Pharmacovigilance | LANSIER

Pharmacovigilance

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

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

A serious adverse event triggers one of the following situations:

  • Serious medical condition (it may not put the patient’s life in danger but may threaten the patient and requires surgery to prevent serious outcomes).
  • Symptoms that put the patient's life in danger.
  • Hospitalization
  • Disability or disability
  • Death.

Adverse drug reaction: It is 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 modify physiological functions.
Suspected adverse drug reaction: Any unwanted clinical condition that may be caused by one or more pharmaceutical products.

Why should adverse effects be reported?

  • To keep our patient safe
  • To track our products and give documentary evidence of other effects.
  • To comply with the current standards and regulations given by the health authorities.

When should it be reported?

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

What essential information should I put in the report?

  • Patient ID information: Name initials, age, sex, weight and height if possible.
  • Beginning date of the adverse event.
  • Description of the adverse event (s).
  • Medication: Name, dose, treatment time. It is important to mention if you also used another associated medicine.
  • Source of information: It is important to specify who makes the report (doctor, pharmacist, nurse, patient, relatives of the patient, etc.)

Where 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

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