Flashcards in ED 2 Deck (16):
State 3 reasons for requesting an extemp... preparation
1) Appropriate licensed formulation is unavailable
2) Allergy to excipients in licensed product
3) Sugar/Alcohol content of liquid prep too high for patient
How can we meet the 5 principles set out in the guidance?
By ensuring quality assurance of the final product
It is good practice to keep records of extemp products prepared in the pharmacy. TRUE or FALSE
State 5 things the record should include
2) Ingredients and quantities
3) Source of ingredients (e.g: Manufacturer)
4) Batch no (where possible) and expiry dates of all ingredients
5) Use by date of prepared product
A clinical check must be done before preparing extemp product. TRUE or FALSE
Name 2 places official formulas for extemp preparations MUST be listed in ?
1) British Pharmacopoeia (BP)
2) British Pharmaceutical Codex (BPC)
Name other sources official formulas can be listed in
(must have BP or BPC listed in title to be official)
When checking the formulae, why should you start with the first ingredient ?
It is likely to be the primary active ingredient
Does the 12th edition of the BPC contain official formulas. YES or NO
What type of containers are used for extemp preparations ?
Amber glass bottles and jars
What type of products are stored in hexagonal ribbed amber glass dropper bottles ?
For unofficial formulas, quantitative measures must be added on label. TRUE or FALSE
How should the expiry date be stated on an extemp product ?
The exact date must be included on the label
State 5 good practices in extemp preparations
1) Working area should be kept tidy
2) Equipment should be cleaned before starting
3) Use one ingredient at a time
4) Clearly label all ingredients
5) Clan and dry all equipments and working area before leaving
What are the legal requirements for labelling of a BP or
BPC (licenced) formula product?
- Name of patient
- Name and address of pharmacy
- Date of dispensing
- Name of the product (or common name) including
strength and formulation if required
- Directions for use
- Precautions for use (Cautionary and Advisory)
- Specific expiry date
- Storage conditions
- Common warning labels