Handbook

Question 1

Extemporaneous dispensing should only take place when?

Answer 1

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.

Question 2

Do you need to supply a PIL with an unlicensed medicinal product?

Answer 2

Not sure.

Question 3

How long must worksheets be kept for?

Answer 3

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.

Question 4

In regards to health and safety, before manufacture of a product has begun, what should be considered? [5]

Answer 4

1. Are there any harmful ingredients?
2. Am I aware of the risks they pose?
3. Am I putting my colleagues, my patients or myself at risk?
4. Do I have the correct protective equipment available if necessary?
5. Would I know what to do in the event of personal contamination?

Question 5

To what do the COSHH regulations 2002 not apply?

Answer 5

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.

Question 6

What do COSHH regs state wrt to formaldehyde lotion BPC?

Answer 6

Must be made in a fume cupboard.

Question 7

Why is the small-scale manufacture of products containing dithranol or coal tar discouraged?

Answer 7

Caustic/carcinogenic.

Question 8

What are the CLP regulations?

Answer 8

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.

Question 9

What is REACH?

Answer 9

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.

Question 10

What does the term water refer to?

Answer 10

Without any other qualification: potable water freshly drawn direct from public supply and suitable for drinking or freshly boiled and cooled purified water.

Question 11

What is the formula for double strength chloroform water?

Answer 11

Active ingredients:

Chloroform 5ml + purified water to 1000ml.

Question 12

Why is it difficult to prepare double strength chloroform water?

Answer 12

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.

Question 13

How can we prepare Chloroform Water BP (Single Strength Chloroform water)?

Answer 13

1 in 40 dilution of Conc Chloro Water BPC:
CCWBPC 2.5ml
Purified water 100ml

Question 14

How can we prepare Double Strength Chloroform water BP?

Answer 14

1 in 20 dilution.
CCWBPC 5ml.
Water: 100ml

Question 15

What is the method for the preparation of DS Chloroform Water BP?

Answer 15

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.

Question 16

What is reconstitution?

Answer 16

Addition of a vehicle (usually water) to dry powder to give a liquid preparation. This usually results in a preparation of limited stability.

Question 17

What does freshly prepared mean?

Answer 17

Must be made not more than 24 hours before it is issued for use.
2 week expiry.

Question 18

What does recently prepared indicate?

Answer 18

Deterioration is likely if the preparation is stored for longer than about 4 weeks at 15-25 degrees.
4 week expiry.

Question 19

How do freshly prepared and recently prepared differ?

Answer 19

FP: 2 weeks expiry
RP: 4 weeks expiry

Question 20

‘Shake the bottle’ should be included on:

Answer 20

All suspensions to ensure any dose is taken from a uniformly distributed mixture.

Question 21

All weights, measures and instruments used in pharmacies are under the control of:

Answer 21

Weights and Measures Act 1985.

Question 22

What type of dispensing balance is used in dispensaries?

Answer 22

Class II dispensing balance with a minimum weigh able quantity of 150mg and maximum of 25g.