Harm from medication errors occurs in all countries of the world. Much
can be learned from the analysis of medication errors with the support of confidential,
non-punitive and independent reporting and learning systems. Countries and organisations
with these systems are better placed to protect patients, educate healthcare professionals
and support institutions to prevent medication errors and implement safer medication
practices. The participants of the meeting recognised:
that medication errors are an important system-based public
health issue and an integral component of the patient safety agenda;
that harm from medications arises from both adverse drug reactions and medication
errors; that although systems are in place to identify and manage harm
from adverse drug reactions, confidential, non-punitive and independent medication
error reporting and learning systems need to be introduced and significantly strengthened
at all levels of the healthcare system; that patients, healthcare workers
and health authorities in all countries are facing similar adverse outcomes arising
from common underlying causes of medication errors; that collaboration
must occur between countries and at all levels of the healthcare system, to share
learning from local, national and international reporting and learning systems,
identify unsafe conditions and support implementation of strategies that prevent
patient harm, that each country should recognize and establish an independent
focal point (centre) for safe medication practice in a collaborative, complementary,
yet distinct way from pharmacovigilance systems; that the patient's
interest receives the highest priority and, therefore, safe medication practice
centres and the error reporting and learning systems they represent, must strive
to be void of any conflicts that compromise the patient's interest. The
participants of the meeting unanimously agreed that health professionals, organisations,
health authorities and other stakeholders should consider the essential following
objectives and call for their achievement at a global level: Promoting
the empowerment of patients, by means of independent and unbiased education and
guidance, to be active participants in their own care. Updating of manufacturing
regulations to ensure that pre-market safety testing of product design features
becomes mandatory. Manufacturers should be required to subject their products
to human factors assessment and user testing, and a complete safety review of
the packaging, labelling and product nomenclature, prior to product approval.
Ensuring that when medication errors are reported to the manufacturers and regulatory
authorities, there is open disclosure, discussion and feedback regarding previous
similar incidents and error analysis to identify contributory factors, root causes,
and an action plan to prevent a recurrence. Ensuring that the above
considerations regarding mandatory user testing and safety evaluation prior to
authorisation are also applied to technology and medical devices used in the handling
or administration of medications. Supporting the dissemination and
implementation of medication-related patient safety solutions, especially those
developed by the WHO World Alliance for Patient Safety. Ensuring that
multidisciplinary policies and procedures governing the practice of clinical staff
involved in the medication use process are developed, implemented and audited
for relevance and compliance. Supporting safe medication practice centres
and establishing medication error reporting systems to communicate safety issues
to healthcare professionals and patients, and to advocate for safe practices at
all levels in the healthcare system. Promoting the incorporation of
safe medication practices in continuing education as well as in undergraduate
and postgraduate training for health professionals having responsibility for medicine
use. Committed to prevent medication errors and to contribute to safer care,
the participants pledge to work together as members of the International Network
of Safe Medication Practice Centres, to promote achievement of these essential
objectives, to encourage and further the development of safe medication practice
centres in all countries and to facilitate cooperation amongst them. This
declaration was signed by the following experts from the following countries: Australia:
Penny Thornton Brazil: Mario Borges, Tania Azevedo Canada: David U Denmark:
Annemarie Hellebeck France: Etienne Schmitt, Marie-France Gonzalvez Hong-Hong:
Anna Lee Ireland: Eileen Relihan, Anna Seoighe Israel: Zvi Levinhar Spain:
María José Otero Sweden: Anne Hiselius UK: David Cousins USA:
Michael Cohen ©La revue Prescrire 1er avril 2007 |