Medicines and Healthcare products Regulatory Agency
First published:
12 May 2016
The Medicines and Healthcare products Regulatory Agency (MHRA) is investigating an issue involving a digital calculator used by some GPs to assess the potential risk of heart disease in patients.
The QRISK®2 Calculator is a predictive algorithm used to support medical practitioners, mainly in GP practices, to help assess the potential risk of cardiovascular disease in patients, as part of their overall evaluation. The issue has resulted in incorrect results being produced for a limited number of patients.
The MHRA is working with TPP, the software provider, as a matter of urgency, to make sure the identified issue is resolved and that any affected patients are identified.
Clinical advice received by the MHRA is that the risk to patients is low and only a limited number of patients are potentially affected. GPs have been informed and they will contact individual patients should any further action be necessary.
Patients should continue to take prescribed medicines and if they have any questions should ask a nurse or doctor at their next routine review.
Why do doctors even need a "tool" to assess a patients risk of developing cardiovascular disease to prescribe statins ? Don't they have a brain ? ? ...
And if they do (have a brain ) they (probably) wouldn't prescribe statins in the first instance ! ! ! ...
Unfortunately it's 'Standard of Care'. Just because a person is given a prescription doesn't mean they must have it filled. But the doctor prescribed it so the doctor has exercised 'risk management'. it's all about 'risk management' not for the patient, the doctor. And Standard of Care.
In many ways, the number affected might not be nearly so important as how seriously that number were affected.
Did a very large number feel very slightly not right because they were wrongly assessed?
Did a small number suffer heart attacks or severe rhabdomyolysis because they were wrongly assessed?
The word limited is entirely inappropriate. Of course it is limited. The number assessed by this system, rightly or wrongly, is smaller than the population of the country. And how limited? It needs a number of some sort, even a range - one thousand to ten thousand?
Bit late for my Mum who now had kidney failure and has to be on dialysis 10 miles away from her home 3 times a week.
Kidney failure being a well known side effect of these dangerous statins.
Doctor wanted to put my Husband on statins already knowing my husband had muscle weakness. ???
muscle weakness is another well know side effect of these dangerous statins.
Husband refused the statins and my Mum, having nearly died, is back to better health and has now has cut down on many prescribed pills, besides the statins.
Stains caused my Mum in Law memory problems and sleepyness, but she recovered immediately once off the dangerous drugs.
That's what I've always said Hidden . I was on holiday a few years ago & started chatting to a woman by the pool about how ill I'd felt since having an oopherectomy & told of her of all the different meds my GP had wanted to prescribe me , I said to her 'well as far as I'm concerned Gp's are nothing more than legal drug pushers', she smiled in a sort of uneasy manner & then informed me she was a surgery practice manager & amazingly said she agreed with me, whether it was out of politeness i'll never know.
"Computer firm TPP, which makes the software, has 40 million patient records."
What I want to know is Why? I've opted out of allowing my records to be copied. But my doctor has also used a risk calculator with my details to try and persuade me I need statins. So how much info does TPP have on me? To do a calculation on a few numbers does not require TPP to have access to my patient record!
I think this probably reflects the technology more than anything.
When setting up systems which allow public access, I think most, possibly all, of them are actually hosted in big data centres operated by a tiny number of companies. The idea of every single surgery managing their own hardware and, most importantly, their own backup and security is way beyond what any but a handful could manage!
The access that TPP have to the records they hold on behalf of surgeries (and, arguably, on behalf of the health secretary) should be extremely limited. That is, purely to ensure that the technology is working properly. Any further access should be treated as a separate request for access.
Whether this is actually achieved is, I accept, difficult to fully assess.
When I think of someone calling a bit of software "a calculator", I think of the calculator program on my PC. I'm 100% positive that Microsoft doesn't store the details of every calculation I do using the calculator program and then link it up to any personal details they have on me. Why would they? So why is it necessary for TPP to store details about me because of their QRisk calculator? I must be missing something obvious here. All that is required for the calculator to work is a few numbers.
I am not convinced that TPP retain every step of the calculation. Seems quite possible they only store the end result.
I think that the QRisk calculator is only one tool within the patient management software system they offer. The majority of it being things like medical record storage.
Reasons to include more than just the result might include exactly what has happened. Perhaps the record actually contains something like:
QRisk gives 75% recommendation of prescribing statins based on <factors such as age, cholesterol, etc.> and using <version 9.1.0 of QRisk>.
By having that, untoward outcomes can relatively easily be identified and acted on.
On the other hand, I could be entirely wrong.
I forgive you HB for quoting from The Sun, my brother-in-law used to work for the paper but I told everyone he was with The Guardian!!!!!
If you ever find the answer to "Why" please share. Makes me wonder if they are putting together a black list of "awkward patients". Nothing would surprise me.
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