Pharmacovigilance: Monitoring Suspected
Adverse Reactions to Animal Medicines
Introduction
Thankfully, harmful, unexpected side-effects to animal medicines are
extremely uncommon. Before any animal medicine is allowed onto the UK market it has, by
law, to satisfy very strict criteria on its quality, its effectiveness and its safety.
However, once an animal medicine is in use, it is vital to know if any animals or people
suffer unexpected problems following use or exposure to the product under field
conditions.
Very occasionally animals may show some small mild reaction to a
medicine - just as you may feel drowsy after certain common medications. But, if your
animal is unwell after treatment with an animal medicine or if you are at all worried,
contact your vet. This is just common-sense, whether or not your animal has received
medication, and it is more than likely that the illness is totally unrelated to the
medicine.
Suspected Adverse Reaction Surveillance Scheme
The Veterinary Medicines Directorate (VMD), which
administers the licensing system, runs a scheme to monitor reports of any
reactions in animals, people or the environment
following the use of animal medicines, called the Suspected Adverse Reaction Surveillance
Scheme.
The purpose of the scheme is to monitor trends in reported suspected
reactions. Reports received by the VMD are prioritised in terms of severity and likely
causality (i.e. to see whether the problem is likely to be linked to the medicine). The
scheme also analyses whether there have been any other reports about the same product or
others like it, whether any further information is required and whether any follow-up is
required.
The legal background
Title VII of the Veterinary Medicinal Products Directive
2001/82/EC,
headed Pharmacovigilance, imposes certain duties on holders of marketing authorisations.
The European Committee for Veterinary Medicinal Products adopted a Note for Guidance
entitled Pharmacovigilance of Veterinary Medicinal Products which came into
operation on 1 January 1998.
This European guideline sets out the recommended framework for
pharmacovigilance which places specific duties on conditions attached to individual
product authorisations. Duties are also placed on member states’ competent
authorities (the VMD in the UK).
Company responsibilities
Article 74 of Directive 2001/82/EC requires the holder of each
marketing authorisation to "have permanently and continuously at his disposal an
appropriately qualified person responsible for pharmacovigilance".
The appropriately qualified person is responsible for setting up and
operating a system which ensures that all information about any suspected adverse
reactions reported to the company is collected and collated at a single point. Records of
suspected adverse reactions must by law be kept for at least 5 years.
Periodic Safety Update reports should be sent in on the request of the
Suspected Adverse Reaction Surveillance Scheme or as required by the VMD. Generally,
however, they are submitted six-monthly for the first 2 years after product authorisation,
annually for the subsequent 3 years, and thereafter every 5 years.
This report lists all the suspected adverse reactions reported to the
company since the last Periodic Safety Update report. This is set into context by looking
at the incidence of reactions, taking account of the number of doses sold. Each Periodic
Safety Update report should contain a concise assessment of the evaluation of the current
safety of the product.
Reporting suspected adverse reactions
If an adverse reaction to an animal medicine is suspected, it should be
reported to the scheme and/or the company involved. Your vet or doctor will normally do
this: they are actively encouraged to do so by both the VMD and NOAH, but the VMD welcomes
anyone reporting such adverse reactions they have experienced or observed. Yellow forms
for doing this are available from the VMD.
Often, vets will contact the manufacturer directly to report a
suspected adverse reaction. Companies are then under a legal obligation to report these to
the VMD - half of all reports come directly from companies.
Only by professionals and owners taking the trouble to report any
problems can the VMD and companies get an idea of any action that may need to be taken.
This could ultimately mean withdrawing the product or a specific batch from the market,
but more usually it will result in more advice being given to users of the medicine as to
how to use it safely, or on possible side-effects.
NOAH encourages active reporting of suspected adverse reactions, but is
pleased that there are so few. This shows that the authorisation system for animal
medicines is doing its job and protecting animals and the public from potential danger.
Definitions
Adverse reaction: a reaction which is harmful and
unintended and which occurs at doses normally used in animals for the
prophylaxis, diagnosis or treatment of disease or the modification of
physiological function (Article 1(10) of Directive 2001/82/EC).
Human Adverse Reaction: an incident where a person reports
adverse effects following exposure to a veterinary medicinal product.
Periodic Safety Update Report: see above, under 'Company
responsibilities'.
Suspected adverse reaction (SAR): any report indicating that
there has or may have been an adverse reaction to a product. The Suspected Adverse
Reaction Surveillance Scheme treats all reports of adverse reactions as suspected until
shown to be otherwise.
FURTHER INFORMATION
- Further information on the Suspected Adverse Reaction Surveillance Scheme and forms for
reporting suspected adverse reactions are available from the
VMD, telephone 01932 336911.
- See also NOAH Briefing Document 19 on
the licensing system for animal medicines.
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