What is Pharmacovigilance Signal Management Process?
Implementation of the Signal Management process has aided in continuous improvement of health promotion and protection with clearer roles and responsibilities for safety issue detection .There is increased transparency and increasing use of validated scientific methods with a focus on simplification and increasing the efficiency. The signal management process consists of detection, validation, confirmation, analysis and prioritization, assessment and recommendation for action. Signal detection is a means of identifying new potential risks and thereafter developing risk minimization action plans to prevent or mitigate these risks at the earliest.
The professionals involved in signal management process should necessarily have the knowledge, technology and expertise to qualitatively and quantitatively assess safety data, identify new safety signals and develop risk management plans. Validation is the process of evaluating the data supporting the detected signal in order to verify that the available documentation contains sufficient evidence demonstrating the existence of a new potentially causal association or a new aspect of a known association, and thereby whether or not it justifies further analysis. It is imperative that confirmed signal should be analyzed and prioritized by the Pharmacovigilance Risk Assessment Committee (PRAC). For small and medium sized companies, assessing all signals in detail is resource intensive and hence prioritizing allows action to be taken quicker and faster. After a signal is prioritized, other sources should be systematically analyzed and reviewed to determine whether sufficient evidence of causality exists, and any further action needs to be taken. If there is a change in the benefit-risk profile as a result of a validated signal it is necessary to notify the concerned regulatory departments within the company and escalate the issue the issue as per global safety norms. After confirmation of a signal the product may be recalled/withdrawn as well as a safety information should necessarily be provided to healthcare professionals, patients. Problems and their solutions can and should be identified in each step thus indicating a good pharmacovigilance practice and thorough documentation for future signals
Future trends in signal management
In future we might see automated signal management process with computerized programs to complete laborious checklist for various adverse events. Thus, reducing time, minimizing resources and expenses.Signal management is the epicenter of pharmacovigilance and drug safety required for patient safety, by drug regulatory bodies and primarily for documenting events, measures and outcomes.
Career prospects in Pharmacovigilance
James Lind Institute provides courses in Pharmacovigilance which help in explaining and identifying relevant sources of information that can be used in signal management. Training sessions provide you with the basic concepts of signal detection and signal management and thereby designing signal management process for institutions and companies of various sizes. It also provides you with the current updates and guidelines from the various drug regulatory bodies around the world.
For more information please visit www.jli.edu.in