Legal Jargon Flashcards
What is the purpose of the Veterinary Medicines Directorate (VMD)?
To protect animal health, public health, and the environment.
What does VMD stand for?
Veterinary Medicines Directorate
What does VMR outline?
Legal text on the manufacture, authorisation, marketing, distribution, and post-authorisation surveillance of veterinary medicines
What is the role of the VMD?
Ensures that the VMR is carried out
Fill in the blank: The VMR sets out the legal text on the _______ of veterinary medicines.
[manufacture, authorisation, marketing, distribution, post-authorisation surveillance]
What can VMD Inspectors serve?
Improvement or seizure notices
VMD stands for Veterinary Medicines Directorate, which regulates veterinary medicines in the UK.
What is the responsibility of the Veterinary Medicines Directorate regarding adverse events?
Monitoring and acting on reports of adverse events from veterinary medicines
Adverse events refer to any unintended effects or issues arising from the use of veterinary medicines.
What does the Veterinary Medicines Directorate test for?
Residues of veterinary medicines or illegal substances in animals and animal products
This testing ensures food safety and animal health.
What role does the Veterinary Medicines Directorate play in authorizing veterinary medicines?
Assessing applications for and authorising companies to sell veterinary medicines
This involves evaluating safety, efficacy, and quality of the medicines.
What aspect of veterinary medicines does the Veterinary Medicines Directorate control?
How veterinary medicines are made and distributed
This includes ensuring compliance with regulations and standards.
Who does the Veterinary Medicines Directorate advise on veterinary medicines policy?
Government ministers
Their role includes advising on the development and implementation of policies.
What regulations does the Veterinary Medicines Directorate make, update, and enforce?
The Veterinary Medicines Regulations
These regulations govern the use and management of veterinary medicines.
What does the Veterinary Medicines Regulations 2013 govern?
Controls on the manufacture, authorisation, possession, distribution, use and post-authorisation surveillance of veterinary medicines and medicated feed.
How often are the Veterinary Medicines Regulations amended?
Periodically after consultation with interested stakeholders.
When were the latest amendments to the Veterinary Medicines Regulations made?
May 2024.
Fill in the blank: The Veterinary Medicines Regulations 2013 ensures that the regulations are _______.
[up-to-date and fit for purpose]
What is the primary purpose of the Health and Safety at Work Act 1974?
To secure the health, safety and welfare of persons at work
This act aims to ensure a safe working environment.
What does the Health and Safety at Work Act 1974 protect besides persons at work?
Persons other than persons at work against risks to health or safety
This includes members of the public who may be affected by workplace activities.
What type of substances does the Health and Safety at Work Act 1974 aim to control?
Explosive or highly flammable or otherwise dangerous substances
The act seeks to prevent unlawful acquisition, possession, and use of these substances.
What is one of the environmental protections included in the Health and Safety at Work Act 1974?
Control the emission into the atmosphere of noxious or offensive substances from premises
This is aimed at maintaining air quality and public health.
What do the Control of Substances Hazardous to Health Regulations 2002 (C0SHH) aim to protect?
Employees and others from the hazards of substances used at work
C0SHH is a key regulation in the United Kingdom regarding workplace safety.
List the general requirements imposed on employers by C0SHH.
- Risk assessment
- Control of exposure
- Health surveillance
- Incident planning
These requirements are essential for ensuring a safe working environment.
True or False: C0SHH requires employers to conduct health surveillance.
True
Health surveillance is a critical component to monitor the health of employees exposed to hazardous substances.
Fill in the blank: The Control of Substances Hazardous to Health Regulations 2002 (C0SHH) requires a _______ to identify potential risks.
[risk assessment]
Risk assessment is a systematic process to evaluate potential risks in the workplace.
What regulations govern the control of hazardous substances?
Control of Substances Hazardous to Health Regulations 2002 (COSHH)
COSHH mandates the safe management of hazardous substances in the workplace.
What should employers have in place regarding hazardous substances?
Policies and procedures for safe storage, use, and disposal
Employers are responsible for ensuring safety protocols are followed.
What does the Veterinary Surgeons Act 1966 regulate?
Management of the veterinary profession, registration of veterinary surgeons, regulation of professional education and conduct, cancellation or suspension of registration in cases of misconduct
The Act ensures the proper functioning and accountability of veterinary practices.
What are the consequences of misconduct under the Veterinary Surgeons Act 1966?
Cancellation or suspension of registration
This provision helps maintain professional standards within the veterinary field.
What type of animals does the Veterinary Surgeons Act 1966 specifically address in scientific procedures?
Protected animals
The Act includes regulations that ensure the humane treatment of animals used in research.
Fill in the blank: The Veterinary Surgeons Act 1966 provides provisions for the _______ of the veterinary profession.
[management]
This encompasses various aspects of veterinary practice and professional oversight.
True or False: The Veterinary Surgeons Act 1966 allows for the use of protected animals in scientific procedures without any regulations.
False
The Act imposes regulations to minimize pain, suffering, distress, or lasting harm to protected animals.
What sets out the bulk of legislation relating to illegal drugs in the UK and serves to prevent the youth and supply of non-medical drugs?
The misuse of drugs act 1971
The misuse of drugs act 1971 defines each drug into classifications but what does it refer to drugs as?
Controlled substances
What sets out expectations that allow the lawful possession use of certain control drugs for medical, dental and veterinary use?
The misuse of drugs regulations 2001
How many schedules are the drugs from the misuse of drugs regulations 2001 categorised into?
5
How are drugs categorised into the schedules?
By the medical usefulness and the potential harms of misuse
Which scheduled drugs are considered to have no legitimate current medical use and other most tightly controlled?
Schedule 1 drugs
Who alongside the VMD have the joint responsibility for ensuring that all registered veterinary practice premises in the UK are inspected and comply with their legal obligations under the VMRS?
The RCVS
Which of the scheduled drugs are strictly controlled including special requirements for prescription, storage, destruction and record keeping, because they are highly addictive and maybe subject to abuse?
Schedule 2
Which scheduled drugs have to have special prescription writing requirements and can be subject to special storage requirements, but aren’t as rigorously controlled?
Schedule 3 (the RCVS advises that all schedule 3 CDs should be stored in a CD cabinet).
What two schedule drug categories have no special controls ?
Schedule 4 & 5
The administration and receipt of which scheduled controlled drug must be recorded in a register?
Schedule 2 (e.g. ketamine and fentanyl).
Who in practice is responsible for the controlled drugs register?
The prescribing veterinary surgeon
Where should control drug cabinets be situated?
In a secure place away from public view
What controls do the RCVS recommend for the controlled drugs cabinet?
The cabinet must be bolted to the wall or floor, it is double locked with separate keys, lock must be different to any other lock on premises, keys must only be available to authorized members of staff, cabinet must not have anything attached to it which identifies it as is controlled drugs cabinet and the cabinet must be kept locked when not in use.
Where should the controlled drugs be stored if a veterinary surgeon is traveling in the car with them?
There should be transported in a lockable bag or box which should be kept locked when not in use, is left unattended in the car for a length of time it should be fixed within the boot of the car and out of sight, the veterinary surgeon must keep a separate controlled drug register for the stock in the car.
What defines who is responsible for the management of handling control drugs in the practice and can provide guidance?
SOP
How long should a controlled drug register be kept for after the date of last entry?
2 years
What should all control drug cabinets comply with?
The misuse of drugs (safe custody) regulations 1973
What temperature should a fridge be between?
2-8°c
What should ambient temperatures be between, for example a dispensary?
8-25°c
Which section of the RCVS code of professional conduct is relevant to veterinary medicines?
4
Which drug prescribing category can be prescribed by a vet and supplied by either a vet or a pharmacist?
POM-V
Which drug prescribing category can be prescribed by anyone of the RQPs and supplied by any one of them?
POM-VPS
Which drug prescribing category can be supplied by anyone of the RQPs?
NFA-VPS
What drug prescribing category can be supplied by any retailer?
AVM-GSL
What must a veterinary surgeon do before prescribing a POM-V medication?
carry out a clinical exam
When can a product only be prescribed verbally?
Only if the prescriber plans to supply an administer the product
When a veterinary medicine is not supplied by the person who prescribed it, what must it be?
Written
How many steps are there in the prescribing cascade?
5
What step in the prescribing cascade is a veterinary medicine with a marketing authorization valid in Great Britain or UK wide for indicated species and condition?
1
What step in the prescribing cascade is a veterinary medicine with a marketing authorization valid for Northern Ireland for indicated species and condition?
2
What step in the prescribing cascade is a veterinary medicine with a marketing authorization valid in Great Britain Northern Ireland or uk wide for a different species or condition?
3
What step in the prescribing cascade is a human medicine with a marketing authorization valid in Great Britain Northern Ireland or UK wide OR an authorized veterinary medicine from outside of the UK?
4
What prescribing cascade step is an extemporaneous preparation prepared by a vet, pharmacist or person holding an appropriate manufacturers authorization located in the UK?
5
What must be provided if a drug under the prescribing cascade is coming from anywhere outside of the UK including Northern Ireland?
Special import certificate
True or false, the only person allowed to prescribe under the cascade is the veterinary surgeon?
True
How should controlled drugs be destroyed ?
Denature kit the stored in cd cabinet for 24hours
True or false, a physical examiantion is required at the time of prescription in all but exceptional circumstances where a vet surgeon prescribes antibiotics, antifungals, antiparasitics or antivirals for an individual animal or groups of animals that are non-production animals
True
