Medication safety is an important issue for ensuring the protection of patients during medication use and the use of health products. It aims to minimize the risks associated with adverse effects, medication errors, and any other complications that may occur during the prescription, dispensing, and administration stages of medications.

To ensure this safety, it is essential to implement rigorous monitoring and proactive management of adverse events. This also relies on close collaboration between healthcare professionals, care teams, regional pharmacovigilance centers, and health authorities.

Throughout this process, the aim is to provide patients with a reliable environment that minimizes risks and improves the quality of care. This effort is particularly important for vulnerable populations, such as children, who require special attention.

Understanding medication safety

Definition and importance

Medication safety encompasses all the measures necessary to ensure that medications are used in a safe, effective, and appropriate manner. Its main objective is to prevent adverse effects and complications within the medication circuit. It ensures that each patient receives the correct medication, under the right conditions, at the correct dosage, while minimizing the risks associated with medication use.

This concept goes far beyond just the pharmaceutical product. It includes risk management, enhanced monitoring of adverse effects, as well as education and information for healthcare professionals and patients. In short, medication safety is a key element in ensuring the quality of care and preserving public health.

Key players in drug safety

Ensuring the safety of health products relies on collaboration between several key players. Physicians and care teams play a central role in prescribing and administering medications appropriately. They must also ensure to avoid medication errors that could compromise patient safety.

Pharmacists, for their part, actively contribute to pharmacovigilance. They ensure the monitoring and reporting of adverse events, thus guaranteeing rigorous risk management. For its part, the Agence Nationale de Sécurité du Médicament (ANSM) defines and enforces strict standards for the marketing authorization of drugs and medical devices. This helps ensure the quality and safety of health products.

Finally, patients themselves play an active role in their own safety. By following the instructions provided and reporting any side-effects or suspected risks, they help to reinforce vigilance around medicines.

The role of the ANSM (National Agency for Medicines and Health Products Safety) in drug safety

Risk monitoring and assessment

The National Agency for the Safety of Medicines and Health Products (ANSM) plays a key role in the enhanced surveillance of medicines and other health products throughout their life cycle. It collects, analyzes, and evaluates reports related to pharmacovigilance, medication errors, misuse, and adverse events. This information comes from various sources, including healthcare professionals and patients.

Thanks to this active monitoring, the ANSM can quickly detect any warning signs, assess the benefit/risk balance of products, and take appropriate measures to ensure patient safety and protect public health.

Marketing authorization procedures

The ANSM plays an essential role in the marketing authorization of drugs and biological products. Before a product is marketed, the agency conducts a thorough scientific evaluation of its quality, efficacy, and safety. This step ensures that only products that meet regulatory standards, with an acceptable benefit/risk balance, are accessible to patients.

In addition, the ANSM (National Agency for Medicines and Health Products Safety) performs quality controls in the laboratory and inspects manufacturing sites to verify compliance with good practices.

Communication and management of health crises

When a health crisis occurs in connection with a drug or health product, the ANSM (National Agency for Medicines and Health Products Safety) intervenes quickly to inform healthcare professionals and the public. It publishes recommendations, alerts, and updates on the measures to be taken to limit the risks to patients.

The ANSM's ability to communicate effectively, coordinate the actions of various stakeholders, and manage emergency situations strengthens the trust of patients and professionals in the healthcare system. This approach contributes to medication safety. Furthermore, the agency collaborates with European and international organizations to harmonize practices and collectively address public health challenges.

Medication errors: prevention and management

Identifying medication errors

Medication errors refer to actions that deviate from good practices and can occur at different stages of the medication circuit: prescription, transcription, dispensing, administration, or monitoring. These errors include dosage errors, incorrect route of administration, administration of an incorrect medication, or errors related to preparation.

While some errors are inconsequential, others can lead to serious adverse effects, such as worsening of pathology or development of complications. The classification of errors takes into account their severity and clinical impact on the patient, ranging from a risk avoided to severe consequences, such as a toxic reaction or hospitalization.

Strategies for preventing medication errors

The prevention of medication errors relies on the implementation of robust systems at each stage of the process. Continuing education for healthcare professionals and awareness of risk management are essential. Computerized tools, such as electronic prescriptions, double-check systems, and standardized medication lists, play a key role in reducing errors.

Furthermore, clear communication between all stakeholders – the physician, the pharmacist, the care team, and the patient – enhances patient safety. Regular monitoring of medication incidents and systematic analysis of adverse events make it possible to identify weaknesses and improve procedures.

Incident and crisis management

When a medication error is detected, rapid and transparent management is essential. This involves assessing the impact on the patient, implementing immediate corrective measures, and preventing recurrence of the incident.

Reports to pharmacovigilance authorities and regional centers allow for an in-depth analysis of the causes. In the event of a health crisis, effective coordination between healthcare professionals, authorities, and healthcare facilities is essential to manage the consequences and restore confidence. This proactive approach encourages a safety culture where each error becomes an opportunity for learning and continuous improvement.

The ANSM Guide on Drug Safety

Objectives and targets

The ANSM Guide on drug safety aims to enhance patient safety by providing healthcare professionals with a structured framework for optimal management of medications and health products. It is intended for physicians, pharmacists, care teams, as well as all stakeholders involved in the medication circuit. Healthcare facilities wishing to improve their practices will also find valuable resources in it.

The main objective is to prevent medication errors, to supervise enhanced monitoring, and to promote effective interprofessional collaboration around risk management related to medications.

Main content and recommendations

The guide highlights several key areas to ensure safe medication use. Among the recommendations are practical tips regarding the prescription, dispensing, and administration of medications. It also emphasizes the importance of reporting adverse events and maintaining active pharmacovigilance.

Key strengths include the development of medication lists tailored to the specific needs of patients, such as children, the implementation of standardized procedures to reduce medication errors, and the importance of clear communication between healthcare professionals and patients.

The guide also emphasizes the need for continuous training for healthcare professionals and encourages the use of technological tools to further secure the medication circuit.

Implementing the guide: issues and perspectives

The implementation of the ANSM Guide constitutes a real organizational challenge and requires strong adherence from healthcare facilities. This implies a collective commitment to making medication safety a shared priority.

The main challenges concern the reduction of side effects and medication errors, while improving the quality of care and patient confidence. In the medium term, the ANSM plans to integrate more digital tools and automation to simplify the monitoring and evaluation of health products. At the same time, it will continue to promote awareness and collaboration among healthcare professionals.

These perspectives aim to build an increasingly safe, transparent, and effective healthcare system.

Conclusion

Medication safety is a major issue for public health. It relies on the prevention of medication errors as well as the effective management of risks associated with medications.

The ANSM plays a central role in monitoring and regulating health products, while providing guides and recommendations aimed at improving the quality of care.

To ensure optimal safety, it is essential that healthcare professionals, patients and authorities collaborate closely. Together, we can strengthen medication safety and build a more reliable healthcare system.

Let's adopt safe practices today and commit to active collaboration for a future where health is better protected.

FAQ

What are the most frequent medication errors reported in healthcare establishments?

The most frequent medication errors in healthcare facilities include:

• Prescription errors: such as using a contraindicated drug or an incorrect dose.
• Administration errors: wrong drug or incorrect route of administration.
• Patient identification errors.
• Problems related to storage and hygiene.

These errors can lead to serious adverse effects, endangering the health of patients.

What recommendations does ANSM have for the safe administration of oral medications, particularly oral solutions?

The ANSM highlights recommendations aimed at securing the administration of oral medications, particularly oral solutions. These guidelines include:

• Clear, precise labeling on packaging.
• Practical advice for prescribers and pharmacists to respect dosages and avoid drug interactions.

These measures help reduce the risk of medication errors.

How can healthcare professionals limit the risk of confusion between different formulations of the same drug, such as trastuzumab?

To avoid confusion between different formulations of trastuzumab, healthcare professionals must:

• Systematically verify the name, form, route of administration, and dosage on the label and prescription.
• Implement strict protocols and perform a double check.
• Ensure clear communication with the patient or caregiver.

These practices are essential to ensure secure administration.

Which administration devices are covered by ANSM recommendations to prevent medication errors?

The ANSM's recommendations mainly target the administration devices for oral solutions, such as:

• Dosing syringes.
• Graduated beakers.
• Measuring spoons.

These devices help to limit dosage or administration errors, whether in children, adults, or the elderly.