Posted by Richard Willett - Memes and headline comments by David Icke Posted on 19 January 2024

Up to 98% of Adverse Effects Go Unreported: Why the Yellow Card Scheme is Not Fit for Purpose

Adverse drug reactions (ADRs) are a major cause of hospital admissions, with 6.5% due to that cause. Analysis of inpatient stays also shows that 15% of patients experienced one or more ADRs – half of them were definitely or possibly avoidable.

In 1964, the Yellow Card Scheme (YCS) was created to act as an early warning system for unexpected adverse drug reactions (ADRs).

The YCS reporting site allows the submission of reports of suspected adverse reactions to the Medicines and Healthcare Regulatory Agency (MHRA). The MHRA says the system ensures the safe and effective use of medicines, vaccines and medical devices. But does it ensure such safety?

To inform our answer, we searched for publications since 2010 (see here).

The reporting of suspected ADRs by the public is a valuable source of information about the possible harms of pharmaceuticals.

A 2011 health technology review of patient reporting showed that in a two-year (October 2005 to September 2007) period, 5,180 patients and 20,949 healthcare professionals (HCPs) submitted Yellow Card reports.

A questionnaire survey was undertaken among those who did a report, leading to 1,362 evaluable responses. Nearly half learnt about Yellow Card reporting from a pharmacy (49%), followed by their GP (16%).

Most respondents (81%) said the report had been their idea. Forty-three (3.2%) were discouraged by someone from making a report, most by their GP. Fifty-six (4.1%) stated an HCP refused to make a report on their behalf.

Patient reporting of serious ADRs was comparable with healthcare professionals, with a high proportion of patient reports (58%) containing at least one reaction term classified as ‘serious’.

Patients were also more likely to document the impact of ADRs on their lives (47% of patients vs 12% of HCP reports).

A comparison of the ‘patient-only’ with ‘HCP-only’ reports showed that only one in 10 of the YCS reports overlapped. Safety signals generated by patients-only data showed that two-thirds were not in the HCP-only dataset.

One third of respondents expected feedback from the MHRA, and two thirds said they would have liked it. Furthermore, 149 patients wanted to know whether any investigation or action would occur due to their report.

Respondents expected an acknowledgement of their report and information about the reaction, including the frequency of similar reports received, how common the effect was, or whether it was a well-known problem.

Read More: Up to 98% of Adverse Effects Go Unreported: Why the Yellow Card Scheme is Not Fit for Purpose

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