Prescribing, dispensing and labelling

Question 1

what are marketing authorisations?

Answer 1

pharmaceutical companies require a MA to be able to sell their drugs
- they are granted by the VMD
Vet medicines must only be prescribed if they hold a MA
MAs are specific to a species and condition
MAs for all products are reviewed after 5 years
- unless a problem has risen

Question 2

what must medicines undergo to get a MA?

Answer 2

pharmacological tests
texicology tests
clinical tests

Question 3

exemption from authorisation of medicines for small pet animals?

Answer 3

can only contain approved ingredients
certain drugs for certain species
- often aviary birds or aquatic fish
products must display that drug is in accordance
products must be sold in a pack suitable for a single course
- stop stock pilling/overdose
- often added to water or applied topically

Question 4

prescribing?

Answer 4

act of dealing, instructing and recording which treatment should be administered
- normally by vet or RAMA
when a medication is dispensed by the same practice that is has been prescribed a written prescription doesn’t need to be produced
a written prescription is necessary when:
- access drug elsewhere (eg online source)
- animal needs human drugs (eg go to pharmacy)

Question 5

under which circumstances can a VN administer POM-V medications?

under which circumstances can an owner administer POM-V medications?

Answer 5

direction of a VS
- must be colleague of same practice

once prescribed by VS
- shown and trained how to administer
can also be authorised agent or member of household

Question 6

prescribing procedures?

Answer 6

can be oral or written

POM-V drugs can only be prescribed to patients under the care of a VS
- following clinical assessment

POM-VPS drugs can be prescribed to animals that aren’t under the prescribers care and no clinical examination is needed

• can be prescribed by vets, pharmacists and SQPs
• need to gather previous history

NFA-VPS and AVM-GSL medications do not require a prescription

• NFA-VPS = any registered premises (practice or pet shop)
• AVM-GSL = any store

Question 7

prescribing regulations?

Answer 7

VS should be satisfied that the person administering the product is competent to do so safely

• ensure this through demonstrations
• safety concerns include ability (eg elderly with arthritic hands)

VS should explain any warning/contra-indications stated on the package or datasheet

• ensure this through pointing out and highlighting
• check understanding through making repeat
• give whatever they need (eg gloves)

VSs, pharmacists and RAMAs can dispense medications matching a prescription from a registered premises

the issuing of repeat prescriptions is at the discretion of the VS

• VSs decide length
• long term condition?
• when need to next be examined?
• side effects from long term use?

Question 8

requirements of a written veterinary prescription?

Answer 8

name, address and telephone of prescriber
qualifications enabling a person to prescribe
name and address of owner/keeper
identification of animal
premises where animal is kept if different to owner
date of the prescription
signature of prescriber
name and amount of product
dosage and administrative instructions
any necessary warnings
withdrawal period if relevant

Question 9

additional prescription requirements for control drugs?

Answer 9

The prescription must be original
- eg not emailed
A declaration that the drug is prescribed for an animal under the VSs care
The amount of the product prescribed is in words and figures
State the dose to be administered
- plus specific instructions in administration
Repeat prescriptions for Sch II and Sch III drugs are not permitted

Question 10

internet sales?

Answer 10

retail supply via the internet
the VMR also apply to the online sale of veterinary medicines
online retailers can be accredited under the VMDs ‘Accredited Internet Retailer Scheme’ (AIRS)
- are permitted to display the logo

Question 11

impact of online pharmaceutical industries on veterinary practices, clients and patients?

Answer 11

practices
- possible decrease in revenue
- practice spends less - more money available
- decrease pressure to supply
- more waste
clients
- cheaper - but getting prescription costs
- delivery easier if old/struggle
- if out of stock delivery straight to patient is better
patients
- animal welfare concern if delay in meds
- cheaper may mean more likely to be bought

welfare of animal > money for practice

Question 12

accessibility of products to clients?

Answer 12

POM-V
- should be stored in the pharmacy and not accessible to clients
POM-VPS
- should be stored in the pharmacy and not accessible to clients
NFA-VPS
- can be displayed to clients but must not be accessible
- locked display cabinet, empty boxes
AVM-GSL
- can be displayed and accessible to clients

Question 13

dispensing packaging types?

Answer 13

coloured fluted bottles
- medicines for external application
- shampoos, soaps, lotions 
plain glass bottles 
- oral liquid medication 
wide-mouthed jars 
- creams and granules  
paper board cartons, cartons, paper envelopes 
- sachets
- strip or blister packed meds
airtight glass, plastic or metal containers 
- oral medications 
- tablets and capsules

consider disabilities
- eg visibly impaired given fluted bottle so know not to drink

Question 14

dispensing medications?

Answer 14

each practice must have an SOP for dispensing

• should include a double check step
• give to colleague to check then both initial label

clients need to be fully informed about any medication that is dispensed to them

• dose required
• contra-indications
• adverse reactions
• storage and handling
• disposal

Question 15

dispensing legal requirements?

Answer 15

the person dispensing should ensure they are legally allowed to supply the meds
should make some checks
- qualifications of the prescriber
- if they have the specific product in stock
(only a VS can alter a prescription and supply an alternative)
- the identity of the client collecting the prescription
(confirm address/patient)

Question 16

general rules for labelling?

Answer 16

veterinary medicines should be labelled before they are dispensed
where possible should be in original packaging
- if not possible then information needs to be provided
- summary or product characteristics (SPC) (paper insert)
labels can be hand written or printed
all labels must be legible and in inedible ink

Question 17

what a label must include?

Answer 17

a name and address of owner/keeper 
veterinary practice name and address
the wordings:
- 'for animal treatment only'
- ' keep out of reach of children'
- 'for external use only'
date of dispensing 
withdrawel periods

Question 18

what a label can include?

Answer 18

animal name
- useful if owner has many
precautions related to product use 
drug name 
- useful if not in original packaging
quantity and strength 
instructions of dosing and administration 
total quantity of drug dispensed 
initials of person dispensing and checker

Question 19

what is the prescribing cascade?

Answer 19

used when specific drugs are not available for the species and/or condition
only a VS can prescribe drugs under the describing cascade
- regardless of the prescription category
the owner of an animal should give consent to these of cascade drugs
- may be explained practice protocol
- or on consent form for surgery
- or specific consent form
drugs prescribed under the cascade are also known as unauthorised

Question 20

record keeping of cascade drugs?

Answer 20

records must be kept for a minimum of 5 years

for food producing animals a record of the administration should be kept in the animal medicine record book

• only cascade drugs approved for animal use can be prescribed
• minimum withdrawal periods are 7 days for milk/eggs and 28 for meat

Question 21

why cascade drugs are needed for exotics?

Answer 21

the large range of species
the limited number of authorised drugs
- small part of market, wont sell many so not worth it
treatment is often indicated without a diagnosis
- difficult to take vitals
- prescribe based on clinical signs
small size of patients can make accurate dosing difficult
differences in metabolic rates needs to be considered
- don’t know dosage or frequency
may require specialist techniques and preparations
- eg hard to give tabekts as not meant for these species

Question 22

cascade drugs with equines?

Answer 22

horses are classsed as food producing animals unless otherwise specified in their passport
for horses not intended for human consumption
- normal prescribing cascade can be followed
for horses intended for human consumption
- additional requirements for food producing animals s
- no human drug prescriptions

Question 23

the prescribing cascade

step 1?

Answer 23

veterinary medicines with a GB or UK MA for the correct species and condition

Question 24

the prescribing cascade

step 2?

Answer 24

veterinary medicines with a NI MA for the correct species and condition

Question 25

the prescribing cascade

step 3?

Answer 25

veterinary medicines with a GB, NI or UK MA for a different species or a different condition

Question 26

the prescribing cascade

step 4?

Answer 26

human medicines from GB, NI or UK
or
veterinary medicines from outside the UK

Question 27

the prescribing cascade

step 5?

Answer 27

preparations prepared by the VS