In order to undertake the systematic approach to drug safety monitoring described above, systems and processes must be established to ensure that all the necessary information is brought together at a single point. For pharmaceutical companies this is recognised in European legislation through the establishment of a requirement for a qualified person for pharmacovigilance. Likewise, regulatory authorities now have clear obligations to transmit data to companies and other authorities. Within a pharmaceutical company or regulatory authority there may be several groups dealing with data that are relevant to drug safety. Links between groups handling pre-clinical studies, clinical trials and pharmacovigilance data are needed, and effective communication between such groups is essential. Functional drug safety groups that review all safety data generated internally or externally are required to avoid issues being overlooked. Drugs or groups of drugs should have individuals assigned (physicians, pharmacists, scientists) who have a particular interest in the field and who take prime responsibility for reviewing emerging information and undertaking initial assessments.
Any group involved in drug safety should aim to identify an emerging signal rapidly. Once an issue has been identified, information about it may be disseminated in many ways. It is important for both regulatory authorities and companies to be prepared to evaluate and manage issues regardless of the original source. Once a signal has been identified from any source the next step is to perform an initial assessment. This process is described in the next section.
Was this article helpful?