Pharmacology Rules Regulations

Front 1

What information is required to be written on a prescription?

Back 1

1) Name & address of the prescriber,
2) credentials of the prescriber,
3) name & address of the person receiving the prescription,
4) a description of animal(s),
5) address where animals are kept if not at owner's address,
6) drug, dose & instructions (including withdrawl period if required),
7) note if prescribing under the cascade,
8) date,

RCVS suggestions:
9) written in indelible format,
10) signed,
11) "For animals under my care"
12) Refill instructions

Front 2

What are the current legal categories of Veterinary Medicines?

Back 2

1) Prescription Only Medicine - Veterinarian (POM-V),
2) Prescription Only Medicine - Veterinarian, Pharmacist, SQP (POM-VPS),
3) Non-Food Animal - Veterinarian, Pharmacist, SQP (NFA-VPS),
4) Authorised Veterinary Medicine - General Sales List (AVM-GSL)

Front 3

What are the 5 schedules of controlled drugs?

Back 3

Sched 1: Vets have no authority to possess or prescribe;
Sched 2: Special requirements for requisition, prescribing, record keeping, storage & disposal;
Sched 3: same prescription & requisition requirements, does not require same record keeping;
Sched 4: exempt from most restrictions, some informal register is encouraged;
Sched 5: preparations containing codeine, cocaine or morphine in less than specified amounts - exempt from most requirements but invoices need keeping.

SUMMARY: All invoices for scheduled / controlled drugs must be kept for 2yrs. Many drugs require locked storage, regardless of whether Sched 2, 3, or 4. Additional requirements vary.

Front 4

What information is required to be written on a prescription for a controlled drug?

Back 4

All details for standard prescription PLUS:

a) must include the form & strength to be dispensed in addition to the total quantity in words and figures,
b) is only valid for 3 weeks rather than standard 6 months and CANNOT BE REPEATED;
c) a written declaration that the animal is under her care is required.

Front 5

What record keeping is required for supplying medications to food producing animals?

Back 5

Veterinary surgeon must:
- on purchase of a product by the owner, record in a bound book:
a) name,
b) date,
c) quantity,
d) withdrawl period,
e) name & address of supplier.

-on administration of a product, also record:
a) name of VS,
b) name of product,
c) date,
d) amount,
e) identity of animal,
f) withdrawal period.

Records must be kept for a period of 5 years.

Front 6

What records are required to be kept for prescription drugs (POM-V and POM-VPS), applicable to all species?

Back 6

Incoming / outgoing transactions:
1) date & nature of transaction,
2) identity of VMP,
3) quantity received or supplied,
4) name & address of supplier or recipient,
5) copy of the prescription and name & address of person who wrote the prescription.

These records must be kept for 5 years.

Front 7

What is the cascade for selecting drugs for non-food animals?

Back 7

If there is no licensed product indicated for the condition & species to be treated, use:
1) a product licensed for another condition in the same species, or the same condition in another species;
2) a human licensed product or import a medicine for veterinary use in another EU state;
3) a product prepared extemporaneously as prescribed by a licensed individual.

* includes horses declared "non-food producing" on the passport

Front 8

What is the cascade for selecting drugs for food-producing animals?

Back 8

The same guidelines apply as for non-food species, ie:
If there is no licensed product indicated for the condition & species to be treated, use:
1) a product licensed for another condition in the same species, or the same condition in another species;
2) a human licensed product or import a medicine for veterinary use in another EU state;
3) a product prepared extemporaneously as prescribed by a licensed individual.

* Additionally:
4) treatment is only for animals on a single holding,
5) if the medicine is imported, it must be licensed for food animals in that state AND
6) the active drug must be listed in Annex I, II, or III in EEC regulations #2377/90 - regarding Maximum Residue Levels (MRL),
7) Withdrawal period specified
a) not less than 7 days for eggs & meat,
b) not less than 28 days for meat,
c) not less than 500 degree days for meat from fish;
and
8) Specific records must be kept for 5 years

**Annex I - MRLS have been established,
Annex II - no MRL required,
Annex III - provisional MRLs set,
Annex IV - PROHIBITED for use in food animals b/c NO MRL can be established

Front 9

What are Medicated Feed Stuffs? (MFS)

Back 9

MFS are now classed as POM-V; a prescription must be completed by a vet in order that the farmer may be supplied with the MFS. MFS that contain dewormer are classed POM-VPS. Antimicrobial growth promoters - banned as of Jan 2006.

Record keeping requirements are same as other POM-V/PS drugs. Manufacture, storage, labeling & distribution have strict requirements.