A value tree for BR assessment of non-prescription drugs

Reproduced from Brass, E.P., Lofstedt, R., & Renn, O. 2011. Improving the Decision-Making Process for Nonprescription Drugs: A Framework for Benefit-Risk Assessment. Clinical Pharmacology & Therapeutics, 90, (6) 791-803.

The value tree above is a visual, hierarchical depiction of key ideas, values, or concepts used in decisions for non-prescription drugs nicotine replacement therapy (see Brass 2011).The centre column identifies the major risk and benefit domains that should be considered for any non-prescription drug. The right-hand column is populated by product-specific attributes mapping to each domain. Each central domain may have attributes, ranging from none to several, that are of relevance for a specific product.The fixed domains were suggestedin benefit-risk assessment of non-prescription drugs to encourage better comprehension and comparable assessment across these drugs. The absence of quantitative data may invite misinterpretation, for example, there are four benefit criteria and five risk criteria in value tree above, which might be seen as slightly greater risk of nicotine replacement therapy than its benefit. The multiple connecting arrows from the central column to the right-hand column may also complicate the judgment further because it becomes unclear how a child node (end of arrow) with more than one parent node (beginning of arrow) is to be analysed.