Thursday, May 26, 2016 by Greg White
The Medicines and healthcare products Regulatory Agency (MHRA) has launched an investigation into a computer glitch, which may have given or denied thousands of patients in England the cholesterol lowering drug, statins.
Pulse magazine reported that a bug in the SystmOne clinical IT software inaccurately assesses a number of patient’s risk for heart disease. As a result, some patients may have been prescribed statins who don’t actually need them.
Approximately 2.5 million people in the UK take statins. It is the first country to make statins available over the counter. The MHRA has notified GPs of errors in the SystmOne clinical IT software since 2009.
In February, the FDA issued a warning that statins can increase the risk for type 2 diabetes, memory loss, befuddlement and other cognitive issues.
Regulators emphasized only a limited number of patients were affected by the computer glitch and that no one should quit taking the medication without first consulting their doctor. Nevertheless, Pulse magazine reports that some GP’s have been issued lists of around 20 patients who should either be taken off or put on statins due to the miscalculations.
As the MHRA noted: “An investigation has been launched into a digital calculator used by some GPs to assess the potential risk of cardiovascular disease 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.”
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.”
Quoting from the Guardian, a spokesperson for the Royal College of GPs added: “Our patients trust the information and advice we give them about their health, so it is essential that the tools we use to inform this [are] accurate.”
“Our patients should be reassured that the MHRA has said that the risk to patients is low, but any error in the technology we use to inform the advice we give our patients is very serious.
“We look to the MHRA for more information about how many patients are affected, and how they propose to minimise any risk to their safety.
“With statins being such a controversial treatment, among both doctors and patients, the seriousness of this error is particularly pronounced. The decision to prescribe statins to patients is never taken lightly, and those who are prescribed them will undertake regular medication reviews.
“We would advise our patients who take statins, and those who have cardiovascular problems but don’t, not to panic as a result of this news. But if they are concerned, they should make a non-urgent appointment with their GP to discuss this.”