http://ec.europa.eu/comm/health/ph_information/dissemination/hsis/hsis_15_en.htm

Adverse events in health care


*The extent of the problem*

Health care is not as safe as it should be. Adverse events are a major
cause of harm to patients. A substantial body of evidence points to
medical errors as a relevant cause of death and injury. Studies in
different countries (e.g. The Harvard Medical Practice Study
<http://qhc.bmjjournals.com/cgi/reprint/13/2/151>, Epidemiology of
medical error
<http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1117772>)
estimates that around 10-16% of hospitalized patients experience an
adverse event related to clinical care, with a mortality rate in these
patients of 5-8%. Adverse events are now widely recognized as a health
systems problem: adverse events affecting individual patients are
usually caused by a sequence of events in the macro -and micro-
environment that involve deficiencies in the structure and organization
of health care, and are not simply a consequence of human error by the
responsible health professional who may be the final link in the
treatment chain.


*EU action on patient´s safety*

In October 2004, the WHO launched the World Alliance for Patient Safety
<http://www.who.int/patientsafety/en/> in response to a World Health
Assembly Resolution (2002) urging WHO and Member States to pay the
closest possible attention to the problem of patient safety. A topic
chosen by the European Commission for the first Global Patient Safety
Challenge <http://www.who.int/patientsafety/challenge/en/> covering 2005
and 2006 was health care-associated infections
<http://ec.europa.eu/comm/health/ph_threats/com/comm_diseases_cons01_en.htm>.

In the same framework, the 2005 Luxembourg Council Presidency adopted
the Luxembourg Declaration on Patient Safety
<http://ec.europa.eu/comm/health/ph_overview/Documents/ev_20050405_rd01_en.pdf>
which recognizes that access to high quality healthcare is a key human
right valued by the EU and the continuous improvement of the quality of
care is a key objective both for patient safety and for efficient
management of health systems. The European Commission aims to improve
patient safety through exchange of information and expertise in line
with the April 2005 "Luxembourg Declaration on Patient Safety" which
provides several recommendations in this field.

On line with these recommendations, a Working Group on Patient Safety
bringing together 24 Member States and representatives of the civil
society has been established, by the High Level Group of health services
and medical care
<http://ec.europa.eu/comm/health/ph_overview/keydocs_overview_en.htm>,
to identify the key patient safety areas where European level
collaboration and coordination of activities could bring added value.
The Working Group is chaired by Sir Liam Donaldson (UK) and Dr Robida
(Slovenia).

Today, the thinking on the safety of patients places the prime
responsibility for adverse events on deficiencies in system design and
organization, not on individual health professionals or products. A
comprehensive approach is essential to enhance the safety of patients by
preventing adverse events, making them visible and mitigating their
effects when they occur.

There is considerable scope for collaboration in ensuring that patient
safety is a priority healthcare issue for all Member States and to
design and implement effective, national patient safety programmes.
Furthermore, as people move more freely across borders, they expect that
the care they receive in any EU Member State meets the same level of
safety and quality.

Moreover, there is large amount of experience and knowledge on patient
safety in the Member States as well as globally. In order to add value
for European level activities in this field, the working group on
patient safety has involved key stakeholders in its work to avoid
duplication of efforts and to achieve effective synergies. The World
Health Organization (especially the World Alliance on Patient Safety),
the Council of Europe and the Organisation for Economic Co-operation and
Development (OECD) <http://www.oecd.org/dataoecd/53/26/33878001.pdf> as
well as European associations for patients (EPF), doctors (CPME), nurses
(EFN), pharmacists (PGEU) and hospitals (HOPE) are actively involved in
the Working Group on Patient Safety. It is essential that the main
players collaborate and coordinate their work in this area to ensure
highest level of patient safety and quality of care at the European level.

In 2006, the Working Group on Patient Safety will have two main strands
of work. Firstly, to make progress in the priority areas, technical
proposals for action will be developed in the working group to
strengthen sharing of information and experiences on adverse events
between EU Member States. In addition, European level action on
reporting and learning systems on adverse events will be a focus of the
technical work.

Secondly, as there are a wide range of issues linked to patient safety,
the working group will also consider ways to develop a strategic
approach on patient safety at the European level.


*The 2005 Eurobarometer survey on medical errors*

The impact of some adverse events in the media and public opinion cannot
be ignored. To know the extent of the problem constitutes a first step
for an institutional response. For this reason the Commission has
carried out, for the first time, a survey on the perception of medical
errors in the European Union. The poll also covers the pre-accession and
candidate countries and the Turkish Cypriot Community.

The European Commission has published in 2006 the results of a
Eurobarometer survey on the perception of medical errors by Europeans
<http://ec.europa.eu/comm/health/ph_publication/eurobarometers_en.htm>.
Almost 4 in 5 EU citizens (78%) classify medical errors as an important
problem in their country. 38% of respondents rank the issue as very
important and a slightly higher share (40%) sees the topic as fairly
important. According to the poll 23% of Europeans say they or their
family has been the victim of a medical error; 18% say this happened in
a hospital, while 11% say they have been prescribed the wrong medication.

o *Medical errors perceived as a prominent problem in Europe*
In Italy (97%), Poland (91%) and Lithuania (90%), at least 9 in 10
respondents perceive the problem as important. The respective shares of
those evaluating the problem as very important reach 61% in Italy, 54%
in Poland and 50% in Lithuania. Citizens of Southern Europe and new
Member States around the Baltic Sea appear to be somewhat more concerned
about the safety of hospital patients while citizens of Western Europe,
in particular of the Nordic Member States, seem to have more confidence
in their healthcare system. 23% of Europeans state they have been
directly affected by a medical error personally or in the family. 18%
indicate that they or their family members have experienced a serious
medical error in a hospital whereas 11% claim to have been prescribed
wrong medication.

o *Incidents in hospitals*
In general, incidents in hospitals appear to be more common than
incidents of unsuitable medication. The highest numbers of incidents
experienced in hospitals are found in Latvia (32%), Denmark (29%) and
Poland (28%) while errors in the medicament prescribed by a doctor are
the most frequent again in Latvia (23%) and Denmark (21%) but also in
Estonia and Malta (18% each). Austria tops the ranking having both the
fewest medical errors in hospitals (11%) and in medical prescriptions
(7%). Incidents are reported to be fairly rare also in Germany and Hungary.

o* Over half of Europeans believe they cannot avoid serious medical
errors in hospitals*
Most respondents (51%) think that it is not likely that they as hospital
patients have an influence on medical decisions affecting them, out of
which 16% believe that it is outright impossible.

o *Europeans trust health professionals but....*
Most EU citizens trust medical professionals not to make a mistake while
treating their patients. Dentists are appreciated with the most
confidence as almost 3 in 4 respondents (74%) trust them. 69% have faith
in doctors and 68% in other medical staff. However, a significant share
of respondents has doubts about the quality of health care provided by
these professional groups. The proportions are respectively: 29% about
doctors, 23% about dentists and 30% not feeling confident about `other
medical staff´. This can be seen to imply that the trust in the
functioning of health care systems could be improved.

The intention of the Commission is to carry out a first analysis based
on citizens´ perception of medical errors and to integrate the results
of this Eurobarometer (prepared with the cooperation of the London
School of Economics) to the work of the patient safety working group and
also possible other areas.


*How to measure errors and adverse events in health care?*

The Center for Clinical Research and Evidence Based Medicine at The
University of Texas developed a paper `Measuring errors and adverse
events in health care
<http://www.blackwell-synergy.com/doi/abs/10.1046/j.1525-1497.2003.20147.x>´
identifying 8 methods used to measure errors and adverse events in
health care and discussing their strengths and weaknesses. The paper
focuses on the reliability and validity of each, as well as the ability
to detect latent errors (or system errors) versus active errors and
adverse events. Proposes a general framework to help health care
providers, researchers, and administrators to choose the most
appropriate methods to meet their patient safety measurement goals.

The British Medical Journal has published a paper on `Detecting and
reporting medical errors: why the dilemma?
<http://bmj.bmjjournals.com/cgi/reprint/320/7237/794>´ Detection and
prevention of errors are obvious goals for any organisation; however
medicine's approach to error has been limited and inadequate.
Motivational factors, both real and perceived, that influence how errors
in medicine are handled must be identified, discussed, and changed if
the patient safety is to succeed.