Midterm Flashcards
What is a parenteral product?
a preparation administered to the body other than through the intestinal tract
parenteral routes
IV, SQ, IM, intradermal (ID), intrathecal (IT), epidural, intra-articular, intra-arterial, intraperitoneal
parenteral pros
- 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
parenteral cons
- 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
NS is given
IV
influenza vaccine is given
IM
insulin is given
SQ
what goes in the sharps
needles, open ampules, broken glass
** NOT empty vials unless broken**
any needlestick injuries should be reported to
a course instructor immediately
efficiency is secondary to
accuracy & good technique
factors influencing sterility
- environmental quality
- proper hand washing
- proper hand hygiene
- use of PPE
- primary & secondary engineering controls
- maintenance of equipment & environment
- ASEPTIC TECHNIQUE
transient hand flora
15% of all flora
removed with hand washing
resident hand flora
85% of all flora
NOT removed by hand washing
spores
- requires physical removal with hand washing
- NOT removed with hand sanitizers or alcohol
proper hand washing is key to
preventing contamination
personal protective equipment (PPE)
shoe covers beard covers hair covers jacket/gown gloves- sterile & powder-free
Donning PPE
- aka “garbing”
- protect preparation from the operator
- protect the operator from the preparation
wash hands prior to donning gloves
- hands can contaminate gloves when donned
- hands can transport particles onto gloves when donned
disinfecting gloves
- 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
critical sites are at greatest risk of contamination
tough, moisture, contact with unclean air
critical sites
- 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
steps of aseptic technique
- 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
when disinfecting vials, ampules & injection ports, allow to remain wet for at least
10 seconds
mix & check preparation against light & contrasting background for
incompatibilities, particulate matter, coring
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
syringes should be capped when
medications will be administered directly from the syringe
positive pressure
- if air added > volume of solution withdrawn
- results in spraying or dripping of solution from vial
negative pressure
- if air removed >volume of solution removed
- results in difficulty removing volume needed from vial
auxiliary label examples
storage conditions administration alerts high-risk meds nonstandard concentrations hazardous agents
batch compounding
involves the compounding of multiple preparations containing the same ingredients
- requires specific documentation
quality of final preparation dependent upon
compatibility & stability parameters
stability
retention of properties & characteristics throughout the storage & use periods
instability results when
a change or degradation of the active ingredients occurs
stability parameters established
secondary to exposure testing by the manufacturer
types of stability
chemical physical toxicological therapeutic microbiological
expiration date
- assigned by the manufacturer
- determined using extensive analytical testing
BUD
- assigned by a pharmacist
- determined based on available scientific evidence or per manufacturer recommendations
MDV BUD
28 days from entering/opening the vial
single-dose vials exposed to ISO class 5 or cleaner
6 hours from entering/opening the vial
any equipment of vial exposed to air quality worse than ISO class 5
1 hour from enter/open
must be discarded after 1 hour
commercially prepared products (ready use product)
as indicated y the manufacturer label until entered/opened
BUD should not be extrapolated to extemporaneous preparations
vial systems
as indicated by the manufacturers until entered/open
RT
20-25C, 68-77F
fridge
2-8C, 36-46F
frozen
-25 to -10C, -13 to 14F
3 types of incompatibility
therapeutic
physical
chemical
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
chemical
result from a chemical reaction between two or more components of a mixture, which affects molecular structure or activity of product
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
evidence of incompatibility
color change precipitate phase separation bubbles heat/cold crystallization
factors affecting affecting stability & campatibility
pH temp light mixing sequence time concentration
calcium phosphate
- formed when calcium salts are added to electrolytes containing phosphate
- chemical rxn physically manifested as formation of precipitates or haze in preparation
calcium & potassium are
physically incompatible
parenteral nutrition
- common source of incompatibilities resulting in calcium phosphate
- nutrition preparations for neonates at high risk
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
preventing incompatibilities
verify solubilities
determine risk of precipitation
determine chemical form of drug
determine storage & handling conditions
visual inspection
look for: hazy/cloudy appearance precipitates color change formation of gas separation of contents temp changes crystallization
compatible
physical or visual compatibility reported
stability for at least 24 hours
incompatible
physical or visual incompatibility
greater than 10% decomposition of one or more components in 24 hours or less
