Medicine Regulation - Political And Legal Frameworks I

Question 1

What are medicinal products (NOT medicines)

Answer 1

For preventing or treating disease in human beings

Restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic
action

Making a medical diagnosis.

Question 2

Does blood count as a medicinal product?

Answer 2

No

Question 3

Modern medicines legislation in the UK was triggered by which tragedy?

Answer 3

Thaolidomide

Question 4

Who are the regulators fro medicines and licensing?

Answer 4

Medicines and Healthcare products Regulatory Agency (MHRA)
an executive agency of the Department of Health and Social Care

The MHRA is also enforcement authority for licensing matters in the UK.

Question 5

Marketing authorisations for human medicines

Answer 5

Human Medicines Regulations 2012

A person may not sell or supply or offer to sell or supply a medicinal product unless that product has a UK marketing authorisation

Summary of Product Characteristics (SmPC)

Question 6

What is off-label prescribing?

Answer 6

Treating a patient who has a condition for which the product does not have a marketing authorisation

A marketing authorisation can be given to treat one condition but not another condition for which it may nevertheless be effective

Question 7

What is an example of off-label prescription?

Answer 7

Medicine for migraines

Medicine for period pains

THEY must be covered by the authorisation and licensed appropriately

Question 8

Revocation, variation or suspension
LIST at least 5 points:

Answer 8

A. Harmful or ineffective
B. Incorrect information
C. Breach of licence
D. Unfulfilled licence
E. Information not provided
F. No longer EU based
G. Non-compliance with Good Manufacturing
Practice (GMP)
H. Unfulfilled licence (non-UK)
I. Public at risk
J. Apply for change
K. Poor manufacturing

Question 9

E. No longer EU based, affect of Brexit?

Answer 9

It may cause shortages in products which are not from the EU, and therefore have not been stockpiled by suppliers

Question 10

J. Apply for change, by authorities

Answer 10

If there is any additional info to be added

Question 11

Orphan drugs

Answer 11

Used to treat conditions that occur infrequently

Cost of R&D would not be recovered by the expected sales

Therefore;
the pharmaceutical industry would be unwilling to develop the medicinal product under normal market conditions.

Question 12

To qualify for orphan designation:

Answer 12

for a disease that is life-threatening or chronically debilitating not more than 5 in 10,000 no satisfactory method exists

Question 13

What are generics?

Answer 13

Have the same composition as a Reference Medicinal Products (RMPs)
Has the same pharmaceutical form
Appropriate bioavailability studies (demonstrated bioequivalence)

Question 14

Generic products are usually _______ that branded medicines.

Answer 14

cheaper

Question 15

Is there guaranteed safety with generic products?

Answer 15

yes, same formula

Question 16

What if there is changes to the branded medicines?

Answer 16

need another authorisation check as the target area may be different in tablets than capsules

Question 17

NHS need to re-emburse pharmacies all over the UK - why use generic products instead of branded?

Answer 17

Cheaper - positive economic effect

Question 18

Why use brands FOR generic?

Answer 18

When a prescription is being written, it may be this specific brand that is needed to be dispensed for that patient

Question 19

Different brand names mean…

Answer 19

Once a patent expires, other companies can develop their own version of the medicine.

These are known as generic brands.

Their active ingredient name always remains the same, but they are marketed under different brand names.

Question 20

Abridged procedures

Answer 20

Manufacturers will have incurred the considerable cost of years of R&D

A competitor can rely on the data for the original product only after the passage of a data exclusivity period.

The data exclusivity period is eight years for products that have been authorised in the UK.

Question 21

Early Access to Medicines Scheme (EAMS)
which enables…

Answer 21

Enables patients to have access to medicines which have not yet been authorised

Question 22

What is special about the EAMS

Answer 22

life-threatening or seriously debilitating conditions

no suitable alternative

Voluntary - relying on the public/ healthcare professionals

Question 23

Define Pharmacovigilance:

Answer 23

Detection, assessment, understanding and prevention of adverse effects or any other drug-related problem

Question 24

Why is Pharmacovigilance important?

Answer 24

Promote the safe and effective use of drugs by providing reliable information

Information obtainable before a medicine is placed on the market is ultimately limited

Question 25

Are licensing authorities involved with pharmacovigilance?

Answer 25

Both the licensing authority and holders of manufacturing authorisations must operate a pharmacovigilance system

Capture and evaluate all information

Take all appropriate measures to minimise and prevent risk.

Question 26

What is the yellow card scheme?

Answer 26

MHRA

Collecting and monitoring information on suspected safety concerns or incidents involving medicines and medical devices.

Voluntary reporting

Early warning that the safety of a product may require further investigation.

Question 27

Is the yellow card scheme relied upon?

Answer 27

The Cumberlege Review (2020) concluded that the Yellow Card scheme could not be relied upon to identify promptly significant adverse outcomes.

Question 28

Where can we find the yellow pages?

Answer 28

At the back of the BNF