Pharmacovigilance

What is pharmacovigilance?

Pharmacovigilance has been defined by the World Health Organisation as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. It involves the monitoring of the safety and effectivity of (veterinary) medicines after official registration. Pharmacovigilance is a joint effort between the government, industry, (veterinary) doctors and (end) users. After all, safe and effective use of the medicines is important for all parties.

It is generally accepted that certain risks are associated with the use of any (animal) medicine. However, these risks must be in proportion to the benefits: the so-called “risk-benefit balance”.

Before a veterinary medicinal product can be registered, extensive research is conducted into the safety and effectiveness of that product. Once the veterinary medicinal product is on the market, unexpected events may still occur. After all, the agent is now being used in large quantities for the first time. Even if a veterinary medicinal product has been on the market for years, unexpected events can still occur, such as interactions with new products or changed circumstances. It is therefore important that information of these unexpected events be collected and analysed so that the regulatory bodies can ensure the continuous safety and efficacy of the product to the end user.

What is an unexpected or adverse event?

The Medicines Evaluation Board (CBG – NL) defines unexpected or adverse events as

‘ An adverse or suspected adverse reaction of a veterinary medicinal product is a reaction that is harmful and unwanted and that occurs at doses that are normally used in the animal for prevention, the making of a diagnosis, the treatment of a disease or the changing of a physiological function.’

In a nutshell, unexpected or adverse events that should be categorized as pharmacovigilance reports are:

• Undesirable reactions in the target animal (s) (also after off-label use) or animals in contact with the target animal (s)
• Undesirable reactions in the person (s) applying the product or person (s) in contact with them
• Lack of expected effectiveness of the product
• Unexpected residual levels even after observing the withdrawal time
• Unexpected effects on the environment
• The contamination and transmission with infectious agents

How to file a pharmacovigilance report?

All pharmacovigilance reports are critically analysed to discover the causality of the unexpected or adverse event. This is based on all of the information that is made available by the person(s) making the report. It is guaranteed that all this information will only be used for the assessment and analysis of the event and therefore be processed accordingly. What kind of information is necessary to make a pharmacovigilance report?

• Identification of the person (s) filing the report
• Details of the animal (s) involved such as species, sex, age
• Details of the person (s) involved such as age, sex
• Details of the product used such as product name, batch number, how it was used
• Details of the event

Once all this information is gathered, it can be filled into the form that can be downloaded below and send by mail.

Instructions:

This form is intended for the notification of adverse events. Please fill out this form as much as possible, based on the information available, and submit it via e-mail to Intracare BV at your earliest convenience.

If you do not have all information yet, please still submit the information available (and submit the remaining information later) Intracare BV can start the evaluation already. If possible, try to strive to send us the information within 3 days after occurring of the AE.

DOWNLOAD FORM HERE

Contact information

Intracare B.V.

Voltaweg 4, 5466 AZ Veghel

The Netherlands

E. pharmacovigilance@intracare.nl

(e-mail preferred)

T. +31 (0)413 354 105

M. +31 (0)613942297

(mobile emergency number)