International OTC evaluation
November 14, 2011
A VALUE-tree method of over-the-
counter medicines regulation
has been proposed in a new report
commissioned by the World Self
Medication Industry.
Published in the Clinical
Pharmacology and Therapeutics
journal, the method defines the
important benefit and risk domains
relevant to nonprescription drugs.
According to the report the value
tree could be used to identify
product-specific attributes in each
domain and could also support
formal benefit–risk assessment
using tools such as a modification
of the International Risk Governance
Council framework which
“systematises an approach to issue
review, early alignment
of stakeholders, evaluation, and
risk mitigation/management”.
The report has been welcomed by
the Australian Self-Medication
Industry which said “it is important
for the medicines industry to
collaborate with regulators to
develop a practical benefit/risk
framework to apply to the OTC sector”.
“The proposed model is based
around a tailored benefit/risk
framework that applies a broader
definition of “benefits”, beyond
clinical trial data, and includes
elements such as consumer
satisfaction, dependency on
healthcare systems and time-off work.
“Our hope is that this will help to
start discussions between regulators
and industry on the way that product
submission and applications can
be assessed with greater
consistency and certainty in the
future,” ASMI’s Executive Director
Dr Deon Schoombie added.
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