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Reporting Pet Drug Side Effects to the VMD: Why, What and How?

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As vets, we know that all drugs can have side effects. All pet medicines are supplied with an information ‘datasheet’ (also known as a ‘Summary of Product Characteristics’) that explains these side effects and how common they are. But, sometimes, this datasheet is wrong. That’s why reporting suspected pet drug side effects is so important. Let’s look at a bit more detail:

The VMD

The Veterinary Medicines Directorate (VMD) is a government agency that licenses and monitors pet drugs. And one of the things they do is monitor reports of side effects – or ‘suspected adverse events’ – SAEs). They collate this data and can force drug companies to change their datasheet, put out warnings about pet medicines, or even remove drugs from the market if they don’t feel they are safe.

Which pet drug side effects need reporting?

Reports should be submitted to the VMD for:

  • Side effects listed on the datasheeet
  • Side effects not listed on the datasheet
  • Drugs that haven’t worked as intended (even if no side effect was seen)
  • Side effects in humans due to exposure to the drug (eg sore hands after using a medicated shampoo)
  • Side effects to the environment (eg patches of grass dying after a flea-treated dog rolls in it)

Reports should be submitted even if:

  • The drug wasn’t used as intended (eg a topical product was accidentally used orally)
  • The drug is intended for a different species (eg a human drug you are using in your pet)
  • You aren’t sure whether the drug was to blame for the reaction

For example, a report should be submitted about an antibiotic that didn’t work, even if your pet didn’t get side effects. And a report should be submitted even if the side effects you see are mild or short-lived. You should submit a report even if the side effects are due to the product being used incorrectly (don’t be embarrassed, you won’t be the only one!). And you should submit a report even if you aren’t sure the drug is at fault.

Who reports side effects of pet medicines?

Suspected reactions and side effects can be reported by:

  • The drug company, for example if they get feedback or a complaint
  • A vet/veterinary practice
  • Pet parents

If you suspect a pet medicine has done your pet harm, you can report it yourself using the VMD form. Don’t worry about the risk duplicate reports if your vet reports it too – the VMD system will spot it and make it a single report.

What information do I need to give when making a report of a pet drug reaction?

The minimum information the VMD require when you make a report of a pet drug side effect is:

  • One or more product names
  • Administration start date of the product(s)
  • The start date of the adverse event(s)
  • The number of animals treated, reacted and the outcome of the events
  • A description of the events
  • Reporter details (minimum email or postal address)

However, they also find it useful to have:

  • More product details (eg batch number, reason for product use)
  • More animal details (eg species, breed, age, weight)
  • Permission for the VMD to contact the reporter (you) and/or your vet for further information
  • Information about location of any rash, or location of any injection/application site

Ultimately, the VMD form has lots of questions, but only a few are required, so you can report suspected side effects even if you don’t have all the details.

What does the VMD do with the information I give them?

I can confirm from the number of follow-up calls I’ve received as a vet that the VMD really do chase down further details they need to investigate every suspected pet drug side effect! In some cases, they’ll contact you for more information. In others, they might contact your vet (if you give them permission) for more details. Occasionally, they’ll involve the drug company – and drug companies may even pay for further testing on your pet if they need to investigate whether their drug caused the problem.

Once they’ve got their information, they can spot patterns. With new evidence, they might change the datasheet to reflect new side effects or just change the information about how frequent side effects are. In extreme circumstances, they might even publicise a warning or remove a medicine’s license.

If you’d like to see the recent changes to medicine information leaflets, the VMD publicises this information on their medicines updates page, here. They also issue urgent information updates here.

More help with pet medicines and safety

The best person to help with any pet drug side effects is your vet – they know your pet’s individual situation best. Our pet medicines database is also a useful place to go for information on your dog’s medications.

Conclusion

All drugs have side effects, but in general their benefits outweigh their risks. That said, to make sure this continues to be the case, we vets need up to date information. As a pet owner, you can report suspected pet drug side effects so that other pet owners have access to better information. To report a suspected problem, just follow the button below.

Report a suspected drug side effect to the VMD
Dr Joanna Woodnutt MRCVS vet
Dr Joanna Woodnutt BVM BVS BVMedSci MRCVS
Since graduating as a vet from the University of Nottingham in 2016, Dr Woodnutt worked in a variety of companion animal roles across the Midlands. She now writes about pets full time from her home in the Channel Islands, where she lives with her husband and young daughter. Dr Woodnutt believes passionately in helping pet parents understand and help their pets.
Dr Joanna Woodnutt BVM BVS BVMedSci MRCVS
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