Drug Legislation

Introduction

The information below is mostly relevant to the United Kingdom.

The Veterinary Medicines Regulations, which are revised and updated on an annual basis, govern the supply and prescribing of veterinary drugs. The Veterinary Medicines Regulations replaced the Medicines Act 1968 in 2005. The Veterinary Medicines Directorate (VMD), which is a department of the Department for Environment, Food and Rural Affairs (DEFRA) check the safety and efficacy of veterinary drugs for owners, animals and the environment prior to a drug reaching the sales market. Once a drug is authorised, the VMD collect information from veterinary surgeons about suspected adverse reactions to medications occurring in the UK via the 'yellow form' MLA252A - this can include incidents where treatments fail to show efficacy. Adverse events occurring in other European Union (EU) Member States, Norway, Iceland and Liechtenstein, should be reported to the relevant competent authority where the event occurred using the EU reporting forms for veterinarians which are available in each EU language on the European Medicines Agency website. The VMD also inspect premises where veterinary drugs are manufactured, stocked or supplied to the general public and enforce the regulations where necessary.

In 2003 the Competition Commission investigated the supply of veterinary medicines, and an Order was drawn up by the Department of Trade and Industry to alter the way in which prescription only medicines (POMs) were supplied to the public in the UK. The aim of the order was to increase public awareness of the price of POMs, to encourage the use of prescriptions to give the public more choice of suppliers, and to increase the manufacturer’s supply of POMs to other outlets such as pharmacies. The Competition Commission’s involvement with veterinary medicines was to investigate potential monopolies; it has no interest in drug safety or efficacy.

Drug Classifications

The following categories of medication are defined by the regulations, and should be displayed clearly on the label of any veterinary medication.

• POM-V or prescription only medicine – veterinarian. Drugs in this class require a clinical assessment of the animal by a qualified vet; the animal must be under his or her care, and only the minimum amount of medication required for treatment should be dispensed. A prescription is always required but it need not be in writing if the vet who prescribed the medication also supplies it. Vets can delegate the handing over of a POM-V medicine to a ‘competent’ person proving that each transaction is individually authorised. The regulations do not define what competent means, but some evidence must be available for the vet to be able to justify delegating to the person concerned - such as attendance at a relevant Continued Professional Development (CPD) event, and a standard operating procedure for use by members of staff who give out POM-V drugs to clients is considered good practice under the regulations. Information must be given to the client on the safe use of the product, and the client must be assessed as intending to use the product in the authorised manner.
• POM-VPS or prescription only medicine – veterinarian, pharmacist or suitably qualified person (SQP). Medicines in this category also require a prescription, but the animal does not have to be clinically assessed or be under the care of a vet. Prescriptions must consider the health and wellbeing of the animal concerned, and can also be written by a pharmacist or a SQP operating from premises registered with the VMD. The vet can delegate the handing over of these medicines to a competent person (see above) and prices of POM-V and POM-VPS medications can be advertised to the public, but not the medications themselves.
• NFA-VPS or non food producing animal – veterinarian, pharmacist, SQP. Medicines in this category do not require a prescription, but must be supplied by a vet, pharmacist or SQP and the supplier must ascertain if the owner is likely to use the drug in the authorised manner. Information must be given on the safe use of the medication. NFA-VPS medication can be advertised to the general public.
• AVM - GSL or authorized veterinary medicine – general sales list. Medicines in this category may be supplied to anyone by any retailer, but must be supplied responsibly by veterinary practices.

RCVS Guidance on animals 'under the care of a vet'

The RCVS have outlined their interpretation of the requirement for an animal to be ‘under the care of the veterinarian’ when prescribing POM-V drugs as follows;

1. The vet must have been given the responsibility for animal’s care by the owner or the owner’s representatives.
2. The animal must have been seen immediately prior to prescribing a POM-V drug, or recently enough for the vet to have personal knowledge of the animal’s condition and current health status.
3. The vet must maintain clinical records for that individual animal (or herd).

Writing Prescriptions

The VMRs stipulate that a prescription must include the following:

1. Details of the person prescribing the medicine – name, address, telephone, qualifications and signature
2. Name and address of the animal owner or keeper and the animal’s identification including species.
3. Address of the premises where the animal is kept, if different to that above
4. Date
5. The name and amount of the medication prescribed, with dosage and administration instructions and any relevant warnings
6. A statement to the effect that the medication is being prescribed under the cascade (see below)
7. The withdrawal period (where relevant).

A prescription is valid for 6 months from the date that it is written, with the exception of prescriptions for controlled drugs which are valid for 28 days and cannot be faxed or sent to a supplier electronically. Controlled drugs, as defined by the Misuse of Drugs Regulations 2001 also need to have additional information added when writing a prescription:

• A declaration that the animal is under the care of the vet signing the prescription
• Details of any arrangements to supply the medication in installments including number of installments and details of the installment interval
• The total quantity of medication in words and figures in the hand writing of the person prescribing the medication, including the strength and number of dosage units.
• The name and address of the person who will receive the drug if not already detailed earlier, also hand written.
• The date and signature must be written indelibly.

Controlled drugs

There are five schedules of controlled drugs:

1. Schedule 1 drugs require a prescription from persons with a Home Office license so these are not applicable to veterinary practice; they include hallucinogenic drugs such as Ecstasy.
2. Schedule 2 drugs include alfentanyl, amphetamines, fentanyl, methadone, morphine, pethidine, and secobarbital. Schedule 2 drugs must be kept in a locked cabinet, or in a locked cabinet that is secured to the car when used by ambulatory vets. A controlled drugs register must be kept to record the supply and use of the drugs, and disposal requires an authorised person such as a policeman to be present as a witness. The whereabouts of the controlled drugs cabinet key needs to be recorded on a register or,alernatively, all vets in the practice can be issued with a key.
3. Schedule 3 drugs include benzphetamine, buprenorphine, midazolam, pentobarbital, and phenobarbital. These drugs have to be stored securely but none of them require a controlled drugs register.
4. Schedule 4 drugs include benzodiazepines and ketamine; there is no specific legal requirement for safe storage or for a controlled drugs register, but as ketamine has increasingly been recognised as a drug of abuse in people, the RCVS now recommend that it is included in the controlled drugs cabinet and a register of supply and use kept.
5. Schedule 5 drugs include codeine and morphine – they are present in very low amounts in veterinary medications and are exempt from all controlled drug requirements.

The Drugs Cascade

The VMR states that legally vets are required to treat animals with medications that have been:

1. safety tested in the species being treated, and
2. have proven efficacy for the condition being treated, wherever possible. This precludes the use of generic drugs from the field of human medicine.

Where there are no products that meet this criterion, vets can prescribe a medicine that is:

1. authorised for the same condition but in another species, or
2. for another condition within the same species.

As these medications have not been tested in the animal for the condition being treated, use of them requires the vet to inform the owner of this and the owner must give consent for the ('off label') use of the medication.

If there is no suitable medication in these categories, then the vet can prescribe:

1. a human medicine authorised in the UK, or
2. a veterinary medicine authorised in a European country (for any species but if it is to be used in food producing animals it must be authorised for use in another food producing species).

Failing these alternatives, it is possible to use a veterinary medicine that has been manufactured by a pharmacist, veterinary surgeon or manufacturer authorised to manufacture that product by the Secretary of State. The Secretary of State must also certificate any medication that has been imported from non EU countries.

It is important to realise that failure to treat animals according to the cascade is a criminal offence.