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Final Exam > Essentials of USP > Flashcards

Essentials of USP Flashcards

0
Q

Which drugs does the U.S. Pharmacopeia include?

A 
Prescription
Non-prescription
Dietary supplements
Veterinary drugs
Healthcare products
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1
Q

The name of the non-governmental non-profit organization that’s activities include creation of standards, patient safety, healthcare information, and verification of products?

A

United States Pharmacopeia

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2
Q

Official definition of 797?

A

USP Chapter 797

Official and enforceable focuses on sterile preparations, describing conditions and practices to prevent harm or death in patients that could result from

  1. Microbial contamination (non sterility)
  2. Excessive bacterial endotoxins
  3. Variability in the intended strength of correct ingredients that exceeds stated limits
  4. Unintended chemical and physical contaminants
  5. Ingredients of poor quality in compounded sterile preparations
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3
Q

What is the term for the accepted standard recognized by other health care providers in the same field of medicine under similar circumstances?

A

Standard of care

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4
Q

Does the FDA have the right to inspect pharmacy?

A

Yes they defer to the states to regulate pharmacy but have authority to inspect pharmacy and enforce USP standards

National Association of Boards of Pharmacy Model Rules and Practice Act
Joint Commission
Pharmacy Compounding Accreditation Board

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5
Q

United States 1st Pharmacopeia?

A

797

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6
Q

What year did USP 797 become official and enforceable?

A

2008

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7
Q

What year was the first U.S. Pharmacopeia developed?

A

1820

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8
Q

Who does 797 apply to?

A

The standards apply to all persons who prepare CSPs and all places where CSPs are prepared

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9
Q

Do 797 standards apply to clinical administration of CSPs?

A

No

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10
Q

Definition of a “compounded sterile preparation” in USP Chapter 797?

A

(1) Compounded biologic, diagnostic, drug, nutrient, or Radiopharmaceutical dosage unite that must be sterile when administered to patients, which include, but are not limited to, baths and soaks for live organs and tissues, implants, inhalation so injections, powder for injection, irritations, metered sprays, and ophthalmic preparations
(2) manufactured sterile products that are prepared strictly according to manufacturers’ labeling or prepared differently than published labeling

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11
Q

What is achieving and maintaining sterility and overall freedom from contamination of a CSP dependent on?

A

Personnel performance
Quality status of components incorporated
Process utilized
Environmental conditions

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12
Q

Responsibilities of Compounding Personnel?

A

Active quality control and assurance
Deficiencies in Compounding can be rapidly identified and corrected
Beyond-use date validation
Ingredients are correct identity, quality, and purity
Ensure personnel adequately skilled, educated, trained to perform and document functions
Maintain appropriate cleanliness, accuracy
Ensuring CSP accurately identified, packaged, sealed, dispensed and distributed

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13
Q

Primary engineering controls?

A

Hood, Isolator, LAFW, PEC, CAI, CACI, BSC

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14
Q

Name for “The Magic Box” fallacy

A

Cleaning hood

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15
Q

Rules in hood?

A

No cosmetics or artifices nails
Remove jewelry and piercings
Garb from dirtiest to cleanest (don shoe covers, hair covers, face masks)
Wash hands
Dry hands with non-shedding towel or electric hand dryer
Don disposable gown

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16
Q

How often should training and evaluation be performed for high risk compounding?

A

Semiannual

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17
Q

What are written procedures for double-checking compounding accuracy?

A

Compounding Accuracy Checks-include label accuracy and accuracy of the addition of all products or ingredients; used containers and syringes should be quarantined with final product until double check is performed; double check should be performed by person other than the compounder

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18
Q

The name of the area where compounding activity is performed?

A

Buffer area

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19
Q

Area where personnel hand hygiene and garbing procedures, staging, order entry, CSP labeling, and other particulate generating activities are performed?

A

Ante area

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20
Q

ISO Air Quality?

A

ISO Class 8-ante area
ISO Class 7-buffer area
ISO Class 5-PEC/hood

Limits are articles in 0.5 m and larger per cubic meter

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21
Q

What ISO class is the buffer area?

A

ISO 7

22
Q

What class is the ante area?

A

Class 8

23
Q

What class is PEC/hood?

A

Class 5

24
Q

How often should the walls, ceilings, and shelves be cleaned?

A

Monthly

25
Q

How often should the floors, counters and work surfaces be cleaned?

A

At least daily

26
Q

When should cleaning procedures be performed in an ISO 5 environment?

A
  1. At the beginning of each work shift
  2. At the beginning of each batch
  3. At least every 30 minutes
  4. When surface contamination is known or suspected
27
Q

How often should airborne testing be conducted for hoods, clean rooms, and ante-areas?

A

Minimum of every 6 months

28
Q

What is designed to demonstrate that the primary and secondary engineering controls, disinfecting procedures and work practices are suitable?

A

Environmental testing

29
Q

What procedure is based on chemical stability and assumed sterility?

A

Beyond use dating

30
Q

What is BUD based on two factors?

A

Drugs chemical stability in conjunction with microbiological limits
Use stability dating only if shorter than sterility BUD

31
Q

Category of high risk would be good at room temperature for?

A

24 hours

32
Q

How long can a high risk category be refrigerated?

A

3 days

33
Q

Freezer for high risk category?

A

45 days

34
Q

How long can low, medium and high risk items be in the freezer?

A

45 days

35
Q

What’s the dating for immediate use drugs?

A

Room temp-1 hour
Refrigerator-1 hour
Freezer-N/A

36
Q

What’s the dating for low risk category drugs?

A

Room temp-48 hours
Refrigerated-14 days
Freezer-45 days

37
Q

Dating for low w/ 12 hour BUD?

A

Room temp-12 hours or less
Refrigerator-12 hours or less
Freezer-N/A

38
Q

Dating for medium risk category?

A

Room temp-30 hours
Refrigerator-9 days
Freezer-45 days

39
Q

Dating for high risk category?

A

Room temp-24 hours
Refrigerator-3 days
Freezer-45 days

40
Q

CSP Risk Categories?

A 
Immediate-Use CSPs
Low-Risk Level
Low-Risk Level with 12 hour or less BUD
Medium-Risk Level
High-Risk Level
41
Q

What exemptions apply to immediate Use CSPs when these requirements are met?

A
  1. CSP involves simple transfer of not more than 3 sterile non-hazardous packages and not more than 2 entries into any one container
  2. No delays/interruptions in preparation
  3. Aseptic technique is strictly followed
  4. Administration begins within 1 hour of the start of preparation.
  5. Unless immediate and compete witnessed administration the CSP must be properly labeled.
  6. Destroyed if not administered within 1 hour time limit.
42
Q

How soon must administration begin for immediate-USE CSPs?

A

1 hour

43
Q

Example of a low risk CSP?

A

Reconstitution of cetriaxone 1 gram and transfer to 50 mL NS minibag

44
Q

What involves only transfer, measuring, and mixing using not more than 3 packages and not more than 2 entries to a single container?

A

Low risk CSP-manipulation limited to ampuls, vials, transfer from sterile syringes to administration containers-in absence of sterility testing storage periods cannot exceed 48 hours at room temp, 14 days refrigerate, and 45 days frozen (-25 to 10)

45
Q

Which risk level must be in a segregated compounding area not in a high traffic area?

A

Low-Risk Level with 12-hour BUD

46
Q

Term for admixtures compounded using multiple additives and/or small volumes such as batch preparations?

A

Medium risk CSP

47
Q

Examples of meds risk CSP?

A

TPN, CSPs requiring more than 3 packages

48
Q

Term for no sterile ingredients utilized before terminal sterilization?

A

High risk CSP

49
Q

Example of non sterile bulk drug, mixing in no sterile devices, exposure to non ISO 5 air>1 hour?

A

High risk CSP

50
Q

What’s the BUD for multiple dose vials?

A

28 days after initial entry unless specified otherwise by the manufacturer

51
Q

How long are single dose vials good for in an ISO 5 environment?

A

6 hours

52
Q

Opened or punctured in worse than ISO 6 conditions?

A

Must discard within 1 hour

53
Q

What are hazardous drug requirements?

A

Requires appropriate gloves be worn at all times hazardous agents are handled, not just compounded. Requires all agents be prepared in a BSC or CACI in a ISO 5 environment within a ISO 7 negative pressure room with an ISO 7 ante area

Final Exam (4 decks)

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