Law And Ethics Consumer Protection Flashcards
Who enforces the laws?
Investigation and action via:
Local trading standards officer
The office of fair trading
Why do we have consumer protection laws?
Protects customers and businesses from unprofessional vendors and rogue traders
Designed to ensure fair trade, competition and the free flow of truthful information in the marketplace
Consumer protection issues are dealt with when complaints are made to the ?
Director General of Fair Trade
What is the OFT?
The Office of Fair Trading
The UKs official consumer and competition watchdog.
Their aim is to make markets work well for consumers, by promoting and protecting consumers interests throughout the UK
Consumer protection act part I
Introduced a regime of strict liability for damage arising from defective products
I.e people can SUE if they are injured by defective products
Consumer protection act part II
Created government powers to regulate the safety of consumer products
Consumer protection act part III
Defined a criminal offence of ‘giving a misleading price indication’
Who is liable for a product that is defected causing harm to a patient?
Producer
Importer
Own-brander
Supplier?- no, unless they’ve failed to identify the produced, importer or own brand
These are the four classes of people who may face liability for a defected product.
What happens if we dispense a medication and it turns out to be defective?
The primary producer of this medication is the license holder
Pharmacist is just the supplier
As long as the pharmacist can show records to identify the license holder/ manufacturer they won’t get in trouble.
What happens with extemporaneous dispensing?
This is an own remedy
So pharmacist carries full responsibility
Also need to maintain records of the producers of the ingredients!
How do you have Liability in a pharmacy?
Supplying unlicensed medicines or off licence use
Crushing tablets to administer
Supplying PILs or counselling administration- YOU are liable for advising on safe and appropriate use of products
Crushing a tablet. Renders it’s use unlicensed. The manufacturer will not be liable for harm done. This is under the _____ ______ Act.
The consumer protection act
What is a defective product?
When safety of a product is not as a person is entitled to expect
Can cause danger/ damage to people or property.
What will the court take into account when deciding if a product is defective?
Marketing- how it’s marketed
Time of supply
Instructions/ warnings with the product- were you warned about the defect?
Reasonable use
In court, the plaintiff (complaining party) MUST show the defective product that has caused the damage
Plaintiff must show even though the warning labels etc were followed, damage still occured
Under the consumer protection act, how long does someone have to make a complaint?
3 years after the date when damage occurred
OR later if it came to the knowledge of the person complaining later on,No claims are considered after 10 years after the product was bought
What is the plaintiff?
The person complaining
Part II of the consumer protection act is to do with safety. What does it ensure?
This tells people it’s an offence to supply, offer or agree to supply or expose or possess goods which fail to comply with a “general safety requirement”
This will ensure
Goods are safe
And that only appropriate information is provided with goods
Regulations in part II “Consumer safety” of the Consumer protection act cannot be made to apply to 3 types of products, these are?
- Controlled drugs- Misuse drugs act
-licensed medicinal products- Human medicines regulations
-Gas supplied under the gas act
This is because they’ve all got their own acts
What can you face if you supply goods that do not meet safety regulations?
It’s a criminal offence
You can face up to 6 months in prison or a fine up to £5,000 (or both!!)
What is DMRC?
Defective medicines report centre
What does DMRC do?
Minimises risk to patients arising from distribution of defective medicine
Need to differentiate between defective medicines and those due to ADRs, accidents and errors
Recalling medicinal products: Class I level of risk?
Defect is life threatening or serious risks to health
Recalling medicinal products: Class II level of risk?
Defect causes mistreatment or harm to patient
Recalling medicinal products: Class III level of risk?
Defect is unlikely to cause harm, but Recall is carried out for other reasons
Recalling medicinal products: Class IV level of risk?
Caution in use
How is the decision to recall a batch made?
Decision made following consultation between the DMRC and the marketing authorisation holdeR
MHRA can also step in with regulatory powers
Once a recall is made, the level of risk of the product / defect must be determined
What is a minor defect?
No important effect upon the therapeutic effect of the product
