REMED: An Essential Method for Improving the Quality and Safety of Medication Care

Patient safety is a top priority in healthcare. At the heart of this concern lies the management of risks associated with medications and related medical devices, an area where errors can have devastating consequences. In response to this challenge, the Medication and Associated Device Error Review (REMED) is emerging as a fundamental method. Developed by the French Society of Clinical Pharmacy (SFPC), REMED is much more than a simple procedure; it is a systemic and educational approach aimed at analyzing errors after the fact to draw collective lessons and implement concrete improvement actions. This article explores REMED in depth, from its definition to its practical application, including its history, scope, and the tools it provides healthcare professionals to build a sustainable safety culture. What is REMED and why is it important? REMED (Review of Errors Related to Medications and Associated Devices) is a continuous quality improvement approach for healthcare and the prevention of iatrogenic drug-related risks. Its English equivalent is "Review of Errors in Medicines." This method helps optimize the organization of therapeutic care for patients where medication and, where applicable, associated medical devices are used. The term "Medication Error Review" is also commonly used. REMED is a structured approach to the post-hoc analysis of anonymized medication error cases. It is distinguished by its collective, multi-professional, and systemic approach. Its main objective is to design and implement actions to reduce risks related to patient medication management. A medication error is defined as the omission or unintentional act occurring during the care process involving a medication, which may lead to a risk or adverse event for the patient (according to AFSSAPS 2010). The SFPC (2006) adds that a medication error is a deviation from what should have been done and is therefore, by definition, avoidable. REMED is crucial because awareness of the need to manage health risks, particularly those related to errors, is gradually growing among healthcare professionals, despite the difficulty of addressing it publicly. The World Health Organization (WHO) reiterated in March 2002 that more than 75% of the causes of healthcare errors are systemic in origin. In France, the Public Health Act of August 9, 2004, established serious adverse events, particularly those related to health products, as a public health issue. Recent reports (Costagliola & Bégaud 2013) estimate that between 10,000 and 30,000 deaths annually in France are attributable to medications. A very large proportion of this medication-related iatrogenesis is, however, preventable because it is linked to an error. The French National Authority for Health (HAS) requires healthcare facilities to implement a health risk management policy starting from the initial certification process. In this context, REMED, as a validated extension of morbidity and mortality reviews by the HAS, becomes an indispensable tool. The systemic analysis conducted during REMED takes into account all the organizational, technical, and human elements of a patient’s medication management. It allows us to move beyond a purely individual-centered approach and to draw lessons about the strengths and vulnerabilities of the healthcare system. By collectively reflecting on the process retrospectively, REMED makes it possible to characterize errors, identify shortcomings, analyze these situations of "non-quality" in a transparent and non-blaming manner, investigate the root causes, and propose improvement actions. The aim is to describe the facts and analyze situations to understand, learn, and act collectively, thereby strengthening the quality and safety of care. Considering the individuals involved as “resource persons” for improvement, without value judgment, is essential to the success and sustainability of the approach.

The History and Recognition of REMED: A Tool Validated by Experts

The French Society of Clinical Pharmacy (SFPC) has been committed to combating medication-induced iatrogenesis for more than ten years. It was within this framework that a dedicated working group, led by Dr. Edith Dufay, was established. As early as 2008, these experts in the field proposed an initial version of the REMED method.

Recognition of REMED accelerated thanks to strategic collaborations. In 2007, REMED was selected as a working theme in partnership with two other learned societies: the French Society of Geriatrics and Gerontology (SFGG) and the French Society for Risk Management in Healthcare Facilities (SOFGRES). A Delphi method was used to define and formalize the method and its tools. A major turning point was the multicenter study MERVEIL (Method for Evaluating the Review of Errors and their Iatrogenesis related to Medications), conducted under the auspices of the SFPC. This study, conducted from 2009 to 2011, involved professionals from 77 healthcare facilities in France, Belgium, and Luxembourg. Its objective was to evaluate and validate REMED as a method for assessing professional practices. The results of the MERVEIL study not only validated REMED but also established it as the standard method for the post-hoc analysis of medication errors. The lessons learned from the MERVEIL study led to the development, in 2013, of a second version of REMED, which is easier to apply and consistent with other risk management methods. The manual for this version 2.0 was published in 2014. Institutional recognition followed quickly: in 2012, REMED was recognized by the French National Authority for Health (HAS) as one of the methods listed within the framework of Continuing Professional Development (CPD). The HAS (French National Authority for Health) has also recognized it as a "validated daughter method" for morbidity and mortality reviews. Today, REMED is considered an indispensable tool for evaluating and improving the safe management of patients treated with health products. Its multidisciplinary approach, developed with expert professionals and field practitioners, takes into account all the organizational, technical, and human aspects of medication management. It proposes the collective implementation of actions to improve the quality and safety of care, thus fully integrating into the organization of healthcare facilities regarding medication risk management. The success of REMED is the result of momentum and collective effort, as highlighted by the presidents of the SFPC (French Society of Clinical Pharmacy), Professor Marie Claude Saux and Professor Rémi Varin. Numerous contributors, including Edith Dufay, as well as members of the working groups, authors, and reviewers, participated in its design and development. The ongoing support of the HAS and various collaborating bodies and societies was essential. The SFPC has made this work freely available to the profession, demonstrating collective pride in this project.

The scope of the REMED investigation: which events are covered?

REMED focuses specifically on preventable adverse events. These are events that would not have occurred if care had been provided in accordance with the standards of care considered satisfactory at the time they occurred. The scope of REMED covers medication errors and/or harm observed in patients as a result of these errors.

More specifically, medication errors are serious incidents that disrupt care activities, compromise patient safety, and can harm patients because they deviate from recommended guidelines or procedures. They include active errors by healthcare professionals, latent errors in organization and teamwork, technical failures, systemic malfunctions, and defects in healthcare products, often in the presence of contributing or triggering factors. These elements constitute adverse events in themselves. The harms are the consequences that these errors cause or are likely to cause in the patient. They can take several clinical forms:

• A worsening of an existing condition or a failure to achieve the expected improvement in health.
• The onset of a new condition, such as a hospital-acquired infection resulting from improperly administered antibiotic prophylaxis, or heart failure caused by forgetting to take a diuretic.
• Impairment of a bodily function, or an adverse effect or harmful reaction caused by one or more medications taken by the patient.

Some of these consequences are considered serious when they result in incapacity or disability (temporary or permanent), physical, emotional, or psychological harm, a life-threatening situation, death, or a congenital anomaly or malformation.

According to REMED, when using the term "adverse event," it is essential to clearly distinguish between the facts (the medication error itself, or a medication error and patient safety incident) and their consequences (the harm caused to the patient, or an adverse drug event and an adverse drug reaction).

Beyond the harm to the patient, a medication error can also have organizational and/or institutional consequences. For the patient, this may mean the need for corrective treatment, increased monitoring, transfer to an intensive care unit, resuscitation unit, dialysis center, or another facility, a prolonged hospital stay, or the hospitalization of an outpatient or resident patient. For the healthcare system, the consequences can be economic, financial, social (related to healthcare staff), legal, or media-related. Sources provide concrete examples, such as a methotrexate overdose resulting in a patient’s death (Example 1), or an omission of thromboembolic prophylaxis leading to phlebitis (Example 2). Cases without serious clinical consequences for the patient, such as the IV injection of a crushed tablet intercepted before harm occurred (Example 3), or a dosing error intercepted by the pharmacist (Example 4), are also relevant events for REMED. REMED does not cover certain types of events. Adverse events related to the spontaneous progression of the patient’s condition and adverse drug effects related to the intrinsic pharmacological properties of the medication are excluded. Similarly, events related to addictive behavior (e.g., drug use by drug addicts) or to the misuse/abuse of a health product (e.g., erythropoietin use by athletes) are excluded due to their intentional nature. It is important to remember that adverse events related to health products must be reported to the organizations responsible for regulatory health surveillance (pharmacovigilance, materiovigilance) because of their potential impact on marketing. Specific medication errors must be reported to the Medication Error Reporting Office of the French National Agency for Medicines and Health Products Safety (ANSM).

Medication Management: A Complex Process at the Heart of REMED

Patient medication management is a highly complex process, often one of the least well-organized in healthcare facilities, as demonstrated by the results of the first accreditation and certification processes conducted by the French National Authority for Health (HAS). This is why the collective interdisciplinary analysis conducted during a REMED adopts a problem-based approach that addresses the impact on the quality of care outcomes. It focuses on the processes and interfaces related to the medication management of patients (whether hospitalized, in long-term care, or outpatient) where an error has occurred.

This process generally consists of five main steps:

1. The diagnosis of the condition, including the establishment of treatment goals, the selection of a treatment strategy, and the prescription of medications and other care.
2. The dispensing of the medication(s) and, if necessary, the delivery of the associated device.
3. The administration of the medication and the patient's intake of it.
4. Therapeutic monitoring of the patient, including a reassessment of the benefit-risk balance.
5. The

This complexity is due to several factors:

• The variety of medical conditions, their level of urgency and severity.
• The variety of available treatments.
• The diversity of patient profiles.
• The involvement of various healthcare professionals whose roles complement one another.
• A series of steps that occur in different geographical locations.
• The integration of an informal communication network into the regular, formalized information flow to facilitate task coordination.

The document outlines the sequence of actions following an adverse event in six phases:

1. Interpretation: The patient or healthcare professional is alerted by an unusual finding or anomaly.
2. Questioning: The professional asks questions, attempts to reconstruct the sequence of events, and analyzes what happened.
3. Detection: The cause is identified, enabling an appropriate response.
4. Intervention: The professional steps in to stop the harmful process, either before or after harm occurs.
5. Recovery: An attempt to resolve the patient’s condition, the success of which depends on the speed of detection, the drug’s potential for harm, the severity of the event, professional experience, risk awareness, the quality of teamwork, and organizational performance.
6. Analysis: The professional identifies the immediate causes. This analysis is rarely formalized or systematic and often stops at the medication error itself, without investigating the root causes.

REMED is the solution to this final step, providing a method for a comprehensive and collaborative analysis—essential for identifying system vulnerabilities and implementing sustainable improvement measures.

Practical Organization of REMED: Implementing an Effective Approach

Implementing REMED is a structured approach that is fully integrated into the continuous quality improvement policy of any organization, whether it is a healthcare facility, a social care facility, a department, a service, a care unit, or a primary care organization. It applies to all areas of activity involved in the therapeutic care of patients using a health product.

A fundamental aspect of REMED's organization is the support of healthcare professionals. The institution's management must implement meaningful changes in behavior and organizational structures to foster a culture of safety. To encourage professionals to report incidents, it is essential to professionalize risk management, make the reporting system visible, and disseminate a charter outlining management’s stance regarding staff who are involved in or have reported an error. Psychological support must be provided to staff involved in a serious adverse event, with the goal of transforming feelings of guilt into a source of strength, helping them see themselves as key to preventing recurrence.

To begin with, the organization of REMED is entrusted to a volunteer healthcare professional who is familiar with the method and recognized by their peers. Internal regulations, tailored to the institution and describing the organization and operation of the MEDIC (Medication Incident Response) system, must be developed and distributed to all relevant professionals. Case identification uses standard risk management and epidemiological search and detection methods. This includes reporting medication errors within the institution, direct observation of care practices, scheduled review of patient records, continuous recording of indicators related to errors or iatrogenesis, and monitoring of sentinel events (such as transfer to intensive care, unplanned readmission, or death). Case selection prioritizes "high-risk" medication errors, whether intercepted or not, that have had or could have had significant clinical consequences for the patient. Eligible cases may include "never events" listed by the ANSM (French National Agency for Medicines and Health Products Safety), errors associated with a type of care (anesthesia), a therapeutic class (anticoagulants), a route of administration (intrathecal), a population (elderly, children), a step in the product circuit (dispensing, administration), or a sector of activity (surgery, pharmacy). REMED is a multidisciplinary team effort. Typical participants include prescribers, pharmacists, pharmacy technicians, nurses, and healthcare managers. Other professionals may be invited depending on the cases studied, and professionals directly involved in the error may participate if invited. A multidisciplinary approach is essential, requiring the presence of at least one representative from the medical, pharmaceutical, nursing, and pharmacy technician professions. Confidentiality is strictly enforced for all participants.

The working group appoints a facilitator to lead the REMED process. Their responsibilities include organizing sessions, writing reports, facilitating discussions, documenting the case analysis, and liaising with the relevant departments within the institution to monitor improvement actions. It is recommended that this role be assigned to a senior practitioner who volunteers, has training in case analysis, and possesses strong interpersonal skills (listening, empathy, rigor, and impartiality).

Traceability and archiving are essential. A standardized and anonymized report, along with an improvement action plan, is prepared and shared with participants. An annual activity report is prepared, and all documents are kept in the institution’s quality records. The dissemination of information must be targeted: comprehensive information for staff directly involved in the event, and more strategic information, focused on improvement actions, for institutional recipients. A structured feedback process is organized, based on the annual review of reported errors and the medication management improvement program. Additional tools are available, such as the medication error tracking chart and the Med'Seth program for monitoring improvement actions. The 5C scenario, which diagrams the chain of causes and consequences of a medication error, is also a key educational tool.

Conducting a REMED session: a structured process with key steps

Conducting a REMED session is part of W. Edwards Deming's PDCA (Plan, Do, Check, Act) continuous improvement model. The collective analysis of an error (or series of similar errors) relies on the REMED binder, whose central tool is the REMED notebook.

Here are the seven structured steps for effectively conducting a REMED session:

Step 0: Before the meeting (PLAN) This is the meticulous preparation phase. It includes logistical planning for the meeting and the creation of an anonymized agenda. A case-specific REMED binder must be created, information recording must begin, relevant scientific documentation must be gathered, and, if necessary, interviews with the individuals involved must be conducted. Supporting those involved and offering them the opportunity to participate in the REMED process are essential for a non-judgmental approach. Finally, all documents, materials, and health products related to the case must be collected, and the drafting of the facts and the characterization of the error must begin. Step 1: Introducing the Meeting (PLAN) The facilitator begins by designating the meeting secretary and distributing the document "REMED in Summary." It is crucial to reiterate the fundamentals of the process: ethical rules, confidentiality, and anonymization. The objectives of REMED are specified: to improve practices and teamwork, to discuss difficulties and organizational shortcomings, and to correct flawed processes. Emphasis is placed on avoiding value judgments to reassure participants and encourage open expression. Data recording in the REMED notebook continues throughout the session. Step 2: Presenting the Case and Identifying Problems Encountered (DO) This step aims to answer the questions "What happened?" and "How did it happen?". After a chronological description of the facts, the 5W2H (Who? What? Where? When? How? How many? Why?) tool is used to clarify and supplement the facts in a non-interpretive manner with the participants. This also involves identifying the safety barriers that failed, those that worked, and the methods for detecting and recovering from errors.

Step 3: Characterize the medication error (MO). This involves determining the type of error. The characterization of the medication error is validated by the participants based on six key elements (Appendix I):

• The health products involved (medicines, treatments, protocols, medical devices).
• The extent to which errors occur (potential, actual, and those intercepted; actual and identified after reaching the patient).
• The nature of the medication error (patient, omission, medication, dose, method, timing, duration of administration).
• The observed severity of the consequences (minor, significant, major, critical, catastrophic, according to the HAS scale).
• The risk associated with the error (whether it carries risk or not).
• The initial stage of the patient care process (identification, prescription, dispensing, administration, follow-up, information, logistics). Consideration is also given to the subsequent stages where the error persisted.

Step 4: Investigate the causes and contributing factors (CHECK) This fundamental step answers the question "Why did this happen?". The tool used for root cause analysis synthesizes recognized frameworks (REEM, Savall, ISMP, ALARM, HAS, MERVEIL). The facilitator guides the exploration of causes by area of investigation. For each problem, the causes and contributing factors are investigated to determine why the safeguards failed (Appendix I). The analysis focuses on eight areas of causes: health products, patients, healthcare professionals, operational tasks and procedures, team functioning, work environment, organization and management, and institutional context. More than 250 possible causes are listed. If necessary, the causes are prioritized using the cause weighting matrix (Appendix L).

Step 5: Synthesize the Action Plan (ACT) This second key step of the REMED process aims to answer the questions "What have we learned?" and "What changes should be implemented?". A climate of trust facilitates everyone's participation. Additional information (internal feedback, literature review) is shared. The next step is to identify the prevention, interception, or recovery actions to be implemented. The action plan is developed to track the progress of the selected measures (Appendix J). If necessary, improvement actions are prioritized by assessing their feasibility and their link to the risk of recurrence of the error (Appendix M). Communication and information procedures for teams and recipients are also established.

Step 6: Closing the Meeting (ACT)At the end of the session, the summary report is read and approved, ensuring that all identifying information has been removed (Appendix K). Reports to the relevant pharmacovigilance systems are recorded as needed. The action plan agreed upon during previous meetings is reviewed. Cases of medication errors to be discussed at the next meeting are selected. Finally, participants sign the attendance sheet.

Step 7: After the Meeting (ACT) This post-meeting step is crucial for the sustainability of the process. Feedback is provided by sending the report to each participant and guest. Reports are submitted to institutions as needed. Monitoring and evaluation of the action plan are being carried out. The REMED is recorded in the annual report, and the medication error case, along with the improvement actions, are documented in the corresponding tracking tables.

Essential REMED Tools: From Binders to Analysis Matrices

The REMED method is accompanied by a range of tools specifically designed to facilitate its organization, implementation, and the analysis of the data it generates. The central tool is the REMED Workbook, available in electronic format and downloadable from the SFPC website (www.sfpc.eu).

The REMED Binder is an interactive tool composed of several tabs:

• Tab 1 - Introduction to the REMED Workbook: Provides an introduction to REMED, its history, its authors, and key definitions.
• Tab 2 - REMED Workbook User Guide: Describes how to use the various tabs, including the color codes for entering information.
• Tab 3 - REMED Workbook: This is the central tool. It guides the REMED process, from case preparation to the multidisciplinary session. It serves as a detailed record, updated as the case is reviewed.
• Tab 4 – List of Questions: Helps structure interviews with professionals and discussions during root cause analysis and the identification of improvement actions, drawing in particular on the QQOQCCP method (Who? What? Where? When? How? How much? Why?).
• Tab 5 – List of Useful Documents: A guide to identifying the relevant documents needed to document findings.
• Tab 6 - Characterization of the Medication Error: Used to identify the six key elements of a medication error for classification purposes.
• Tab 7 – List of Causes: Provides more than 250 possible causes, categorized into 8 areas of investigation (healthcare products, patients, healthcare professionals, operational tasks and procedures, team dynamics, work environment, organization and management, institutional context). This list synthesizes various risk analysis methods.
• Tab 8 – Improvement Actions Table: Allows you to track the implementation of approved improvement actions. The information entered in the REMED Logbook is automatically transferred to this tab.
• Tab 9 - Summary Report: Generates an anonymized summary report of the analyzed case, to be used for communication purposes.

In addition to these basic tools, the binder also includes optional, so-called "expert" tools:

• Tab 10 – Cause Weighting Matrix (Appendix L): Allows you to prioritize the identified causes based on the strength of their link to the error that occurred, in an objective manner and without making value judgments.
• Tab 11 – Matrix for Prioritizing Improvement Actions (Appendix M): Helps prioritize improvement actions by assessing their feasibility and the strength of their link to the risk of the error recurring.

These tools are designed to be scalable and not to constrain healthcare professionals to excessive formalism, while ensuring the harmonization of the REMED approach.

In addition to the binder, other supplementary documents are available to strengthen the management of risks associated with healthcare products:

• The list of "never events," provided by the ANSM.
• The list of sentinel events associated with health products, compiled by the SFPC.
• The 5C framework for medication errors (Causes, Consequences, Corrections, Chronology, Residual Consequences). This educational tool outlines the sequence of events, highlighting their complexity and timing.
• The Charter for Encouraging the Reporting of Adverse Events, proposed by Lunéville Hospital.
• A table tracking medication errors reported at the facility.
• The Medication & Therapeutic Safety Program (Med'Seth), which facilitates the identification and monitoring of initiatives to improve medication management.

All of these resources can be downloaded from the SFPC website, providing professionals with the necessary means to organize, conduct, and analyze medication error analyses in a structured and effective manner.

REMED in the service of a safety culture and continuous professional development

REMED is more than just an analytical method; it is a powerful tool for transforming the safety culture within healthcare facilities and actively contributing to the ongoing professional development of healthcare providers. Awareness of healthcare risk management is gradually growing, and REMED is part of this trend by providing a framework for addressing errors in a constructive manner.

Historically, addressing errors has been difficult for healthcare professionals, as they were often viewed in a way that placed the blame on individuals. However, as early as 2002, the WHO emphasized that the causes of errors are systemic in nature in more than 75% of cases. REMED specifically adopts this systemic, non-blaming approach. It encourages viewing those involved in an error as key contributors to improving the quality and safety of care—a factor essential to the success and sustainability of the initiative. This perspective allows us to move beyond a focus solely on individuals and instead draw lessons about the strengths and vulnerabilities of the healthcare system.

REMED promotes an educational approach that is essential for fostering a culture of safety:

• It provides a better understanding of the complexity of the process of managing patients' medication.
• It helps improve professional practices related to medication management.
• It ensures the continuous improvement of knowledge through feedback.
• It improves communication among healthcare professionals, a key factor in preventing errors.
• It is part of an ongoing effort to improve the quality and safety of medication management, as well as to control and manage risks associated with health products.

In France, the 2004 Public Health Law established serious adverse events as a public health problem, highlighting the importance of reducing adverse drug events. REMED aligns perfectly with these objectives. It is also cited in the HAS methodological guide on patient safety.

Active participation in REMED allows professionals to partially fulfill their individual requirements under Continuing Professional Development (CPD). In fact, REMED is one of the methods specifically listed by the French National Authority for Health (HAS) in its December 2012 document titled "Continuing Professional Development – CPD Methods and Procedures." It also contributes to the certification processes for healthcare facilities and to quality and risk management, as well as to their contractual arrangements (multi-year performance contracts, contracts for proper use).

REMED is in line with the provisions relating to patient rights and the quality and safety of care, whether the patient is hospitalized, a resident, or an outpatient. It is a tool that supports the implementation of the requirements of the decree of April 6, 2011, relating to the management of the safety of medication care for hospitalized patients.

In conclusion, REMED is a "remedy for error" by transforming error, inherent in all organized human activity, into a pedagogical tool. As medication care is a complex process, REMED offers a multi-professional method to improve it, based on error-based learning and taking into account the entire patient care process. It is a collective effort whose success, measured by user satisfaction and the relevance of the answers and leads provided, will directly benefit patients. REMED is therefore a pillar for proactive medication risk management and a constantly evolving safety culture.

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