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Compounding > Quiz 1 > Flashcards

Quiz 1 Flashcards

1
Q

How much (%) of Rx are compounded?

A

1%

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2
Q

How much growth (%) of overall Rx is expected?

A

4-6%

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3
Q

Do most insurances cover compounded drugs?

A

no

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4
Q

Compounding

A

preparation, mixing, assembling, packaging and labeling of a drug or device in accordance with a licensed practitioner’s prescription to create a medication tailored to the needs of a patient when a commercially available drug does not meet those needs

preparation of drugs for an Rx/ in anticipation of an Rx based on prescribing patterns

manipulation of commercial products

sterile and non-sterile

could also include diluting, pooling

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5
Q

Should you compound if a drug is available commercially or withdrawn from the market?

A

No

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6
Q

Why do pharmacists compound?

A

Pharmacists are the only group that can
allergies
dosing requirements
route of administration
drug shortages

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7
Q

Who do we compound for?

A

pediatrics
animal
hospice
geriatrics
those w/ swallowing issues

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8
Q

Traditional Compounding

A

preparation of a medication to be dispensed directly to the patient, pursuant to a valid prescription for that patient created by a pharmacist

503A of FD&C act
not intended to be resold
Rx/anticipation of Rx
no new drug application
Triad Relationship
Not for Re-sale
Preparations
BUD
Pharmacy License
Pharmacist oversees
State Boards of Pharmacy
USP Standards <795,797>

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9
Q

What is the compounding triad?

A

Prescription
patient
pharmacist

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10
Q

Manufacturing

A

mass production of drug products that have been approved by the food and drug administration
sold to pharmacies for resale

no Rx
un-limited quantities
not patient specific
For re-sale
NDA
products
exp dates
no pharmacy license
no pharmacist
FDA
cGMP

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11
Q

Drug Quality and Security Act (DQSA) 2013

A

amended the FD&C Act

added section 503B to create and govern outsourcing facilities

grants the FDA more authority to regulate/monitor the manufactured compounded drugs

503B pharmacies are held to higher regulatory standards including cGMP and subject to FDA inspection

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12
Q

NECC Meningitis Outbreak

A

64 people dead
751 people impacted
contaminated compounding

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13
Q

Outsourcing

A

503B of FD&C
No Rx
limited quantities/ office stock
not patient specific
not for resale
for use in facility/office
no NDA
preparations
BUD
Pharmacy License Optional
Pharmacist Oversees
State and FDA
USP standards <795,797>, cGMP

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14
Q

Accuracy

A

all together; true number

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15
Q

Precision

A

hit the target; repetition

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16
Q

Class 3 Torsion Balance is also known as?

A

Class A

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17
Q

What side does the weight go on on the torsion balance?

A

the right

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18
Q

MWQ

A

minimum weighable quantity
Sensitivity Requirement x 20

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19
Q

What kind of spatulas are there?

A

metal and rubber

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20
Q

Apothecary graduates

A

measure and mix liquids

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21
Q

Ceramic Mortar and pestle

A

things will stain
rougher on the inside

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22
Q

glass mortar and pestle

A

smooth
cheap
does not absorb liquids
will scratch with metal spatula

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23
Q

What does CVEs stand for?

A

Containment ventilated enclosures

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24
Q

What does BSCs stand for?

A

biological safety cabinets

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25
Q

CVEs, BSCs, Single-use containment systems are what kind of devices?

A

Closed System

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26
Q

What are single-use containment glove bags used for?

A

antibiotics, hazardous drugs, and hormones

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27
Q

What does HD stand for?

A

hazardous drug

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28
Q

Advantages of Suppository

A

patients that:
can’t swallow/absorb drug
are seizing or vomiting
have no oral route, an obstruction in GI tract, and GI absorption issues

good for drugs that get destroyed by GI tract

avoids 1st pass metabolism

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29
Q

Disadvantages of Suppository

A

hard to compound
unpredictable absorption
inconvenient to administer to patient
invasive/embarrassing to Pt
hard to incorporate drugs >5mg per suppository

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30
Q

What kind of effect does a urethral insert have?

A

Local, no absorption

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31
Q

Rectal Route

A

small surface area
2-3 mL of fluid
little buffering capacity
neutral pH

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32
Q

Oleaginous or Fatty Bases

A

Cocoa butter (theobroma oil)
- melts at 30-36 C
- polymorphs if over-heated
- melt to opulent creamy, not clear and golden
- melts to release API in 5 +/- 2 mins
- water soluble API preferred
CRT or Refrigerator Temp
Comfortable
Messy on melt if no sphincter
hand warm to insert

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33
Q

Cocoa butter has a variation in density based on?

A

the region of harvest

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34
Q

Hydrogenated Vegetable Oil Bases

A

FattiBase, Witepsol
melts at 45-50 C
no polymorph
melts to release API

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35
Q

Water Soluble/Miscible Bases

A

Polybase, PEG< melting temp increased with MW (>1000 solid at Room temp)
Glycerin-gelatin based
dissolves
absorbs water, disintegrates, drug is released
preservatives due to water
CRT storage, tight seal to not absorb atmospheric water
cause burn/sting as water absorbed
may cause defecation
moisten with water to insert

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36
Q

Glycerin-gelatin based suppositories are often administered?

A

vaginally

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37
Q

When choosing a suppository base what do we consider?

A

systemic vs local effect
route
patient comfort
compatibility and stability of API
nature of the base

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38
Q

Stiffening agents

A

add rigidity to suppositories
paraffin, beeswax, cheryl alcohol

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39
Q

Preservatives

A

retard microbial growth
prevent oxidative reactions from microbial enzymes
methyl/propylparabens

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40
Q

What lubricants should be used for suppository molds?

A

mineral oil- water soluble, PEG bases
glycerin- cocoa butter
other non-toxic oils

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41
Q

What is the range of PEG molecular weight?

A

350-1000

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42
Q

What does increasing the amount of PEG mean for the melting temperature?

A

it increases

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43
Q

Hand rolling

A

mix components, roll into log, cut it
only cocoa butter
slow, inaccurate at times

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44
Q

Compression molding

A

mix components, press into mold to get shape
bases increase
not convenient, hard to balance base and API

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45
Q

Fusion Molding

A

no heat sensitive drugs
most common
calculate for extra doses, calibrate molds with melted base, density factor/double cast method, lubricate molds, melt base + incorporate drug, pour, cool, remove, quality test, package

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46
Q

Density factor

A

calculation of the amount of base compared to 1g of another

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47
Q

double casting

A

melt and pour twice
done when density factor is unknown
in portion of melted base, incorporate all ingredients, pour melted mix into molds, fill remainder of mold volume with plain melted base, shave off excess then removed cooled suppositories, remotely, repour in molds

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48
Q

Trituration

A

reducing particle size with force, normally mortar and pestle

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49
Q

Calibration

A

measure volume in an accurate device
measure in graduate cylinder, pour into bottle, make a line

50
Q

What are the 2 sections of the pharmacopeia?

A

General Chapters <795>
Monographs

51
Q

What does the USP set?

A

standards

52
Q

Which USP chapters are enforceable?

A

1-999

53
Q

Who enforces USP chapters?

A

FDA, state board, accreditation organizations

54
Q

What are chapters 1000-2000 about?

A

informational

55
Q

<795>

A

pharmaceutical compounding- non-sterile preparations
provides compounders with minimum standards to be followed for non sterile preparations for humans/animals

56
Q

<797>

A

Pharmaceutical Compounding - Sterile Preparation

57
Q

<800>

A

Handling Hazardous Medications

58
Q

Examples of Compounders

A

RPh
Tech
Vets
Dentist
Nurses
Physicians
RPT

59
Q

What does CNSP mean?

A

compounded non sterile preparations

60
Q

What are some examples of CNSPs?

A

Solid Oral
Liquid Oral
Rectal
Vaginal
Optic
Nasal Sprays/Irrigations
Topicals

61
Q

Examples of what does not apply to <795>

A

Non sterile Radiopharmaceuticals
Splitting tablets
repackaging
HDs
injectables
ophthalmics
1 dose for 1 Pt admin within 4 hours

62
Q

Simple category of non sterile compounding

A

From a USP monograph
peer reviewed journal
reconstitution/manipulation a commercial product by adding 1/+ ingredients as stated by the manufacturer (not in revisions)

63
Q

Moderate Category of Nonsterile compounding

A

Requires calculations and/or procedures
stability of final preparation is not given

64
Q

Complex Category of Nonsterile compounding

A

Requires special training, equipment, facilities, or procedures

65
Q

Is adding components not stipulated in the labeling to conventionally manufactured products compounding?

A

Yes

66
Q

What does COA stand for?

A

Certificate of Analysis

67
Q

What does QA stand for?

A

Quality assurance; program

68
Q

What does QC stand for?

A

Quality control; test

69
Q

Shall has been replaced with must which means?

A

absolute

70
Q

Should means what in compounding?

A

expected, but if not it is ok

71
Q

Nonsterile Compounding Components

A

Building and Facilities
Equipment
Cleaning
QA, QC
Education, hygiene, training, garbing, processes
Document knowledge and competency Q12 mo
Designated persons

72
Q

What are responsibilities of the compounder?

A

Record Keeping
Beyond Use Dating
Compounding Process - acceptable strength, quality, purity, packaging, labeling

73
Q

Types of <795> Record Documentations

A

Formulation Record
Compounding Record
SOP
SDS

74
Q

MFR stands for?

A

master formulation record

75
Q

SOP stands for?

A

Standard operating procedures

76
Q

SDS stands for?

A

safety data sheets

77
Q

What is an MFR?

A

file of compounded formulas
consistent source for preparing the preparation
related to preparation not prescription

78
Q

What does the MFR include?

A

Name
strength
dosage form
ingredients and quantity
equipment needed
mixing instructions
assigned beyond use date
container for dispensing
storage requirements
any quality control procedures, physical description
reference sources

79
Q

Compounding Record

A

documents the ingredients and personnel responsible for compounding activity per RX
includes MFR reference if used
EVENT related
Compounded Rx needs to be on label

80
Q

What does the compounding record include?

A

Name
Strength
formulation record reference for preparation
sources and lot numbers of ingredients
total number of dosage units
name of person who prepared the preparation and the name of the compounder who approved the preparation
date of preparation
assigned internal ID number
BUD
Quality Control Procedures

81
Q

Standard operating procedure

A

step-by-step instructions compiled by an organization, using their specific facility, equipment, process

82
Q

Material Safety data sheet

A

all employees must have access
required for all bulk chemicals
not required for pre-manufactured drug products

83
Q

BUD

A

beyond use date
date after which a compounded nonsterile preparation is not to be used, stored, or transported
Day 1 is the day of compounding
different from manufacturers expiration dates
assigned conservatively
must be in tight, light-resistant containers

84
Q

When manufactured products are used can you use the expiration date as the BUD?

A

No

85
Q

When does the manufacturers expiration date supersede the BUD assignment?

A

When it is shorter than the BUD

86
Q

When can USP limits be exceeded for BUD?

A

when there is supporting valid scientific stability information

87
Q

What is the maximum BUD?

A

180 days

88
Q

BUD for Water containing oral and topical formulations

A

non-preserved 14 days
preserved 35 days
water activity > 0.6

89
Q

BUD for Non aqueous formulations

A

oral - 90 days
other - 180 days
water activity < 0.6

90
Q

Compounding Process

A
  1. Judge suitability of prescription
  2. Perform calculations
  3. Identify necessary equipment
  4. Don appropriate attire and wash hands, globe
  5. Clean the compounding area and equipment
  6. Assemble necessary materials
  7. Compound preparation following formulation record/prescription, according to art and science of pharmacy
  8. Assess weight variation, adequacy of mixing, clarity, pH, etc. Quality Control
  9. Annotate compounding log, describe appearance of Rx, assign BUD, Document
  10. Label Rx
  11. Sign and Date the Rx- ensuring all procedures carried out to ensure uniformity, identity, strength, quantity, purity
  12. Clean all equipment and store appropriately
91
Q

Active Pharmaceutical Ingredient

A

substance intended to be used in compounding of a preparation, furnishing pharmacological activity/other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans/animals or affecting structure and function of the body

92
Q

Added substance

A

ingredient needed to compound a preparation but is not intended or expected to cause a pharmacologic response if administered alone in the amount/concentration contained in a single dose of the compounding preparation

aka inactive ingredient, excipient, pharmaceutical ingredient

93
Q

ASHRAE

A

American Society of Heating, Refrigerating, and Air-Conditioning Engineers

94
Q

Biological safety cabinet

A

ventilated cabinet that may be used for compounding, have 3 classes

Class 2 has Types A1, A2, B1, and B2

95
Q

CETA

A

controlled environment testing association

96
Q

Certificate of analysis

A

report from the supplier of a component, container, or closure that accompanies the supplier’s material and contains the specifications and results of all analyses and a description of the material

97
Q

Cleaning

A

process of removing soil from objects and surfaces, normally accomplished by manually or mechanically using water with detergents or enzymatic products

98
Q

Component

A

any ingredient used in the compounding of a preparation, including any API, added substance, or conventionally manufactured product

99
Q

Compounded nonsterile preparation

A

nonsterile preparation created by combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer’s labeling,or otherwise altering a drug/bulk drug substance

100
Q

compounding personnel

A

personnel trained to compound/ oversee compounding of preparations

101
Q

Compounding Area

A

a space that is specifically designated for nonsterile compounding

102
Q

Container Closure system

A

packaging system components that together contain and protect the dosage form

includes primary and secondary packaging components

103
Q

Containment glove bag

A

single-use disposable glove bag that is capable of containing airborne chemical particles

104
Q

Containment ventilated enclosure

A

full/partial enclosure that uses ventilation principles to capture, contain, and remove airborne contaminants through high-efficiency particulate air filtration and to prevent their release into the work environment

105
Q

Conventionally manufactured product

A

pharmaceutical dosage form, usually the subject of an FDA approved application, that is manufactured under current good manufacturing practice conditions

106
Q

Designated person

A

one/more individuals assigned to be responsible and accountable for the performance and operation of the facility and personnel for the preparation of CNSPs

107
Q

FDA

A

food and drug administration

108
Q

Hazardous drug

A

any drug identified by at least one of the criteria:
carcinogenicity
teratogenicity
developmental toxicity
reproductive toxicity in humans
organ toxicity at low dose in humans or animals
genotoxicity
new drugs that mimic existing HDs in structure/toxicity

109
Q

Label

A

a display of written, printed or graphic matter on the immediate container of any article

110
Q

labeling

A

all labels and other written, printed, or graphic matter that are on any article or any of its containers/ wrappers

111
Q

Purified water

A

minimal quality of source water for the production of purified water is drinking water whose attributes are prescribed by the US Environmental Protection Agency, the European Union, Japan, or the World Health organization

may be purified using unit operations that include demonization, distillation, ion exchange, reverse osmosis, filtration/other suitable purification procedures

112
Q

Quality Assurance

A

system of procedures, activities, and oversight that ensures the compounding process consistently meets quality standards

113
Q

Quality Control

A

sampling, testing, and documentation of results that, taken together, ensure that specifications have been met before release of the CNSP

114
Q

Reconstitution

A

process of adding a diluent to a conventionally manufactured product to prepare a solution/suspension

115
Q

Release inspection and testing

A

visual inspection and testing performed to ensure that a preparation meets appropriate quality characteristics

116
Q

Sanitizing agent

A

agent for reducing, on inanimate surfaces, the number of all forms of microbial life including fungi, viruses, and bacteria

117
Q

Specification

A

tests, analytical methods, and acceptance criteria to which any components, cnsp, container closure system, equipment,or other material used in the compounding of CNSPs must conform to be considered acceptable for its intended use

118
Q

Stability

A

extent to which a product/ preparation retains physical and chemical properties and characteristics within a specified limits throughout its expiration or BUD

119
Q

Water activity

A

measure of the fraction of total water that is unbound and freely available to participate in chemical, biochemical, or physiochemical reactions or provide an environment that can support microbial growth

120
Q

When in doubt go with the BUD that is?

A

the closest/shortest

Compounding (6 decks)

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