The time has come for pharmaceutical companies to embrace the practice of conducting “live” field-based reviews of their company representatives’ activities as they interact with the healthcare community.
Monitoring has been a recommended component of company based compliance programs for years and many organizations have embraced some form of monitoring of their data or activities. However, live field-based monitoring programs are quickly becoming an expected component of industry compliance programs.
Many companies have voluntarily begun, or in some cases have been required through recent Corporate Integrity Agreements, to step up their efforts in this area. An example of areas where companies are focusing and evolving is live monitoring of promotional speaker programs, full-day compliance ride-alongs with sales representatives and MSLs, consultant/advisory board meetings and external conference activities.
While the activities being monitored are routine, implementing a field-based monitoring program is not. Live field-based monitoring can be time consuming, expensive and, if poorly implemented, can add to your risk exposure and irreparably damage the trust between the field force and corporate office.
However, done properly, an effective field-based monitoring program can help your organization to:
- Better understand the effectiveness of your compliance training and procedures;
- Identify and differentiate between individual compliance violations and systemic compliance issues that may require further root cause analysis;
- Assist in the development of improved policies and procedures as well as the enhancement of your current communications and training; and
- Demonstrate an industry commitment to ethical and appropriate interactions with the healthcare community.
The following outlines some of the key areas to address prior to sending compliance personnel into the field.
Scope and Scale
There are no secret formulas to determining the optimal scope (products and activities to review) and scale (number of reviews to conduct) for your field-based monitoring program. However, there are key criteria that should be taken into consideration.
Key Criteria for Field-Based Monitoring Programs
- How large is your sales force and how many products does each representative carry?
- How many promotional events are conducted annually (e.g., speaker programs, consultant meetings, external conferences attended)?
- What is the compliance risk profile for each product?
- Have there been any past compliance issues reported?
- What is your available budget and personnel resources?
Budget dollars and resources are obviously an important factor in determining the scope and scale of your field-based monitoring program. Given the significant resource costs and travel expenses likely to be incurred, developing the program is not to be approached lightly or without consideration of your potential budget limitations.
However, do not limit the initial assessment of your needs to the budget dollars you think you will have available. Doing so can impact how you look at the criteria outlined above and negatively affect your decision making process and the effectiveness of your monitoring efforts.
Regardless of the initial scope and scale of your field-based monitoring program, it is important to set milestones to evaluate your progress and findings and make adjustments based on your observations and any changes in your sales activities or recent industry enforcement trends.
Process and Protocol
As any pharmaceutical sales person will tell you “life happens” in the field. Meaning, that no matter how well you plan or script interactions, humans are involved in the sales process, and humans sometimes go off script. It is the representative’s responsibility to control these interactions in order to provide relevant helpful information in a compliant manner.
The additional variable of a compliance person can change the dynamics of the interaction, and if it is not done well, it can have a negative impact on the sales force and healthcare community. In order to avoid these risks, it is important to spend time up front planning your program’s details, creating and documenting the review processes and protocols, which clearly define how your program will be conducted.
Must-Have Details To Include In Your Program
- The process by which reviews will be selected and scheduled including the allocation of programs, events or ride-alongs by product and region
- What information should be communicated to the different parties involved (i.e., management, sales representative, contracted healthcare professional, program attendees, etc.)
- When and how will the sales representative be notified
- What are the expectations of the field-based reviewer (e.g., should they be expected to step in if there is a violation, how should they handle refusals to cooperate from sales representatives or speakers)
- How will cancelled events be treated
- What is the post-program follow-up process and timing.
Internal Records Review
To enhance the efforts of your field-based monitoring, coordinate an internal review of associated records and communications related to the monitored interactions, such as:
- Expense submissions
- Attendance sheets
- Call Notes
- Email correspondence
- Medical information requests
Don’t forget to include sales management in your planning efforts. If they understand how the reviews will be conducted and have the ability for them to provide input regarding the monitoring team’s interactions with their representatives and customers, it can go a long way in gaining their full support of your efforts.
If sales management is not fully engaged in the development of the program, they are more likely to be suspect of the observations and therefore less likely to utilize the findings to their fullest.
Reporting and Analysis
In order for the Compliance team to properly and consistently follow up on individual observations and identify trends that may signal more systemic compliance gaps, it is important to provide some structure to the reporting and analysis of your field-based monitoring efforts. Templates, such as field observation worksheets and periodic summary analysis reports designed in advance, can provide structure and guidance for the monitors helping to alleviate confusion on the part of both the monitor and the recipient of the report(s).
The field observation worksheets provide a structured means of capturing and reporting details regarding each program, event or ride-along monitored. These details include logistical and background information, initial compliance assessments by risk area and a format for documenting specific issues observed. It also serves to ensure that each program, event or ride-along is monitored in a thorough and consistent manner.
While the field observation worksheets provide the details, for analysis purposes it is beneficial to define the granularity by which you would like to report and analyze the observations across products, sales regions, therapeutic areas or other business factors. Doing so allows you to provide valuable and timely information to management regarding events taking place under their scope of operation. It also provides valuable insights to the compliance team to enable them to spot trends that may imply a breakdown or gap in your compliance policies, communications and/or training that need to be investigated and resolved.
Selection and Preparation of Monitors
Regardless of whether you use internal resources or seek the assistance of a third-party to conduct your field monitoring reviews, resource cost is by far the most significant component of your field-based monitoring program. Factoring in time for preparation, travel, on-site review and report preparation – a single review can require as much as a full two-day commitment by the reviewer.
While there may be some temptation to minimize these costs by using junior level staff (e.g., entry-level internal audit personnel), sending inexperienced and/or underprepared staff to try to understand and appropriately review highly complex, business-critical interactions with healthcare professionals is an invitation for failure.
Reviewers not only need to have the necessary product and compliance knowledge to recognize and understand potential issues but also should have the ability and experience required to avoid negatively impacting the dynamics of the interaction.
Given the likelihood that you will not immediately have at your disposal sufficient resources with the requisite knowledge, experience and availability to fully support your field-based monitoring program, it is important to create training programs and tools that will help you address whatever gaps may exist.
Training Programs & Tools To Include
- Product training on the approved product message along with details regarding potential messaging issues such as off-label topics, off-limit clinical trials and product safety information.
- Reviewer Guidebook that includes information like details regarding relevant compliance policies and procedures and compliance risk profiles for each product in scope.
- Reviewer shadowing opportunities to allow less-experienced individuals to shadow a more experienced reviewer (typically at a large speaker program or other event where an additional company individual can easily blend in).
Implementing a robust monitoring program of your field-based interactions with health care professionals is a challenging, time consuming and expensive endeavor. However, ignoring this vital element of an effective compliance program can prove even more costly in the long run. Field-based interactions with health care professionals conducted by company representatives and contracted physicians have come under ever increasing scrutiny by government regulators and can expose your company to significant risk if not conducted properly. Regularly monitoring a sample of these interactions can help you identify and correct non-compliant behavior early and demonstrate your commitment to compliant management of these legitimate and useful interactions.
Robert Merrill is president of Searchlight Compliance Advisors. Under his direction, the company provides compliance advisory services for general counsel, compliance office, board of directors and internal audit functions. Services include the following: compliance monitoring and auditing, compliance program reviews, specific legal and regulatory risk assessments, performance assessments, policy development, global investigations and corporate governance.