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For Equine Vets Everywhere

guidance on medicines and passports

Classification of medicines that can be used in food producing animals

The list of 'essential' medicines (the 'Essentials List') for the treatment of horses was updated in February 2013 (Commission Regulation 122/2013). This lists medicinal substances (drugs) that do not have marketing authorisations for use in food producing horses, but that can be administered to horses that are classified as food producing animals (passport section IX not signed) provided that

  • the prescribing cascade is followed
  • their use is followed by a 6-month withholding period before the animals can enter the food chain.
  • their use must be recorded in the horse's passport (see below).


    The change adds 20 further substances to the existing list that can be used in such horses, including triamcinolone. Two agents have been removed from this list (hydroxypropyl methyl cellulose eye drops; Hydromellose and dioctyl sodium sulfosuccinate; Dioctyl) because they are now classified as substances that are allowed in food producing horses by Regulation 37/2010 (see below). A full list of substances on the Essentials List can be found here

    What are the record keeping requirements for these drugs?

    In horses excluded from the food chain (by declaration in section IX of the passport).

    • There are no requirements for the client to maintain records
    • Clinical records must be maintained by veterinary surgeons irrespective of section IX

     

    In horses classified as food producing animals (where section IX of the passport is not signed or where no passport is available)

    • The use of the 'essential medicines' or medicines authorised for food producing species that are prescribed under the cascade must be recorded in the passport.
    • Medication records for 'allowed substances' (Commission Regulation 37/2010) with marketing authorisations for use in food producing horses can be made in the horse's passport or in a separate medication record.
    • Meat withholding times must also be recorded: these can be found on the drug data sheet or Product Package insert.


      There are substances (e.g. some anaesthetic agents like ketamine and isoflurane, some antimicrobials like ceftiofur, some NSAIDS like carprofen and some substances used in breeding management like cloprostenol) that are 'allowed' in the European Regulation but which have UK marketing authorisations excluding their use in food producing horses and requiring the horse to be declared not for human consumption.

      When there is a difference between the European Regulation and the UK Marketing Authorisation:

      • such substances can be used in food producing horses provided
        • the prescribing cascade is followed
        • a minimum meat withholding time of 28 days is set and a record is made in the passport.


        Examples of some of these 'allowed' and 'essential' substances is shown below. The table includes links to the specific legislation that lists the classification of agents in each category.

        Classification

        Including links to relevant EU legislation

        Description

        Withdrawal period

        Allowed substances with MRL (37/2010) with UK marketing authorisations for use in food producing horses

        Final or provisional MRLs (e.g. flunixin, meloxicam) or substances for which no MRLs are required (e.g. detomidine, butorphanol, ketoprofen, lidocaine, dembrexine, deslorelin)

         

        As stated in data sheet

        Allowed substances (37/2010) but with UK marketing authorisations prohibiting use in food producing horses

        (No MRL required)

        Drugs for which no MRLs are required (e.g. ketamine, isoflurane)

        Prescribe following the rules of the cascade; minimum meat withholding time 28 days

        Essentials List

        Drugs described as essential for treatment of horses (e.g. acepromazine)

         

        Prescribe following the rules of the cascade; minimum meat withholding time 6 month

        What drugs are specifically prohibited in food producing animals (i.e. animals where section IX of the passport is not signed, or when the passport is not available)

        Drugs not listed in the 'allowed'  or the 'essentials' list must not be used. These include those drugs previously listed in annex IV and now listed in Table 2 of 37/2010 (such as metronidazole and chloramphenicol including ocular medication) and those for which MRLs have not been determined (e.g. pergolide, phenylbutazone and suxibuzone).

         

        What should I do when no passport is available?

        If an animal requires treatment and the passport is not available, it must be assumed that the horse IS INTENDED FOR HUMAN CONSUMPTION. In that situation veterinary surgeons should prescribe drugs that are permitted for food producing animals. Usage must be recorded by the owner once the passport is available and you should provide written guidance to the owner in these cases. The BEVA emergency treatment form is recommended.

         

        Where no alternatives are available, drugs not permitted in food producing animals can be used in an emergency situation and a document detailing the requirements of the owner to sign section IX should be given.  Further details can be found on the VMDs guidance notes (VMGN 16) and on a summary document.

         

        The passport is not available, but I have a record on our practice management system that this horse has section IX signed. What should I do?

        If you already know that a specific horse has been excluded from the food chain then there is no need to examine its passport each time you treat the animal. The veterinary surgeon is responsible for appropriately identifying that animal. Further details can be found on the VMDs guidance notes (VMGN 16) and on a summary document.

         

        Example scenarios where the passport is not available (i.e. the horse should be considered as a food producing animal). In all situations the client must be informed of the need to update the passport. The BEVA emergency treatment form should be used in such cases.

         

        Scenario

        Interpretation

        Consideration

        Pony with colic requiring analgesia, you elect to administer phenylbutazone

        Although this is a clinical emergency situation there are many alternative NSAIDs that could be used in this situation.

         

        Ketoprofen,

        Flunixin,

        Meloxicam are examples of drugs that could be substituted for phenylbutazone

        Horse with colic due to septic peritonitis where peritoneal fluid is foul smelling and you elect to administer metronidazole

        This is a clinical emergency, where no alternative drug has the anaerobic spectrum of activity. As such the use of metronidazole might be justifiable under the cascade. Metronidazole can only be used where section IX is signed to exclude the horse from the food chain

        Metronidazole use would require animals to be subsequently excluded from the food chain. Written instructions should be given to the owner

        Horse with melting corneal ulcer, you elect to use chloramphenicol eye drops

        Although this is an emergency situation, chloramphenicol is a prohibited substance and cannot be used in food producing animals, even in ocular medications.There are alternative ocular medications that could be used under the cascade that can be used in food producing animals.

        Cloxacillin which is allowed in food producing animals is unlikely to provide appropriate spectrum of activity in a melting ulcer. Therefore the use of Ofloxacin (on the essentials list) could be justified under the cascade with a 6 month withdrawal period. As a quinolone it should be reserved for serious infections such as this.

        Horse with chronic low grade forelimb lameness. You elect to treat with suxibuzone

        This does not represent a clinical emergency and therefore there is no justification for the use of suxibuzone. Alternatives could be used while a replacement passport is obtained

        A new or replacement passport should be obtained before suxibuzone is dispensed

        Horse with septic stifle joint requiring general anaesthesia. You elect to anaesthetise with ketamine and maintain with isoflurane in oxygen

        This is a clinical emergency. Although UK marketing authorisations prohibit their use in food producing horses, they can be used under the cascade since they are listed on table 1 of 37/2010 (allowed substances)

        Ketamine and isoflurane can be prescribed following the rules of the cascade with a minimum withholding period of 28 days

        Horse with hirsutism and laminitis. You elect to treat with pergolide and phenylbutazone

        Neither drug can be used in the absence of a passport. In an emergency analgesia should be provided using alternative agents permitted in food producing animals. Management of chronic pituitary disease would not be classified as an emergency

        Alternative analgesic agents can be used until a new or replacement passport is available. Pergolide administration should be delayed until a passport is available