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Animal Medicines > legislation > Flashcards

legislation Flashcards

(46 cards)

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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)

Study These Flashcards
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)

Study These Flashcards
A

vet / pharmacist / SQP – prescriber.

21
Q

how is the cascade legislated?

(1 mark)

Study These Flashcards
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)

Study These Flashcards
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)

Study These Flashcards
A

medicine must be authorised for food-producing species.

24
Q

what are the minimum withdrawl periods for milk and meat?

(2 marks)

Study These Flashcards
A

milk = 7 days
meat = 28 days

25
legal requirement that applies to horses? ## Footnote (1 mark)
to have a passport + containing whether animal is companion or for food.
26
what does imported medicine need? ## Footnote (1 mark)
special import certificate / special treatment certificate
27
what are extemporaneously prepared medicines? ## Footnote (1 mark)
drugs made for the occassion - reformulated to individual case.
28
examples of extemporaneously prepared medicine? ## Footnote (3 marks)
reformulate human medicine autogenous vaccines mixtures
29
who can manufacture extemporaneously prepared medicines? ## Footnote (3 marks)
authorised manufacturer vet pharmasict
30
labelling requirements for authorised use? ## Footnote (4 marks)
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
labelling requirements - RCVS guidance for POM-V? ## Footnote (6 marks)
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
specific labelling for cascade use? ## Footnote (5 marks)
VS name, that prescribed product identification of animal / group of animals expiry datw any special storage precaution withdrawl period
33
record keeping for food producing animals? ## Footnote (5 marks)
date of exam owner name + adress trade name of product batch number dose administered
34
additonal requirements for record keeping for cascade drugs? ## Footnote (5 marks)
ID + number of animal treated result of VS clinical exam name + quanity of active substance duration of treatment withdrawl period
35
aim of exemptions for small pet animals (ESPA)? ## Footnote (1 mark)
to improve availability of veterinary products for these species
36
does ESPA require marketing authorisation? ## Footnote (1 mark)
no
37
what does ESPA not include? ## Footnote (2 marks)
antibiotics + anaesthetics
38
what administration is ESPA restricted to? ## Footnote (2 marks)
topical + oral
39
what are not for food-producing species? ## Footnote (7 marks)
rabbits ferrets small rodents terrarium animals caged birds homing pigeons ornamental fish
40
what category do homeopathic drugs fall under? ## Footnote (1 mark)
AVM-GSL
41
who governs control drugs? ## Footnote (1 mark)
misuse of drugs regulations 2001
42
who is alerted if things go wrong with control drugs? ## Footnote (1 mark)
suspect adverse reaction surveillance scheme (SARSS)
43
who / what is affected by an adverse reaction? ## Footnote (4 marks)
animal people food environment
44
what does lack of efficiacy mean? ## Footnote (1 mark)
drug does not work as indended
45
who is responsible for pharmacovigilance? ## Footnote (3 marks)
manufacturers animal health professionals public (responsibility of all involved)
46
4 pillars of pharmacovigilance? ## Footnote (4 marks)
1. person identifiable as reporter 2. identifable patients 3. medicinal product that caused reaction 4. one or more suspected adverse reaction

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