Advertising, Labelling + Packaging Requirements

Question 1

What is advertising of a medicine ?

Answer 1

• anything designed to promote the prescription, supply, sale or use of that medicinal product

Question 2

What medicines are advertisements prohibited for ?

Answer 2

• CD’S and POM’s
• exceptions for approved vaccine campgains

Question 3

What are the general principles of advertising ?

Answer 3

• Ads must only be published if the product has a MA
• Ads must comply with the SPC
• Ads should encourage rational use, avoiding exaggeration and being non-misleading.

Question 4

What are the rules for hospitality in advertising to healthcare professionals?

Answer 4

• hospitality may only be given to healthcare professionals (HCPs) qualified to prescribe or supply.
• it must be reasonable and related to scientific or professional meetings.
- gifts or financial advantages are only allowed if they are inexpensive and relevant to the profession.

Question 5

Who monitors medicinal product advertising?

Answer 5

• self-regulatory bodies like the UK ASA (Advertising Standards Authority)
• legal provisions are enforced by health ministers

Question 6

What are the form and content requirements for advertising medicinal products?

Answer 6

• Clear identification that it is an advertisement and that the product is a medicinal product.
  Must include:
  - The name of the medicinal product.
  
  • The common name of the active ingredients
  • Information necessary for the correct use of the product.
  • an invitation to read the package leaflet or instructions carefully.

Question 7

What guidance is available for advertising and promoting medicines in the UK?

Answer 7

• The ‘Blue Guide’ published by MHRA provides detailed guidance on advertising and promoting medicines in the UK

Question 8

What is the definition of immediate packaging under HMR 2012?

Answer 8

• refers to the container or packaging in direct contact with the medicinal product.

Question 9

What is the definition of a package under HMR 2012?

Answer 9

• container or any box/packet enclosing one or more containers of the product
• and any additional box enclosing the package.

Question 10

What is meant by medicines on prescription?

Answer 10

• medicines on prescription are those that are dispensed against a prescription

Question 11

What are the general labelling regulations for medicinal products under HMR 2012?

Answer 11

• All containers and packages must be legal, comprehensible, and indelible.
• must be in English, unless it’s an orphan medicinal product (to treat rare disease)

Question 12

What information must be included on the label of a medicinal product ?

Answer 12

• name, strength, and form of the medicinal product
• whether the product is for babies, children, or adults
• common names of up to three active substances.
• expiry date (month and year).
• batch number of the manufacturer.
• administration method and route (if necessary)
• pharmaceutical form + contents by weight volume or number of doses of the product
• name and address of MA holder

Question 13

What additional labelling requirement does Blister pack need ?

Answer 13

• name and address of MA holder

Question 14

What information is legally required on a dispensed medicinal product?

Answer 14

• Patient’s name.
• Supplying pharmacy’s name and address.
• Date of dispensing.
• Name of the medicine.
• Directions for use (e.g., “Take ONE tablet THREE times a day”).
• Precautions for use (e.g., “For external use only”).

Question 15

What does the RPS recommend also appears on the dispensing label ?

Answer 15

• Keep out of the reach and sight of children’
• Use this medicine only on your skin’ where applicable.

Question 16

What specific recommendation applies to secure environments for dispensing labels?

Answer 16

• Include the prisoner number as a definitive patient identifier.

Question 17

What other optional information can pharmacists add to a dispensing label?

Answer 17

• Additional information deemed necessary for safe use.
• Quantity of medicine (not legally required but good practice).
• BNF advisory and cautionary labels (at the pharmacist’s discretion).

Question 18

What are BNF Cautionary and Advisory Labels, and where can they be found?

Answer 18

• BNF codes appear next to drugs in the BNF.
• These labels provide specific cautionary or advisory information about the drug.

Question 19

How should BNF Cautionary and Advisory Labels be used?

Answer 19

• Recommended to be added to the dispensing label.
• The information should also be provided during consultations with patients or carers.

Question 20

What does the prescription endorsement “NCL” mean?

Answer 20

• NCL stands for “No Cautionary Label.”
• Prescribers can endorse a prescription with NCL if cautionary labels are not required.

Question 21

Why should the actual container of a medicine be labeled instead of the outer container?

Answer 21

• the outer container may be discarded, leading to loss of labelling information
• labelling should be applied directly to the actual container (e.g., inhaler or cream tube).

Question 22

How can pharmacists optimize labelling ?

Answer 22

• pharmacists can substitute directions, names, or precautions with a similar alternative if deemed inappropriate, without contacting the prescriber
• must keep a record of any changes.

Question 23

What is required for assembly or pre-packaging of medicines by a pharmacy?

Answer 23

• requires an MHRA license if medicines are supplied to a separate legal entity (e.g., one NHS Trust to another).

Question 24

What must be included on the label when medicines are broken down from bulk?

Answer 24

• name of the medicine.
• quantity in the container
• quantitative particulars (ingredients).
• handling and storage requirements (if applicable).
• expiry date.
• batch reference number (e.g., LOT number).

Question 25

‘Hub and Spoke’ dispensing model

Answer 25

• changes to HMR around ‘hub and spoke’ dispensing models
  • Dispensing / assembly process can be done in a separate pharmacy premises (hub)
  • staff in the spokes freed up to provide more direct patient care

Question 26

What is a Patient Information Leaflet (PIL)?

Answer 26

• a package leaflet included in the packaging of a medicinal product.
• outlines details about the identity, strength, and formulation of the medicine.
• provides instructions for safe and proper use and information about missed doses.

Question 27

What precautionary information must a PIL include?

Answer 27

• Contraindications.
• Drug interactions.
• Special warnings.
• Information for particular groups (e.g., pregnant, breastfeeding, or elderly persons).

Question 28

What additional information must a PIL contain?

Answer 28

• Information about adverse effects.
• A full list of ingredients.
• Therapeutic group and indications.

Question 29

What is the requirement for child-resistant packaging for medicinal products?

Answer 29

• should be used for all solid oral and external dose preparations, unless a valid reason is provided.

Question 30

When can non-child-resistant packaging be supplied?

Answer 30

• If a patient, carer specifically requests it due to difficulty in opening the packaging.
• Pharmacists may supply a non-child-resistant lid in these cases.

Question 31

Why might medicines remain in their original packaging instead of child-resistant containers?

Answer 31

• the original pack may not be child-resistant but has specific reasons for remaining unchanged (e.g., regulatory or compatibility).
- some liquid medicines may not have child-resistant packaging available.

Question 32

What are the child-resistant packaging rules for regulated medicines like aspirin, paracetamol, and elemental iron?

Answer 32

• must be supplied in opaque or dark-tinted child-resistant packaging.
- exceptions apply if sold or supplied under a pharmacist’s supervision in a registered pharmacy