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EudraVigilance (EV)

Pharmacovigilance

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Pharmacovigilance: Background information (FAQs)

What is pharmacovigilance?

The word pharmacovigilance is derived from the Greek ‘Pharmaco’ (medicine) and the Latin ‘Vigilantia’ (vigilance, watchfulness). It is the process of monitoring, evaluating and improving the safety of medicines in use. It is carried out by pharmaceutical companies on their products and by government agencies on all medicinal products. Healthcare professionals (e.g. Doctors and Pharmacists) have a role too, in reporting suspected side effects of medicines to government agencies or pharmaceutical companies.

What is a side effect?

This is an unwanted response to a medicine. It may rarely be a positive experience but it is usually negative. It may manifest as symptoms (e.g. headache, nausea) or as an illness (liver or kidney problems). Doctors and pharmacists call these ‘adverse drug reactions’ or ‘adverse reactions’.

How common are side effects?

Adverse reactions can occur with any medicine. Adverse Reactions related to the administration of the medicine are clearly listed in the information to prescribers (the Summary of Product Characteristics (SPC)) and in the package leaflet available to the patient.
Side effects can vary from patient to patient. Many patients will get no side effects whatsoever. Even when they do happen, in most situations the benefit of the medicine to that individual patient can still maintain a positive balance. If side effects become troublesome, however, you must promptly inform the doctor or pharmacist who looks after your medical care.

What is a serious adverse reaction?

One that results in death or is life threatening. Also, when a reaction leads to hospital admission or when it is disabling (e.g. blindness, deafness). Adverse reactions linked to a birth defect are also considered serious irrespective of the severity of the birth problem.

What should one do in case of serious reactions?

It can be very difficult to determine cause and effect of a drug and a serious reaction. The doctor or pharmacist who is familiar with the medical history of the patient is best placed to make an assessment. If a side effect is possibly related to the medicine you are taking, the Healthcare Professional should report to the government authorities and/or to the pharmaceutical company concerned. For European medicines, the EMA collects all such reports within a central database called EudraVigilance.

Can patients report directly?

There is nothing to stop a patient reporting via their doctor or pharmacist. These health care professionals can help put the information into the right medical context for further evaluation by the authorities, particularly if they suspect a serious or severe reaction

What regulatory action can be taken?

Sometimes, this action will involve warnings to the public and the medical community aimed at ensuring the safe use of a medicine and the prevention of future side effects. In extreme situations and, when justified, medicines have been removed from the market in order to protect public health. This is when the balance of risks outweighs benefits of the particular medicine.

How do you judge that there is a side effect?

This is done by careful evaluation of each case. The fact that a report is received does not necessarily mean that the drug is responsible. In some situations the problem could be due to other medicines taken at the same time or pre-existing medical conditions.
Features that suggest a real side effect are:

  • When no concomitant medicines are taken
  • When no other medical conditions (apart from the one under treatment) are present
  • Improvement when the suspected medicine is stopped
  • A recurring problem if such a medicine is re-started
    Please note, however, that a patient should not stop treatment of their own accord without consulting their doctor or pharmacist.

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Last update: Tuesday, 25 July 2006.

 

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