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Federal Law Flashcards

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1
Q

What are the required elements of a controlled prescription?

A
  1. Patient name
  2. Patient address
  3. Prescriber name
  4. Prescriber address
  5. Prescriber DEA
  6. Prescriber signature (NOT manual)
  7. Drug name
  8. Drug strength
  9. Drug DF
  10. Directions for use
  11. Date of issue
  12. Quantity
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2
Q

What are the required elements of a prescription label?

A
  1. Rx #
  2. Date filled
  3. Name/address of pharmacy filling
  4. Name of prescriber
  5. Any directions/cautionary statements on prescription & name of patient if on Rx
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3
Q

What are the requirements of childproof packaging according?

A

<80% of kids can open on first attempt within 5 minutes
<85% of kids can open in less than 5 minutes after being shown how
>90% of adults can open

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4
Q

How many times can prescription be transferred?

A

CII - never
CIII-V - once (unless pharmacy has live shared database)
non-control - forever

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5
Q

How does partial filling for a CII work?

A

Prescriptions can be partial filled one time as long as the remainder is filled within 30 days that it was originally written AND the patient/provider requests the partial fill.
If pharmacy has to partial fill because it was OOS, then they have 72 hours to fill the remainder or forfeit the rest of the prescription
Partial fills can be done for patients in hospice. Prescription is good for 60 days from date of original written

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6
Q

What are the requirements for an emergency prescription?

A
  1. Medication must be required immediately for appropriate patient care
  2. No substitutions available
  3. No way for provider to provide written copy of prescription
    Provider has 1 week to provider paper copy accounting for the emergency supply with words “For emergency dispensing” written on it
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7
Q

What elements can be changed on a controlled prescriptioin (per federal)?

A

CIII-V - can change everything but patient name, provider name, and drug name
CII is based on state laws (same in IN)

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8
Q

When is it appropriate to fax controlled prescriptions?

A
  1. For any CIII-CV medication
  2. For injectable C2 narcotic medications intended for immediate administration
  3. For narcotic C2’s dispensed for hospice patient
  4. For all C2 prescriptions from LTCF
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9
Q

What providers can prescribe in every state?

A
  1. Physicians
  2. Veterinarians
  3. Podiatrists
  4. Dentists
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10
Q

What do DEA #’s start with?

A

A,B,F,G - big 4 providers
X - for DATA 2000 prescribers
M - midlevel practitioners

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11
Q

Pattern for DEA # validity?

A

1 + 3+5 +2(2+4+6)=7

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12
Q

Who is responsible for ensuring a medication is being used appropriately?

A

The pharmacist and the provider share responsibility

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13
Q

How many patients can DATA 2000 prescribers have?

A

Year 1 - 30
year 2 - 100
Year 3+ - 275

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14
Q

What can DATA 2000 prescribers prescribe?

A

buprenorphine/naloxone

buprenorphine

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15
Q

What are schedule 5 medications?

A

Pregabalin
Codeine with cough syrup
Locosamide

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16
Q

What are schedule II medications?

A 
narcotics
stimulants
cocaine
methamphetamine
nabilone
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17
Q

How are devices classified?

A

Type I - least possibility of causing harm

Type III - life-saving device

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18
Q

How are recalls classified?

A

Class I - death

Class III - unlikely to cause harm?

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19
Q

T/F: Recalls for medications are mandatory

A

False

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20
Q

T/F: Recalls for devices are mandatory

A

True

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21
Q

Which pharmacy inspections canNOT be refused?

A

Board of pharmacy (in IN)

FDA (generally just looking at compounding)

22
Q

Which pharmacy inspections can be refused?

A

DEA - can come back with a search warrant

23
Q

What is allowed on the labeling/advertising of natural supplements?

A

Claims about the effect on the body (ie Vitamin c is an antioxidant)
NOT claims about treating specific disease states

24
Q

Do natural supplements have to prove that they are safe and effective?

A

No - no need to show efficacy

25
Q

What is an orphan drug?

A

Drug for condition affecting <200,000 people in US

26
Q

Which comes before clinical trials - new drug app or investigational drug app?

A

INvestigational drug is before

New Drug app is after

27
Q

What drug application is used for generic equivalence?

A

Abbreviated new drug application

28
Q

T/F: Pharmaceutic equivalents have to come in the same dosage form

A

True - must have same strength, dosage form

Do NOT have to have the same clinical/safety data (that’s therapeutic equivalence)

29
Q

Not following REMS or Poison Prevention Packaging Act is example of what crime?

A

Misbranding

30
Q

what has to be on OTC product labeling but not Rx labeling?

A

the directions for use and warnings

31
Q

Do pharmacies have to follow cGMP for compounding?

A

No

32
Q

What is the Durham Humphrey Amendment?

A

Describes who is allowed to prescribe and allows refills

33
Q

What is the PPPA?

A

Poison prevention packaging act

34
Q

what are exceptions to the PPPA?

A 
Any non-oral dosage forms
Steroid taper packets
OC monthly packaging
Erythromycin granules/suspension
mebendazole (600mg)
Potassium (50mEq)
Cholestyramine powder
Colestipol powder (5g)
35
Q

Who can waive PPPA?

A

Provider - one time only
patient - blanket waiver
NOT PHARMACIST

36
Q

Patient package insert

A

Dispensed at every fill in every location (inpatient/outpatient)
Required for estrogen/contraceptives

37
Q

MedGuide

A

Required for every fill in outpatient setting only

38
Q

What is the Prescription Drug Marketing Act?

A
  1. Prevents the sale of samples in pharmacies
  2. Prevents the sale of drugs from hospitals to other businesses because hospitals get preferential pricing
  3. Prevents importing cheap drugs
  4. Rewards whistleblowers financially
  5. Requires that records be kept for 3 years
  6. Requires wholesalers to have a license
39
Q

What is the federal anti-tampering act?

A

Requires tamper-evident packaging on OTC products and makes it a crime to tamper with or conspire to tamper with products

40
Q

What is the dietary supplement health and education act?

A

Treats the supplements as food - no need to prove efficacy, but statements limited to effect on structure/function

41
Q

Where does each copy of DEA 222 go?

A

Copy 1 - stays with purchaser
Copy 2 - stays with distributer
Copy 3 - mailed to DEA by distributer

42
Q

How long do you have to keep DEA 222?

A

3 years

43
Q

How often do you have to inventory controlled substances?

A

every 2 years

44
Q

When do you have to count the exact number in C2 inventory and when can you estimate?

A

exact number if bottle contains >=1000
Otherwise can estimate
C2 always requires exact #

45
Q

What is the maximum day supply a prescriber can write for C2s at one time?

A

90 days - can have 3 different prescriptions that have “dispense after date”

46
Q

Can central fill fill controls?

A

Yes

47
Q

A presrcriber can dispense how many days for addiction treatment if not an authorized treatment program?

A

3 days - 1 day at a time

48
Q

what are the two roles that pharmacies can be distrbuters of controlled substances?

A

Give to reverse distributors for destruction

Give to physicians for office administration (must be <5% of total controls dispensed annually)

49
Q

What form for disposal of controls?

A

DEA 41

50
Q

What form for lost controls?

A

DEA 106

Law (2 decks)

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