The core of any pharmaceutical company’s pharmacovigilance process is the safety data. This data is collected through multiple sources, including spontaneous reports, clinical trials, observational studies, registries and surveys of patients or healthcare providers.
The safety data from a product may be collected from thousands of clinical trial patients before it is approved for the market; however, the signal will become more profound and new signals will arise when the product finally reaches millions of consumers. Post-marketing surveillance studies and observations are a significant source of safety signals in drug safety. But contrary to the clinical safety data, the collection of postmarketing safety data is less structured and more diverse, so pharmaceutical companies need to proactively seek and acquire safety data through multiple media and sources.
Collecting post-marketing safety data is complex, largely because of the amount of communication required to reach multiple media, sources and destinations. By identifying an effective communication system that channels the knowledge of the safety profile and the importance of product risk surveillance to the targeted media, the pharmaceutical company can enhance the quality of the safety data it receives, while extending the risk management programme outwards.
Safety data collection can be proactively planned through the implementation of product-driven web forums and patient registry programmes that promote direct lines of safety surveillance to capture the rational and desirable data.
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