American Society for Pharmacy Law


Join us for thought-provoking discussions with your fellow ASPL members, the 3rd Wednesday of each month.  Registration is complimentary to all ASPL members.



Wednesday, September 22, 2001

12:00 – 1:00 pm Central
Developing Compliance Processes for Service Programs with Drug Manufacturers


Shannon Wiley, Bass, Berry & Sims PLC
Mike Hess, Bass, Berry & Sims PLC

Often times the analysis of an arrangement between a drug manufacturer and pharmacy ends when the contract is signed.  This ignores the dynamic nature of these relationships and fails to appreciate the risk that can arise if the arrangement evolves or is not implemented as contracted.  The speakers will address both regulatory concerns that arise during contract negotiation and provide suggestions for how a pharmacy can utilize its internal compliance program to maintain operationally sound and compliant arrangements.  Services such as drug adherence communications, data sales, administration of free drug programs, and other drug administration and financial assistance support can often be structured to reduce regulatory risk. However, that risk mitigation is dependent on the contract being performed within certain operational guardrails.  A pharmacy’s compliance department is well suited to periodically audit aspects of arrangements with drug manufacturers.  This regular review helps catch issues early and provides a document trail to show compliance efforts in the event of a regulatory investigation.  Specific steps a compliance department can take to reduce risks related to manufacturer arrangements include: audits of the services provided to ensure no “scope creep”, focused training of sales and other personnel developing the programs on unique fraud and abuse risks, and auditing data reports being provided.