Week 10 Medicine regulation

Question 1

Legislation

Answer 1

Modern medicines legislation in the UK was triggered by the
thalidomide tragedy

Question 2

Medicinal products

Answer 2

NOT medicines (HMR2012)
->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.
->Human blood is expressly excluded

Question 3

Regulators

Answer 3

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 4

Marketing authorisations for human medicines

Answer 4

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 5

Off-label prescribing

Answer 5

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 6

Revocation, variation or suspension

Answer 6

-Harmful or ineffective
-Incorrect information
-Breach of licence
-Unfulfilled licence
-Information not provided
-No longer EU based
-Non-compliance with Good Manufacturing Practice (GMP)
-Unfulfilled licence (non-UK)
-Public at risk
-Apply for change
-Poor manufacturing

Question 7

Orphan drugs

Answer 7

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 8

Orphan drugs 2

Answer 8

To qualify for orphan designation:
-For a disease that is life-threatening or chronically debilitating
-Not more than 5 in 10,000
-No satisfactory method exists
Orphan medicinal products will benefit from up to 10 years of market exclusivity from similar products

Question 9

Generics

Answer 9

Have the same composition as a Reference Medicinal Products
(RMPs)
Has the same pharmaceutical form
Appropriate bioavailability studies (demonstrated bioequivalence)
Typically, cheaper than branded medicines

Question 10

Generics 2

Answer 10

Branded generic -> generics that have a brand name
-Encourage medical practitioners to prescribe branded generics which have a lower price than non-branded generics

Question 11

Abridged procedures

Answer 11

->Manufacturers will have incurred the considerable cost of years of R&D (research and development)
->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
-Market exclusivity

Question 12

Early Access to Medicines Scheme (EAMS)

Answer 12

Enables patients to have access to medicines which have not yet been authorised
-Life-threatening or seriously debilitating conditions,
-No suitable alternative
-Voluntary
->riskier, potential untested side effects

Question 13

Pharmacovigilance

Answer 13

-Detection, assessment, understanding and prevention of adverse effects or any other drug-related problem
-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 15

Yellow card scheme 2

Answer 15

The Cumberlege Review (2020) concluded that the Yellow Card
scheme could not be relied upon to identify promptly significant
adverse outcomes
Best system we have up to now, paper BNF / online form

Question 15

Pharmacovigilance 2

Answer 15

-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 15

Yellow card scheme

Answer 15

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