Extemporaneous Dispensing 2 Flashcards
Reasons for requesting an extemporaneous
preparation
• Appropriate licensed formulation unavailable
– Liquid dosage forms when only tablets / capsules available
– Dilution of creams / ointments when higher strength only available
– Discontinued licensed medications
• Allergy to excipients in licensed preparations
• Sugar or alcohol content of liquid preparations too
high for patient
How can we meet the 5 prinicples set out
in the guidance?
Quality Assurance of the final product
- Alternatives
- Production staff
- Raw materials
- Manufacturing unit
- Documentation
- Compounding
- Labelling
- Final check
Record Keeping and • Record should include:
• Good practice to keep records of extemp products
prepared in the pharmacy
• Record should include:
– Formula
– Ingredients and quantities
– Source of ingredients (i.e. Manufacturer)
– Batch numbers and expiry dates of all ingredients where in existence (INTERMEDIATE PRODUCTS ARE NOT ALWAYS GIVEN A BATCH NUMBER)
– Use by date of prepared product
Extemporaneous preparations – clinical
safety
• Before preparing an extemp product YOU need to be sure it is clinically appropriate
– Official formula
– Unofficial formula
Official Formulae
• Must be listed in:
• British Pharmacopoeia (BP)
• British Pharmaceutical Codex (BPC)
– Up to and including 11th edition as 12th edition does not contain formulae
– BPC in title
• Formulae may be listed elsewhere, e.g. Martindale, BNF
– Must have BP or BPC in title to be official
Official Example
- Rx for
- Wool Acohols 6 g
- White Soft Paraffin 10 g
- Hard Paraffin 24 g
- Liquid Paraffin 60 g
- Wool Alcohols Ointment BP Formula
- Wool Alcohols 60 g
- White Soft Paraffin 100 g
- Hard Paraffin 240 g
- Liquid Paraffin 600 g
Unofficial example
- Rx for
- Magnesium trisilicate 7.5 g
- Light magnesium carbonate 7.5 g
- Sodium bicarbonate 7.5 g
- Suitable vehicle to 150 mL
Magnesium Trisilicate - Mixture BP Formula • Magnesium trisilicate 50 g • Light magnesium carbonate 50 g • Sodium bicarbonate 50 g • Conc. Peppermint emulsion 25 mL • Suitable vehicle to 1000 mL
Checking Formulae
• Start with first ingredient in the formula
– Likely to be the primary active ingredient
• Consider the role of other ingredients in the formula
– Are they necessary?
– Will they affect the expiry date of the finished product?
Legal Requirements - Labelling
- Name of the patient
- Name and address of the pharmacy
- Date of dispensing
- Name of the product (or common name e.g. The Nose Drops)
- Directions for use
- Precautions for use (cautionary and advisory)
- KOOR(AS)OC
Legal Requirements - Labelling
• If a product is an unoffical formula
- If a product is an unoffical formula (not BP or BPC) it MUST contain the quantitative particulars of the preparation
- The formula can be expressed as a % or as the exact quantities used
Legal Requirements - Labelling
Extra Precautions for use on extemp preps:
• Expiry date (dd/mm/yyyy) – ‘Use before….’ – ‘Do not use after….’ • Storage conditions – ‘Protect from light’ – ‘Store in a fridge’
Legal requirements - Labelling - Common warning labels:
• ‘Not to be taken’, ‘Do not swallow’ – For anything that should not be swallowed • ‘For external use only’ • ‘For rectal use only’ • ‘Shake the bottle’ – (for suspensions)
Containers
- Amber glass bottle
- Amber glass fluted/ribbed bottle
- Amber glass cream/ointment jar
- Amber glass dropper bottles (should be hexagonal ribbed for external products)
Good Practice
• Keep your working area tidy
• Ensure all equipment is clean before starting
• Only use one ingredient at a time
• All weights and volumes to be checked by a colleague at the time of weighing/measuring
• Ensure balances are kept clean
– i.e. clear up any spillages immediately!
• Clearly label all ingredients
– Place weighing boats, measuring cylinders etc on pieces of labelled paper
• Clean and dry all equipment and your working area before leaving
