Patient's role in pharmacovigilance

by Fleming. Team

Read the full interview with Carlos Nunes from The European Federation of Allergy and Airways Diseases Patients’ Associations, Portugal, and learn about the current role of patients in pharmacovigilance.

1. How has patient engagement changed in the past five years?

In recent years, we have observed very positive development regarding patient engagement. In the past five years, it has increased almost threefold.

The major report has come from medical doctors and pharmaceutical companies – it is 45% each. The other 10% has come from other sources such as nurses or patients themselves.


2. To what extent do patients use the option of reporting adverse events directly?

In the last six years, the patient associations have done a great job. Direct reporting of adverse events increased from 2-3% in 2008 to 7% in 2015. Most of the direct reports of adverse events came from patients suffering from:

General disorders and administration site conditions – 17%
Skin and subcutaneous tissue disorders – 13%
Gastrointestinal disorders – 10%
Nervous system disorders – 9%
Infections and infestations – 7%
Blood and lymphatic system disorders – 6%
Respiratory, thoracic and mediastinal disorders – 5%

Among the active substances with the highest number of direct reports of adverse events belong the following:

Antineoplastic Agents – 26%
Immunosuppressants – 8%
Antivirals for Systemic Use – 6%
Antibacterials for Systemic Use -6%
Immunostimulants – 5%


3. Do you think they have enough information about the importance and the process of reporting adverse events?

Currently, patients have a lot of information about the process and its importance. Unfortunately, the percentage of direct adverse events reporting should have been higher. There are still several difficulties and barriers to overcome, however, in the last years there has been an increase of online reports.

Find out more about patient's role in pharmacovigilance at the

Europe Pharma

Pharmacovigilance & Risk Management Strategies

Visit event website

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