Thousands of patients may have been wrongly put on statins, while others at high risk of heart attacks have been advised against the drugs in error, following a major NHS blunder.
Medicines regulators have issued an alert to 2,500 GP practices, warning them that computer tools which assess patients’ risk of heart disease have been hit by glitches.
The errors, in the system used by one in three practices, mean that patients with little risk of heart disease may have been needlessly prescribed the cholesterol-lowering drugs, while those in grave danger of heart attacks were not offered the medication.
The Medicines and Healthcare Regulator Agency (MHRA) has launched an investigation into the failings affecting software which has been in use since 2009.
Urging GPs not to use the system, until errors are fixed, it said the problems meant that risks of heart disease could have been “under or overstated”.
The regulator said it believed a “limited” number of patients were affected, and said no one should come off medication without speaking to their doctor.
But Pulse magazine has been told that some GPs have been sent lists of around 20 patients who should either be put on statins, or taken off them, because of the miscalculations.
Current NHS advice is that anyone with a 10 per cent chance of cardiovascular disease within the next decade should be advised to take the cholesterol-busting medication.
Such scores are calculated using software which takes account of factors such as blood pressure, weight, health problems and family medical history.
The MHRA has now ordered GPs to contact patients affected by a glitch in the QRISK2 digital calculator provided by UK IT company TPP.
An MHRA spokesperson said: “An investigation has been launched into a digital calculator used by some GPs to assess the potential risk of cardiovascular disease (CVD) in patients.
“We are working closely with the company responsible for the software to establish the problem and address any issues identified.
“Clinical advice 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.”
Deputy chair of the GPC’s IT subcommittee Dr Grant Ingrams said the problem was significant.
He said: “It affects everyone who has had a QRISK, and SystmOne are sending out messages to say ‘look at these patients’. But then you have to see if the change is significant, and whether you would have made a different decision at the time, or put them on a different treatment”.
Dr Ingrams said: “There’s potential harm both ways…What happens when a patient who had been of a high risk and this hadn’t been identified and they’ve now had a stroke or heart attack?
“Similarly if someone had a low risk and they’ve been put on a statin and had a side-effect who’s responsible? That’s the clinical risk.”
Dr William Beeby deputy chair of the GPC’s clinical and prescribing subcommittee, said the glitch “certainly had the potential to impact on patient confidence”.
He told Pulse magazine: “If you do hear that an assessment tool your doctor uses is incorrect then of course people are going to either stop their statins or they’re going to contact you and ask what their real risk is?
“It’s the tool we’ve been told to use. So if the tool is inaccurate, then you start to lose confidence and the doctors will then lose confidence as well.”
A TPP spokesperson said: “TPP is dealing with the Clinical Safety Incident involving the QRISK2 Calculator in SystmOne. The tool is intended to support GPs in assessing patients at risk of developing cardiovascular disease and in developing treatment plans. The QRISK2 Calculator is presented within SystmOne as an advisory tool.
“We are actively working to ensure the issues identified are addressed and to ensure that clinicians are informed of any patients that may have been affected as soon as possible.”
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