As consumers and health systems move toward greater reliance on self-care, regulatory and clinical decision making should be improved through new tools to assess the unique benefits and challenges of self-care non-prescription [‘over-the-counter’, (OTC)] products, according to a new White Paper published in the peer-reviewed journal Clinical Pharmacology & Therapeutics.
Regulators are working within a complex environment where systems to assess non-prescription medicines and approaches vary from country to country. There is often insufficient distinction between the evaluations of prescription-only and non-prescription medicines. Current approaches focus more on risk, rather than its management, and tend to overlook the particular beneficial features of non-prescription medicines. Often some attributes, like quality of life enhancements and the value of access and convenience, are difficult to incorporate within current regulatory frameworks.
In response to the current situation, Professor Eric Brass (University of California, Los Angeles) has collaborated with Prof. Ragnar Lofstedt (Kings College, London), and Prof. Ortwin Renn (University of Stuttgart) to create a new benefit-risk framework that allows comprehensive identification of relevant benefit and risk features for non-prescription medicines.
The researchers use a “Value-tree Framework” that allows identification of the benefits and risks, and identification of those that are most clinically relevant. The approach facilitates early dialogue and agreement between manufacturers and regulators on the weighting of the most important characteristics, key gaps in the data and the approach to integrated benefit-risk assessment.
To assist with decision-making processes over time, the method also supports alternative formal benefit-risk methods, including multiple criteria analysis. The team used a revised International Risk Governance Council (IRGC) Framework to create a so-called “OTC Nautilus” that emphasizes transparency, communication and evidence-based decision making supplemented by balanced expert opinion.
“While today we focus so much on risk mitigation, it is likewise vital for us to ensure there is a thoughtful consideration of the benefits that may be derived from a given product,” said Prof. Lofstedt. “Any risk needs a frame of reference and our approach, using in this case the revised IRCG framework, is designed to give regulators and other stakeholders a more holistic look at a product and its intended use.”
“The right tools can facilitate more fully informed regulatory decisions with a view to enabling appropriate access to effective non-prescription medicines while protecting the public’s health,” said Prof. Brass.
The paper complements wider World Self Medication Industry (WSMI) modernization initiatives to enhance appropriate access to non-prescription medicines globally.
“Industry and regulators must unite to advance the way we view and regulate self-care products by embracing new tools such as the new benefit-risk framework that will help ensure the consumer will continue to have access to valuable medicines under appropriate regulatory control,” said Dr David Webber, Director-General of WSMI.