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Animal Medicines > legislation > Flashcards

legislation Flashcards

1
Q

role of legislation?

(4 marks)

A

safety
welfare
efficacy
honesty

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2
Q

what defines a veterinary medicine?

(3 marks)

A
  1. presentation = any substance presented as having properties for treating / preventing disease in animals
  2. function = any substance that may be used in animals to restore, correct / modify physiological functions by exerting pharmacological, immunological / metabolic action / making a medical diagnosis.
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3
Q

what does medicine require?

(1 mark)

A

marketing authorisation licence

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4
Q

what should a medicine be?

(3 marks)

A

safe
efficicacy = produce desined result
quality when mass produced

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5
Q

who can approve / withdraw marketing authorisation?

(1 mark)

A

VMD / EMA

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6
Q

who is VMD?

(1 mark)

A

executive branch of DEFRA

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7
Q

what is the VMD responsible for?

(5 marks)

A

ensure animal meds safe + effective
ensure animals treated correctly
protect owners from mis-selling of drugs
prevent over-use of human meds
prevent meds entering food-chain via meat / milk.

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8
Q

what laws / regulations are medicines under?

(6 marks)

A

veterinary medicine regulations 2013
misuse of drugs regulations 2001
hazardous waste waste regulation 2005
– controlled waste regulation 1992
– environmental protection act 1990
enterprise act 2002

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9
Q

what are the 4 licencing categories?

(4 marks)

A

POM-V
POM-VPS
NFA-VPS
AVM-GSL

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10
Q

what does POM-V mean?

(1 mark)

A

prescription only medicine - veterinarian

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11
Q

what must apply for POM-V prescription?

(3 marks)

A

clinical exam needed
animal under VS care
VS must be satisfied competence of owner

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12
Q

what does POM-VPS mean?

(1 mark)

A

prescription only medicine - veterinarian, pharmasist, SQP.

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13
Q

what must apply for POM-VPS prescription?

(2 marks)

A

prescriber must be satisfied with competence
no exam needed.

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14
Q

what is NFA-VPS?

(1 mark)

A

non-food producing animal - veterinarian, pharmasist, SQP

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15
Q

what is AVM-GSL?

(1 mark)

A

authorised veterinary medicine - general sales list
(can be supplied by any retailer)

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16
Q

what is a withdrawl period?

(1 mark)

A

length of time until medicine residues in food have fallen to safe level (but not zero).

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17
Q

what does max residue limit need to allow for?

(1 mark)

A

safe ingestion level

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18
Q

who regulates SQPs?

(1 mark)

A

AMTRA

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19
Q

dispensing requirement for SQP?

(2 marks)

A

can dispense on own prescription / on reciept of prescription from RQP. can only dispense in original packaging.

20
Q

who is responsible for ensuring correct handling over of medication?

(1 mark)

A

vet / pharmacist / SQP – prescriber.

21
Q

how is the cascade legislated?

(1 mark)

A

schedule 4 of veterinary medicine regulations.

22
Q

if no medicine is authorised in UK for specific condition what cascade can be used?

(4 marks)

A

licenced in NI for indicated species and condition
licenced in UK/NI for another species/condition.
licenced in UK/NI for human use
extemporaneous preperation.

23
Q

what applies for food-producing species?

(1 mark)

A

medicine must be authorised for food-producing species.

24
Q

what are the minimum withdrawl periods for milk and meat?

(2 marks)

A

milk = 7 days
meat = 28 days

25
Q

legal requirement that applies to horses?

(1 mark)

A

to have a passport + containing whether animal is companion or for food.

26
Q

what does imported medicine need?

(1 mark)

A

special import certificate / special treatment certificate

27
Q

what are extemporaneously prepared medicines?

(1 mark)

A

drugs made for the occassion - reformulated to individual case.

28
Q

examples of extemporaneously prepared medicine?

(3 marks)

A

reformulate human medicine
autogenous vaccines
mixtures

29
Q

who can manufacture extemporaneously prepared medicines?

(3 marks)

A

authorised manufacturer
vet
pharmasict

30
Q

labelling requirements for authorised use?

(4 marks)

A

contain required information
label isnt legally required if supplied in original packaging
label shouldnt obscure information
if supplied in another, the vet must suitably label the container + suplly written information to ensure safe use.

31
Q

labelling requirements - RCVS guidance for POM-V?

(6 marks)

A

name + address of vet practice supplying medicine + name + adress of owner
date of supply
name + quanity of product, strength + directions
‘for animal treatement only’ unless impractical to do
‘for external use only’ for topical preparations
‘keep out of reach of children’

32
Q

specific labelling for cascade use?

(5 marks)

A

VS name, that prescribed product
identification of animal / group of animals
expiry datw
any special storage precaution
withdrawl period

33
Q

record keeping for food producing animals?

(5 marks)

A

date of exam
owner name + adress
trade name of product
batch number
dose administered

34
Q

additonal requirements for record keeping for cascade drugs?

(5 marks)

A

ID + number of animal treated
result of VS clinical exam
name + quanity of active substance
duration of treatment
withdrawl period

35
Q

aim of exemptions for small pet animals (ESPA)?

(1 mark)

A

to improve availability of veterinary products for these species

36
Q

does ESPA require marketing authorisation?

(1 mark)

A

no

37
Q

what does ESPA not include?

(2 marks)

A

antibiotics + anaesthetics

38
Q

what administration is ESPA restricted to?

(2 marks)

A

topical + oral

39
Q

what are not for food-producing species?

(7 marks)

A

rabbits
ferrets
small rodents
terrarium animals
caged birds
homing pigeons
ornamental fish

40
Q

what category do homeopathic drugs fall under?

(1 mark)

A

AVM-GSL

41
Q

who governs control drugs?

(1 mark)

A

misuse of drugs regulations 2001

42
Q

who is alerted if things go wrong with control drugs?

(1 mark)

A

suspect adverse reaction surveillance scheme (SARSS)

43
Q

who / what is affected by an adverse reaction?

(4 marks)

A

animal
people
food
environment

44
Q

what does lack of efficiacy mean?

(1 mark)

A

drug does not work as indended

45
Q

who is responsible for pharmacovigilance?

(3 marks)

A

manufacturers
animal health professionals
public
(responsibility of all involved)

46
Q

4 pillars of pharmacovigilance?

(4 marks)

A
  1. person identifiable as reporter
  2. identifable patients
  3. medicinal product that caused reaction
  4. one or more suspected adverse reaction

Animal Medicines (20 decks)

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