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.
Problems with the system
Problems within the system include the inability to distinguish between suspected drug reactions and the underlying condition, impeding the ability to determine signals of harm.
To try and overcome this problem, investigators analyse the proportional reporting ratio (PRR): the spontaneous reporting rate of a particular drug divided by the corresponding proportion for all or several other drugs in the database. This shows whether a given adverse event is reported disproportionately for certain drugs.
The reporting of adverse events can also be assigned causation based on set criteria.
Underreporting
The ability to detect signals and assign causation is hindered by the substantial problems with underreporting of adverse drug reactions. In the U.K., patients have been involved in safety reporting since 2005; however, only one in 12 patients is aware of the possibility of reporting.
A 2006 systematic review of 27 studies reported that underreporting of adverse events was, on average, 94%. It could be as high as 98%, meaning only two in every 100 adverse drug reactions are reported to the MHRA.
This finding is backed by a recent analysis of anticoagulants that compared Yellow Card reports to hospital reports of gastrointestinal bleeds over five years. The North-West of England Hospital Trust recorded 12,013 bleed-related emergency admissions. Of these, 1,058 were taking DOAC anticoagulants. However, only six DOAC Yellow Card reports (0.56% of the possible) were made by the Trust during the period.
In 2018, the MHRA reported that it was “estimated that only 10% of serious reactions and between 2% and 4% of non-serious reactions are reported.”
The Independent Medicines and Medical Device Safety Review (IMMDS; also known as the Cumberlege report) reported gross underreporting with the current system.
The IMMDS recommended that “the spontaneous reporting platform for medicines and devices, the Yellow Card system, needs reform” and that “the MHRA should be required to invite representatives of those who report adverse events (both patients and healthcare professionals) to be involved in evaluating and making decisions on specific safety concerns”.
The IMMDS review showed that patients had been let down and that the reporting problems for devices were, if anything, much worse than for drugs.
The review called for significant reforms at the MHRA due to its mishandling of safety concerns linked to pelvic mesh.
In Europe, EudraVigilance provides online access to suspected side-effect reports. In the U.K., the responsibility falls to the MHRA. The MHRA publishes this information for suspected harms in interactive Drug Analysis Profiles (iDAPs).
They display an overview of all U.K. spontaneous suspected ADRs reported through the Yellow Card Scheme.
However, the system could be more user-friendly and easier to search. For example, medicines are listed alphabetically by the name of the active ingredient, not by the brand name. Clearly, the system for accessing patient information leaflets needs to be better thought through.
As an example, a search for aspirin leads to 7,638 results. Once a disclaimer has been agreed to and ticked, the end user is provided with a bewildering array of choices with documents that are poorly constructed and often impenetrable.
In July 2023 Carl warned MPs that the Yellow Card system should come with a warning:
Professor Carl Heneghan described how under-reporting of adverse drug reactions to the Yellow Card system could be as high as 98%, meaning the ability to detect signals and assign causation is substantially hindered.
The question is whether a system devised 60 years ago is fit for purpose. In the next post in this series, we’ll scrutinise this question further in terms of Covid vaccine data reporting.
Prof. Carl Heneghan is the Oxford Professor of Evidence Based Medicine and Dr. Tom Jefferson is an epidemiologist based in Rome who works with Professor Heneghan on the Cochrane Collaboration. This article was first published on their Substack, Trust The Evidence, which you can subscribe to here.
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“Equality” —–A cautionary tale.—– “Equality” according to who? Does “equality” mean the same to a black person who are convinced they are oppressed as to white person who does not feel like an oppressor? Does “equality” mean the same to someone on minimum wage as it does to a billionaire? Do people want “equality” of opportunity or do they think we should have “equality of outcomes? —–I suggest “equality” is in the eye of the beholder.
Vernal looks like a total mincer to me, what do you think Varmint?
Not by looking at his face. Only by listening to his words and looking at his actions. The whole “equality” business is just like every other commie scam.
Vernal look rather effete to my gimlet eye. Why are we giving non jobs to such utterly mediocre mincers?
If you give someone a well-paid job with prestige and power, and you call it “Head of Equality”, they have no incentive to increase “equality” because if they did then they’d be out of a job.
Exactly
Like SAGE, who only exist when there’s an “emergency”, or the WHO who peddle “pandemics”, or pharma companies who may prefer us to rely on their “treatments” instead of looking after ourselves.
Orwell prediction comes true, yet again!!!
And what a surprise he’s not Mother’s Pride.
Any organisation with an ‘Equality Officer’ deserves to be shut down in its entirety.
Off-T
Slightly.
https://thenewconservative.co.uk/islam-demands-labour-will-comply/
Even Frank Haviland is issuing words of warning as sectarian politics pushes in to the space vacated by the Uniparty.
How precisely does expressing oppositon to the policy and actions of the state of Israel in the middle-east compromise the safety of Jewish students at Oxford?
Are you actually serious? I’d guess you are just plain stupid but hey, maybe you think you are right and there is nothing to see here just like 1936.
I guess that you don’t have an answer to the question and that’s why you’re trying to insult me instead.
The excerpt mentions two demands of the protestors:
Professor Goldman asserts that this would compromise the safety of Jewish students […] at Oxford. However, he doesn’t state why he believes so and you calling me names and waving Nazi tokens doesn’t demonstrate that, either. Hence, so far, there’s no reason for this assertion. I can think of a meta-reason, namely, both Goldman and you really want someone powerful to shut these protests down, nat-con style.
I actually find it impossible to believe you said that to be honest. Does it not occur to you what “From the River to the Sea” means? How would you feel if a bunch of your co-workers chanted, day after day, a slogan which meant they wish to kill you?
Seriously, does it really not compute that they are deliberately and knowingly targeting Jewish students? I cannot, for the life of me, see how you can not see this.
Does it not occur to you what “From the River to the Sea” means? How would you feel if a bunch of your co-workers chanted, day after day, a slogan which meant they wish to kill you?
I “feel” you’re making an incoherent statement. “From the River to the Sea” refers to the country between the river Jordan and the Mediterranean Sea which is supposed to be liberated from Israeli control. This doesn’t express a wish to kill aynone, not even necessarily for someone to be killed there, as a peaceful solution is perfectly conceivable and not really more unlikely than any other, ie, totally unlikely, as Israel is the military great power in this area and this is unlikely to change anytime soon.
BTW, my position on that is that I resent being dragged into the petty squabbles between J-semites and M-semites in a “distant country I know (next to) nothing of” and couldn’t care less about. Except maybe a bit of Schadenfreude that our former enemies (ie, enemies of the central powers) in this region are still at each other throats fighting for the spoils of 1918.
I did think this was funny, mind. The terrorist-supporting, Jew-hating rape-apologists won’t see the humour though. To them every word reported by actual terrorist organizations, who can’t stop declaring how much they hate, well, everyone who isn’t them, is the Gospel;
https://twitter.com/TheBabylonBee/status/1788257560182571464
Many years ago the leftie nutcases stood solidly behind the Jews at the Battle of Cable Street. Today they are the Nazi’s. Socialism does not really change much, it just has a change of clothes now and again. The sad thing is that people like this fool, and those in the camps, do not even realise who they are.
The Black Shirts of Oswald Mosley were fascists but not antisemitic, at least until their marches were sabotaged by Communists & Jews.
The rise of Oswald Mosley:https://www.youtube.com/watch?v=V4ZZkPTTkrM
Maybe Nigel Biggar, the Regius Professor Emeritus of Moral Theology at Oxford should resign as he has obviously lost his “moral” compass by supporting the Jewish slaughter of the indigenous Palestinians.
Do please look up some history and remove the “indigenous” bit. Also, did you know that Israel has the best record in the world for not killing civilians? They make a point of warning exactly where they are going to attack and give civilians time to move.
Perhaps the terrorist-supporting Jeremy Corbyn fan club on here could remind us of a time when Israel actually initiated a conflict in the Middle East, in comparison to their many hate-fueled, barbarian jihadist neighbours that surround them. I’d rather be surrounded by a load of Jews than live in a Muslim majority neighbourhood any day of the week.
You are hilarious.
Love the satire.
This is hilarious:What are the conspiracy theories MPs have been warned about? (msn.com)
Good grief. More taxpayers money wasted. So if the usual “fact checkers” – ‘trusted news initiative’ FFS – declare a conspiracy theory then we are supposed to believe it.
Yeah right.
So there is no ‘reset?’
There is no ‘replacement?’
We really are living through ‘1984’ and 2 + 2 definitely equals 5.
I thought this letter written by Jewish students to the community of Columbia University was excellent. I will never ever, for as long as I live, understand why people would wish to deny these people their fundamental right to self-determination in their homeland. Muslims have 50+ nations, many of which they got rid of Christians and Jews from, and if there are any still left in some of those places they live like second class citizens, persecuted and murdered every single day. And yet they have the absolute audacity to begrudge and war over a tiny piece of land, approx the size of Wales, which is the only place the Jews get to call ”home”. There is no sense, no rational to that sort of mindset, none.
And yet these ‘useful idiots’, these cheerleaders of terrorists have the temerity to show their ignorance by accusing Israel of ”ethnic cleansing”?! LOL Well I think opening a history book might be a good place to start before you accuse Jews of ethnic cleansing, because the Muslims know a thing or two about being ‘colonizers’, to put it mildly. Approx 2 million Muslims/Arabs live peacefully, enjoying equal rights in Israel. How many Jews and Christians can say the same living in the majority Muslim countries?
”Many of us sit next to you in class. We are your lab partners, your study buddies, your peers, and your friends. We partake in the same student government, clubs, Greek life, volunteer organizations, and sports teams as you.
Most of us did not choose to be political activists. We do not bang on drums and chant catchy slogans. We are average students, just trying to make it through finals much like the rest of you. Those who demonize us under the cloak of anti-Zionism forced us into our activism and forced us to publicly defend our Jewish identities.
We proudly believe in the Jewish People’s right to self-determination in our historic homeland as a fundamental tenet of our Jewish identity. Contrary to what many have tried to sell you – no, Judaism cannot be separated from Israel. Zionism is, simply put, the manifestation of that belief.
Many of us are not religiously observant, yet Zionism remains a pillar of our Jewish identities. We have been kicked out of Russia, Libya, Ethiopia, Yemen, Afghanistan, Poland, Egypt, Algeria, Germany, Iran, and the list goes on. We connect to Israel not only as our ancestral homeland but as the only place in the modern world where Jews can safely take ownership of their own destiny.
The evil irony of today’s antisemitism is a twisted reversal of our Holocaust legacy; protestors on campus have dehumanized us, imposing upon us the characterization of the “white colonizer.” We have been told that we are “ the oppressors of all brown people ” and that “the Holocaust wasn’t special”. Students at Columbia have chanted “we don’t want no Zionists here”, alongside “death to the Zionist State” and to “go back to Poland” where our relatives lie in mass graves.”
https://docs.google.com/document/u/1/d/e/2PACX-1vRQgyDhIjZupO2H-2rIDXLy_zkf76RoM-_ZIYsOfn9FkI7TETgRtOfXK9VobMvGh6iEZfDPgALXJTCR/pub
Well 10 out of 10 for consistency, at least. 0 out of 10 for common sense, decency or democracy.
He managed to mess up the police then move on to Oxford? His credentials must be brilliant because from Essex to Oxford is quite an upgrade. Whoever appointed him should be ashamed. Mind you, these days every HR department has to kowtow to Stonewall. Diversity champion my foot!