As required by law and Pfizer policy, Sales Colleagues must adhere to strict requirements regarding documentation of their receipt and delivery of starters and management of their starter inventory.
Starter Storage Requirements
Starters must be stored securely and under temperature-controlled conditions in accordance with the
hazardous materials or any other substances that could cause contamination or otherwise degrade them.
Starters may be transported in an automobile trunk during the business day, but should never be left there overnight. For this reason, only the number of starters that are expected to be distributed on a particular day should be carried in a Sales Colleague’s trunk, with any excess quantities removed and returned to storage at the end of the day.
If starters are stored in a commercial warehouse unit, the lease contract for that space should be in Pfizer’s name with access made available to both the Sales Colleague and his/her manager during normal hours of operation.
Accurately Document Receipt and Delivery of Starters
To accurately document receipt and delivery of starters, Sales Colleagues must strictly adhere to the policies and procedures in the Starter Operations Compliance Manual, including:
Guidelines for acknowledging the receipt of starter shipments immediately upon acceptance;
Documentation of the starters delivered to licensed HCPs;
Procedures for transferring starters between Sales Colleagues; and Entry of starter transactions into iCUE at the time of their occurrence.
Failure to adhere to these policies and procedures can place Sales Colleagues and Pfizer at risk under the PDMA and other applicable laws, distort their on-hand reported inventory balance, and undermine the reconciliation of their annual starter inventory.
Key Points: Documenting the Receipt and Delivery of Starters
Document all starter transactions completely and accurately at the time they occur.
Utilize the iCUE tablet to document all starter transactions (unless one of the limited exceptions permitting paper SAFs described in this Chapter apply).
Provide complete, accurate and truthful information on all eSAFs (and paper SAFs, in the very limited circumstances when a paper SAF is permitted).
Witness the receiving HCP sign the iCUE screen (or paper SAF) at the time of delivery.
Immediately report any and all shipment shortages or overages, starter losses, and thefts to Starter Operations for further evaluation and reporting to the FDA.
Completion of eSAFs and SAFs
Sales Colleagues using an iCUE tablet must utilize the tablet for every starter transaction – subject to two very limited exceptions outlined below. A paper Starter Activity Form (SAF) may only be used:
When a Sales Colleague is dropping starters at an institution that requires the starters be left with its pharmacy and not with the individual HCPs requesting them (in this case, the dual-signature “In House Pharmacy” SAF described in this Chapter must be used), or
With prior written approval from Starter Operations in very limited, infrequent circumstances while the iCUE system is inoperable due to significant hardware or software malfunctions for an extended period of time, until such time as the underlying causes of the malfunction are resolved. (Sales Colleagues should ensure that their iCUE tablets are charged; drained batteries do not qualify as an iCUE malfunction.) Written requests may only be submitted by Sales Colleagues by e-mailing a description of the issue, and information provided as part of the CSC Help Center assigned ticket, to [email protected].
If a paper SAF is utilized as permitted above, Sales Colleagues must enter the information into iCUE as soon as possible after completing the paper SAF transaction.
The iCUE and paper SAF starter call records are designed to document requests from licensed prescribers for starters and confirm their receipt of provided starters (or a pharmacist’s receipt of starters in the case of “In-House Pharmacy” Forms). The iCUE (and paper SAF) starter transactions are Pfizer’s legal record of each starter transaction and must accurately reflect the date on which the request and delivery occurred, the name, address, license number and professional designation of the prescriber and the products and quantities that they are given.
The iCUE eSAF (or paper SAF) must be completed in its entirety before it is presented to the prescriber for signature. If a prescriber does not provide his/her signature to confirm request/receipt of starters, the Sales Colleague must not provide him/her with starters. A receipt form may be provided to a physician when using the iCUE tablet by checking the receipt requested by mailbox option on the screen. (If using a paper SAF in the limited circumstances described above, the yellow copy of the form must be left with the recipient to retain for their records.)
Witnessing Signatures for Starters
Q. When a Sales Colleague delivers starters to a physician’s office, can the receptionist take the iCUE tablet to the HCP for signature?
A. No. The iCUE tablet should never be given to anyone to take away and should always remain in the Sales Colleague’s immediate proximity. Pfizer policy requires that the Sales Colleague always personally witness the HCP signing the form or iCUE tablet. In this way, if questions come up regarding the HCP signature (e.g., during a subsequent audit or inspection), the Sales Colleague will be able to verify that he or she witnessed the HCP signing and receiving the starters. (However, in the limited circumstances where a paper SAF is permitted, a receptionist may take the SAF to the HCP for signature as long as you can clearly see the HCP signing the form.)
Reconciling Starter Inventory
The PDMA requires that every Sales Colleague have at least one physical inventory count of their starters taken within each 12 month period. Successful reconciliation requires accurate starter recording in iCUE, timely call reporting, routine synchronization of the tablet with the iCUE server and the correction of any errors or discrepancies found in the course of recording starter information.
Sales Colleagues should regularly review their weekly iCUE Starter Activity Reports (SARs) and periodically conduct their own physical inventory count. This count should be reconciled against the
Ending Balance Report that is sent to each Sales Colleague with their SAR. If a Sales Colleague finds an error or discrepancy when reconciling starters, he or she should immediately contact Starter Operations for further guidance.
In addition, all starter losses and thefts should be reported to Starter Operations immediately so that the required notification can be submitted to the FDA within five days.
Reminder on Expired Starters
Expired starters cannot be given to a healthcare provider under any circumstances and should be shipped promptly to Pfizer’s authorized destruction facility. Sales Colleagues should rotate their starters upon receiving each delivery, placing those closest to date of expiration in front to ensure that they distribute them first.
HCPs seeking to return expired or damaged starters should be directed to call Pfizer’s Starter Customer Service Team (800-533-4535) to schedule an appointment for the pickup of those items.
Paying for Bins in Starter Closets
Q. Can a Sales Colleague pay for bins or space in starter closets in physicians’
offices?
A. No. Paying for space in starter closets could violate anti-kickback laws.