Product safety and pharmacovigilance
Pharmacovigilance is the science of identifying, evaluating, understanding and preventing the adverse effects that can occur with the use of medicines. It’s all about identifying and minimizing risks posed to patients and appropriately communicating them in our product labelling. Risk management involves both the assessment of risk related to the most important adverse effects and the efforts taken to minimize them. Nothing is more important to us than the safety of the people who use our products.
Every drug goes through rigorous safety testing before it’s approved for use, but very rare side effects may only become apparent after it goes on general sale. Some side effects may affect less than one in 10,000 patients, but they require the same assessment and monitoring as more common side effects. This is one of the tasks of our pharmacovigilance department.
Shire’s focus on a relatively small number of specialist disease areas helps us to develop relationships with the physicians that treat those diseases and with groups representing patients. These relationships provide helpful communications channels and are one of the ways in which we can quickly hear about unexpected or unusual side effects experienced by patients. Any adverse events are then reported to the relevant health authorities and are used in the continual assessment of the risk/benefit profile of a medicine. Within Shire, our safety governance process ensures that senior management is apprised of significant safety issues associated with our products.
We compile detailed risk management plans for our products as needed, and continue to ensure that we promptly update our product labeling with new information. We comply fully with global regulations regarding investigational and post-marketing drug safety and successfully undergo the periodic assessments and inspections made by major regulatory authorities, including the U.S. Food and Drug Administration and the European Medicines Agency.
As part of our ongoing Responsibility commitment to product safety and pharmacovigilance, we will continue to evaluate safety data in real-time, including reports from health care professionals, patients and other stakeholders; data from ongoing clinical trials; and information published in the medical literature. This will ensure that prompt decisions are made about adding new information to our product labels that can assist health care professionals and patients in making benefit-risk decisions. We will also develop and implement risk management strategies for our marketed products, and ensure that we have the right processes and systems in place to fulfill the demands of evolving global legislation and regulations related to pateint safety evaluation.
Reflecting on 2011
- Enhanced our processes to comply with new global safety regulations, including implementation of the new FDA clinical trial safety data evaluation requirements
- Developed risk management plans for Shire products undergoing registration in new global markets
- Implemented the use of insurance company claims databases, when appropriately suited, to supplement the evaluation of postmarketing safety information
Core to our responsibility mission is ensuring on behalf of our patients and their healthcare providers that Shire has the right processes and capabilities to evaluate and communicate the safety of our products—both those undergoing clinical investigation as well as those marketed worldwide.
Susan Rosen
Senior Vice President Global Pharmacovigilance and Risk Management
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