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PHRM 871 > Exam 2 > Flashcards

Exam 2 Flashcards

1
Q

Why was the Controlled Substances Act enacted?

A
  • Created new category of substances and drugs
  • Used registration to control the distribution of controlled entities

Overall: reduce the diversion of controlled substances to illicit markets

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2
Q

Factors to Determine Scheduling or Removal from Schedules

A
  1. Its actual or relative potential for abuse
  2. Scientific evidence of its pharmacologic effect, if known
  3. The state of current knowledge regarding the drug or other substance
  4. Its history and current pattern of abuse
  5. The scope, duration, and significance of abuse
  6. What, if any, risk there is to public health
  7. Its psychic or physiological dependence liability
  8. Whether the substance is an immediate precursor of a substance already controlled under this subchapter
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3
Q

What can the Factors to Determine Scheduling or Removal from Schedules lead to

A
  1. Becomes scheduled when it was previously not
  2. Changes to a different schedule than it was previously in
  3. Is removed from the schedules entirely
  4. Remains in its current position (controlled/uncontrolled)
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4
Q

Schedule I: Medical Use?

A

No

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5
Q

Schedule I: Abuse Potential?

A

High

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6
Q

Schedule I: Physiological Dependency?

A

Not defined

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7
Q

Schedule I: Physical Dependency?

A

Not defined

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8
Q

Schedule II: Medical Use?

A

Yes

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9
Q

Schedule II: Abuse Potential?

A

High

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10
Q

Schedule II: Psychological Dependency?

A

Severe

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11
Q

Schedule II: Physical Dependency?

A

Severe

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12
Q

Schedule III: Medical Use?

A

Yes

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13
Q

Schedule III: Abuse Potential?

A

Lower than I or II

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14
Q

Schedule II: Psychological Dependency?

A

High

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15
Q

Schedule III: Physical Dependency?

A

Moderate to low

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16
Q

Schedule IV: Medical Use?

A

Yes

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17
Q

Schedule IV: Abuse Potential?

A

Lower than III

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18
Q

Schedule IV: Psychological Dependency?

A

Limited

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19
Q

Schedule IV: Physical Dependency?

A

Limited

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20
Q

Schedule V: Medical Use?

A

Yes

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21
Q

Schedule V: Abuse Potential?

A

Lower than IV

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22
Q

Schedule V: Psychological Dependency?

A

Limited

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23
Q

Schedule V: Physical Dependency?

A

Limited

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24
Q

Schedule I examples

A

MDMA
marijuana
heroin
mescaline

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25
Q

Schedule II examples

A 
Adderall
Cocaine
Fentanyl
Methadone
methamphetamine
Pentobarbital
26
Q

Schedule III examples

A

anabolic steroids
buprenorphine
ketamine

27
Q

schedule IV examples

A 
alprazolam
chlordiazepoxide
phenobarbital 
phentermine
tramadol
28
Q

schedule V examples

A

lomotil
pregabalin
vimpat
robitussin

29
Q

who determines the minimum schedule for a substance

A

federal government, but states may place them in a higher schedule

30
Q

manufacturer labeling of controlled substances

A
  • manufacturers must place a symbol indicating what schedule a controlled substance is in as a part of the drug’s labeling.
  • The symbol must be located on the label of the commercial container
  • symbol or notation must be large enough to easily identify the product’s schedule while on a pharmacy or warehouse shelf
31
Q

which agency is tasked with enforcing controlled substance laws and regulations of the US

A

DEA

32
Q

who fills out DEA form 224

A
  • retail pharmacy
  • hospital/clinic practitioner
  • teaching institution
  • mid level practitioner
33
Q

who fills out DEA Form 225

A
  • manufacturer
  • distributor
  • researcher
  • analytical laboratory
  • importer
  • exporter
34
Q

who fills out DEA form 363

A

narcotic treatment programs

35
Q

who fills out DEA form 510

A

domestic chemical

36
Q

registration renewal timing

A

In most cases, registrations must be renewed every years, however, the dispensing or instructing registration type if valid for 3 years

37
Q

manufacturing coincident activities allowed

A

I-V: may distribute that substance or class for which registration was issued; may not distribute any substance or class for which not registered

II-V: May conduct chemical analysis and preclinical research (including quality control analysis) with substances listed in those schedules for which authorization as a mfr. was issued

38
Q

distributing coincident activities allowed

A

may acquire schedules II-V controlled substances from collectors for the purposes of destruction

39
Q

Dispensing or instruction coincident activities allowed

A

May conduct research and instructional activities with those substances for which registration was granted, except that a mid-level practitioner may conduct such research only to the extent expressly authorized under state statute. A pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in Schedule II–V in a proportion not exceeding 20% of the complete solution, compound or mixture. A retail pharmacy may perform central fill pharmacy activities.

40
Q

research coincident activities allowed

A 
A researcher may manufacture or import the basic class of substance or substances for which registration was issued, provided that such manufacture or import is set forth in the protocol required in §1301.18 and to distribute such class to persons registered or authorized to conduct research with such class of substance or
registered or authorized to conduct chemical analysis with controlled substances.

May conduct chemical analysis with controlled substances in those schedules for which registration was issued; manufacture such substances if and to the extent that such manufacture is set forth in a statement filed with the application for registration or reregistration and provided that the manufacture is not for the purposes of dosage form development; import such substances for research purposes; distribute such substances to persons registered or authorized to conduct chemical analysis, instructional activities or research with such substances, and to persons exempted from registration pursuant to §1301.24; and conduct instructional activities with controlled substances.

41
Q

importing coincident activities allowed

A

may distribute that substance or class for which registration was issued; may not distribute any substance or class for which not registered

42
Q

chemical analysis activities allowed

A

May manufacture and import controlled substances for analytical or instructional activities; may distribute such substances to persons registered or authorized to conduct chemical analysis, instructional activities, or research with such substances and to persons exempted from registration pursuant to §1301.24; may export such substances to persons in other countries performing chemical analysis or enforcing laws related to controlled substances or drugs in those countries; and may conduct
instructional activities with controlled substances.

43
Q

First big four practitioner DEA beginning letter

A

A,B,F or G

44
Q

Mid-level practitioner DEA beginning letter

A

M

45
Q

What is the second letter for DEA registration

A

first initial of the prescriber’s last name or the last name they first applied for registration

46
Q

How to verify the DEA number

A
  1. Add the 1 , 3 , and 5 digits together,
    ndth th
  2. Add the 2 , 4 , and 6 digits together and multiply by 2,
  3. Add the result from step 1 and step 2,
  4. Determine if the right-most digit from step 3 matches the DEA number’s final digit (the
    check digit).
47
Q

Do pharmacists need a DEA number?

A

No, because registration requirements are waived for an agent or employee of a person registered to engage in a particular activity

48
Q

Do common or contract carriers require a DEA

A

No since these companies usually don’t know what’s in a package they are carrying

49
Q

Individual practitioners may dispense, administer, or prescribe controlled substances under an institutional DEA number as long as:

A
  1. It is done in the usual course of their professional practice
  2. They are permitted to administer, dispense, or prescribe by the jurisdiction in which they’re practicing
  3. The institution they’re working for has verified they are permitted to dispense, administer, or prescribe drugs within the jurisdiction they’re working
  4. The practitioner is acting only within the scope of their employment in the institution
  5. The institution authorizes the practitioner to administer, dispense, or prescribe under the hospital DEA number and uses a specific internal code to the DEA number for each practitioner authorized
  6. The institution keeps a current list of internal codes and the practitioners they match for verification purposes
50
Q

How to secure controlled substances in schedules II through V

A

dispense such substances throughout the stock of non-controlled substances in such a manner as to obstruct the theft or diversion of the controlled substances

51
Q

Do CIIs have to be locked up based on federal law

A

no

52
Q

How to secure controlled substances during schedule I

A

stored in a securely locked, substantially constructed cabinet

53
Q

How do practitioners store controlled substances

A

locked cabinet

54
Q

what drugs do practitioners store in a safe or steel cabinet equivalent to a US Government Class V security container

A

thiafentanil
carfentanil
etorphine hcl
diprenorphine

55
Q

Employee screening rule

A

Registrant is now allowed to employ anyone who has been convicted of a felony relating to controlled substances or who has had an application for registration with the DEA denied, registration, revoked, or has surrendered their DEA registration for cause

56
Q

How long should records and inventories of controlled substances per federal law

A

kept for at least 2 years from the record or inventory date

57
Q

What records and inventories of controlled substances need to be kept

A

a complete and accurate record of each substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of

58
Q

what must be kept in a registered location and not in a central locations

A

DEA form 222
Inventories
Prescriptions

59
Q

What must schedules III, IV, and V invoices contain

A

Date

Labeled as controlled

60
Q

What is the form to order schedule I or II drugs

A

DEA form 222

61
Q

Who should order and execute DEA form 222

A

the individual who signed the most recent registration paperwork

If unavailable, POA

62
Q

How many years do DEA 222s need to be kept?

A

2 years; however, state laws and insurance contracts may require forms to be kept for longer

PHRM 871 (3 decks)

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