So, You’re Now Under A CIA. How can the Medical Information function help?
According to the last DIA MedComms, March 2016 in Orlando, Med Info Departments within companies that have recently gone under CIA can help their companies adjust to the new level of scrutiny in several ways.
First, by ensuring CIA Compliance.
Med Info CIA requirements include maintaining a robust database documentations requirements such as name, nature and topic of interest, exact language used in inquiry, name of sales rep, evaluation of off-label inquiry, nature and form of response, etc.
Most companies seasoned in MI practice generally use a program, such as IRMS or other content manager to accomplish this, but under CIA, it time to step up your game and train team members to not skimp.
Finding a standard training plan that works can be complicated, but it doesn’t have to be. Consistency and harmonization are key. RxER helps companies design these training and operational plans.
Second, performing a quarterly analysis of inquiries.
Performing a quarterly analysis of inquiries can help retrospectively drive continuous improvement.
inquiry reports for each therapy area
sales reps with the most number of inquiries for each product and assessment of off-label requests generated by sales rep by geographic area
This can lead to separate reports that provide valuable insights to the organization and can be of great use to MA TA teams as well as field medical teams.
Finally, there are other policies to consider revamping, including:
what type of medical information can be distributed
how to respond to off-label requests
internal review process of responses
how sales reps and other medical personnel handle off-label requests
submission of product information to compendia
HCP signatures for rep-facilitated questions
If your company needs help developing SOPs, or needs a second pair of eyes to review and revitalize your department operations, partner with us to get you compliant quickly.