Pharmaceutical companies must manage their sales force to ensure that they are in compliance with the requirements for distribution, storage, and handling of the drug samples in their possession. The Prescription Drug Marketing Act (PDMA) states that all drug samples shall be stored by manufacturers or distributors under conditions that will maintain their stability, integrity, and effectiveness and will assure that the drug samples are free of contamination, deterioration, and adulteration. The Act also states that drug manufacturers or distributors shall conduct at least annually complete and accurate inventories of all drug samples in the possession of manufacturers’ and distributors’ representatives.

PDMA is part of the broader FDA regulatory umbrella that covers the State licensing of pharmaceutical sales reps. Manufacturers, distributors, and sales representatives must be compliant with FDA guidelines for State wholesale distributor licensing which gives acceptable assurance to the FDA of good storage and handling practices for drug samples. The FDA also requests that independent personnel conduct inventories of manufacturer and distributor representatives.

Solution:

In efforts to comply with PDMA and FDA requirements, many pharmaceutical companies have outsourced the audits and inventories of prescription drug samples in the possession of their sales representatives.

Global Compliance has been providing sample inventories and audits for pharmaceutical companies for six years. We have built a network of highly trained and experienced auditors, geographically dispersed across the U.S., Puerto Rico and U.S. Virgin Islands who physically count and validate drug samples in the possession of each sales representative. We continue to automate our processes and invest in technological upgrades in order to reduce the overall cycle time for conducting inventories and audits across widely dispersed sales forces.

Global Compliance was first to market with true bar code scanning of prescription drug samples allowing a paperless environment and real-time data transfer. This efficient process is completed in the following manner:

• Our experienced pharmaceutical auditors schedule appointments with sales representatives to count the representative’s current inventory stock and to evaluate their physical storage locations
• Audit observations and count data are recorded in a hand-held device using a hand-held bar code scanner (manual option also available)
• Upon audit completion, the field auditor synchronizes data collected in the hand-held device via cradle connection to a PC and a secure Global Compliance Web site
• A Physical Inventory Summary Report containing the results of the audit is generated and forwarded within hours

In addition to annual sample accountability inventories, we also accommodate:

• Random and for-cause audits
• Random physician office visits
• Fleet inspections
• Storage facility inspections
• Property collection services
• Sales representative close-outs

Outcome:

Outsourcing of sample accountability inventories and audits allows the pharmaceutical company to avoid extreme opportunity costs inherent with internal management and administration. The pharmaceutical company can focus on core competencies that include the researching, manufacturing, and marketing of the drugs while still facilitating PDMA compliance. Sales management, who has traditionally performed the sample accountability function, avoids the time consuming task, allowing them to focus on revenue-generating activities.

By outsourcing to Global Compliance, you can eliminate your current paper process while completing your inventories and audits in a more timely fashion. Our proprietary software facilitates electronic bar code scanning of drug samples and yields greater accuracy of data in addition to more rapid completion of inventories and audits, allowing immediate access to data for purposes of process tracking and reconciliation.