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.
To join in with the discussion please make a donation to The Daily Sceptic.
Profanity and abuse will be removed and may lead to a permanent ban.
Pandemic Treaty is legalised tyranny. Sadly, puppet Sunak has already got his fountain pen out, itching to sign.
****
Stand in the Park Make friends & keep sane
Sundays 10.30am to 11.30am
Elms Field
near Everyman Cinema & play area
Wokingham RG40 2FE
Another whackjob nutbar conspiracy theory coming true.
Just a cockup however.
No evil, demonic, fascist intent.
Just hard working experts saving the world.
Experts. Who approve mRNA shots in 6 month old babies. Those guys?
Really? So you are content that the WHO could mandate that you take whatever medical treatment they demand? Bodily autonomy is perhaps THE core human right – the state STOPS at my skin. The WHO agreement will throw this away. Maybe you like being a slave? For that is what this will make you.
I’d rather assumed he/she(?) was taking the p***.
Are we now on daily login?
That happened to me a while back. Seemed to happen more with my phone for some reason. Touch wood it’s all back to normal as it’s a pain in the arse, but at least now we don’t have to click on multiple pictures of dodgy fire hydrants or traffic lights! lol Morning to you, btw. 🙂
Seems fairly random to me. Sometimes go for weeks without logging in, others times I need to log in more often.
I have to sign in most days.
Excellent piece from Prof Fenton et al, supporting what we sceptics have been banging on about since the start. Flu never did disappear did it? But now the sneaky b’stards want those deemed ”high risk” to rock up for a double-whammy of Covid plus flu jab. Insane!
”Despite the similarity of the symptoms of flu with those of SARS-CoV-2 it was, at least initially, the infection fatality rate for SARS-CoV-2 that differentiated it from the flu – its novelty was dependant on its perceived elevated lethality. However, over time the infection fatality rates for SARS-CoV-2 have converged on that for the flu and now the deadliness of one is indistinguishable from the other. Why then do we, three years later, do we consider SARS-CoV-2 to be more novel than flu or any other respiratory viral infection?
Given that the symptoms of both overlap to an extent which makes each completely indistinguishable from the other based on clinical presentation, legitimate questions have been raised as to the circumstances that led SARS-CoV-2 to be identified as a novel virus in the first place.
Given we cannot trust PCR tests for SARS-CoV-2, why should they be accepted as proof of the absence of flu? The evidence suggests that influenza and SARS-CoV-2 do not significantly interfere with each other, and given no false positives for flu were reported at all, how else can we explain the disappearance of flu except by changes in the PCR testing process?
These are no doubt controversial conclusions but, given the evidence, a reasonable question to ask is: Was covid-19 disease actually entirely new, or is it simply caused by misattributing flu, or the myriad of other causes of respiratory illnesses, as SARS-CoV-2? Or is there some other unknown mechanism that generates one or the other or indeed both?”
https://wherearethenumbers.substack.com/p/peek-a-boo-flu
SARS-Cov-2 was obviously a cure for flu 😁
‘What governments should do’
Britain’s government should bring back the Common Cold Unit and put Professor Carl Heneghan in charge of it.
Then we might get more of the sense for which the Common Cold Unit was, rightly, famous:
‘It is therefore arguable that in the case of infections like coronavirus or rhinovirus colds, which are normally quickly self-limited, the best approach would be to relieve the patient’s discomfort and disability and leave their immune system to take care of the virus.‘
D.A.J. Tyrrell, Head of the Common Cold Unit, 1992
In truth the WHO has no control over us and this treaty doesn’t really change that. This is simply providing our government and other bodies with something to hide behind, should it suit them.
But certainly anything global beyond the most basic common sense e.g. ISO codes is to be treated by default as suspicious, probably evil.
Nothing to do with health and everything to do with power, control, money and (in the case of Governments) deniability.
“We were following The $cience.”
Insofar I recall this correctly, one health is supposed to mean health of humans, animals and the planet. The planet is a ball of stone with a mass of 5,972,000,000 trillion metric tons hurtling through space at a speed of 29.87 km/s and it has no health, especially none the WHO could somehow influence. That’s the good reason to reject this: It authorises the WHO to act to the detriment of living animals (humans being a primate species) if it believes this would somehow benefit the aformentioned ball of stone. What such a benefit could conceivably be is anybody’s guess.
The WHO is an evil supranational vampire body literally sucking the life out of world. The mRNA platform is a sick joke, literally, and Gates & Co should be in court.
Luckily we’ve got Jeremy ‘burner phone’ Farrar stepping up to save the world as the new WHO excess deaths czar or something. Best of British!
In other news: what’s VAIDS?
There should be a debate on a referendum after the online petition, but I doubt we will allowed a vote. There should be a referendum on any significant transfer of sovereignty. We lend our politicians these powers, they are not theirs to give away.
Great article.
And for me the biggest argument it is that supranational or national forced measures are causing massive harm at individual level, as we have seen with Covid. Public health should only ever inform, advise, support and re-assure.
On a side note One Health means something entirely different. In short it is collaboration between human-, animal-, and environmental health. These often work in silos and should work together as interventions in one area often have (unintended) consequences in other areas.
The fact that this differentiates between humans and animals should already ring a bell: Humans are a primate species. As opposed to other animals, they have the unpleasant ability of articulating their own wants. It’s better to claim to speak for polar bears because these are not going to voice contradicting opinions.
Environmental health is a completely ill-defined term. It’s based on the notion that someone knows what state a very complex system such as animal and plant life on earth, should really be in. What this someone believe to be the right state fot this complex system is then called healthy to express his deep-felt conviction that he is really omniscient and that all opinions except his own are seriously bad and must be eliminated to maintain a healthy state of affairs.
If WHO had its way we would be in lockdown over monkeypox. Our Government will sign the Treaty nonetheless. There are not enough independent minded MPs to block it. With phantom environmental emergencies to contend with too, it begs the question what are the advantages of having a population in a state of permanent fear? Ask yourself what vested interests stand to benefit? The very people that promoted the global panic in the first place
The WHO treaty will facilitate the introduction of digital IDs and CBDCs by enabling the shutdown of parts of the economy they want to destroy (small businesses) and help the parts they want go grow (global businesses). Rather than tackling inflation head on with interest rates, sparking a global recession and drawing attention to themselves the central bankers) are using mechanisms like the WHO treaty to do it under cover of fear-inducing “pandemics”. Listen to Catherine Austin Fitts:
https://theconsciousresistance.com/the-activation-23/
The WHO continues its anti-democratic agenda and is trying to change from an advisory organisation to a controlling one. It’s time we kicked the WHO into touch and set up a new organisation with a group of top scientists from like-minded countries who can advise governments with a full explanation of their advice, so governments can correctly balance health benefits against cost and other impacts. After recent events, it’s clear that science is not a single solution thing and democratic governments should have the option to use their own trusted scientists to analyse the recommendations from any organisation and make their decisions based on what is best for their country. It might also be better in the UK if ministerial appointments are decided by the education and knowledge of the minister about the subject they are supposed to be administering. Let’s not have another Hancock disaster.
There is absolutely no chance of having ministers with education and knowledgerelevant to the department they represent. The slithering serpents would not accept anyone who was vaguely qualified. Their own incompetence might be shown up.