lecture 6: Veterinary medicines regulations Flashcards
what is the veterinary medicines regulations?
one piece of legislation written in plain English
when was the VMR’s updates?
2005 then annually till 2009
2011
latest is 2013
how are vet CDs controlled?
still under the misuse of drugs act
what is a veterinary medicinal product?
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
can you have a VMP on the market without an MA?
no- its an offence
rules on manufacturing, wholesale and records with vet medicines?
same as human meds
records kept for 5 years
where can you find a list of VMPs in the UK and their summary of product characteristics?
PRODUCT INFORMATION DATABASE ON THE vmd WEBSITE
Who can prescribe VMPs?
registered qualified persons (RQP):
vets
pharmacists
suitably qualified persons
what can RQP prescribe/ supply?
products falling within their scope of qualification and registration they hold
POM-V
POM- Veterinarian
POM-VPS
POM- veterinarian, pharmacist, suitably qualified person
NFA-VPS
Non food animal- veterinarian, pharmacist, SQP
AVM-GSL
Authorised veterinary medicine- general sales
what does a vet need to prescribe and supply veterinary medicines?
Registration with the RCVS
Do they need this registration to prescribe AVM-GSL?
NO
What is a VPP?
veterinary practice premises- registered with the RCVS
vets can only supply medicines from these premise
The vet must be present when any medicine (except a AVM-GSL) is being handed over. TF
true- unless they:
authorise each transaction individually before product is supplied
are satisfied that the person who hands it over is competent
where can pharmacists supply VMPs from?
registered GPhC premises
VPP or premises approved and registered for the storage and supply of VMPs by an SQP
must a pharmacist be present when its handed over?
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
what is a SQP
suitably qualified person
animal medicine advisor who is qualified to prescribe and supply certain vet medicines under the VMR
How do you become a SQP?
examination
two organisations responsible for training and registering SQPs?
- animals medicines training regulatory authority
- vet skills ltd
what can SQPs supply?
POM-VPS that they have prescribed or has been prescribed by a vet, pharmacist or other SQP
NFA-VPS
When is a product classed as a POM-V?
when there’s a strict limit on its use due to safety
requires vet specialist knowledge for use
has narrow safety margin
CDs schedule 2,3 are POM-V’s?
true
any new substance is usually classed as?
POM-V
Who can prescribe a POM-V?
a vet
what must the vet do before prescribing the POM-V?
Carry out a clinical assessment
animal must be under his care
if the vet prescribes more than the minimum amount of VMP needed for treatment?
its an offence
when is a medicine classed as a POM-VPS?
when its used to reduce endemic diseases in herds, flocks or individual animal
why aren’t these classed as POM-V?
Despite the risks the users can be made aware with simple advice and training
what are POM-V and POM-VPS mostly used for?
food producing animals
POM-V and POM-VPS are products which need special precautions to avoid risk to??
target species
person administering
the environment
what are NFA-VPS mostly used for?
pets
NFA-VPS is equivalent to what human class?
P
what properties of drugs make it AVM-GSL
wide safety margins
treatment of common ailments
special advice not required
when can certain medicines be placed on the market without a MA?
Subject to certain conditions, exemptions for small pet animals
what does this apply to?
only VMs labelled exclusively for use in a list of animals not intended for human consumption
list of animals:
aquarium animals cage birds homing pigeons terrarium animals small rodents ferrets rabbits
products marked under this exemption may be sold by?
any retailer
can pharmacists supply a POM-V?
YES
Any RQP prescribing a POM-V or POM-VPS or supplying a NFA-VPS must:
ensure recipient is competent to use
advise on safe administration
provide warnings
limit the amount supplied to minimum amount required for treatment
are there any restrictions on the supply of AVM-GSL?
NO
do AVM-GSL need to be sold from a retail building?
no but responsible approach to the supply is still expected
records needed for receipt and supply of POM-V and POM-VPS?
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
how long must this record be kept?
5 years
a vet prescription may be oral or written. TF?
true
when MUST it be written?
if the VMP is not supplied by the person who has prescribed it
how long are POM-V and POM-VPS prescriptions valid for?
6 months or shorter is indicated by Rx-er
what if the POM-V is a CD schedule 2,3 or 4?
28 days
what must be on a vet prescription?
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
what additional information must be added to the Rx if its for a CD schedule 2 or 3?
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
can a community pharmacist supply a POM-V product without a written Rx?
yes
are EEA and Swiss vets allowed to prescribe for animals in the UK?
yes providing they are registered with the RCVS
animals are under their care and a clinical assessment has been carried out
can UK pharmacists dispense the EEA/Swiss prescription?
yes at their discretion and subject to professional judgement
CD schedule 2,3 requirements?
- RCVS reg number of vet
- name of animal and owner address
- name and form of drug
- amount prescribed in words and figures
- strength
- dose
‘take as directed/ required’ is acceptable on a CD Rx?
no
if you dispense against a fax or email?
advised to ask for original Rx to follow
you can legally dispense CD against a fax. TF
FALSE
What needs to be on the immediate label of VMPs?
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'
when can labels be amended?
in accordance with Rx (eg to change a dose)
when do we use the vet cascade?
when there is no suitable authorised VMP in the uK for treatment of an animal
what must the prescription state if prescribed under cascade?
that its prescribed under the cascade or similar
who can prescribe under the vtiary cascade?
only vets
first stage of the vet cascade for food and non food producing animals?
VMP authorised for use in another species or for a different condition in the same species
step 2 in the vet cascade for food and non food producing animals?
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
step 3?
medicine prepared extemporaneously
SQP may only dispense _____ under the cascade?
an authorised VMP under the cascade
a pharmacist may dispense… under the cascade?
authorised VMPs
human medicines
extemp preparations
each supply must be against a….
vet prescription
what must a label contain under the cascade?
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”
when does this label not need to be done?
if prescribed, supplied and administered by a vet
what if all the information doesn’t fit on the label?
must be given on a separate sheet
it isn’t an offence to comply with these labels?
false, it is
permethrin affects on cats and dogs?
works on dogs
toxic to cats
are medicines marketed under the exemptions for small pet animals astill VMPs?
yes but without a legal distribution category
it is legal to sell or supply unauthorised vet medicines including human medicines for an animal. TF
no, unless it takes place under the cascade
is the previous true even if a vet surgeon asks the animal owner verbally to purchase an OTC human product from a pharmacy
yes it is still unlawful
