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pharmacy semester 2 > lecture 6: Veterinary medicines regulations > Flashcards

lecture 6: Veterinary medicines regulations Flashcards

1
Q

what is the veterinary medicines regulations?

A

one piece of legislation written in plain English

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2
Q

when was the VMR’s updates?

A

2005 then annually till 2009
2011
latest is 2013

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3
Q

how are vet CDs controlled?

A

still under the misuse of drugs act

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4
Q

what is a veterinary medicinal product?

A

any substance or combination of substances which has properties of treating/ preventing disease in animals
OR
• that may be used in, or administered to, animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis

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5
Q

can you have a VMP on the market without an MA?

A

no- its an offence

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6
Q

rules on manufacturing, wholesale and records with vet medicines?

A

same as human meds

records kept for 5 years

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7
Q

where can you find a list of VMPs in the UK and their summary of product characteristics?

A

PRODUCT INFORMATION DATABASE ON THE vmd WEBSITE

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8
Q

Who can prescribe VMPs?

A

registered qualified persons (RQP):
vets
pharmacists
suitably qualified persons

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9
Q

what can RQP prescribe/ supply?

A

products falling within their scope of qualification and registration they hold

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10
Q

POM-V

A

POM- Veterinarian

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11
Q

POM-VPS

A

POM- veterinarian, pharmacist, suitably qualified person

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12
Q

NFA-VPS

A

Non food animal- veterinarian, pharmacist, SQP

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13
Q

AVM-GSL

A

Authorised veterinary medicine- general sales

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14
Q

what does a vet need to prescribe and supply veterinary medicines?

A

Registration with the RCVS

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15
Q

Do they need this registration to prescribe AVM-GSL?

A

NO

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16
Q

What is a VPP?

A

veterinary practice premises- registered with the RCVS

vets can only supply medicines from these premise

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17
Q

The vet must be present when any medicine (except a AVM-GSL) is being handed over. TF

A

true- unless they:
authorise each transaction individually before product is supplied
are satisfied that the person who hands it over is competent

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18
Q

where can pharmacists supply VMPs from?

A

registered GPhC premises

VPP or premises approved and registered for the storage and supply of VMPs by an SQP

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19
Q

must a pharmacist be present when its handed over?

A

same as vet
true- unless they:
authorise each transaction individually before product is supplied
are satisfied that the person who hands it over is competent

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20
Q

what is a SQP

A

suitably qualified person

animal medicine advisor who is qualified to prescribe and supply certain vet medicines under the VMR

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21
Q

How do you become a SQP?

A

examination

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22
Q

two organisations responsible for training and registering SQPs?

A
  • animals medicines training regulatory authority

- vet skills ltd

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23
Q

what can SQPs supply?

A

POM-VPS that they have prescribed or has been prescribed by a vet, pharmacist or other SQP
NFA-VPS

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24
Q

When is a product classed as a POM-V?

A

when there’s a strict limit on its use due to safety
requires vet specialist knowledge for use
has narrow safety margin

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25
Q

CDs schedule 2,3 are POM-V’s?

A

true

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26
Q

any new substance is usually classed as?

A

POM-V

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27
Q

Who can prescribe a POM-V?

A

a vet

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28
Q

what must the vet do before prescribing the POM-V?

A

Carry out a clinical assessment

animal must be under his care

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29
Q

if the vet prescribes more than the minimum amount of VMP needed for treatment?

A

its an offence

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30
Q

when is a medicine classed as a POM-VPS?

A

when its used to reduce endemic diseases in herds, flocks or individual animal

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31
Q

why aren’t these classed as POM-V?

A

Despite the risks the users can be made aware with simple advice and training

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32
Q

what are POM-V and POM-VPS mostly used for?

A

food producing animals

33
Q

POM-V and POM-VPS are products which need special precautions to avoid risk to??

A

target species
person administering
the environment

34
Q

what are NFA-VPS mostly used for?

A

pets

35
Q

NFA-VPS is equivalent to what human class?

A

P

36
Q

what properties of drugs make it AVM-GSL

A

wide safety margins
treatment of common ailments
special advice not required

37
Q

when can certain medicines be placed on the market without a MA?

A

Subject to certain conditions, exemptions for small pet animals

38
Q

what does this apply to?

A

only VMs labelled exclusively for use in a list of animals not intended for human consumption

39
Q

list of animals:

A 
aquarium animals 
cage birds
homing pigeons 
terrarium animals 
small rodents 
ferrets 
rabbits
40
Q

products marked under this exemption may be sold by?

A

any retailer

41
Q

can pharmacists supply a POM-V?

A

YES

42
Q

Any RQP prescribing a POM-V or POM-VPS or supplying a NFA-VPS must:

A

ensure recipient is competent to use
advise on safe administration
provide warnings
limit the amount supplied to minimum amount required for treatment

43
Q

are there any restrictions on the supply of AVM-GSL?

A

NO

44
Q

do AVM-GSL need to be sold from a retail building?

A

no but responsible approach to the supply is still expected

45
Q

records needed for receipt and supply of POM-V and POM-VPS?

A 
name 
date of receipt/ supply
batch number 
quantity 
name and A of supplier
name and A of RX-er and keep a copy of Rx
46
Q

how long must this record be kept?

A

5 years

47
Q

a vet prescription may be oral or written. TF?

A

true

48
Q

when MUST it be written?

A

if the VMP is not supplied by the person who has prescribed it

49
Q

how long are POM-V and POM-VPS prescriptions valid for?

A

6 months or shorter is indicated by Rx-er

50
Q

what if the POM-V is a CD schedule 2,3 or 4?

A

28 days

51
Q

what must be on a vet prescription?

A 
N&A, telephone no and qualification of Rx-er 
signature 
N&A of keeper of animal
species of animal and ID 
date valid for
medicine information 
warnings 
if RX is repeatable 
'prescribed under the cascade' if necessary
52
Q

what additional information must be added to the Rx if its for a CD schedule 2 or 3?

A

the statement ‘ the item has been prescribed for an animal or herd under the care of the vet’
RCVS registration number of Rx-ing vet
+usual CD requirements

53
Q

can a community pharmacist supply a POM-V product without a written Rx?

A

yes

54
Q

are EEA and Swiss vets allowed to prescribe for animals in the UK?

A

yes providing they are registered with the RCVS

animals are under their care and a clinical assessment has been carried out

55
Q

can UK pharmacists dispense the EEA/Swiss prescription?

A

yes at their discretion and subject to professional judgement

56
Q

CD schedule 2,3 requirements?

A
  • RCVS reg number of vet
  • name of animal and owner address
  • name and form of drug
  • amount prescribed in words and figures
  • strength
  • dose
57
Q

‘take as directed/ required’ is acceptable on a CD Rx?

A

no

58
Q

if you dispense against a fax or email?

A

advised to ask for original Rx to follow

59
Q

you can legally dispense CD against a fax. TF

A

FALSE

60
Q

What needs to be on the immediate label of VMPs?

A 
name, strength and form 
name and proportions of each substance 
ROA
batch number 
expirary 
'for animal treatment only' 
if POM-V and POM-VPS should also say 'to be supplied only on veterinary prescription'
61
Q

when can labels be amended?

A

in accordance with Rx (eg to change a dose)

62
Q

when do we use the vet cascade?

A

when there is no suitable authorised VMP in the uK for treatment of an animal

63
Q

what must the prescription state if prescribed under cascade?

A

that its prescribed under the cascade or similar

64
Q

who can prescribe under the vtiary cascade?

A

only vets

65
Q

first stage of the vet cascade for food and non food producing animals?

A

VMP authorised for use in another species or for a different condition in the same species

66
Q

step 2 in the vet cascade for food and non food producing animals?

A

if there’s no such product, either:

  • a UK medicine for human use or
  • a VMP not authorised in the UK but is in EU countries
67
Q

step 3?

A

medicine prepared extemporaneously

68
Q

SQP may only dispense _____ under the cascade?

A

an authorised VMP under the cascade

69
Q

a pharmacist may dispense… under the cascade?

A

authorised VMPs
human medicines
extemp preparations

70
Q

each supply must be against a….

A

vet prescription

71
Q

what must a label contain under the cascade?

A

a) Name and address of pharmacy supplying
b) Name of prescribing vet
c) Name and address of animal owner
d) Identification (incl. species) of animal or group of animals
e) Date of supply
f) Expiry date (if applicable)
g) Name and quantity of active ingredients
h) Dosage and administration instructions
i) Any special storage precautions
j) Any necessary warnings for user re:
a. target species, administration or disposal of product
k) Withdrawal period, if relevant
l) Words
a. “For animal treatment only” and
b. “Keep out of reach of children”

72
Q

when does this label not need to be done?

A

if prescribed, supplied and administered by a vet

73
Q

what if all the information doesn’t fit on the label?

A

must be given on a separate sheet

74
Q

it isn’t an offence to comply with these labels?

A

false, it is

75
Q

permethrin affects on cats and dogs?

A

works on dogs

toxic to cats

76
Q

are medicines marketed under the exemptions for small pet animals astill VMPs?

A

yes but without a legal distribution category

77
Q

it is legal to sell or supply unauthorised vet medicines including human medicines for an animal. TF

A

no, unless it takes place under the cascade

78
Q

is the previous true even if a vet surgeon asks the animal owner verbally to purchase an OTC human product from a pharmacy

A

yes it is still unlawful

pharmacy semester 2 (15 decks)

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