Field Inventory Services-Sanofi Inventory and Audit Training

Overview Pharmaceutical Companies are required by the Prescription Drug Marketing Act (PDMA) of 1987 to conduct at least annually, a complete and accurate physical inventory of all drug samples in the sales representatives possession. Pharmaceutical Companies ship samples to their sales representatives who in turn distribute samples to physicians. Physicians give the samples to their patients. While samples are in the possession of the sales representative it is their responsibility to account for all samples received from their company and dispensed to physicians and to ensure they are stored in accordance with the labeling guidelines and company Standard Operating Procedures (SOP).

Under the PDMA it is a violation to: Overview Under the PDMA it is a violation to: Sell or trade drug samples. Deliver drug samples to anyone not licensed to prescribe. Deliver drug samples without a signed written request from a licensed prescriber.

Overview Sanofi has contracted with BuzzeoPDMA to conduct annual & random inventories. Sanofi refers to their representatives as Sales Professionals (SPS). Annual inventories are conducted on all sampling SPs. Random inventories are conducted on approximately 33% (per sanofi SOPs) of all sampling SPs. Each quarter SPs are selected for an annual & random inventory. Random inventories are conducted early in the quarter & annual inventories later in the quarter. Per sanofi; the 2 projects can not occur in the same month. It is important that you adhere to the timelines set for each of these projects. If you are unable to meet a given timeline, notify our office immediately so we can reassign. If the SP is not able to schedule within the given timeline, notify our office. Never schedule past a due date unless our office authorizes it.

Overview The inventory worksheet is the same for both the annual & random inventories. For both projects you will take a physical count by lot number of all samples in the SPs possession. Lot numbers are found on the exterior of the sample case and also on the sample unit. Make sure you record the correct lot number on the worksheet. A Storage review is completed in conjunction with annual and random inventories.

Sample Inventory Worksheet Conduct inventory of all samples the SP has. This includes expired, damaged and samples the SP may be getting ready to return. If the SP has samples from another company count and record them. Once you are off site, immediately notify our office. If the SP has samples not listed on the worksheet enter them on the blank lines provided Ensure correct lot numbers are recorded, double check. Double check your math. Entries must be recorded neatly. Use Good Documentation Practices for any errors made by you or the SP. All pages must be signed and completed by you & the SP even if the SP does not have samples.

Sample Storage Samples should be stored and handled under conditions that maintain their stability, integrity, and effectiveness and ensure that the drug samples are free from contamination, deterioration and adulteration per the PDMA. This can be accomplished by following the labeling requirements of each drug and by client specific standard operating procedures (SOPs).

Sanofi Storage Requirements Samples must be in a secured locked area. Samples must not be accessible to children, animals or unauthorized individuals. Samples must be stored in a temperature controlled environment, if required, to meet package insert requirements. Samples must not be in contact with floor surface. Samples must be kept separate from product literature. Commercial storage units cannot be shared by SPs. Commercial storage units cannot be used to store personal items. District Manger must be listed on the contract.

Sample Storage Review Form Completed with the annual inventory. Automobile section applies to every SP. Provide a detailed description of where samples are stored in the home. Be precise. i.e. First floor hall closet on shelves with door locked. Review each statement with the SP, record the correct response. Questions 6, 7 and 8 apply to commercial storage only. Write N/A next to the question if storage is in the home. Questions 6-8: You and the SP should go to the facility office to verify the answers by viewing the contract. Question 9: Record information for samples not listed on worksheet. Question 10: Record information on expired samples. Note: Questions are often not completed correctly during the inventory. Make sure all information is captured. Failure to do so prohibits processing of the paperwork until corrections are confirmed.

Random Audits As part of a sample distribution security and audit system (required by the PDMA) companies are required to conduct random audits on randomly selected Sales Representatives. The same paperwork is completed for the randoms, as is done for the annual inventories.

Reminders Ask SP to have samples organized by product, strength and lot number. This will expedite the physical counting. Review forms and directives prior to scheduling with the SP. Keep the web site updated with received, contact, appointment & mail dates. Check all paperwork for accuracy before leaving the appointment. Make sure the worksheet and storage form are signed by you AND the SP even if the rep does not have samples. Paperwork with errors or missing information will be returned to you for correction delaying processing time and your compensation. We expect you to complete assignments accurately and within the specified timeline.

Common Errors Incorrect math. Incorrect lot numbers. Missing forms. Missing signatures. Lack of or incorrect ‘Good Documentation Practices’. Lack of or incorrect SP NM number. SPs name spelled wrong.

Completed Paperwork Quality review is completed. FIS contacted if errors or omissions noted. Inventory entered into Sample Guardian (our inventory system) in the Richmond office. Sample Guardian recognizes incorrect lot numbers & wrong NM numbers & will not accept the inventory, causing processing delays. Paperwork that cannot be processed will be returned to you for correction.

Assessment Please log onto the link below to access the exam. You must receive a passing grade in order to work on the sanofi project. You will have 2 attempts to pass the exam. No password is needed. Print a copy of the assessment summary (indicating a ‘pass’) for your files. https://secure.testcraft.com/BUZ254/assess.aspx?aid=SANOFIAVENTIS15&apass=buzzeo V 2 042015 Thank you