Quiz 1 Flashcards
1
Q
How much (%) of Rx are compounded?
A
1%
2
Q
How much growth (%) of overall Rx is expected?
A
4-6%
3
Q
Do most insurances cover compounded drugs?
A
no
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
5
Q
Should you compound if a drug is available commercially or withdrawn from the market?
A
No
6
Q
Why do pharmacists compound?
A
Pharmacists are the only group that can
allergies
dosing requirements
route of administration
drug shortages
7
Q
Who do we compound for?
A
pediatrics
animal
hospice
geriatrics
those w/ swallowing issues
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>
9
Q
What is the compounding triad?
A
Prescription
patient
pharmacist
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
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
12
Q
NECC Meningitis Outbreak
A
64 people dead
751 people impacted
contaminated compounding
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
14
Q
Accuracy
A
all together; true number
15
Q
Precision
A
hit the target; repetition
16
Q
Class 3 Torsion Balance is also known as?
A
Class A
17
Q
What side does the weight go on on the torsion balance?
A
the right
18
Q
MWQ
A
minimum weighable quantity
Sensitivity Requirement x 20
19
Q
What kind of spatulas are there?
A
metal and rubber
20
Q
Apothecary graduates
A
measure and mix liquids
21
Q
Ceramic Mortar and pestle
A
things will stain
rougher on the inside
22
Q
glass mortar and pestle
A
smooth
cheap
does not absorb liquids
will scratch with metal spatula
23
Q
What does CVEs stand for?
A
Containment ventilated enclosures
24
Q
What does BSCs stand for?
A
biological safety cabinets
25
CVEs, BSCs, Single-use containment systems are what kind of devices?
Closed System
26
What are single-use containment glove bags used for?
antibiotics, hazardous drugs, and hormones
27
What does HD stand for?
hazardous drug
28
Advantages of Suppository
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
29
Disadvantages of Suppository
hard to compound
unpredictable absorption
inconvenient to administer to patient
invasive/embarrassing to Pt
hard to incorporate drugs >5mg per suppository
30
What kind of effect does a urethral insert have?
Local, no absorption
31
Rectal Route
small surface area
2-3 mL of fluid
little buffering capacity
neutral pH
32
Oleaginous or Fatty Bases
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
33
Cocoa butter has a variation in density based on?
the region of harvest
34
Hydrogenated Vegetable Oil Bases
FattiBase, Witepsol
melts at 45-50 C
no polymorph
melts to release API
35
Water Soluble/Miscible Bases
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
36
Glycerin-gelatin based suppositories are often administered?
vaginally
37
When choosing a suppository base what do we consider?
systemic vs local effect
route
patient comfort
compatibility and stability of API
nature of the base
38
Stiffening agents
add rigidity to suppositories
paraffin, beeswax, cheryl alcohol
39
Preservatives
retard microbial growth
prevent oxidative reactions from microbial enzymes
methyl/propylparabens
40
What lubricants should be used for suppository molds?
mineral oil- water soluble, PEG bases
glycerin- cocoa butter
other non-toxic oils
41
What is the range of PEG molecular weight?
350-1000
42
What does increasing the amount of PEG mean for the melting temperature?
it increases
43
Hand rolling
mix components, roll into log, cut it
only cocoa butter
slow, inaccurate at times
44
Compression molding
mix components, press into mold to get shape
bases increase
not convenient, hard to balance base and API
45
Fusion Molding
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
46
Density factor
calculation of the amount of base compared to 1g of another
47
double casting
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
48
Trituration
reducing particle size with force, normally mortar and pestle
49
Calibration
measure volume in an accurate device
measure in graduate cylinder, pour into bottle, make a line
50
What are the 2 sections of the pharmacopeia?
General Chapters <795>
Monographs
51
What does the USP set?
standards
52
Which USP chapters are enforceable?
1-999
53
Who enforces USP chapters?
FDA, state board, accreditation organizations
54
What are chapters 1000-2000 about?
informational
55
<795>
pharmaceutical compounding- non-sterile preparations
provides compounders with minimum standards to be followed for non sterile preparations for humans/animals
56
<797>
Pharmaceutical Compounding - Sterile Preparation
57
<800>
Handling Hazardous Medications
58
Examples of Compounders
RPh
Tech
Vets
Dentist
Nurses
Physicians
RPT
59
What does CNSP mean?
compounded non sterile preparations
60
What are some examples of CNSPs?
Solid Oral
Liquid Oral
Rectal
Vaginal
Optic
Nasal Sprays/Irrigations
Topicals
61
Examples of what does not apply to <795>
Non sterile Radiopharmaceuticals
Splitting tablets
repackaging
HDs
injectables
ophthalmics
1 dose for 1 Pt admin within 4 hours
62
Simple category of non sterile compounding
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
Moderate Category of Nonsterile compounding
Requires calculations and/or procedures
stability of final preparation is not given
64
Complex Category of Nonsterile compounding
Requires special training, equipment, facilities, or procedures
65
Is adding components not stipulated in the labeling to conventionally manufactured products compounding?
Yes
66
What does COA stand for?
Certificate of Analysis
67
What does QA stand for?
Quality assurance; program
68
What does QC stand for?
Quality control; test
69
Shall has been replaced with must which means?
absolute
70
Should means what in compounding?
expected, but if not it is ok
71
Nonsterile Compounding Components
Building and Facilities
Equipment
Cleaning
QA, QC
Education, hygiene, training, garbing, processes
Document knowledge and competency Q12 mo
Designated persons
72
What are responsibilities of the compounder?
Record Keeping
Beyond Use Dating
Compounding Process - acceptable strength, quality, purity, packaging, labeling
73
Types of <795> Record Documentations
Formulation Record
Compounding Record
SOP
SDS
74
MFR stands for?
master formulation record
75
SOP stands for?
Standard operating procedures
76
SDS stands for?
safety data sheets
77
What is an MFR?
file of compounded formulas
consistent source for preparing the preparation
related to preparation not prescription
78
What does the MFR include?
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
Compounding Record
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
What does the compounding record include?
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
Standard operating procedure
step-by-step instructions compiled by an organization, using their specific facility, equipment, process
82
Material Safety data sheet
all employees must have access
required for all bulk chemicals
not required for pre-manufactured drug products
83
BUD
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
When manufactured products are used can you use the expiration date as the BUD?
No
85
When does the manufacturers expiration date supersede the BUD assignment?
When it is shorter than the BUD
86
When can USP limits be exceeded for BUD?
when there is supporting valid scientific stability information
87
What is the maximum BUD?
180 days
88
BUD for Water containing oral and topical formulations
non-preserved 14 days
preserved 35 days
water activity > 0.6
89
BUD for Non aqueous formulations
oral - 90 days
other - 180 days
water activity < 0.6
90
Compounding Process
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
Active Pharmaceutical Ingredient
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
Added substance
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
ASHRAE
American Society of Heating, Refrigerating, and Air-Conditioning Engineers
94
Biological safety cabinet
ventilated cabinet that may be used for compounding, have 3 classes
Class 2 has Types A1, A2, B1, and B2
95
CETA
controlled environment testing association
96
Certificate of analysis
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
Cleaning
process of removing soil from objects and surfaces, normally accomplished by manually or mechanically using water with detergents or enzymatic products
98
Component
any ingredient used in the compounding of a preparation, including any API, added substance, or conventionally manufactured product
99
Compounded nonsterile preparation
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
compounding personnel
personnel trained to compound/ oversee compounding of preparations
101
Compounding Area
a space that is specifically designated for nonsterile compounding
102
Container Closure system
packaging system components that together contain and protect the dosage form
includes primary and secondary packaging components
103
Containment glove bag
single-use disposable glove bag that is capable of containing airborne chemical particles
104
Containment ventilated enclosure
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
Conventionally manufactured product
pharmaceutical dosage form, usually the subject of an FDA approved application, that is manufactured under current good manufacturing practice conditions
106
Designated person
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
FDA
food and drug administration
108
Hazardous drug
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
Label
a display of written, printed or graphic matter on the immediate container of any article
110
labeling
all labels and other written, printed, or graphic matter that are on any article or any of its containers/ wrappers
111
Purified water
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
Quality Assurance
system of procedures, activities, and oversight that ensures the compounding process consistently meets quality standards
113
Quality Control
sampling, testing, and documentation of results that, taken together, ensure that specifications have been met before release of the CNSP
114
Reconstitution
process of adding a diluent to a conventionally manufactured product to prepare a solution/suspension
115
Release inspection and testing
visual inspection and testing performed to ensure that a preparation meets appropriate quality characteristics
116
Sanitizing agent
agent for reducing, on inanimate surfaces, the number of all forms of microbial life including fungi, viruses, and bacteria
117
Specification
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
Stability
extent to which a product/ preparation retains physical and chemical properties and characteristics within a specified limits throughout its expiration or BUD
119
Water activity
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
When in doubt go with the BUD that is?
the closest/shortest
