Labelling And vetinary Medicines

Question 0

In terms of the drug, what must be on your label?

Answer 0

Name of product, matching the Rx
Form of product
Strength
QUANTITY

Question 1

What must always be on your label? (ie what is Pre-printed by system)

Answer 1

Keep out of reach of children (Pre-printed)
Name and address of pharmacy are legally required
Patients Name and DATE are legally required

Question 2

When writing directions on the label, what is preferred for children? And animals?

Answer 2

GIVE is preferred to Take

Question 3

If you’ve made a POM entry, what should be included on your label?

Answer 3

A reference number

POM entries made for private prescriptions and emergency supplies

Question 4

If the medicine is an emergency supply at request of a PATIENT, what should be included on Label? What about are request of a doctor?

Answer 4

At request of patient: emergency supply to be written on label
At request of doctor: does not need emergency supply written

Question 5

What additional label should be added to Liquid emulsions, suspensions and aerosol formations?

Answer 5

Shake well before use

shake gently before use proffered for some preps

Question 6

For products applied to the skin or scalp, what extra label is needed?

Answer 6

for external use only

May include the label ‘Spread thinly on the affected skin only’ for eg Betnovate RD cream

Question 7

On labels for EYE, EAR, NASAL, VAGINAL and RECTAL products, what caution should be included?

Answer 7

Not to be taken by mouth

Question 8

What extra labels are requires for vaginal suppositories? Eg Diclofenac 50mg suppositories

Answer 8

Not to be taken by mouth

Store in a cool place

Question 9

What extra labels would be needed for Pilocarpine 1% eye drops?

Answer 9

Not to be taken by mouth
Discard four weeks after opening

The discard four weeks after opening label must be included on labels for all eye preparations.

Question 10

Some granules and powders for reconstitution have a short shelf life once reconstituted (made up into suspension). What additional info on the label should be present?

Answer 10

Specific expiry date after which they shouldn’t be used,

Eg discard after dd/mm/yy

Question 11

What should be on the label of extemporaneously manufactured products?

Answer 11

Should have specific expiry date

Should have Batch Number of product both on label

Question 12

In terms vetinary medicinal products and human medicinal products, which can be interchanged?

Answer 12

Medicinal products for human use can be used to treat animals under certain circumstances, under the Vetinary Cascade
But vetinary medicines can NEVER be used to treat Humans!!

Question 13

Are vetinary medicines under the Medicines act?

Answer 13

No, not anymore since 2005.

Vetinary Medicines Directorate (VMD) was established, this issues new Vet Medicines Regulations each year.

Question 14

What animals does the vetinary medicines regulations cover?

Answer 14

Medicines supplied for most animals

Including birds, reptiles, fish, molluscs, crutacea and bees

Question 15

Do vetinary medicines need Marketing authorisations, if they’re not under the control of the MHRA?

Answer 15

Yes, they need something similar to a marketing authorisation, issued by the veterinary medicines directorate.

Question 16

Who can provide advice to the vetinary medicines directorate?

Answer 16

The Independent vetinary products committee
They offer advice on behalf of the Minister of Agriculture
They consider appeals

Question 17

What does POM-V mean?

Answer 17

POM- Veterinarian

Question 18

What does POM-VPS mean?

Answer 18

Vet, pharmacist and suitably qualified person

Suitably qualified person must be registered with animal medicines training regulatory agency

Question 19

NFS-VPS, what’s this for?

Answer 19

For non food producing animals

Question 20

AVM-GSL, what does AVM stand for?

Answer 20

Authorised veterinary medicine

Question 21

When can POM-V medicines be supplied?

Answer 21

Only If prescribed by a vet after clinical assessment of the animal
Can be supplied by a vet or a pharmacist

Question 22

How long must records of POM-Vs be kept?

Answer 22

5 years

Question 23

When can POM-VPS been prescribed? Does the animal need to be clinically assessed? 

Answer 23

Can be prescribed by any registered Qualified person
(vet, pharmacist or SQP)
Clinical assessment of animal is NOT needed
Pharmacist or SQP can supply against prescription from a Vet, OR vice versa.
Again record of supply should be kept for 5 years

Question 24

Can NFA-VPS (for non food producing animals) be supplied without a prescription?

Answer 24

Yes They're used to prevent or limit the effects of disease in NFAs NFAs: horses, cats, dogs?

Question 25

Do any restrictions apply with AVM-GSLs?

Answer 25

No, no restrictions They have wide margins of safety Used to alleviate the signs of disease, or to treat common ailments Eg may be flea-killing products, that you can buy in pet stores

Question 26

What does the small animals exemptions scheme involve?

Answer 26

Permits certain medicines to be marketed without a marketing authorisation, subject to certain conditions, for vet MPs exclusively for use in specified animals, that aren't intended for human consumption. Eg for fish, caged birds, small rodents

Question 27

``` Controlled drugs (VMGN 20) Schedule 2 and 3 are classified as ______ under the Vet regulations. They're subject to both Vet regs and _______ for prescriptions, supply and record keeping, storage and disposal. ```

Answer 27

Classified as POM-V | Subject to both Vet regs and MDA regs

Question 28

What is the code for vetinary Prescritpions?

Answer 28

VMGN3 Prescriptions can be oral or written

Question 29

What must a Vetinary prescription include?

Answer 29

Name, address, and TELEPHONE number of prescriber  Qualification of Prescriber (Vet) Name and address of OWNER of the animal SPECIES of animal ANIMALS NAME NUMBER of animals (premises where it's kept if different to owners address) Date Signature Name, strength, quantity Dosage and administration instruction (as directed is NOT allowed) Warnings Withdrawal period possibly If its been prescribed under the CASCADE (ie it's a medicine for human use but is being given to the animal) then a statement needs to be on there saying this If prescriptions repeatable, the number of REPEATS

Question 30

Can you alter Vetinary prescriptions if you notice something wrong?

Answer 30

No, this is against the law | Unless you are authorised by the person who signed the Rx

Question 31

How long are vetinary prescriptions valid for?

Answer 31

6 months after appropriate date | Unless for CD schedules 1-4 (28 days)

Question 32

What is an important statement that must be on CD Prescritpions for Animals?

Answer 32

Declaration that the CD is prescribed for an animal under the VETS CARE

Question 33

With vetinary CD prescriptions, when aren't Repeats allowed?

Answer 33

Repeats of Sch2 and 3 drugs aren't allowed

Question 34

It's an offence to supply a medicine licensed for humans for administration to animals, unless it's _____

Answer 34

Under the CASCADE

Question 35

A pharmacist supplying a vetinary medicinal product must be present when it's handed to the owner UNLESS:?

Answer 35

They have authorised each transaction individually before the product is supplied And only if they're satisfied that the person handing it over is competent to do so.

Question 36

If a vetinary Medicinal Product is in the manufacturers original packaging and is NOT prescribed under the Cascade, then what are the requirements on labelling?

Answer 36

There is NO LEGAL requirement to label! But it's good practice to do so with name and address of pharmacy, name and address of owner, and the date of the supply.

Question 37

With veterinary medicines prescribed under the cascade, ie the medicine is for use in humans, what additional things need to be on the label?!

Answer 37

``` Should say GIVE not take Name of animal and it's species (eg Jack the Dog) Name and address of OWNER Name of prescriber For animal treatment only Expiry date (potentially) reference number from POM BOOK Keep out of reach of children Name and address of pharmacy DATE ```

Question 38

What must be written in a POM book entry for POM-V and POM-VPS (if under the cascade)?

Answer 38

``` "Jack the Dog" Owners name and address Drug, strength, quantity Directions Batch number vet name, vet address, vet TELEPHONE No Date on Rx: date supplied: For animal under vets care For administration under the veterinary prescribing cascade ```

Question 39

Sheep dips: a liquid formulation of insecticide or fungicide

Answer 39

Supply must only be to a person qualified to use it They must have a certificate You must keep a record of the certificate number for 3 years If the sheep dip also contains an organophosphorous compound, you must also supply; a4 laminate instruction sheet 2 pairs of protective gloves

Question 40

What vetinary products is it an offence to advertise?

Answer 40

Any POM-V or POM-VPS Any human medicine for administration to an animal Any "off label" use of a product

Question 41

What are most often supplied from pharmacies in terms of vetinary medicines?

Answer 41

Prophylactic medicines for fleas and worms for pets that do not require diagnosis

Question 42

What kinds of Vet medicines can pharmacists prescribe?

Answer 42

POM-VPS NFA-VPS NOT POM-Vs! These can only be prescribed by a Vet after clinical assessment

Question 43

Pharmacists can only supply human medicines for animal use against a _____ from a vet, pharmacists cannot prescribe these themselves. These are POMs, GSLs and Ps that are all used I'm humans.

Answer 43

Against a WRITTEN prescription from a vet (oral not good enough) This includes GSL and P medicines