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UPCOMING EVENTS

Dr. Wendy Heckelman will be presenting at the Preconference II Session on:
 "Enhancing Sales Performance Through Field Based Monitoring" at the 16th Pharmaceutical Compliance Congress and Best Practices Forum in Washington, D.C.

Wednesday, October 21, 2015 at 8:50 a.m.

pharma congress

Please visit us at our booth in the Exhibit Hall

UPCOMING EVENTS

Please come see our presentation at the Poster Session during the
Annual HBA Conference Atlanta, GA
Marriott Marquis
November 3-5, 2015

WEBINAR

Field Based Monitoring: Best Practices for Pharmaceutical Companies

Please register here to participate on
September 25, 2015
12:00 pm -1:00 pm EST

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IN THE NEWS 

Spring, 2015
Field Based Monitoring, Mitigating Risk, Maximizing Success

 

 

February, 2013

Mitigating Compliance Risks Across the Sales Execution Cycle

Rx for Compliance

September, 2013 

How to Create a Culture of Compliant Business Writing  


May, 2012 

Creating a Culture of Compliance with Lessons from NASA and the OIG

 

August, 2011 

 
February, 2011
 
Optimizing Sales Performance with Field Based Monitoring
 

 

Pharm Rep

March, 2011  

Inspect What You Expect: Field Based monitoring programs can help companies avoid problems before they start

Pharm Exec logo 

October, 2009 

The Changing Pharmaceutical Sales Landscape

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IN THE NEWS
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Field Based Monitoring - Best Practices for Pharmaceutical Companies
Field Based Monitoring ("FBM") of commercial business activity has become a standard component of comprehensive compliance programs in the pharmaceutical industry. Many companies have voluntarily started, or in some cases have been required through Corporate Integrity Agreements, to increase their efforts in this area. Many pharmaceutical companies are now regularly monitoring the interactions between sales professionals and healthcare providers during compliance ride-alongs. Companies are also monitoring promotional speaker programs, the communications of MSLs, contracted speakers, consultant/advisory board meetings, and external conference activities. While the activities being monitored are routine, implementing a field-based monitoring program is not. Field-based monitoring can be challenging, time consuming, and if not properly implemented, can add to your risk exposure and damage the trust between the field force and the home office. The primary goals of an effective field-based monitoring program are to:
  • reduce compliance risks
  • differentiate between individual compliance violations and systemic compliance issues
  • ensure compliant behavior and identify opportunities for continuous improvement
     

Below are a few best practices for implementing a field-based monitoring program that provides value to the compliance team and the sales organization as a whole.

 

1.  The development of a field based monitoring program should begin by first assessing the scope and measures needed of the field based monitoring program. To do so, consider the following questions:
  • Have there been instances of past compliance issues reported?
  • How large is your sales force?
  • What is the compliance risk profile for each product?
  • How many promotional speakers are you contracting with to speak on behalf of the product?
  • How many promotional events (e.g., speaker programs, conferences, etc.) are conducted annually?

2.  Include sales management in your field based monitoring planning efforts. While some sales leaders see FBM as a burden, FBM can be used to monitor more than just compliant behavior. FBM can monitor compliant sales performance. Companies can further maximize their return on investment in FBM by ensuring they have behavioral training in place. This ensures field representatives know how to translate standards into performance in the field and then monitor for follow-up. If sales management is not fully engaged in the development of the program, they are more likely to be resistant to the process and skeptical of the observations.


3.  Carefully select and develop your compliance monitors. Whether you decide to use internal resources or a third-party to conduct your monitoring reviews, be sure the compliance monitors understand the organization's sales strategy and behavioral expectations. There may be some temptation to minimize cost by using junior-level staff to conduct field-based monitoring. Reviewers need to have the necessary product and compliance knowledge to identify and understand potential issues. They also need to have the credibility and professionalism needed to avoid negatively impacting the dynamics of the field interaction.

4.  Clarify expectations with the sales force for field based monitoring. In addition to having a written field based monitoring policy sales professionals can reference, it is important for them to understand the benefits of compliance for themselves and the organization. Establish behavioral standards and provide behavioral based training for the sales force. Be sure the sales force and all speakers are aware of what will be observed, documented, and how the process will be completed.

5.  It is important to establish an automated and reliable real-time reporting system for field based monitoring. Field observation worksheets and periodic summary analysis reports enable the monitors to have a structured and consistent approach to their activities. Identify upfront what elements need to be included in your reporting for appropriate analysis and review by stakeholders. Doing so allows you to provide valuable and timely information to management and spot trends, validate compliance, and identify additional training needed.

6.  Reference the OIG monitoring work plan. While you shouldn't base your entire program solely on the OIG's focuses, your organization's FBM approach should adhere to the OIG guidance.
Following these best practices will position your organization for a best in class Field Based Monitoring program and secure an important element of an effective overall compliance program. 
Please feel free to contact us for more information on Field Based Monitoring and assistance with implementing FBM in your organization.

Sincerely,

Wendy Heckelman, Ph.D.
 
(954) 385-0770 
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