title: Embedding 'speaking up' into systems for safe healthcare product development and marketing surveillance.
abstract: Robust, active cooperation, and effective, open communication between all stakeholders is essential for ensuring regulatory compliance and healthcare product safety; avoiding the necessity for whistle-blowing; and, most essentially, meeting the transparency requirements of public trust.The focus here is on what can be done within a healthcare product organization (HPO) to achieve actionable, sustainable policies and practices such as leadership, management, and supervision role-modelling of best practice; ongoing process review and improvements in every department; protection of those who report concerns through robust policies endorsed at Board level throughout an organization to eliminate the fear of retaliation; training in open, non-defensive team-working principles; and mediation structure and process for resolution of differences of opinion or interpretation of contradictory and volatile data.Based on analyses of other safety systems, workplace silence and interpersonal breakdowns are warning signs of defective systems underlying poor compliance and compromising safety. Remedying the situation requires attention to the root causes underlying such symptoms of dysfunction, especially the human factor, i.e. those factors that influence human performance. It is essential that leadership and management listen to employees' concerns about systems and processes, assess them impartially and reward contributions that improve safety.Fundamentally, the safety, transparency, and trustworthiness of HPOs, both commercial and regulatory, can be judged by the extent of the freedom of their staff to 'speak up' when the time is right. This, in turn, consolidates the trust of external stakeholders in the safety of a system and its products. The promotion of 'speaking up' in an organization provides an important safeguard against the risk of poor compliance and the undermining of societal confidence in the safety of healthcare products.
authors.affiliation: NDA Regulatory Science Ltd, London, UK. brian.edwards@ndareg.com
authors.forename: Brian
authors.initials: B
authors.lastname: Edwards
authors.forename: Bruce
authors.initials: B
authors.lastname: Hugman
authors.forename: Mary
authors.initials: M
authors.lastname: Tobin
authors.forename: Matthew
authors.initials: M
authors.lastname: Whalen
mesh_terms: D001291:Attitude of Health Personnel; D003142:Communication; D004345:Drug Industry / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D004364:Pharmaceutical Preparations / Q000592:standards; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000592:standards; D035642:Whistleblowing / Q000523:psychology*
chemical_list: D004364:Pharmaceutical Preparations