Question 1

What is an adverse effect?

Accepted Answer

An adverse effect is an unexpected effect resulting from taking a health product in the event of proper use or during any other use (overdose, misuse, drug abuse, medication error).

This term refers to all harmful and unwanted reactions caused by taking medication(s) or other health products, which can sometimes lead to death and/or hospitalization.

Question 2

What is Accountability?

Accepted Answer

This is the estimate of the probability of a relationship between taking a product and the occurrence of an adverse effect.

More simply, the imputability calculation allows you to determine whether a link can be established between an adverse effect and the taking of a product such as a drug, a cosmetic, a food supplement, etc…

Question 3

What algorithm is used to calculate imputability?

Accepted Answer

To obtain a safe and reliable result, we have chosen to use an internationally recognized method called the Naranjo algorithm.

The Naranjo algorithm, also called the Naranjo scale or score, is an international questionnaire designed by Naranjo et al. to determine the likelihood that an adverse effect is actually due to taking a health product (drug, dietary supplement, cosmetic, etc.) rather than the result of other factors.

At the end of the calculation of the probability according to the Naranjo method, a score is obtained. This score is then assigned to one of the 4 categories: 
 • Clear link
 • Possible link
 • Possible link
 • Dubious link

These categories ultimately make it possible to standardize the identification and classification of adverse effects on an international scale.

Question 4

What is Vigicare?

Accepted Answer

Vigicare is a free Web Application, dedicated to adverse effects related to taking products such as: drugs, food supplements and cosmetics. Based on an artificial intelligence system using scientific data enriched by user data, Vigicare's services allow you to quickly analyze your symptoms and determine whether or not they are correlated to the administration/taking of a product.

Question 5

What is Vigicare's mission?

Accepted Answer

Allow you to access a reliable analysis of your symptoms and determine if a causal link can be established between them and various health and care products.

We developed this application to fight against a major public health problem: the lack of knowledge of adverse effects.

Vigicare is our response to facilitate everyone's access to reliable information and analyzes on the potential adverse effects of drugs and all other health and care products.

Question 6

What is the WHO?

Accepted Answer

The World Health Organization (WHO) is the United Nations specialized agency for global health. Its main mission is to promote health, preserve global security and serve vulnerable populations by, among other things, assessing the health risks presented by medicines and health products intended for human beings.

Question 7

What is a security profile?

Accepted Answer

The safety profile provides information about the possible risks associated with a drug, medical device, cosmetic, dietary supplement, etc. Patients and healthcare providers should conduct a benefit assessment and disadvantages to make the decision that best meets the patient's specific needs and conditions. This profile must be reassessed at regular intervals in order to guarantee the safe use of the product. These reassessments are mainly based on adverse effects reported by patients and healthcare professionals to pharmacovigilance organizations.

Question 8

Who is behind Vigicare?

Accepted Answer

The Vigicare application is a web application founded in 2022 by pharmacists in collaboration with doctors. To find out more you can visit the page of our website!

Question 9

What data sources is Vigicare based on?

Accepted Answer

Vigicare mainly uses public data from European and global vigilance (WHO).

Question 10

What are the differences between the free version and the premium version of Vigicare?

Accepted Answer

Vigicare Premium is a subscription (€3.99/month without commitment) which gives you access to additional features:
 ● Unlimited product search to find out the safety profile (adverse effects by age group, gender, etc.)
 ● Ability to use the functionalities (adverse effects-imputability and adverse reaction reporting) offline
 ● Unlimited use without advertising

Question 11

Does the VigiCare application use user data?

Accepted Answer

User data is used solely for the purpose of enriching the Vigicare application and allowing access to the most reliable and complete information possible. The principle of minimizing data collection is however fully respected. This data is neither shared nor sold to a third party. 
For more information, do not hesitate to consult our privacy policy.

Question 12

How is my data protected?

Accepted Answer

The protection of your personal data is a priority for Vigicare, which has implemented a set of technical and organizational measures to ensure this. The application uses a certified health data host that complies with international cybersecurity standards.

Question 13

How to contact the Vigicare team?

Accepted Answer

Our team answers all your questions. To do so, go to the contact section!

Question 14

How do you report side effects?

Accepted Answer

The WHO and many countries have set up online reporting portals to facilitate the reporting of adverse reactions. These sites allow healthcare professionals and individuals to report any adverse event or unusual effect that has a negative impact on health to the health authorities in just a few clicks.

To simplify your process, you can directly access our (free) Vigicare application!

Question 15

What is pharmacovigilance?

Accepted Answer

Pharmacovigilance is defined by the WHO, as “the science and activities related to the detection, evaluation, understanding and prevention of adverse drug reactions or other possible problems related to health products” . More concretely, pharmacovigilance allows the detection of signals of adverse effects that would not have been identified upstream during the development of the drug.

Question 16

Why is it important to report a potential side effect?

Accepted Answer

When health products are under development, they are tested on a limited number of participants selected for clinical trials. Although this allows researchers to observe the most common side effects, rare side effects are statistically less likely to be observed at this stage. However, once the health product or cosmetic hits the market, a much larger and more diverse population is exposed to it, and rare side effects become more likely to occur. Identifying and investigating unknown or poorly understood side effects is essential to help ensure the safe use of various health products, and this can only be done if adverse effects are reported.

Question 17

What should I do if I suspect the appearance of an adverse effect?

Accepted Answer

If you suspect that the appearance of unusual symptoms is the result of taking a health or care product, you can first go to the Vigicare application to calculate the link of imputability. Depending on the result, if a causal relationship is suspected, you can report your effects and, if necessary, contact a healthcare professional (your doctor, pharmacist or any other qualified healthcare professional).

In any case, never stop a treatment or change the dose without first asking your doctor for advice. Only a health professional will be able to advise and guide you appropriately. The balance between the benefits and harms of a drug is not the same for all patients, and individual decisions must be made between patients and their healthcare providers.

Question 18

What happens once a potential side effect has been reported?

Accepted Answer

The national pharmacovigilance center that receives the report will evaluate it and identify potential unknown or poorly treated risks. All the data collected will allow health authorities to monitor the use and safety profile of health products and, if necessary, recalculate the benefit/risk ratio conditioning their marketing.

Question 19

How are side effects classified?

Accepted Answer

Potential adverse reactions extracted from VigiCare reports are structured by mapping originally reported symptoms to standardized medical terminology, allowing for statistical analyzes of the data. One of the benefits of this process is that it allows similar terms to be grouped together and presented in a hierarchical structure. The standard terminology used in Vigicare is MedDRA (Medical Dictionary for Regulatory Activities).

Question 20

What is a CRPV?

Accepted Answer

A Regional Pharmacovigilance Center is tasked by the ANSM with collecting adverse effects from medicines (and other health products) at the regional level, evaluating them and transmitting them to the ANSM. It also informs healthcare professionals and patients about the drug, its risks, its use and its proper use

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