European Alliance for Access to Safe Medicines
EAASM
The EAASM will strive to ensure that patients within the EU are aware of falsified and substandard medicines and unsafe medical practices and that national governments have put in place mechanisms to protect the population.
ID: 861368611058-84
Lobbying Activity
Meeting with Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)
30 May 2022 · Nano-medicines and EU regulatory Framework.
Response to Evaluation and revision of the general pharmaceutical legislation
26 Apr 2021
The European Alliance for Access to Safe Medicines (EAASM) welcomes the revision of the EU general pharmaceuticals legislation and with a view to protect patient safety and enhance scientific and technological developments in Europe, it is firmly resolved to significantly reduce medication errors and promote, at European and national levels, the implementation of comprehensive electronic traceability systems in hospital settings.
In line with the Commission’s vision to build a stronger European Health Union, in which all EU countries prepare and respond together to public health challenges, the EAASM calls for the implementation of comprehensive electronic traceability systems in the hospital settings at both European and national levels, to significantly reduce medication errors and protect patient safety. This is key to enable innovation and harness the benefits of digital and emerging science and medical technology, and to enhance the security of supply of medicines and address shortages.
Medication errors are a common cause of harm to patients in acute care settings and can include prescribing, preparation, dispensing and administration mistakes. These errors can lead to no harm, minor harm, ranging to major errors which can result in morbidity, mortality and poor quality of life for the patient. This can lead to lack of efficacy of medication, suboptimal patient adherence and poor patient experience. In turn, these may have significant health and economic consequences, including the increased use of health services, preventable medication-related hospital admissions and death. High workloads and lack of health care personnel contribute to 23% of medication errors.
The main victims of medication errors are the patients who are harmed and their families. The second victims are the caregivers and staff who sustain complex psychological harm when they have been involved in errors that harm patients while caring for them.
In the UK, a 2017 study in the English NHS quantified 237 million medication errors in one year, 21.3% in prescription, 15.9% in dispensing and 54.4% in administration. The WHO estimates the annual cost of medication errors at $42 billion USD annually.
But according to the WHO, all medication errors are potentially preventable.
In Spain, 42.8% of adverse effects are deemed preventable. The solution is available and affordable. As a result of the burden of medication errors in acute care setting across European countries and in line with the WHO initiative “The Third Global Patient Safety Challenge: Medication Without Harm”, the EAASM has decided to launch a major European patient safety project.
The European Collaborative Action on Medication Errors and Traceability (ECAMET) is a patient safety initiative developed by a group of health professionals and stakeholders, working together to tackle the issue of medication errors through the implementation of a Pan-European survey which will act as a catalyst to identify best practices and thus stimulate innovation in the hospital setting via proven digital processes and internal dynamic behavioural changes.
The role of medication traceability in preventing medication errors in acute care settings is critical. Medication traceability includes the following concepts:
• Automated storage and electronic dispensing cabinets systems
• e-Prescription and e-preparation systems
• Electronic scanning systems, such as barcoded medication administration (BCMA)
• Smart pumps
• Full connectivity of systems in the acute care setting
The revision of the general pharmaceutical legislation provides the opportunity for putting patient safety at the heart of the EU health policy scene and for implementing comprehensive electronic traceability systems in the hospital settings at both European and national levels, key to significantly reduce medication errors.
Please visit the ECAMET website www.ecamet.eu. to learn more about the Alliance members and ongoing activities.
Read full responseResponse to Pharmaceutical Strategy - Timely patient access to affordable medicines
7 Jul 2020
The European Alliance for Access to Safe Medicines (EAASM) is an independent, pan-European, non-profit organisation dedicated to protecting patient safety by ensuring access to safe and legitimate medicines. The EAASM champions the fight against falsified medicines as well significant patient safety initiatives to enhance medication error safety, compounding practices, unlicensed/off-label usage of medicines and the field of nanomedicines to help ensure patient safety and well being across Europe.
On behalf of the EAASM, we would like to underline the need for action that will enhance patient safety in three main areas:
1. The need for a robust regulatory framework for nanomedicines and nanosimilars
Currently no specific, robust nor overarching regulatory framework designed for nanomedicines exists and strong regional differences still remain in Europe. The EAASM believes that it is the right time to set the scene for building a consensus so that this regulatory weakness can be addressed and thus provide the highest quality medicines with safety, efficacy and quality attributes. This not only applies to existing medicines but the plethora of new medicines that are in the pipeline.
Even with existing licensed nanosimilars there is a question mark over the capability of the regulatory framework to adequately assess copies once the patent of the originator medicines has expired. There is evidence that such ‘follow-on’ products do not deliver the same efficacy and safety. Within this context, a centralised regulatory process is needed.
In collaboration with other European associations, the EAASM is calling upon the European Commission and Member States’ health authorities and regulatory bodies to address unmet medical needs and enhance quality, safety and efficacy of nanomedicines and nanosimilars by addressing patient safety issues due to significant regulatory challenges across Europe.
2. The need for digital medication traceability systems within the hospital environment
According to the WHO, medication errors occur when unreliable medication systems and/or human factors such as fatigue and lack of health care workers affect the practice of prescribing, dispensing, administering and monitoring medication. The most frequent errors occur during the medication administration phase in hospitals. High workloads and lack of health care personnel contribute to 23% of medication errors. Despite the lack of consolidated data of medication errors at the European Union level, according to the European Medicines Agency the medication-error rate in the hospital setting varies from between 0.3% and 9.1% at prescription initiation and between 1.6% and 2.1% at the dispensing stage.
The EAASM believes that patient safety would be greatly enhanced with digital technology traceability solutions and further education of health care professionals. Modern software technology enables systems that guarantee the traceability of medication in hospitals to prevent errors, including among others: automated storage and electronic dispensing cabinets systems, electronic prescription (CPOE) systems, electronic preparation systems, bar-coded single-dose systems, bar-coded medication administration systems (BCMA) and smart medication administration pumps, connected if possible to BCMA and prescription systems.
3. The need for stricter control of compounding in hospitals to ensure patient safety
A recent EAASM scientific publication has revealed that patient harm has occurred when compounding takes place in hospitals.
It also makes recommendations such as
1. Stricter regulation is necessary to prevent similar cases from occurring in the future as the European market for compounded medications grows;
2. A pan-European survey to gain greater understanding of compounding procedures and techniques. This would provide valuable information to the benefit of hospital systems and their patients.
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