W-19: Defining Excellence and Best Practices in Medical Information for AMCP Dossier Creation and Compendia Review

Poster Presenter

Sally Stansbury

Associate Director of Medical Information
Takeda
United States

Objectives

The objective of this project is to create standard operating procedures (SOPs) to fill the unmet need for guidance documents on Academy of Managed Care Pharmacy (AMCP) Dossier creation and the Compendia review process.

Method

Feedback was collected from members of the working Medical Information team to identify gaps in providing key resources to health care professionals (HCPs). Once key priorities were established, the team worked to create internal standard processes by which resources could be delivered effectively.

Results

Members of the Medical Information (MI) team were asked to provide insight into processes effecting patient outcomes that weren’t working efficiently. AMCP Dossier creation and Compendia Review were identified as areas needing more clarity in order to best meet the needs of external HCPs, who would ultimately be providing information or services to their patients. AMCP Dossier supports reimbursement and/or formulary placement consideration of a new product, new indication, or new formulation of an existing product. Compendia provide extensive product information to HCPs. Both the AMCP Dossier and the Compendia aid HCPs in making educated decisions on behalf of their patients. MI team members review select major compendia for errors or omissions for all approved products. Key stakeholders were identified to contribute to the stepwise approach in completing AMCP Dossier creation and the Compendia review process. These stakeholders included medical affairs, health economics and outcomes research (HEOR), compliance, and legal counsel. One new SOP was developed (AMCP Dossier) and 1 SOP was updated (Compendia Review) with new processes. Training was provided to MI personnel in order to ensure SOPs were interpreted and executed correctly. This led to 100% of compendia reviews being completed on time with no findings from compliance review. There is now alignment on responsibilities of all included stakeholders for AMCP Dossier creation. The creation and approval has been smoother since implementation of the new SOP.

Conclusion

The creation of SOPs and the internal MI training has allowed MI to drive excellence in external facing deliverables. Best practice has been adopted by all stakeholders involved and the new processes led to increased MI visibility and increased efficiency within the organization. Working with HEOR will open up opportunities for future collaboration.