Veterinary Medicines Regulations 2013 - VMP, Who can Rx & supply Flashcards
Which legislations do vet meds fall under
EU directives: Veterinary Medicinal Products Directive 2001/82/EC – as amended by 2004/28/EC
=> Veterinary Medicines Regulations
Except - CDs are still controlled under The Misuse of Drugs Act 1971
Which animals are covered by vet med regs
Cats, dogs, pigs, birds, rabbits, exotic animals, horses, cows
Which regulatory bodies are involved with vet meds
the vet meds directorate (government body), the national office of animal health (NOAH)
What is a vetrinary medicinal product (VMP)
= Any substance or combination of substances:-
presented as having properties for treating or 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
It is an offence to place a VMP on the market unless it has…
…a Marketing Authorisation
Same type of rules apply to manufacturing, wholesaling, including records, as apply to human medicines
Who can prescribe VMPs
Registered Qualified Persons (RQPs)
- Veterinary surgeons
- Pharmacists
- Suitably qualified persons (SQPs)
According to the distribution category of veterinary medicinal product concerned
RQP may only Rx and/or supply products falling within
scope of qualification and
registration they hold
What are the 5 distribution categories of VMPs
POM-V - pom (vet)
POM-VPS - pom (vet, pharmacist, suitably qualified person)
NFA-VPS - non food animal (vet, pharmacist, suitably qualified person) (P meds)
AVM-GSL - authorised veterinary medicine (has an MA) - general sales
CDs (under the misuse of drugs act)
What are the registration requirements for vets
Registration:
Vet may only prescribe & supply veterinary medicines (other than AVM-GSL) if they are registered with theRCVS
Vets may only supply medicines from premises registered with theRCVSas Veterinary Practice Premises (VPP)
Registered practice premises subject to inspections.
What are the supplying requirements for vets
Supplying:
Vet supplying a veterinary medicine (other than AVM-GSL) must be present when it is handed over, unless they:
authorise each transaction individually before product is supplied
are satisfied that person who hands it over is competent
What are the rules around pharmacists supplying vmps
Supply VMPs – from premises which have been registered
- as a pharmacy with GPhC
- VPP or premises approved and registered for the storage and supply of VMPs by an SQP
Supplying pharmacist must be present when it is handed over, unless pharmacist:
- authorises each transaction individually before product is supplied
- is satisfied that person who hands over is competent
What is a suitably qualified person
= animal medicine advisor who is qualified to prescribe and/or supply certain veterinary medicines under the VMR
Must pass examination
Two organisations responsible for training and registering SQPs:
Animal Medicines Training Regulatory Authority (AMTRA)
Vet Skills Ltd
What can an sqp supply
SQPs can supply
- POM-VPS that
>they have prescribed or
>have been prescribed by a veterinary surgeon, pharmacist or another appropriately qualified SQP
-and NFA-VPS
When is a medicine designated as POMV
When it requires a strict limitation on its use for specific safety reasons
requires vet’s specialised knowledge for its use/application
has narrow safety margin
is Government policy to demand professional control at high level
When are products designated as sch2/3 CDs
CDs Schedule 2, 3
Products with new active substances usually classed as POM-V
All products containing narcotic or psychotropic substances
When cn a vet prescribe a pom V
A veterinarian must:
- Carry out a clinical assessment of the animal (doesnt have to include a physical assessment)
- The animal(s) must be under their care (formal responsibility)
It is an offence to prescribe more than minimum amount of VMP required for treatment
When would a medicine be in the POM-VPS class
A medicine is POM-VPS when:
used to reduce or prevent effects of endemic disease in herds, flocks or in individual animals (such as treatment for worms and other parasites)
use implies risks for user, animal, consumer safety or environment, but users can be made aware of suitable countermeasures through simple advice
professional user can be given adequate training in its regular use
What types of meds are POM-V and POM-VPS
Products for food producing animals
Products in which special precautions must be taken to avoid any unnecessary risk to:
- the target species
- the person administering the product
- the environment
Products that may interfere with future diagnosis
New VMP
When do we use NFA-VPS
able to be bought without a script
Used for non food producing animals
e.g. pets of all kinds
This category is equivalent to P for human medicines, i.e. some control over supply
Which type of medicines are avm-gsl
Equivalent to GSL for humans Wide safety margin Treatment of common ailments Special advice not required *Dont* need to be sold in places that must exclude the public
What are the exemptions for small pet animals
Permits certain medicines to be placed on market without MA, subject to certain conditions
applies only to VMs labelled exclusively for use in one of following animals not intended for human consumption:
- aquarium animals
- cage birds
- homing pigeons
- terrarium animals
- small rodents
- ferrets
- rabbits
Products marketed under this exemption may be sold by any retailer
When supplying a pom-c, pom-vps or nfa-vps the practitioner must…
Ensure recipient is competent to use product for prescribed/authorised purpose
Advise on its safe administration
Provide information about contraindications/ warnings etc.
Limit the amount of product prescribed (supplied) to minimum amount required for immediate treatment
Whar are the rules around retail supply of avm-gsl
There are no restrictions on supply
e.g. do not need to be sold from retail building
Responsible approach to supply of these medicines still expected
What are the record requirements for receipt & supply of POM-V & POM-VPS
Name of medicine Date of receipt or supply Batch number Quantity Name and address of supplier or recipient Name & address of Rx-er + keep copy of Rx if there is written Rx Keep for 5 years! Dont need a specific register
What are the veterinary prescribing requirements for POM-V & POM-VPS
A prescription may be oral or written (must be written if dispensed outwith the vet practice)
Valid for 6 months
(or shorter if indicated by Rx-er)
(unless CD Schedule 2, 3 or 4 => 28 days)
A written Rx must be in ink or indelible or transmitted in a secure electronic format
What are the veterinary Rx requirements
- Name, address, telephone number, qualification and signature of the prescriber. Where Schedule 2 or 3 CDs have been prescribed, the Royal College of Veterinary Surgeons (RCVS) registration number of the prescriber must also be included.
- Name and address of the owner.
- Identification and species of the animal and its address (if different from the owner’s address).
- Date. prescriptions are valid for six months or shorter if indicated by the prescriber (the Veterinary Medicines Directorate (VMD)has confirmed in the case of repeatable prescriptions all supplies must be made within 6 months or shorter if indicated by prescriber). Prescriptions for Schedule 2, 3 and 4 CDs are valid for 28 days.
- Name, quantity, dose and administration instructions of the required medicine NB: The VMD advises that ‘as directed’ is not an acceptable administration instruction.
- Any necessary warnings and if relevant the withdrawal period (i.e. the time that must elapse between when an animal receives a medicine and when it can be used for food).
- Where appropriate, a statement highlighting that the medicine is prescribed under the veterinary Cascade (e.g. ‘prescribed under the Cascade’ or other wording to the same effect).
- Where Schedule 2 or 3 CDs have been prescribed, a declaration that ‘the item has been prescribed for an animal or herd under the care of the veterinarian’ – usual CDs prescription requirements apply (see section 3.6.7).
- If the prescription is repeatable, the number of times it can be repeat
What are the Rx requirements for CD schedule 2 and 3 VMP
Rx requirements are as for POM-V & POM-VPS but must also comply with Misuse of Drugs regulations:
- Declaration that CD is prescribed for an animal/ herd under vet’s care
- Specify RCVS registration number of Rx-ing vet
- Name of animal, full name of owner and address where prescribed CD is to be delivered
- Name and form of drug
- Amount of product prescribed in both words and figures
- Strength of preparation (if more than one strength available)
- Dose to be administered
NB.“Take as directed” or “Take as required” not acceptable
How do we check potentially fraudulent vet scripts
If client new, telephone vet on Rx
check name & address of the vet or practice on theRCVSwebsite
check name & address of pharmacist on theGPhC or PSNI website
check List of SQPs&Register of ApprovedSQPRetailers Premises
if the prescription is unclear or there are amendments check with the prescriber
If you do dispense against faxed or emailed Rx’s
- Advised to ask for original Rx to follow
- NB. Illegal to dispense CD against fax!
What are the manufacturers labelling requirements for VMPs
All labels and package inserts should be
- In English and
- Have ‘UK authorised veterinary medicinal product’
a. Name of VMP, strength and form*
b. Name and proportion of each active substance* and of any excipient if this is specified in MA
c. Route of administration (if not apparent)*
d. Batch number*
e. Expiry date*
f. Words “For animal treatment only”*
- and for POM-V and POM-VPS products also the words “To be supplied only on [veterinary] prescription”*
g. Contents by weight, volume or number of dose units
h. Marketing authorisation number
i. Name and address of MA holder or distributor
- Have to be on immediate container label
j. Suitably labelled space to record discard date (if relevant)
k. Target species
l. Distribution category – in box
m. Words “Keep out of the reach of children” or “Keep out of reach and sight of children”
n. Storage instructions
o. In-use shelf life (if appropriate)
p. For food-producing species, withdrawal period for each species or animal product concerned (even if zero days)
q. Any warning specified in MA (target species or user or environment) considered essential for that product
r. Disposal advice
s. Full indications
t. Dosage instructions
u. Contraindications
v. Any further information required by MA
Where can the manfacutrers labelling requirements be found on the package
If all of the above can be placed on package, then there is no need for any package inserts
If not, all with * have to be on immediate container label
+ words “Keep the container in the outer carton”
+ package leaflet with all above required info
What are the labelling requirements for dispensed VMPs
RCVS PSS requirements for labelling VMPs
Medicines other than POM-Vs
In accordance with their MA and the VMR.
Name and address of the practice supplying the product.
POM-V Medicines:
All must be legibly and indelibly labelled with:
Name and address of the animal owner
Name and address of the veterinary practice supplying the medicine
Date of supply
Name, strength and quantity of product
Dosage and directions for use
‘For animal treatment only’
For topical preparations ‘For external use only’.
When do we administer medicines under the cascade
If there is no suitable authorised VMP in the UK for the treatment of an animal, a vet may treat the animal following ‘the Cascade’
=> in sequence
Only vets can prescribe under the cascade
Rx needs to state
“prescribed under the Cascade”
“for administration under the Cascade”
(or similar)
What are the 5 steps in the cascade
Prescribe….
- Licenced VM with GB/UK marketing authorisation for indicated species and condition
- VM with MA in northern ireland for indicated species and condition
- VM with MA in GB,NI or UK for diferent species or condition
- Human medicine with MA in GB, NI or UK OR authorised VM from outside UK
- Extemp rep (bu vet, pharmacist or person holding manufacturers authorisation in UK)
WHi can dispense under the cascade
Suitably Qualified Person (SQP) may dispense an authorised VMP
Pharmacist may dispense:
- authorised VMPs
- human medicines
- extemporaneous preparations
Each against a vet’s Rx
What must be included on the label under the cascade
The product must be labelled with
(unless prescribed, supplied & administered by a vet):
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:
target species, administration or disposal of product
k. Withdrawal period, if relevant
l. Words
- “For animal treatment only” and
- “Keep out of reach of children”
NB. If do not fit on label must be on separate sheet
It is an offence to not comply with above
What are the issues when using human meds in animals
Human and veterinary medicinal products containing the same active substances are not necessarily interchangeable.
Animal species react differently to medicines between themselves
E.g.
Permethrin works in dogs but is poisonous to cats
Ibuprofen is poisonous to dogs
These risks relate to all the components of the medicine, not just the active ingredient
What are the rules around the sale of unauthorised vet meds
Medicines not being used for their indication are only available under cascade
Check for veterinary alternatives
NB. Medicines marketed under the Exemptions for Small Pet Animals are still veterinary medicines
(without legal distribution category,
but good manufacturing practice still required)
It is unlawful to sell or supply unauthorised veterinary medicines (medicines not licensed as veterinary medicines), including human medicines such as GSL and P medicines, for an animal unless this takes place under the veterinary cascade.
This applies even if a veterinary surgeon asks the animal owner verbally to purchase an over-the-counter human product from a pharmacy.
Records of a CD Schedule 2 POM-V in the CD Register need to be kept for…
2 years. CDs dont follow vrt regs, they follow cd regs under the misuse of drugs act
