Making sense of the data

This is where the science delivers its benefits

UMC regularly screens the international pooled data, automatically and manually, to discover if there are any patterns of harm that emerge in data from more than one country. Such reports are reviewed by a panel of experts and conclusions are reached about the strength of evidence for a medicine being the cause of harm. This evidence is rarely conclusive. When there is a suspected safety issue that requires further investigation and discussion, it is known formally as a ‘signal’. UMC then shares the findings with national pharmacovigilance centres, WHO, and the public through various channels, including UMC’s SIGNAL and WHO Pharmaceuticals Newsletter. The intention is that member countries should then take account of the findings in their own decisions and efforts to protect patients in their territory.

A signal is a hypothesis – a tentative, incomplete explanation of harm with all the necessary evidence supporting it. A signal is always a preliminary assessment of the strength of the suspected association between a medicine and an adverse effect. The evidence from individual case safety reports can rarely be conclusive. Confirmation of the signal hypothesis usually requires further research, often with a larger population of patients. There is a full discussion of the meaning of a signal in the link below. 

What is a signal?

Find common terms in pharmacovigilance here or a more extensive list in the glossary.

When you have a problem with your health and are seeking help, ask about all the things you want to understand, especially the benefits and risks of your medicines – maybe including some of these questions.

If something goes wrong and you feel your medicine is making you ill or upsetting you or not having any effect at all – go back and tell your health provider about it. Make sure they consider the possibility that your symptoms are caused by your medicine.

Ask them if they will report the problem to the pharmacovigilance centre in your country OR report the problem yourself to your local or national pharmacovigilance centre, preferably where you live.

You will have contributed, in however small a way, to making the use of medicines safer and more intelligent in the future.

In many countries, patients and consumers are encouraged to report adverse effects directly to their pharmacovigilance centre. To find out what happens in your country, you can ask your health provider or search for your local or national pharmacovigilance centre on the internet.

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Last modified on: April 28, 2019