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For Equine Vets Everywhere

VETERINARY "SPECIALS" (UNAUTHORISED EXTEMPORANEOUS VETERINARY MEDICAL PRODUCTS)

 

The Veterinary Medicines Regulations 2013 establish a regime known as the “cascade” that empowers veterinary surgeons to prescribe medications other than authorised medications – commonly referred to as “specials” – in certain circumstances in the interests of animal welfare (eg, where suitable authorised medications are unavailable or optimal treatment calls for a bespoke formulation). 

The use of veterinary "Specials" is regulated by Schedule 2 Part 4 of the The Veterinary Medicines Regulations 2013 and guidance is provided by the VMD in Guidance on applying for an authorisation to manufacture veterinary medicines (ManA)

Guide to Use of Specials

is it illegal to use specials?

No. Special veterinary medicines can be lawfully used under the prescribing cascade, Detailed guidance on the use of the cascade can be found hereVeterinary surgeons must consider the availability of alternatives (eg, veterinary medicines licensed for use in horses or food animal species, and human or veterinary medicines licensed for use in small animals).  

Specials manufacturing is closely regulated by the VMD and manufacturers cannot produce 'pharmaceutically equivalent' products to licensed veterinary medicines. 

The Veterinary Medicines Directorate (“VMD”) has published guidance (Guidance Note 13) explaining that it “does not seek to interfere with the veterinary surgeon’s clinical judgment in determining the best available treatment to the animal under his or her care ... provided that the veterinary surgeon ... is able to justify the choice of treatment based on animal welfare” but that veterinary surgeons should only exercise this discretion after giving due consideration to any available alternatives.

When is it appropriate to use specials?

A special may be preferred over any such alternative where the veterinary surgeon considers that the route of administration, strength or formulation of the authorised product is inappropriate. The following table sets out more detail regarding the circumstances in which a special may be preferred:

Dosage

The veterinary surgeon considers that optimal treatment requires a dosage regime that is different from an authorised product’s labelled specifications.

Individual characteristics

Particular characteristics of the patient animal (eg, age, general condition, sensitivity to a particular substance, etc) contra-indicate the use of an authorised product.

Animal owner considerations

Particular characteristics of the patient animal’s owner mean that an authorised product would not be optimal for treatment (eg, an elderly or disabled owner may have difficulty in crushing and administering tablets, etc).

Chronic infections

A condition persists following treatment with an authorised product.

Complex conditions

The patient animal has multiple conditions (eg, pneumonia with fluid retention) and the veterinary surgeon considers that an extemporaneous preparation is required in order to minimise incompatibilities and side effects.

Unavailability of product

An authorised product cannot be obtained in a reasonable time (eg, one does not exist or supply is interrupted). Please note that the VMD publishes a list of known supply issues online (see here).

Note: In horses intended for human consumption, specials should only be used where the active ingredient is listed in either 37/2010 or 122/2013 (Essentials).

Practical example – Doxycycline paste for equine use

The authorised doxycycline product for treatment of chickens is a dilute concentration of the hydrochloride salt in liquid form.  For horses, this has an unpleasant taste and large volumes would be required for dosage, it can also lead to oral and oesophageal ulceration.  Accordingly, a veterinary surgeon may consider that an extemporaneous preparation of the monohydrate salt in a more concentrated paste form is preferable because: (i) the paste can be mixed with an appropriate flavouring agent that horses tolerate well; and (ii) a lower volume will be required for dosage.  These advantages will make dosing significantly easier and thus improve prospects for effective treatment.

is cost a reasonable justification for the use of specials?

BEVA do not believe that cost is a valid justification for the use of veterinary specials, unless in exceptional cases where animal welfare would otherwise be compromised. It is difficult to predict situations where this may occur and therefore veterinary surgeons  are urged to keep extensive records to justify their decision making in case of future audit. 

WHAT SHOULD I TELL CLIENTS?

Clients should be made aware of the unauthorised status of the product and should be provided with detailed client information leaflets that address potential adverse events and discuss the limitations of veterinary specials.  BEVA has developed an example leaflet for this purpose, which is available on the BEVA website alongside individual medicine leaflets. (see www.beva.org.uk/cascade).

can i hold specials in stock?

Veterinary specials can be held in stock but stock levels should be justified by clinical needs under the cascade, taking into account the shelf-life of the relevant product. 

Where should i obtain special medicines?

Veterinary surgeons should ensure that they obtain specials only from reputable specials manufacturers that hold a Manufacturing Extemporaneous Products (Specials) Authorisation from the VMD.  Such licensed manufacturers are required to comply with the principles of Good Manufacturing Practice (GMP).  Specials should be ordered directly from the manufacturer and not via a third party or wholesaler. It is important to note specials are not available for sale except through veterinary surgeons; they cannot be dispensed against a prescription by a client.

BEVA has created a MEMBERS PRODUCT DATABASE to help members to source difficult to purchase medicines. This includes experiences from individuals of sources they have used to locate such medicines. BEVA does not endorse any supplier and this database is simply to allow members to share experiences of such medicines and their suppliers in a secure environment.

Where can i obtain more information about how to use an individual special medicine?

Specials manufacturers are unable to formulate advice about the use of such products, including dose or indication. No data sheet is included with each medicine, since their use relies upon veterinary understanding of these products. BEVA's drugs app (android and iOS) contains dosing information and can be downloaded free by members. Furthermore the MEMBERS INFORMATION DATABASE includes members shared by members (login reguired)

BEVA's VIEW OF SPECIALS