OTC Switch: Label Development, Testing and Rationale

OTC Switch: Label Development, Testing and Rationale

Designing a Novel Evidence-Based Approach to OTC Label Development and Comprehension to Achieve Appropriate Self-Selection

Background

Switching a drug from prescription to over-the-counter (OTC) can benefit public health and generate revenue for a pharmaceutical or consumer healthcare company.  Decision making by consumers about use of an OTC drug commonly occurs without the benefit of a learned intermediary such as a prescriber or pharmacist.

As a result, the OTC Drug Facts label is the primary risk management tool for OTC drugs.  A well-designed label enables consumers to determine if an OTC medication is appropriate for them to use based on their own medical history and current medical status.  Effective communication of dosing and when to stop use are also critical. Development of an appropriate label for the OTC product is indispensable to a successful switch attempt and depends on behavioral research such as label comprehension, self-selection, and actual use studies that meet the standards for this type of research.  Guidance from the Food and Drug Administration (FDA) describes principles and methods for conducting label comprehension studies in accordance with behavioral research standards.  

Situation

A large pharmaceutical company was evaluating the feasibility of switching a formulation of an existing prescription product to OTC.  The client asked Pinney Associates to develop an evidence-based solution to address inappropriate consumer self-selection.

Our Approach

Pinney Associates behavioral research scientists and OTC switch experts developed step-by-step approach to developing an appropriate Drug Facts label for the drug. Our experts conducted an issues assessment to define the problem, based on a detailed analysis of earlier switch decisions by the FDA, prescription experience with the drug, and previous behavioral research. 

Results

PA experts designed a novel approach to label development, label comprehension and self-selection testing to establish credible scientific evidence that the proposed label would avoid previous issues that have precluded drugs from being approved for OTC marketing.  The behavioral research program focused on the specific problem within the context of the complete label, and included evaluation of both the language and design for an OTC Drug Facts label that supports appropriate self-selection decisions.