Medicine Regulation - Political And Legal Frameworks I Flashcards
What are medicinal products (NOT medicines)
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.
Does blood count as a medicinal product?
No
Modern medicines legislation in the UK was triggered by which tragedy?
Thaolidomide
Who are the regulators fro medicines and licensing?
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.
Marketing authorisations for human medicines
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)
What is off-label prescribing?
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
What is an example of off-label prescription?
Medicine for migraines
Medicine for period pains
THEY must be covered by the authorisation and licensed appropriately
Revocation, variation or suspension
LIST at least 5 points:
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
E. No longer EU based, affect of Brexit?
It may cause shortages in products which are not from the EU, and therefore have not been stockpiled by suppliers
J. Apply for change, by authorities
If there is any additional info to be added
Orphan drugs
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.
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
What are generics?
Have the same composition as a Reference Medicinal Products (RMPs)
Has the same pharmaceutical form
Appropriate bioavailability studies (demonstrated bioequivalence)
Generic products are usually _______ that branded medicines.
cheaper
Is there guaranteed safety with generic products?
yes, same formula
What if there is changes to the branded medicines?
need another authorisation check as the target area may be different in tablets than capsules
NHS need to re-emburse pharmacies all over the UK - why use generic products instead of branded?
Cheaper - positive economic effect
Why use brands FOR generic?
When a prescription is being written, it may be this specific brand that is needed to be dispensed for that patient
Different brand names mean…
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.
Abridged procedures
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.
Early Access to Medicines Scheme (EAMS)
which enables…
Enables patients to have access to medicines which have not yet been authorised
What is special about the EAMS
life-threatening or seriously debilitating conditions
no suitable alternative
Voluntary - relying on the public/ healthcare professionals
Define Pharmacovigilance:
Detection, assessment, understanding and prevention of adverse effects or any other drug-related problem
Why is Pharmacovigilance important?
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
Are licensing authorities involved with pharmacovigilance?
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.
What is the yellow card scheme?
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.
Is the yellow card scheme relied upon?
The Cumberlege Review (2020) concluded that the Yellow Card scheme could not be relied upon to identify promptly significant adverse outcomes.
Where can we find the yellow pages?
At the back of the BNF
