P3- prescribing veterinary medicines

what medicines are by law prescription only products?

-antibiotics and anti-infectives

-immunological medicines

-narcotic drugs and psychotropic substances

-magistral formulas, autovaccines

-medicinal products intended to animals requiring a withdrawal period before slaughter

-any medicinal product for injection

a drug requiring what route of administration requires prescription?

injection

what is a prescription?

the standardised document by which legally authorised doctors prescribe medication for being dispensed in authorised centres

which are the centers that are considered to be authorized for dispensing prescription medicine?

pharmacy offices, livestock entities or groups, and legally authorised commercial establishments, always under the control of their respective pharmaceutical services.

what does therapeutic void mean?

there are limited or no effective treatment options available for a particular disease

when there is a medication that doesn't exist in a European Union country, we call this a ________. in this case, what do we do?

therapeutic void.

in this case, we can make an "exceptional prescription"- when we can prescribe a drug that is not indicated in the marketing authorization. here, the vet is responsible for any adverse reactions.

in what case would we make an exceptional prescription?

an exceptional prescription is made when there is a "therapeutic void'" (the drug needed is not available to us). in the case of an exceptional prescription, the vet is responsible for any adverse reactions.

what is the "cascade prescription"?

a regulatory framework used in veterinary medicine to guide the prescribing of medications when licensed products are not available or suitable for a specific condition or species. The cascade system allows veterinarians to use alternative medications under certain conditions, ensuring that animals receive appropriate treatment even when licensed products are not directly applicable.

There are 3 levels to this cascade.

what is level 1 of the cascade prescription?

it is when the medication needed for the patient is not available, so we use either a medicine intended for that species, but use it for a different application, or we use a medicine that is intended for another species.

in the first case, the washout time is as indicated in the technical specifications.

in the second, we must increase the washout time to 50% over the highest washout time that appears in the technical specifications.

if a patient requires a specific medication but it is not available, and neither is a medication for another animal species, what do we do?

we use a medication authorized in humans that has the desired effect.

this is considered level 2 of the cascade prescription.

what is level 3 of the cascade prescription?

it is the circumstance that we do not have access to the desired medication, a medication for another animal species that would work, or even a human medication. in this case, the veterinarian can prescribe a magistral formula, officinal preparation, or autovaccine that is approved for veterinary use.

when none of the drug cascade medications are available, then what may be used?

an authorized veterinarian medication in a third country for the same animal species and the same indication

as a veterinarian, to acquire a medicine for professional use, what must we do?

complete an order form for professional use. here, we can include all the medicines we want to order from the supplier, indicating the number of packs

how can a veterinarian officially obtain narcotic drugs?

they must fill an order form and an official narcotic voucher.

this is a voucher book that is issued by the health authority. it can be obtained at the Official College of Veterinarians. It consists of 2 sections- one for the pharmacy and one for the vet.

The vet can use this to get the amount of the narcotic drug that is required for 7 days of treatment or the quantity that the vet estimates is necessary for the correct provision of their service, but with a max of 5 medicine boxes per voucher.

what is the maximum amount of narcotics that a vet can request at a time (per voucher)?

5 medicine boxes

how can a veterinarian request Hospital use medicine or human clinical packaging medicine?

they must fill an Order form + Official voucher for Hospital Use and Human clinical packaging (EC) Medicines.

this is issued by the health authority and obtained at the Official College of Veterinarians. It consists of 1 section for the vet and 1 for the pharmacy. The vet can request up to 5 containers per voucher, but can write as many vouchers that they need.

can we prescribe hospital use and clinical packaging medications for private use?

NO, it is only allowed for professional use by a veterinarian

what does Regulation 2019/6 state?

it specifies that veterinary prescriptions will only be issued after a clinical examination or any other appropriate assessment of the health status of the animal or group of animals by a veterinarian

what must occur for a veterinarian to be able to issue a prescription?

they must complete a clinical examination or another appropriate health assessment of the animal.

this is specified by by regulation 2019/6

for an owner to be able to purchase a medicine for their animal, what must they do?

they must have a correctly completed veterinary prescription, consisting of an original and 2 copies- one for the vet and 1 for the owner.

only 1 medicine per prescription can be prescribed

once an owner has a veterinary prescription, how long is it valid for?

30 days from when it is given, except for antimicrobials, which are valid 5 days from the date of prescription.

prescriptions for medications are valid for __________ days

30

(except for antimicrobials, which are valid for 5 days)

what are the 3 parts that make up the veterinary prescription (for non-food producing animals)?

treatment

identification (of the animal and owner)

other information

what information is included within the treatment section of the prescription form?

-name of the medicine

-active ingredient(s)

-dosage form and concentration

-prescribed quantity or number of the container, including the container size

-dosage regimen

-warnings

what information is included within the "Identification" section of the prescription form?

-ID of the animal/group of animals

-full name/details of the owner of the animals

-veterinarian name and contact details

-unique prescription number

if there is the case of an exceptional prescription due to therapeutic void, what must the veterinarian do officially?

correctly fill a veterinary prescription, and write "EXCEPTIONAL PRESCRIPTION"

when a veterinarian prescribes a narcotic drug, can they use the same prescription sheet as for any other medication?

no, there is a separate paper specifically for official prescription for narcotic drugs.

this prescription is issued by the health authority and can only be purchased from the Official College of Veterinarians. It consists of an original (for the pharmacist) and 2 copies (1 for the vet and 1 for the owner)

what are the regulations regarding the amount of narcotic medicine that an animal can be prescribed?

only 1 medicine for a particular animal/prescription, and the maximum number of containers that is necessary for one month of treatment.

once a prescription is written for a narcotic drug, how long does it stay valid for?

10 days

can a vet use the same prescription type of paper for a companion animal and a production animal?

no, there is another type of prescription that is needed for production animals. It is purchased from Official Collage of Veterinarians. It could be electronic. The veterinarian must be registered in the program of the Conselleria de Agricultura.

to be able to prescribe medications to production animals, the veterinarian must be registered in the _______

Conselleria de Agricultura

what information must be included in the prescription for production animals?

1. identification

2. treatment

3. other information

same information as other animals, but +the farm code

what is prophylaxis?

The administration of a drug to an animal or group of animals before there are clinical signs of a disease, in order to prevent the appearance of such disease or infection

what is metaphylaxis?

The administration of a drug to a group of animals after diagnosis of a clinical disease in part of the group, in order to treat clinically ill animals and control the transmission of the disease to animals in close contact and in danger and that may already be infected.

when prescribing medications, we try to use as _______ (much/little) as possible and as _________(much/little) as necessary.

little; much

we always prescribe medicine under the right conditions for the medicine to be __________ and _______. it must be safe for:

effective and safe

safe for:

-the animal receiving it

-the person administering it

-the person who will consume the animal

-the environment