1
Q
What is the definition of parenteral?
A
adj: administered by any way other than through the mouth: applied, for ex, to the introduction of drugs or other agents into the body by injection
para enteron: beside from the intestine
parenteral products must be sterile!!
2
Q
Definition of aseptic technique
A
-the ability of personnel to manipulate sterile preparations, sterile packaging components, & sterile administration devices in a way that excludes the introduction of viable microorganisms
3
Q
Intravenous injections
A
- peripheral: injection to the arm or leg
* central: use of a central venous catheter)
4
Q
Intra-arterial (IA)
A
- uncommon for the administration of medication –> to the high pressure side of the circulatory system
- testing (1st pass kinetics, arterial pressure)
5
Q
Intramuscular (IM)
A
-injection to within muscle tissues
6
Q
Intrathecal (IT)
A
-injection to the meninges of the spinal cord
7
Q
Epidural
A
-injection to the tissues surrounding the spinal cord, not the spinal cord itself
8
Q
intradermal (ID)
A
injection within the skin
9
Q
Subcutaneous (Sc, SQ)
A
injection beneath the skin
10
Q
Definition of Sterility
A
- freedom from all living organisms, an absolute term & no such thing as almost sterile*
- all parenteral & ophthalmic dosage forms must be sterile!
11
Q
Health status in terms of sterility
A
- sterile prep personnel should be free from infectious diseases
- -> if you have a “cold” and are coughing and/or sneezing stay out of the sterile prep room!
(chills, fever)
12
Q
Personal Prep for sterile room
A
- cover both head and facial hair
- remove cosmetics likely to flake
-remove finger and wrist jewelry
13
Q
Hand-washing rules
A
- scrub hands & arms to elbows
- plain soap and water not enough for high risk situations (alcohol, chlorhexidine gluconate, iodophors, hexachliphene, parachlorometaxylenol & triclosan)
- use 3-5ml for 30 secs
- wash hands even if gloves are to be worn (leakage rate can be more than 50%) also wash hands after gloves removed
14
Q
Gloves
A
- selection based on type of compounding, material durability, reliability, comfort & protection from bacteria or hazardous drug penetration
- for IV room- use SURGICAL gloves
-change ~1 hour
15
Q
Glove composition**
A
- latex
- vinyl
-synthetic
16
Q
Gowns
A
- should be made of a low-particulate material that protects against bacterial passage and drug permeability
- Tyvek: standard for non-permeable garments
17
Q
other coverings (shoes & masks)
A
- shoe covers & sticky mats (change frequently)
- masks: don just prior to working in hood, change each time leaving compounding area, surgical masks offer no protection against inhaling of powdered or aerosolized hazardous drugs
18
Q
LAFS horizontal flow hood
A
- filtered air is directed toward the pharmacist/tech from a plenum (and HEPA filter) located at the back of the hood
- most common for general purpose parenteral
19
Q
BSC Vertical flow hood
A
- filtered air is directed downward from a plenum (and HEPA filter) located at the top of the hood
- used for chemo therapy
-provides more protection for the pharmacist/tech than does the horizontal hood
20
Q
Laminar Air Flow
A
- HEPA Filter removes 99.97% of all particles 0.3 microns or larger
- operate for at least 15 min prior to use –> most institutions require 30 mins
21
Q
What is the greatest disadvantage of a laminar air flow vibe?
A
a false sense of security
22
Q
ISO classifications of particulate matter in room air
A
(0.5 um and >) theres a whole chart but basically the smaller the number- the higher the air quality
23
Q
What are pyrogens?
A
- metabolic products of living organisms, or the dead microorganisms themselves
- chemically: lipopolysassharides, soluble in water but insoluble in organic solvents
-aseptic technique (ideally) prevents the introduction of pyrogens to parenteral products
24
Q
pharmacologic effects of pyrogens
A
- vary with the microbial source of the pyrogen & pt receiving the injection
- in man, pyrogenic reaction is fever & chills
- following injection, latent period 45-90 mins, then rapid rise in body temp, chills, headache & malaise
- anaphylaxis
25
Sources of pyrogens
- water used as the solvent
- containers used in preparation, packaging, storage or administration
-chemicals used in the preparation of the solution
26
Elimination of pyrogens
- dry heat: for metal and glass containers
- chemically: for solutions (disadvantage: can destroy drugs)
-synthetic filter media: 0.22 micron filter
Best approach: *prevent them from occurring*
27
unnecessary factors for when preparing sterile products
talking, laughing, chewing gum, eat/drink
28
CSP risk levels
-assigned according to relative possibility that a compounded sterile product might become contaminated
29
*LAFS
laminar airflow system
30
*BSC
biologic safety cabinet
31
*RABS (CAI & CACI)*
-restricted access barrier system
CAI: compounding aseptic isolator
CACI: compounding aseptic containment isolator
32
Clean rooms: an environment where contamination is limited/controlled to prevent:
*particles, organisms & pyrogens*
33
Clean rooms: environmental control:
*temperature, humidity & relative barometric pressure*
34
Clean room design (list all the things in there and they supplies they are made from)
- layout: equipment & traffic flow
- walls: epoxy coated
- flooring: seamless, vinyl
- ceiling system: gasketed, t-grid
- filtreation/Air flow: HEPA, positive pressure
- lighting: sealed, gasketed
- easy clean surfaces
35
Clean room classifications: class 100,000
- particle count not to exceed a total of 100,000 particles per cubic foot of a size 0.5 micron and larger
- and/or 700 particles per cubic foot of a size 5 microns and larger
36
Clean room classifications: class 100
- particle count not to exceed a total of 100 particles per cubic foot of a size 0.5 micron and larger
- and/or 0.7 particles per cubic foot of a size 5 micron and larger
37
end product testing: product observation
- container leaks & integrity
- particulates in solution
-solution color, volume and odor
38
end product testing: retrospective check:
- calculations
- ingredients
- quantities
- containers
39
end product testing: analytical testing
- evaluates the contents of prepared sterile products
| - weight verification (specific gravity), refractometry verification, spectrometry, pH testing, microbial testing
40
Process Validation
- systematically demonstrates that a process will reproducibly meet its claim
- involves manipulation of microbial growth media according to the aseptic process being validated
-should schedule process under worst conditions
41
How to validate aseptic processes
- a growth medium: is introduced with a sample of the process being evaluated (product/process sample)
- the medium will support organisms introduced to the process by the operator
- the sample must be a product of the same aseptic process being validated
* should be conducted: at random intervals & without the operator's knowledge*
42
more stability: *3 things in green*
- the extent to which a Rx preparation remains within specified limits in terms of: *chemical composition, physical composition & microbiologic activity/contamination*
- at the time of use a medication must be: *at the stated potency & safe for administration to the pt*
43
Product stability:
*is subject to specific storage conditions & is the primary basis for an expiration date/time*
44
Lyophilization
- drugs in solution tend to be less stable than those in dry or suspended form
- a process of *rapid freezing & drying under high vacuum (sublimation), the product is a dry powder*
45
Sterilization
- 0.22 micron filter
| - autoclave
46
antioxidants
- metasulfite & sulfite ions
| - sodium salts, potassium salts (metabisulfite, bisulfite & sulfite)
47
Inert and semi-inert gasses
*nitrogen, carbon dioxide & helium*
48
Particulate matter
-may be present in parenteral products: undesirable, unintentional, potentially harmful to the pt, mobile, undissolved substances
49
Sources of particulate matter
- IV solution and/or additives: manufacturing process
- packaging components: paper, cardboard
- IV tubing/sets and administration devices
- preparation processes: laminar flow hood, patient bedside
50
IV fluid incompatibility*
* occurs when a drug is combined with an IV fluid or another drug, to produce by physiochemical means, a product unsuitable for administration to the patient *
ex: phenytoin in D5W (a physical & chemical incompatibility)
51
Therapeutic classification of incompatibilities
-2 or more drugs administered concurrently, result in undesirable antagonistic or synergistic pharmacologic action - drug/drug interaction
52
Physical classification of incompatibilities
the combination of ONE or more drugs in solution resulting in compositional change & appearance (change in color, formation of turbidity, precipitation & evolution of a gas)
53
Chemical classification of incompatibilites
-degradation of drug substances as a result of being in solution & as a result of being in contact with other drugs
54
The greatest single factors (3) causing incompatibility between IV fluids and their contents:
*variations in pH, solubility & stability*
55
minimizing incompatibilities
- use freshly prepared solutions whenever possible
- encourage use of as few additions as possible
- study to demonstrate proficiency in IV therapy
- educate MDs/Rns
- be skillfull with reference materials (Trissel's, Clinical Pharmacology)
56
Parenteral administration advantages
- fast
- some drugs not effective orally
- uncomplicated admin. where the pt is: uncooperative, nauseous, unconscious *NPO*
- patient compliance: gives MD control of drug, pt must return for therapy, cant trust some pts to take medications
- correction of fluid/electrolyte imbalance
- TPN administration: when pt is NPO
57
Parenteral administration disadvantages
- special training required (special procedure, aseptic)
- invasive
- pain
- difficult to reverse
- more expensive
- incompatibilities
58
IV compatibility *idk other green things to know*
* -in general, use smallest possible bag
- refrigerate vs room temp
- light sensitivity
- pay attention to manufacture's codes when provided*
59
sterility & integrity requirements for sterile IV admixtures
*freedom from living organisms, freedom from dead organisms & pyrogens*
60
H2O insoluble
*dead organisms, parts of dead organisms & metabolic products of organisms*
61
H2O soluble
*lipopolysaccharides, metabolic products of organisms*
62
hypotonic
< 277 mM
63
isotonic
~277 mM
64
hypertonic
> 277 mM
65
where does the central route access?
- major veins
- access to the venous system close to the heart
-*superior vena cava, inferior vena cava & subclavian vein (PICC line)*
66
indications for peripheral admin.
- administration of drugs
- administration of fluids (maintain hydration & volume)
- surgery (anesthesia, drugs)
- transfusion
- to maintain or correct electrolyte imbalance
- administration of nutritional solutions
67
advantages of peripheral admin (with respect to central**
- veins are relatively easy to access
- drugs, solutions and blood can be administered quickly
-administration is easy to see and monitor
68
Disadvantages of peripheral admin (with respect to central) **
- short term access
- immobilization of the limb
-less forgiving of tonicity extremes
69
indications for central admin
- large volume fluids
- hypo/hypertonic fluids
-pH imbalanced fluids
70
**advantages of central admin (compared to peripheral)
1-rapid infusion of large volumes
2-a means of measuring CVP (*central venous pressure)
3-eliminates repeat peripheral venipuncture (decreased vein irritation & vein damage)
4-decrease patient discomfort
71
**disadvantages of central admin. (with respect to peripheral)
risk of complications: pneumothorax, sepsis, thrombosis/embolism, organ perforation
-decreased in patient mobility
-surgical implant
72
intra-aeticular
*injection to the joints
73
intra-synovial
*injection to the joint fluid areas
74
intraventicular
*injection to the ventricles of the brain
75
intra-cardiac
*injection to the heart (epi)
76
Potential complications of IV therapy
- bad news: most medical & pharmacologic interventions present some risk to patient
- parenteral therapies are more likely to have serious complications
- good news: most complications can be prevented or minimized
- precautions
77
phlebitis
- inflammation of the veins
- can be induced by insertion of VADs *vascular access device*
- characterized by tenderness, redness, puffiness, hardness & increased temp
- at tip of VAD & in the direction of blood flow
78
extravasation
- undesirable
- liquids are infused into peripheral space surrounding vein
-misplaced VAD
79
infiltration
- undesirable
| - extravasation fluids are absorbed by surrounding tissues
80
Extravasation/Infiltration (general signs and symptoms)
-at the IV site: pain, discomfort, burning, feeling of tightness, decreased temp, cant back flow blood, decreased flow rate
81
Extravasation/Infiltration (drug specific signs & symptoms)
- tonicity & pH extremes (hypo/hypertonic solutions)--> v irritating
- tissue necrosis: chemo, dopamine, epinephrine
82
infection
local: contaminated IV site and/or tissues near VAD, sterile and non-sterile necrosis & sepsis (tissue destruction)
Systemic: fever, chills, malaise & septicemia
83
Air Embolism
- an object blocking a blood vessel- blood clot, fat, amniotic fluid, air, other objects --> MI
- > 5ml of air- right ventricle of the heart, cavitation & fatal
84
Air embolism (signs and symptoms)
-respiratory distress, weak pulse, increased CVP, decreased BP & unconsciousness
85
Allergic reactions
-histamine release: itching, tearing, runny nose, coughing, wheezing, anaphylaxis
86
Injection def:
-a drug in solution *or lyophilized powder* in a suitable vehicle intended for parenteral administration
87
Infusion fluid
* IVF, intermittent, single, small volume dose (50 ml, 100 ml) *
- continuous infusion, single large volume dose (ex: D5W- 1000 mL)
88
Sterile solids labeled: sterile drug
-no buffers, no diluents, no added substances
89
Sterile solids labeled: drug for injection
-buffers, diluents, added substances
90
Sterile suspension
- drug is initially in dry (lyophilized) form
- will yield a suspension after reconstitution with a suitable vehicle
ex: Unasyn (amp/sulb)
91
solutions of irrigation:
- used to bathe or flush open wounds and body cavities (dressings, surgical procedures)
- never use *parenterally*
92
what are vehicles (when used for injections):
- water
- sterile water
- bacteriostatic water
- oils (sesame oil)
93
what are some solubilizing agents? (4)
polyethylene glycol, propylene glycol, glycerin & ethyl alcohol
94
what is an admixture?
-the combination of 2 or more parenteral dosage forms for administration as a single entity
Additives: when a small volume drug is added to a larger volume vehicle, the drug may be referred to as an additive
-large volume solutions: often used to administer electrolytes, often administered alone
95
what is an advantage of an ampule?
*do not require preservatives*
96
what is a disadvantage of ampules?
*contamination by glass shards upon opening, filtration required*
97
what are some advantages of vials?
*dosing flexibility, decreased waste-multi-dose vial*
98
what are some disadvantages of vials?
- coring (going thru that latex rubber stopper)
- drug interaction with latex
- latex allergy
* increased waste- single dose vial*
99
what is dead space?
-space collectively occupied by: needle bore, needle hub, luer couplings and all fluid occupying space in a syringe when the plunger is set to zero ml
100
what is vascular pressure?
- pressure within a blood vessel
* a function of: myocardial contraction, smooth muscle activity in vasculature, hydrostatic force (due to gravity)*
- applies to venous and arterial vessels
101
infusion pressure
- gravity: drip chamber must be at sufficient height above the infusion site
- hydrostatic pressure: ex* IA infusion: 140 mm x 13.534 = 1894.76 mm ~ 75"
102
what is resistance?
a function of:
- diameter and length of IV tubing
- -> resistance to flow increases as tubing diameter decreases, as tubing length increases
- -> resistance to flow decreases as tubing diameter increases and as tubing length decreases
103
when are infusion pumps indicated?
- a greater degree of infusion accuracy is required (PCA, complicated regimens)
- higher pressures are required (intra arterial infusion, when multiple resistance factors are present)
- risk of fluid over load or drug overdose
104
small volume parenteral (SVP)
< 150ml*
| -piggy back bags, prefilled syringes
105
large volume parenteral (LVP)
> 150ml*
| -hydration fluids (electrolytes) & TPN
106
glass IV container types
- based upon *resistance to water attack, release of alkali*
| - availability: 1 ml to 3,000 ml
107
advantages of glass containers
* -protection against gas and vapor permeation
- protection against punctures
- easy to inspect contents
108
disadvantages of glass containers
* -pH changes due to ion leaching
- flaking due to: phosphates, citrates, tartrates
- breakable
- storage and disposal complications
- difficult to detect hairline fractures
109
polyvinyl chloride (PVC)
- contains plasticizers (softens container, pliability & may leach into preparation)
- drug sorption (surface adherence & integration with plastic)
- incineration
110
Polyolefin
- contains no plasticizers (rigidity or semi-rigidity)
- no drug soption problems
- incineration
- impermeability to air
- a mixture of polyethylene and polypropylene
111
advantages of plastic containers
*disposable, lightweight, inexpensive, unbreakable, minimal storage space, can be frozen & no venting is required (airborne contamination less likely)
112
disadvantages of plastic containers
*ports awkward to manipulate (increases touch contamination), absorption/adsoprtion/leaching concerns (PVC), permeability (PVC), difficult to determine fluid levels, difficult to detect particulates, puncture easily (PVC)
113
primary IV set
- usually for a single (primary) fluid
- for continuous infusion (can be used for intermittent infusions too)
- exceptions: TPN
114
secondary IV set
(never used alone, always with primary)
- attaches to a primary set at a Y site
- for continuous or intermittent infusion
115
4 filters and their green def
5 micorn: filters most non-living particles
1. 2 micron: filters most non-living particles, candida
0. 45 micron: filters gross particulates, filters most fungi and bacteria
0. 22 micron: filters all bacteria except rickettsia, does not filter pyrogens or viruses
116
Parenteral Nutrition
- the provision of all basic metabolic and nutritional requirements via the IV route
- central administration (most common & preferred over peripheral)
117
Benefits of parenteral nurition
- all nutrients mixed in single daily container: dextrose, amino acids, fat, *electrolytes, trace elements, insulin, drugs*
- one IV pump
- one administration set
- touch/manipulation contamination is minimized due to single bag
118
disadvantages of parenteral nutrition
- not all nutrient admixtures are physically and chemically stable
- some potential combinations *will precipitate and or will crack (fat emulsion)
119
Peripheral parenteral nutrition
- less preferred than central TPN
- relatively uncommon
- peripheral route provides low-risk nutritional support for supplement until enteral nutrition established
- gut may work, but not sufficiently to meet all the patients nutritional needs
120
Harris-Benedict equations
Men: BEE = 66.67 + (13.75 * kg) + (5 * ht) - (6.76 * age)
Women: 655.1 + (9.56 * kg) + (1.85 *ht) - (4.68 * age)
121
Caloric TPN Sources
- amino acids (protein): 4 kcal/gram
- dextrose (glucose): 3.4 kcal/gram
- fat (lipids): 9 kcal/gram
122
Quick estimate/ short cuts for BEE, maintenance & anabolism
BEE = 25 * wt in kg
Maintenance: 30 * wt in kg
anabolism: 35 * wt in kg
123
what to use when administering drugs/fluids to the venous system use:
* needles/syringes, catheters, implanted ports
| - establish a connection
124
General considerations for vascular access devices:
*vein location, condition and availability, specific indication, infusion rate, tonicity, pH and vesicant potential, duration of therapy, patient compliance/cooperation
125
Venipuncture
- access to arm or hand (leg or foot)
* metacarpal, cephalic, basilic*
- safest form of vascular access
- lowest risk of life threatening complications
- for short term therapy
126
venipuncture device selection criteria:
-catheter length, lumen diameter, infusion rate, osmolarity/ pH of infusion fluids, length of therapy, pt activity level, pts age & body image/scarring
127
Central Venous access
- an indirect connection to: superior vena cava, inferior vena cava
- most commonly through the subclavian vein: *over the needle, through the needle & over a guidewire (most common)
128
what are used for short term catheres?
* polyurethane, PVC (can pushed into the lumen of the vein into which it is being placed)
129
what is used for long terms catheres?
silicone rubber - more flexible so it cannot bt manipulated into some way
130
disadvantages of short-term catheters
*tissue irritation, local infection, systemic infection, thrombus formation (PVC), vessel rupture
131
long term catheters (advantage & disadvantage)
- made of silicone rubber: much less thrombogenic than polyurethane or PVC
- more flexible than short term
* advantage: physiologically more compatible
* disadvantage: insertion more difficult than short term catheters
132
Hickman catheter
- silicone rubber
- single or multiple lumen
- open ended, tears/kinks easily (disadvantage)
* requires routine Heparin flush (disadvantage)
* indicated for ling-term CV access & home therapy
133
Broviac catheter
- single lumen
| - small inner lumen: pediatric, elderly, slower infusion rates
134
Groshong catheter
- silicone rubber
- closed end --> pressure sensitive 2 way valve
- tears or kinks easily
* indications: long-term CV access, use for heparin allergy*
135
PICC
- peripherally inserted central venous catheter*
- silicone rubber
- beside insertion (advantage)
- may occlude peripheral vessels, long path to CV circulation (disadvantage)
* indications: long-terms CV access, head and/or neck injury
136
Cytotoxic drugs
-a drug that damage or destroys cells and is used to treat various types of cancer
AKA: *chemotherapeutic drugs, antineoplastic drugs, antimetabolic drugs,*
137
MOA of cytotoxic drugs
-*inhibition of cell growth and/or division of cancer cells*
| Selective towards: * cancers, tumors, bone marrow, skin, epithelial tissues, fetal tissue, hair follicles & fingernails
138
therapeutic index of cytotoxic drugs
- the dosage range of a particular drug in which a desired pharmacologic effect is realized without introducing toxicity to the pt
* VERY narrow!, rescue therapy must be initiated following chemotherapy in order to restart DNA, RNA and protein synthesis*
139
certain chemo drugs are known to:
- be teratogenic (particularly in the 1st trimester)
- *known to suppress testicular function, spermatogenesis
- *pregnant or breast-feeding women should be excused from preparing hazardous drugs & consider excusing men actively trying to father a child for a specified time period*
140
what 2 precautions must be taken:
* 1) use of a vertical flow hood
| 2) proper handling technique
141
Vertical flow hood
- HEPA filter and fan plenum
- moves air: *downward direction, away from the operator
- purpose: protection of personnel/pharmacist, prevent release of aerosolized drug*
142
Type A cabinet
* 70% back into the cabinet through HEPA filter, remainder returns to room through HEPA filter
- under positive pressure: disadvantage! (if there is a breach- there is a tendency for the contamination to come out and go into the room)
143
Type B1 cabinet
* 30% back into the cabinet through HEPA filter, remainder vented to the outside through HEPA filter
* under negative pressure
144
Type B2 cabinet
* 100% vented to the outside
| * under negative pressure
145
Type B3 cabinet
* 70% through HEPA filters back into the cabinet, remainder vented to the outside
* under negative pressure
146
Biological safety cabinet leave on & operating:
*24 hours per day & 7 days per week
Turning off blower will cause recirculation of contaminants into clean room
*if really need to turn off: throughly clean before shutdown, cover operator opening with plastic and tape before shutdown*
147
Chemo glove rules
- 2 fresh pairs at beginning of task: 1 pair under gown & 1 pair over cuffs
change: **
1) outer pair immediately if mildly contaminated
2) both pairs if outer pair is torn or punctured
3) both pairs in the event of a spill
4) both pairs after each hour of use
148
Ampules (steps)
-ensure tip contents transferred to main body: *gentle tapping against work surface, swirling, gentle finger snap*
149
Type 1 glass container
- borosilicate glass
- highly resistant to H2O attack
- high chemical stability
- low thermal expansion coefficient --> high resistance to thermal shock
- may be sterilized before or after filling
150
Type 2 glass container
- glass is treated with soda lime
- sterilization with dry heat prior to filing is preferred
- pH of contents must be <7 --> for entire time prior to expiration date
- suitable for: solutions, powders and oils
151
Type 3 glass container
- soda lime glass
- sterilization with dry heat prior to filing is REQUIRED
- pH of contents must be <7 --> for entire time prior to expiration date
- suitable for: solutions, powders, oils
Compound My Ass ( P2 Fall)
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