Challenge of Delivering Engaging and Effective Compliance Training to Life Sciences Sales & Marketing Professionals (Part 3 of 6)

Note that the ideas presented in this article are my own and do not reflect the opinions of my current employer.

Episode 1: Kim meets Dorgan Dave

Kim’s journey began with her violating the core principles of ethical and compliant promotion of life science products. She violated a long list of policies that didn’t get her fired but did result in receiving disciplinary action. Kim had to go through re-training, coaching, and attend The Workshop. The workshop is led by “Dorgan Dave”, a formal sales executive who went on national television and made untruthful and misleading claims about his companies’ blockbuster product. While the “Dorgan Dave” story was based on an actual industry case, we exaggerated his crimes and said that he broke some laws which caused him to lose his job, pay back past bonuses, go under house arrest, and conduct community service which included running The Workshop.

 

At the end of each episode, the main character sat down at a computer to reflect on what she had learned. I came up with this idea, based on learning research. This strategy allowed us to summarize the learning points of each episode without breaking out of the story. The closing scenes are excellent mechanisms for compliance trainers or instructional designers to leverage when developing facilitator guides, or eLearning knowledge checks. That provides a way for students to reflect on the question, “What did Kim learn in this episode?”

This first episode sets up Kim's challenge to get back into the field and start selling again. This is a fall-from-grace story. Kim, an award-winning pharmaceutical sales representative is placed on the bench. She doesn't appreciate the importance of compliance with company policies and has not yet made the connection with her actions and how they may lead to illegal activities. 

After watching this episode, the student will begin to make a connection with the character Kim and may start to reflect on their own behaviors. If you are watching this video as part of a training course, you can ask students to assess Kim's behaviors and list out what she did wrong. Discuss the fairness of her disciplinary action. Do your students agree the disciplinary action?

Up next: Episode 2, Gina's Story which was influenced by a discussion with a Department of Justice Attorney. 

 

 

 

Challenge of Delivering Engaging and Effective Compliance Training to Life Sciences Sales & Marketing Professionals (Part 2 of 6)

Note that the ideas presented in this article are my own and do not reflect the opinions of my current employer.

Creating The Workshop Educational Video Series

We kicked off the project on a blistery cold winter day in Chicago. Me and two scriptwriters from The Second City were going through my research on the pharmaceutical sales and marketing profession, and the compliance challenges they face each day. After a few hours of brainstorming, we took a break. One of the scriptwriters, referring to pharmaceutical salespeople, said: “I think these people need therapy”. We ended the day with a laugh and we headed back to our hotels with plans to re-group the next morning. I thought about our design discussions and the “therapy” comment while exercising in the hotel gym the following morning. I pictured a comedy movie that I had seen where people sat around a circle sharing their stories in a therapy session. I wondered what it would be like if the main character was asked to sit and listen to stories by other life science professionals who had violated healthcare laws and faced the consequences. I had a long list of industry case summaries, including a story told to me by a Department of Justice attorney. The idea was hatched.

Kim, a sales representative and the main character in the story made a few compliance missteps in the field that landed her in a therapy-like workshop led by a former sales executive who was under house arrest for his past crimes. The other people in the workshop were from different pharmaceutical companies except for one character who was a physician. I wanted to add the perspective of the healthcare profession to balance out the discussions. The character, Dr. Filmore balanced out the stories and provided the comedy relief to the serious discussions in the group. I have now completed 17 episodes of The Workshop with The Second City to develop four unique stories including Season 1: Kim’s Journey, Season 2: Todd’s and Sarah the MSL, Season 3: Nora’s Coaches Adam, Season 4: Jim FLIBs Speaker Programs, Season 5: Jake and Call Notes, and at the time of writing this, we are working on Season 6: Matrix Teams the Musical. Each season addresses multiple principles related to pharmaceutical sales and marketing compliance topics.

Season 1, Kim’s Journey

The first season (or series) of The Workshop targeted product-promotion compliance topics typically covered in a sales new-hire program. The principles covered in Season 1 included, (a) delivering balanced, truthful, and non-misleading messaging, (b) staying on-label,  (c) avoiding violations of the anti-kickback statute and the false claims act, (d) providing proper oversight of speaker programs, (e) using samples to influence script writing, (f) protecting patient information when providing patient support, and (g) the value of speaking up.

Next up: I will break down Episode 1 and provide ideas for using the videos in a Compliance Training course.

Can we Teach Sales and Marketing Professionals about Business Ethics using Entertainment Education Programs?

Between 1991 and 2012, US pharmaceutical company settlements both civil and criminal exceeded $30 billion dollars (Rodwin, 2015).  The question asked by Rodwin (2015) and others (Gagnon, 2013; Outterson, 2012) is whether financial fines have had an effect stemming illegal and unethical business management practices in the pharmaceutical industry. Most of these cases involved unethical sales and marketing practices where profits appear to have been placed ahead of patient safety and a physician's right to make unbiased clinical decisions for their patients. While it is clear that pharmaceutical research has led to thousands of products that have both improved and extended hundreds of thousands of lives when net profits are the key performance indicator, companies are at risk for making unethical business decisions to achieve financial goals (Tang et. al, 2018). While pharmaceutical companies are not charitable organizations, they have an obligation to educate their employees on how to balance financial objectives with the goal of improving healthcare outcomes through clinical research and responsible commercialization of their approved products. 

What problem was addressed in this study?

The general problem was that while management at some companies spend an average of $200,000 annually on compliance and ethics training (Kann, 2013), the effectiveness of these programs to raise employee awareness of compliance risks, and improve ethical decision-making is in question (Treviño, Nieuwenboer, and Kish-Gepharts, 2011; Warren, Gaspar, & Laufer, 2014).  The more specific problem was that sales and marketing managers consistently struggle to identify compliance risks, effectively judge the ethical nature of sales and marketing strategies, and demonstrate behavioral intentions to speak-up.  The target audience for this study included pharmaceutical sales managers and employees from a large pharmaceutical company located in the US-North East.

What was the purpose of this study?

The purpose of this quantitative experimental study was to compare the effectiveness of two types of entertainment-education (film vs image-text eLearning) on ethical decision-making and behavioral intentions to speak-up in the pharmaceutical sales professions. Researchers and practitioners may use findings from this study to determine whether a high-cost professionally developed entertainment-education video is significantly more effective than an e-Learning course using static images and on-screen text to influence ethical issue awareness, ethical judgments, and behavioral intentions to speak-up. Note that I did not evaluate the impact of the types of images used in the eLearning course. The images were screen captures from the film version that showed the facial expressions of the actors in the film. These facial expressions may have influenced the results of the findings. 

Can we teach ethics and compliance to pharmaceutical salespeople using entertainment-education?

The effects of the entertainment-education interventions had the strongest effect on speak-up intentions, compared to the effects on ethical issue awareness and ethical judgment.  After watching the video or reading the story of Kim, 43% changed their behavioral intentions to speak up in a positive direction for the scenario with implications for patient safety.  Given the significant effect observed in this study of the entertainment-education narrative on behavioral intentions to speak up, compliance training managers may choose to use an entertainment-education training intervention to address low behavioral intentions to speak up.

References

Gagnon, M. (2013). Corruption of pharmaceutical markets: Addressing the misalignment of financial incentives and public health. The Journal of Law, Medicine & Ethics, 41(3), 571-580. doi:10.1111/jlme.12066

Kann, R. (2013). Compliance and ethics training benchmarking reports (Rep. No. CELC7083113SYN) (A. K. McDougall, Ed.). District of Columbia, MD: Corporate Executive Board.

Outterson, K. (2012). Punishing health care fraud — is the GSK settlement sufficient? New England Journal of Medicine, 367(12), 1082-1085. doi: 10.1056/NEJMp1209249

Rodwin, M.A. (2015). Do we need stronger sanctions to ensure legal compliance with pharmaceutical firms? Food and Drug Law Journal, 70, 435-452

Tang et. al, (2018). Monetary Intelligence and Behavioral Economics: The Enron Effect—Love of Money, Corporate Ethical Values, Corruption Perceptions Index (CPI), and Dishonesty Across 31 Geopolitical Entities. Journl of Business Ethics Education, 148, 919–937

Treviño, L. K., Nieuwenboer, N. A., & Kish-Gephart, J. J. (2014). (Un)Ethical behavior in organizations. Annual Review of Psychology, 65(1), 130708143622004. doi:10.1146/annurev-psych-113011-143745

Warren, D. E., Gaspar, J. P., & Laufer, W. S. (2014). Is formal ethics training merely cosmetic? A study of ethics training and ethical organizational culture. Business Ethics Quarterly, 24(1), 85-117. doi:10.5840/beq2014233

 

Challenge of Delivering Engaging and Effective Compliance Training to Life Sciences Sales & Marketing Professionals (Part 1 of 6)

Note that the ideas presented in this article are my own and do not reflect the opinions of my current employer.

Introduction

We were in the third year of a Corporate Integrity Agreement (CIA). The Chief Compliance Officer, disappointed with the low impact of the existing training program, presented the following challenge to me. How can we improve compliance training programs, while complying with the expectations from the Health & Human Services (HHS) Office of Inspector General (OIG)? The training at that time included a 2-hour information-centric online e-Learning course and an 80-slide presentation presented by compliance professionals. The training covered all of the important topics while having the tendency to lull learners into a deep sleep. I was faced with the task of successfully closing out the companies’ CIA and re-engineering the training model to both meet HHS: OIG expectations, and more effectively engage sales and marketing professionals. First, I took the time to learn the expectations of the federal government while researching the appropriate instructional strategy.

Expectations from the US Government

The expectations from the HHS: OIG has changed in recent years. Training and education requirements in recent CIAs include some of the same requirements as years past with the caveat that companies must now have a detailed written training plan. Referring to the 2019 Jazz Pharmaceutical CIA (Section C), the OIG required a written plan for annual training on (a) their compliance program, (b) all job-relevant Federal healthcare programs, FDA requirements, and the companies’ policies and procedures. The training plan had to include training topics, length of training, scheduling, and the format (e.g., online vs live). Those were the only requirements for the training program. What does the HHS: OIG mean when they refer to “applicable Federal healthcare programs and FDA requirements”?

When life science compliance managers develop training that targets the sales and marketing of life science products, they refer to several regulations which include the Food, Drug, and Cosmetic Act (FDCA), the Anti-Kickback Statute (AKS), the False Claims Act (FCA), the more recently the Sunshine Act. The Food, Drug, and Cosmetic Act Chapter V is part of Title 21 of the United States Code.  Part A, Section 501, references the misbranding of drugs and devices. As you review the FDCA, AKS, FCA, Sunshine Act, review recent CIAs, and Department of Justice (DOJ) settlements, you quickly realize that you need a law degree to figure out what the requirements are for your sales and marketing teams. You can also appreciate why compliance attorneys tend to develop lengthy training presentations as they combine the law with your company’s policies and procedures. As an instructional designer, my goal was to define the expected behaviors for sales and marketing professionals in the life sciences industry and develop an instructional strategy to address those behaviors.

In summary, the expectation of the HHS: OIG and FDA, are that life science industries conduct ethical research that results in products that are both effective and safe for patients, with the understanding that no drug or medical device is ever 100% effective or safe. Once the FDA approves a product to enter the market, the expectation is that (a) manufacturers educate healthcare practitioners with truthful and non-misleading information about their products, (b) continue to monitor the effectiveness and safety of the product, and (c) practice fair and ethical sales and marketing practices. Manufacturers need to provide healthcare professionals with truthful scientifically-substantiated information about the product and not use any selling strategy that could be interpreted as buying the physician’s business. Recent cases against pharmaceutical have focused on the latter principle of providing goods or services to influence the writing of prescriptions, which can be interpreted as a bribe or kickback. The challenge of teaching sales and marketing professionals all of these laws, regulations, and policies is that it seems too much to learn and apply while focusing on their task of promoting the companies’ products.

The Workshop Educational Video Series

Life science compliance training professionals need to present industry case studies, the principles of the PhRMA Code,  US federal healthcare laws, and their company policies to their sales and marketing teams without putting them to sleep. Sales and marketing professionals are focused on the task of marketing the company's products. It is very difficult to keep the attention of a salesperson on laws and policies that they may perceive as obstacles to their goals. As a compliance training professional, you need to first gain their attention by using stories and visuals that will not only engage but reframe a person’s way of seeing the world. While showing an EE video to a senior-level marketing executive, after uncontrolled laughter at the absurdity of the behaviors of the marketing team in the story, he stopped in his tracks and asked the question, “what does this say about our marketing team?” The story and humor caught his attention and in a split second, he shifted from laughter to a self-reflective type question. In communications and educational research, the technique used in The Workshop video series is referred to as “entertainment-education (EE)". Entertainment-education (EE) is an approach to communicating an educational message through storytelling, acting, and connecting with a reader’s or viewer’s emotions. Laughter is a powerful emotion. Just the right level of tension or stress is also an emotion. In the design of The Workshop educational video series, we set out to develop an educational story with this balance of tension, emotion, humor, and reality. After 6 months of research and an ah-ha moment the morning after a creative design session, I came up with the idea for The Workshop.

Many success stories are preceded by failure. My first EE project was called ThePhaRM. In ThePhaRM, the balance of tension, humor, and reality wasn’t quite right. We tipped the scale a bit too much on the side of sarcastic in-your-face humor that was rejected by the audience. Several salespeople told me that it was offensive to them because it felt like an affront to their profession. It made them look foolish. Sales and marketing people didn’t connect with the characters emotionally. I went back to the drawing board. I conducted about a year of additional research by attending conferences, conducting interviews, reading industry cases and research papers and then started on The Workshop project with the team at The Second City. I applied my research findings to the design of The Workshop. The result was dramatic when compared to the feedback to ThePharm video series. Salespeople came up to me in meetings and told me repeatedly that they couldn’t believe how real it was. They loved the stories and the characters. Some people told me that they were watching the videos at home with their families. This is the type of effect that you want to have with a well-designed entertainment-education program. You want your learners to connect with the story and the characters while causing self-reflection on their past behaviors. The Workshop was designed to teach the principles of compliant promotion of life science products while also causing people to reflect deeply on ethical business decision-making.

To be continued ...