Marketing medicines for off-label usage is the bane of the pharmaceutical industry. According to the report 2015 Year-end FDA and Health Care Compliance and Enforcement Update – Drugs and Devices, recoveries worth USD 5.9 million were made from drug makers for violating labeling regulations. Many other companies received warning letters from the Food and Drug Administration (FDA) for promoting the unapproved use of medicines.
How can pharmaceutical firms prevent the off-label marketing of drugs? What does it take to ensure medical reps adhere to FDA’s labeling norms? Well, you need to focus on one of the key elements of effective compliance – good training.
Proper training educates your medical reps on the consequences of off-label marketing, and this goes a long way in adhering to the norms specified by the drug regulator. Many pharmaceutical companies are using e-learning to train their staff on compliance issues as the training format is cost-effective. Furthermore, online courses are ideal to train a geographically-dispersed workforce as they can be accessed anytime, anywhere. Today, we will look at a few strategies to deliver training of high efficacy on off-label marketing norms.
1. Gamifying the courses
One of the major issues in delivering good training on off-label marketing norms (or for that matter any regulatory aspect) is learner humdrum. The content of compliance courses deals with laws and rules, and most staff members consider it dry and boring.
This problem can be overcome very effectively through gamification. Gamification helps break learner monotony and makes the learning environment fun-filled, leading to better training. For instance, we have developed a gamified course on off-label marketing of drugs, which is based on the story of a medical rep Jim who flouts the FDA norms, causing his firm to lose millions. As a result, the company goes into doldrums, and many reps, including Jim, lose their jobs.
2. Using videos
Most pharmaceutical companies convert their instructor-led compliance training materials in the form of PowerPoint presentations into online courses, and those on off-label marketing are no exception. However, presenting content in the form of bland bullet points can “kill” learner interest, resulting in poor learning.
Videos are an ideal solution to this problem. Videos go a long way in engaging your people and help them retain the learning longer. A study conducted by researchers at the Massachusetts Institute of Technology (MIT) showed that video-based learning is highly effective. It is a good idea to develop micro learning videos (each of about 5 to 10 minutes in duration) to train your people on the various aspects of off-label marketing. For instance, you can create a video to demonstrate the consequences of violating the norms pertaining to the sponsorship of investigator initiated trials.
3. Utilizing scenarios and case-studies
The “boundary” between the permitted and non-permissible use of medicines is very thin. I’m sure you would agree with me that any effort to educate your staff on norms pertaining to the off-label marketing of drugs would be futile, if it doesn’t help them identify the “grey areas”. You need to make sure your medical reps can distinguish what constitutes a violation of FDA norms and what doesn’t.
You can use problem-based learning (PBL) elements such as scenarios and case-studies very effectively to help your people differentiate between legal and off-label marketing of drugs. One of our clients uses online learning scenarios to enable its staff identify what can be deemed as acceptable evidence to support promotional claims.
Good training is very useful to combat the menace of off-label promotion of drugs. Many firms are using e-learning to train their staff to promote their drugs in an FDA-complaint manner. You can use gamified courses and videos to deliver engaging training on norms pertaining to the off-label marketing of medicines. PBL elements help you train your medical reps to identify what constitutes legal usage of a drug. Hope you liked this post. How do you train your people to prevent off-label promotions? Do share with us.