Side Effects : What to Do in Case of Side Effects ? How to Report Them ?

When a medication is prescribed or taken in self-medication, side effects may occur. In this situation, it is crucial to report these side effects to contribute to the pharmacovigilance system, an essential process for monitoring medications. This approach helps to a better understanding of potential risks associated with a medication and it helps improve its safe use. Let's explore together what to do in case of side effects and how to report them.

The Importance of Reporting a Side Effect :

Reporting side effects is a crucial act for patient safety. It is an integral part of pharmacovigilance, a system that aims to continuously monitor the effects of medications once they are on the market. By reporting a side effect, whether it is minor or severe, one can prevent serious accidents and inform healthcare professionals and patients about possible discomfort related to taking a medication. These reports are centralized and processed by the Regional Centers of Pharmacovigilance (CRPV) distributed throughout French territory.

Pharmacovigilance enables several crucial actions :

• Detecting unknown effects : Some side effects may only appear after extensive use of the medication, so reporting them allows for awareness and careful study.

• Better understanding of known effects : The frequency and severity of some side effects can vary based on populations, dosage, etc. Reporting helps improve the understanding of these effects.

• Reassessing the benefit-risk balance : Reporting side effects can lead to a reevaluation of the balance between the expected benefits of a medication and the risks it presents.

• Promoting better medication use : The collected information contributes to educating healthcare professionals and patients about proper medication use.

Should a Side Effect be Reported in the Case of Self-Medication ?

Reporting side effects is necessary whether the medication was prescribed by a healthcare professional or taken in self-medication. Any suspected side effect related to a medication, regardless of its severity or nature, should be reported to a healthcare professional and declared to the competent authorities, whether by the patient themselves or their representative (for example, a child's parents).

It is important to emphasize that even if the side effect is mentioned in the medication's leaflet, patients are encouraged to report it. Patient reports play a crucial role in collecting information about medication-related side effects.

Who Can Report a Side Effect ?

Anyone affected by a side effect (patient or representative) or authorized to prescribe, dispense, or administer medications must report the occurrence of a side effect.

• Patients or representatives : Patients or their representatives can report side effects that they suspect are related to medication use.

• Healthcare professionals : Physicians, pharmacists, and other healthcare professionals are obligated to immediately report any suspected side effect related to a medication or product they are aware of.

• Pharmaceutical companies : Pharmaceutical companies are also obligated to report any side effect they are aware of, in accordance with French and European regulations.

How to Report a Side Effect ?

Reporting a side effect can be done online on the website of the French National Agency for Medicines and Health Products Safety (ANSM) using the dedicated form (www.ansm.sante.fr/declarer-un-effet-indesirable), on the government's portal designed for this purpose (Select Profile - Portal for Reporting Undesirable Health Events), or manually by filling out the form and sending it via email or mail to the corresponding Regional Center of Pharmacovigilance (CRPV) based on the reporter's place of residence.

To facilitate these procedures, we have developed the Vigicare application in collaboration with healthcare professionals. This web application allows both patients and professionals to report their side effects to health authorities in less than 5 minutes.

In conclusion, reporting side effects is a responsible and civic act. It contributes to the safety of medication treatments by helping to a better understanding of the risks associated with medications and by helping promoting a better use of pharmaceutical products. Anyone suspecting a side effect is encouraged to report it promptly so that competent authorities can take swift action to ensure public health.

If you wish to report a side effect, visit our web application at Vigicare.io !