Regulatory Bodies And Legislation Flashcards
What are some of the tasks veterinary nurses could carry out in practice
Ordering and stock control
Administering meds
Calculating drug doses
Advising clients on how to medicate an animal at home
Recognising adverse reactions to medication
Why do we need legislation surrounding veterinary medicines
Antimicrobial resistance
Animals for human consumption
Use of controlled meds
Health and safety
Supply of distribution
Environment
Animal ethics and welfare
How many new antibiotics have been made since the 1980s
None
How many countries have extensive drug resistance
123
Antimicrobial resistance has caused how many deaths a year globally
Estimated 700,000
What’s the predicted increase in antibiotics use by 2030
3x
Since 2014 we have reduced antibiotic use by how much
55%
How have we improved animal welfare
NSAIDs are used as analgesics to reduce antibiotic use.
Mastitis in cows
How have farmers improved animal welfare
Additional education has been provided for them
What is one health
An initiative to protect public health by considering the effect of veterinary/animal health and the environment on human health
How many infectious diseases can be transmitted from animals
6/10
What is significant about the UK regarding antibiotic usage on livestock
We are the lowest users of them in Europe
What does Veterinary medicines Reg 2013 govern
All aspects of veterinary medicine usage including
Wholesalers
Retail
Storage
Prescribing
Supplying
Labelling
Record keeping
Monitoring
When the VMR was updated in 2013 what 2 changes were made
Advertising of POM-V to professional keepers of animals was prohibited
Advertising of POM-VPS medicines to owners or keepers of horses was prohibited
What was the impact from the VMD changes
Less awareness for owners
Get drugs cheaper elsewhere
Not influenced by brand so will ask vet
Misuse of drugs regulations 2001 role
Controls the supply, possession and storage of controlled drugs
Deals with scheduling of controlled drugs
Promotes education and research into drug dependence and addiction
Hazardous waste regulation 2005 role
Relates to the classification and disposal of hazardous waste
Require businesses to register with environment agaency if producing significant amount of hazardous waste a year
Control of Substances Hazardous to Health Regulations (COSHH) 2002
Covers the management of risks associated with hazardous substances including all pharmaceutical products
Veterinary medicine Directorate (VMD)
An executive agency of the government department DEFRA
Veterinary medicine Directorate (VMD) responsibility
Enforcement of the veterinary medicines regulations (VMD)
Issuing and monitoring Marketing Authrisations (MA)
Develop and update legislation
INSPECT / SEARCH PREMISES(not including PSS - practice standard scheme)
Enforce prosecutions against illegal marketing or use off products - seizing products
Environmental risk assessment purposes
Evaluates that new or current vet medicines do not possess a threat to human animal or environmental health
Process of environmental risk assessment
Identify potential environmental hazards/risks
Identify the need for reducing the risk
Ensure appropriate labelling advice and instructions are in place
What does environmental risk assessment NOT consider
Environmental contamination from manufacturing, transportation or storage
VMD enforcement tools
Advisory / warning letters
Improvement notices (min of 14 days to make change)
Seizure notices
Destruction of products
Police cautions/prosecutions - for non compliance with VMR
Examples of offences that have resulted in the seizure of products
Possessions of unauthorised products
Administration or medication not in accordance with MA
Marketing drugs as veterinary medicines when they are not
Unauthorised possession of POM-V products
Failure to supply accurate records of sales POM-VPS product
Seizure at border of unauthorised imported products
What does AMTRA stand for
Animal medicines training regulatory authority
Role of the AMTRA
Maintain a register of Registered Animal Medicine Advisiors (RAMAs) and registered premises other than veterinary practices
Regulate practicing RAMAs
Monitor CPD for RAMAs
Authorise training centres for the delivery of RAMA qualifications
RCVS meaning
Royal College of Veterinary Surgeons
Role of RCVS
Monitor vet professional conduct including the use of vet medicines
Hold a list of registered premises
Oversee the Practice Standards scheme
When an improvement notice is isssued what is the minimum amount of time that a practice will be given to make improvements
14 days
Why is the practice standard scheme relevant to veterinary medicine
There is a medicine module and if a practice is in the PSS they don’t have routine VMD inspections
What is the name of the executive agency of the government department DEFRA that is responsible for enforcing the Veterinary Medicine Regulations 2013
Veterinary Medicine Directorate
How do the VMD promote animal health and welfare
Assuring the safety, quality and efficacy of veterinary medicines
What are the VMD responsible for in relation to animal products
Testing for residue of veterinary medicines or illegal substances
When should newly registered premises be inspected by
Within 6 months
State the year each came into force
Veterinary Medicine Regulation
Misuse of drugs regulations
Hazardous waste regulations
COSHH
2013 - inspections
2001 - controlled drugs
2005 - 200kg of waste a year
2002 - hazardous substances
Requirements of a pharmacy
Permanent building
No public access
Not within a residential home
Frosted glass and bars on windows
No direct sunlight
Organised
Disabled access if required
Storage for medication
Clearly marked emergency exits
Fire fighting equipment
PPE
Pharmacy can have
Sink
Non slip stool/ladder
Dispensing and labelling area
Bottles and bags for dispensing medications
A pill counter
Scales
Computer and label printer
Things that shouldn’t be in a pharmacy
Food
Food in fridge
Not a communal area
The general Public
Under which circumstances would the VMD inspect a vet practice that is a member of the PSS
Reported or suspected non compliance with VMD
What is the purpose of exemptions from authorisations for medicines for small pet animals scheme
To low drugs for small pet animals to be marketed in a cost effective way
What is one health
An initiative to protect public health by considering the effect of veterinary
Why should medication be protected from the adverse effects of light, temperature extremes and moisture
Prevent bacteria growth
May dissolve if moist or get wet
Potential for drugs to denature
May react with light
Out of date
