It is the public health activity that aims to detect, quantify, evaluate and prevent the risks arising from the use of medicines once they have been marketed.

It is dedicated to identifying unknown adverse drug reactions (ADRs).

In Chile, the current legal framework defines an Adverse Drug Reaction (ADR) as a “harmful and unintentional reaction that occurs at doses normally used in humans.”
ADRs constitute a public health problem, since they are a cause of morbidity and mortality and increased health care costs, which is already well documented. 
ADRs can cause hospitalizations, surgeries, and loss of productivity, and in some countries these consequences exceed the cost of medications.

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PHARMACOVIGILANCE OBJECTIVES

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• Early detection of ADRs and unknown or previously undescribed interactions.

• Determine predisposing or precipitating factors for ADRs.

• Estimate quantitative aspects of the benefit/risk relationship of medications and disseminate the information necessary to improve their regulation and prescription.

• Inform health professionals, health authorities and public opinion regarding the use and safety of medications.​

The Chilean Pharmacovigilance Program is the responsibility of the National Center for Drug Information and Pharmacovigilance CENIMEF, of the Public Health Institute of Chile.

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This Program began in April 1995, adopting the system of voluntary or spontaneous communication of suspected adverse drug reactions (ADR) in a standard form.

The Holders of Health Registries in Chile are actors of enormous relevance in the national Pharmacovigilance system, since, according to both the current regulatory framework and WHO recommendations, they, that is, the pharmaceutical industry, are ultimately responsible. of the safety and effectiveness of its products.

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To safeguard the safety of its medicines, each company that markets pharmaceutical products must implement and maintain a Pharmacovigilance system that allows it to receive, record and manage information on alleged ADRs.

Googpharma® has a PHARMACOVIGILANCE program required by both our Health Authority as well as our foreign suppliers.

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We have Chemical-Pharmaceutical professionals in charge of developing standard operating procedures to comply with the requirements of the ISP and foreign suppliers.

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We report monthly to CENIMEF-ISP whether or not we have received notifications of suspected AMR.

According to the agreements signed with our foreign suppliers, Googpharma® must prepare and send monthly ADR reports.

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Extract from the Drug Safety Agreement with foreign suppliers:

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“Googpharma® must nominate a contact person for pharmacovigilance. This person must be appropriately qualified to fulfil the responsibilities for pharmacovigilance and must be informed about the local pharmacovigilance obligations in the territory. This person must speak English and the national language in order to discuss relevant details with the persons concerned and is responsible for all correspondence regarding adverse drug reactions. This person ensures, that the staff is trained in pharmacovigilance.

Googpharma® will send all information about adverse drug reactions concerning the products to the foreign supplier immediately, but not later than 3 calendar days after clock start.”

https://www.ispch.gob.cl/anamed/farmacovigilancia/​

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