Though comprehensive figures are difficult to obtain for Europe as a whole, national surveys suggest that the incidence of 'Adverse drug events' (ADEs) is around the same level as in the United States. US data shows that serious mistakes occur in one out of every 10 hospital admissions, 60 percent of them involving medications - and that does not take into account prescriptions given by doctors outside of hospitals. In effect, patients seeking treatment for a disease frequently run the risk of inadvertently being given drugs that may have dangerous side effects or cause other healthcare problems or even death.
'ADEs are a major problem around the world. The wrong types of drugs may be prescribed, the incorrect dosages given, drug interactions overlooked… and, most alarmingly, the vast majority of ADEs go undetected: often doctors simply don't realise that the drugs the patient is taking are causing them problems,' says Régis Beuscart, a professor at the Centre Hospitalier Regional et Universitaire de Lille in France.
Prof. Beuscart coordinated the 'Patient safety through intelligent procedures in medication' (PSIP) project, leading a team of researchers from across Europe who developed innovative technologies to help doctors prescribe the right drugs based on patients' personal medical histories, the effects and side-effects of the drugs and other situation-specific factors. Their software system, developed with EUR 7.27 million in funding from the European Commission and currently in use in hospitals in Bulgaria, Denmark and France, promises to reduce the incidence of ADEs by as much as 20 percent, potentially saving thousands of lives every year.
Due to the lack of comprehensive, standardised description of ADEs, the researchers at first built a taxonomy to describe the characteristics of ADEs observed in hospitals. This taxonomy is available on the PSIP website.
To determine the frequency of occurrence of ADEs in the participating hospitals, they used data and semantic mining techniques in a set of 105,000 medical records. Strictly anonymised to protect patients' privacy and converted to a common data model, the information enabled the researchers to identify real cases where patients had suffered adverse effects from being administered the incorrect drug or combination of drugs. They looked not only at the known drug interactions and the condition being treated but, most importantly, at the patient's other existing medical conditions and risk factors, such as age and medical history. They then employed statistical analysis to define characteristics for 56 common Adverse Drug Events identified through a set of 236 rules.
Using the set of rules, the team developed a software decision-support system using so-called ADE Scorecards for healthcare professions, including doctors, nurses and pharmacists, to warn them on a case-by-case basis of the potential risks of prescribing or administering certain drugs to specific patients.
By inputting the patient's data, diagnosis, and drug information, the scorecard system warns the doctor, for example, not to place a patient at high risk of developing gastric disorders such as ulcers under pain killers involving Non-Steroidal Anti-Inflammatory Drugs after undergoing surgery. Such a treatment is fine for most patients, but all too often such drugs are also administered to people at risk of developing stomach ulcers, leading to additional health complications and even death from internal haemorrhaging.
Elderly at greatest risk
'The problem is particularly acute among elderly patients and people with multiple health problems,' Prof. Beuscart notes. 'Some people, elderly patients in particular, may be taking as many as 10 or 20 different types of medications - it is impossible for a doctor to know by themselves all of the possible interactions between the drugs and how they will interact individually and in combination with the patient's different conditions.'
In a series of trials that led to ongoing use of the system at hospitals in Bulgaria, Denmark and France, it showed an accuracy of 50 percent in detecting potential ADEs, far higher than other methods used to date.
'Once we showed them that the system could detect the risk of ADEs in patients who already had ADEs that were going undetected, the response from healthcare workers to the system was overwhelmingly positive,' the project coordinator says. 'I'm a physician and I know how reluctant healthcare professionals can be to adopting new technology, but many were surprised by the results.'
The project team designed the software with a user-centred focus and web-based interface, ensuring that it fits into the working procedures of healthcare professionals and can be easily integrated with hospitals' existing information systems. The researchers worked closely with healthcare professionals, conducting focus groups, design games, and critique workshops to try to match the system to users' expectations and preferences as much as possible.
The ease of integration was highlighted particularly in Bulgaria. The system was integrated with the hospital information system at the University Specialised Hospital for Active Treatment of Endocrinology (USHATE) in less than six months, despite needing to adapt the interface to the Cyrillic script of the Bulgarian language. Implementation was aided by the fact that at USHATE's hospital information system was developed in-house without recourse to proprietary software from third companies.
'This allowed tight integration of the system, whereas in the other trials it had to be more loosely coupled because the hospitals use third-party software,' Prof. Beuscart explains.
A prototype version is still being used by the Bulgarian hospital, and will also be introduced in a hospital in neighbouring Greece in the near future. Meanwhile, the PSIP system is also continuing to be used in Denmark and will be extended to additional hospitals in France over the coming months.
'Several companies have expressed interest in using what we have developed in their hospital information systems and we are working with a couple of companies in France to develop commercial software based on the results of the PSIP project,' he explains.
In addition to saving lives and improving patient care, the PSIP technology also promises to save money for hospitals and healthcare systems. One implementation scenario estimates that the PSIP ADE Scorecards application could lead to an improvement in the prevention of ADEs by three percent per year over five years. Given that three common ADEs (hyperkalaemia, renal insufficiency and coagulation disorders) increase a patient's stay in hospital by 5.3 days at a cost of EUR 4,500 on average, the system, if installed in hospitals across Europe, would save millions of euros per year.
With Europe's population aging and people taking ever-increasing numbers of drugs to treat diseases associated with old age and maintain their quality of life, the risk of ADEs will only increase in the future. The technology developed in the PSIP project, if implemented widely, promises to counter that trend.
PSIP received research funding under the EU's Seventh Framework Programme.