Veterinary Medicines Regulations 2013 - VMP, Who can Rx & supply

Question 1

Which legislations do vet meds fall under

Answer 1

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

Question 2

Which animals are covered by vet med regs

Answer 2

Cats, dogs, pigs, birds, rabbits, exotic animals, horses, cows

Question 3

Which regulatory bodies are involved with vet meds

Answer 3

the vet meds directorate (government body), the national office of animal health (NOAH)

Question 4

What is a vetrinary medicinal product (VMP)

Answer 4

= 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

Question 5

It is an offence to place a VMP on the market unless it has…

Answer 5

…a Marketing Authorisation

Same type of rules apply to manufacturing, wholesaling, including records, as apply to human medicines

Question 6

Who can prescribe VMPs

Answer 6

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

Question 7

What are the 5 distribution categories of VMPs

Answer 7

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)

Question 8

What are the registration requirements for vets

Answer 8

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.

Question 9

What are the supplying requirements for vets

Answer 9

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

Question 10

What are the rules around pharmacists supplying vmps

Answer 10

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

Question 11

What is a suitably qualified person

Answer 11

= 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

Question 12

What can an sqp supply

Answer 12

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

Question 13

When is a medicine designated as POMV

Answer 13

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

Question 14

When are products designated as sch2/3 CDs

Answer 14

CDs Schedule 2, 3
Products with new active substances usually classed as POM-V
All products containing narcotic or psychotropic substances

Question 15

When cn a vet prescribe a pom V

Answer 15

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

Question 16

When would a medicine be in the POM-VPS class

Answer 16

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

Question 17

What types of meds are POM-V and POM-VPS

Answer 17

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

Question 18

When do we use NFA-VPS

Answer 18

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

Question 19

Which type of medicines are avm-gsl

Answer 19

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

Question 20

What are the exemptions for small pet animals

Answer 20

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

Question 21

When supplying a pom-c, pom-vps or nfa-vps the practitioner must…

Answer 21

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

Question 22

Whar are the rules around retail supply of avm-gsl

Answer 22

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

Question 23

What are the record requirements for receipt & supply of POM-V & POM-VPS

Answer 23

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

Question 24

What are the veterinary prescribing requirements for POM-V & POM-VPS

Answer 24

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

Question 25

What are the veterinary Rx requirements

Answer 25

1. 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. 2. Name and address of the owner. 3. Identification and species of the animal and its address (if different from the owner’s address). 4. 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. 5. Name, quantity, dose and administration instructions of the required medicine NB: The VMD advises that ‘as directed’ is not an acceptable administration instruction. 6. 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). 7. 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). 8. 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). 9. If the prescription is repeatable, the number of times it can be repeat

Question 26

What are the Rx requirements for CD schedule 2 and 3 VMP

Answer 26

Rx requirements are as for POM-V & POM-VPS but must also comply with Misuse of Drugs regulations: 1. Declaration that CD is prescribed for an animal/ herd under vet’s care 2. Specify RCVS registration number of Rx-ing vet 3. Name of animal, full name of owner and address where prescribed CD is to be delivered 4. Name and form of drug 5. Amount of product prescribed in both words and figures 6. Strength of preparation (if more than one strength available) 7. Dose to be administered NB.“Take as directed” or “Take as required” not acceptable

Question 27

How do we check potentially fraudulent vet scripts

Answer 27

If client new, telephone vet on Rx check name & address of the vet or practice on the RCVS website check name & address of pharmacist on the GPhC or PSNI website check List of SQPs & Register of Approved SQP Retailers 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!

Question 28

What are the manufacturers labelling requirements for VMPs

Answer 28

All labels and package inserts should be 1. In English and 2. 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

Question 29

Where can the manfacutrers labelling requirements be found on the package

Answer 29

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

Question 30

What are the labelling requirements for dispensed VMPs

Answer 30

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’.

Question 31

When do we administer medicines under the cascade

Answer 31

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)

Question 32

What are the 5 steps in the cascade

Answer 32

Prescribe.... 1. Licenced VM with GB/UK marketing authorisation for indicated species and condition 2. VM with MA in northern ireland for indicated species and condition 3. VM with MA in GB,NI or UK for diferent species or condition 4. Human medicine with MA in GB, NI or UK OR authorised VM from outside UK 5. Extemp rep (bu vet, pharmacist or person holding manufacturers authorisation in UK)

Question 33

WHi can dispense under the cascade

Answer 33

Suitably Qualified Person (SQP) may dispense an authorised VMP Pharmacist may dispense: - authorised VMPs - human medicines - extemporaneous preparations Each against a vet’s Rx

Question 34

What must be included on the label under the cascade

Answer 34

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

Question 35

What are the issues when using human meds in animals

Answer 35

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

Question 36

What are the rules around the sale of unauthorised vet meds

Answer 36

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.

Question 37

Records of a CD Schedule 2 POM-V in the CD Register need to be kept for…

Answer 37

2 years. CDs dont follow vrt regs, they follow cd regs under the misuse of drugs act