Advice on Animal Remedies (Veterinary Medicines)

The main requirements concerning the sale and supply of animal remedies (veterinary medicines) are set out in the European Communities (Animal Remedies) (No.2) Regulations 2007 (S.I. No. 786 of 2007) (as amended), which can be accessed on www.irishstatutebook.ie or via the PSI website. All pharmacists engaging in the sale and supply of animal remedies should ensure that they are familiar with these regulations.

This advice is set out under the following sections:

  • Classification of animal remedies
  • Storage
  • Record keeping requirements
  • Veterinary prescription requirements 
  • Endorsing requirements for veterinary prescriptions
  • Emergency supply of animal remedies
  • Veterinary requisitions

Classification of Animal Remedies

The route of sale or supply of an animal remedy depends on its category. The classification or category can be readily identified as it is indicated on the labelling or outer packaging of the product. If you are ever in doubt as to the classification of an animal remedy, information can be checked at www.hpra.ie.

A veterinary practitioner (vet) can supply all remedy classifications; however there are other restrictions on who can sell or supply each class of product and under what circumstances, as outlined below.

Animal remedies are classified into 6 categories:

1. Veterinary Practitioner Only (VPO-1/VPO) These medicines may only be sold or supplied by a vet, or by an authorised wholesaler to a vet. The symbol VPO-1/VPO will be displayed on the labelling or outer packaging of the product. Pharmacists/pharmacies are not permitted to sell or supply these medicines to any person, including to veterinary practitioners.

2. Prescription Only (POM)

These medicines may only be supplied by a pharmacist, from a pharmacy, in accordance with a veterinary prescription. The symbol POM or V-POM will be displayed on the labelling or outer packaging of the product.

Certain POM animal remedies may also be sold or supplied by a responsible person from ‘licenced merchant’ premises, in accordance with a veterinary prescription.

3. Prescription Only Exempt POM(E)

These medicines may be sold from a pharmacy without a prescription, but the sale must be personally made by a pharmacist. The symbol POM(E) will be displayed on the labelling or outer packaging of the product.

4. Pharmacy Only (PS)

These medicines may be sold from a pharmacy, without a prescription, under the personal supervision of a pharmacist. The symbol PS will be displayed on the labelling or outer packaging of the product.

5. Licensed Merchant (LM)

These medicines may be sold from a pharmacy, without a prescription, under the supervision of a pharmacist. The symbol LM will be displayed on the labelling or outer packaging of the product. The sale of these medicines is not restricted to pharmacies. They are also available from other ‘licensed merchant’ premises, e.g. farmers’ co-ops.

6. Companion Animal Medicines (CAM)

These medicines may be sold from a pharmacy, without a prescription, under the supervision of a pharmacist. The symbol CAM will be displayed on the labelling or outer packaging of the product. The sale of these medicines is not restricted to pharmacies. They are also available from ‘licensed merchants’ and ‘companion animal remedies sellers’ (e.g. pet shops).

Pharmacists should ensure that appropriate advice is given every time an animal remedy is sold or supplied. This will enable animal owners to use the products safely and effectively.

Storage

Animal remedies should be stored in a pharmacy in a manner which meets all relevant requirements as set out in the PSI’s Guidelines on Storage of Medicinal Products within a Retail Pharmacy Business. They should be stored separately from human medicines and the parts of the premises used for the storage of animal remedies should be clearly identified as such.

POM animal remedies must be stored in the dispensary, and must not be stored in an area where they would be accessible to the public for selection. POM (E) animal remedies should also be stored in the dispensary to ensure the sale is personally made by a pharmacist. PS and LM animal remedies should be stored in an area of the pharmacy under the personal control of the pharmacist, such as behind the pharmacy counter.

Pharmacists should check the pharmacy shelving in the public areas of the pharmacy to ensure that no animal remedies are inadvertently located in an area in which they should not be stored. We have previously found, for example, that certain prescription only pet wormers, ‘spot-on’ flea preparations and ear drops have been mistaken as being LM remedies.

All animal remedies must be stored in accordance with the requirements of their marketing authorisations. The storage conditions for a medicinal product, including the temperature requirements, are normally specified on the outer packaging of the product. All animal remedies requiring storage between 2-8°C must be kept in a separate animal remedies pharmaceutical grade refrigerator.

You are also reminded that extra precautions are needed if an animal remedy has a strong odour which may compromise other medicines/products at the pharmacy. These products should be stored in a part of the premises isolated from other medicinal products.

Please ensure that all expired, damaged or ‘patient-returned’ animal remedies are segregated from active stock and promptly disposed of.

Record Keeping

Animal Remedies / Veterinary Register

A record of all purchases and sales of POM, POM(E), PS and LM animal remedies (both incoming and outgoing transactions) must be maintained in the pharmacy. This is commonly known as an animal remedies register or veterinary register. You also need to keep these records for any human medicines supplied for use in animals. You don’t have to keep this record for purchases and sales of companion animal medicines (CAM).

This record must contain:

  • The date the transaction occurred
  • The precise identity of the animal remedy (i.e. name, form, strength) or medicinal product
  • The quantity received or supplied
  • The name and address of the supplier or purchaser
  • The manufacturer’s batch number of the product received/supplied, and
  • Where the transaction relates to the supply of a prescription only medicine (POM), the serial number of the veterinary prescription.

Invoices received for animal remedies may contain all of the relevant information for ‘incoming’ transactions. These animal remedies invoices should be kept separate from other pharmacy invoices. The record can be maintained as a daily printed computer record or in a separate register or folder. However you choose to keep the record, it must contain all the details listed above and be available for inspectors to review at inspection. Please note that some of these details may not be automatically recorded on a computer-generated record.

Annual Audit

The legislation also requires pharmacists to carry out an audit of their animal remedies stock at least once a year. Incoming and outgoing supplies of animal remedies must be reconciled with supplies currently in stock. This can be carried out by way of a stock take. If discrepancies are noted they must be specifically recorded. The pharmacist must retain a record of this reconciliation and make it available for inspection.

Retention of Records

The legislation requires each of the above records to be kept at the premises for five years.

Veterinary Prescription Requirements

Animal remedies designated Prescription Only (POM) may be sold/supplied by a pharmacist from a pharmacy, in accordance with a veterinary prescription. (In emergency circumstances the legislation provides for the “emergency supply” of a prescription only animal remedy to be made at the request of a vet)

Before a pharmacist dispenses a prescription only animal remedy, they must review the veterinary prescription to ensure that the prescription meets the legislative requirements. The prescription must:

  • Be in ink
  • Be issued and signed by a registered veterinary practitioner
  • Bear the name and address of the vet in block capital letters
  • Contain a declaration that the prescription is granted in respect of an animal under the prescribing vet’s care
  • Be assigned a serial number
  • Specify a date of issue and period of validity
  • Specify the name and address of the person to whom the prescription is granted
  • Contain a description of the animal or animals to which the prescription relates
  • Contain details of the animal remedy prescribed, including the remedy’s name and veterinary product authorisation (VPA) number
  • Specify the quantity of the animal remedy prescribed
  • Specify the dose rate
  • Specify the manner and site of administration
  • Specify the withdrawal period to be observed and any special instructions, precautions or risks, where applicable

A veterinary prescription may not be dispensed later than 12 months after the date of issue, and the pharmacist must be satisfied that it is safe to dispense the animal remedy as prescribed.

Please note that a faxed copy or photocopy of a veterinary prescription is not an original valid prescription and may not be used to authorise the supply of a prescription only animal remedy.

Endorsing Requirements for Veterinary Prescriptions

The European Communities (Animal Remedies) (No. 2) Regulations 2007 (S.I. No. 786 of 2007) (as amended) require that veterinary prescriptions are marked (endorsed) in the following way:

When a veterinary prescription is dispensed in full, the prescription must be:

  1. Marked with the word “dispensed”,
  2. Marked with the date of supply, and
  3. Signed by the pharmacist.

The prescription must be retained at the pharmacy for five years and made available to inspectors upon request.

Where a veterinary prescription is partially dispensed, the prescription must be endorsed with:

  1. The quantity of medicine supplied,
  2. The date supplied, and
  3. Signed by the pharmacist.

Where the veterinary prescription is partially dispensed, the legislation states that a copy of the prescription must be retained at the pharmacy. The copy must also be marked with the quantity supplied, the date of dispensing and be signed by the pharmacist. The original prescription may then be returned to the person to whom the prescription was granted. As with prescriptions which have been dispensed in full, copies of prescriptions must be retained at the pharmacy for five years and made available to inspectors upon request.

Don’t forget to record the details of the dispensing in the animal remedies register.

Emergency Supply of Animal Remedies

The legislation provides that a pharmacist may dispense an emergency supply of a prescription only animal remedy at the request of a vet, but only in limited emergency circumstances. Emergency supplies may only occur where:

  • By reason of emergency, the vet is unable to furnish a prescription immediately
  • The vet undertakes to furnish the prescription within 72 hours
  • The animal remedy is supplied in accordance with the vet’s directions 
  • The animal remedy is not a controlled drug listed in schedule 1 or 2 of the Misuse of Drugs Regulations 1988 (S.I. No. 328 of 1988) (as amended)
  • The animal remedy is labelled correctly
  • The supply is recorded in the animal remedies register.

The vet must undertake to furnish the prescription within 72 hours, and should he/she fail to do so the legislation states that the pharmacist shall not supply an animal remedy at the request of that vet in the future.

Please note that the ‘emergency supply’ of a prescription only animal remedy at the request of a member of the public is not permitted.

Veterinary Requisitions

A vet must obtain animal remedies for use in the course of their veterinary practice from a licensed animal remedies wholesaler/manufacturer. The only exemption to this requirement is in circumstances where a medicinal product is required by the vet for use in accordance with the cascade system. Information on the cascade system is detailed in regulation 18 of the European Communities (Animal Remedies) (No. 2) Regulations 2007 (as amended), which sets out the circumstances in which a medicine that does not have an animal remedies authorisation (i.e. a licensed human medicine) may be prescribed or administered to an animal.

A vet may only procure a medicinal product from a pharmacist for use in accordance with the cascade system where a requisition is provided. In instances where the medicine required is a controlled drug, as listed in the Misuse of Drugs Regulations 1988 (as amended), the requisition must:

  • Contain the name and address of the practitioner
  • State that he/she a vet
  • Specify the purpose for which the drug is required
  • Specify the total quantity to be supplied
  • Be signed by the practitioner/ recipient

Vets should follow this format when requisitioning any medicinal product for use in accordance with the cascade system from a pharmacy.

The pharmacist must be satisfied that the requisition is written by a registered veterinary practitioner. A pharmacist who supplies such medicinal products must satisfy himself/ herself, in so far as is possible, that the medication will be used appropriately. It is also recommended that the requisition contains a declaration by the vet that the medicine is required for administration in accordance with regulation 18 of the European Communities (Animal Remedies) (No. 2) Regulations 2007 (as amended).

Don’t forget to record the details of the supply in the animal remedies register. These requisitions must be retained at the pharmacy for five years and made available to inspectors upon request.

Reminder
All legislation which governs this area is set out in The European Communities (Animal Remedies)(No. 2) Regulations 2007 (S.I. No. 786 of 2007) (as amended), which can be accessed in full on www.irishstatutebook.ie or via the PSI website.

(This was originally included in three parts in PSI Newsletters in 2012. It was updated in February 2016)