Prescribing and Dispensing

Question 1

Name the 3 aims of the Veterinary Medicines Regulations 2013

Answer 1

1. To control risks to human health, animal health, and the environment through safe use of veterinary medicines.
2. To provide assurance on efficacy
3. To provide reliable information to users

Question 2

How is the regulation of drugs achieved (governing bodies)

Answer 2

Data assessment and authorisation by VMD
Centralised application of European Medicine Agency

Question 3

Name the processes by which the regulation of medicines is achieved (x4)

Answer 3

1. Certification and qualification
2. Prescribing, dispensing and supply of veterinary medicines
3. Testing, inspection and investigation
4. Post-marketing authorisation

Question 4

What is an SQP and what can they do

Answer 4

Suitably Qualified Person
Can supply some medicines, work in accordance with the VMD code of practice
Must have training and have passed exams

Question 5

What is a POM-V medicine

Answer 5

Prescription-only medicine from a Vet
Must be prescribed by a veterinary surgeon following a clinical exam of the animal, which must be under their care

Question 6

When can POM-V medicines be prescribed

Answer 6

Must be prescribed by a veterinary surgeon following a clinical exam of the animal, which must be under their care

Question 7

When is a medicine classed as POM-V (x4)

Answer 7

1. It requires a strict limitation on its use for specific safety reasons
2. It requires the specialised knowledge of a veterinary surgeon for its use/application
3. It has a narrow safety margin requiring above-average care in its use
4. It is government policy to demand professional control at a high level

Question 8

What is a POM-VPS medicine

Answer 8

Prescription-only medicine from a vet, pharmacist or SQP

Question 9

Can a POM-VPS medicine be prescribed without a clinical assessment of an animal

Answer 9

Yes

Question 10

What must the prescriber do before prescribing a POM-VPS

Answer 10

1. Be satisfied the person who administers the medicine is competent to do so
2. Advise on warnings/contraindications and safe administration

Question 11

When is a medicine classified as a POM-VPS

Answer 11

When used to reduce or prevent the effects of endemic disease in herds, flocks or in individual animals e.g. antiparasitic drugs

Question 12

What is a NFA-VPS drug

Answer 12

Non-Food Animal medicines which can be prescribed by a vet, pharmacist or SQP

Question 13

When is a medicine classed as a NFA-VPS

Answer 13

It is indicated for use only in non-food animals with no requirement for a prescription-only status
It is used routinely to prevent or limit the effects of endemic disease in non-food animals

Question 14

What is the Small Animal Exemption Scheme (SAES)

Answer 14

Medicines for use in certain pet species the active ingredient of which has been declared by the Secretary of State as not requiring veterinary control
they are exempt from the requirement for a marketing authorisation
Pet species - fish, cage birds, ferrets, rabbits, small rodents

Question 15

What is an AVM-GSL medication and what does it mean

Answer 15

Authorised Veterinary Medicine – General Sales List
No legal restrictions

Question 16

How many schedules of controlled drugs are there

Answer 16

5

Question 17

What 4 things should be taken into account when prescribing a medication

Answer 17

1. The circumstances of the animal being treated
2. The available authorised vet medicines
3. The need for responsible use of medicines
4. The competence of the person who is administering the product

Question 18

How many years must records of drugs be kept for

Answer 18

5 years

Question 19

What are the requirements for the premises where medicines are stored/supplied

Answer 19

Listed on a register as a Veterinary Practice Premises (VPP)
Premises must be in a permanent and secure building
The building must not allow the entrance of birds or vermin

Question 20

List the drug distribution categories

Answer 20

POM-V
POM-VPS
NFA-VPS
AVM-GSL

Question 21

What 3 laws regulate prescriptions

Answer 21

Vet surgeons act
Veterinary medicines regulation
Misuse of drugs act

Question 22

What are the 5 schedules of controlled drugs and what controls are they subject to

Answer 22

Schedule 1 - possession requires a home office licence
Schedule 2 - drugs obtained and supplied must be recorded in a register
Schedule 2 and 3 - prescriptions are subject to additional requirements
Schedule 4 and 5 - have fewer controls

Question 23

Define “under your care” when talking about POM-V prescriptions

Answer 23

The veterinary surgeon must have been given the responsibility for the health of the animal or herd by the owner or the owner’s agent
Veterinary surgeon must maintain clinical records of the animal

Question 24

What things must someone who is prescribing medicines do before prescribing

Answer 24

1. the person using the product is competent
2. advise safe administration
3. advise on any warnings or contraindications
4. Do not prescribe more than the minimum quantity required for the treatment

Question 25

Who do you report a prescription misuse to

Answer 25

Veterinary Medicines Directorate (VMD)

Question 26

Define an Adverse Event

Answer 26

Any observation in animals, whether or not considered to be product-related, that is unfavourable and unintended and that occurs after any use of a veterinary medicine Includes lack of efficacy

Question 27

Name the 4 types of adverse events

Answer 27

1. Lack of expected efficacy 2. Unexpected AE 3. Serious AE 4. Non-serious AE

Question 28

What is an unexpected adverse event

Answer 28

If the nature, severity or outcome of an observed AE is not described in the SPC = unexpected

Question 29

What is a serious adverse event

Answer 29

Results in death, or increased rates of death in a species for which there is an expected death rate Life-threatening clinical signs Significant disability or incapacity Congenital anomalies or birth defects Permanent or prolonged signs.

Question 30

Define an Adverse Reaction to a drug

Answer 30

A reaction to veterinary medicine which is harmful and unintended and which occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or to restore, correct or modify a physiological function.

Question 31

What are the characteristics of the drugs in each of the 5 controlled drug schedules

Answer 31

1 - no current therapeutic use 2 - have therapeutic use but are highly addictive 3 - misuse may lead to low or moderate physical dependence or high psychological dependence 4 - misuse may lead to limited physical dependence or psychological dependence 5 - potential for abuse is extremely low

Question 32

Give examples of schedule 2 drugs used in veterinary medicine (x6)

Answer 32

Methadone Morphine Fentanyl Ketamine Pethidine Quinalbbarbitone

Question 33

Give examples of schedule 3 drugs used in veterinary medicine (x5)

Answer 33

Buprenorphine Tramdol Gabapentin Midazolam Pentobarbitone

Question 34

Give examples of schedule 4 drugs used in veterinary medicine

Answer 34

Part 1 - diazepam, alprazolam Part 2 - Nandrolone, clenbuterol, somatotropin

Question 35

Give an example of a schedule 5 drugs used in veterinary medicine

Answer 35

Paracetamol with codeine (Pardale)

Question 36

What does procurement of schedule 2 and 3 drugs require

Answer 36

A requisition form

Question 37

How are schedule 2 drugs stored

Answer 37

Kept in a locked cabinet Recorded in Register

Question 38

Which schedule 3 drugs must be kept in a locked cabinet (x4)

Answer 38

Buprenorphine, Diethylpropion, flunitrazepam and temazepam

Question 39

If being kept in a vehicle, how are schedule 2 and 3 drugs stored

Answer 39

In a locked box which must be secured to the vehicle itself

Question 40

Who can prescribe a controlled drug

Answer 40

An MRCVS

Question 41

How are controlled drugs disposed of

Answer 41

Must be made irretrievable before disposal - denaturing kits - soap for tablets - cat litter

Question 42

What are the requirements when destructing a schedule 2 drug

Answer 42

Witnessed by - Veterinary Medicines Regulations (VMR) inspector - Controlled Drug Liaison Officer (CDLO) - Independent MRCVS Must be recorded in CDR (controlled drugs register)