Following a statement issued by the MHRA, an investigation has been launched into how a digital calculator (QRISK2) used by GPs to assess the potential risk of cardiovascular disease, has resulted in incorrect risk estimation scores being calculated. The SystemOne’s version of the QRISK2 calculator is used in more than 2,500 practices across the country and it is now thought that incorrect scores could have been determined for potentially hundreds of thousands of patients, dating as far back as 2009.
The MHRA confirmed that it was only the interaction between QRisk2 and SystemOne that have caused the alert and this must be reiterated to patients when concerns are being raised. Having said that, this is a major system error, one that could potentially result in a loss of confidence in the tool and one that could create a lot of additional work to already excessive GP workloads.
The risk to patients can vary and includes:
– Thousands of patients may have been prescribed statins when they are not indicated.
– Patients who should not be on statins may suffer unnecessary side effects from being on them.
– Patients may choose to stop their statins because of a loss of confidence in the decision making process. This may cause cholesterol to return to dangerously high levels in just a few weeks.
– The risk of a cardiovascular event from not being on a statin, when in actual fact one should have been commenced.
The numbers of patients affected by use of the tool are thought to be low because this is a tool to aid to clinical decision making. Therefore, the hope is that only a small number of patients will require changes to their CVD management plan. If only one patient is affected by a software system error this, however is one patient too many. GPs and the company that manufactures the SystemOne software system, TTP, are therefore working frantically to enable practices to identify patients to ensure that they receive accurate risk estimation scores and treatment where necessary is altered accordingly.
TTP have temporarily, but only recently suspended the use of their tool until the glitches within the system have been identified. The MHRA are working closely with the company to get to the root cause of the problem. One thing is certain, it is going to take a lot of time and reassurance from TTP before many GPs find confidence in this particular brand of the tool, especially in the face of so many other competitors whose end product is much more reliable. In the meantime GPs are advised that if it is necessary to use an algorithm to assess a patients risk then QRISK2 is available at www.qrisk.org