ABSTRACT: Pharmacovigilance is the process of detecting, evaluating and preventing the adverse effects of medicines – veterinary pharmacovigilance concerns the safety of veterinary medicines used for the treatment or prevention of disease in animals. The Veterinary Medicines Directorate (VMD) is the organisation that is responsible for veterinary pharmacovigilance in the UK and veterinary nurses have a very important role to play in the processes that it implements, undertaking many of them on a daily basis.

Adverse reactions occur in veterinary practice, and anyone who notes a Suspected Adverse Reaction (SAR) has a responsibility to report it to the Veterinary Medicines Directorate (VMD) under the Suspected Adverse Reaction Surveillance Scheme (SARSS). Veterinary surgeons and veterinary nurses are in a unique position to observe adverse reactions and they play a key role in the reporting system.

Examples of adverse reactions include changes in normal parameters, such as bradycardia; as well as localised reactions, such as abnormal pain on injection or injection site reactions. Even reduction of efficacy of the product as manifested in animals suffering from diseases that they have been vaccinated against, for instance.

While the reporting of suspected adverse events is voluntary, the Royal College of Veterinary Surgeons (RCVS) considers it to be part of a veterinary surgeons professional responsibility to the general public. Pharmacists and Suitably Qualified Persons (SQPs) should also record and report adverse events – and it is noted in their codes of professional conduct.

Animal owners have an important role to play too, and reports from this source are encouraged. Suspected adverse events can be reported to the marketing authorisation holder (manufacturer) of a veterinary medicine, or to the VMD. The SARS Scheme is divided into human and animal adverse reactions.

Reports can be made easily on line at http://www.vmd.defra.gov.uk/adversereactionreporting, or via the ‘yellow form’ system (Figure 1).

Figure 1: Old style SARSS yellow' reporting forms – these can now be reported on line

The reporting of suspected adverse reactions is a key part of the process of ensuring the safety of medicines and, as such, plays a part in keeping existing medicines on the market and available for veterinary use.

Scope of pharmacovigilance

Veterinary pharmacovigilance covers all adverse events in animals associated with veterinary medicines. These include: adverse reactions in animals which occur after use in accordance with the advice on the label or following off- label use. This includes accidental administration of medications to a non-target species, such as permethrin spot-ons used on cats, and when medications are dispensed incorrectly and then administered suspected lack of expected efficacy after use in accordance with the label instructions

adverse reactions in humans following exposure to a veterinary medicinal product or to a treated animal are within the scope of pharmacovigilance too. Examples of this include needle- stick injuries, and when medicines have come in to contact with the skin.

Dermal reactions are fairly common with large animal pour-on parasiticides, shampoos and spot-ons. 

•  Part of the marketing authorisation from the VMD includes packaging and the application process, and if there are multiple reports then a review of packaging and warnings on packaging can occur.

Two further situations are included in the scope of pharmacovigilance, and should be reported to the VMD under SARSS. These are:

•  adverse effects in animals of non target species, humans or plants through exposure to a veterinary medicine present in the environment 

•  levels of residues of veterinary medicines in tissues or food products of treated food-producing animals, which are above the maximum residue limits when the recommended withdrawal period of the given veterinary medicine has been respected.

Veterinary nurses have a role to play in reporting adverse reactions, even if they are known reactions rather than suspected reactions; for example, a cat accidentally given high doses of a NSAID developing acute renal failure.

Patterns of accidental dispensing should be monitored, and nurses are in a prime position to record these errors and to put into place procedures to prevent these incidents from occurring (Table 1).

Check … and check again

Recording of dispensing practice can help to reveal patterns; steps can then be taken to help reduce errors. For example, errors may occur at specific times of day – often at busy times, or when fewer staff are present and workload consequently increases.

If two specific drugs are being mixed up when being dispensed, the practice needs to review the circumstances in order to pinpoint why this is occurring. Factors can include packaging being similar, tablet size (strength) being the same, the name of the medication sounding the same or starting with the same letter, or use of manufacturers dispensing envelopes that are similar for both products (Figure 2).

Figure 2: Placing similar looking products apart from each other should be advocated

Many human pharmacies have problems with generics that are packaged in similar boxes. In these cases, the pharmacies will specifically stock a different brand of the generic drug – even if it is more expensive – so that the packaging is different, and therefore reduces the likelihood of dispensing errors (Figure 3).

Figure 3: Use of different packaged generic medications can be

All medicines should be double checked prior to dispensing, this is a requirement if the prescribing veterinary surgeon is not on site when the medications are to be dispensed (Figure 4).

Figure 4: Double signing of checked medications

Veterinary nurses are often responsible for the dispensing of medications and stock control, and pharmacovigilance is an important part of this process that should not be over looked. 


Nicola Ackerman BSc(Hons) RVN CertSAN CertECC C-SQP

Nicola works as the senior medical nurse at The Veterinary Hospital in Plymouth. She graduated from Hartpury College with an Honours Degree in Equine Science, and subsequently qualified as a veterinary nurse. Nicola is a past officer of the BVNA, but now is the vice-chair of The'Pet Obesity Taskforce. and sits on the VMD's appraisal panel for suspected human adverse reactions.

To cite this article use either

DOI: 10.1111/j.2045-0648.2012.00206.x or Veterinary Nursing Journal Vol 27 pp 313-314



• VOL 27 • August 2012 • Veterinary Nursing Journal