Pharmacovigilance: Laboratorios Lansier

What is Pharmacovigilance?
It is the science of activities related to the detection, assessment, understanding and prevention of adverse drug effects or any other related health problem.

What is an adverse event?
It is an unexpected medical problem that occurs during a treatment with a drug or other therapy. Adverse events can be mild, moderate, or severe, and may have been caused by something other than the administered medication or therapy. These are also called a side effect. Some examples are: headache, skin redness, gastrointestinal problems (nausea, vomiting, heartburn, diarrhea).

A serious adverse event is one that triggers one of the following situations:

• Serious medical condition ( that may be life-threatening but requires an intervention to prevent serious outcomes).
• Symptoms that threaten the patient's life.
• Requires or prolongs hospitalization.
• Temporary or permanent disability
• Death.

Adverse drug reaction: Any harmful or unintended reaction that appears after the use of a drug or pharmaceutical product in humans for prophylaxis, diagnosis or treatment or to change physiological functions.
Suspected adverse drug reaction: Any unwanted clinical condition that indicates to have a causal relationship with one or more pharmaceutical products.

Why should adverse effects be reported?

• To keep our patient safe
• To monitor our products and document other effects.
• To comply with the current standards and regulations given by the health authorities.

When should they be reported?

• When an unwanted effect occurs, during or after the use of any of our products.
• In case of overdose
• In the event of misuse of Laboratorios Lansier products.
• Reports can be oral or written (phone call, interview, letter, e-mail, etc.)

What information is essential in the report?

• Patient –identifying information: Name initials, age, sex, weight and height if possible.
• Onset date of the adverse event.
• Description of the adverse event (s).
• Medication: Name, dose, treatment time. It is important to mention if the patientalso used another concomitant medicine.
• Source of information: specify who is making the report ( physician, pharmacist, nurse, patient, relatives of the patient, etc.)

To whom should adverse effects be reported?
Laboratorios Lansier Pharmacovigilance Unit:

• Lansier website, Pharmacovigilance option.
• Email: farmacovigilancia@lansier.com
• Telephone number: (511) 208 9200 Annex 205
• WhatsApp +51 977-642-678 / +51 997-574-457