compliance training

Using ADDIE to Optimize Your Compliance Training Curriculum, Part 2: Design

PharmaCertify Team , , , , ,

This is the second post in a series about using the ADDIE learning model as a framework for building a better compliance training curriculum.

In our last post, we began with the first step in the ADDIE model, A (Analyze), and explored a way to analyze your compliance training needs so you can obtain a clear picture of those needs. The result was a list of the activities your employees engage in that contain some form of compliance risk, with columns indicating the risk level and frequency of each activity for each employee group. For example:

With this information in hand, it’s time to move on to the first D in the ADDIE model – Design. Now that you have identified your training needs, how are you going to meet them? How do you decide whether to create eLearning modules, live workshops, microlearning, performance support tools, etc.?

Several factors should help drive your design decisions.

Activity Risk

Make sure you address high-level risks first. This doesn’t necessarily mean all high-level risks need to receive the same level of resources or attention (other factors are at play), but it does mean that you need to implement a solution that properly addresses each high-level risk activity.

Select the chart to see examples of how various activities might be mapped in terms of risk and frequency.

Activity Frequency

Employees who perform an activity more frequently will tend to remember the steps involved (and the associated compliance guidance), while the opposite will be true of those activities performed less frequently.

For example, sales representatives may call on doctors almost every day. It’s a high-risk activity, but repetition breeds familiarity. However, the same sales representatives may only occasionally plan and host a speaker program. So, a quick reference guide or refresher training to remind them of their responsibilities would be helpful.

Regardless of the frequency of an activity, all learners benefit from a training solution that includes spaced reinforcement and that does not rely on just one crowded learning event. But for less frequent activities, reinforcement and reference materials are even more critical.

Learner Characteristics

Also take into account the characteristics of your learners. Think about these questions:

  • How many people engage in each activity? Some training modalities, like live workshops and coaching, are well suited for smaller populations but may not be practical for larger groups.
  • How many groups engage in the same activity? Are there groups who can receive the same training on a topic?
  • What are your learners’ levels of experience? Foundational training may be more important for new learners, whereas experienced learners may need more reinforcement or training that goes deeper into specific issues.
  • Where are your learners located? In-person training events may not be an option for a dispersed group.

Other Considerations

Here’s a quick review of other factors to consider.

  • Which activities can be addressed through common solutions? For example, can all transfers of value and transparency concerns be addressed through a single learning solution?
  • How stable is the subject matter? Are regulations, policies, or practices changing soon? You may want to hold off on an elaborate learning solution until the dust settles.
  • What resources do you have available? What’s your training budget? How many employees can you dedicate to training initiatives? Some solutions will be more practical and economical than others.

DOJ Recommendations

As you consider your choices, don’t forget to review the training recommendations found in the US Department of Justice’s Evaluation of Corporate Compliance Programs. Along with recommending timely, periodic, risk-based training that is appropriately tailored, the guidance notes that “Other companies have invested in shorter, more targeted training sessions to enable employees to timely identify and raise issues to appropriate compliance, internal audit, or other risk management functions.”

Possible Solutions

Weighing all the factors discussed above should help you narrow down the approaches that would help you best meet your learners’ training needs.

For example, low-risk, low-frequency activities might be best addressed by requiring learners to read the relevant policy and electronically sign an attestation. You can also provide job aids and other performance support tools learners can reference at the point of need, ie, when they are about to engage in the activity.

The Compliance Foundations eLearning module, Compliant Product Promotion, is a great starting point for all sales employees.

Likewise, when training on a high-risk activity, consider blending core training with reinforcement and performance support tools. For example, you could deploy a foundational eLearning module on promotional interactions for all sales employees, supplemented by live Q&A sessions for individual brand teams and micro-learning videos that periodically reinforce of key risks.

And don’t forget the value of communication. Website banners, short emails, and physical posters can all be used to remind employees of important principles and practices.

No Matter the Solution, Follow Good ID

Once you settle on a specific solution, remember to follow sound instructional design principles. Focus on the learning objectives, ie, what people need to know and be able to do, rather than chunks of content. Remember the goal is not to turn your employees into junior compliance experts; it’s to help them perform their jobs in compliance with your company’s policies and procedures and thereby reduce your company’s compliance risk. If nothing else, put yourselves in the learner’s shoes as you make your design decisions.

Conclusion

While this post merely scratches the surface, we hope it’s given you some practical design considerations to think about when creating or refreshing your compliance training curriculum.

In our next post, we’re going to stay with the topic of design a little longer, but this time we’ll discuss visual design and the role it plays in creating effective learning experiences.

Until then, thanks for reading!

Dave Correale
Senior Instructional Designer

Using ADDIE to Optimize Your Compliance Training Curriculum

PharmaCertify Team , , , , ,

Part 1: Analysis

This is the first post in our series on using the ADDIE learning model as a framework for building a better compliance training curriculum. We begin with the A (Analysis) stage of the model as a first step for creating or refreshing a curriculum.

With so many compliance concerns piling up in your inbox, it can be hard to take the time to pause and analyze your training needs without rushing towards solutions. But until you have a clear picture of  your needs, how can you be sure the solutions you are deploying really address them?

Whether you are creating your company’s first compliance training plan or working with a mature plan that has evolved over time, don’t skimp on the analysis. Otherwise, you risk creating a convoluted curriculum with redundancies, gaps, and an uneven emphasis on content over risk. And while analysis is an ongoing task, taking the time to conduct a formal analysis that looks at the big picture and gives you a foundation to build (or rebuild) from is important.

Start with the Risks

One way to begin your analysis is to list all of the activities your employees engage in that contain some form of compliance risk. After all, if your ultimate goal is to reduce risk, why not put those risks front and center in your planning?

We’re all familiar with the annual risk assessments that virtually all life science companies perform. They provide an overview of macro areas of risk and are therefore good overall guidance for compliance professionals. However, it is important to also consider the “risks within the risks.” The key here is to be granular enough so that you build an informative picture of the risks your company faces – one that gives you the flexibility to address risks that apply to different audiences, in different ways, and at different frequencies.

For example, to simply list “speaker programs” as a risk glosses over the individual activities involved in a speaker program that expose different people to various types, levels, and frequencies of risk. These could include speaker selection, attendee tracking, program meals, and the handling off-label questions.

Identify Your Learners

Next, it’s time to identify the groups of individuals who are potentially exposed to the risks you have listed. You could create these groups as columns that bisect your rows of risk activities. Again, it’s important to achieve the right level of specificity. Under the commercial umbrella, for example, you’ll want to break out field sales, sales operations, marketing, etc. so you can recognize the different needs for each function.

Add Risk Levels and Frequency

Not all risks are created equal; nor do they occur with the same frequency for the same groups of employees. It’s important to recognize both of these factors when analyzing your training needs.

The value of distinguishing activities that present higher levels of risk is obvious, but frequency is just as important. Someone who engages in a high-risk activity on a frequent basis has a different learning need than someone who engages in the same activity on a less frequent basis.

Since risk level and frequency can vary for each learner group, you can further divide your columns and assign risk levels and frequency, as shown in this example.

Next Step: Design

Completing the activity described above is not necessarily a quick and easy task, and you may need input from others to ensure its completeness and accuracy, but it’s a critical first step toward designing (or redesigning) a better compliance training curriculum to help you reduce risk across your company. And that will be the topic of our next blog post as we move on to the D in the ADDIE model, Design.

In the meantime, if you’d like a complimentary template of the spreadsheet described in this post, which we call the Compliance Curriculum Analysis Tool (CCAT), email us at info@pharmacertify.com. We’ll be happy to show you the tool and ideas on how to use it.

Thanks for reading!

Dave Correale
Senior Instructional Designer

Using ADDIE to Keep Your Compliance Resolutions

PharmaCertify Team , , ,

In this week’s post, Dave Correale, a Senior Instructional Designer at NXLevel Solutions, introduces a new blog series on using the ADDIE model to help build a better compliance training curriculum.

Now that the relatives have gone home, the ill-advised presents have been returned, and the eggnog in the back of the fridge has spoiled, it’s time to consider a New Year’s resolution to refresh and revive your compliance training strategy.

But getting your arms around your compliance training needs and developing a plan to address them can seem overwhelming. One tool that can help is the ADDIE model. In the training industry, we use ADDIE as a model for developing individual training solutions, but it can also be an effective tool for organizing your approach to a broader training strategy. Over the next several blog posts, we’ll use the ADDIE model as a framework for helping you build a compliance training plan worth celebrating.

Analysis – In this post, we’ll provide practical tips on how you can identify and prioritize your training needs. There are a lot of factors to consider, and we’ll discuss concepts and tools you can use to bring order out of the chaos.

Design – This post will be a two-parter. In Part 1, we’ll look at instructional design and how to design solutions to meet the training needs identified in the analysis stage. How do you choose whether to create eLearning modules, live workshops, microlearning, performance support tools, etc.?

In Part 2, we’ll discuss visual design and the role it plays in creating effective learning experiences. Do your training solutions look generic, or do they reflect your organization’s culture? Do your visual choices support or distract from your learning objectives?

Development – After design, it’s time to develop. But what do you develop first? And do you build it in-house or use a vendor? Is there an off-the-shelf solution you could use? Do you have existing assets that just need a refresh? We’ll explore the thought process that goes into deciding how to best use the resources you have available.

Implementation – How you implement your training plan is as important as the plan itself. Planning, timing, communication, support from the business, and getting the most out of your available learning platforms are just some of the elements we’ll examine in this post.

Evaluation – Finally, how effective is your compliance training? How can you tell? This post explores ways to determine whether your training is having an impact.

So, clean out the fridge, put the decorations away, and stay tuned for more tips on how to reduce risk through better compliance training.

Training-Related Reflections on PCF’s 23rd Compliance Congress, Part 3

PharmaCertify Team , , , , ,

The Changing Field Medical Maze

Welcome to my third post on the 23rd Annual Pharmaceutical and Medical Device Ethics and Compliance Congress. Through these posts, I have been reviewing some of the key topics covered during the conference and providing my reactions, as well as related tips and suggestions for creating better a compliance training curriculum.

This week, I touch on key points raised concerning the special relationship between field medical and commercial teams, and the training needs created by that relationship. Spoiler alert: the more things change, the more your sales representatives need to understand the role of your medical team.  

Ghosts of Conferences Past

In past years, presenters at compliance congresses would be quick to emphasize the need to draw a hard line between the actions of medical and commercial personnel. Medical was siloed into the communication of science, and product promotion was left to the commercial team — and never the twain shall meet … well, except for the joint interactions during which their separate permissible actions were clearly delineated.

The safest path was to ensure the actions of the medical team were laser-focused on science and external interactions only occurred at the request of healthcare professionals. And the easiest (and most straight-forward) path to compliance by both teams was through role-based training that made clear the appropriate actions for each –‘Sales reps, you can do this, and MSLs, you can do that’ (and vice versa).

Ghosts of Conferences Present

Well, in recent years, “the times, they are a changing.” As presenters in the Medical Affairs Today: Managing Evolving Risks session and the Recent Federal and State Enforcement Actions session noted, a shift is underway in the industry. Now some medical personnel are quicker to proactively provide information to HCPs, rather than just in response to a medical information request. Or, as it was said in the Recent Federal and State Enforcement Actions session, “Companies are shifting to a patient-centric focus, and that’s creating a sense of one company … that’s causing us to see a lot of creative ideas by medical, which poses some challenges.”

In terms of enforcement, one could understand why the industry would be lulled into a false sense of security. After all, recent corporate integrity agreements have hardly focused on the relationship between commercial and medical. But, as was highlighted in the Recent Federal and State Enforcement Actions session, some recent CIAs do include provisions relating to that relationship and the sharing of information. In addition, enforcement actions are typically lagging in nature, and settlements follow a few years after the actual conduct.

Promotion is Promotion, No Matter the Source

Presenters in both sessions made clear that the government doesn’t care what your role is. While collaboration across the two groups can have the noblest of intentions, sales reps and medical personnel must consider the potential risks of their actions. Guardrails are needed from the outset and the mistaken belief that the medical team’s actions and words cannot be interpreted as promotional just because of their job titles must be exposed for the dangerous fallacy that it is. To borrow a phrase from the Medical Affairs Today session, the medical team “cannot be driving towards promotional claims and they cannot be salesy.”  Both teams need to be reminded of this on a regular basis through a multitude of touchpoints throughout their schedules – in other words, through continuous reinforcement and performance support.

Take the Role-Based Fork in the Road Carefully

By now, you may be asking how you should adjust your medical personnel’s compliance training in response to this industry shift, but that should not be your only concern. The training plan for your commercial team may need to be evaluated and modified as well. More than ever, sales representatives must understand the role of medical personnel, and what medical personnel are and are not permitted to do during joint interactions with HCPs.

An effective and modern commercial training plan includes a broad understanding and overview of the field medical role. Do your reps understand the role of field medical personnel? Are they continuously reminded of the need to keep the medical and commercial roles distinct? To appropriately prepare sales reps for their interactions with HCPs, their training should cover the need for the field medical role, its purpose, examples of typical field medical activities, and the principles behind them.  

Joint Interactions Need Joint Training

Presenters in the Medical Affairs Today session touched on the need for collaboration between medical and commercial and the number of situations where their paths can cross, including HCP introductions, payor communications, speaker programs, and medical congresses. These interactions are filled with risk, so the divide between the two roles, and how each team can navigate that divide needs to be emphasized continuously in training.   

Foundational training on joint interactions doesn’t need to be divided into multiple modules to effectively cover the requirements of each team. A successful collaboration demands the sharing of knowledge that can only be achieved through a collaborative training initiative.

On the reinforcement front, opportunities to remind those involved in joint interactions abound.  For example, shortly before the start of a conference, you could deploy a microlearning that covers the rules for commercial vs. medical/scientific booths. Or a virtual live JEOPARDY game, for example, can be populated with questions related to HCP/MSL introductions, senior-level interactions, and interactions with payors. (By the way, we offer the only officially licensed JEOPARDY™ game on the market. It’s cool, it’s a great learning tool, and it’s easily customized with your content. Visit our website for a demo.)

Finally, it’s not all about interactions with HCPs. Both teams should be regularly reminded of the guardrails around internal interactions, too (eg, medical is not permitted to share an HCP’s response to an off-label question with commercial).

Summary  

While the perception of the field medical role may be changing, the need to educate both your medical and commercial teams about each other’s purpose and functions has not.

The end of the year is a good time to re-evaluate your training plan to ensure your commercial and field medical curricula feature the foundational training, reinforcement solutions, and performance support tools necessary to establish and maintain a sense of compliance across both teams. If you’d like to see demos of the custom and off-the-shelf training courses we have helped your peers deploy in the life sciences industry, please contact us at info@pharmacertify.com.

Thanks for reading! Happy holidays and best wishes for an even more compliant 2023!

Sean Murphy
PharmaCertify by NXLevel Solutions         

The Formula for Building a Better Compliance Training Curriculum!

PharmaCertify Team , , , , , ,

Editor’s Note (September 13, 2022): this post has been updated to include additional suggestions for foundational, reinforcement, and performance support compliance training solutions.

In its guidance related to the evaluation of corporate compliance programs, the Department of Justice repeatedly stresses the importance of appropriately tailored and risk-based training. The guidance suggests prosecutors should “assess the steps companies have taken to ensure policies and procedures have been integrated into the organization.” I can still almost hear the pleas of compliance professionals wondering exactly how they are going to accomplish such integration. The solution is found in a straightforward formula: foundational + reinforcement + performance support = integration (F+R+PS = I). I know, it’s not as simple as the Properties of Equality we all learned in junior high school, but we’ve seen it work time and time again.

Reset the Forgetting Curve

As the Ebbinghaus Forgetting Curve illustrates, the information humans remember after a learning event drops steeply soon after completion of that event. In fact, that loss of recall continues to increase until it finally flattens around 30-days post event. So, F+R+PS = I to the rescue!

Starting with a Strong Foundation

Let’s start with the first elements of the integration formula, foundational training.

Industry-specific foundational training should be used to cover topics such as interactions with health care professionals.

Any successful journey toward integration begins with effective foundational, training. In its guidance, the DOJ instructs prosecutors to consider the form, content, and effectiveness of that training. But what is “effective” foundational training? It begins with relevancy. Does your eLearning feature content to which your learners can relate? Are the scenarios based on interactions and situations your learners are likely to face? Is the content written in plain language? Has the content been vetted by subject matter experts who understand the nuances of interactions with HCPs, HIPAA, or product promotion? For all those reasons and more, broad-based, cross-industry training doesn’t work and is frankly a waste of time and budget. As you know, your sales representatives aren’t benefitting from scenarios featuring ethical discussions between two insurance employees.

Effectiveness also requires a fresh graphic design and user interface. Modern training development tools allow for the use of illustrated images to represent characters such as doctors, sales representatives and MSLs. Let’s be honest, stock photos scream stock photos – or as I call them, “shiny happy doctors and sales reps.” Illustrated characters also offer more opportunity for inclusion of characters that ALL employees can relate to. Your learners want to see representations of themselves in their training.

Finally, effective foundational training is built with proven instructional design strategies in mind. Are the learning objectives specific enough to be meaningful?  Is the content logically organized? Are knowledge checks and interactive exercises appropriately woven into the training? Can the questions in the assessment be mapped directly to the content in the module?

The Compliance Foundations Suite of eLearning modules includes HIPAA for Pharmaceutical Employees .

This isn’t to say effective eLearning always has to be custom developed. Industry-focused, creative, engaging, and modern off-the-shelf training is a great solution for establishing an effective base. So, if you’re with an emerging pharmaceutical or medical device company with limited time and resources, off-the-shelf training is a viable option. Just do your homework and talk to your peers to make sure it’s the right off-the-she solution. (Shameless pitch – we can help!) Of course, custom development does present an opportunity to take your curriculum to another level with more options for branded training laser-focused on your policies if the budget is available.

Also, don’t fall into the current trap of thinking all training has to be short to be effective. Yes, you want to keep foundational eLearning modules no longer than 30 minutes or so, but if 30 minutes are necessary to cover a comprehensive overview of the topic, the learners can sit through it. After all, if we can binge-watch our favorite streaming series, we certainly have the attention span to complete a 30-minute module, assuming it is relevant and engaging.

Reinforcement Drives Retention

Integrate microlearning modules to cover more targeted topics like the 2022 updates to the PhRMA Code.

The second element of the formula for more effective training is reinforcement. When strategically deployed following the initial workshop or eLearning, reinforcement solutions in the form of microlearning modules serve to boost learning, reinforce key topics, and help flatten that nasty Forgetting Curve. For example, if gifts and meals are a high risk for your HCP-facing employees, a scenario-based mini module built around a common situation they face in the field, deployed soon after the foundational training on interactions with HCPs, is an ideal way to increase retention of critical information.

Microlearning modules aren’t the only effective tools for making training more effective, though. Reinforcement learning nuggets could include quizzes and games deployed repeatedly over time. Look for games that can be completed individually or in a multi-player virtual workshop. The Compliance JEOPARDY! game from PharmaCertify, for example, is available in both formats and is easily customized with your content. By the way, it’s the only officially licensed JEOPARDY! game on market and it’s an instantly recognizable way to pull learners into an important reinforcement activity. They’ll even thank you for it.  

The Virtual Compliance Reality Escape Room features a series of customized scenarios and challenges.

Other reinforcement approaches could include virtual or live workshops with content built around the situations sales representatives are likely to face in the field. Why not create a a virtual escape room, for example, with challenges customized for the situations your learners can expect to face in the their daily interactions? (Let me know if you’d like to see a demo of the escape room we built for a client, which recently won a gold Brandon Hall Award for Best Compliance Training!)

The effective integration of compliant practices and policies requires the continuous deployment of a variety of reinforcement solutions. Government agencies like the DOJ and the OIG have made it clear in their guidance, and recent industry settlements and corporate integrity agreements highlight the need as well.

Supporting Their Performance

We’ve come to the ”PS” in the equation that holds the key to achieving integration in a life sciences compliance equation: performance support. Performance support includes those just-in-time resources that people need when they are in-the-moment and can’t remember compliance guidance.

Digital support tools like electronic banners support compliance training messages and themes. When splashed across the company intranet and incorporated into digital messaging from the compliance department and the C-Suite, they remind everyone of the key messages from the foundational and reinforcement training.

Video launched on the company intranet is an effective way to support key messages.

Don’t shy away from the use of video either. Despite what some high-end production companies will tell you, you don’t need to use your entire training budget on a high-end video. You’re not creating Compliance: The Live Action Musical. You’re looking for ways to support your efforts with a creative and engaging video. Tools like Vyond are affordable and easy-to-learn way to accomplish those goals. Many of our clients are developing short (1-3 minute) videos that are pushed out via hyperlink and housed in a library on the compliance page of their intranet. Some even use platforms like Microsoft Stream as an internal YouTube, so that people can rate and comment on the videos.

Finally, materials like quick reference guides support positive behavior and deliver critical reminders when people need them most…as they are about to engage in activities rife with the potential for compliance violation. And other print material like posters and comic books are a great and thematically fun way to drip the learning throughout the duration of a compliance training campaign.

Summary

The key to success and “effectiveness” in compliance training, foundational + reinforcement + performance  support = integration, will not be remembered among the great formulas in history (rest easy Albert Einstein), but any compliance professional would be wise to heed its power. At PharmaCertify, we’ve spent the last 15 years developing compliance training for the life sciences industry. We have the in-house compliance expertise, along with the instructional design and production skill, to help you implement this formula as a necessary step toward meeting the expectations of the regulators, your peers, and perhaps most importantly, your learners.

That’s why we are planning webinars, video-based chats, infographics, more blog posts, and other resources to showcase examples of how our clients are utilizing each stage of the formula to increase the effectiveness of their training. Subscribe to this blog and follow us on LinkedIn and Twitter to keep abreast of the details to follow as we continue to provide the information you need to help reduce risk through training. After all, it’s our mission.

Thanks for reading!  

Sean Murphy
PharmaCertify by NXLevel Solutions

Building Better Compliance Training: 5 Ideas for Reinforcement Training

PharmaCertify Team , , , ,

Welcome to this installment in the Building Better Compliance Training series. Our mission at PharmaCertify is to help you reduce risk through better compliance training, and my goal in this series to provide you first-hand tips and ideas for creating a more effective compliance training curriculum.

In my last post, I revealed the formula for making compliance training more effective: Core Training + Reinforcement + Performance Support = Integration (C+R+PS = I). This time, I focus on the ”R” of that formula and offer five proven methods for reinforcing core training to help ensure your learners recall key concepts and policies when adherence is needed most, particularly during interactions with healthcare professionals.

Since studies show that as much as 90 percent of information learned during one event is forgotten within 30 days (remember the Forgetting Curve), here are five ideas to help ensure your learners don’t fall victim to this sad statistic:

The PharmaCertify PhRMA Code QuickTake focuses on the latest update to the Code.

Go “micro” to make it memorable.

Microlearning is all the rage, and for good reason. Targeted microlearning modules (we call them Compliance QuickTakes) are an ideal way to reinforce critical concepts introduced in core training. Launching a QuickTake on gifts and meals soon after core training on promotional practices, for example, helps improve retention of your company’s policies on a topic fraught with compliance risk.

In addition, today’s eLearning development tools (e.g., Articulate Storyline) make it easier and more cost effective than ever to create reinforcement modules from larger, foundational eLearning. So don’t fall into the trap of thinking one-and-done eLearning is going to meet the needs of a team facing the risk of the proverbial Forgetting Curve at every turn, especially when the opportunity to flatten that curve is just a few select reinforcement modules away.

Lights, camera, animation!

Animated video, featuring illustrated characters, is a compelling method for developing modern videos and a welcome relief for audiences steeped in the disappointment of reinforcement programs populated with dry content and unrecognizable stock photos. Illustrated characters offer a flexibility not easily matched with stock photography, and let you easily create a set of actors equal in diversity to your company’s personnel.

One of our clients regularly launches “Compliance Moments” videos to reinforce key topics from their core training. The programs feature serious content presented in a light (sometimes humorous) tone to help make the messages stick. Having a scriptwriter who combines a keen sense of instructional design with an awareness of how to create realistic scenarios is a must to make the training work. (P.S. we have these.) 

Videos with illustrated characters are an effective way to enhance retention.

Solve a compliance mystery.

Who doesn’t like a good mystery? And who wouldn’t prefer solving a compliance mystery over the typical slide-based presentation?

The Compliance Mystery opens with a series of clues in the form of emails, texts, and receipts from HCP meals.

The days of a compliance officer speaking to a PowerPoint deck are fading fast and your learners expect a higher quality of workshop training. As importantly, a strategically scheduled compliance mystery workshop gives you the opportunity to take a “deeper dive” into the content and immerse participants in the learning, whether the environment is live or virtual.

It’s the ideal reinforcement opportunity as learners act as compliance detectives, work together to identify red flags and determine the best course of action for each scenario. To ramp up the learning even more, try sharing team scores from a leaderboard during the workshop.

It’s engaging, it’s modern, and it’s a great way to make the training relevant as you enhance retention of compliance policies and best practices.

Play a game…virtually, or in a live workshop.

Scenario-based games make the training more relevant.

Games work for reinforcement. In fact, according to a recent study, 80 percent of US workers believe game-based learning is more effective. And if they believe it, they welcome it, especially over the standard compliance training formats.

While games such as JEOPARDY! (which we also offer), come with the built-in advantage of being familiar to the learners, the format and gameplay doesn’t have to be recognizable to be effective. The key is simplicity, fun, and flexibility to customize the categories with your content.

Customize the content to focus on the topics and questions that need reinforcement.

Put simply, games work for reinforcement because they require participants to retrieve information from the long-term memory, process it in the working memory, then re-encode it back into the long-term memory (okay, maybe that wasn’t put simply).

“Escape” to more effective reinforcement training.

Escape rooms are a familiar concept for your audience. And familiarity breeds learning.

A Compliance Escape Room interface.

So, why not create a virtual compliance escape room to help reinforce the rules and policies around topics like virtual sales calls, speaker programs, and medical conferences? The virtual rooms we have created for clients feature a series of clickable clues followed by a series of knowledge checks based on those clues.

An important note: the knowledge checks should be challenging enough that learners will need to revisit the clues to think through the correct answers. Make it subtle and challenging. Returning to the clues to recall the correct information helps the knowledge retention process and serves to strengthen reinforcement of the messages.  

Throughout 2022, we will continue to post articles on this blog, as well as infographics and tips sheets on the Insights page of our website to help you build a better compliance training curriculum. In the meantime, if you’d like to see demos of the products referenced in this article and discuss how we can help you reduce risk through training, contact us at info@pharmacertify.com.

Thanks for reading!
Sean Murphy

A New Year, a New and Improved Compliance Training Curriculum

PharmaCertify Team , , , , , ,

Welcome to 2022 and a brave, new (and hopefully more effective) world in life sciences compliance training! Over the last two years, the industry has had to navigate the convergence of new and important regulatory documents (DOJ’s Evaluation of Corporate Compliance Programs, OIG’s Serious Fraud Alert on Speaker Programs), as well as updates to leading industry guidance (PhRMA Code, AdvaMed Code). Mix in a series of corporate integrity agreements and settlements focused on key topics, along with a global pandemic, and you have a perfect recipe for a shift in how risk is evaluated and remediated.

So, what’s the appropriate method for recalibrating your compliance training curriculum in response to these events and forces? The solution is as easy as A, B, C, and D:  

Assess Your Company’s Compliance Training Curriculum

Regular risk assessment is a long-time best practice for building and maintaining effective compliance programs. It’s nothing new, and as usual, the major conferences from Informa and PCF in 2021 included multiple sessions where risk assessment was a major topic of discussion. But this time, the regulatory guidance and industry code updates added a sense of urgency to the importance of this best practice.

The Compliance Curriculum Analysis Tool

But what good is a risk assessment if you don’t then assess your training curriculum against that risk? When we work with clients, we evaluate where they are in the product development process, and what training they’re already delivering on which topics, in what form, and at what frequency. It is often a revealing process, identifying gaps and redundancies in topics, and when and how the information is covered.

Good news! It doesn’t have to be a complicated process. Using tools like our Compliance Curriculum Analysis Tool (CCAT) can help.  And it can also be as straightforward as evaluating compliance risk for the product you are about to launch and establishing a baseline of online foundational curriculum around topics like HIPAA and Interactions with HCPs. No matter where you are in the product development cycle, know your risk levels as they relate to topics and audiences. Then look for opportunities to effectively address those risks in your curriculum with a continuous stream of foundational and reinforcement training.

Blend the Formats

The 2022 PhRMA Code Changes QuickTake eLearning Module

The days of using one large PowerPoint deck to train on all things compliance during onboarding sessions are long gone. Good riddance. Effective, well-designed training covering critical topics like bribery, kickbacks, HCP interactions, and speaker programs is readily available.

But the curriculum all stakeholders now expect doesn’t stop at eLearning modules covering foundational topics. You should also plan reinforcement training to help ensure that proper behaviors are integrated into your learners’ daily practices.

If your risk assessments show speaker programs to be a big risk area, don’t count on that one eLearning module or live training session to quell that risk. Why not launch a mini module specifically covering the selection and training of speakers? We call them QuickTakes. In fact, today’s development tools allow for smaller, more focused sections to efficiently and cost effectively be pulled from the larger modules.

Virtual workshops and games can be utilized to train on topics best discussed in live environments, where follow-up discussions and dialogue strengthen the core lessons. For example, if your assessments identify off-label promotion as high risk due to the nature of your company’s products, design a “compliance mystery” workshop, with scenarios replicating real-life environments sales representative can expect to experience in the field.

Compliance JEOPARDY!

Or, ramp up the competition and raise the level of learning with an online or virtual game like our Compliance JEOPARDY!, which is currently the only officially-licensed Jeopardy game on the market.

Finally, does your curriculum include performance support and just-in-time tools to help guide the learners before and after training events? Print and digital support materials can be designed in conjunction with the training and delivered to learners where they need it most – at their fingertips in the field.

A blended curriculum is not only the best approach for “making the learning stick,” it’s what the government, the industry, and perhaps most importantly, your audiences, now expect.

Communicate Across the Company

I admit that every time I heard the phrase “tone from the top” over the last ten years, I found myself wondering why the same topic was covered ad nauseum and seemingly at every conference. Then, a variation on that mantra started to seep into the presentations: “tone from the middle.” The reality is that key messages and lessons in compliance are delivered from the middle, more specifically, managers. And bringing those managers into the communication process helps ensure those in the field are reminded of the importance of compliance every day. It’s why presenters at conferences constantly stress the need to “partner with the business” and why compliance needs to be integrated throughout the company.

Speaking of communication, what does your plan look like? If you don’t have one, you should. Digital banners, animated video, and posters help reinforce the themes related to training and carry the messages across the company. For example, a QuickTake module covering kickbacks can easily be exported into a video for hosting on the company’s intranet. Or consider the approach we’ve taken with a number of clients to portray the compliance department in a more approachable light and produce lighthearted videos showcasing the risks involved in engaging with your company’s HCP partners.

Deliver It Continuously

One of my previous blog articles asked what a 170-year-old German psychologist had to do with compliance training and learning. The answer then, and even more so now considering the forces at work in the industry, is “everything.” Hermann Ebbinghaus is credited with theorizing fundamentals of human learning, including the learning curve, the spacing effect, and the forgetting curve. The forgetting curve essentially states that what humans remember after a learning event drops steeply after the completion of that event.

Continuous delivery helps reset the forgetting curve.

What Ebbinghaus theorized is interwoven into the government documents and settlements we’ve witnessed in recent years: “one and done” just doesn’t cut it. Unless you are taking a continuous approach to the delivery of your company’s compliance training components, you’re probably not taking every step possible to maximize the learning.

Are you deploying training nuggets across the learners’ timelines? Does your training plan include ongoing assessments and quizzes to help flatten that forgetting curve and increase knowledge retention? Are you asking for feedback from the learners on the quality of the training materials and adjusting accordingly? Have you explored available platforms for repurposing and sharing your training content?

In the DOJ’s guidance, the agency noted that some “companies have invested in shorter, more targeted training sessions to enable employees to identify and raise issues to appropriate compliance, internal audit, or other risk management functions.” The possibilities for doing that extend well beyond the creation of shorter eLearning modules. The availability of video, animation, podcasts, quizzes, and games, as well the delivery platforms necessary to continuously deliver those components, all create the opportunity to envelop learners in a framework of minimized risk.

Summary

The advent of new regulatory guidance documents and revised industry codes, as well as the implementation of recent industry settlements, affect the way risk is evaluated and judged in the life sciences industry.

We may be facing an onslaught of requirements and regulatory expectations during a time when the norms of business have been disrupted and disorganized, but using the instructional techniques and concepts outlined above, you have the opportunity to not only navigate your way through those changing expectations, but to elevate your compliance training curriculum to one that helps you rest easier on those waves of change.  

Thank you for reading! As always, my colleagues and I at PharmaCertify welcome the chance to discuss the compliance training challenges you may be facing.

Sean Murphy
PharmaCertify by NXLevel Solutions
smurphy@nxlevelsolutions.com

Reduce Compliance Risk: Play a Game

PharmaCertify Team , , , , ,

In this week’s post, Dave Correale, Senior Instructional Designer at NXLevel Solutions, discusses the benefits of using games to reinforce key compliance concepts and make training more engaging.

Imagine you’ve been given a 30-minute slot at an upcoming sales meeting. You’d really like to use the time to reinforce your company’s privacy principles, but you don’t want to just present a boring slide presentation. You know a game would be more fun, but would it be effective? How do you build a game around privacy principles, anyway? Besides, you’re not sure you even have the time or resources to build an effective game.

Let’s explore the first question: Would it be effective? While some of the more ambitious claims surrounding game-based learning are not yet substantiated by research, there is strong evidence that games can increase learner motivation and engagement, critical factors in the success of any learning program.

But how do you build an effective learning game around a topic like privacy? One mistake some people make when implementing a training game is they focus too much on the game and not enough on the objectives. Games are not a panacea. A game will likely not be effective for learning if it is not designed to meet specific instructional objectives. And just because a game is effective for one set of learners, in one specific circumstance, it not necessarily be effective for all learners in all circumstances. Just because you are using a game for learning, you cannot ignore valid instructional design principles and practices.

Fortunately, there are many types of games to meet many different types of learning objectives in a variety of circumstances. The level of participation itself can be diverse: games can involve teams or individuals playfully competing against each other in real time, or they can involve single players whose only competition is the game itself.

Let’s return to your 30-minute slot at a fictional sales meeting. Your goal is to reinforce learning on a topic your learners should already be familiar with. You could have employee teams play against each other in a “Jeopardy-style” contest. We’ve all seen the actual Jeopardy!® board – there’s room there to deliver a lot of content. But instead of bullet points, you’re leveraging familiar game show mechanics to raise curiosity among the learners and harness their competitive instincts. You can also build deeper connections between your employees and engage virtual employees in something more than just polling questions.

Single-player games also afford a number of possibilities. Perhaps your company is concerned with the number of recent settlements involving speaker programs. Players could work their way through an unfolding speaker program scenario where they need to engage with the speaker before the program and then respond to situations that arise during the speaker’s presentation. As they respond to each situation, the game moves forward, learners see the consequences of their decisions, and important lessons are learned or reinforced.

Finally, what about the time and resources required to design and develop an effective game? This is why PharmaCertify’s library of learning games is a good fit for ethics and compliance teams. Our collection of prebuilt games, which includes the only official Jeopardy!® game available, are easily customized to help you increase learner engagement and meet your learning objectives while requiring a fraction of the time and cost required to build a game from scratch. Contact Dan O’Connor at doconnor@nxlevelsolutions.com to see a demo and start planning your next compliance training success story.

And look for additional posts in the future that continue to discuss how game-based learning solutions can help you reduce compliance risk and strengthen your culture of ethics.

Thanks for reading!

David Correale, Senior Instructional Designer, NXLevel Solutions

Key Messages from the 2021 Virtual Pharmaceutical Compliance Congress (And How the Messages Affect Your Compliance Curriculum)

PharmaCertify Team , , , , ,

In what was hopefully the last of the “virtual” compliance conferences (fingers and toes crossed), the 2021 Pharmaceutical Compliance Congress (PCC) offered time-tested and established standards (insert “tone from the top” and “ethics-based approach” here), thankfully blended with new best practices, trends, and suggestions from an impressive list of industry executives and government representatives. Some of the key messages from the three-day conference are listed below, along with my thoughts on how those concepts affect your training curriculum in 2021 and beyond.  

1. OIG’s Special Fraud Alert on Speaker Programs still ripples across the industry.

The comments surrounding the OIG’s Fraud Alert released last November certainly were not revelatory, but the fact that industry insiders and regulators are still stressing its importance is meaningful. The Alert was referenced right out of the gate in the presentation by Jim Stansel of PhRMA, and one presenter in the Enforcement Trends presentation summarized its impact by saying, “OIG has thrown down the gauntlet on speaker programs with the Fraud Alert.” As the industry moves away from virtual engagements toward more in-person programs, expect intensified scrutiny.

Speaker programs remain a hot topic for enforcement, and as the industry emerges from the pandemic, your learners need refresher training on the foundational rules of compliant speaker programs and the key concepts associated with those programs. We can help, with our recently updated PharmaCertify Foundations eLearning module, Managing Speaker Program Risk.

2. Data is your friend. (Or should that be “Data are your friend? That one always confuses me.)

The need to scrutinize data has been a recurring topic of conversation, and this year’s PCC was no exception. Having access to data in the right form and unitizing that data to identify trends and outliers is key to an effective compliance program. “Be proactive to dig deep into the data,” one presenter at the Chief Compliance Officer Showcase on Day 1 suggested, “and identify field personnel who are consistently right at the meal limits.”

In life sciences compliance, the devil is in the data, and an informed evaluation of data is critical when updating and optimizing your compliance training curriculum. What is the data telling you? If you’re seeing concerning trends, you’ve got a training challenge. And if you’re not seeing any trends, you’re probably not looking hard enough, or you’re not gathering the right data. As my colleague, Dan O’Connor, pointed out in the Creative Compliance Training Solutions presentation, “when you send out post-training surveys, don’t ask the learners if they liked the training, focus on what they learned and ask them what they can apply in their jobs.” The data is out there, you just have to find it.

3. An ounce of compliance prevention is worth a pound of effectiveness.

In the Former Prosecutor Panel, one presenter emphasized the need to proactively address issues, whether a company is establishing its compliance program or reinforcing important policies as the business evolves. “Getting legal advice on the front of the program is important,” he says, “and when you move back to live interactions, refresh employees on the perils of speaker programs.”

No matter the topic, an adaptive approach to learning is the most effective way to ensure your audience is mastering the concepts and policies. Retention is enhanced when training is rolled out on a continuous basis, in the form of microlearning nuggets, where learners are asked to repeatedly demonstrate their knowledge and understanding. You will sleep better knowing you’ve taken steps to reduce risk.

4. Join in the innovation.

During the Chief Compliance Officer Luminary Panel, one presenter pointed out that the pandemic has forced companies to be innovative in how they navigate business activities, and she reminded the audience that the compliance department “should play a big role in that innovation.” The day of compliance and business operating in siloed fashion are long over. “A seat at the table” is no longer a hopeful cliché randomly mentioned at compliance conferences. To facilitate a true partnership under which compliance polices and best practices are integrated into the daily activities of the workforce, everyone involved needs to understand that risk tolerance in the industry has changed, and the only way to reduce that risk is through a unified spirit of collaboration and innovation.

That notion of cooperation and collaboration extends to training. When compliance training and concepts are integrated regularly into each employee’s full curriculum and daily work, learning is enhanced and stronger ethical cultures are forged. And as was referenced on Day 1 of the conference, statistics from the Ethisphere Institute, an organization focused on defining and measuring corporate ethical standards, show that companies with strong ethical cultures perform better.

5. Evaluate your vendors’ compliance programs as part of your due diligence.

The idea of conducting due diligence before hiring third-party vendors has long been espoused at compliance conferences. But I was intrigued to hear a presenter in the Fireside Chat with CCOs suggest an even deeper dive into a vendor’s compliance program to evaluate whether its practices and principles align with those of your company.

On the training front, that includes a thorough evaluation of the vendor’s compliance training program. Do they cover the high-risk topics pertinent to your company and its products? Do they conduct compliance training in general? How often do they train their employees? How accurate and focused is that training in terms of content? These are the type of questions that need to be incorporated into your third-party vendor risk questionnaire and considered before the contracts are signed.

6. The Sunshine Act rises again.

Too often, life sciences professionals regard Sunshine Act/Open Payments training as a “one and done” event. But as presenters in the Analysis of OIG Special Fraud Alert on Speaker Programs and Assessment of Future Activities session pointed out, Medtronic’s recent settlement with the OIG included a payment to resolve allegations that it failed to accurately report payments to CMS. This topic is too big and too risky to not being training more aggressively.

In addition to refreshing the content in our Compliance Foundations module, The Sunshine Act and Open Payments, we recently added The Sunshine Act Payment Categories QuickTake module to our library of customizable off-the-shelf products. The five-minute module is the perfect complement and reinforcement course to the foundational training, which covers the topic at a higher level.

7. The pandemic is not an excuse.

The notion that the pandemic does not give companies an excuse to lose sight of compliance was repeated daily throughout the conference. Industry leaders and government representatives reminded the audience that the shift to virtual interactions and programs will not be viewed as justification for breaking the law or acting in bad faith. Even though the way in which business is conducted has changed, the core principles and rules governing compliance have not.

The same holds true for your training curriculum. Don’t use the pandemic as an excuse to “put off” searching for ways to enhance training and increase engagement. In fact, you should be doing just the opposite as the industry shifts back to more live interactions. We can help with our Compliance Curriculum Analysis Process (CCAP), which is a comprehensive process to identify training gaps and reinforcement opportunities in your training components.

8. Expect continuing focus on foundations and copay assistance.

Enforcement trends around patient support programs and foundations are growing. It’s a topic on the minds of regulators and routinely on compliance conference agendas. As one of the presenters in the Keynote Enforcement Panel on Emerging Trends Enforcement put it, “we are seeing a ton of copay assistance cases in our district.”

Emphasis needs to be placed on patient program training. And to borrow a phrase, we’ve got a module for that. The Compliance Foundations module, Patient Programs and Their Risks, is a great starting point. Module topics include protecting patient privacy, discussing programs with HCPs, working with vendors, and a topic that is top of mind in life sciences – donations to foundations.  

Conclusion

The organizers of the virtual PCC have made the main stage and on-demand sessions available until May 29 for attendees. If you were there, I highly recommend you visit the conference site for content you may have missed or to revisit the sessions most relevant to you and your company. It’s one of the perks of attending a virtual event.   

While Informa made every effort to replicate the look, agenda, and networking opportunities associated with a live event, it cannot match the on-site conference experience. Fortunately, I am told Informa is planning a live conference for the fall, which will be welcomed news if the dates don’t conflict with those of the Pharmaceutical Compliance Forum’s conference. Bring on the real thing!

Thanks for reading; I look forward to seeing you “live and in person” at a conference before too long!

Sean Murphy
PharmaCertify by NXLevel Solutions

Jen Anderson of Vertex, Jackie Parris of Incyte, and Dan O’Connor of PharmaCertify present during the Creative Compliance Training Solutions session at the virtual 2021 Pharmaceutical Compliance Congress.

Compliance Training Lessons from the 2020 Virtual Pharmaceutical Compliance Congress

PharmaCertify Team , , , , , ,

Part 3: Compliance Training in An Uncertain Time

This is the third and final post in a series covering the compliance training lessons learned at the 2020 Virtual Pharmaceutical Compliance Congress. Throughout the conference, regulators and industry professionals stressed the need for constant evaluation and modification of all aspects of a compliance program, including the training program. The successful mitigation of risk in a program requires continual careful documentation and evaluation of training topics, audiences, and deployment frequency, as well as the effectiveness of the tools utilized to deploy the training.   

We’ll see you back in Washington D.C. for PCC2021!

To say 2020 has been an eventful and tumultuous year for the life sciences industry is an understatement. The COVID-19 pandemic has forced sudden change in the way in which business is conducted and created a milieu of unforeseen compliance concerns. Those issues were certainly not lost on the presenters at the 2020 Virtual Pharmaceutical Compliance Congress as timely suggestions for managing the “new normal” were blended with more traditional content related to building and managing an effective compliance program. One presenter summarized it interestingly when she said, “the plan you prepared in January does not make sense with what you need to focus on now.”

The need for on-going risk assessment was repeated throughout the conference, beginning in the Enforcement Docket Deep Dive session with one U.S. Attorney commenting, “programs must be updated over time to align with changes in the business and changes in settlements.” That risk assessment includes the on-going analysis and evaluation of a training curriculum, particularly as the way in which the industry interacts with each other and with HCPs continues to evolve.

A Rush to Roll Out New Training

The rush to cover new topics based on updated policies for virtual interactions can lead to a convoluted curriculum and do more harm than good. Regularly scheduled, comprehensive curriculum analysis helps ensure ongoing training covers existing and new topics with the right audiences, at the right level of detail, with the proper frequency based on the level of risk – and that analysis should not be pushed aside solely for the sake of expediency.

A “risk level” analysis has always been a foundational step in identifying content gaps and the need for updates in the topics covered. 2020 is no exception as the pandemic has forced a change in the way field teams interact with HCPs and conduct support programs. During the session, Look at How In-House Legal and Compliance Departments are Evolving in 2020 to Help Address Business Challenges, one compliance officer succinctly put it, “The way in which we do business has changed, so policies need to be more precise and training must be more engaging.”

Curriculum analysis begins with documenting a detailed list of topics covered in current training materials versus those required by the shift to virtual engagements. (Incidentally, PhRMA’s Statement on Application of PhRMA Code Section 2 During Emergency Periods is a good starting point for those changes). Your documentation should specifically include the target audience for each topic and indicate the level of risk each topic represents for each audience, as well as the frequency and level of detail at which each topic is presented.

Following the documentation phase, an analysis is necessary to determine whether the level of training versus the risk for the audience is sufficient. As a final step, solutions to address gaps and redundancies can be planned as new topics are added to the curriculum.

Increasing Retention and Enhancing Learning

An effective training curriculum also requires ongoing “engagement evaluation” to ensure learning is maximized. Let’s face it, the sudden onslaught of new and updated policies on virtual interactions is causing confusion. During the Candid Conversations on Key Themes and Industry Insights session of the conference, more than one panelist cited the movement to virtual programs as the topic keeping them up at night. The variables abound, and just updating foundational training programs with new policies is risky and flawed. More novel methods of training (quizzes, gamification, microlearning, etc.) offer opportunities to integrate nuggets of information into the curriculum and cut through the clutter of change to help raise engagement levels.

One industry speaker highlighted this best when he said, “You need to give them the tools to deal with awkward situations in this new way of conducting business, like how to respond to off-label questions.” That tool list begins with updated training components deployed repeatedly and strategically across the learner’s timeline. The changes wrought by COVID-19 only heighten the need to evaluate your curriculum for its power to change individual behavior – especially with updates to policies and changes in SOPs happening at such an unforeseen rate.

Unsolicited Change

The unknown can be daunting. The writer and poet Raheel Farooq once wrote, “The greatest fear in life is not of death, but unsolicited change.” We, as an industry, a country, and a world, have certainly seen our share of unsolicited change this year and it wasn’t lost on the presenters at this year’s conference. Panelists were quick to admit they didn’t have all the answers in terms of how training, and compliance in general, should be managed in these tumultuous times, but that’s okay. I’m confident most attendees would agree that the opportunity to share concerns, questions, and ideas was worthwhile, valuable, and reassuring. Kudos to all the presenters and conference organizers for making the 2020 Pharmaceutical Compliance Congress such a success under such difficult circumstances. I look forward to attending the 2021 conference “live and in-person,” as I am sure do you.

Thanks for reading!

Sean Murphy
PharmaCertify By NXLevel Solutions