximums

A

-3.6 g per day
-9 g per 30 days

33
Q

Things that tech trainees cannot do:

A

-Accept new verbal prescription orders/verbal refill authorizations from a prescriber
-Stock automated dispensing units, floor stock, and crash carts
-Request refill authorizations
-Send/receive transfers
-Contact prescriber for clarification of prescription

34
Q

Things that Registered techs cannot do:

A

-Perform sterile compounding
-Accept new verbal prescription orders/verbal refill authorizations from a prescriber
-Send/receive transfers
-Contact prescriber for clarification of prescription

35
Q

Vaccine Admin

A

-Flu/COVID WITHOUT prescription if 7 years of age or older
-All CDC recommended vaccines WITH a prescription if age 7-13
-All CDC recommended vaccines WITHOUT a prescription if 13 years or older

Excludes Rabies vaccine

36
Q

Other approved RPh Injections

A

LAI meds allowed if under protocol and HAS a prescription:
-Long acting opioid antagonist for addiction
-Long acting antipsychotic injections
-Hydroxyprogesterone caproate
-Medroxyprogesterone acetate
-Cobalamin (B12)

37
Q

For immunizations, the ratio of interns to pharmacists is _______.

A

6 to 1

38
Q

Ohio Schedule II Opioids

A

-Fentanyl
-Hydrocodone
-Hydromorphone
-Meperidine
-Methadone
-Morphine
-Oxycodone
-Oxymorphone
-Tapentadol

39
Q

Ohio Schedule III Opioids

A

-Buprenorphine
-Codeine
-Dihydrocodeine/ ASA/CaffeineO

40
Q

Ohio Schedule IV Opioids

A

-Butorphanol
-Tramadol

41
Q

Act that prohibits interstate sale of adulterated/misbranded food and drugs

A

Pure Food and Drugs Act of 1906

42
Q

Act that created child proof caps

A

Poison Prevention Packaging Act of 1970

43
Q

Amendment that defined Legend vs. OTC medications

A

Durham-Humphrey Amendment of 1951

44
Q

Act that created the 5 different controlled substance classes

A

Controlled Substance Act of 1970

45
Q

For NON-CONTROLLED substances, the RPh may change the following without verification with the prescriber:

A
  1. Dosage form
  2. Drug strength
  3. Drug QTY
  4. Directions

As long as:
-Drug is generically equivalent
-Rx is for a human
-DAW is not written

46
Q

Things that cannot be changed on a prescription:

A
  1. Patient name
  2. Drug name
  3. Prescriber name
47
Q

Pharmacist CE Requirements:

A
  1. 30 hours every 2 years
  2. Due on odd years
  3. 2 hours in law
  4. 2 hours in med safety
48
Q

Technician CE Requirements:

A
  1. Registered = 10 hours every year (2,2)
  2. Certified = 20 hours q2years (1,1)
  3. Due on even years
49
Q

T/F: Gabapentin qualifies as a drug that does not need to be reported to OARRS

A

FALSE

50
Q

NDC Code

A

12345-6789-0

12345 = Labeler code
6789 = formulation, dosage form, physical form
0 = size and type of package

51
Q

DEA # Code

A

AP5836727

-“A” signifies practitioner (could also be B, F, G, or M for mid-level)
-“P” signifies practitioner last name
-Sum of digits (1+3+5) + ((2+4+6)x2)
-Last digit of total sum = last number of DEA number

52
Q

Emergency C-II Fill

A

-If deemed an emergency situation
-Prescriber must provide RPh with a written prescription for the emergency med within 7 days
-Abides by partial fill rules

53
Q

Things that a pharmacist can do under a consult agreement with a physcian:

A
  1. Manage a patient’s drug therapy for specified diagnoses or diseases
  2. Order and evaluate:
    -Blood
    -Urine
    -Other labs/diagnostics related to drug therapy being managed
54
Q

Pharmacist can enter consult agreement with:

A

-Physicians
-PAs
-Clinical Nurse Specialists
-Clinical Nurse Midwives
-Certified Nurse Practitioners

P5 (2 decks)

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