Regulation of veterinary medicinal products and prescribing responsibilities

Question 1

What does the Summary of Products Characteristics include

Answer 1

Information about the medicine
§ Specific to use of that formulation in the named target species
§ Presented in a standardised format
§ Updated when new indications or withdrawal periods agreed
§ Updates on the basis of pharmacovigilance reports - emphasises the importance of reporting adverse events

The SPC is not the same as the datasheet (e.g. Available via NOAH compendium) or the package leaflet, as the SPC often contains additional information (e.g. Pharmacology)

Question 2

Controlled drugs schedule

Answer 2

Schedule 1: non-medicinal (e.g. Hallucinogens, ecstasy, raw opium, cannabis)

Schedule 2: opiates, ketamine, amfetamine, cocaine, medicinal cannabis

Schedule 3: Barbiturates (including phenobarbital), buprenorphine, gabapentin, tramadol, midazolam

Question 3

How long is a prescription for schedule 2-4 drugs valid for?

Answer 3

28 days

Question 4

What schedules are repeat prescriptions valid for?

Answer 4

4-5

Question 5

When should you report a suspected adverse event?

Answer 5

For all medicinal products
§ Authorised use causing an adverse event in the animal (even if already stated in SPC) or human end-user
§ Cascade use causing an adverse event (off-label VMP, human product, EU VMP, extemporaneous medicines, etc.)
§ Even if there are complicating factors or you are not 100% certain it was caused by the product

Microchips
§ Chip migration
§ Failure to read
§ Implantation reaction