MHRA investigates problems with cardiovascular risk calculator used in GP practices

Medicines and Healthcare Products Regulatory Agency

An urgent investigation has been launched by the UK medicines safety regulator to discover how many patients have been given the wrong information about their risk of cardiovascular disease following a computer error with an assessment tool.

The Medicines and Healthcare products Regulatory Agency (MHRA) says it is working closely with the software company TPP to discover why the problem arose and how many patients have been given an incorrect result.

The error applies to the QRISK2 calculator run through TPP’s SystmOne, a clinical software system used by GP practices, according to a MHRA spokesperson who confirmed an investigation was under way. The calculator is a predictive algorithm used to assess the potential risk of cardiovascular disease in patients. A problem with the calculator has resulted in the risk being under or overstated in a proportion of patients.

“We have advised GPs to not use the QRISK2 Calculator option until further notice. If necessary, GPs can use the QRISK2 Calculator on the www.qrisk.org website, which is not affected by this issue,” the MHRA spokesperson says. “The MHRA is working closely with TPP as a matter of urgency to make sure the identified issue is resolved and that affected patients are identified.”

The MHRA says the risk to patients is low and, pending the outcome of the investigation, is advising patients to take their medicines as prescribed.

Last updated
Citation
The Pharmaceutical Journal, May 2016;Online:DOI:10.1211/PJ.2016.20201174