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What written information should be provided with a split pack of a POM V?

For a Veterinary Medicine Product supplied in a container other than that specified in the marketing authorisation (e.g. tablets dispensed into smaller containers) the person supplying the product must ensure that the container is ‘suitably labelled’ and must supply sufficient written information for the medicine to be used safely. This legal requirement may be met by:

  • Labelling the product in accordance with the PSS’s requirements (see below) and providing a copy of the package insert or the SPC to the client.
  • Providing the NOAH data sheet, or a link to the data sheet online.
  • Using a dispensing envelope supplied by the drug company, or that includes that practices own written information.

RCVS PSS requirements for labelling VMPs:
All POM-V medicines supplied by the practice must be legibly and indelibly labelled with:

  • Name and address of the animal owner
  • Name and address of the veterinary practice supplying the medicine
  • Date of supply
  • Name, strength and quantity of product
  • Dosage and directions for use
  • ‘For animal treatment only’
  • For topical preparations ‘For external use only’.

Related FAQs

  • As per the RCVS Controlled Drugs Guidance, discrepancies between the amounts recorded as used, the volume of the product left in the vial, and the total stated volume must be avoided.  The Veterinary Medicines Directorate (‘VMD’) advise that pharmaceutical companies try to ensure that every bottle of medicine is precisely filled but some small variability may occur.  This may result in discrepancies regarding the amount of Controlled Drugs used when taking into consideration the volume remaining in the container.  There may also be some wastage within the needle and hub of the syringe each time the product is withdrawn, known as ‘deadspace’.  The Home Office has advised the VMD that discrepancies of up to 10% should not cause undue concern.  Reconciliation at the end of each bottle is recommended to avoid consolidation of errors.  Obviously, a balance of LESS than expected should be treated with greater concern.  While efforts should always be made to minimise wastage, the Home Office, the VMD, and RCVS Practice Standards Inspectors are all aware that some wastage due to deadspace will be unavoidable and these small discrepancies should always be recorded.

    A Standard Operating Procedure (‘SOP’) should be in place, detailing what to do in the event of a discrepancy. The BSAVA state that one way of accounting for deadspace volume is to add this to each dose dispensed, but the volume is likely to vary, depending on the manufacturer of the needle and syringe, and the size of the syringe used - typically this is 0.05mls.

    In reconciling, the RCVS recommends estimating by eye, making a scale on an empty bottle (for example), and then measuring a full bottle against it, or for more accuracy, weighing the bottles and recording weights.  Physically withdrawing remaining volume from a multi-dose bottle to allow for it to be accurately measured via needle/syringe, before returning the drug to the bottle, is not recommended, due to a health & safety risk of repeatedly drawing out volumes of controlled drugs, increasing the risk of them blowing back into someone’s face, and of course, increased wastage.

  • The VMD advise that for all CDs, a veterinary surgeon should consider prescribing only 28 days’ worth of treatment unless in situations of long-term ongoing medication (e.g. when treating epilepsy in dogs).

    If more than 28 days’ worth of treatment is prescribed, it must be ensured that the owner is competent to use the medicine safely.

  • When prescribing under the Cascade, veterinary surgeons should ensure they obtain written consent* for use of that medicine from the client. A consent form template is available from the VDS (which has been reproduced in the RCVS PSS Small Animal module).

    It should be noted it is generally unacceptable for veterinary surgeons to use an all embracing “general” lifelong consent for any and all products provided under the Cascade that might be given to any animal.  Practically, this means specific consent needs to be obtained from a client for each unauthorised medicine used. 

    However, it is acceptable for a lifelong consent form to be used for a specific ongoing condition requiring unauthorised medicine for that particular medicine in that particular animal.  It is also acceptable to use lifetime consent in the case of exotics where there are no licensed products available.

    *Subject to Covid-19 restrictions

  • All such medicines supplied by a veterinary practice must be labelled in accordance with the Veterinary Medicines Regulations ‘VMRs’.  For products supplied under the Cascade, the following information must be always included: 

    1. The name and address of the pharmacy, veterinary surgery or approved premises supplying the veterinary medicinal product
    2. The name of the veterinary surgeon who has prescribed the product
    3. The name and address of the animal owner
    4. The identification (including the species) of the animal or group of animals
    5. The date of supply
    6. The expiry date of the product, if applicable
    7. The name or description of the product, which should include at least the name and quantity of active ingredients
    8. Dosage and administration instructions
    9. Any special storage precautions
    10. Any necessary warnings for the user, target species, administration or disposal of the product
    11. The withdrawal period, if relevant
    12. The words ‘Keep out of reach of children’ and ‘For animal treatment only’.
  • In 47% of PSS assessments, assessors found that there was lack of evidence of temperature monitoring for medicines.

    Medicines need to be stored at the correct temperature in accordance with the Summary of Product Characteristics.

    Where medicines are to be stored at ambient room temperature, the temperature should be kept between 8°C and 25°C and should be monitored. This is especially important where the outside temperature is particularly high or low.

    Medicines such as vaccines and insulin need to be refrigerated between 2°C and 8°C. They should only be removed from the refrigerator for immediate use.

    Fridge temperatures should be monitored daily, ideally by the same person, and the results logged, or if monitored by using an electronic data logger these should be alarmed, the alarm checked daily to make sure it has stayed within range and the data downloaded weekly.

    A written standard operating procedure should be in place, detailing the actions to be taken should the temperatures fluctuate outside the recommended limits.

  • It is an offence under the VMR to supply or administer an out of date or expired medicine. This applies to all veterinary medicinal products, including CDs.

    All multi-dose injectables will have an “in use shelf-life” that tells the user how long the vial can be used for, after it has first been broached. It is an offence under the VMR to use a medicine for longer than this period.

    Multi-dose vials should be marked with the date of first opening, or the date of expiry, and any medicine left in the vial after the specified time must be discarded/denatured. If the medicine is a Schedule 2 CD, denaturing must be independently witnessed.

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