High-risk medications are treatments with an increased risk of causing errors or incidents that can seriously harm the health and safety of patients. These risks may arise from their composition, method of administration, or management during care.

Identifying these medications is essential to reduce adverse events, which are often avoidable and affect the quality and safety of care. Tools and initiatives, such as those developed by OMEDIT in regions (Brittany, PACA-Corsica, Centre-Val de Loire), help healthcare professionals ensure rigorous management. The goal is to administer the right medication at the right dose, at the right time, and to the right patient.

Discover in this article the issues related to these drugs and the strategies to strengthen patient safety. You will also learn how everyone, professional or patient, can help prevent errors.

Understand high-risk medications.

Definition and categorization

A high-risk drug is one whose use requires enhanced safety at every stage: prescribing, dispensing,administration and therapeutic follow-up. This vigilance is essential to avoid errors that can have serious or even fatal consequences for patients.

In France, this concept is governed by an order dating from April 2011, which highlights that these drugs often have a narrow therapeutic margin. Internationally, they are called "High-Alert Medications" by organizations such as the Institute for Safe Medication Practices (ISMP). This institute regularly publishes a globally recognized list.

The most common categories include anticoagulants, insulins, narcotics and sedatives, as well as concentrated electrolyte solutions.

The criteria that make a drug a potential risk

Several criteria determine that a drug presents a high risk. First of all, a narrow therapeutic margin implies that the difference between an effective dose and a toxic dose is small, requiring precise control. Then, the complexity of administration or management, such as a rapid intravenous injection or the use of drugs in psychiatry, can increase the risk of incidents.

Errors can also arise from confusion between medications with similar names or appearances. Finally, some treatments require constant monitoring after administration, and the consequences of errors can be particularly serious, justifying their classification in this category.

Patient safety: Issues and risks

Incidents related to high-risk medications

Incidents involving high-risk medications constitute a significant portion of serious adverse events in hospital and outpatient settings. In France, nearly 212,500 hospitalizations per year are due to adverse drug events (ADEs), causing approximately 2,760 annual deaths. Among these ADEs, 75% involve medications classified as high-risk, highlighting the importance of rigorous and secure management.

These incidents can result from dosage errors, incorrect administrations, omissions, or confusion between medications. The consequences of these errors vary, ranging from temporary disorders to situations that seriously endanger the lives of patients.

Factors contributing to medication errors

Numerous factors explain medication errors, particularly for high-risk medications. First of all, failure to comply with official recommendations, such as those in the summary of product characteristics (SmPC) or guides intended for healthcare professionals, is a frequent cause. This includes errors in dosage, duration of use, or failure to comply with specific precautions.

Approximately 16% of Serious Adverse Events could be avoided with better compliance to protocols. Furthermore, administration errors due to the complexity of procedures, incorrect patient identification, or communication issues between care teams significantly increase the risks.

Finally, inappropriate self-medication or misuse by the patient also plays a role. This underscores the importance of clear information and adapted training at all levels to ensure optimal safety.

Prevention strategies and risk management

Improving prescription practices

To limit the risks associated with high-risk medications, it is important to work on improving prescription practices. This includes continuous training for healthcare professionals to raise awareness of the specificities of these medications and high-risk medication situations. The implementation of clear and validated protocols, as well as the use of computerized prescription support tools, play an essential role in reducing dosage or therapeutic choice errors.

In addition, the personalization of the list of high-risk medications by each hospital, in accordance with the recommendations of the OMEDIT or international organizations, makes it possible to better target the specific risks in each local context.

Securing the medication circuit

Securing the medication circuit is a central pillar in the prevention of administration errors. This requires a strict organization of the drug pathway, from dispensing in the pharmacy and its storage under suitable conditions, to its administration to the patient, with systematic double-checking.

Measures such as the use of specific lists of high-risk medications, clear differentiation of vials, and the implementation of local initiatives to limit visual similarities help reduce confusion. In addition, tools such as bar coding systems and electronic tracking enhance care safety in healthcare facilities.

The role of healthcare professionals and pharmacovigilance

Healthcare professionals play an essential role in preventing medication errors associated with high-risk medications. Their vigilance, specific training, and ability to collaborate in a multidisciplinary manner are essential to quickly identify and correct anomalies.

Furthermore, pharmacovigilance is a key element of risk management. It relies on the active monitoring of adverse events and on feedback, allowing for the adjustment of practices and lists of high-risk medications. Regional organizations such as the OMEDIT play a valuable role in disseminating safety alerts and supporting hospitals in their quality initiatives.

The role of patients in risk management

Patient information and education

Patient safety also relies on better information and education regarding high-risk medications. It is important to be fully informed about the specific characteristics of your treatment, the precautions to take, and any potential adverse effects.

To ensure you understand the issues and guarantee good adherence, this information must be clear, accessible, and adapted to your situation. Dialogue with healthcare professionals, such as your doctor or pharmacist, is essential to dispel your doubts and raise awareness of the associated risks.

In addition, educational tools such as safety flashes, designed by organizations such as the OMEDIT, can enrich your education and strengthen your understanding.

Active patient participation in their therapy

Beyond information, your active engagement in managing your treatment plays a key role in reducing errors and risks. This includes regularly checking your medication list, strictly adhering to prescriptions, and immediately reporting any anomalies, such as unexpected effects or administration difficulties.

By becoming an active participant in your health, you actively contribute to the safety of care and the rapid detection of adverse events.

This involvement, in collaboration with the care teams, promotes personalized and safe care, while reducing the risks associated with high-risk medications.

Technology and innovation for safety

Digital Monitoring and Alerting Tools

Technological advancements have profoundly transformed the risk management associated with high-risk medications. Dedicated digital tools now enable precise monitoring and rapid alerts in critical situations.

One notable example is the MEDISSIMO platform, which offers a detailed medication review. This solution centralizes all information relating to the treatment of patients, whether in an institution or at home. It guarantees complete traceability, from dispensing in the pharmacy to the actual taking of the medication by the patient. This process involves all the players concerned: pharmacists, nurses, patients and even their families. These digital tools strengthen collaboration between healthcare professionals and ensure rigorous monitoring, reducing the risk ofadministration errors and undesirable drug interactions.

Artificial intelligence for detecting risks

Artificial intelligence (AI) is now a key lever for strengthening patient safety in the face of high-risk medications. By analyzing enormous volumes of data from pharmacovigilance, AI is able to detect early signals of adverse events or administration errors in real time.

Associated with Big Data, AI automates reporting and anticipates risks through powerful algorithms capable of identifying complex patterns. This technology revolutionizes drug monitoring, offering increased responsiveness and unprecedented transparency. It plays an important role in protecting healthcare safety, particularly within the framework of initiatives supported by the OMEDIT, at the national and regional levels.

Specific cases of high-risk medications

High-alert medications

High-alert medications are a specific category of treatments that require increased vigilance. Their uniqueness lies in their high potential to cause serious adverse events if an error occurs. These medications often have a narrow therapeutic margin, meaning that a slight overdose or incorrect administration can lead to severe toxic effects.

Among the drugs concerned are anticoagulants, chemotherapeutic agents such as 5-fluorouracil (5-FU), insulins, products used in anesthesia and resuscitation, as well as certain psychiatric treatments. These substances, by their nature, require particular attention to avoid any error that could endanger patients' health.

To ensure the safety of their use, strict protocols govern their prescription, dispensing, storage and administration in hospitals. These protocols are often reinforced by regional initiatives led by organizations such as the OMEDIT (Observatories of Medicines, Medical Devices and Therapeutic Innovation) in regions such as Brittany, PACA-Corsica or Centre-Val de Loire. These approaches aim to reduce frequent errors, such as injection errors, dose or molecule confusions, while ensuring optimal therapeutic monitoring.

Finally, some drugs, such as fenfluramine or Mediator, have been withdrawn from the market or subjected to restrictions due to their proven major risks. These examples illustrate the importance of continuous monitoring and enhanced vigilance for high-risk drugs, in order to best protect patients.

Policies and regulations

International standards and local guidelines

The regulation of high-risk medications is based on international standards designed to harmonize the safety and quality of medical products worldwide. Organizations such as the International Council for Harmonisation (ICH) or the ICMRA coalition, which includes regulatory authorities from many countries, play a key role in developing common guidelines. These guidelines promote consistent management of drug-related risks and encourage cooperation between national bodies. This helps to accelerate access to safe and effective treatments, while ensuring rigorous monitoring of adverse events and transparent communication between the various stakeholders in the sector.

In France, the decree of April 6, 2011, specifically governs medication management in healthcare facilities. This decree emphasizes securing the prescription, dispensing, storage, and administration of drugs with a narrow therapeutic margin. These provisions are aligned with international best practices, thus ensuring optimal management of the most sensitive medications.

Impact of legislation on securing high-risk drugs

National legislation plays a decisive role in securing high-risk medications. It imposes precise obligations on healthcare professionals and hospitals, in particular the implementation of integrated quality management systems, continuous team training and the use of specific tools to prevent errors. These tools include lists of high-risk medications, drawn up by the OMEDIT in the various regions.

In addition, regulations provide for the mandatory reporting of adverse events and administration errors. This reporting process makes it possible to capitalize on feedback to implement appropriate corrective actions. In addition, legislative frameworks encourage the adoption of technological innovations, in particular to improve traceability and secure medication administration. These measures contribute durably to the protection of patients, regardless of the care setting.

Conclusion

The management of high-risk medications is a central issue for ensuring patient safety. It requires the mobilization of all stakeholders, whether healthcare professionals, patients themselves, or their families. Through approaches such as identification, standardization, increased vigilance, and the integration of innovative technological solutions, it is possible to prevent administration errors and limit adverse events.

To go further, it is essential to continue promoting awareness, strengthening team training, and encouraging active collaboration between the various stakeholders. Regional mechanisms, such as the OMEDIT, play a key role in this dynamic. Together, let's commit to adopting these best practices to provide safer care and aim for continuous improvement in the quality of care.

FAQ

Which drugs are most at risk, and why?

The riskiest medications are those with an unfavorable benefit-risk balance. Among them are:

• Strontium ranelate, known for its serious neurological and cardiovascular disorders.
• Quinine, which can cause serious side effects.
• Certain anticancer drugs.
• Cardiac treatments such as dronedarone or ivabradine.

These drugs often have side effects that are disproportionate to their effectiveness.

What precautions should I take to ensure safety when taking several medications simultaneously?

To ensure safe intake of several medications at the same time, here are the essential precautions:

• Consult a healthcare professional regularly.
• Check for possible drug interactions.
• Strictly adhere to the prescribed doses.
• Never change or stop treatment without medical advice.
• Report any unexpected side effects.

How to recognize and report an adverse drug reaction?

To identify an adverse effect, be attentive to abnormal symptoms that appear after taking a medication. Here are the steps to follow:

• The symptoms observed.
• The chronology of events.
• Medications taken.
• Evolution after treatment cessation.

How can I store and use my medication properly to avoid errors and risks?

To properly store your medications and limit risks:

• Respect the recommended temperature (15-30°C or refrigeration as appropriate).
• Protect them from light, humidity and heat.
• Store them out of the reach of children, in a safe, dry place.
• Keep them in their original packaging.
• Always check the expiration date.
• Never mix multiple medications in the same container.

If in doubt, seek advice from your pharmacist.