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compounding > Lecture 7: Miscellaneous Sterile Meds > Flashcards

Lecture 7: Miscellaneous Sterile Meds Flashcards

1
Q

Small volume parenteral (SPV)

A

containers holding 100 mL or less (25, 50, 100)
- minibag
- ampules
- vials
- prefilled syringes
- ready to use systems

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2
Q

Large volume parenteral

A

containers holding 100 mL or more (250, 500, 1L)
- Plastic bags
- glass bottles

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3
Q

Plastic bags LVP Pro

A

more common
dont break/shatter
weigh less
easier to store/dispose

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4
Q

Plastic bag LVP con

A

insulin/others adsorb to plastic
may leach/pull plasticizer out (use PVC free bag)
Punctures easily

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5
Q

Glass LVP pro

A

safely use, avoid some adsorb
easy to inspect contents

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6
Q

Glass LVP con

A

breakable
challenging to store/dispense

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7
Q

Vials SVP

A

glass or plastic
liquids or lyophilized powder
single or multi dose

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8
Q

Single dose vial

A

no preservative
discard after 1 use
otherwise = bacterial infections

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9
Q

Multi dose vial

A

contains preservative
inhibit growth

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10
Q

Generally you discard multi dose vials after _____ days

A

28 days after intial use
Otherwise check manufacturer spec

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11
Q

prefilled syringes

A

not common in pharmacy compounding
manufacturer dispense
can manipulate for pt need

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12
Q

Ready to use systems

A

Specifically designed minibag w/ adaptor for attaching a drug vial
- admixing just before administration
- expensive

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13
Q

Needles for compounding

A

17-20 gauge
viscous solution = larger lumen (17) //cyclosporin
rubber closure cored easily = smaller lumen (20)

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14
Q

Needle gauge range

A

27 (smallest) to 13 (largest)

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15
Q

Choosing needle for patient care depends on

A

patient age/size
administration rate (faster rate, larger volume - big needle)
administration type (IM, IV, SQ, intradermal)

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16
Q

Preservatives

A

required in all multiple-dose parenteral products to inhibit microbial growth that may be introduced during withdrawal of individual doses

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17
Q

Antioxidants

A

prevent oxidative decomposition of drugs in solution
- Maintain product stability by being preferentially oxidized and gradually consumed over the shelf life of the product
- Salts of sulfur dioxide are the most common antioxidants used in aqueous parenterals

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18
Q

Most manufacturers don’t put antioxidants because

A

Sulfur salts = allergy risk

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19
Q

Buffers

A

Drug solubility/stability may require certain pH
Buffer systems for parenterals consist of a weak base and the salt of a weak base OR a weak acid and the salt of a weak acid (to keep that drug at a certain pH to improve stability)

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20
Q

Changes in pH happen over time

A

Dissolving glass constitutes
Releasing constitutes from rubber/closures/plastic components in packaging
Dissolving gases and vapors from the airspace in the container
Reactions within the drug product itself

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21
Q

Solubilizing agents

A

Added to increase drug solubility by using non-aqueous solvents

22
Q

Chelating agents

A

infrequently but occasionally needed, added to inactivate metals (copper, iron, zinc) that catalyze oxidative degradation of drug molecules

23
Q

Sources of metal contamination

A

Raw material impurities
Solvents (i.e. water)
Rubber stoppers
Containers
Equipment used in the manufacturing process

24
Q

Inert gases

A

enhancing integrity of oxygen sensitive medications by displacing the air in the solution (remove oxygen and replace it with a different gas)

25
Q

Impact of med additives greatest for

A

special populations (elderly, pediatric/neonatal)
- Don’t always have the reserve to process and metabolize these additives the same way an adult patient would
Hypersensitivities
Liver/renal dysfunction
Propylene glycol/benzyl alcohol toxicity

26
Q

HD propylene glycol toxicity

A

continuous or prolonged IV use
–> accumulation = metabolic acidosis
affects adults (hepatic/renal insufficiency) and children (VLBW infants + neonates)

27
Q

HD benzyl alcohol toxicity

A

Neonates affected - gasping syndrome
large amounts = fatal toxicity (metabolic acidosis = extreme respiratory distress, CNS dysfunction, hypotension, CV collapse)

28
Q

How to avoid gasping syndrome in neonates

A

use preservative-free medications to avoid benzyl alcohol

29
Q

Filters

A

used to remove glass, microorganisms, air

30
Q

Filter needle

A

ampule
- separate disk or within tubing for IV administration)

31
Q

Filtration can take place at different steps in medication use

A
  1. during compounding (of most concern)
  2. during administration (in line filters)
31
Q

Filtration can take place at different steps in medication use

A
  1. during compounding (of most concern)
  2. during administration (in line filters)
32
Q

Filters classified by

A

pore size

33
Q

TPN filter size

A

0.22 microns

34
Q

TNA and lipid filter size

A

1.2 micron

35
Q

Particle filter size

A

5 microns

36
Q

Bacterial filter size

A

0.22 micron

37
Q

Amphotericin B filter

A

5 micron, into D5W

38
Q

Infliximab filter

A

in line sterile nonpyrogenic low protein binding filter
pore size ≤ 1.2 microns

39
Q

Air embolism

A

when air introduced into circulation - lodges
rare but fatal
remove air from syringes
use in line filter (not used for all administration)

40
Q

Pyrogens

A

metabolic byproducts of living organisms
rarely fatal but can cause discomfort
- fever, chills,
- increase BP, decreased respiration
- nausea, severe diarrhea
- pain in back of legs

41
Q

Sterile intranasal/inhalation

A

Local = albuterol
systemic = fentanyl, midazolam (sedation)
Consider adding buffers, preservatives, tonicity adjusters, antioxidants, surfactants, viscosity inducing agents

42
Q

sterile irrigation

A

used to flush, soak, irrigate wound/body cavities
ex: bladder irrigation
CONSIDER TONICITY, pH related to site
Can’t be given parenterally

43
Q

Epidural administration

A

temporary or permanent catheter - space in central cavities between dura mater and vertebral column
For pain management
MUST BE STERILE ANd PRESERVATIVE FREE — otherwise can cause nerve damage

44
Q

Intrathecal administration

A

medication placed into the subarachnoid space (underneath the arachnoid mater, the innermost meninge), filled with cerebrospinal fluid (CSF) that baths the brain and spinal cord
Highest risk of bacterial contamination
Because CSF is a great media for bacteria growth

45
Q

Uses of intrathecal administration

A

(less common than epidural ROA)
- Single doses of narcotic medications
- Antibiotics to treat specific CNS infections (systemic antibiotic administration doesn’t penetrate certain space)
- Chemotherapy
- Implantable infusion pumps for chronic medication administration (i.e. intrathecal Baclofen, reduce spasticity)

46
Q

Ophthalmic prep

A

deliver drug on the eye, into the eye, or onto conjunctiva
May be solutions, suspensions, ointments, (compounded) or inserts (not compounded/from manufacturer)

Also require that pH, viscosity and tonicity of the formulation is tightly controlled

May be used for local effect (miosis, mydriasis, anesthesia) or for reduction of intraocular pressure

47
Q

Transcorneal transport

A

NOT an effective process (drugs administered topically onto the eye really don’t absorb into the eye very well)
If medications are needed in interior of eye they must be administered intravitreally/intraophthalmic via an injectable process

48
Q

Opthalamic prep complexity

A

Also require that pH, viscosity and tonicity of the formulation is tightly controlled
Technically complex, requires extensive calculations for appropriate pH and tonicity
Viscosity enhancers may be added to increase viscosity and subsequently, drug exposure

49
Q

Garbing Procedure for Non-Hazardous Medication Preparation

A

Remove all jewelry, jackets, vests, hats, etc.
Shoe covers, stepping over line of demarcation
Face mask, head/hair cover(s)
Wash hands
At least 30 seconds
Hands, forearm, fingernails
Don gown
Enter cleanroom
Hand cleansing with alcohol-based product
Don sterile gloves
Routinely disinfect gloves with sterile 70% isopropyl alcohol

50
Q

Cleaning hood

A

When cleaning the horizontal laminar airflow workbench (LAFW), the correct order of cleaning surfaces and the motion to clean is:
Top, using side to side motion from inside out
Hanging pole using gripping motion
Sides, using top to bottom motion from inside out
Bottom, using side to side motion from inside out
Use a new wipe for each surface cleaned
Cleaning the diffuser (the “back” of the hood, the grate in front of the HEPA filter) is controversial and facility-dependent based on type of compounding being completed
If diffuser is to be cleaned, should be occur first

compounding (12 decks)

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