Customized Compliance Solutions
Full compliance with industry regulations for drug samples is an essential part of your marketing efforts. If your company has existing compliance policies and procedures, DirecTeam CSO™'s project team can incorporate them into the program we develop for you. If the client prefers, our team is also qualified to assume full responsibility for generating the policies and procedures that ensure compliance with the requirements of the Prescription Drug Marketing Act (PDMA).
The PDMA requires that drug manufacturers or distributors conduct complete and accurate inventories of all drug samples in the possession of their sales representatives, at least annually. The FDA recommends assigning personnel who are independent from a company's sales and marketing function to conduct the annual inventories and to reconcile the sales representatives' sample activities.
The client and DirecTeam CSO™'s project team work in close partnership to create the distinct features of a sample management program that best fits client needs and satisfies all reporting and sample management regulations. Solutions can range in sophistication from straightforward, paper-based systems all the way up to fully automated signature capture systems.
DirecTeam CSO™'s experienced managers will ensure that the following minimum requirements are met:
- Maintain an up-to-date list of representatives' sample storage locations;
- Determine that storage conditions are consistent with maintaining the samples' stability, integrity, and effectiveness;
- Determine that security and storage conditions are adequate to protect drug samples from contamination, deterioration, or adulteration;
- Ensure that representatives are appropriately authorized to handle samples in those states that require registration at the representative level;
- Ensure that all sample-related activities and inventories are promptly reconciled at the predetermined intervals;
- Ensure that records (paper or electronic) of sample request and distribution capture the information required by the PDMA;
- Manage, if necessary, record retention and retrieval for the client;
- Investigate and report unresolved sample inventory discrepancies to the client;
- Conduct, at least annually, a physical inventory of the representatives' sample storage locations;
- Coordinate, as necessary, random and for-cause audits;
- Coordinate signature verifications and/or random physician visits;
- Coordinate sales close-outs of sales representatives' territories and client property collection.