Drug Safety 2007; 30 (10): 919-990 0114-5916/07/0010-0919/$44.95/0
ABSTRACTS
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Oral Presentations O.16 The Culture of Safety: Why a Product is Only as Safe as the Healthcare System Allows A. Olsen1,2 1 Pharmaceutical Safety Institute, New Hope, Pennsylvania, USA; 2 Quintiles, Inc, Raleigh, North Carolina, USA In addition to the principles described in the Erice Manifesto of 2007, the U.S. Institute of Medicine (IOM) report (“To Err is Human”), the 2005 Declaration of Luxembourg declares that a “culture of safety” is essential for restoring trust in the safety of healthcare systems. This naturally should extend throughout the life sciences sector, yet little has been debated. Safety culture must be implemented systemically and not in a piecemeal fashion simply addressing individual organisational short-comings: Robust processes of interaction within and among the range of stakeholders are required (from regulators and healthcare providers through research sponsors and their representatives) to define the dimensions of safety culture and drive reform. Over the past forty years, advances in pharmaceutical and device technology, as well as commercialisation and globalisation, have outpaced the ability of the medical products sector to improve performance in Safety. The current safety system is inadequate, reinforced by evidence of society’s reaction to product withdrawals and multiple public and industry surveys and polls. In addition, with the increased emphasis on corporate social responsibility, there is a significant negative impact of litigation on the reputation of the whole sector. Implementing a collaborative safety culture applicable to the continuum of drug development is necessary for the Global Human Community. The presentation will address how organisations can counteract the current reactive and divisive approach to safety founded on blame, this will include: Discussion of the Guiding Safety Principles to act as business ground rules for safety and how future benchmarking will help implement the Principles; A safety competency framework to define the core responsibility roles within the System, such as how the Chief Safety Officer (CSO) in a company relates to the Qualified Person for pharmacovigilance (QPPV); and, Processes and techniques for implementing a blame-free and reporting culture based on continuous improvement and organisational learning including human factors training and systems-based thinking. Overall, the presentation will aim to stimulate debate and action about increasing collaboration to move forward a safety culture based on Principles driven by the needs of our customers and underpinned by regulations.
