Labelling

Question 1

The medicines labelling regulations 1994 applies to all medicinal products in the UK, what is the packaging requirements that s licensed product must have?

Answer 1

• Prominent labelling with ingredients
• Space for dispensing label with a POM
• Info in braille

Question 2

What must an MA get to change the labelling on a product?

Answer 2

Variation to their MA - process 30-90 days

Question 3

List the standard labelling requirements

Answer 3

• Name of product
• Recommended international propriety name
• Active ingredients, form and strength
• Excipients
• Route of administration
• ‘Keep all medicines out of reach & sight of children’
• Warning particular to product
• Expiry date
• Special storage conditions
• Disposal precautions
• MA no, name and address
• BN no
• If product is for self admin. Any required instructions for use
• P/POM written clearly

Question 4

List the legal requirements that must appear on dispensed medicinal products.

Answer 4

• Patient name
• Name and address of supplier
• Date of dispensing
• Name of product
• Direction for use
• Precautions relating to use

Question 5

What are good practice labelling requirements?

Answer 5

BNF cautionary and advisory labels

Question 6

What does the RPS recommend to add onto labels?

Answer 6

‘Keep out of sight and reach of children’

Question 7

What is a PIL?

Answer 7

Legally required to be given in the sale/supply of product

Question 8

What are the advantages of PILs?

Answer 8

• Gives info to patient/ carers
• Useful to assist pharmacists with patient counselling
• Encourages patient to be informed and their medicines encouraging adherence.

Question 9

What are the disadvantages of PILs?

Answer 9

• List of SEs and cautions may worry patient
• May be unrelated to patient condition
• Leaflets may differ between different manufacturers

Question 10

Define CRC

Answer 10

Child resistant container

Question 11

List products that are legally required to be in a CRC and exemption from CRC

Answer 11

• Products containing aspirin, paracetamol, Fe more than 24mg, in tablet, capsule, lozenge, pastille, suppository and liquid.
• Cough & cold oral liquid products containing certain antitussive, antihistamine, expectorants and decongestants

exemptions - Effervescent and single dose unit products

Question 12

Professional responsibility to supply all solid dose, oral liquid and external liquid products in a CRC unless:

Answer 12

• Medicine is in a patient pack or original container
• Patient can’t open CRC
• Patient requests to not have a CRC
• No suitable CRC exists
• Patient requests a 7 day compliance aid