Never Events: understanding, preventing, and acting on avoidable medical errors

In the field of healthcare, patient safety is an absolute priority. Yet, despite technological advances and rigorous protocols, serious incidents can occur. Among these, a particular category is designated as "Never Events". These are medical errors of such severity that, in theory, they should "never" happen. These incidents, although often preventable, can have tragic consequences, ranging from irreversible neurological damage to death. Understanding their nature, identifying their root causes, and implementing effective prevention strategies is a crucial issue for all healthcare facilities.

Sources reveal that 75% of errors related to health products concern so-called "high-risk" medications, and most of them are on the list of Never Events. This statistic underscores the critical importance of addressing these events not only for the protection of patients but also to strengthen public confidence in the healthcare system. This article explores in depth what Never Events are, why they occur, what the 16 most recent identified events are, and how to prevent them effectively, notably through the integration of digital tools.

What is a "Never Event"? Definition and issues in healthcare.

The term "Never Event" refers to adverse health events of such severity that they are considered completely avoidable if appropriate safety protocols had been scrupulously applied. It specifically concerns medication-related incidents that can have dramatic repercussions on patients' lives. These incidents are characterized by their predictable nature and their direct link to human or systemic errors.

The concept of "Never Event" emerged in the United States in 2001. Originally, it was used to describe particularly shocking medical errors, such as surgery performed on the wrong site or the wrong patient. The French terminology, adopted in particular by the Haute Autorité de Santé (HAS), describes these events as incidents that "should never happen". This is a strong notion that highlights the inexcusable nature of these errors and the need for absolute prevention.

The stakes of Never Events are twofold. On the one hand, they reflect a serious failure in healthcare systems, directly compromising patient safety. On the other hand, their occurrence, often made public, can considerably damage the trust of users in healthcare professionals and hospitals. The fact that these events are preventable but still occur raises fundamental questions about the quality and safety of care. According to the HAS, an alarming proportion of 75% of errors related to health products concern "high-risk" drugs, and a large majority of these errors are on the list of Never Events. This statistic highlights the imperative need to understand the underlying mechanisms of these incidents and to implement robust strategies to eradicate them. Never Events are therefore critical indicators of a hospital's safety performance, and their prevention is a fundamental objective for any healthcare organization concerned with protecting its patients.

The root causes of "Never Events": Beyond the isolated error.

It is essential to understand that Never Events are only rarely the result of a single isolated human error. In reality, they most often result from multiple and complex dysfunctions within healthcare systems. These systemic weaknesses create an environment conducive to errors, even with qualified and dedicated staff. Sources identify several key factors that contribute to the occurrence of these serious events:

• Absence of protocols or checklists: One of the cornerstones of healthcare safety is the standardization of practices. The absence of clear and detailed protocols, or the non-use of checklists, can lead to critical omissions and inconsistencies in procedures. For example, the non-use of a surgical checklist to confirm the patient's identity and the area to be operated on is a major risk factor that can lead to surgery on the wrong patient or the wrong site. These tools are designed to ensure that all essential steps are followed, thereby reducing the likelihood of errors due to oversight or negligence.
• Poor communication between professionals: Communication is the cornerstone of care coordination. A lack of clarity in the exchange of information, omissions during transmissions between teams or departments, or misunderstandings can directly lead to errors in the execution of care. When vital information regarding a patient, medication, or procedure is not properly transmitted or understood, the risk of incidents increases drastically.
• Overwork and fatigue of medical staff: Healthcare professionals are often faced with demanding working conditions and excessively busy schedules. This overload of work, combined with a lack of rest, inevitably leads to physical and mental fatigue. Fatigue impairs vigilance, reduces concentration, slows reaction times, and decreases decision-making ability, thus significantly increasing the risk of errors, even for routine tasks.
• Technological or equipment defects: Technological advances are crucial in the field of healthcare, but they can also introduce new risks. Misuse of equipment due to a lack of professional training, or a technical defect in the device itself, can directly cause a serious incident. For example, an infusion pump that is incorrectly programmed due to a misunderstanding of its operation or a material malfunction can lead to a critical overdose or underdose.

In summary, Never Events are not mere "isolated oversights" but symptoms of a deeper systemic weakness within healthcare organizations. It is also emphasized that these events frequently concern medications with a narrow therapeutic index. This means that the difference between an effective dose and a toxic dose is minimal, making any dosage or administration error potentially fatal. Understanding these complex causes is the first step towards developing effective prevention strategies, which must address the systemic roots rather than the individual manifestations of the error.

The official list of "Never Events": A constant evolution for patient safety.

The recognition and categorization of Never Events are key elements for patient safety. The identification and dissemination of these lists allow healthcare facilities to focus their prevention efforts on the most critical and potentially devastating risks. The history of Never Events is marked by constant evolution, reflecting the learning and continuous improvement of healthcare systems.

The concept originated in the United States in 2001, where an initial list included 28 serious preventable events, divided into 7 categories. Canada has also adopted a similar approach, with a list of 15 categories of "never events" since 2015. In France, the Agence Nationale de Sécurité du Médicament (ANSM) initially introduced a list of 9 "never events" in 2021.

However, patient safety is a constantly evolving field. That is why the list of Never Events is regularly updated to incorporate new knowledge, feedback, and changes in medical practices. The new list of Never Events was officially published in the Official Bulletin of May 31, 2024. This update is an important milestone, with each healthcare facility having received the updated list via its Regional Health Agency (ARS).

This latest version identifies 16 distinct Never Events. Official dissemination by the Regional Health Agency (ARS) ensures that all actors in the healthcare system are informed of the priority risks to be controlled. This dynamic of updating highlights an increased awareness of the complexity of care and the need for constant vigilance. Transparency around these lists allows professionals to focus on high-risk situations, develop specific protocols, and strengthen training to prevent these incidents. The list of these 16 events is the current roadmap for enhanced safety in healthcare facilities.

"Never Events" related to high-risk medications and critical routes of administration.

Among the 16 Never Events identified, several directly concern high-risk medications and errors related to specific routes of administration, the consequences of which can be dramatic. Precision and vigilance are essential in these contexts.

1. Error in the management of patients treated with anticoagulant medications: Anticoagulants, such as heparin or fraxodi, are very high-risk medications due to their ability to alter blood coagulation. They are essential for preventing thrombosis or treating conditions such as phlebitis, but mismanagement of their administration or incorrect dosage can lead to severe and uncontrollable bleeding, potentially fatal. Close monitoring of coagulation parameters and rigorous dose adjustments are crucial.
2. Error in the administration of injectable potassium chloride (KCl): Concentrated potassium chloride is used to correct severe electrolyte imbalances, but its administration is extremely delicate. Inappropriate administration, such as a too-rapid infusion rate or excessive concentration, can cause serious cardiac disorders, including cardiac arrest. This medication requires particular attention at each stage of its preparation and administration.
3. Error in the preparation of injectable specialties for which the preparation method is at risk: Injectable drugs require sterile preparation and absolute precision. Any error in dilution, mixing of components, or failure to comply with sterility rules can have disastrous consequences. This can lead to serious infections, adverse reactions due to incorrect concentration, or systemic complications that endanger the patient's life.
4. Administration error involving intrathecal injection instead of intravenous: Intrathecal injection is a highly specific route of administration, reserved for certain medications that must act directly on the central nervous system by being injected into the space around the spinal cord. Injecting a drug designed for intravenous administration (into a vein) intrathecally is an extremely serious error that can cause irreversible neurological damage (paralysis, sensory impairment) or lead to the patient's death. Administration route verification protocols must be infallible.
5. Administration error involving parenteral injection instead of oral or enteral route: Administering a medication by parenteral injection (e.g., intravenous, intramuscular, subcutaneous) when it was intended to be administered orally or enterally (via the digestive tract) is a Never Event. The preparations and dosages are radically different between these routes. Such an error can lead to massive overdoses and systemic toxic effects, as the body is not prepared to absorb the substance as quickly or at such high concentrations via the injected route.

These examples illustrate the necessity for absolute rigor in the handling of high-risk medications and strict adherence to routes of administration. Any error in this area can have irreversible consequences.

Specific "Never Events": From pediatrics to anesthesia.

The list of Never Events extends beyond general medication errors to include very specific situations, often linked to vulnerable patient populations or critical care environments such as the operating room.

6. Overdose of anticancer drugs, particularly in pediatrics: Anticancer drugs (chemotherapy) are extremely potent substances. Their doses are often calculated with minute precision, to the milligram, based on individualized criteria such as the patient's weight and body surface area. This precision is all the more critical in children in pediatrics, where margins for error are virtually non-existent. An overdose, even a minimal one, can cause very serious toxic effects on vital organs and, in the most tragic cases, lead to the patient's death.
7. Error in the methotrexate administration schedule by oral or subcutaneous route (outside of oncology): Methotrexate is a drug used in several indications. Outside the context of oncology (where it is administered according to very different schedules), methotrexate is generally administered once a week, not daily. A frequency error, leading to daily administration for example, can lead to severe toxicity, affecting the bone marrow, liver, or kidneys, and endangering the patient's life.
8. Error in insulin administration: Insulin is an essential drug for regulating blood sugar in diabetic patients, but it is classified as a high-risk drug. An error in dose (too high), type (confusing rapid-acting with long-acting insulin), or timing of administration (in relation to meals) can lead to severe hypoglycemia. This excessive drop in blood sugar can cause seizures, permanent neurological damage, and, in extreme cases, coma or even death.
9. Error in the administration of drugs used in anesthesia or resuscitation in the operating room: The environment of the operating room and resuscitation services is by nature a high-intensity place where errors can have immediate consequences. Confusion between anesthetic drugs, for example between a curare (which causes muscle paralysis) and a local anesthetic, is a Never Event. Such confusion can lead to unexpected paralysis, life-threatening respiratory depression, or, conversely, insufficient anesthesia that exposes the patient to pain or awakening during the operation.
10. Error in the administration of medical gases: The use of medical gases is common in many clinical settings, but misidentification of gases is a major risk. Administering nitrous oxide instead of oxygen, or using the wrong gas, can lead to hypoxia (lack of oxygen in the tissues), burns in the case of flammable gas, other serious complications, or even the patient's death. The color of the bottles and the connection systems are standardized to minimize these risks, but constant vigilance remains necessary.
11. Error in programming administration devices (infusion pumps, electric syringes...): Electronic devices such as infusion pumps or electric syringes are designed to administer drugs with great precision. However, errors in their programming, in particular incorrect flow rate or dose settings, can have disastrous consequences. These errors can lead to rapid and severe overdoses, or conversely, insufficient drug administration, compromising the effectiveness of the treatment and the patient's safety.
12. Error in the administration or use of small single-dose plastic containers, particularly in maternity or pediatrics.: Small single-dose containers, often made of plastic, are common in maternity and pediatrics for precise dosing. However, these single doses often contain concentrated doses of medications. Misuse, confusion between different products, or a calculation error can lead to accidental overdoses in particularly fragile and sensitive patient populations, with potentially serious consequences for their health.

These Never Events highlight the need for robust protocols, continuing education, and increased vigilance, especially in high-risk environments and for vulnerable populations.

"Never Events" and the management of substances with a narrow therapeutic index.

Some Never Events are specifically related to drugs that have a narrow therapeutic margin, meaning that the difference between the effective dose and the toxic dose is very small. This makes their use particularly risky and requires extreme rigor.

13. Lidocaine overdose by intravenous route: Lidocaine is a widely used local anesthetic, but it is also used intravenously to treat certain cardiac arrhythmias. However, an overdose of lidocaine intravenously can cause serious cardiac disorders (such as bradycardia or cardiac arrest) or severe neurological disorders (seizures, coma), due to its direct action on the nervous and cardiovascular systems.
14. Error in the use of colchicine: failure to comply with dosage regimens and/or contraindications, particularly in cases of drug interactions and renal or hepatic insufficiency: Colchicine is a drug used primarily to treat gout. It has a very narrow therapeutic margin, meaning that slight dose exceedances can lead to severe toxicity. Failure to comply with dosage regimens, contraindications (such as renal or hepatic insufficiency that prevents the body from properly eliminating the drug), or ignoring drug interactions (which can increase its concentration in the body) can cause serious, potentially fatal poisoning.
15. Error in the use of methadone: failure to consider contraindications, drug interactions, and overdoses: Methadone is a potent opioid used for the management of severe chronic pain or in opiate withdrawal programs. Its potency makes it particularly dangerous if misused. Inappropriate dosage, failure to respect contraindications (certain pre-existing conditions), or combination with incompatible medications (drug interactions) can cause severe respiratory depression, serious cardiac disorders (QT interval prolongation, arrhythmias), and lead to a fatal overdose.
16. Misuse of fluoropyrimidine: administration without the mandatory search for dihydropyrimidine dehydrogenase (DPD) deficiency: Fluoropyrimidines, such as 5-fluorouracil, are essential chemotherapy drugs. However, in some patients, a genetic deficiency in dihydropyrimidine dehydrogenase (DPD), a key enzyme in the metabolism of these drugs, can lead to a toxic accumulation of the substance. Prior screening for this DPD deficiency is therefore mandatory before administering these drugs. Failure to screen and administer the treatment to a deficient patient can lead to severe, often fatal, toxicity because the drug is not properly metabolized by the body.

These examples highlight the complexity of drug administration and the importance of understanding the pharmacological specificities of each substance, as well as the patient's clinical and genetic status, to prevent errors that can prove fatal.

Never Events" prevention strategies: A global, systemic approach.

The prevention of Never Events is an ethical imperative and an operational priority for any healthcare system. It cannot be ensured by a single isolated measure, but requires a combination of organizational, technical, and human measures. These strategies aim to create safety barriers at each stage of the care process, thereby reducing the likelihood of errors occurring and reaching the patient.

Here are the key strategies for preventing Never Events:

• Train professionals on Never Events to minimize errors: Awareness and continuous education of medical and nursing staff are fundamental. This training should include not only knowledge of specific Never Events and their consequences, but also associated prevention protocols, identification of at-risk situations, and best practices for avoiding errors. Training should be regular and updated to reflect changes in lists and knowledge.
• Implement a double-check system for prescriptions to limit dosage errors on patients: Double-checking is an essential practice. It involves at least two independent healthcare professionals verifying and validating the prescription, preparation, and administration of medications, especially high-risk ones. This process helps detect dosage errors, medication or patient mix-ups, and potential incompatibilities before they reach the patient.
• Establish detailed protocols and procedures for each Never Event based on explanatory sheets: Standardization is crucial. Clear, written, and accessible protocols, describing step-by-step procedures for handling high-risk medications or performing delicate procedures, reduce variability in practices and the risk of errors. These explanatory sheets should be concise, precise, and easy to understand for all relevant personnel.
• Use checklists before administering health products to ensure no information is missed: Inspired by aviation, checklists are simple but extremely effective tools to ensure that all critical steps are followed and that no essential information is omitted. For the administration of health products, it is possible to use the 5 rights (right patient, right drug, right dose, right route, right time) as a basis for a complete and systematic checklist.
• Clearly label syringes, single doses, and vials: Rapid and unambiguous visual identification is essential to avoid medication mix-ups. Clear, standardized labels, with legible information on the name of the medication, its concentration, the date of preparation and expiration, are fundamental barriers against errors.
• Disseminate clear best practice recommendations on dose calculations and contraindications: Dose calculation errors are a frequent cause of Never Events, especially for drugs with a narrow therapeutic margin. Providing clear recommendations, conversion tables, or reliable dose calculators is essential. Similarly, widespread and systematic dissemination of contraindications and drug interactions allows professionals to adapt the treatment to the specific situation of each patient.
• Display the list of Never Events in the corridors and transmission rooms: Constant visibility of Never Events serves as a permanent reminder of the severity of the risks and the importance of vigilance. This physical presence of the list can encourage staff to remain alert to at-risk situations and adopt best practices.
• Promote an environment where caregivers can report errors without fear of punishment (non-punishment charter): A safety culture is strengthened when professionals feel confident to report errors, whether proven or near-misses (situations that could have led to a Never Event). A no-punishment charter, focused on learning and improvement rather than guilt-tripping, encourages reporting, helping to identify systemic failures and prevent their recurrence.
• Systematically analyze errors to learn from them and avoid repetition: Every incident or near-miss is a learning opportunity. In-depth root cause analysis, rather than focusing on individual errors, is essential to identify systemic weaknesses and implement effective corrective actions. This process of continuous analysis is the driving force behind improved patient safety.

These strategies, when combined and rigorously applied, form a robust shield against the occurrence of Never Events, transforming healthcare facilities into safer environments for all.

The role of digital tools in optimizing the prevention of "Never Events."

In the digital age, technology offers powerful solutions to enhance patient safety and prevent Never Events. The use of dedicated software is increasingly recognized as an effective means of managing Never Events. These digital tools are not just databases; they are integrated systems designed to anticipate risks, streamline processes, and facilitate decision-making.

Here's how a digital tool can optimize Never Events prevention:

• Anticipating and limiting risks with digital risk mapping: Dedicated software enables digital risk mapping, providing a clear view of potential vulnerabilities within the facility. This visualization helps to identify high-risk areas of Never Events, enabling targeted preventive measures to be implemented before an incident occurs.
• Integration of actions into a global digital plan and notification of project leaders: Corrective and preventive actions proposed to reduce Never Events can be directly integrated into the hospital's global digital action plan. The "project leaders" (individuals responsible for implementing these actions) are automatically notified, ensuring better monitoring and rapid execution of necessary measures.
• Centralized training monitoring and update alerts: The training of professionals on the prevention of Never Events can be managed directly via the digital tool. In addition, automatic alerts can be sent to the professionals concerned when their training requires an update or reminder, ensuring that all staff are constantly aware of the latest recommendations and best practices.
• Declaration and optimized analysis of adverse events: Adverse events, particularly those related to Never Events, can be declared and analyzed directly on the tool. This centralization provides an optimal view of all incidents that have occurred, facilitating the identification of trends, recurring causes, and areas requiring particular attention for continuous improvement.
• Centralization of fact sheets via Electronic Document Management (EDM): The software may include Electronic Document Management (EDM) where practical fact sheets are centralized, explaining each Never Event, the risks arising therefrom, and the associated prevention protocols. This EDM is accessible to all professionals, ensuring rapid and easy access to vital information at the point of care, thereby reducing the risks associated with lack of knowledge or forgotten procedures.

In summary, digital tools are not mere gadgets; they are strategic levers for transforming healthcare risk management. They make it possible to anticipate dangers, centralize best practices, and guarantee precise monitoring of incidents, thereby promoting continuous improvement of safety and enhanced protection of patients. Their integration represents a major advance in the fight against Never Events.

Never Events represent a major challenge to patient safety in the healthcare system. As sources demonstrate, they rarely result from a single isolated error, but rather from complex systemic failures, ranging from lack of protocols and communication to staff overload. The list of 16 Never Events, recently updated and disseminated by the Regional Health Agencies, highlights the importance of high-risk medications and delicate procedures where the slightest error can have fatal consequences.

However, preventing these events is not only possible but imperative. It relies on the adoption of a comprehensive approach, combining rigorous organizational measures, reliable technical tools, and a human culture focused on learning and non-punishment. Continuous professional training, the implementation of double checks, the use of checklists, and the systematic analysis of incidents are all essential pillars for building a safer care environment.

The integration of specialized digital tools also plays an increasing and crucial role in this process. By enabling risk mapping, action tracking, training management, and centralized analysis of adverse events, technology offers powerful means to anticipate and reduce risks. By investing in these solutions and adopting constant vigilance, hospitals can move towards the ultimate goal: ensuring that "Never Events" truly become events that never happen, thus guaranteeing the best possible protection for each patient.

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