Medicines and vaccines have transformed the prevention and treatment of diseases over time. In addition to their benefits, they can have side effects, some of which may be undesirable and/or unexpected. Pharmacovigilance is the science and the activities related to the detection, assessment, understanding, and prevention of adverse effects or any other medicine or vaccine related problem.

The pharmacovigilance seeks to ensure that the benefit-risk ratio remains favorable throughout the life cycle of amedicine , i.e., from the time it is authorized until it is withdrawn from the market, or its production is discontinued. Pharmacovigilance comprises various activities involving the management and analysis of public health risk to ensure the rational use of medicines. Risk identification, quantification, and assessment associated with the use of medicines can avoid or minimize harm to patients and can prompt the adoption of necessary measures, including any necessary regulatory actions.

Objectives of pharmacovigilance

Improve patient care and safety in relation to the use of medicines and all medical interventions
Improve public health and safety in relation to the use of medicines;
Detect problems related to the use of medicines and communicate findings in a timely manner
Contribute in the assessment of the benefit-risk ratio, effectiveness, and risk of medicines, leading to the prevention of harm and maximization of benefits
Encourage the safe, rational, and more effective (including cost-effective) use of medicines
Promote the understanding, education and training of pharmacovigilance and its effective communication to the public.

Pharmacovigilance Programs in some countries of The Americas

Link to the official sites of the regulatory agencies of the main countries of the region.

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The Regional Pharmacovigilance Network of the Americas

The network is to promotes the exchange of information, resources and experiences between National Regulatory Authorities of the Americas, to strengthen the vigilance of medicine safety in the Region.

Caribbean Sub-regional Network - VigiCarib

VigiCarib is a voluntary sub-regional system that the Member States of the Caribbean Community (CARICOM) use to report suspected adverse drug reactions (ADRs) and substandard or counterfeit medical products..

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The WHO global benchmarking tool (GBT)

Tool for evaluation of national regulatory systems is the primary means to objectively evaluate national regulatory systems for medical products.

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PAHO Response

Promotes guidelines and recommendations on the safe, rational, and more effective use of medicines.
Provides technical cooperation with national medicine safety surveillance systems and encourages work through global networks to promote pharmacovigilance in countries.
Establishes and maintains links with WHO collaborating centers to provide technical support on pharmacovigilance to countries.
Encourage training to develop and strengthen the capacity of national vigilance systems for medicine safety.
Promotes studies, method development and implementation of innovative tools to generate new evidence on medicine safety.

Based on CSP30/10 "Policy for the strengthening of national regulatory systems of medicines and other health technologies", the regulatory strengthening approach addresses the following points:
Governance and stewardship
Strengthening of systems,capacities and operations
Convergence
Regulatory framework. GBT

From Pharmacovigilance the following actions contribute to this construction:

Active Pharmacovigilance

The active pharmacovigilance consist of the aplication of procedures based on systematic and detailed collection of data on harmful effects assumed to be induced by medicines in certain population groups.
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Risk Management Plans and Periodic Safety Reports

Documents that the national drug regulatory authority or other competent authority of a country requires from the marketing authorization holder of a medicine or vaccine.

Pharmacovigilance of COVID-19

Vaccines

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Medicines

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Sub-group for COVID-19 vaccines regulatory support

This sub-group provides technical support in the regulatory processes for the adequate introduction and safety surveillance of COVID-19 vaccines and related therapies.

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Recursos

Pharmacovigilance for COVID-19 vaccines dashboard

Regional vaccination dashboard

Periodic Update Reports on AEFI – COVID-19 vaccines

Herramientas

Support tool for causality assessment

Tools for the causality assessment of adverse events following immunization (AEFI)

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VigiMobile

Is a new offline app to report AEFI

Computer bridges

Computer bridges are customized software programs (developed for different structures and data-capture formats), allowing the user to transform data associated with reports of adverse events to an appropriate standard for electronic case reporting

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Pharmacovigilance toolkit

Toolbox with access to the most important resources used in pharmacovigilance

LINK TO THE TOOLKIT

Trainings

CVSP

Basic Self-Learning Course in Pharmacovigilance PAHO/WHO

:

To present and promote the understanding of the basic concepts in post-authorization safety surveillance of medicines and vaccines to contribute to the strengthening of human resources in the national pharmacovigilance systems.

Completed editions: