How does medicine become safer?
The longer a medicine is on the market the more we are able to identify, characterize and report new or changed risks associated with its use; this leads to a better understanding of its effects in different patient populations.
The collection of safety reports ensures a company can provide the most complete information on the safety of its products to patients, healthcare professionals and to its regulators.
Monitoring the safety of a medicine once it is on the market is the cornerstone of Pharmacovigilance.
Here are the three essential processes that heavily contribute to the evaluation of adverse events and help to make a medicine safer to use.
1. Adverse Event Handling
Adverse event reports, also referred to as “Individual Case Safety Reports” in the industry, are an important source of safety information used to develop and monitor a medicines safety profile. Once received, a reported adverse event has to go through vigorous stages of review and assessment. Such reports will then need to be shared with regulatory authorities.
2. Risk Management
Whilst adverse event handling is a focal point of Pharmacovigilance and requires great resources, the aim of risk management is to address uncertainties in the safety profile of medicines at different points in the product life-cycle, and to plan accordingly. This essentially determines what side effects are listed within a medicines packaging.
Specialists determine to what extent the medicine could have caused the adverse event based on the information provided, this is known as “Causality Assessment”. A patient’s prior overall health, diet, and medical history play an important role in how they will react to the product; However, this information is often not provided initially in sufficient detail, requiring a rigorous process that requires further information gathering or follow-up.
The accumulated number of cases will eventually construct enough data to better define a medicines safety profile. When a new unexpected trend of adverse events is identified, it is managed as a “signal” and will be assessed to identify the risk to specific to a patient population.
3. Regulatory Compliance
Governments regulate the manufacturing, marketing, and distribution of medicines in an effort to protect the public’s interests. This is enforced through various guidelines that manufacturers and importers of medicines have to abide by. These guidelines often include reporting of ‘Adverse Events’ and ‘Aggregate Safety Reports’ to regulatory authorities.
Furthermore, regular or even spontaneous inspections by regulatory authorities are used to ensure compliance.
Many regulatory authorities have now developed systems to allow patients to report adverse events directly to their authority’s database. These are then accessed by the manufacturer to be included in the safety surveillance of the respective medicine.
Although there is much more to demystify for the general public in regards to what makes their medicine safe, these three short summaries describe the building blocks essential for a robust Pharmacovigilance system.
Author: Ruben Ebert
Editor: Alex Fernandez
