Central Intravenous Additive Service (CIVAS) Products Flashcards
What is the definition of ‘Parenteral’?
Next to/beside ‘enteral’ (alimentary tract)
- Free of, or you methods to keep free of, pathological organisms
- Includes IV, SC, IM, Nasal, Topical Etc.
Why is aseptic preparation of parenterals necessary?
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
Why use the parenteral route?
- 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
What is chemotherapy?
Palliative, adjuvant or neo-adjuvant treatment for cancer
What are the typical presentations of CIVAS products?
Syringe
Infusion bag
Infusion device
What are the risks associated with CIVAS products?
Infection Thrombophlebitis Extravasation Air embolism Dose errors Incorrect drug, site, rate Incorrect formulation
Why is pharmacy involved in CIVAS products?
Risk of uncontrolled environment
Cost of the drug
- Where dose is
How can patient factors/requirements affect the formulation?
- Dose range
- Access
- Volume
- Rate of administration
- Other drugs
- Setting (hospital, homecare)
- Patient type
How can physical presentation of the starting material affect the formulation?
- Solution
- Freeze dried powder
- > diluent
- Emulsion
- Suspension
- > restricted routes
How can drug properties affect the formulation?
Stability - pH - Solution/solid - Catalyst - Diluent Light Storage Temperature - Room, Refrigeration, Freeze/thaw Concentration - Consider infusion bag overage Solubility - Co-solvents Physical stability - vibration
How can the container affect the formulation?
Adsorption Leaching Oxygen permeability Moisture permeability Closure of container (microbiological) Rate of administration
How can starting material specification (specifically ophthalmic solutions) affect the formulation?
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
How can starting material specification (specifically subcutaneous) affect the formulation?
Volume restricted
- Ideally 5mL
How can starting material specification (specifically intrathecal) affect the formulation?
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
What information does the Summary of Product Characteristics (SmPC) usually provide?
Dose & Administration information
- reconstitution details and stability
Pharmaceutical Particulars
- excipients, incompatibilities, shelf life, storage
Generate by company
Available on the MHRA website