New Standardized Criteria to Identify Adverse Events of High Severity

pharmaceuticsPM CLINICAL takes a look at the concept of adverse event and possible criteria established by EMA to identify serious adverse events.

In recent years, the European Regulatory Authorities have launched a number of new initiatives to improve the field of Pharmacovigilance, which paved the way for new European legislation adopted in 2012. These efforts have also included the creation of the Pharmacovigilance Risk Assessment Committee (PRAC), known for improving the EudraVigilance database, public pharmacovigilance with the introduction of new training courses and a new medical monitoring services. Other important PRAC objectives include a faster intervention on patients by the regulatory authorities and a greater network that allows various drug users to exchange information.

These improvements can be applied in a wide range of medical events, which can happen for different reasons, mostly categorized as “serious”; causing the EMA to make a list of criteria to help pharmaceutical companies identify the right level of severity of them.

An adverse event can be defined as an “any unfavorable episode of a medical nature that happens to a patient or a subject participating in a clinical trial in which a pharmaceutical product is administered and does not necessarily have a causal relationship with this treatment “.

According to EMA, following the new regulations, the list of so-called adverse events designated records with 62 entries; containing serious medical events, often causally associated with drugs in various therapeutic / pharmacological cases that may occur due to the use of various health products: including anaphylactic shock, blindness, liver failure, pancreatitis, pulmonary hypertension, and ventricular fibrillation.

Therefore, the EMA decided to list them all, along with the working group of experts EudraVigilance. These were as follows:

• Death,

• Deadly disease,

• Request hospitalization or prolongation of hospitalization,

• Persistent or significant disability / invalidity,

• Congenital anomaly / birth defect

PM Clinical recommends use of expert support for all Pharmacovigilance operations, in order to obtain the best results in terms of Quality & Compliance. PM Clinical provides consulting services for drug safety and risk management for the collection, monitoring, evaluation and analysis of information on drug safety and the detection of new adverse events. Our team is composed of personnel with 30 years of experience in the area of pharmacovigilance and headed by a Director who is a qualified EU QPPV.