Pharmacovigilance is defined by the World Health Organization as the detection, assessment, understanding and prevention of adverse reactions or other safety issues associated with medicines and medical devices.

 

 

Pharmacovigilance aims at detecting, recording and assessing adverse reactions to drugs and medical devices in order to prevent them.
The implementation of the Pharmacovigilance System is focused on maximizing benefits and minimizing risks in the use of our products in the community.

 

 

The security monitoring goes along with the product´s entire lifecycle, whether it is a new drug, a generic drug or an older medicine available on the market, for which is always possible to detect new evidences regarding their safety profile.

The spontaneous reporting of adverse reactions by health professionals is a valuable information that needs to be collected, processed and then 'returned' to the medical community and to patients. Thus, it is provided access to the latest and most accurate information about drug safety.

Through continuous and effective monitoring of drug safety it is possible to inspire and build the confidence of patients, health professionals and society as a whole.

 

 

In Pharmacovigilance, a safety sign consists of a hypothesis supported by data which may or may not justify the relation between the event and the suspected drug. Thus, it is a warning that needs further investigation. Although the safety signs may arise from other sources, the most common source is spontaneous reporting.

Examples of Safety Signs:
A new side effect that was not described before
The increased severity or specificity of a known adverse effect
Increasing frequency of a known adverse effect
New drug interactions

Any new information about contraindications, precautions and overdose

 

Adverse reaction is any noxious and / or unintended reaction to a drug, which occurs at doses which are normally used in humans for prophylaxis, diagnosis, treatment of diseases or recovery, correction or modification of physiological functions.

 

 

Adverse Drug Reaction (ADR)

Any noxious and/or unintended reaction to a drug, which usually occurs at doses used for prophylaxis, diagnosis, treatment of diseases or recovery, correction or modification of physiological functions, in human use. There is a cause-effect relation between the adverse event and the drug.

 

Serious Adverse Reaction

Any adverse reaction that is life-threatening, leads to death, requires hospitalization or its prolongation, results in a significant or persistant disability, involves a congenital anomaly, or also if it is classified as medically important.

 

Unexpected Adverse Drug Reaction

An adverse reaction whose nature, severity, intensity, or effect is incompatible or not described in the Summary of Product Characteristics.

 

Quality problems

Non-compliance of drug parameters (altered integrity, visible abnormalities and contamination by microorganisms and other changes in the final product).

 

Lack of Therapeutic Effect

Absent effectiveness of product / drug.

 

Other Problems

Labeling errors in the Product Information Leaflet (PIL) and / or packaging of the product / drug, which may have some interference, namely in the therapeutic compliance and effectiveness or in the exacerbation of the adverse reactions.

 

 

The causal attribution made by Well Pharma refers to a clinical judgment that determines if a product/drug could be responsible for the emergence of an adverse reaction.
Once proven or not a causal relation between the adverse reaction and the drug/product, a decision is taken, which eventually leads to contact the competent authorities and other health professionals, and apply the appropriate safety measures.

 

 

The notification of adverse reactions to drugs in clinical practice by health professionals, allows detection of rare adverse effects or specific ones to certain races, geographic regions or different clinical settings.
The evaluation of safety signals is of utmost importance in the notification process.

 

 

All suspected serious adverse reactions, even those already described in the Summary of Product Characteristics.

All suspected adverse reactions not described in the Summary of Product Characteristics, serious or non-serious.

All suspicions of an increased frequency in adverse reaction, whether severe or non-severe.