Nonprescription drugs provide unique challenges to regulators. The improved access associated with nonprescription access vs. prescription status may permit additional consumers to access effective drugs. However, the use by consumers of drugs in the absence of healthcare professional supervision may result in unacceptable rates of misuse and suboptimal clinical outcomes. The project applies and modifies the IRGC risk governance framework for identifying, assessing and managing important risk and benefit domains relevant to nonprescription drugs. The framework can be used to comprehensively identify product-specific attributes in each domain. This approach has the potential to provide a structured and transparent tool for regulatory decision making for nonprescription drugs.
- Ragnar Löfstedt, Kings College, London
- Eric Brass, Harbor-UCLA Medical Center, USA