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TITANIUM PLATFORM

Sample Program

Hand-carry, direct-to-practitioner, direct-to-representative, hybrid, remote sampling and more

Distribution Management

Full-service and nationally available warehousing, fulfillment, distribution, and logistics services

Compliance Program

Spend transparency, practitioner license validation, representative licensing, and distribution licensing.

KOL & Targeting

Key opinion leader identification, sentiment analysis, and dynamically generated HCP targets

Digital Solutions

Hosted web portals, e-signature capture, and alternative e-commerce digital channel capabilities

Learning Programs

Online & asynchronous enterprise training

CASE STUDY

Optimizing Sample Loss Reporting for PDMA Compliance

Strategic Compliance Enhancement: Tailoring Sample Loss Thresholds in Pharmaceutical Marketing

The Background

The Client, a mid-size pharmaceutical manufacturer actively promoting, and sampling multiple products, engaged QPharma to ensure compliance with the Prescription Drug Marketing Act (PDMA). This included mandatory reporting of significant losses of drug samples to the FDA, a requirement under 21 CFR §203.34(c). The initiative was driven by increased regulatory scrutiny under §6004 of the Affordable Care Act, and the company’s transition to QPharma’s services, recognizing the need for a well-documented rationale and robust compliance procedures.

 

The Challenge

 

    • The Client had a numerical value assigned for reporting a significant loss and it was applied to all products

    • Products being sampled have varying degrees of associated risk such as black market, and recreational value, thus increasing the likelihood of diversion

    • Neither the Client nor the former vendor partner could produce documented rationale regarding how the numerical threshold was determined

 

The Story

The client required a tailored, risk-based framework to establish compliant, and justified drug sample loss thresholds for various products.

 

QPharma’s Solution

 

    • Risk Assessment Framework: QPharma implemented a proprietary matrix to create a risk profile for each sampled product, setting lower loss tolerances for higher-risk products.

    • Factors Considered for Loss Tolerance: Key factors influencing the Significant Loss Threshold (SLT) included market status, public health impact, distribution packaging, sampling volumes, black market potential, and production costs.

    • Flexible Loss Metrics: The methodology allowed the client to adopt specific loss metrics—either as a percentage, a numerical quantity, or a combination of both—tailored to each product’s risk profile.

 

Titanium Results

The Client was able to provide appropriate SLT rationale documentation for each product sampled with its higher risk products having a lower loss tolerance. The adjusted loss thresholds not only satisfied the Client’s compliance concerns, but also allowed the business to more closely monitor its higher cost samples and adjust its marketing strategies accordingly.

Table of Contents

4 Reasons
Why People Choose QPharma

It is a long established fact that a reader will be distracted by the readable content of a page when looking at its layout.

Industry Leading Solutions

Combining subject matter expertise with technical excellence, we offer comprehensive solutions tailored to meet the diverse needs of our clients.

Unparalleled Compliance Expertise

Our deep understanding of PDMA compliance and industry best practicesensures adherence and support in meeting regulatory requirements.

Tailored to Your Needs

Titanium is configurable and scalable, allowing customization to meet your specific business needs, whether you require standard, ad-hoc ,or custom reporting options.

White Glove Customer Service

We prioritize building solid partnerships with our clients, providingpersonalized and responsive support throughout our relationship.

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TITANIUM PLATFORM

Sample Management

Hand-carry, direct-to-practitioner, direct-to-representative, hybrid, remote sampling and more

Distribution Management

Full-service and nationally available warehousing, fulfillment, distribution, distribution licensing, and logistics services

Compliance Program

Spend transparency, practitioner license validation, and representative licensing

KOL & HCP Targeting

Key opinion leader identification, sentiment analysis, and dynamically generated HCP targets

Digital Solutions

Hosted web portals, e-signature capture, and alternative e-commerce digital channel capabilities

Training Solutions

Online & continuing education enterprise training

INDUSTRIES SERVED