Pharmaceutical companies need to monitor and audit drug samples distributed under the Prescription Drug Marketing Act of 1987 (PDMA). Utilizing a customer relationship management (CRM) system designed for pharmaceutical companies can be a useful tool in preventing fraud and keeping track of sampling activity. For years, pharmaceutical sales representatives delivered samples in person. With the advent of COVID-19 and social distancing requirements, the FDA allows pharmaceutical and life sciences companies to provide samples through multiple distribution methods. It is vital to have a centralized system for monitoring and auditing the sample distribution process.
The PDMA Record Keeping Process
To ensure your PDMA sampling program stays within federal guidelines, pharmaceutical companies must monitor the ongoing process to maintain a high quality and compliance level. The monitoring process needs to be systematic. These federal guidelines were defined to provide ongoing fraud protection for consumers. Monitoring intervals vary depending on the sampling programs, but often run on a weekly, monthly or quarterly. Auditing the programs means reviewing and verifying these sampling programs to identify potential fraud risks. Auditing focuses on the financial statements and needs to be objective to comply with regulations. One way to ensure monitoring is effective is to make sure reps are reporting deliveries within a prescribed timetable. Gaps in the schedule are warning signs that a potential fraud may be occurring. Utilizing sample accountability services will help identify problems with the distribution process.
Adjusting the PDMA Record Keeping and Distribution Process
Identifying gaps in deliveries does not always indicate fraudulent practices. There may be a distribution problem instead. In some instances, sales representatives either order too many samples or cannot distribute the samples, which ends up piling up in a storage facility. By monitoring the delivery schedules, PDMA monitors will be able to straighten out the sampling issues. By sending samples on a less frequent basis, the company will avoid spoilage and also reduce costs.
Maximizing Disbursements during COVID-19
The PDMA sample requirements during the pandemic required reduced disbursements of samples as well as strict record keeping and reporting. Sample program administrators will benefit by using centralized record management processes. It is important to have the systems and procedures to deal with abnormalities in the disbursement process.
Signature Audits Reduce Fraud Risks
Auditing the sales representative’s signatures on sample reports is another tool for reducing potential fraud risks associated with sample distribution. Keeping track of sales representatives during their employment is one step towards avoiding fraud. Monitoring when sales representatives are hired, going on vacation and leaving the company are essential steps in the auditing process. Dealing with discrepancies can also be challenging. Of course, it is crucial a pharmaceutical company avoid customers receiving expired or missing samples.
Additional Tactics for Fraud Protection
It is a good practice to require sales representatives to conduct a physical inventory count regularly. An annual physical inventory is a requirement, but it is maybe unreasonable to require a quarterly or monthly inventory of sample products. Other tactics for controlling your PDMA processes include using third-party monitoring and auditing firms for conducting physical inventories. Keeping track of data is essential to prevent fraud and mismanagement. Having a solid data sharing policy and transmittal policy will avoid gaps in monitoring and inventory miscounts.
Consistency is the Key to Reducing Fraud
Consistent programs make it less likely to make mistakes in disbursements and record keeping processes. Having a central source of data also ensures samples aren’t miscounted or fall through the cracks. Consistent sample accountability services that include monitoring and auditing processes reduce the chance of fraud or mistakes in record keeping. Using a centralized system like SampleIQ and the CATS CRM solution from Synergistix can be a good step in preventing fraud.