All medical products, whether intended for animal or human use, undergo a rigorous approval of their safety and efficacy before they are allowed on the market. However, once there is experience of ‘real world’ use, there are rare occasions when unforeseen problems – known as ‘adverse events’ – arise, which may not have been evident during their pre-approval assessment. These may include interactions with other medicines, environmental factors or issues arising from long-term use. For this reason, it is essential that all medicines are monitored throughout their use, not just when entering the market.
This process is known as pharmacovigilance. In animal medicines, pharmacovigilance has an extra layer of complexity; where issues do appear, they may arise either in the animals themselves or in humans as a result of their use. Pharmacovigilance needs to be rigorous enough to detect both eventualities.
Detecting any adverse events is a collective responsibility for everyone involved in animal health, and the animal health industry is committed to playing its part in making this process as effective as possible. Veterinarians, doctors, farmers and the general public all have the opportunity to report suspected adverse events. All animal health companies that market medicines are legal obliged to record any information they receive about adverse events involving their products.
The animal health industry recognises the value of a strong pharmacovigilance system. Our members have invested heavily, and will continue to invest, in making the time, resources and expertise available to respond rapidly to any potential problem. They work closely with the competent authorities in each country to make the process effective, providing regular updates – periodic safety update reports – listing any adverse events or other issues reported to them.