Handbook Flashcards
Extemporaneous dispensing should only take place when?
There is no equivalent licensed preparation available.
This may arise where the market is too small for a commercial product to be viable, where a product requires a special formulation, or where a formularly product is too unstable to be made and stored commercially.
Do you need to supply a PIL with an unlicensed medicinal product?
Not sure.
How long must worksheets be kept for?
One year after the expiry date of the product or for FIVE years, whichever is longer. Article 22 (2) of EC directive 75/319/EEC.
In regards to health and safety, before manufacture of a product has begun, what should be considered? [5]
- Are there any harmful ingredients?
- Am I aware of the risks they pose?
- Am I putting my colleagues, my patients or myself at risk?
- Do I have the correct protective equipment available if necessary?
- Would I know what to do in the event of personal contamination?
To what do the COSHH regulations 2002 not apply?
Asbestos.
Lead.
Substances below ground in mines.
Any substance which is hazardous to health solely because it is radioactive, explosive, flammable, at high pressure or at high or low temperature. All of these are covered in separate legislation.
What do COSHH regs state wrt to formaldehyde lotion BPC?
Must be made in a fume cupboard.
Why is the small-scale manufacture of products containing dithranol or coal tar discouraged?
Caustic/carcinogenic.
What are the CLP regulations?
Controls the classification, labeling and packaging of substances and mixtures.
Does not apply to medicines but may apply to raw ingredients purchased for the manufacture of extemporaneous products.
What is REACH?
Regulation in the Registration, Evaluation, Authorization and Restriction of Chemicals Regulation.
EU regs, 1st June 2007.
SDS (Safety Data Sheets) are now a part of REACH.
What does the term water refer to?
Without any other qualification: potable water freshly drawn direct from public supply and suitable for drinking or freshly boiled and cooled purified water.
What is the formula for double strength chloroform water?
Active ingredients:
Chloroform 5ml + purified water to 1000ml.
Why is it difficult to prepare double strength chloroform water?
Solubility of chloroform in water is 1 in 200. In practice both single strength and double strength C water is prepared from Concentrated Chloroform Water BPC.
How can we prepare Chloroform Water BP (Single Strength Chloroform water)?
1 in 40 dilution of Conc Chloro Water BPC:
CCWBPC 2.5ml
Purified water 100ml
How can we prepare Double Strength Chloroform water BP?
1 in 20 dilution.
CCWBPC 5ml.
Water: 100ml
What is the method for the preparation of DS Chloroform Water BP?
1) Measure approximately 85-90ml of freshly boiled and cooled purified water in a 100ml conical measure.
2) Measure 5ml of Concentrated Chloroform Water BPC 1959 in a 5ml conical measure and add to the water. Stir vigorously.
3) Make up to volume (100ml) with more freshly boiled and cooled purified water and stir.
What is reconstitution?
Addition of a vehicle (usually water) to dry powder to give a liquid preparation. This usually results in a preparation of limited stability.
What does freshly prepared mean?
Must be made not more than 24 hours before it is issued for use.
2 week expiry.
What does recently prepared indicate?
Deterioration is likely if the preparation is stored for longer than about 4 weeks at 15-25 degrees.
4 week expiry.
How do freshly prepared and recently prepared differ?
FP: 2 weeks expiry
RP: 4 weeks expiry
‘Shake the bottle’ should be included on:
All suspensions to ensure any dose is taken from a uniformly distributed mixture.
All weights, measures and instruments used in pharmacies are under the control of:
Weights and Measures Act 1985.
What type of dispensing balance is used in dispensaries?
Class II dispensing balance with a minimum weigh able quantity of 150mg and maximum of 25g.
