13 May 2016
The Medicines and Healthcare products Regulatory Agency (MHRA) has been made aware of an issue with a digital calculator used by some GPs to assess the potential risk of cardiovascular disease (CVD) in patients, which has resulted in incorrect results for some patients.
The QRISK2 Calculator in SystmOne (supplied by the company TPP) is a predictive algorithm used by healthcare professionals, mainly GPs, to help assess the potential risk of heart disease in patients. The issue with the calculator has resulted in incorrect results being produced for some patients. For affected patients, the potential risk of heart disease could have been under or overstated.
GPs running TPP in their practice have been requested not to use the QRISK®2 Calculator option until further notice. If necessary, theQRISK®2-2016 Calculatorcan be used instead.
MHRA is working with TPP as a matter of urgency to make sure the identified issue is resolved and that any affected patients are identified.
TPP will be in communication with practices to inform them of any patients who may be affected. Clinical advice received by MHRA indicates the risk to individual patients is small and affects a limited group of patients. These patients should be re-evaluated at their next routine appointment.