Spontaneous reporting*

‘Spontaneous’ (or voluntary) reporting of adverse effects is when health professionals or patients decide that they will report suspected harm from a medicine to their local or national pharmacovigilance centre.

It’s a system that relies entirely on the motivation of individuals to record and send information about something bad that has happened to a patient to the organisation responsible for collecting reports of adverse effects (usually a local or national pharmacovigilance centre). Paper forms are the commonest method of communication, but online reporting and apps (mobile applications) are also now available in some places and are an important development for the future.

‘In all countries … national [pharmacovigilance] systems rely heavily on spontaneous (or voluntary) reporting … … by health professionals, manufacturers or directly by patients. Of all the sources of data for drug safety monitoring, the spontaneous reporting systems provide the highest volume of information at the lowest maintenance cost, and have proven their value in the early detection of patient safety issues related either to the products themselves or to their use.’

Pal SN, Duncombe C, Falzon D,  Olsson S, WHO Strategy for Collecting Safety Data in Public Health Programmes: Complementing Spontaneous Reporting Systems; Drug Saf (2013) 36:75–81

VigiBase, the WHO database of individual case safety reports, contains over 20 million reports, many of which are spontaneous reports from health professionals or patients. These have been contributed by members of the WHO Programme over nearly fifty years. While the benefits of spontaneous reporting are evident, there are also several significant shortcomings: a very small percentage of adverse effects are actually reported (research suggest around 5%); it is impossible to judge how common an adverse effect might be because there is rarely any denominator data, such as the number of prescriptions written for a specific drug; the quality of information reported is not always good enough to make a scientific case for a causal link between medicine and effect.

As a source of unique data, spontaneous reporting remains important, but complementary methods are essential for pharmacovigilance to realize its potential in the prevention of harm to patients. Longitudinal analysis of manual and electronic health records, observational studies, randomised control trials and meta-analyses are essential components in the overall picture of the safety of patients and their medicines. There are current projects, like WEB-RADR, looking at social media as possible sources of valuable insight.

Read more about current collaborations

As pharmacovigilance broadens its horizons to embrace patients’ total experience of therapy, creative new ways of capturing data and information are needed. Currently we have access to only a very small – though important – part of the whole picture.

*A note on terminology: this familiar term is used throughout this website and in many other places, but it is slowly being replaced by the more accurate and inclusive term, pharmacovigilance reporting (system). References to postmarketing and safety surveillance reporting systems are also to be found in the current literature.

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Last modified on: May 27, 2019