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Pharmacy Law and Ethics (2) > Controlled Substances > Flashcards

Controlled Substances Flashcards

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1
Q

Who established a “closed” system for manufacturing, distributing, and dispensing controlled substances?

A

CSA- controlled Substances Act

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2
Q

Criteria used for determining schedule/class of a drug product: (8)

A
  • Actual/relative potential for abuse
  • Scientific evidence of it pharmacological effect
  • State of current scientific knowledge
  • History and current pattern of abuse
  • Scope, duration, and significance of abuse
  • Risk to the public health
  • Physiological or psychic dependence liability
  • Whether the substance is an immediate precursor of a substance already controlled
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3
Q

How many control classes/schedules are provided by the CSA?

A

5

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4
Q

Class/Schedule I (3)

A
  • High potential for abuse
  • No currently accepted medical use in treatment in the US
  • Lack of accepted information on safety of their use, even under medical supervision
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5
Q

Class/Schedule II (4)

A
  • High potential for abuse
  • accepted medical use in treatment in the US
  • currently accepted medical use with severe restrictions
  • Abuse may lead to severe physical or psychological dependence
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6
Q

Class/Schedule III (4)

A
  • Potential for abuse but LESS than that of drugs listed in Schedules I or II
  • Current ACCEPTED MEDICAL use in treatment in the US
  • Abuse may lead to moderate or low physical dependence o
  • HIGH psychological dependence
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7
Q

Class/Schedule IV (3)

A
  • Potential for abuse but less than Schedule III
  • Current ACCEPTED MEDICAL USE in treatment in the US
  • Abuse may lead to LIMITED physical or psychological dependence
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8
Q

Class/Schedule V (3)

A
  • Potential for abuse but less than Schedule IV
  • Current ACCEPTED MEDICAL USE in US
  • Abuse may lead to LIMITED physical or psychological dependence
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9
Q

How can Manufacturers, distributors, and dispensers legally posses and dispense controlled substances in the scope of your profession?

A

must register with the DEA

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10
Q

T/F? Practitioners and mid-level practitioners CAN prescribe controlled substances WITHOUT registering with the DEA.

A

-false - CAN NOT - - they must register with DEA

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11
Q

How many DEA forms are there?

A

4

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12
Q

What type of DEA form is needed for dispensing controlled substances?

A

DEA Form 224

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13
Q

What type of DEA form is needed for Manufacturer, Distributor, Importer, Exporter or Researcher?

A

DEA Form 225

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14
Q

What type of DEA for is needed Narcotic Treatment Programs? (i.e. Methadone clinic)

A

DEA Form 363

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15
Q

When must the DEA have notice of change? (3)

A
  • Modification: name or address change
  • Transfer: registrant dies, legal existence ceases, professional practice discontinues, or business is sold -Termination:registrant dies, legal existence ceases, or professional practice discontinues
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16
Q

DEA number is a?

A

9-character code consisting of 2 letters and 7 digits

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17
Q

Physician DEA number:

A

First character for physicians is “A”, “B” or “F”

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18
Q

Mid-level practitioners DEA number:

A

First character for mid-level practitioners is “M”

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19
Q

Distributors DEA number:

A

First character for distributors is “P” or “R”

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20
Q

T/F? The second character of the DEA # is usually, ALWAYS, the first letter of the registrant’s last name.

A

false -NOT always

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21
Q

How to verify DEA numbers? (3)

A
  • Step 1: Add 1st, 3rd, and 5th digits
  • Step 2: Add 2nd, 4th, and 6th digits and multiply times 2
  • Step 3: Add Step 1 and Step 2…the right most digit of this step MATCHES the 9th character
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22
Q

Which digit of Step 3 must match the 9th charter of the registrants DEA number?

A

right most digit

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23
Q

Exemptions to DEA Registration? (3)

A
  • Agent or employee of any registered manufacturer, distributor, or dispenser if acting in the usual course of business or employment
  • Common or contract carrier or employee of, whose possession of the controlled substance is in the usual course of business or employment
  • Ultimate user (PATIENT) who possesses the controlled substances for a lawful purpose
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24
Q

T/F? Pharmacists employed by a registered pharmacy or institution DO NOT have to register individually?

A

-false - DO have to

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25
Q

What form must be used in order to purchase controls?

A

DEA 222

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26
Q

“Paper” DEA Form 222 is a _________ form.

A

triplicate

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27
Q

What must be signed and dated by the authorized registrant or Power of Attorney?

A

“Paper” DEA Form 222

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28
Q

Which triplicate copy of the “paper” DEA 222 Form must be submitted to the “supplier”

A

Attorney Copy 1 (Brown) and 2 (Green)

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29
Q

The Supplier keeps ______ and forwards ______ to the DEA?

A

-copy 1 -copy 2

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30
Q

T/F? Any modifications made on the DEA 222 form makes in VALID if corrected?

A

-false - ANY modifications/write overs make the form VOID

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31
Q

Which copy of the “paper” DEA 222 Form is kept by the “purchaser”?

A

-Copy 3 (Blue)

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32
Q

The number of containers received and the date(s) received are recorded on which copy?

A

Copy 3 (Blue)

33
Q

T/F? Transfer of Schedule I or II drugs from one registrant to another requires the use of DEA Form 222

A

-true - i.e.- sale of controls between two pharmacies

34
Q

Exceptions to filling Orders using DEA 222? (5)

A
  • Pharmacist discontinuing a pharmacy
  • Registrant’s registration is expiring and they are not re-registering
  • Registrant is returning product to the supplier
  • Registrant authorized to conduct chemical analysis or research and is distributing the product to another authorized analyst or researcher
  • Registered compounder of narcotic substances for use at an off-site narcotic treatment program
35
Q

When can a DEA Form 222 NOT be filled? (3)

A
  • Incomplete, illegible, or not properly prepared, executed or endorsed
  • Altered (erasure or changed in any manner)
  • An order form that is incorrect may NOT be corrected → A new order form must replace it
36
Q

If an order is NOT filled for any reason, the supplier must do what?

A

return Copies 1 and 2 to the purchaser with explanation

37
Q

Who may legally engage in these activities concerning the Contolled Substance Act?

A

Only those registered with the Drug Enforcement Agency (DEA)

38
Q

Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 AKA

A

AKA “Controlled Substance Act” (CSA)

39
Q

What was created in 1973 replacing several different federal agencies?

A

Drug Enforcement Agency (DEA)

40
Q

Who is charged with administering all parts of the CSA (control substance act)?

A

DEA

41
Q

Who must coordinate activities with the FDA since controlled substances are drugs and subject to the FDCA?

A

DEA

42
Q

Who does the DEA work closely with?

A

state boards of pharmacy

43
Q

What if controlled substance violations are found during a routine pharmacy investigation?

A

the state board informs the DEA

44
Q

Two types of controlled substances are?

A

Narcotic and Non-narcotic

45
Q

T/F? NON-NARCOTIC drugs are natural or synthetic OPIUM OR OPIATE AND ANY DERIVATIVE

A

-false -NARCOTIC

46
Q

Who may administer, dispense, and prescribe controlled substances under the registration of the hospital or institution?

A

Individuals acting in the normal course of business or employment

47
Q

The criteria the hospital/institution must meet for individuals administering, dispensing, and prescribing controlled substances under the registration of the hospital or institution? (4)

A
  • verification of the practitioner is permitted to dispense, administer, or prescribe within the jurisdiction
  • authorization for the practitioner to dispense, administer, or prescribe under the hospital registration
  • designates a specific internal code for each practitioner
  • current list of internal codes and corresponding practitioners made available at all times to other registrants and law enforcement agencies for verification of prescribing authority
48
Q

When must a certificate of registration be returned to the DEA with any unexecuted order forms, inventory disposed of in accordance with DEA requirements?

A

When TERMINATION occurs

49
Q

T/F? The second character of the DEA # is ALWAYS, the first letter of the registrant’s last name.

A

-false -usually, BUT NOT ALWAYS

50
Q

What is required for each sale or transfer of a Schedule I or II controlled substance?

A

A DEA Form 222 or its electronic equivalent

51
Q

What does the Supplier do as it pertains to the DEA 222 Form? (3)

A
  • completes the order
  • records the number of containers furnished and the date shipped
  • keeps Copy 1 and forwards Copy 2 to the DEA
52
Q

What does the Purchaser do as it pertains to the DEA 222 Form? (2)

A

-records on Copy 3 the number of containers received -records the date(s) received

53
Q

T/F? Fulfillment of DEA 222 orders is allowed by registered manufacturers ONLY.

A

-false -manufacturers or distributors only

54
Q

T/F? IF an order CANNOT be completely filled by the supplier, it MAY NOT be partially filled.

A

-false; it MAY be partially filled and the balance supplied by additional shipment within 60 days of the order form

55
Q

T/F? The balance of a CII partial DEA 222 order must be shipped within 30 days?

A

-false -60 days

56
Q

Exceptions to the rule that Fulfillment of DEA 222 orders is allowed by registered manufacturers or distributors ONLY: (5)

A
  • Pharmacist discontinuing a pharmacy
  • Registrant’s registration is expiring and they are not re-registering
  • Registrant is returning product to the supplier
  • Registrant authorized to conduct chemical analysis or research and is distributing the product to another authorized analyst or researcher
  • Registered compounder of narcotic substances for use at an off-site narcotic treatment program
57
Q

What does the purchaser do once they receive DEA Copies 1 and 2 back from a supplier that could not fill request? (2)

A

-Copies 1 and 2, along with the explanatory statement must be attached to Copy 3 and retained in the purchaser’s files -“VOID” is written on the incorrect/returned form when filed

58
Q

What must happen when an item is CANCELED by the supplier on the DEA 222 Form? (2)

A
  • the cancellation must be noted on Copies 1 and 2 by drawing a line through the item
  • “Canceled” is written in the space provided for the number of items shipped
59
Q

What must be reported immediately to the DEA?

A

Loss of any used or unused order forms by any purchaser or supplier

60
Q

T/F? If an order goes unfilled because the DEA 222 form is lost, the purchaser must complete another form

A

true

61
Q

T/F? Purchaser must prepare a statement with DATE of the lost form that indicates the good covered by the first order form were not received because the order form was lost.

A

-false -SERIAL NUMBER and DATE

62
Q

When a DEA 222 Form is lost what happens with Copy 3 of the “second” order.

A

It along with the “lost” statement must be kept with Copy 3 of the “first” order form

63
Q

What happens if the “first” order form (of a lost order form) is subsequently received?

A

the supplier must write “Not accepted” on the face of the form and return Copies 1 and 2 to the purchaser who must attach it to Copy 3

64
Q

T/F? Suppliers retain Copy 3

A

false -Copy 1

65
Q

T/F? Purchasers retain Copy 3

A

-true

66
Q

T/F? All DEA 222 forms must be KEPT TOGETHER with all other records of the Registrant?

A

maintained separately from

67
Q

T/F? Records must be kept for a minimum of 2 years?

A

-true

68
Q

Who keeps copy 2 of the DEA 222 Form?

A

the DEA

69
Q

CSOS - Controlled Substance Ordering System (2)

A

-Provides an electronic equivalent to DEA Form 222 -Permits but does NOT requires, registrants to order electronically and maintain electronic records

70
Q

Advantages of using CSOS: (4)

A
  • Greater Ordering Freedom: no maximum number of line items
  • Faster Transactions:electronic “certificate” contains same identification information as DEA Form 22 which allows timely and accurate validation by the supplier
  • Accurate Orders:reduces the number of ordering errors
  • Decreased Cost:greater accuracy + decreased paperwork = lower transaction costs
71
Q

T/F? Registrants who purchase controlled substances for the purpose of repackaging for the sale within the pharmacy or to other registrants, DO NOT HAVE TO register as a manufacturer.

A

false - MUST

72
Q

Pharmacy may compound a controlled substance for “office use” so long as the product: (3)

A
  • is an aqueous, oleaginous, or solid dosage form
  • Final product does not contain >20% controlled substance
  • is only distributed to a practitioner authorized to dispense
73
Q

T/F? An individual practitioner registered with the DEA acting in the normal course of professional practice MAY NOT issue a prescription for a controlled substance for a legitimate medical purpose?

A

-false -MAY

74
Q

Responsibility for proper prescribing and dispensing lies where?

A

upon the prescribing practitioner with corresponding responsibility rests with the pharmacist who fills the prescription

75
Q

What is NOT a prescription?

A

A prescription that is NOT issued in the usual course of professional treatment or part of legitimate and authorized research

76
Q

Knowingly filling an unauthorized RX is violation of what?

A

Controlled Substance Act

77
Q

When must practitioners be separately registered with the DEA?

A

In order to administer or dispense narcotic drugs in any schedule to a narcotic drug-dependent person for “detoxification treatment” or “maintenance treatment”

78
Q

Physicians who are not registered with the DEA may do what? (3)

A
  • administer narcotics for relief of acute withdrawal while arrangements are made for treatment
  • MAY NOT administer more than a one day supply
  • Emergency treatment may not extend for more than three days

Pharmacy Law and Ethics (2) (7 decks)

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