1
Q
What is a parenteral product?
A
a preparation administered to the body other than through the intestinal tract
2
Q
parenteral routes
A
IV, SQ, IM, intradermal (ID), intrathecal (IT), epidural, intra-articular, intra-arterial, intraperitoneal
3
Q
parenteral pros
A
- patient is unable to take drug by mouth
- drug inactive when taken orally
- immediate onset of action
- direct delivery to an organ, lesion, muscle or nerve
- depots of drug into muscle for long-acting drug delivery
- implantable pump advantages
4
Q
parenteral cons
A
- parental products are more costly
- special training, devices & equipment
- once administered, can’t be removed
- contaminated products can cause serious harm or death
- pain & tissue damage upon administration
5
Q
NS is given
A
IV
6
Q
influenza vaccine is given
A
IM
7
Q
insulin is given
A
SQ
8
Q
what goes in the sharps
A
needles, open ampules, broken glass
** NOT empty vials unless broken**
9
Q
any needlestick injuries should be reported to
A
a course instructor immediately
10
Q
efficiency is secondary to
A
accuracy & good technique
11
Q
factors influencing sterility
A
- environmental quality
- proper hand washing
- proper hand hygiene
- use of PPE
- primary & secondary engineering controls
- maintenance of equipment & environment
- ASEPTIC TECHNIQUE
12
Q
transient hand flora
A
15% of all flora
removed with hand washing
13
Q
resident hand flora
A
85% of all flora
NOT removed by hand washing
14
Q
spores
A
- requires physical removal with hand washing
- NOT removed with hand sanitizers or alcohol
15
Q
proper hand washing is key to
A
preventing contamination
16
Q
personal protective equipment (PPE)
A
shoe covers beard covers hair covers jacket/gown gloves- sterile & powder-free
17
Q
Donning PPE
A
- aka “garbing”
- protect preparation from the operator
- protect the operator from the preparation
18
Q
wash hands prior to donning gloves
A
- hands can contaminate gloves when donned
- hands can transport particles onto gloves when donned
19
Q
disinfecting gloves
A
- immediately after being donned
- prior to & after cleaning LAFW
- prior to each preparation
- prior to re-entering ISO class % environment
- if suspected or known contamination
- periodically during prolonged durations of compounding in the PEC
20
Q
critical sites are at greatest risk of contamination
A
tough, moisture, contact with unclean air
21
Q
critical sites
A
- needle: hub, tip & shaft of needle
- syringe: tip of syringe & ribs of plunger
- vials & ampules- rubber closer when penetrated, opening of ampule
- additive bag- injection port
22
Q
steps of aseptic technique
A
- gather supplies
- disinfect vials, ampules, & injection port
- prepare syringe & needle
- enter vial
- withdraw contents
- inject into diluent/solution
- mix & check final admixture
- cover & label admixture
23
Q
when disinfecting vials, ampules & injection ports, allow to remain wet for at least
A
10 seconds
24
Q
mix & check preparation against light & contrasting background for
A
incompatibilities, particulate matter, coring
25
steps for reconstitution
- determine diluent
- determine concentration of reconstituted drug
- remove vial cover
- disinfect additive port of bag
- removed desired diluent volume
- stabilize vial on workbench, insert needle into vial. Do not invert vial
- using milking technique to add contents of syringe
- allow contents to completely dissolve
- inspect solution in vial
- determine the volume of drug to be removed
- re-insert needle into vial avoiding original puncture site
- withdraw volume
26
syringes should be capped when
medications will be administered directly from the syringe
27
positive pressure
- if air added > volume of solution withdrawn
| - results in spraying or dripping of solution from vial
28
negative pressure
- if air removed >volume of solution removed
| - results in difficulty removing volume needed from vial
29
auxiliary label examples
```
storage conditions
administration alerts
high-risk meds
nonstandard concentrations
hazardous agents
```
30
batch compounding
involves the compounding of multiple preparations containing the same ingredients
- requires specific documentation
31
quality of final preparation dependent upon
compatibility & stability parameters
32
stability
retention of properties & characteristics throughout the storage & use periods
33
instability results when
a change or degradation of the active ingredients occurs
34
stability parameters established
secondary to exposure testing by the manufacturer
35
types of stability
```
chemical
physical
toxicological
therapeutic
microbiological
```
36
expiration date
- assigned by the manufacturer
| - determined using extensive analytical testing
37
BUD
- assigned by a pharmacist
| - determined based on available scientific evidence or per manufacturer recommendations
38
MDV BUD
28 days from entering/opening the vial
39
single-dose vials exposed to ISO class 5 or cleaner
6 hours from entering/opening the vial
40
any equipment of vial exposed to air quality worse than ISO class 5
1 hour from enter/open
| must be discarded after 1 hour
41
commercially prepared products (ready use product)
as indicated y the manufacturer label until entered/opened
| BUD should not be extrapolated to extemporaneous preparations
42
vial systems
as indicated by the manufacturers until entered/open
43
RT
20-25*C, 68-77*F
44
fridge
2-8*C, 36-46*F
45
frozen
-25 to -10*C, -13 to 14*F
46
3 types of incompatibility
therapeutic
physical
chemical
47
therapeutic influences
- chemical or physical incompatibilities can result in influences in therapeutic efficacy of drugs
- loss of efficacy of one or more of active ingredients when administered together
- can administer separately or with adequate time between drugs
48
chemical
result from a chemical reaction between two or more components of a mixture, which affects molecular structure or activity of product
49
physical
results in changes in the physical properties of the product in term of appearance, palatability, uniformity, dissolution, & susceptibility
- most physical incompatibilities are the result of chemical rxns
50
evidence of incompatibility
```
color change
precipitate
phase separation
bubbles
heat/cold
crystallization
```
51
factors affecting affecting stability & campatibility
```
pH
temp
light
mixing sequence
time
concentration
```
52
calcium phosphate
- formed when calcium salts are added to electrolytes containing phosphate
- chemical rxn physically manifested as formation of precipitates or haze in preparation
53
calcium & potassium are
physically incompatible
54
parenteral nutrition
- common source of incompatibilities resulting in calcium phosphate
- nutrition preparations for neonates at high risk
55
preventing calcium phosphate
```
utilize Ca gluconate over CaCl
maintain low pH of final admixture
increased amino acid conc
decreased dextrose conc
store compound at lower temp
avoid higher temp during admin
do not add Ca & P salts in close sequence
Calc solubility of Ca
use slower infusion rates
```
56
preventing incompatibilities
verify solubilities
determine risk of precipitation
determine chemical form of drug
determine storage & handling conditions
57
visual inspection
```
look for:
hazy/cloudy appearance
precipitates
color change
formation of gas
separation of contents
temp changes
crystallization
```
58
compatible
physical or visual compatibility reported
| stability for at least 24 hours
59
incompatible
physical or visual incompatibility
| greater than 10% decomposition of one or more components in 24 hours or less
Parenterals
flashcards
Decks in class (4)
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