Salamanca Declaration To Promote Safe Medication Practices Globally
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 error-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 first meeting of the International Network of Safe Medication Practice Centres was held in Salamanca, Spain, November 17-19, 2006.
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 harmthat 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 for 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 co-operation amongst them.
This declaration was signed by the following experts from the following countries:
|Brazil:||Mario Borges, Tania Azevedo|
|France:||Etienne Schmitt & Marie-France Gonzalvez|
|Ireland:||Eileen Relihan & Anna Seoighem|
|Spain:||María José Otero|