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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COP28: comedy gold…..the gift that keeps giving…..after flying there on private executive jets, they’ll probably have a side meeting on how to get there on their private yachts next time….oh…hang on…..
https://www.cop28.com/en/schedule/responsible-yachting-today-tomorrow
Yes, I saw that one about responsible yachting. To me, a yacht has masts and sails which can be made of wood and cloth so what’s the problem? Hmmmmm
I used to follow a YT channel of a couple who were crossing oceans in a sailing boat – high tech materials, and a battery to work their high tech comms equipment that enabled them to get where they needed to go safely –
satellite, radar, GPS etc. All very “green”.
I saw them. I think they had a baby with them too. It was very inspiring. Travel around the world on your own with no laws, government regulations or limits of where to go (well almost).
A prepper’s ideal final escape from the techno totalitarian nightmare.
It was during lockdown in part so they largely avoided all that crap
The discussion will focus on a variety of technical solutions developed to make the yachting experience more responsible and sustainable. Sunreef Yachts Eco representatives will share an insight into the R&D activity of the company and practical solutions that can be implemented to ensure cleaner boating. This will include a conversation about electric, hybrid and hydrogen propulsion, battery technology, plant-based composites, bottom paints, modern photovoltaics, sustainable interior finishing, water management, energy management, air conditioning. The focus will also be on the evolution of technology and future trends.
My emphasis in bold. I can see that they are not talking about the yachts I had in mind i.e. your little sailing boat with its entirely sustainable profile involving things like sails, ropes, rudders, tillers, hulls and masts often made of wood but yachts for the super wealthy with their ‘air conditioning’ and ‘energy management’ requirements! I had a look at Sunreef’s range – some of them even have helipads. So, not the yachts for thee and thou but the yachts for they and them!
There is “science” and then there are “myths”. ———-There is no evidence that CO2 is causing or will cause dangerous changes to climate. It certainly has not done so up till now and we keep getting told that the CO2 that we have “pumped” into the atmosphere since the 1700’s is causing climate change. But that is falsified by the fact that there is no increase in the frequency or intensity of any type of weather event. Yet computer models full of assumptions, guesses and speculations where basic parameters are either poorly understood or totally unknown are presented as “the science”——MODELS ARE NOT SCIENCE, and guess what ? They have all been totally wrong till now anyway. —-So if it is clearly not about science, what is it about? —————CO2 is the one gas that can be directly tied to Industrial Capitalism, and I am afraid that is what it is really about. The wealthiest people and countries emit the most and the poorest people and countries emit the least. The wealthiest people who live in the prosperous west are to stop emitting CO2 , which really means they are to stop using fossil fuels because we can afford to dabble in expensive niche technologies ike wind and sun and we are to send money to poorer people by way of bribes to tell them to leave their fossil fuels in the ground——-“Reparations” or “climate justice” or some other eco socialist terminology is used that really is about total control of the worlds wealth and resources, and the excuse for all of this anti capitalist central planning is “climate change”, the greatest pseudo scientific fraud ever.
“The wealthiest people who live in the prosperous west are to stop emitting CO2 …”
Well, not quite, since all human beings are CO2 generators: with every breath we breathe, we exhale 100 times the amount of CO2 we inhale. I learned that in biology at school – a long time ago, when schools used to educate. We are, after all, animals that survive by converting O2 to CO2. So those of us who really believe CO2 is destroying the planet need to … hold their breath!
Another cracker from Mr Morrison, thank you.
It was a pleasure to meet you briefly on Monday evening at Lola’s.
Always like reading Mr Morrison he has a terrific sense of humour and the way his takes the p*** out of these climate change net zero freaks is second to none.
I noticed the Met Office were panicked yesterday into releasing a YouTube video on the 1.5%.
Funnily enough, they didn’t mention any of the points raised above!
Another fact recently established in a study shows that a total transformation to so-called ‘renewables’ would require a further 80 million kilometres of high voltage transmission cabling – or in layman’s terms 80 million kilometres of steel wire and pylons.
https://joannenova.com.au/2023/12/your-clean-green-future-needs-another-80-million-km-of-high-voltage-lines/
There is no intention to make “a total transformation to so-called ‘renewables’ “. That is simply a myth. The intention is to reduce the population such that the elites have everything to themselves with a slave population to service them.
https://www.conservativewoman.co.uk/the-cop-squad-are-coming-for-our-cows/
As many of us here know attacks on food supplies are an integral part of the depopulation plan. So they are going to reduce methane – in other words cattle.
Here we go again.
The people intent on selling vegan replacement products for meat and dairy have hitched their waggons to chlimate cange a long time ago. They’d obviously very much like to get some of the money, too, and if government could be persuaded to outlaw competing products people preferably buy, this would also help the bottom line a lot.
Just as with COVID, whoever can tries to exploit the scam to further his own agenda, whatever it might be.
“Climate change” is a desperate operation by the western world order to cling on to global power, against the tide of the growing wealth and influence of non western powers.
When you put yourself in the mindset that most of the people in positions of power are sociopaths, everything makes perfect sense.
If you think that people in positions of power are trying to serve the common good, you’re not only completely lost, you’re a useful idiot. Fodder for their cannon.
Anything that seems like serving the common good is nothing more than the temporary and absolute minimum alignment of interests required for the sociopaths to get their way.
Ridiculous. Asia won’t follow the West as it commits economic suicide.
What is “doing an Ali Jaber?”
Blowing a firkin hole in someone’s argument so big that they have no possibility of reply.
Excellent, HP! I’ll have to remember that one!
Thanks Aethelred
Monro. You literally couldn’t make this up! The have yachts on sustainable sailing while telling the rest of us to stay in harbour!
At least Al Jaber has a scientific training (Chemical Engineering), in contrast to most of these climate grifters. Mary Robinson (who I met as a guest speaker at a conference) is an incredibly self important member of The EUOirish elite. Like the old drunk Higgins and others she lives in a bubble sealed off from the chaotic country she has created. Looking forward to seeing her try hard not to patronise Connor McGregor when he enters the fray!
A Conservative sub 60 seats election result will put a lid on this climate nonsense.
Imagine the naivete of people who believe anybody can measure a single temperature for the earth and to 1.5 degrees! Temperatures are infinite and chaotic all over the earth and can vary 10 degrees or more within a 100 mile radius. From daytime to nighttime they can vary 30 degrees. And then to set political goals set on this! Pseudoscience at It’s best.
Two reasons Chris Morrison is my favourite writer here:
Where can I see more of him?
Charring Cross Station, outside WH Smith 4-45 pm Sunday. Will be carrying a brolly, wearing a Ganex raincoat and sporting a red rose.