New paper on OTC benefit/risk framework published
November 2011

During 2011, a WSMI task force has worked with outside experts in both medicines, risk management and modeling to develop a paper illustrating a new benefit/risk model for nonprescription medicines. The paper, prepared under the authors’ editorial control through a grant provided from WSMI, was published in the November 2 online edition of Clinical Pharmacology and Therapeutics (http://www.nature.com/clpt/journal/v90/n6/full/clpt2011231a.html) under the title: ‘Improving the Decision-Making Process for Nonprescription Drugs: A Framework for Benefit-Risk Assessment’. The paper’s authors are Professor Eric Brass (UCLA, USA), Professor Ragnar Löfstedt (King’s College London, UK) and Professor Ortwin Renn (University of Stuttgart, Germany).

Three core themes within the paper and in WSMI’s efforts are:

1. OTC benefits/risks are incremental to the same ingredient when prescription
2. Risks are comparatively easy to define, while incremental benefits are less so
3. A more explicit framework can better draw out relevant questions before and during development, evaluation, risk management, and monitoring

The paper develops tools or a model that seeks to:

• Comprehensively identify benefit and risk characteristics for nonprescription drugs
• Allow for early, transparent agreement among stakeholders around benefits and risks
• Optimize benefit-risk assessment tools for application to nonprescription drugs while providing flexibility for regulators to adapt to unique needs
• Illustrate the application of the proposed tool.

The WSMI taskforce grew out of a recognition that regulators in many parts of the world are discussing or developing benefit/risk models to provide tools for a more structured way to frame or discuss data and knowledge about medicines. For non-prescription (OTC) medicines, evaluating risk/benefit models is particularly challenging: risks are frequently well documented and publicized, while the benefits can be harder to quantify or define, particularly quality of life improvements and understanding the value of something as fundamental as convenience and accessibility.