legislation Flashcards
role of legislation?
(4 marks)
safety
welfare
efficacy
honesty
what defines a veterinary medicine?
(3 marks)
- presentation = any substance presented as having properties for treating / preventing disease in animals
- 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.
what does medicine require?
(1 mark)
marketing authorisation licence
what should a medicine be?
(3 marks)
safe
efficicacy = produce desined result
quality when mass produced
who can approve / withdraw marketing authorisation?
(1 mark)
VMD / EMA
who is VMD?
(1 mark)
executive branch of DEFRA
what is the VMD responsible for?
(5 marks)
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.
what laws / regulations are medicines under?
(6 marks)
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
what are the 4 licencing categories?
(4 marks)
POM-V
POM-VPS
NFA-VPS
AVM-GSL
what does POM-V mean?
(1 mark)
prescription only medicine - veterinarian
what must apply for POM-V prescription?
(3 marks)
clinical exam needed
animal under VS care
VS must be satisfied competence of owner
what does POM-VPS mean?
(1 mark)
prescription only medicine - veterinarian, pharmasist, SQP.
what must apply for POM-VPS prescription?
(2 marks)
prescriber must be satisfied with competence
no exam needed.
what is NFA-VPS?
(1 mark)
non-food producing animal - veterinarian, pharmasist, SQP
what is AVM-GSL?
(1 mark)
authorised veterinary medicine - general sales list
(can be supplied by any retailer)
what is a withdrawl period?
(1 mark)
length of time until medicine residues in food have fallen to safe level (but not zero).
what does max residue limit need to allow for?
(1 mark)
safe ingestion level
who regulates SQPs?
(1 mark)
AMTRA
dispensing requirement for SQP?
(2 marks)
can dispense on own prescription / on reciept of prescription from RQP. can only dispense in original packaging.
who is responsible for ensuring correct handling over of medication?
(1 mark)
vet / pharmacist / SQP – prescriber.
how is the cascade legislated?
(1 mark)
schedule 4 of veterinary medicine regulations.
if no medicine is authorised in UK for specific condition what cascade can be used?
(4 marks)
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.
what applies for food-producing species?
(1 mark)
medicine must be authorised for food-producing species.
what are the minimum withdrawl periods for milk and meat?
(2 marks)
milk = 7 days
meat = 28 days
legal requirement that applies to horses?
(1 mark)
to have a passport + containing whether animal is companion or for food.
what does imported medicine need?
(1 mark)
special import certificate / special treatment certificate
what are extemporaneously prepared medicines?
(1 mark)
drugs made for the occassion - reformulated to individual case.
examples of extemporaneously prepared medicine?
(3 marks)
reformulate human medicine
autogenous vaccines
mixtures
who can manufacture extemporaneously prepared medicines?
(3 marks)
authorised manufacturer
vet
pharmasict
labelling requirements for authorised use?
(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.
labelling requirements - RCVS guidance for POM-V?
(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’
specific labelling for cascade use?
(5 marks)
VS name, that prescribed product
identification of animal / group of animals
expiry datw
any special storage precaution
withdrawl period
record keeping for food producing animals?
(5 marks)
date of exam
owner name + adress
trade name of product
batch number
dose administered
additonal requirements for record keeping for cascade drugs?
(5 marks)
ID + number of animal treated
result of VS clinical exam
name + quanity of active substance
duration of treatment
withdrawl period
aim of exemptions for small pet animals (ESPA)?
(1 mark)
to improve availability of veterinary products for these species
does ESPA require marketing authorisation?
(1 mark)
no
what does ESPA not include?
(2 marks)
antibiotics + anaesthetics
what administration is ESPA restricted to?
(2 marks)
topical + oral
what are not for food-producing species?
(7 marks)
rabbits
ferrets
small rodents
terrarium animals
caged birds
homing pigeons
ornamental fish
what category do homeopathic drugs fall under?
(1 mark)
AVM-GSL
who governs control drugs?
(1 mark)
misuse of drugs regulations 2001
who is alerted if things go wrong with control drugs?
(1 mark)
suspect adverse reaction surveillance scheme (SARSS)
who / what is affected by an adverse reaction?
(4 marks)
animal
people
food
environment
what does lack of efficiacy mean?
(1 mark)
drug does not work as indended
who is responsible for pharmacovigilance?
(3 marks)
manufacturers
animal health professionals
public
(responsibility of all involved)
4 pillars of pharmacovigilance?
(4 marks)
- person identifiable as reporter
- identifable patients
- medicinal product that caused reaction
- one or more suspected adverse reaction
