Patient Safety & Product Quality

Policies and approach

The Group takes patient safety very seriously. Patient safety is fundamental to the integrity of its global brands and businesses. The Group actively promotes responsibility and concern for the safety of its patients, products, employees and the general public in all aspects of its business.

Management Systems

Patient safety and product quality are embedded in the Group’s culture and patient-focused business model.

The Group operates a Patient and Product Safety Group which includes pharmacovigilance medical teams established to monitor the safety of the Group’s marketed and investigational products in a comprehensive manner on a continuous basis.

This also includes a Risk Evaluation and Mitigation Strategies (REMS) program to mitigate the risks of accidental overdose, misuse and abuse for SUBOXONE Film and to mitigate the risk of serious harm or death that could result from intravenous selfadministration for SUBLOCADE™ in the US. The Group measures the impact of the REMS program and reports the results to the US FDA as required.

Indivior believes that patient safety and product quality are not just an obligation but a responsibility.

Connecting patients to help

In 2017, over 9.1 million unique visitors in the US accessed Indivior’s opioid dependence websites, representing a 3% increase over 2016 visits.

Turn-to-Help.com is a patient and family resource for educational materials on the disease of OUD and treatment options. The site also provides a search tool for patients to help them locate a waivered healthcare provider in their area.

Suboxone.com is intended to support patients at each stage of their journey, including providing tools to help patients find a waivered healthcare provider as well as providing savings cards for medication.

In 2017, nearly 613,000 ‘Find A Doctor’ searches were completed on these two websites.

In Australia, Indivior also makes available for patients a website, TurntoHelp.com.au, to connect families and patients to resources.

Global quality

Our responsibility is to the patients we serve. To this end, we are committed to a culture of innovation and quality defined by the following four principles:

  • Our patients are at the heart of what we do and we continually seek to build and maintain their trust in us. This drives our passion for the continuous improvement of our products and processes and is at the heart of our guiding principles.
  • Our people are empowered to continuously identify and evaluate risk and we are focused on achieving ‘zero’ quality defects and waste. Our people have confidence in the products we manufacture and distribute globally.
  • Our regulators are viewed as partners in helping us achieve standards of excellence. We seek to ensure our quality systems and processes are globally harmonized, and view feedback as continual learning opportunities.
  • Our shareholders understand our culture of quality. We focus on creating value by driving continual improvement, seeking to achieve excellence in compliance at all levels, standardizing and simplifying our processes to reduce costs and flawlessly executing our pipeline and supply chain so that our growth potential is exceeded.