Causality Assesment

While initially a suspect, the reporting of adverse reaction must go through an analysis of causality. 

The World Health Organization recommends that the analysis of causality follow certain patterns. In its official website http://www.who-umc.org/DynPage.aspx?id=22682, there are general guidelines to determine if a suspected adverse reaction is related to drug use.

Therefore, a suspected adverse reaction can be:

• CERTAIN
• PROBABLE/ LIKELY
• POSSIBLE
• UNLIKELY
• CONDITIONAL/ UNCLASSIFIED
• UNASSESSIBLE/ UNCLASSIFIABLE

Uppsala Monitoring Centre

Importance of spontaneous reporting

Spontaneous reporting is the core data-generating system of pharmacovigilance, relying on healthcare professionals (and in some places consumers) to identify and report any suspected adverse drug reaction to their national pharmacovigilance centre.

Through the analysis of spontaneous cases there is the opportunity to assess early signs of possible changes in the risk profile of the drug.

Initially, the spontaneous reporting is a suspect. It is necessary to verify whether there is causal link between the emergence of adverse effects and use of the product, or to what extent the drug may actually be involved with the adverse symptoms experienced by patients. It´s called Causality Assesment

Importance of Pharmacovigilance

Before being placed on the market, the products go through rigorous testing and are developed through systematic scientific research. Only after an extensive review of studies in animals and data on safety and efficacy (pre-clinical tests) is that the drug passes through the phase of clinical research (phases I, II and III). 

Even with the scientific rigor to clinical studies are conducted after approval the drug will win a much larger scale: millions of patients may use the drug in uncontrolled situations. 

Hence the importance of pharmacovigilance: examining the risks involved with the use of the pharmaceutical product in "real world".

Pharmacovigilance - Risk/Benefit

Although they have been designed to bring benefits to patients, no drug is free risk of causing adverse reactions. The risk is inherent to the treatment. 

Managing this risk is primary responsibility of this new science called of "PHARMACOVIGILANCE. 

Best practices to manage this risk is what we will discuss carefully in this blog.