Labelling Medicines

Question 1

What are the standards for labelling?

Answer 1

In English 
legible 
indelible 
clear 
comprehensible

Question 2

What are the requirements for a label?

Answer 2

name and address of the patient 
date of birth the patient 
name and address of the suppling pharmacy 
date of dispensing 
name of medicine
= total quality and strength 
directions for use
= dosage instructions
precautions
= warning labels and counselling
RPS recommends 

phrase
- ‘keep out of the reach and sight of children’

Question 3

What are the legal requirements of a prescription?

Answer 3

name and address of the patient 
date of birth of the patient 
- if under 12 years old
name and address of the supplying pharmacist/pharmacy
signature of the prescriber 
- indelible ink
date of prescribing 
- must be within 6 months of dispensing
legally required phrase
- 'keep out of the reach and sight of children'

Question 4

Why is it important to label prescription with more than one medicine correctly?

Answer 4

to show the patient the entire required quantity

to show the order of usage

Question 5

Why is labelling needed?

Answer 5

To make sure the patient receives sufficient information and advice to enable the safe and effective use of the prescribed medicine

Question 6

What are additional auxiliary, storage and dispensing information required for labelling?

Answer 6

shake the bottle
store in a cool place
discard after … days after opening, do not use after…
- antibiotics, eyedrops (must be sterile = free from microbes), diluted liquids and topical preparations

for external use only
potency

Question 7

What are non-relevant medicinal products?

Answer 7

unlicensed products
- do not have the MHRA license
extemporaneously prepared products
specials

Question 8

What are the labelling requirements for non-relevant medicinal products?

Answer 8

batch number
- if the preparation has been prepared extemporaneously against a prescription

expiry date
- should be indicated if the preparation has been prepared extemporaneously or the shelf life has been shortened
= diluted products

Question 9

What are assembled medicinal products? Why are they used?

Answer 9

pre-packed products

- it is the breaking of bulk products into smaller quantities

Question 10

What are the labelling requirements for assembled medicinal products?

Answer 10

name of the medicinal product
quantitative particulars of the medicinal product
= ingredients 
quantity 
= total dose 
special handling or storage requirements 
the expiry date 
the batch reference

Question 11

What is Chemist’s Nostrum?

Answer 11

medicinal products prepared in a registered pharmacy for retail sale from that pharmacy which are not advertised

• OTC
• extemporaneous preparation

Question 12

What are the labelling requirements for Chemist’s Nostrum?

Answer 12

name of the product
pharmaceutical form
quantitative particulars 
= ingredients 
quantity 
= total dose
directions for use
handling and storage requirements 
batch number 
expiry date

phrase = ‘keep out of the reach and sight of children’
warning labels
name and address of supplier
legal label - GSL, P, POM

Question 13

What are relevant medicinal products?

Answer 13

medicinal products with marketing authorisation

Question 14

What are the labelling requirements for relevant medical products?

Answer 14

brand and its common (generic) name
the active ingredient
= expressed quantitatively and qualitatively per dosage unit or form of administration
pharmaceutical form
contents by weight, volume or number of doses
a list of excipients with recognised action
= all excipients for injections, eye or topical products
method and route of administration
‘keep out of the reach and sight of children’
special warnings
expiry date
store out of the reach and sight of children
special warnings
expiry date
storage precautions
special disposal precautions for waste
The name and holder of the MA
The address of the MA holder
MA number
batch reference

medicinal labelling - POM, P, GSL
auxiliary labelling

braille
dispensing area minimum size = 35x70mm
labelling cannot be promotionla
indicate if the strength is adult or child - if there is more than one strength

Question 15

What is a PIL? When must it be supplied?

Answer 15

patient information leaflet
- must be supplied with every prescription/relevant medicinal product

leaflet with information about the medicinal product being supplied

• what is it
• how it should be used
• storage
• warnings

Question 16

What are DVLA warnings?

Answer 16

Driving and Vehicle Licensing Agency

- labels used the medicine impairs the patients ability to drive and operate tools or heavy machinery