REMED: an essential method for improving the quality and safety of medication care

Patient safety is an absolute priority in healthcare. At the heart of this concern is the management of risks associated with medications and related medical devices, an area where errors can have devastating consequences. Faced with this challenge, the Review of Errors related to Medications and Associated Devices (REMED) emerges as a fundamental method. Developed by the French Society of Clinical Pharmacy (SFPC), REMED is more than just a procedure; it is a systemic and pedagogical approach aimed at analyzing errors a posteriori 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 to healthcare professionals to build a sustainable safety culture.

What is REMED and its importance

The REMED (Review of Errors related to Medications and Associated Devices) is a continuous quality improvement and prevention of drug-induced iatrogenic risk approach. Its Anglo-Saxon equivalent is the "Review of Errors in MEDication". This method helps to optimize the organization of the therapeutic management of patients where the drug and, where applicable, the associated medical device are used. The expression "Review of medication errors" is also commonly used.

REMED is a structured approach to a posteriori 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 the risks associated with patient medication management.

A medication error is defined as the omission or performance of an unintentional act during the care process involving a medication, which may be the cause of a risk or adverse event for the patient (according to AFSSAPS 2010). 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 them publicly. The World Health Organization (WHO) pointed out in March 2002 that more than 75% of the causes of errors in healthcare are systemic in origin. In France, the Public Health Law of August 9, 2004, established serious adverse events, particularly those related to health products, as a public health problem. Recent reports (Costagliola & Bégaud 2013) estimate between 10,000 and 30,000 annual deaths in France attributable to medications. A very large proportion of this drug-induced iatrogenesis is, however, avoidable because it is associated with an error. The Haute Autorité de Santé (HAS) requires healthcare facilities to have a health risk management policy from the very first certification process. In this context, REMED, as a validated daughter method of morbidity and mortality reviews by the HAS, is becoming an indispensable tool.

The systemic analysis conducted during REMED takes into account all organizational, technical, and human elements of a patient's medication management. It allows us to move beyond reflection focused solely on individuals and to draw lessons about the strengths and vulnerabilities of the healthcare system. By reflecting collectively a posteriori on the process, REMED allows us to characterize errors, identify failures, analyze these "non-quality" situations in a transparent and non-blaming manner, search for root causes, and propose improvement actions. It involves describing the facts and analyzing the situations to understand, learn, and act collectively, thereby strengthening the quality and safety of care. Considering the people 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's (SFPC) commitment to combating drug-related iatrogenesis dates back more than ten years. It is within this framework that a specific working group, led by Dr. Edith Dufay, was established. As early as 2008, these expert and field professionals proposed a first version of the REMED method.

Recognition of the REMED has accelerated through 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 of Healthcare Facility Risk Management (SOFGRES). A DELPHI method was used to define and formalize the method and its tools.

A major turning point was the multi-center MERVEIL study (Méthode d'Évaluation de la Revue des Erreurs et de leur Iatrogénie liées aux Médicaments), conducted under the aegis of the SFPC. This study, conducted from 2009 to 2011, involved professionals from 77 healthcare establishments in France, Belgium and Luxembourg. Its aim was to evaluate and validate REMED as a method for assessing professional practices. The results of the MERVEIL study not only validated the REMED, but also positioned it as the reference method for a posteriori analysis of medication errors.

The lessons learned from the MERVEIL study made it possible to propose, in 2013, 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 was not long in coming: in 2012, REMED was recognized by the Haute Autorité de Santé (HAS) as one of the methods listed within the framework of Continuing Professional Development (CPD). The HAS also retained it as a "validated daughter method" of 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 and field professionals, takes into account all organizational, technical and human elements of medication management. It proposes the collective implementation of actions to improve the quality and safety of care, thus fully aligning with the organization of healthcare facilities in terms of medication risk management.

The success of the REMED is the result of a collective momentum and effort, emphasized by the presidents of the SFPC, Pr Marie Claude Saux and Pr Rémi Varin. Numerous contributors, notably Edith Dufay, as well as members of the working groups, writers, and reviewers, participated in its design and evolution. The constant support of the HAS and various collaborating bodies and societies has been essential. The SFPC has made this work freely available to the profession, demonstrating collective pride in this work.

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

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

More precisely, medication errors are dreaded events that disrupt care activity, reduce the level of safety, and can harm the patient because they deviate from recommendations or procedures. They encompass active errors by professionals, latent errors in the organization and teamwork, technical failures, systemic dysfunctions, as well as defects in health products, often in the presence of contributing or triggering factors. These elements in themselves constitute undesirable events.

Harms are the consequences that these errors generate or are likely to generate in the patient. They can take several clinical forms:

• Aggravation of an existing pathology or lack of expected improvement in health.
• Occurrence of a new pathology, such as a nosocomial infection following poorly managed antibiotic prophylaxis, or cardiac decompensation due to forgetting to take a diuretic treatment.
• Impairment of a bodily function, or an adverse effect/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, moral or psychological harm, a life-threatening condition, death, or a congenital anomaly/malformation.

According to REMED, when the expression "adverse event" is used, it is essential to distinguish between the facts (the medication error itself, or medication error and patient safety incident) and their consequences (the harm occurring to the patient, or adverse drug event and 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 implementation of corrective treatment, increased monitoring, transfer to an intensive care unit, to resuscitation, to a dialysis center or to another hospital, prolonged hospitalization, or hospitalization of an outpatient or resident. For the healthcare structure, the consequences can be economic, financial, social (related to healthcare personnel), legal, or media-related. The sources provide concrete examples, such as an overdose of methotrexate leading to the death of a patient (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 but intercepted before harm (Example 3), or a dosage error intercepted by the pharmacist (Example 4), are also relevant events for REMED.

REMED does not cover certain types of events. Excluded are adverse events related to the spontaneous evolution of the patient's pathology and adverse drug reactions related to its intrinsic pharmacological properties. Similarly, events related to addictive behavior (e.g., drug use by drug addicts) or the misuse/diversion of a health product (e.g., use of erythropoietin by athletes) are excluded because of their intentional nature.

It is important to remember that adverse events related to health products must be reported to the organizations managing regulatory health monitoring (pharmacovigilance, materiovigilance) due to their possible impact on marketing. Specific medication errors should be reported to the Medication Error Desk of the National Agency for Medicines and Health Products Safety (ANSM).

Medication management: a complex process at the heart of REMED

The patient's medication management is a process of great complexity, which is often one of the least well organized in healthcare facilities, as shown by the results of the first accreditation and certification processes of the HAS (French National Authority for Health). This is why the interdisciplinary collective analysis conducted during a REMED adopts a problem-based approach affecting the quality of care outcomes. It targets the process and interfaces related to the medication management of patients (hospitalized, residents or outpatients) where an error has occurred.

This process is generally broken down into five major steps:

1. The diagnosis of the pathology, with the definition of therapeutic objectives, the choice of a therapeutic strategy, then the prescription of drugs and other care.
2. The dispensing of the drug(s) and the delivery, if necessary, of the associated device.
3. The administration and intake of the medication by the patient.
4. The patient's therapeutic monitoring, including the re-evaluation of the benefit/risk balance.
5. The patient's information.

This complexity is due to several factors:

• The diversity of pathologies, their degree of urgency and severity.
• The diversity of available therapies.
• The diversity of patient profiles.
• The intervention of various healthcare actors whose roles are complementary.
• The sequence of numerous steps that take place in geographically different locations.
• The superimposition of an informal communication network on the regular and formalized information circuit to facilitate task coordination.

Despite our best efforts, the incidence of medication errors is high. When an undesirable event occurs and a professional or patient becomes aware of it, an immediate reaction takes place. This reaction combines, in variable order, the detection of immediate causes, the interruption of the erroneous act and the implementation of measures to recover the situation or mitigate the consequences for the patient. However, the process often stops at this stage, without any systematic search for root causes, questioning of organizations or sharing of experience. REMED is designed to remedy these shortcomings.

The document details the sequence of behaviors following an adverse event in six phases:

1. Interpretation: The patient or professional is challenged by an unusual event or anomaly.
2. Interrogation: The professional questions, tries to retrace the chronology, and analyze the events.
3. Detection: The cause is identified, allowing for an appropriate response.
4. Interception: The professional intervenes to interrupt the erroneous process, before or after damage occurs.
5. Recovery: Attempt to rectify the situation in the patient, the success of which depends on the speed of detection, the dangerousness of the drug, the severity of the event, the experience of the professionals, awareness of the risk, the quality of teamwork, and the performance of the organizations.
6. Analysis: The professional inventories the immediate causes. This analysis is rarely formalized or systematic, and often stops at the medication error itself, without looking for the root causes.

REMED is the response to this final step, offering a method for in-depth and collective analysis, essential for identifying system vulnerabilities and implementing sustainable improvement actions.

Practical organization of REMED: implementing an effective approach

The implementation of a REMED is a structured approach that is fully integrated into the continuous quality improvement policy of any structure, whether it is a hospital, a medico-social establishment, a department, a service, a care unit or a primary care structure. It concerns all sectors of activity involved in the therapeutic management of patients using a health product.

A fundamental aspect of the REMED organization is thesupport provided to healthcare professionals. Management must bring about a real change in behavior and organization to promote a culture of safety. To facilitate the involvement of professionals in reporting events, it is crucial to professionalize risk management, make the reporting system visible and distribute a charter defining the management's position towards staff involved in or having reported an error. Psychological support must be offered to staff involved in a serious undesirable event, the aim being to transform their feelings of guilt into a moral force that will enable them to see themselves as resource persons in preventing recurrences.

To start, the organization of the REMED is entrusted to a volunteer healthcare professional, familiar with the method and recognized by their peers. Internal regulations, adapted to the hospital and describing the organization and operation of the REMED, must be developed and disseminated to all professionals concerned.

Case finding uses the usual methods of research and detection in risk management and epidemiology. This includes reports of medication errors within the facility, direct observation of care practices, programmed study of patient records, continuous recording of indicators relating to errors or iatrogenesis, and monitoring of sentinel events (such as transfer to intensive care, unplanned re-hospitalization, or deaths).

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, errors associated with a type of care (anesthesia), a therapeutic class (anticoagulants), a route of administration (intrathecal), a population (elderly, child), a stage of the product circuit (delivery, 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 they are offered the opportunity. Multidisciplinarity is imperative, requiring the presence of at least one representative from the medical, pharmaceutical, nursing, and pharmacy technician professions. Confidentiality is mandatory for all participants.

A facilitator is appointed by the focus group to lead the REMED. His or her role is to organize the sessions, write up the minutes, lead the discussions, formalize the case analysis and liaise with the establishment's authorities to monitor improvement actions. It is recommended that this role be entrusted to a senior practitioner with training in case analysis and interpersonal skills (listening, empathy, rigor, impartiality).

Traceability and archiving are essential. A standardized and anonymized report, as well as an improvement action plan, are drafted and communicated to the participants. An annual activity report is established, and all documents are stored in the structure's quality documents. The dissemination of information must be targeted: complete information for the personnel concerned by the event, and more strategic information, focused on improvement actions, for institutional recipients.

Structured feedback is organized on the basis of the annual review of reported errors and the medication management improvement program. Complementary tools are available, such as the Medication Error Tracking Chart and the Med'Seth program for tracking improvement actions. The 5C scenario, which illustrates the sequence of causes and consequences of a medication error, is also a key teaching tool.

Conducting a REMED session: a structured process in key steps

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

Here are the seven structured steps for conducting an effective REMED:

Step 0: Before the meeting (PLAN)This is the meticulous preparation phase. It includes the logistical planning of the meeting, the establishment of an anonymized agenda. It is necessary to create a REMED file specific to the case being processed, start recording information, gather relevant scientific documentation, and, if necessary, conduct interviews with the people involved. Supporting the people involved and proposing participation in the REMED are essential for a non-blaming approach. Finally, it involves collecting all documents, materials, and health products related to the case being studied and starting to write down the facts and characterize the error.

Step 1: Introduce the meeting (PLAN)The facilitator begins by appointing the session secretary and distributing the document "REMED in summary". It is essential to recall the fundamentals of the approach: ethical rules, confidentiality, and anonymization. The objectives of the REMED are specified: to improve practices and teamwork, to communicate difficulties and organizational flaws, and to correct failing processes. Emphasis is placed on the absence of value judgment to reassure participants and encourage free expression. Data recording in the REMED notebook continues throughout the session.

Step 2: Present the case and identify the 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 QQOQCCP (Who? What? Where? When? How? How much? Why?) tool is used to clarify and complete the facts in a non-interpretive way with the participants. It also involves identifying the safety barriers that failed, those that worked, and the methods of detection and recovery of errors.

Step 3: Characterize the medication error (DO)This involves determining the typology of the error. The characterization of the medication error is validated by the participants according to six significant elements (Appendix I):

• The involved health products (medication, treatment, protocol, medical device).
• The level of realization of the error (potential, proven and intercepted, proven and identified after reaching the patient).
• The nature of the medication error (patient, omission, medication, dose, method, timing, duration of administration).
• The severity of the consequences observed (minor, significant, major, critical, catastrophic, according to the HAS scale).
• The risk associated with the error (risk-bearing or not).
• The initial stage of occurrence in the patient care process (identification, prescription, dispensing, administration, monitoring, information, logistics). Reflection is also carried out on the secondary stages where the error continued.

Step 4: Research the causes and contributing factors (CHECK)This fundamental step answers the question "Why did it happen?". The tool used for the search for root causes synthesizes recognized grids (REEM, Savall, ISMP, ALARM, HAS, MERVEIL). The facilitator guides the scanning of causes by areas of investigation. For each problem, the causes and contributing factors are sought, identifying why the barriers failed (Appendix I). The reflection focuses on eight areas of causes: health products, patient, healthcare professionals, tasks and operational procedures, team functioning, work environment, organization and management, and institutional context. More than 250 possible causes are listed. If necessary, a prioritization of the causes is carried out using the cause weighting matrix (Appendix L).

Step 5: Synthesize the action plan (ACT)This second highlight of the REMED aims to answer the questions "What have we learned?" and "What changes should be implemented?". The climate of trust facilitates the expression of all. Additional information elements (internal feedback, literature search) are shared. It then involves identifying the prevention, interception, or recovery actions to be implemented. The action plan is built to track the progress of the measures taken (Appendix J). If necessary, the improvement actions are prioritized by evaluating their feasibility and their link with the risk of error reproduction (Appendix M). The methods of communication and information for the teams and recipients are also established.

Step 6: Close the meeting (ACT)At the end of the session, the summary report is read and validated, ensuring its complete anonymization (Appendix K). Declarations to the concerned vigilance systems are recorded if necessary. The program of actions decided during previous meetings is reviewed. Cases of medication errors for the next meeting are selected. Finally, the participants are recorded on a sign-in sheet.

Step 7: After the meeting (ACT)This post-meeting step is crucial for the sustainability of the approach. Feedback is ensured by sending the report to each participant and guest. Declarations to the institutions are made if necessary. The monitoring and evaluation of the action plan are implemented. The REMED is recorded in the annual report, and the case of medication error as well as the improvement actions are recorded in the corresponding monitoring 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, conduct, and the exploitation of the data it generates. The central tool is the REMED Workbook, available in electronic version and downloadable from the SFPC website (www.sfpc.eu).

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

• Tab 1 - Presentation of the REMED Workbook: Provides an introduction to REMED, its history, its authors, and key definitions.
• Tab 2 - Instructions for Using the REMED Workbook: Describes the instructions for using the various tabs, including the color codes for entering information.
• Tab 3 - REMED Notebook: This is the central tool. It guides the REMED process, from case preparation to the multi-professional session. It serves as a detailed report, completed as the case is studied.
• Tab 4 – List of Questions: Helps structure interviews with professionals and discussions during the analysis of causes and the search for improvement actions, based in particular on the QQOQCCP method (Who? What? Where? When? How? How much? Why?).
• Tab 5 – List of Useful Documents: A reminder to identify the relevant documents needed to objectify the findings.
• Tab 6 - Characterization of the ME: Allows determination of the six significant elements of a medication error for its classification.
• Tab 7 – List of Causes: Proposes more than 250 possible causes, classified into 8 areas of investigation (health products, patient, healthcare professionals, tasks and operational procedures, team functioning, work environment, organization and management, institutional context). This list summarizes various risk analysis methods.
• Tab 8 – Improvement Action Table: Allows monitoring of the implementation of decided improvement actions. The information entered in the REMED Notebook is automatically transferred to this tab.
• Tab 9 - Summary Report: Generates an anonymized and synthetic report of the analyzed case, a communication medium.

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

• Tab 10 – Cause Weighting Matrix (Appendix L): Allows prioritization of identified causes based on the intensity of their link with the error produced, objectively and without value judgment.
• Tab 11 – Improvement Action Prioritization Matrix (Appendix M): Helps prioritize improvement actions by assessing their feasibility and the intensity of their link with the risk of error recurrence.

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 additional documents are offered to strengthen the management of risks associated with health products:

• The list of "events that should never happen" (never events), provided by the ANSM.
• The list of sentinel events associated with health products, established by the SFPC.
• The 5C scenario of a medication error (Causes-Consequences, Corrections, Chronology, Residual Consequence). This educational tool schematizes the sequence of events, highlighting the complexity and temporality of the events.
• The charter to encourage the reporting of adverse events, proposed by the Centre hospitalier de Lunéville.
• A table tracking medication errors reported in the facility.
• The Drug & Therapeutic Safety Program (Med'Seth), which facilitates the identification and monitoring of actions 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 not limited to being a simple method of analysis; it is a powerful lever for transforming the safety culture within healthcare facilities and actively contributing to the continuous professional development of healthcare professionals. Awareness of health risk management is gradually growing, and REMED is part of this dynamic by providing a framework for addressing errors constructively.

Historically, professionals found it difficult to confront errors, often perceiving them with a blaming character. However, as early as 2002, the WHO emphasized that the causes of errors are, in more than 75% of cases, of systemic origin. REMED precisely adopts this systemic and non-blaming approach. It encourages considering the people involved in the occurrence of an error as resource persons for the improvement of the quality and safety of care, an essential factor for the success and sustainability of the approach. This vision makes it possible to go beyond the sole reflection centered on individuals to draw lessons on the strengths and vulnerabilities of the healthcare system.

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

• It allows for a better understanding of the complexity of the process of medication management for patients.
• It contributes to the improvement of professional practices related to medication care.
• It ensures the improvement of knowledge through feedback.
• It strengthens communication between healthcare professionals, a key element in preventing errors.
• It is part of the continuous improvement of quality and safety in medication management, as well as the control and management of 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 validate their individual obligations within the framework of Continuing Professional Development (CPD). Indeed, REMED is one of the methods specifically listed by the Haute Autorité de Santé (HAS) in its document "Continuing professional development – CPD methods and modalities" of December 2012. It also participates in the certification processes of healthcare facilities and in quality and risk management, as well as their contractual arrangements (multi-year objective contracts, good use contracts).

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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