Compliance managers tend to focus their attention mainly on field-force interactions with doctors and other healthcare professionals
(HCPs). But a closer look reveals that there are many other areas of risk associated with the communication of off-label information.
Several different departments may be involved in the process. Vendors may be used to distribute off-label information. As
a result, evaluation and monitoring should be done activity by activity, taking into account all possible departments and
Most companies find that they have 10 to 15 risk areas associated with off-label promotion. These can best be approached by
distinguishing the direct from the indirect.
Direct-risk areas involve interaction between company personnel and HCPs. The most obvious are field sales and field medical
(for example, medical science liaison, or MSL) interactions. Other venues include speaker programs, advisory boards, formulary
reviews, and medical conferences. Each is a forum where off-label information may be discussed—sometimes appropriately, sometimes
not. In addition, drugmakers publish and disclose medically relevant information. The concern here is that processes supporting
these communications may break down and activities are reclassified as inappropriate marketing.
Indirect-risk areas usually encompass a company's control processes (for example, compensation/bonus structures). Aligning
these control processes with the goal of preventing off-label marketing helps reinforce a company's culture of compliance.
In addition, well-designed control processes can produce documents and data to allow compliance managers to measure scores
on goal. These processes address three basic questions: What do we tell our people to do (training and annual planning)? How
do we motivate them (compensation and discipline)? And how do we record and track their activities (systems and data collection)?
Evaluation and Monitoring Methodologies
Strategically addressing each risk area and applying across-the-board monitoring to all involved departments can be tricky.
But there are a number of monitoring methodologies that can help identify risky behavior before violations occur.
Given the variety of risk areas, companies are likely to use more than one technique for measuring compliance. Evaluating
field-force compliance is likely to require different measures than those used for marketing, say, or discipline. What follows
are different evaluation and monitoring methodologies that can be used to create a compliance professional's maintenance program.
Evaluation: Interviewing/Process Assessment Interviewing is the core evaluation tool for any process assessment. Interviews are conducted in order to determine what is
actually occurring (human behavior) as compared with what is supposed to occur (company policy). Compliance managers should
prepare questionnaires and checklists to serve as interview guidelines. Typically, interviews should be designed not to uncover
violations by one person or department but to reveal systemic problems that increase the company's compliance risk. In addition,
interviews will often bring to the surface other departments' roles in the process.
Monitoring While interviewing to evaluate the process of information dissemination provides the main guide to taking action, additional
monitoring tools are recommended to assess operational risk:
Online surveys and case studies: Surveys allow for much-broader coverage of the MSL and field sales functions than interviews alone do. In addition, by using
questions in the form of case studies, the survey can capture some of the complexities inherent in real-world situations.
The results of the online survey and responses to the case studies also serve as a valuable resource for training programs,
pointing out specific compliance (and possibly geographic areas) that require more attention.
Live-event evaluations: Compliance managers should attend company-sponsored speaker programs, advisory boards, and other events for a firsthand perspective
of the level of compliance to off-label communication policies. Observations could include:
» The balance of discussions between staff and HCP participants and attendees
» Analysis of the composition of HCP participants
» Testing of controls on materials presented or provided