Improving the decision-making process
for non-prescription medicines 

 

An article by Professors Eric Brass (UCLA, USA), Ragnar Löfstedt (King’s College London, UK) and Ortwin Renn (University of Stuttgart, Germany) on ‘Improving the Decision-Making Process for Nonprescription Drugs: A Framework for Benefit-Risk Assessment’ was published in the Clinical Pharmacology and Therapeutics Journal. The authors examine in their article how the benefits and risks of the use of non-prescription medicines can be adequately assessed.

The benefit-risk assessment model proposed by the authors in the article is based on two main elements:

1. A value tree framework of benefits and risks for non-prescription medicines. The framework identifies the major risk and benefit areas that should be considered for any non-prescription medicine and makes it possible to populate by product-specific data each of the areas. The advantage of the value tree framework is that it can be applied early in development and therefore facilitate discussion with competent authorities. It can be considered as the first step in the assessment process (‘pre-review step’).


https://pbs.twimg.com/media/AmPqcYkCEAACmKC.jpg
Brass, E.P., R. Lofstedt, and O. Renn, Improving the Decision-Making Process for Nonprescription Drugs: A Framework for Benefit-Risk Assessment. Clin Pharmacol Ther, 2011. 90(6): p. 791-803.


2. Integrating the value tree framework with a multi-criteria analysis tool for decision making, the “OTC nautilus”, is the second element and step of the assessment model. The “OTC nautilus” includes a multi-stage process. It starts with a pre-review phase which is then followed by a review of benefits and risks, a phase of benefit-risk characterization (constructing benefit-risk profiles), evaluation (multicriteria analysis) and risk management, including monitoring and control. Benefit-risk communication and stakeholder involvement are pivotal elements to the process and each of the various phases referred above.


https://pbs.twimg.com/media/AmPr1elCEAAW9Rs.jpg
Brass, E.P., R. Lofstedt, and O. Renn, Improving the Decision-Making Process for Nonprescription Drugs: A Framework for Benefit-Risk Assessment. Clin Pharmacol Ther, 2011. 90(6): p. 791-803.


Together, the proposed tools:

  • Allow the comprehensive identification of relevant benefit and risk features of non-prescription medicines in general as well as of specific products intended to be moved from prescription to non-prescription status.
  • Facilitate early agreement between companies and regulators on the most important characteristics of the product under consideration, the potential data gaps and the best approach for an integrated benefit-risk assessment.
  • Use adequate benefit-risk methods and in particular multi-criteria analysis.
  • Integrate evidence, transparency and communication into the decision making through balanced expertise.