PLE3 Human Meds Regulations & Advertising

Question 1

Which act regulates the UK drug industry?

Answer 1

Human Medicines Act 1968

Question 2

The medicines regulatory body (UK)

Answer 2

MHRA

Question 3

What is a marketing authorisation?

Answer 3

required to sell or supply any product in the UK

Granted by MHRA when safety, quality &efficacy standards are passed

Question 4

Outline each stage of clinical trials (1-3)

Answer 4

Phase I – <100 healthy people – side effects & how it works.

Phase II – ~700 patients with condition – common short term side effects

Phase III – 100s-1000s patients - how medicine works & safety in general population, breadth of side effects – labelling & info when it is marketed.

Question 5

Outline some reporting schemes

Answer 5

Yellow card
black triangle
MHRA quality checks
research on anonymised patient records

Question 6

What is the yellow card scheme?

Answer 6

ADRs reported by public/HCPs

Question 7

Black Triangle

• who reports an ADR?
• what is it?
• how long is it required?

Answer 7

• HCP
• symbol which accompanies newly marketed meds, requiring pharmacovigilence & further probationary monitoring
• 2 years

Question 8

Medicine alerts: severity from Class 1-4

Answer 8

Class 1 : most severe

Class 4 : least severe

Question 9

Class I medicine alert:

Answer 9

immediate recall - risk to health, possibly life-threatening

Question 10

Class II medicine alert

Answer 10

48h recall, may be harmful but not life-threatening

Question 11

Class III medicine alert

Answer 11

5 days recall, unlikely to harm patient

Question 12

Class IV medicine aert

Answer 12

Caution with use - no threat to patient safety

Question 13

State the 3 necessities of advertising

Answer 13

Product has MA
Advertised info aligns with product SPC
Encourages rational use
Scientifically proven evidence

Question 14

What is required on the outer packaging of a product?

Answer 14

Name, form, strength
API
Dosage units/volume
Excipients
Method of administration
Expiry
'Keep out of sight & reach of children'

Necessary warnings
Special storage requirements

Name & address of MA holder
Number of MA
Batch no,
Instructions for use

Question 15

Aspects of dispensing labelling

Answer 15

• Patient name
• Pharmacy name & address
• Date of dispensing
• Product name
• Directions for use
• Precautions related to product use
• ‘Keep out of reach and sight of children’
• Quality - not legally required but good practice

Question 16

Is the PIL a legal requirement?

What does it include?

Answer 16

Yes

• product identification
• therapeutic indications
• relevant info contraindications, interactions…
• Instructions for use, undesirable effects & action to take
• expiry & leaflet revision date.