What is the Regulatory Framework for Pharmacovigilance

The World Health Organization (WHO) defines Pharmacovigilance as the set of activities for the detection, recording and evaluation of adverse reactions, with the aim of determining the incidence, severity and causal link with drugs, based on a systematic and multidisciplinary study of the effects medicines.

Notification System Overview

The most important objective of pharmacovigilance is the identification of adverse events related to medications. Clinical observation and notification of suspected adverse reactions are usually the fastest and most effective methods to generate alerts (or signals) or causation hypotheses, and also to design specific studies of active pharmacovigilance that will allow knowing the safety profile of medications used by the general population and those destined for specific subpopulations.

In order for any of the pharmacovigilance systems applied to be effective, all health professionals in contact with patients taking medications must be involved in the notification. Do not forget that all this information must be centralized in a specialized agency and be endorsed by the health authority, for its timely dissemination to the community.

What is an adverse drug reaction?
The WHO defines adverse drug reaction as “Any harmful and unwanted response to a drug that occurs at doses commonly used for prophylaxis, diagnosis or treatment or for modifying physiological functions”.

What is the importance of Pharmacovigilance?
The notification of suspected adverse reactions to medicines by health professionals, allows the detection of signs associated with the safety of medicines, which can lead to:
• Detection of new adverse drug reactions;
• Change in the frequency of adverse reactions already known;
• Identification of new drug interactions;
• Issues associated with how to use the medication;
• Better knowledge of the medication profile.

Who should report adverse drug reactions?
Doctors, Pharmacists, Nurses or other health professionals. In case of suspected adverse reaction, the user can share the case with his doctor
or pharmacist so that he can notify the competent authorities.

How to report an adverse reaction?
Health professionals can submit reports of suspected adverse reactions associated with Lundbeck’s drug for:

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