This article* is an update from Dr Henrietta Hughes, Patient Safety Commissioner for England.
Slow, siloed, disjointed, dismissive. The Cumberlege review heard from patients who had been campaigning for years or decades without being heard, or their concerns acted upon. InFact raised concerns about sodium valproate being dispensed in plain white packaging without warning labels in 2013. Ten years later, the Government has just published the response to a consultation on white boxes. The plans will improve information and safety for patients taking sodium valproate, but also enable pharmacists and pharmacy technicians to use their discretion when there is a mismatch of 10% between the prescription (often in multiples of 28) and the pack size.
Good news, but also a stark reminder of how slow the response is to the very people who are impacted by harm.
What will it take for the evidence that patients raise to be seen as important as other sources in the hierarchy as evidence? Why is it that when thousands of patients are all saying the same thing, that the system is so slow to react? It’s clear that participants in clinical trials do not mirror the intended population whether for medicines or medical devices, so post marketing surveillance is particularly important, and we all have a responsibility to keep our minds open when patients give feedback or raise concerns.
Patients describe being ignored, dismissed and ‘gas lighted’ when describing symptoms and signs, being told it’s all in their head, that they are hysterical, not to believe everything they read on social media. And yes, they are mainly women.
We need to hear the early signals of harm and to act on these swiftly and in a co-ordinated way. This is particularly important with the recent Budget announcement that the MHRA will be able to rely on licensing of medicines and medical devices in trusted jurisdictions.
We need a listening culture that values the voices of patients and families and that can translate the feedback into action.
Patients should not have to push this information to providers and regulators – we need a system that draws the feedback into the centre. Instead of relying on the traditional hierarchy of evidence when identifying harm, we need a feedback loop as exists when we introduce quality improvements and for this feedback to be escalated directly to MHRA using the yellow card system. Without this the same problems will persist and we will look back in a further ten years and say: we were responsible – what did we do to stop harm?
@InFactUK @KathSansom @meshcampaign @carlheneghan @MHRA #patientvoice
This article was first published on LinkedIn.
There are no comments to display.
Create an account or sign in to comment
You need to be a member in order to leave a comment
Create an account
Sign up for a new account in our community. It's easy!Register a new account
Already have an account? Sign in here.Sign In Now