Let me tell you about this joint session between ESMO and EONS considering patient safety. The idea, of course, is that all healthcare professionals, as we are, are concerned with the huge problem that we face in securing patient safety. This is an ethical necessity and it is also a financial obligation. Patient harm is considered, according to a recent OECD survey and report, the fourteenth disease burden worldwide, this is comparable with tuberculosis and malaria. It has been in 2012 the fifth cause of death in the United States according to the Centre for Disease Control after cardiac disease, COPD, cancer and stroke. This comes with amounts of loss, of financial losses, which are beyond the imagination. It seems that, again according to American studies, loss in one year exceeds or comes close to one trillion dollars. So we clearly have to tackle this problem and we have to tackle it on different levels and this symposium was supposed to give, and gave, a great perception of the layers of intervention in assuring patient safety.
There is a necessity of changes on multiple levels. Of course every single individual healthcare provider has to assure that his patient is safely treated. But it is clear since ten, fifteen years, and since a publication which brought to public the extent of the problem of errors, of medical errors, that was a report from the Institute of Medicine called To Err is Human in 2000, it is clear that the main problems in patient safety are system errors and are not linked to one person but to a dysfunctional system. That means that we can’t just tackle the problem by trying to pick out the bad apples, we have to have a more broader approach which has still to involve every individual because if every individual will say, ‘Well, it’s not me, it’s the system,’ it won’t work. But beyond that we need structures which can detect errors and we need structures which will provide campaigns, which will give accreditation and which will oversee the whole project of patient safety.
This is a major effort on many layers, if you’re going that way, let’s go back to the individual. So every individual will have to try to make his best to treat in a most professional and transparent way. And every individual should have the opportunity, the moral necessity but also the opportunity, to freely report mistakes. To do that it has, to some degree, be tolerated and accepted and if he’s going to be immediately put on trial or be the bad apple he won’t report it. So there has to be a kind of confidential system of reporting errors; these errors have to be analysed, they have to be then put transparently to the patient and his family, they have a right to know that something went wrong, and they have to lead to an amendment to change, to progress, which will certify that this kind of error will less, or better not, happen anymore again.
That’s a complex procedure and it requires that both we change our state of mind in which always one single person is responsible but this person will still have to be responsible, ethically speaking, to do the best job he can.
When it comes to involvement you’ve mentioned people working through large systems. Does that include all the large stakeholders that we’ve been getting acquainted with at this year’s ESMO? With patient advocates, with pharma representatives, with clinicians from, like you say, all these different layers throughout, all coming together?
Most certainly. You can say that there is a responsibility of a politician to ensure that accreditation, including safety, is put into place. That campaigns which reach out, prevention campaigns, are properly being done. There is an obligation for the medical director to ensure that he has an open safety culture, a friendly safety culture, which will enable him to pick out, to identify, the errors, the system errors. And then have consequent management of the conclusions of this. There has to be a legislation. So at every single place and let’s go, ‘Yes, certainly we have as the Society for Medical Oncology, from my personal point of view, an obligation to do our best to provide education, to provide guidelines, to provide standards to ensure patient safety.’ This, by the way, was one of the contributors - the presentation of guidelines considering chemotherapy extravasation. Here we are on the clinical level of the multi-layer cake, if you want to put it, of management of patient safety. There are still too many accidents with very irritating or harmful necrotising agents being used to treat our patients and these guidelines are supposed to help in a very pragmatic way and a very simple way our clinicians to ensure that utmost harm is prevented.
How are we able to resolve this tremendous rush towards new therapies being brought out and new trials and new trial formats with, like you say, this basic grounding that there are some very fundamental mistakes that come down to human error that require a complete tidal change in terms of attitudes towards practice and research? Is it not exceeding our grasp in some ways?
I’m not sure that I would put this in the same basket. I do agree with you that we have an ever-quicker changing landscape with new drugs, with new formats to study these drugs, to put them into practice. This may rather be a problem for the community oncologists who are suddenly faced with drugs which have completed their trials which are out there and for which they may lack the necessary routine and the necessary know-how of handling.
I do think that in trials you have a very well-structured management, you even probably have a better management of patient safety than in off-trial situations. It makes me think of the second presentation I had in compliance to oral treatments. There is a meta-analysis on non-oncologic drugs which shows that even if you are adhering to a placebo you have an overall survival benefit and that’s probably because you are better checked while you are on study and while you are taking your placebo. No, I think the problem you mentioned I would agree with is the fact that we have an explosion of new drugs which are already put into practice which are out there and for which we, to some degree, lack standardised recommendations for follow-up, for delivery and probably routine in prescription.
By way of summary or conclusion, what would you say would be the best way for clinicians and committee members to stay up to date with the latest in ethical guidelines for safety for what can be best achieved? Or what’s the best way for them to be as up to date as they can and to ensure that safety for their patients?
I would again say that the ethical values or the background for patient safety are pretty clear. What may not be clear, depending on the country or the environment you live in, is whether they have been put into place in a way which enables you to clearly analyse these. So it is clear that every one of us should try already to find out whether there is no safety institution in these hospitals. I wouldn’t be surprised that a lot of my colleagues are not truly knowledgeable about that and I also think that there is a need for true proactive collaboration together. Many of us in the past, including me, have considered these institutions, these patient safety departments, rather cumbersome or bothersome and we need to work together, we have to. To keep up to date, well the best… one of the origins of patient harm is lack of education in itself. So you have to remain up to date; ESMO provides excellent services together also with other, of course, societies in educating oncologists to keep up to date, to keep to standards. The regular use of our guidelines and of our expert recommendations are paramount in safely applying the right decisions in treatment. You probably, apart from that, have to open up your notebook every day and have a look what’s new and check your knowledge and re-check them again and again.
