The Pharmaceutical Journal
Vol 278 No 7437 p123
3 February 2007

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Concerns about patient reporting of suspected ADRs unfounded, UK researchers say

Patient reporting of suspected adverse drug reactions has more potential benefits than drawbacks, according to a review published in the British Journal of Clinical Pharmacology this month (2007;63:148).

Alison Blenkinsopp, of the department of medicines management at Keele University, and colleagues conducted a review of published literature, and of reported international experience, and found that concerns about low quality and large numbers of irrelevant patient reports appear to be unfounded.

The researchers found a paucity of studies into patient reporting systems. They identified seven studies for their review, none of which included spontaneous reporting by patients. In most cases reports were requested from patients by health professionals or by researchers. They also found that there has been little formal evaluation of existing international patient reporting schemes.

Overall, the researchers’ findings provide evidence that patient reporting does add value to professional reports of ADRs by identifying possible new reactions. Reported international experience has been positive to date, with several countries indicating that patient reports do identify possible new ADRs that are not included in existing summaries of product characteristics, they say. Available data show patient reports comprise 7–15 per cent of total reports, they add.

It is now important that those countries with patient reporting systems publish data on the reports received and how that information has been used to improve the management of ADRs, say the researchers.

Professor Blenkinsopp told The Journal: “One of the initial concerns that regulators had was that they would be overwhelmed by reports and this hasn’t happened. Patients need to be aware that they can make a report and pharmacists in community, primary care and hospital can play an important role here by making patient reporting forms visible and easily accessible, and encouraging patients to make reports.”

In the UK, patients have been able to submit electronic ADR reports direct to the Medicines and Healthcare products Regulatory Agency since January 2005, and paper and telephone reports since the autumn of that year.