Imagine a compliance program that ensures sales representatives know what to do or say with exquisite clarity when facing sensitive situations. One in which reps understand the way new or revised laws and regulations or [promotional] violation letters directly impact their interactions with HCPs. And where compliance support for tricky situations is accessible 24/7.
Simply put, imagine a one-stop resource at which sales reps can find centrally managed business process rules to achieve commercial objectives compliantly.
I’ve just described a new approach to standard compliance training using a highly orchestrated, synchronized approach to helping sales reps achieve sales objectives compliantly and with confidence. The approach is called a “quality system” and this topic was addressed during a panel on Innovation in Training of Field and Sales Forces at the 2015 FDLI conference, which I moderated. This article shares highlights from the panelists.
Michele Sharp, Senior Director, Regulatory Affairs at Eli Lilly and Company, described the four components that comprise a “quality system.”
1. “Integrated Standards or policies focus on interactions between the field sales organization and HCPs based on particular rules; for example, the Anti-kickback Law (allowable gifts), the Sunshine Act (transparency of payments), and the PhRMA Code, to name a few.”
2. “Business Processes inform reps on how to execute sales activities that may have compliance risk using common sense instructions; for example, how to handle business meals, speaker programs, product sampling and office visits.”
3. “The Organization component identifies the right people for the right roles with the right span of control, and offers a robust training school with testing to ensure an understanding of requirements.”
4. “Governance and Management Controls address the role played by the leadership team who routinely looks at measurements and trends and determines whether action should be taken. If change is needed, the leadership team approves procedure changes and ways to communicate change through a consistent and predictable channel for the rep.”
“The four components are designed to support one another and are improved continuously,” Sharp explained. “This approach is not unlike the principles of quality systems used in manufacturing, clinical operations or pharmacovigilance.”
What can a “quality system” do to help reps sell effectively while remaining compliant? “Reps need real-world responses to real-world situations, and they can’t be expected to remember a multitude of rules,” stated James M. Flaherty, Jr., Associate General Counsel, FDA Regulatory, Fresenius Medical Care North America. “We have to help reps gracefully handle difficult questions from HCPs without killing the conversation or angering the HCP,” he continued. “Reps need a simple and easy-to-remember way to avoid non-compliant behavior, in other words, to stay safe.”
Safe Islands for Reps
The quality system for rep training utilized by Fresenius is aptly named Safe Islands, which includes the following safety sources.
- All Approved “Labeling”
- Prescribing Information (PI)
- Instructions for Use (IFU)
- Promotional Materials
- Objection Handling Scripts
“The Safe Islands methodology,” Flaherty explained, “is a simple and memorable four-step process for live training and written materials to address common difficult questions or scenarios.”
“We teach the field force how to redirect a conversation that could take them into dangerous waters. Reps may feel ‘lost at sea’ when asked about an off-label issue regarding an unapproved use or information beyond the approved labeling. Or they may not know the answer to an on-label topic.”
Practice the Pivot
Flaherty described the methods by which sales reps can practice pivoting or bridging to a Safe Island topic and, when relevant, referring the HCP to Medical by utilizing a Medical referral card, website, fax or phone as appropriate.
A common challenge for reps for which a quality system approach to training would be useful is described by Kimberly Belsky, Executive Director, OneSource Regulatory (and most recently with Valeant Pharmaceuticals). “While awaiting advisory comments from the Office of Prescription Drug Promotion (OPDP) about core launch materials, it’s not unusual for sales reps to be trained at risk during a launch meeting. Training includes several days of presentations, role-playing, objection handling, detailing and situations in which potential new claims are reinforced through the energy of a launch. The company then receives advisory comments and needs to adjust messages and retrain reps.”
What Not to Say and Why
Quality training in this situation shouldn’t just focus on what you can’t say, but why you can’t say it,” Belsky emphasized. “This means equipping the reps with an understanding of the regulatory requirements and reasons for changes in the environment. A quality system will ensure that the sales team understands the basis of the changes required so they don’t think that ‘we’ in the office or OPDP just don’t understand what the HCPs or consumers need.”
“Compliance training should be a ‘program’ not just a ‘course’ and evolve and build on compliance concepts to allow for varying levels of skills and experience. It should be interactive, engaging, exciting and meaningful,” stressed Kirsten Morasco, Principle of KLM Consulting. “Bottom line, training needs to meaningful and relevant to participants. People should welcome this training, not dread it. Compliance training cannot be one more requirement an employee needs to check off the list.”
Compliance Training for All
Morasco also believes that compliance training, “Should be required for everyone. Even management. So yes, leaders, this means you. If we are going to have a culture of compliance, leadership needs to embrace it and they need to model the behavior we want our staff to exude.”
The panel concluded with a clear definition of “good” compliance training and how to achieve a culture of compliance. The question of whether a “check the box” rules-based mentality works, or whether a value/judgment-based orientation builds stronger roots for compliant behavior was raised. Morasco noted, “A quality system approach has worked for Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP). Now we can apply this organized framework in the sales organization to embed integrity, values and ethics into corporate culture.”