MEDICATION AND PATIENT HARM
The United States National Coordinating Council for Medication Error Reporting and Prevention defines a medication error as: “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing, order communication, product labelling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use”.(2)
Medication errors are a common cause of harm to patients in acute care settings. They cause the highest adverse events in hospitals, not only in terms of number, but as well in morbidity and mortality.(3)
It has been estimated that in some countries approximately 6-7% of hospital admissions appear to be medication related, with over two-thirds of these considered avoidable and therefore due to errors. These errors can lead to no harm, may be minor or range to major errors which can result in morbidity, mortality and poor quality of life for the patient. In turn, these may have significant health and economic consequences, including the increased use of health services, preventable medication-related hospital admissions and death.
Medication errors can include prescribing, preparation, dispensing, administration mistakes as well as monitoring errors.
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.(1)
1. Medication errors in the hospital setting represent the most common adverse effect on health systems
Medication errors constitute the highest adverse events in hospitals, not only in terms of number, but as well in morbidity and mortality.
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.(4)
In the UK, a 2017 study in the English NHS(5) quantified 237 million medication errors in one year, 21.3% in prescription, 15.9% in dispensing and 54.4% in administration.
In Spain, the National Study on Adverse Effects Linked to Hospitalisation (ENEAS 2005)(6) published in 2006 concluded that the incidence of adverse effects in hospitalised patients was 8.4%, the most common adverse effect being medication errors, which accounted for 37.4% of the total. The “Patient Safety Strategy in the National Health System. 2015-2020 period”(7) indicates that there are up to 17 medication incidents per day for every 100 patients hospitalised, 16% in prescription, 27% in transcription, 48% in dispensing and 9% in administration.
2. Medication errors in a hospital setting are preventable
According to the WHO, all medication errors are potentially preventable.(1)
According to the ENEAS study in Spain, 42.8% of adverse effects are deemed preventable.(6)
Clinical evidence shows that the introduction of traceability systems in hospitals would allow a significant reduction in medication errors, as well as improve the efficiency and quality of care of nursing staff.
3. Medication errors cause suffering for patients and incremental costs for health systems, which undermine their sustainability
Every day, medication errors in the health care field lead to unnecessary lengthening of stays for patients with an enormous additional cost for health care systems, patients and their families. They also involve indirect social costs, resulting from the loss of productivity due to disability.
The WHO estimates the annual cost of medication errors at $42 billion USD annually.(1)
In Spain, the “Patient Safety Strategy in the National Health System. 2015-2020 period”(7) estimates the cost of medication errors around 2 billion euros (representing 3% of the total National Healthcare expenditure).
The estimated cost to the NHS of avoidable adverse events related to medication in hospitalised patients, plus those that led to hospital admissions and emergency consultations, would be approximately £98.5 million (representing 2.9% of NHS health care expenditure).(5)
4. Preventing medication errors in the hospital setting is a good practice that promotes the well-being of everybody
The prevention of medication errors is a requirement for safe and quality health care, and constitutes best practice that satisfies bioethical requirements.(9)
5. Global priority launched by the WHO in 2017
A global initiative called “The Third Global Patient Safety Challenge: Medication Without Harm”(1) aims to reduce medication errors and the associated harm in all countries around the world by 50% within 5 years. In this third challenge, health ministers are invited to establish national plans covering four aspects of the safe use of medication: the involvement of patients and the general public; medicines as products; the education, training and monitoring of health professionals; and medication management systems and practices.
6. The solution is available and affordable
There is no doubt that education of health care professionals combined with technology and reporting processes are critical success factors in solving this patient safety issue.
Nowadays, the level of 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, barcoded medication administration systems (BCMA) and smart medication administration pumps, connected if possible to BCMA and prescription systems, resulting in:
In short, medication traceability systems make it possible to standardise hospital processes, prevent medication errors in all phases of the process and improve nursing efficiency, allowing more time to be spent on care and less time on administrative tasks.
The European Alliance for Access to Safe Medicines (EAASM) is an independent, pan-European initiative dedicated to protecting patient safety by ensuring access to safe and legitimate medicines. The EAASM champions patient safety initiatives relating to medication safety, such as compounding practices, unlicensed/off-label usage of medicines and the field of nanomedicines to help ensure patient safety and wellbeing across Europe.
As a result of the burden of medication errors in acute care setting across European countries, the EAASM board has decided to launch a major European patient safety project aimed to promote the prevention of medication errors in acute care settings through the implementation of medication traceability systems.
To achieve the objective of the project , the EAASM is working to create one European alliance made up of Scientific and Patients’ organisations, under the project name “The European Collaborative Action on Medication Errors and Traceability” [ECAMET].
With patient safety at its heart, the Alliance’s composition and focus will include experts from acute care settings that are more susceptible to medication errors namely: pharmacy, oncology and intensive care, nurses as well as patient organisations.
The project has the overall objective to reduce medication errors and promote, at European and national levels, the implementation of comprehensive electronic traceability systems in acute care settings, thus enhancing patient safety and quality of healthcare:
1. Create awareness of the importance of medication patient safety in the hospital environment
2. Call on European institutions and Member State’s authorities to promote regulations and guidelines on medication traceability to prevent medication errors.
3. Promote medication traceability in European Member States with a focus on acute care settings as the most efficient way to prevent medication errors.
PROJECT’S STRATEGY AND TACTICS
To achieve the objectives of the ECAMET project , the following strategic initiatives will be taken:
1. Creation of a European Alliance of Scientific and Patient organisations
The EAASM is contacting European Scientific and Patient organisations to be part of the ECAMET project. The following associations have positively welcomed and endorsed the ECAMET project:
2. Creation of a Scientific Committee (SC)
The SC will oversee the project and ensure that each step will be scrutinised and thus optimise the outcomes. The SC will include representatives of organisations, scientific associations and experts, who will drive the ECAMET project forward and generate awareness of the topic.
The Scientific Committee currently comprises:
3. Creation of a comprehensive Pan-European survey among clinicians
The Pan-European survey among clinicians will be managed by a European market research company.
It will include questions about the size of the problem of medication errors, the level of awareness and education and the existing traceability systems in place in acute care settings.
The survey will be delivered to the following groups of clinical experts: oncologists, pharmacists, intensive care specialists and nurses.
The pan European survey will be conducted in large countries and one small to medium size country and the methodology will ensure a statistically representative sample.
There will be a consolidated report and separate reports by specialty namely: General, Oncology and Intensive Care Units.
4. Creation of a White Paper
The Pan-European survey will act as the foundation for a White Paper which highlights the issues surrounding medication errors across several EU countries and puts forward solutions and opportunities for the future to prevent them
5. Creation of a Joint Call to Action
Creation of a Joint Call to Action calling upon health authorities, policy makers, health care professionals and patients to join hands to prevent unnecessary harm in hospital settings by promoting medication traceability and innovative quality standards for patient safety across Europe.
6. Advocacy work
Advocacy work at institutional level (Europe and country state members), including bilateral meetings with relevant policy makers of the European Parliament and European Commission to build momentum and gather consensus, along with an awareness-raising campaign at European level. Advocacy work will include:
Stakeholders participating in the ECAMET are voluntary participants and therefore cannot be required to append their names to documents, publications, etc without their consent. The European Alliance for Access to Safe Medicines (EAASM) would oversee the project stages in collaboration with the members of the Scientific Committee and will be responsible for progressing the deliverables of the ECAMET.
THE ROLE OF MEDICATION TRACEABILITY
The role of medication traceability in preventing such 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
Studies have shown that Medication traceability technology results in the following benefits.(11)
EU Transparency Register Number: 861368611058-84