Pharmacovigilance

Pharmacovigilance encompasses activities aimed at detecting, evaluating, understanding, and preventing adverse reactions and other possible problems related to the use of medications and vaccines. Through the information received, we can continuously monitor the safety profile of our products, identify potential risks, and take the necessary actions to help protect patient health.

Every report provides valuable information. Although a single case alone does not determine whether a medication or vaccine caused an event, the combined evaluation of reports can help to: 

• • Identify potential risks or safety signals.
  • Better understand product effects under real-world conditions of use. 
  • Detect rare or previously unknown reactions.
  •  Update recommendations, warnings, or safety measures when appropriate 
  • Promote the safe and responsible use of medications and vaccines. 
  • Protect other patients. 

There is no such thing as an insignificant report. If you have a suspicion, report it. 

Anyone who is aware of an event can report it, including: 

• • Patients. 
  • Family members, legal representatives, or caregivers. 
  • Doctors, pharmacists, nurses, and other healthcare professionals. 
  • Clinics, hospitals, pharmacies, and vaccination centers. 
  • Distributors, commercial allies, and other companies. 
  • Grupo Allmed employees. 

It is not necessary to be a healthcare professional or to have all the case details to submit a report.

To help us properly evaluate the case, please provide all the information you have available. 

Information of the affected person

• • Initials or full name.
  • Age or date of birth.
  • Gender.
  • Weight, if know. 

Product information

• • Name of the medicine or vaccine.
  • Presentation and concentration.
  • Lot number and expiration date, if available.
  • Dose, frequency, and route of administration. 
  • Treatment start and end dates. 
  • Reason for using the product.

Event information

• • Description of what happened.
  • Start date. 
  • Duration and evolution of the event. 
  • Medical care or treatment received. 
  • Current status or result of the event. 
  • Other medications used. 
  • Illnesses, allergies, or relevant medical history. 

Contact information

• • Name of the person making the report. 
  • Patient relationship. 
  • Email address or phone number. 

The contact information will allow the Pharmacovigilance team to communicate with the reporter if additional data is required. 

The following may participate in the pharmacovigilance process: 

The person making the report: Communicates the event and provides any available information.

The patient or affected person: The individual who experienced the event after using the medication or receiving the vaccine. They may or may not be the same person making the report. 

Healthcare professionals: Can provide clinical information, medical history, test results, and details about the treatment or care received. 

The Grupo Allmed Pharmacovigilance team: Receives, documents, evaluates, and follows up on the report, maintaining the information under applicable confidentiality and data protection measures.

Manufacturers or respective holders: When applicable, they may participate in the evaluation and follow-up of information related to product safety. 

The health authority: Receives the corresponding notifications and uses the information to monitor the safety of medications and vaccines.

Once the report is received, the Grupo Allmed Pharmacovigilance team will: 

1. Register the provided information. 

2. Verify that the report contains the minimum necessary data for its evaluation. 

3. Contact the reporter to request additional information if needed. 

4. Evaluate the case in accordance with applicable procedures. 

5. Follow up when necessary. 

6. Communicate the information to the manufacturer, holder, or health authority, when applicable. 

Receiving a report does not mean it has been confirmed that the medication or vaccine caused the event. Each case must be evaluated considering all available information. 

Your report can help protect other patients.

The safety of medications and vaccines continues to be evaluated after they are marketed. By sharing your experience, you contribute to generating greater knowledge about our products, identifying potential risks, and strengthening measures designed to protect public health. 

Reporting is also caring. 

• • Adverse event: Any unfavorable medical occurrence that takes place during or after the use of a medication or vaccine, even if it has not been determined that the product caused it. 
  • Adverse reaction: A harmful and unintended response for which, after evaluation, there is at least a reasonable possibility of a causal relationship with the medication or vaccine. 

The person making the report does not need to determine whether it is an adverse event or an adverse reaction. That evaluation is the responsibility of the specialized Pharmacovigilance team.

Yes. It is enough for a suspicion to exist or for the health problem to have occurred during or after using the medication or receiving the vaccine. 

The Pharmacovigilance team will evaluate the available information. Even an incomplete report can be useful, and additional details can be requested later.

When in doubt, report.

Grupo Allmed offers two options for reporting an adverse event: 

Option 1. Direct reporting through the website

This option allows you to complete and submit the report digitally, quickly, and securely without downloading documents.

The user must: 

1. Select the button named "Complete online form"

2. Enter the available information.

3. Review the provided data. 

4. Accept the corresponding privacy notice.

5. Select "Submit report"

Once the form is submitted, the system will display a confirmation message indicating that the report was successfully received. 

Option 2. Report via downloadable form

This option allows you to download the form to complete it electronically or manually. 

The user must:

1. Select the button named  "Download form"

2. Fill out the available information.

3. Save or scan the document.

4. Send it to the email: reportesfv@grupoallmed.com 

5. Use the subject line: ¨Adverse event report – (product name)¨. 

Do not delay the report if you do not have all the information. Send the details you have available, and the Pharmacovigilance team can contact you to request additional information when necessary.