By Judy Fox
Commandment #10 – Thou Shalt Conduct Inventory and Reconciliations
The PDMA states, “…a manufacturer or authorized distributor of record that distributes drug samples shall establish, maintain, and adhere to written policies and procedures describing its administrative systems for…conducting the annual physical inventory and preparation of the reconciliation report…”
While inventories and reconciliations are established in written processes and procedures, the two entities deserve their own commandment.
The PDMA requires that at a minimum an annual inventory and reconciliation must be conducted. The best way to determine if more frequent inventories and reconciliations are warranted, a pharmaceutical company should determine how they will use the information that is collected, what other methods are utilized to determine compliance, if the volume of sampling activity would warrant more frequent monitoring and reconciliations. The physical inventory and reconciliation must be conducted by someone other than the sales representative.
A reconciliation report takes into consideration all activities surrounding samples, such as shipments, transfers, theft and loss, and of course, disbursements. Some pharmaceutical companies conduct only the required annual physical inventory and reconciliation, others find it helpful to conduct them throughout the year and use the results to monitor their sampling program.
Reconciliation reports, regardless of the frequency, should all be disbursed at the same time, with everyone receiving a report regardless of the reconciliation status. Those that are below the acceptable threshold (or considered “reconciled”) should receive a report and those that are above the acceptable threshold should receive the initial report and updated reports as they work through the reconciliation process. Everyone should be instructed to keep all reports with their other documents for a minimum of three (3) years.
Significant loss thresholds should be determined through several factors including, but not limited to the potential for diversion of the drug, the volume of sampling and the cost of the drug. Many companies find it helpful to establish a corporate threshold to bridge the gap between an acceptable reconciled variance and a reportable variance level.
A corporate threshold will serve to identify employees with a potential for reportability or those who may repeatedly “fly under the radar” of reportability, but warrant further corporate surveillance.
Thresholds can be determined by using variance percentages, quantities or a combination of both, as long as the threshold remains privileged information and is not shared with the corporate sampling community.
In addition to fulfilling the PDMA requirements, Pharmaceutical companies often have a wealth of information in the data collected for reconciliation reports and don’t do anything with it.
The information in reconciliation reports can serve as a business tool and is often used to determine and evaluate sampling trends for the sales and marketing team, “red flag” areas that may require additional surveillance and monitoring and/or identify areas of non-compliance such as failure to turn in documentation.