Prescribing & Dispensing: The Prescribing Cascade

Question 1

what does authorized vet meds mean

Answer 1

scientific assessment of quality, safety, and efficacy

potential risks to the environment, animals, operators and consumers

SPC of dose, route of admin, etc

Question 2

what are problems with unauthorized medicines

Answer 2

1. may not be of consistent quality
2. may not be safe and effective
3. may pose a risk to consumers if administered to a food producing species

Question 3

what are exemptions to the cascade (3)

Answer 3

1. products for research (ASPA)
2. exceptional circumstances (disease outbreak)
3. immunological products for imported or exported animals

Question 4

what is the cascade

Answer 4

a mechanism to allow us to prescribe unauthorized medicines to our patients

Question 5

when is the cascade legal

Answer 5

1. three steps of the decision tree are followed
2. justified with regard to the animal’s welfare
3. not using the drug as a cost-saving exercise

Question 6

who can prescribe and dispense under the cascade

Answer 6

only a vet can prescribe

a pharmacist may dispense an authorized VMP for use under the cascade, human medicines or extemporaneously prepared medicines against a prescription from a vet

an SQP may dispense an authorized VMP for use under the cascade against a prescription from a vet, provided they have the relevent qualification for that species

Question 7

what is good practice before you prescribe a medicine under the cascade

Answer 7

get informed consent from the owner RCVS recommends

Question 8

what is required for food animals

Answer 8

extra regulations to protect the consumer

Question 9

what are the regulations to prescribing under the cascade in food animals (5)

Answer 9

1. treatment restricted to a single holding
2. if using an imported product, it must be authorized in a FP species in the other member state
3. active substances must be listed in Table 1: allowed substances
4. vet must specify appropriate withdrawal period
5. vet must keep specified records

Question 10

what is maximum residue limit (MRL)

Answer 10

max safe concentration of residue resulting from use of a vet medicinal product

expressed in mg/kg

Question 11

what is a withdrawal period

Answer 11

period of time, following treatment of an animal with a veterinary medicine, in which the meat, milk, eggs or honey from the treated animals must not enter the food chain due to possible presence of residues from pharmacologically active substances

Question 12

how do you set a withdrawal period

Answer 12

the vet does this

check the SPC –> if the species is different or dose is higher then the minimum statutory withdrawal period should be set

Question 13

what records must be kept (10)

Answer 13

1. date of exam
2. name and address of owner
3. animal ID and number treated
4. result of clinical assessment
5. trade name of product
6. batch number
7. name and quantity of active substance
8. dose administered and/or supplied
9. duration of treatment
10. withdrawal period

Question 14

how long do records need to be kept

Answer 14

5 years

Question 15

what is step 1 in the prescribing cascade

Answer 15

a product authorized in the UK for use in another animal species (must be another food-producing species)

or a product authorized for another condition in the same speices

Question 16

what is step 2 in the prescribing cascade

Answer 16

a human medicinal product authorized in the UK

OR

a veterinary medicinal product authorized in another EU member state for use in an animal species (in the case of a food-producing animal it must be a food-producing species)

Question 17

what is step 3 in the prescribing cascade

Answer 17

a medicinal product prescribed by the responsible VS and prepared extemporaneously by a pharmacist, a vet surgeon or a person holding a manufacturing authorization authorizing the manufacture of that type of product

OR

a medicine imported from third countries

Question 18

what are the tables

Answer 18

Table 1: allowed substances

Table 2: prohibited substances

Question 19

what is table 1

Answer 19

substances in which an MRL has been established, is being established or doesn’t need to be established

Question 20

what are table 2 substances

Answer 20

MRL cannot be established

any residue at any level, constitutes a hazard to human health

administration of substances listed to food-producing animals is prohibited

Question 21

what needs to be done before prescribing for a horse in the UK

Answer 21

check the passport

see if the horse is intended for human consumption

if not then treat as for any companion, non-food animal

follow normal cascade

Question 22

if the horses is intended for human consumption what should you do

Answer 22

follow the food animal cascade

Question 23

what is the essential substances list

Answer 23

additional substances that can be used in horses intended for consumption

BUT a minimum 6 month withdrawal period

Question 24

which medicines are not permitted in horses intended for human consumption

Answer 24

anything listed in table 2

and anything not listed in either

table 1 or essential list

Question 25

what if there is no horse passport

Answer 25

treat as intended for human consumption

Question 26

can phenylbutazone be used in horses intended for human consumption

Answer 26

no