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
Who is liable
This is in rank order Manufacture Importer Anyone acting as a manufacture (Tesco paracetamol) Supplier (pharmacist)
For medicine it is usually the MA holder who has liability but it passes to pharmacist if they can’t track the manufacture
When can claims be made
Can be made upto 3 Years after injury
Can sue upto 10 Years if after 3 Years if when they found out they had a claim
To succeed the claimant must prove (on the balance of probability) the product was defective and caused the damage
What defence are there
If defendant didn’t supply product- fake or stolen
Safety was compromised by obeying other laws
Someone else caused the fault
Product was not supplied in the course of business (2nd hand, charity)
The defect is due to overall product and the defendant is a manufacturer of a component
What legislation did the consumer rights act 2015 replace
Sales of goods act
Unfair terms in consumer contracts regulation
Supply of goods and services
Good under the consumer rights act should
Be of a satisfactory quality
Be fit for purpose
Match the description
Be installed correctly
Consumers have right to reject goods in 1st 30 days
Repair or replacement in 1st 30 days
Price reduction or reject- if repair is unavailable or unacceptable
