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Pharmacy management > Regulatory Bodies And Legislation > Flashcards

Regulatory Bodies And Legislation Flashcards

1
Q

What are some of the tasks veterinary nurses could carry out in practice

A

Ordering and stock control
Administering meds
Calculating drug doses
Advising clients on how to medicate an animal at home
Recognising adverse reactions to medication

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2
Q

Why do we need legislation surrounding veterinary medicines

A

Antimicrobial resistance
Animals for human consumption
Use of controlled meds
Health and safety
Supply of distribution
Environment
Animal ethics and welfare

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3
Q

How many new antibiotics have been made since the 1980s

A

None

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4
Q

How many countries have extensive drug resistance

A

123

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5
Q

Antimicrobial resistance has caused how many deaths a year globally

A

Estimated 700,000

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6
Q

What’s the predicted increase in antibiotics use by 2030

A

3x

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7
Q

Since 2014 we have reduced antibiotic use by how much

A

55%

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8
Q

How have we improved animal welfare

A

NSAIDs are used as analgesics to reduce antibiotic use.
Mastitis in cows

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9
Q

How have farmers improved animal welfare

A

Additional education has been provided for them

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10
Q

What is one health

A

An initiative to protect public health by considering the effect of veterinary/animal health and the environment on human health

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11
Q

How many infectious diseases can be transmitted from animals

A

6/10

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12
Q

What is significant about the UK regarding antibiotic usage on livestock

A

We are the lowest users of them in Europe

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13
Q

What does Veterinary medicines Reg 2013 govern

A

All aspects of veterinary medicine usage including
Wholesalers
Retail
Storage
Prescribing
Supplying
Labelling
Record keeping
Monitoring

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14
Q

When the VMR was updated in 2013 what 2 changes were made

A

Advertising of POM-V to professional keepers of animals was prohibited
Advertising of POM-VPS medicines to owners or keepers of horses was prohibited

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15
Q

What was the impact from the VMD changes

A

Less awareness for owners
Get drugs cheaper elsewhere
Not influenced by brand so will ask vet

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16
Q

Misuse of drugs regulations 2001 role

A

Controls the supply, possession and storage of controlled drugs
Deals with scheduling of controlled drugs
Promotes education and research into drug dependence and addiction

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17
Q

Hazardous waste regulation 2005 role

A

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

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18
Q

Control of Substances Hazardous to Health Regulations (COSHH) 2002

A

Covers the management of risks associated with hazardous substances including all pharmaceutical products

19
Q

Veterinary medicine Directorate (VMD)

A

An executive agency of the government department DEFRA

20
Q

Veterinary medicine Directorate (VMD) responsibility

A

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

21
Q

Environmental risk assessment purposes

A

Evaluates that new or current vet medicines do not possess a threat to human animal or environmental health

22
Q

Process of environmental risk assessment

A

Identify potential environmental hazards/risks
Identify the need for reducing the risk
Ensure appropriate labelling advice and instructions are in place

23
Q

What does environmental risk assessment NOT consider

A

Environmental contamination from manufacturing, transportation or storage

24
Q

VMD enforcement tools

A

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

25
Q

Examples of offences that have resulted in the seizure of products

A

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

26
Q

What does AMTRA stand for

A

Animal medicines training regulatory authority

27
Q

Role of the AMTRA

A

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

28
Q

RCVS meaning

A

Royal College of Veterinary Surgeons

29
Q

Role of RCVS

A

Monitor vet professional conduct including the use of vet medicines
Hold a list of registered premises
Oversee the Practice Standards scheme

30
Q

When an improvement notice is isssued what is the minimum amount of time that a practice will be given to make improvements

A

14 days

31
Q

Why is the practice standard scheme relevant to veterinary medicine

A

There is a medicine module and if a practice is in the PSS they don’t have routine VMD inspections

32
Q

What is the name of the executive agency of the government department DEFRA that is responsible for enforcing the Veterinary Medicine Regulations 2013

A

Veterinary Medicine Directorate

33
Q

How do the VMD promote animal health and welfare

A

Assuring the safety, quality and efficacy of veterinary medicines

34
Q

What are the VMD responsible for in relation to animal products

A

Testing for residue of veterinary medicines or illegal substances

35
Q

When should newly registered premises be inspected by

A

Within 6 months

36
Q

State the year each came into force
Veterinary Medicine Regulation
Misuse of drugs regulations
Hazardous waste regulations
COSHH

A

2013 - inspections
2001 - controlled drugs
2005 - 200kg of waste a year
2002 - hazardous substances

37
Q

Requirements of a pharmacy

A

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

38
Q

Pharmacy can have

A

Sink
Non slip stool/ladder
Dispensing and labelling area
Bottles and bags for dispensing medications
A pill counter
Scales
Computer and label printer

39
Q

Things that shouldn’t be in a pharmacy

A

Food
Food in fridge
Not a communal area
The general Public

40
Q

Under which circumstances would the VMD inspect a vet practice that is a member of the PSS

A

Reported or suspected non compliance with VMD

41
Q

What is the purpose of exemptions from authorisations for medicines for small pet animals scheme

A

To low drugs for small pet animals to be marketed in a cost effective way

42
Q

What is one health

A

An initiative to protect public health by considering the effect of veterinary

43
Q

Why should medication be protected from the adverse effects of light, temperature extremes and moisture

A

Prevent bacteria growth
May dissolve if moist or get wet
Potential for drugs to denature
May react with light
Out of date

Pharmacy management (9 decks)

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