MHRA information on TPP and QRISK®2
- Medicines and Healthcare products Regulatory Agency
- First published:
- 12 May 2016
- Last updated:
- 9 June 2016, see all updates
The Medicines and Healthcare products Regulatory Agency (MHRA) investigated 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.
Read the alert that was sent to GP practices (PDF, 48.6KB, 1 page)
Update regarding TPP investigation
Following an investigation into the QRISK®2 Calculator in SystmOne run by TPP, code mapping errors were identified and as a precaution the tool was temporarily disabled. We can now confirm that the problem has been fixed. The 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.
As a result of this issue, patients may have received an incorrect QRISK2 score and this may have been overestimated or underestimated. The overall risk to the whole population of patients affected is low. GPs will contact patients who have had incorrect scores, identify those who may benefit from being reassessed and, if required, discuss different approaches individuals can take to reduce their risk of cardiovascular disease.
In the meantime patients should continue to take their prescribed medication. If they have any questions then we would advise they speak to a nurse or doctor at their next routine review.
Published: 12 May 2016
Updated: 9 June 2016
- Updated with results of the investigation.
- First published.