Monday, 30 July 2018

The slow progress of clinical safety, a problem of "many hands"

Cristina Roure


In this section we usually discuss overdiagnosis and overtreatment, but today we will talk about the difficulty in achieving safe care environments for patients.

Some will remember the publication in the year 2000 of the report “To err is human. Building a safer Health System” by the Institute of Medicine's Quality Care, which created a big impact in the media due to the alarming figures of deaths caused by medical errors in the USA. (1). Since then, a lot of work has been done in order to improve patient safety, and a lot of progress has been made for the dissemination of the clinical safety culture, and a great deal of effort and resources have been devoted to the implementation of safe practices for reducing the risk of medical errors.

However, the evidence concerning the real impact that these practices have globally on the incidence of adverse events in patients is scarce and imperfect. Once again, successes achieved by specific interventions at the local level are not always reproduced when attempts are made to generalize them. Thus, for example, the mandatory adoption of surgical safety checklists in 101 hospitals in Ontario in 2014 (2) failed to reproduce any of the spectacular results obtained previously by the Safe Surgery Saves Lives study, with almost 8,000 patients and promoted by the WHO, which in 2009 had shown significant reductions in mortality and surgical complications in eight hospitals with very different characteristics from around the world (3).

Why is it so difficult to accomplish the safety achievements of other sectors, such as aviation or the nuclear industry, when we apply their methods to health care? Peter Pronovost, precursor of the "zero bacteraemia" programs, and Professor Mary Dixon-Woods dedicate an article in the series "The problem with ..." of the BMJ Quality and Safety to answer this question (4). The authors explain that clinical safety is one of those problems that in the politico-social field are known as a "problem of many hands". The concept applies to problems as diverse as climate change or the economic crisis of 2008, and now to patient safety. All of them share a context in which multiple actors (organizations, groups and individuals) collectively contribute to a result, but none of them is directly responsible for it individually.

The health system is a paradigmatic example of the problem of "many hands" because it’s a fragmented system involving a multitude of interdependent but at the same time autonomous agents such as regulatory agencies, health organizations, insurance companies, technology, software, medicines or health products providers, professionals of various levels of care, associations of patients or professionals, etc. The system has a "spontaneous and natural" operation in which each agent acts according to their own objectives and interests. The network is not the result of a previous design with a shared objective, so that despite the isolated actions to reduce the risk in the patients of each of the multiple actors, the overall result on safety is poor.

If you are interested in the subject and have 20 minutes, I recommend that you listen to Professor Mary Dixon-Woods, it will help you better understand the difficulties and challenges of patient safety.





However, the health system is not unique. The sectors that have inspired us, such as aviation, the nuclear industry or the petrochemical industry, share these challenges but have made progress, and have done so through coordination mechanisms at the sector level, establishing universal safety standards and international, not local, legal requirements. Does anyone think that each manufacturer decides on the possibility of installing or not seat belts in vehicles? Or that each airline decides if it implements a safety checklist at takeoff or landing?

Let's consider the example of medicines called Look-alike and Sound-alike or LASA drugs, which have similar names or appearance for corporate reasons, and which are involved in one in every thousand dispensations and one in every thousand prescriptions which lead to sometimes fatal, errors. Each health agent looks for mechanisms to manage this problem on a local scale, through flashy re-labelling (also subject to error) or through the so-called Tall man lettering, which helps us differentiate, for example, levoTIRoxina from levoFLOXacina. The evidence on the effectiveness of this type of local post-marketing strategies is, once again, inconclusive (5). Wouldn’t it be more effective for the pharmaceutical industry to establish international safety standards in naming the medicines and the regulatory authorities to define guidelines that would prevent the pharmaceutical industry from prioritizing their brand image over patient’s safety?

Charging the responsibility of facing the challenges of patient safety exclusively to individual health organizations can have the same result as for many years had charging the responsibility of a medical error on the professional involved and not in the security deficits of the system: a slow collective advance and a high frustration risk.


Bibliography

  1. Kohn, L.T.; Corrigan, J.M.; Donaldson, M.S.; editors. To err is human: building a safer health system. Washington DC: National Academy Press, Institute of Medicine; 1999.
  2. Urbach, D.; Govindarajan, A.; Saskin, R.; Wilton, A.; Baxter, N. Introduction of Surgical Safety Checklists in Ontario, Canada. N. Engl. J. Med. 2014; 370:1029-1038.
  3. Haynes, A. et al, Safe Surgery Saves Lives Study Group. A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population. N Engl. J. Med. 2009; 360:491-499.
  4. Dixon-Woods, M.; Pronovost, P. Patient safety and the problem of many hands. BMJ Qual Saf 2016; 25: 485-8. 
  5. Lambert B.L.; Schroeder S.R.; Galanter W.L. Does Tall Man lettering prevent drug name confusion errors? Incomplete and conflicting evidence suggest need for definitive study BMJ Qual Saf 2016; 25:213-217.

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