Frequently Asked


What is Pharmacovigilance?

According to the most recent definition made by the World Health Organization (WHO), Pharmacovigilance is a science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem.
WHO, Good Pharmacovigilance Practices for the Americas..

What to report to the Pharmacovigilance area?

Drug-associated problems can be of various types depending on where they occur in the drug chain:

Among the main ones are:
-Medication errors
-Adverse Drug reactions
-Possible therapeutic failures
-Quality problem

In addition to the above, there are some other types of events that must be reported:

-Off-label uses: Refers to any use of a drug that is not covered by the marketing license.
-Uses during pregnancy: Refers to the use of any of the Auro Pharma products in women who are pregnant, even if the woman or the fetus do not present an unfavorable clinical condition associated with the use of the drug. This information serves to establish safety profiles associated with use during pregnancy. These types of reports include lactation and use during conception.

-Overdose and poisoning: These include any consumption of the drug at a higher dose or frequency than recommended, whether or not it leads to harm to the patient. These can be accidental or intentional.

-Abuse and misuse: Refers to the use of the product for inappropriate purposes. For example, the use of certain medications for recreational purposes such as hallucinogens or psychoactives. They may or may not harm the patient.
-Adverse reactions suspected to be caused by quality defects or counterfeit products.

-Drug interactions: The use of another drug intervenes in some of the pharmacokinetic or pharmacodynamic characteristics of the drug.

-Suspected transmission of an infectious agent: The suspicion that an infectious agent (virus, bacteria, etc.) has passed into the consumer’s body through the medication.

What minimum information should a report made to the Pharmacovigilance area contain?

To consider that a report meets the quality characteristics that allow an adequate analysis of the information, it is important to have at least the following points:

i. Patient details: Obtained in order to confirm that there is an identifiable patient. This is used to obtain additional information such as concomitant medication or comorbidities typical of the patient’s clinical condition that can contribute to the understanding of the presentation of the adverse reaction, to establish risk factors, age restrictions and other safety information that is only obtained with data related to the patient.

ii. Reporter details: The reporter’s data allows the source of the information to be established and is vital when following up on the case. At this point it is important, when the information is received, to obtain as many contact details as possible from the reporter so that later contact can be established from the Pharmacovigilance Area.

iii. Auro Pharma product involved: It is necessary to know which product the report refers to, since without this information it would not be possible to initiate a formal investigation in each case.

iv. Event Details: At this point it is important to know what adverse experience occurred with the product. This is the section that will allow identifying information that defines the safety profile of the product in its commercialization stage. Therefore, here it is important to allow the reporter to express all the details that he considers relevant.

It is important to clarify that despite not having the four previous points, the case must be reported to Pharmacovigilance, so that it is from this instance that the validity of the information is evaluated.

How can I make reports to the Pharmacovigilance area of Auro Pharma Inc. Canada?

At Auro Pharma, there are several mechanisms for reporting information to the Pharmacovigilance Area:

Email: Sending a message to the email address,
Calling the phone number 1-855-648-6681.
Through the official website of Auro Pharma in the Pharmacovigilance section.