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What is Pharmacovigilance?

Pharmacovigilance is the science related to the detection, assessment, understanding, and prevention of adverse reactions or any health problems associated with medicines or vaccines.
Objectives of Pharmacovigilance

Understanding the Impact of Pharmacovigilance

Improve patient care and safety regarding the use of medicines and all medical interventions.
Detect issues related to the use of medicines and communicate findings in a timely manner.
Improve patient care and safety regarding the use of medicines and all medical interventions.
Promote safe, rational, and more effective (including cost-effective) use of medicines.
Contribute to risk-benefit assessment, effectiveness, and risk of medicines, leading to harm prevention and benefit maximization.

Promover la comprensión, la educación y la formación en farmacovigilancia y su comunicación efectiva al público. (Organización Panamericana de la Salud, s.f.)

Improve patient care and safety regarding the use of medicines and all medical interventions.
Detect issues related to the use of medicines and communicate findings in a timely manner.
Promote safe, rational, and more effective (including cost-effective) use of medicines.

Improve public health and safety in relation to the use of medicines.

Contribute to risk-benefit assessment, effectiveness, and risk of medicines, leading to harm prevention and benefit maximization.

Promote understanding, education, and training in pharmacovigilance and effectively communicate it to the public. 

GLOSSARY
GLOSSARY
Objectives of Pharmacovigilance

Understanding the core elements of pharmacovigilance and its relevance in public health.

Clearing Doubts

Frequently Asked Questions

Clearing Doubts

Frequently Asked Questions

History

Discover the history of pharmacovigilance

Pharmacovigilance is the science related to the detection, assessment, understanding, and prevention of adverse reactions or any health problems associated with medicines or vaccines.
1805
Morphine Poisoning
Morphine was commonly used for pain relief. A soothing syrup for teething, composed of morphine sulfate and alcohol, was marketed in the USA and UK. Its sale was prohibited in 1930 due to adverse effects such as addiction, coma, and death.
1805
1931 - 1932
Chloroform Poisoning
Cases of death from chloroform anesthesia procedures were collected. This event is considered the beginning of pharmacovigilance.
1931 - 1932
1935
Clioquinol Poisoning
Neurological problems were reported in people who took high doses of "Entero-Vioform," a medication for intestinal infections containing Clioquinol. Cases of blindness were recorded in children treated with this compound.
1935
1937
Diethylene Glycol Poisoning
Known for its solvent properties but not its extreme toxicity. There were mass poisonings and deaths due to cross-contamination in medications in several countries. The rapid handling of this crisis led to improvements in regulation.
1937
1938
Milestones in Drug Regulation
Multiple adverse effects caused by drugs prompted regulatory milestones. In the USA, safety demonstration of drugs before commercialization became a requirement in 1938.
1938
1957 - 1961
Thalidomide Issues
Marketed in Germany as a sedative. A year later, it was promoted as an effective and safe drug for combating vomiting and discomfort in the first trimester of pregnancy. It was withdrawn in 1961 due to the incidence of phocomelia, a congenital malformation.
1957 - 1961
1964 - 1968
Pharmacovigilance and Systematic Notification Collection Systems
Emerging in response to the thalidomide catastrophe.

The Yellow Card Scheme was created in the UK in 1964, and the WHO International Drug Monitoring Program was established in 1968, proposing the creation of an International Drug Monitoring Center.
1964 - 1968
1970
Practolol Poisoning
This medication was marketed in the UK in 1970 and caused "Practolol Syndrome," which included severe problems such as blindness and intestinal obstruction. Deaths occurred due to the delayed onset of these effects, leading to the development of a more organized method for reporting medication side effects (Prescription Event Monitoring, PEM).
1970
1978
Foundation of the World Health Organization (WHO) Collaborating Centre for Pharmacovigilance
The WHO International Drug Monitoring Program was moved to Uppsala, Sweden, becoming the WHO Collaborating Centre. Under this agreement, WHO is responsible for policy, coordination, and dissemination, while Sweden provides facilities. WHO also supports the Centre financially and promotes its findings.
1978

Regulatory Authorities

LATIN AMERICA

Argentina

ANMAT (National Administration of Drugs, Food, and Medical Technology).

Bolivia

State Agency of Medicines and Health Technology (AGEMED).

Brazil

National Health Surveillance Agency (ANVISA) and Sanitary Surveillance Center (CVS) in São Paulo.

Chile

Public Health Institute (ISP).

Colombia

National Institute of Food and Drug Surveillance (INVIMA).

Costa Rica

Ministry of Health of Costa Rica.

Ecuador

National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA).

El Salvador

National Pharmacovigilance Center - Ministry of Health El Salvador.

Guatemala

Ministry of Public Health and Social Assistance of Guatemala.

Jamaica

Ministry of Health and Wellness of Jamaica.

Mexico

Federal Commission for Protection against Sanitary Risks (COFEPRIS).

Nicaragua

Ministry of Health of Nicaragua (MINSA).

Paraguay

DINAVISA (National Directorate of Sanitary Surveillance).

Panamá

Ministry of Health of the Republic of Panama.

Peru

General Directorate of Medicines, Supplies and Drugs (DIGEMID).

República Dominicana

General Directorate of Medicines, Foods, and Health Products (DIGEMAPS).

Trinidad y Tobago

Ministry of Health of the Republic of Trinidad and Tobago.

Uruguay

MSP (Ministry of Public Health).

Venezuela

National Center for Pharmacological Surveillance (CENAVIF).

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GLOSSARY
GLOSSARY

This Pharmacovigilance site does not collect Adverse Drug Reaction Reports.
If you wish to report an adverse effect or technical complaint regarding a pharmaceutical product, please contact your healthcare provider and/or the Health Authorities in your respective country.

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