Product Liablity And Consumer Protection Flashcards
Why is pharmacovigilance important
Only a small amount of people in pre clinical trials
Lab conditions in clinical trial may not represent actual clinical action in real life
Some ADRs may occur after prolonged exposure
Rare ADRs may not have occurred in trial
Which groups will always be excluded from trials
Pregnant women Children Elderly Those with multiple disease states Those vulnerable to ADRS
These are the most important group to have the information on as these are the ones that will be getting the drug
What is the process of pharmacovigilance
Monitoring the use of medicines in everyday practise to identify previously unrecognised ADRS or patterns in the effects
Assessing the risk and benefits of medicines in order to determine what action, if any, is needed to improve there safety
Monitoring the impact of action taken
What is the yellow card scheme
A spontaneous reporting scheme for suspected ADRS
Started in 1964 due to thalidomide
MA holders are legally obliged to report suspected ADRS via the scheme
Who can report ADRs
Doctors and medical students Dentists Coroners Pharmacists and pre-reg Nurses- inc midwifes Optometrist Chiropodist Paramedic Patient, parent or carers
What should be reported on
vaccines Herbal medicines Blood factors + immunoglobulins Homeopathic medicines All marketed devices on UK market Defective medicines Fake medicines E-cigs Black triangle drugs Any serious ADR
Why is a drug black triangle
Contains a new active ingredient
It is a biological medicine such as a vaccines or a medicine derived from plasma
It has been given conditional approval- MRHA wants more data regarding saftey
New medicines as companies are required to provide more long term data on medicines
Why do we report all black triangle ADRs
To confirm the risk/benefit profile established during the pre-marketing phase
To increase our understanding of the safety profile of a new medicine
To ensure that we identify previously unrecognised side effects as quickly as possible
What constitutes a serious reaction
Fatal Life threatening Disabelling Incapacitating Hospitalisation Congenital abnormalities Medically significant
Why do we not report older drugs
No longer require intensive monitoring as black triangle products because the safety has been established
However if it is a serious reaction then we report
What is post marketing evaluation
Allows variation and renewal of MA
Change from 2nd line to 1st line treatment
Changing to permit usage in a different age group
Reclassification of medicine POM->P
Regulation of advertisement and promotion
What are the different consumer protection legislations
Trades descriptions 1968
Consumer protection act 1987
General product saftey 2005
Consumer rights 2015
What does the trade description act 1968 cover
Illegal to falsley describe goods, services or business
Description covers a range of factors e.g. quantity/size, composition, purpose, endorsement
Covers all descriptions- oral, written and visual
Offence knowingly making a false statement about a good
What does the consumer protection 1987 and general product saftey 2005 cover
1) product liability
2) safety of goods
3) misleading prices
What is product liability
This is liability without fault
Also known as strict liability
This means people damaged by a defective product can sue the supplier for damages, without having to prove negligence
