Central Intravenous Additive Service (CIVAS) Products Flashcards

1
Q

What is the definition of ‘Parenteral’?

A

Next to/beside ‘enteral’ (alimentary tract)

  • Free of, or you methods to keep free of, pathological organisms
  • Includes IV, SC, IM, Nasal, Topical Etc.
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2
Q

Why is aseptic preparation of parenterals necessary?

A

Must be sterile

  • Parenteral and ophthalmic products
  • Some topical preparations

Cannot sterilise by autoclaving
- Drug stability

Drugs presented as freeze-dried powders
- Must be reconstituted and diluted

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3
Q

Why use the parenteral route?

A
  • If patient is nil by mouth
  • If drug is broken down by GI tract (e.g. proteins)
  • If drug is not absorbed
  • GI tract not functioning
  • First pass metabolism
  • Local action
  • Dialysis
  • Speed or duration of action
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4
Q

What is chemotherapy?

A

Palliative, adjuvant or neo-adjuvant treatment for cancer

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5
Q

What are the typical presentations of CIVAS products?

A

Syringe
Infusion bag
Infusion device

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6
Q

What are the risks associated with CIVAS products?

A
Infection
Thrombophlebitis
Extravasation
Air embolism
Dose errors
Incorrect drug, site, rate
Incorrect formulation
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7
Q

Why is pharmacy involved in CIVAS products?

A

Risk of uncontrolled environment
Cost of the drug
- Where dose is

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8
Q

How can patient factors/requirements affect the formulation?

A
  • Dose range
  • Access
  • Volume
  • Rate of administration
  • Other drugs
  • Setting (hospital, homecare)
  • Patient type
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9
Q

How can physical presentation of the starting material affect the formulation?

A
  • Solution
  • Freeze dried powder
    • > diluent
  • Emulsion
  • Suspension
    • > restricted routes
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10
Q

How can drug properties affect the formulation?

A
Stability
- pH
- Solution/solid
- Catalyst
- Diluent
Light
Storage Temperature
- Room, Refrigeration, Freeze/thaw
Concentration
- Consider infusion bag overage
Solubility
- Co-solvents
Physical stability
- vibration
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11
Q

How can the container affect the formulation?

A
Adsorption
Leaching
Oxygen permeability
Moisture permeability
Closure of container (microbiological)
Rate of administration
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12
Q

How can starting material specification (specifically ophthalmic solutions) affect the formulation?

A

Ophthalmic solutions contain:

  • pH/Buffers (4.5 - 11.5)
  • Preservatives
  • Antioxidants
  • Viscosity enhancers

Tonicity and Osmolarity

  • Lacrimal fluid is iso-osmotic with 0.9% sodium chloride
  • n.b. the eye can tolerate 0.6-1.8% sodium chloride
  • 300 mOsm/L is ideal, 200-600 mOsm/L is acceptable
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13
Q

How can starting material specification (specifically subcutaneous) affect the formulation?

A

Volume restricted

- Ideally 5mL

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14
Q

How can starting material specification (specifically intrathecal) affect the formulation?

A
Avoid antimicrobials, antioxidants, pyrogens and preservatives
- Toxic to CNS
- Use NaCl as tonicity-adjusting agent
Particulates ok
- e.g. microspheres for slow release
Lower endotoxin limit
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15
Q

What information does the Summary of Product Characteristics (SmPC) usually provide?

A

Dose & Administration information
- reconstitution details and stability
Pharmaceutical Particulars
- excipients, incompatibilities, shelf life, storage

Generate by company
Available on the MHRA website

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16
Q

What does ‘Trissel’ provide?

A

350+ drug monographs
Stability & compatibility
- No peer review
- Useful general reminder

17
Q

What do ‘Cytotoxic & CIVA handbooks’ provide?

A

Written & reviewed by aseptic pharmacists
In-depth summary of individual drug stabilities
Preparation information

18
Q

What errors are associated with incorrect labelling?

A

Administering wrong drug or dose
- if label does not correspond with the contents
Administering an unstable product
- if expiry date is wrong

19
Q

What information needs to be provided on a label?

A
Patient name and identification
Drug name
Total drug dose
Total volume
Diluent
Route
Storage instructions
BN + expiry
Handling instructions
Ward

Professional appearance, clarity & placement to avoid obscuring graduations
Reconciliation