Key Training Takeaways from the 2021 Virtual Compliance Congress for Specialty Products

Although Informa’s virtual 2021 Compliance Congress for Specialty Products was targeted to those companies that focus on rare and orphan diseases, many of the key messages shared by the panel of industry professionals and regulators were applicable to compliance professionals from companies of all shapes and sizes.

Here are some of the key takeaways from the three-day conference, with my thoughts on what those messages mean for your compliance training program:

To say the pandemic has changed the way life sciences conducts business may be cliché, but based on the presentations in this conference as well as the Pharmaceutical Compliance Congress in April, at least some of those changes are here to stay. Change begats an increased volume of risk, and in the opening session, Keeping Up with Industry Trends — Top Compliance Concerns Facing CCOs, presenters emphasized the need for risk assessments now more than ever.

1. The current pace of change highlights the importance of risk assessment.

You need to take the same approach with your training curriculum. What are the key risk areas based on your company’s products? How often are the topics relevant to your product covered in live and online training? Are key areas addressed with reinforcement and just-in-time training? We call this process the Compliance Curriculum Analysis Process (CCAP). In fact, I wrote about how the process can improve outcomes for the publication, Life Science Compliance Update, back in 2017. Thanks to the pandemic, and increased governmental scrutiny, it’s even more relevant today.  

2. Choose the right company when making a career move.

While most presentations in compliance conferences are focused on the best practices and concepts necessary to optimize a program, hearing one of the presenters stress the need to be aware of culture before joining a company was refreshing and enlightening. As the presenter pointed out, you cannot be shy about exploring whether the company makes compliance meaningful and if compliance is valued – before you accept a job offer.

Don’t forget to explore their approach to training as well. Are they regularly rolling out the kind of creative training and microlearning that helps flatten the “forgetting curve” my colleague Dan O’Connor, Erica Powers of Sage Therapeutics, and Karen Snyder of Ironwood Pharmaceuticals addressed in the Optimize Your Compliance Training: A Practical Approach to the DOJ’s Guidance session? (By the way, you really should see the slides from that presentation and the examples of fun an innovative training your peers are using to help reduce risk. Drop me an email at smurphy@nxlevelsolutions.com if you’re interested.)

3. Equip leaders with consistent and proper messaging.

In a twist on the familiar “tone-from-top” mantra, another presenter in the opening CCO session stressed the need for the compliance department to take the lead in providing leadership with the proper messaging needed to reinforce that tone. As he said, “consistency is key as you cascade communication across your program.” It applies to training as well. Not only does the C-Suite need to be trained in the same concepts and policies as employees, they, and the management team, need to be repeatedly reminded of the need for a seamless message. As we’ve been told in just about every conference over the last five years, you need to earn a “seat at the table” with leadership. Once you’re in that proverbial seat, helping them espouse the messaging necessary to keep your program consistent is the key to keeping it meaningful.

4. Don’t decline meetings during the pandemic.

During the Compliance During a Pandemic session, presenters spoke at length about the importance of open lines of communication and the need to make every attempt to meet with business colleagues whenever possible. The businesses and field employees need to know you are accessible when they have questions. As another presenter chimed in, “you need to constantly make sure they know who to go to.”  That concept extends to your training curriculum. Does your training include surveys and other feedback mechanisms? Do you encourage outreach in your eLearning? Creating and nurturing an open dialogue can only make your training more effective, during the pandemic and beyond.

5. If you’re going to have live speaker programs, you need to be wary of red flags.

That’s according to one presenter during the prosecutors’ presentation on high-priority risk areas. As he put it, the very fact that HHS even issued the Special Fraud Alert on Speaker Programs should be interpreted as a warning. While multiple presenters in other sessions suggested their companies will move to hybrid models with virtual and live programs, the opinions of the prosecutors were clear: expect the OIG’s focus to be on the live versions.

Managing Speaker Program Risk is one of the newly updated Compliance Foundations eLearning modules available from PharmaCertify. It covers the critical content your reps need to understand to remain in compliance, and like all our modules, it’s easily customized with your policies and content! Contact me to see a demo.

6. Not every patient advocacy organization is the size of the American Diabetes Association.

Day 2 kicked off with the Optimize and Mitigate Risk within Patient Interactions and Support Programs. Presenters noted the trickiness in dealing with advocacy groups in particular – not all the groups will be large and experienced enough to understand the potential pitfalls of compliance. You may need to educate them on the guidelines and principles, and that can be a challenge, especially on the delivery front since outside learners often don’t have access to your internal learning management system.

PharmaCertify can help with the Access LMS platform. Access LMS is a cloud-based, affordable alternative for reaching outside vendors and organizations with your compliance training. It’s simple, it’s easy-to-use, and it won’t break your budget. Contact my colleague, Dan O’Connor, at doconnor@nxlevelsolutions.com to see a demo. 

7. Dig deep into the weeds with MSL/commercial training.

The relationship between the medical and commercial divisions is nuanced and fraught with risk. During the Compliant Frameworks for Medical Affairs and Commercial Interactions session, a presenter whose company recently launched its first product reinforced the need for detail. While medical/commercial interactions have always been a pain point for her, she clarifies gray areas on topics such as “the rules for visiting HCPs together,” with what she calls “ways of working documents that clarify what each group can do and why.

At PharmaCertify, we take the same approach with our MSLs and Sales Reps: Understanding the Divide Compliance Foundations module. The content is designed to cover each role in a manner that helps reps and MSLs understand their own rules as well as those of the other group. I’d be happy to send you a content outline.

8. Follow the money. The prosecutors are.

It’s no secret that the government is scouring Open Payments data. And they are following the trail of money flowing to HCPs. During the enforcement panel, one prosecutor bluntly stated, “if you pay a provider hundreds of thousands of dollars, we are going to be looking at it.”

Reps need to consistently be reminded of HCP spend limits and incorporating microlearning components like on-going assessments and quizzes into your curriculum is key to ensuring those numbers are top of mind. We’d welcome the opportunity to show you how it works.    

Summary

Kudos to Informa and all presenters for putting forth a valuable and important learning experience despite the challenges that always accompany a virtual event. The pandemic has changed the way in which we share ideas, best practices, and personal experiences as much as it has changed the industry in general. As the world inches back to a more “normal” approach to information sharing, I anxiously await the day when we can again meet in person in a conference exhibit hall and exchange ideas for how you can reduce risk and build a stronger ethical culture through training.

Thanks for reading!

Sean Murphy
PharmaCertify by NXLevel Solutions

Key Training Takeaways from the KENX Biopharma and Biotech Corporate Compliance Summit

There is a new player in the life sciences commercial compliance conference space. After focusing on the GxP compliance field for years, the Knowledge Exchange Network (KENX) has joined the lineup of organizations targeting the commercial side of the industry. With Informa Connect (CBI) and PCF setting such a high bar for compliance conferences for years, I was looking forward to the possibility of hearing even more ideas for building an effective compliance program during KENX’s recent Biopharma and Biotech Corporate Compliance Summit webinar.

And that is exactly what happened, as an impressive array of industry leaders and established vendors presented new tips and suggestions for reducing risk and building an effective compliance program for established and emerging companies alike. Here are five key takeaways from the day-long webinar that may help you optimize your compliance training curriculum (that is, after all, our mission and passion at PharmaCertify):

1. “Establish a relationship with senior sales personnel so compliance is top of mind for new hires from the start.”

While the “partner with the business” refrain has been espoused frequently over recent years, the idea of turning to the sales leaders to make sure sales representatives hit the proverbial ground running is a compelling twist – particularly for compliance professionals from emerging companies, where resources are limited. Just as compliance needs to have a seat in the business, the business (and sales) needs to be part of the compliance committee to help establish a baseline of compliance expectations and avoid miscues from the start.

2. “The best practices and the rules are evolving quickly, especially during the pandemic. Keep in touch with your peers to discuss how they are managing the evolution to virtual interactions and changing policies.”

I have written about how the larger compliance conferences offer a rare opportunity for compliance professionals to interact with their peers one-on-one and soak in best practices for compliance. But isn’t it a shame that those opportunities are so rare? They don’t have to be. Organizations like KENX, Informa Connect, and PCF offer smaller one-day sessions focused on a plethora of topics, and even when conducted virtually, these programs offer a chance to connect with those who are dealing with the same challenges as you. Even if it’s through a compliance training group like the one we created on LinkedIn, sharing common experiences, successes, and bumps in the road is a critical tool for navigating the morass of changing policy and priorities during the pandemic.

3. “Study the 2020 OIG Fraud Alert to identify the areas that are top of mind for government regulators moving forward.”

A cursory review of the special fraud alert released by the OIG last November reveals nothing revelatory or surprising in terms of the fraud and abuse risks related to speaker programs. Rather, as was noted during the webinar, the importance of the alert lies more in the mere fact that the agency released it. On page 3 of the document, the agency states “Our investigations have revealed that, often, HCPs receive generous compensation to speak at programs offered under circumstances that are not conducive to learning or to speak to audience members who have no legitimate reason to attend.” Anyone who has been paying attention to recent settlements is not shocked by such a statement but the language points to two of the areas the OIG considers to be of primary concern for compliance violations. Consider this special alert as a shot across the bow of the industry. The focus on the speaker programs isn’t going away anytime soon, and now is the time to make sure your policy and training targeting reps, presenters, and vendors is up to date and covers all the risk areas.   

4. “Trade show vendors have probably not thought through the potential compliance concerns of holding the meetings virtually. You need to be engaged with them about those details beforehand.”

Compliance training cannot end with employees, especially during a pandemic when the rules are constantly changing. When a vendor is organizing a trade show or conducting any business on behalf of the company, the risk grows exponentially. Are your trade show vendors aware of the rules and your policies regarding product promotion and scientific exchange? Have you fully considered the ramifications of building and delivering online training for vendors? Don’t assume that your vendors are going to take the same diligent approach to compliance as you do and don’t just hope they stay abreast of the latest best practices around virtual communication. If you launched vendor training prior to the pandemic, consider adding microlearning refresher training to highlight changes in policy.

5. “Utilize a campaign approach to training to support branding efforts and make the concepts more memorable.”

The session titled, “Training – Best Practices for Promotional Compliance challenges in a Virtual World, Creative Solutions to Keep Sales Reps from Going Off the Guardrails” offered a range of tips for changing behavior through core training, performance support, and reinforcement training (I know, I’m biased because the co-presenter was my colleague, Dan O’Connor, but you really should see this slide deck). No matter your budget, rolling out branded components across a learner’s timeline, rather than launching one large bolus of content, has been proven to enhance learning and increase the retention of that content. The “Forgetting Curve” is real, and if you want to make your training more memorable, you need to make it continuous.

All the presentations during the Biopharma and Biotech Corporate Compliance Summit offered enough nuanced twists on familiar topics to make a one-day commitment of time worthwhile. The last year has seen an upheaval in how the industry conducts business, which has resulted in a sudden need for changes to compliance practices and policies. Even with established organizations like PCF and Informa Connect continuing to keep their own events timely and relevant, there is always room for another player. Welcome to the party, KNEX.

Thanks for reading!

Sean Murphy
PharmaCertify

Ten Training Takeaways from the 21st Pharmaceutical and Medical Device Ethics and Compliance Congress

The Pharmaceutical Compliance Forum (PCF) went to great lengths to replicate the experience of a live conference in this year’s virtual Pharmaceutical and Medical Device Ethics and Compliance Congress. The virtual conference platform featured presentation rooms and realistic exhibit halls that made navigating the user interface simple and logical.

Organizers took advantage of the virtual nature of the conference to maximize the amount of content available through live presentations, along with a plethora of recorded presentations available for viewing any time. In fact, if you attended the conference, the sessions will remain available to you for up to six months – so don’t be shy about logging back in and catching up on what you missed.

I’ve done just that over the last few weeks and in the spirit of the PharmaCertify mission to help you reduce risk and strengthen the compliance culture in your company, here are ten key conference takeaways to help you build a more effective training curriculum.

  1. Meals, meals, meals.
    How to handle meals during the pandemic (in speaker programs and otherwise) continues to be a common refrain during conferences. Speakers from the pharmaceutical and medical device industries touched on the topic, with the conversation mostly focused on the importance of sending meals only to HCPs’ offices and hospitals, and not to their homes. PhRMA’s guidance released earlier this year is a good starting point for updating policies and building new training: https://phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/P-R/PhRMA-Code-Section-2.pdf. Clearly if you have not addressed the way in which meals should be provided in your policies and subsequently in your training, you should.
  2. Remember the changes to the Sunshine Act.
    Speaking of updates, attendees were reminded that the changes to the Sunshine Act go into effect in January. If your core Sunshine Act training hasn’t been updated, you need to make your learners aware of the changes in the list of covered recipients and the nature of payment categories…quickly!
  3. Be aggressive.
    Throughout the conference, government regulators agreed that they tend to view companies that have a robust compliance program more favorably during investigations. Or, as one panelist in the AUSA Roundtable put it, “if you’ve properly dealt with the problem, we’re probably going to go away.” That extends to your compliance curriculum. So not only is a “check the box” approach to training a bad idea in terms of learning, it also isn’t going to impress regulators when they come calling. A modern and effective curriculum needs to be evaluated against your company’s risk, and it needs to be supplemented with regular nuggets of training spread across the learner’s timeline.
  4. Keep the communication flowing.
    An effective curriculum doesn’t end with the deployment of training. The importance of on-going communication during the pandemic was reiterated in multiple sessions throughout the conference. Presenters focused on how the sudden shift in the way business is conducted has forced them to think about how they stay in touch with leadership and the field. The need to think differently has clearly given birth to ideas and best practices that will continue post-pandemic. Whether designating “compliance liaisons” from the businesses to bring ideas and questions back from the field, or rotating people from the businesses through the compliance department, presenters are finding creative methods to ensure compliance stays top of mind for the long term.
  5. Patient support and speaker programs are still in focus.
    Gregory Demske and Mary Riordan reminded attendees that the OIG’s focus is still squarely on patient support programs and speaker programs. And interestingly, Demske encouraged viewers to ask themselves if they really need to go back to in-person speaker programs after the pandemic and warned that the agency is going to continue to look carefully at “payments to prescribers that are under the guise of speaker programs.” Recent CIAs focused on speaker programs and patient support programs are a good starting point as you evaluate your training plan.
  6. Pay attention to social media.
    According to presenters in the social media mini summit, 70-80% of patients get information from online resources. While that’s not a surprising number in our digital age, it’s concerning in light of the dearth of guidance from federal agencies. Presenters emphasized the need to stay abreast of the emerging social media platforms and evaluate training plans in context of the limited social media guidance that is available. And the risks of social media aren’t limited to the pharmaceutical industry. In the Medical Device Roundtable session, one presenter warned that cutting-edge technology often can lead to representatives being overly enthusiastic on social media. It’s a scary, changing world online, and as a compliance professional, you need to be continually addressing it in targeted training.
  7. Customize training for company-specific risk.
    I may be biased, but the discussion about the risk-frequency framework by Dan O’Connor in the State-of-the-Art Compliance Training mini summit is “can’t miss” conference viewing. If you did miss it, let me know, and I will be happy to coordinate a brief review of the concept with Dan. The framework is a great starting point for evaluating the appropriate mix of training based on the riskiness of the activity and the frequency at which that activity occurs. Ours is not a one-style-of-training fits all world and the framework is a good way to look at your curriculum and make adjustments in the tools and techniques to address risk accordingly.
  8. Emphasize a culture of integrity, not just compliance.
    Those of us who have been working in life sciences compliance for a long time know the industry has been touting the need to shift away from a rules-based approach to compliance to one based on values and ethics. That shift is in process and was best summarized by a presenter in the Integrating Ethics and Compliance session when she said she finds the word “compliance” to be limiting and she prefers the word “integrity” to emphasize that how one does something is as important as what someone does. Or, as another presenter in the same session said, “now is the time to create a culture where people are comfortable speaking up.” That’s the language of a values-based approach and it certainly seems like it’s here to stay. Does your training incorporate these themes?
  9. The core rules still apply.
    While COVID-19 has changed the way in which business is conducted and how interactions occur, the core principles of compliance still apply. In fact, as multiple regulators and industry professionals were quick to note, “COVID is not an excuse for non-compliance.” Some of the details may have changed, but speaker programs need to be monitored, speakers need to be trained, reps need to stay on-label, federal regulations still apply,  and state disclosure laws need to be followed.
  10. More risk is okay if you have a strong foundation to manage that risk.
    Many years ago, when I started working in compliance training, I could not have imagined someone being bold enough to publicly say more risk is okay. But there I was in the CCO Fireside Chat, when I heard a presenter confidently say, “striking a balance between the legal environment and business goals is key.” To my surprise, he followed up by saying, “and to help the business be more risk tolerant you need training that is sticky and impactful.” The assessment is an honest and refreshing one, and hearing the word “sticky” used in reference to compliance training brings music to the ears of someone who has been part of a team encouraging the industry to do that for 15 years. The future may be filled with more engaging and dynamic training after all.
  11. Thanks for reading!

    Sean Murphy
    PharmaCertify By NXLevel Solutions

Compliance Training Lessons from the 2020 Virtual Pharmaceutical Compliance Congress

Part 2: A Continued Focus on Speaker Programs and Patient Support Programs

This is the second in a series delving into compliance training lessons learned at the 2020 Virtual Pharmaceutical Compliance Congress. Before the sudden changes brought on by COVID-19, speaker programs and patient support programs were two of the hottest topics in the industry and the pandemic has only heightened the concern. Through live presentations and on-demand sessions available throughout the conference, regulatory officials and industry representatives offered suggestions for managing the programs.

Speaker Programs

During the Enforcement Deep Dive and the DOJ and SEC Insights sessions, panelists reviewed the recent settlements and CIAs related to speaker programs. The cases mostly focused on what one presenter referred to as the “hallmark red flags” he and his colleagues look for in an investigation: repeat speakers and attendees, speakers who were high-prescribing HCPs, alcohol being served, and less than adequate attendance. Alleged violations in the settlements were based on everything from the inappropriate fees paid to speakers and improper promotional activities at the programs, to some companies paying speakers for programs that never occurred.

While regulators provided the groundwork related to traditional topics like speaker criteria and compensation, and attendee management, industry professionals shared tips for effectively managing the programs during a pandemic. In the session titled, Operational Considerations for Speaker Programs During a Pandemic, presenters offered a list of considerations such as updating training on tracking and reporting attendance; adding up to an hour of prep time so all participants have the opportunity to get comfortable with using the technology; and reviewing existing HCP contracts and adjusting provisions for travel since travel to the programs is not currently required.

Not surprisingly, the practicality of providing meals during the pandemic was raised throughout the conference. During the DOJ Enforcement Trends Related to Speaker Programs on-demand session, the challenges with documenting and tracking consumption were raised as a unique risk associated with virtual programs. For example, “ensuring attendees stay for the educational component of a program,” and “providing meals in a way that accounts for COVID-19 related health and safety issues” are suddenly necessary considerations.

Virtual speaker programs raise challenges the industry has not had to consider before the pandemic. Presenters offered an important reminder as to why diligence to how these programs are executed is more critical than ever, by reminding the audience that “government agencies have made it clear they will scrutinize conduct…companies should still comply with codes of conduct and government regulations. There is no COVID-19 defense.”

Patient Support Programs

On the patient support program front, the emphasis in investigations is on what one presenter called “good evidence of bad motivation.” As with speaker programs, the fundamental rules continue to apply. For example, the programs cannot be used to influence a provider’s or patient’s medical decisions and patient privacy must always be protected. Grants and donations to foundations cannot be driven by sales and marketing, or as one presenter put it, “the commercial side should never determine how much goes to foundations.”

With patient foundations being a focus in recent CIAs, presenters during the Enforcement Snapshot and Best Practices Related to PAPs, Coupons and Foundations session covered the important requirements established in those settlements, including the need for a governance committee that is solely responsible for activities related to copay foundations; the importance of establishing an annual budget for donations to foundations; the requirement that donations must be selected using a risk-based approach and random sampling; and the need to be aware of state limitations on copay assistance, such as Massachusetts and California not permitting assistance when a generic is available.

Presenters also pointed out that settlements involving patient support programs have changed for one significant reason: the foundations have also been targeted and have entered into agreements with the government. As one presenter put it, “that means the foundations have skin in the game. Gone are the days when manufacturers called all the shots around contributions to foundations, program design, and compliance controls.”

The requirements detailed in recent settlements point to the need for updated policies and practices, and subsequently, updated training around patient support programs. Not only does core training need to be modified, a new approach is needed to ensure pull through on the significant changes.

A New Approach to Training

Clearly, the fundamental rules related to speaker programs and patient support programs have not changed and still need to be addressed in training, as they were before the onset of the pandemic. speaker programs and patient support programs continue to be high-risk activities. When they are not managed properly, companies face the potential for off-label promotion, false claims, and Anti-Kickback Statute violations, to name just a few. But the nuances of how these programs are executed are now in flux and require serious consideration in terms of content updates and delivery modalities.

Foundational training remains an important starting point. Dedicated training on speaker programs should still include core topics such as program logistics, audience requirements, speaker compensation and training, and answering off-label questions. And patient support program courses must continue to focus on areas such as protecting patient privacy, working with vendors, and working with patient assistance foundations.

Clearly, COVID-19 requires changes to how both types of programs are planned and executed. To ensure targeted employees stay in compliance a supplemental approach towards reinforcement may be appropriate. For example, mini modules covering the provision of meals should be considered to stress the details of updated policies. In addition, microlearning components in the form of mini-assessments, videos, and podcasts are a valuable way to increase the retention of new and updated policies as well as the foundational topics. And custom scenario-based training is an ideal format for highlighting aspects of policies that are particularly relevant to conducting these programs during the pandemic.

Increasing the retention of compliance training is more challenging than ever given the changes in which your field staff and other employees conduct business. The information shared during the Pharmaceutical Compliance Conference serves as a reminder that speaker programs and patient support programs continue to be high areas for risk and a focus of investigations. The onset of COVID-19 has complicated that risk by forcing the industry to rethink how the programs are managed and how employees are trained on the details. Creating a continuous training curriculum, with new microlearning components integrated across learners’ timelines, is critically important to ensuring those details are not lost while understanding that the potential for violations are increased.

Thanks for reading!

Sean Murphy
PharmaCertify By NXLevel Solutions

Up Next: Enhancing Training Engagement in a Changing Industry and World

In a Virtual Detailing World, the Rules Regarding Good Product Promotion Still Apply

Life sciences detailing has changed, even if only temporarily, but the rules and best practices related to good product promotion have not. As field sales teams acclimate themselves to the reality of meeting with healthcare professionals through virtual means, they need to ensure those rules aren’t lost in the milieu of that change.

For example, no matter the means by which promotional speech is delivered, the FDA defines it as “any affirmative statement about a prescription drug or medical device.” Regardless of format, promotional statements made while meeting with healthcare professionals must always be truthful and accurate.

Representatives must never exaggerate or mislead the healthcare professional regarding the use, safety profile, or any other aspects of the product and any statements made about a product must include the benefits and the risks associated with the use of the product. They must never overstate the effectiveness of the product, make efficacy claims not supported by substantial research or misrepresent clinical study data. Fair balance cannot be ignored just because a rep is not meeting with the healthcare professional in person.

Products may only be promoted for uses approved by the FDA. In fact, if a healthcare professional asks a representative about an unapproved or off-label use, the rep needs to refer the question to the medical affairs department and, even during a virtual visit, a rep must never steer a conversation with the intent of prompting the healthcare professional to ask an off-label question.

Now is not the time to let the emphasis on good and compliant product promotion slip through the cracks. Updated training and microlearning covering topics like promotional speech, the Bad Ad Program, the use of social media, off-label marketing, and the dissemination of reprints and scientific publications is more important than ever to keep field sales teams compliant and effective.

Thanks for reading!

Sean Murphy
PharmaCertify By NXLevel Solutions

Note: the training content shared in this post is from our Good Product Promotion eLearning module, one of the 26 customizable modules available in our Compliance Foundations suite.

 

The 2019 DOJ Guidance Document: A Baseline for Life Sciences Compliance Training

Sean Murphy
Product and Marketing Manager

One of the significant events of 2019 affecting life sciences compliance was the April release of a new guidance document, Evaluation of Corporate Compliance Programs, (https://www.justice.gov/criminal-fraud/page/file/937501/download) by the criminal division of the Department of Justice (DOJ).  The primary intent of the document is to guide prosecutors and courts as they evaluate corporate compliance programs, but it also serves as an important baseline for life sciences businesses evaluating all areas of their compliance programs, including the training curricula.

The guidance document highlights three questions for prosecutors to consider when evaluating a program:

  1. Is the corporation’s compliance program well designed?
  2. Is the program being applied in good faith?
  3. Does the corporation’s compliance program work in practice?

In this post, I examine the DOJ’s document in more detail, and discuss its implications for your compliance training curriculum.

Risk-Based Training

In reference to a “well-designed compliance program,” the DOJ stresses the need for prosecutors to focus on whether a company’s program is customized for the particular risk profile of that company. According to the guidance, prosecutors should “understand the company’s business from a commercial perspective, how the company has identified, assessed, and defined its risk profile, and the degree to which the program devotes appropriate scrutiny and resources to the spectrum of risk.” The company’s periodic training and certification should include all “directors, officers, relevant employees, and, where appropriate, agents and business partners.” In addition, training should be tailored to “audience size, sophistication, or subject matter expertise.”

In pursuit of these standards, foundational training is an effective method for providing a baseline, but additional risk-focused content continuously delivered to individual business units is one way to address that risk. As an example, scenario-based mini modules covering the topics highlighted in risk assessments and audits of the compliance hotline should follow the more comprehensive foundational training for each business unit to make it more relevant and engaging. In addition, microlearning nuggets in the form of quizzes, assessments, and contests have been proven to drive higher retention rates when delivered strategically across a learner’s calendar. Targeted, continuous learning covering the topics deemed critical to each business unit is the key to truly reducing risk.

Curriculum Analysis

On the topic of risk-based training, the DOJ recommends prosecutors ask, “What analysis has the company undertaken to determine who should be trained and on what subjects?” In line with that suggestion, a compliance curriculum analysis is a critical first step for any compliance professional interested in understanding the details of existing organizational training and it’s a necessary starting point for the reconfiguration of that curriculum to effectively address the risks. The categories covered in the analysis should include:

  • Training Type (eLearning, Live, Webinar)
  • Topic(s) Covered
  • Level of Training (Awareness, Detailed, General, etc.)
  • Length
  • Audience(s)
  • Risk Rating Per Audience (Low, Medium, High)

An instructional design analysis should also be included to determine if the proper learning objectives are established and followed, and the visuals, audio, navigation, and assessment are optimized for learning. The data should then be curated into a spreadsheet with sortable cells and columns to allow for an organized and multi-level review of all training programs and topics. At PharmaCertify, we use our Compliance Curriculum Analysis Tool, or CCAT, to assist our clients with this analysis. Once the CCAT is complete, we summarize to highlight the strengths, gaps, and redundancies in the overall curriculum.

Test and Test Again

The document also delves into the measurement of training effectiveness by encouraging prosecutors to ask if employees have been tested on what they learned and how the company has addressed employees who fail all or a portion of the testing. While the inclusion of standard assessments with each course is an assumed necessity, using assessments as learning tools has been shown to strengthen long-term memory.

A study by Jeffrey D. Karpicke and Henry Roediger III, of the Department of Psychology at Washington University revealed that learners are poor judges of what they remember, and when given the choice, they stop studying before they have mastered the subject. So even when they think they know it, they don’t, and assessments spaced repeatedly over time is the best method to increase the retention of critical compliance policies and best practices. When possible, alternative types of tests should also be deployed, including:

  • Pre- and post-training tests to measure gains scores
  • Priming assessments to encourage the formation of cognitive schema
  • Diagnostic assessments to help target remediation
  • Cumulative exams to encourage information retrieval and re-encoding

Effective Implementation, Review, and Revision

Finally, prosecutors are asked to consider whether a compliance program is a “paper program, or one implemented, reviewed, and revised, as appropriate in an effective manner.” This holds true not just for the program in general, but for the compliance training curriculum. Just as the corporation should “provide for a staff sufficient to audit, document, and analyze the results of the efforts,” the proper resources and time need to be dedicated to the evaluation of the current curriculum, with subsequent modifications conducted accordingly.

The DOJ’s Evaluation of Corporate Compliance Programs document refers to a compliance program’s capacity to evolve as a hallmark of its effectiveness. That evolution is necessary because “a company’s business changes over time, as do the environments in which it operates, the nature of its customers, the laws that govern its actions, and the applicable industry standards.” An effective life sciences compliance training curriculum must align the current business with the environment, customers, and laws, and now is the time to bring all of those components together.

I hope the insights above are helpful as you continue to improve your compliance training effectiveness throughout 2020. Thanks for reading!

 

What I Heard at the 20th Annual Pharmaceutical and Medical Device Life Sciences Compliance Congress…and What It Means for Your Compliance Training!

Dan O’Connor of PharmaCertify and a panel of industry leaders share their experiences during the training workshop at this year’s Pharmaceutical and Medical Device Compliance Congress.

Presenters at this year’s Life Sciences Compliance Congress from the Pharmaceutical Compliance Forum (PCF) covered some of the same ground as previous conferences (tone at the top, sharing resources, mine the data, etc.) while mixing in a significant amount of new content and thought-provoking ideas for the attendees to consider. PCF even added an impressive amount of “mini-summits” to the agenda to ensure the content appealed to compliance professionals dealing with a variety of risks. It was a challenging, yet worthwhile, amount of information to absorb.

Following are some of the more interesting ideas shared at the conference, along with thoughts on what they mean for the compliance industry and for anyone interested in building and maintaining a successful compliance program.

  1. “Don’t worry about developing a culture of compliance, develop a culture of integrity instead.”
    The idea of making compliance concepts more relatable or understandable is nothing new and it was discussed extensively during this year’s Chief Compliance Officer Roundtable. According to the presenters, employees understand “integrity” more than they understand building a “culture of compliance.” The panelists offered examples of how they strive to integrate the concept of integrity throughout the company – from annual integrity awards, to asking every employee to write how they model integrity and ethical behavior in their daily business activities. As they put it, “don’t make it a compliance policy issue, make it an integrity issue.”
  2. “Don’t underestimate the ability of people to rationalize.”
    The life sciences industry holds the potential to “alleviate pain, restore health, and extend life.” While that is a noble responsibility, it holds the potential for dangerous rationalization. It’s too easy to think, “since we are saving lives, I need to get this product out faster…so I need to make this sale as quickly as possible,” or “I know my product is better than the competition, so I need to do whatever is needed to make the sale.” Continuous training is needed to instill a sense of responsibility in learners and help guard against the dangers of rationalization.
  3. “If you don’t get access to the Board as a member of the compliance team, that company is not a place you want to be.”
    Surprisingly, this one came from the AUSA Roundtable. I did not expect to hear career advice offered by a group of Assistant U.S. Attorneys, but it reinforces the notion that the compliance department must be integrated into the entire company, top to bottom, to be effective. It was a theme carried throughout the conference and led to compelling debates around topics like whether the compliance department should report to the legal department (hint: most regulators prefer to see it having the clout that comes with being a standalone department).
  4. “The shift to a patient-centered business model comes with risk.”
    During the session on “charitable contributions compliance considerations,” panelists focused on the need to avoid any suggestion that support programs and assistance programs are being used to increase sales. The separation between more sales and making products available to more patients is a fine line. As was also mentioned (and most industry insiders know), the list of Corporate Integrity Agreements (CIAs) focused on donations is growing. Panelists stressed the need to be careful about “where the charitable money is coming from.” If it comes from the commercial budget, it will be considered a commercial payment.
  5. “Communication style and protocol is key when dealing with co-pay foundations.”
    During the Helping Patient Access to Products session, presenters raised surprising points about the nuances of communication. As an example, “smiley face icons” in emails may seem innocuous, but they need to be avoided not only for general inappropriateness purposes, and because they hold the potential to be misleading during an investigation. Does that “wink” imply a favor or quid pro quo? The key throughout all communication is to avoid any suggestion that a support program is being used to overcome a co-pay barrier.
  6. “International cooperation across policing agencies continues to increase.”
    According to the presenters in the US DOJ and US SEC Update on FCPA Enforcement session, they are seeing a growing number of referrals from overseas regulatory bodies – significantly more than they saw ten years ago. Risk is rising, as are the number of whistleblower cases, and the panelists encouraged audience members to carefully review the DOJ’s April 2019 Evaluation of Corporate Compliance Programs document for what the agency considers to be the best practices for building and maintaining an effective program and reducing risk.
  7. “The lack of understanding between pharmaceutical sampling and medical device sampling is like day and night, and that makes it complicated.”
    Much of the Annual Medical Device Roundtable was understandably dedicated to the challenges associated with “asset management.” Consider that every missing, or unaccounted for, device could be considered a kickback during an investigation.  As one panelist emphasized, “the government has zero tolerance for asset management problems.” Another raised the interesting point that companies must ensure they are loaning devices to HCPs for the right reasons, and not because those HCPs want “to replace a machine that is currently not functioning” or “to use it for one test.”
  8. “Sharing resources can become political. Your initiatives may get pushed back when budgets are tightened.”
    The sessions dedicated to compliance for small to mid-sized businesses always provide unique insight to those attendees faced with limited resources and budget and this conference was no exception. The idea of reaching out to other areas of the company for support is a common refrain, and the added twist of what happens when budgets tighten was thought provoking. As the presenters explained, when compliance is a priority with corporate and with the Board, fighting that pushback gets easier. Tone at the top may be a bit cliché, but it’s a powerful weapon in the battle for time and money.
  9. “A corporate integrity agreement can be an opportunity to improve your overall compliance program.”
    Dreading the thought of a CIA is understandable, but the five years spent abiding by the terms of the settlement provides the momentum to build up a budget and showcase the importance of the program. Buy-in from corporate on resources is automatic during the CIA and it serves as the blueprint for what can be accomplished moving forward. Exiting the CIA is the time to evaluate lessons learned and evaluate methods for making the compliance program even stronger. From a training standpoint, the end of a CIA is also the time to evaluate what mandated programs were successful and explore opportunities to deploy more targeted, role-based training.
  10. “Your risk assessment needs to guide your monitoring and make it more meaningful.” This is actually a hybrid of statements made by Mary Riordan of the Office of Inspector General (OIG) during her much-anticipated annual speech and multiple presenters throughout the two days of presentations. The bottom line: a successful compliance program cannot be a cookie cutter effort, replicated from one company to another. Risks assessments need to be conducted at least on an annual basis and every aspect of the compliance program, including training, should be evaluated and modified accordingly. Continuous improvement is needed to make it meaningful and relevant.

What Else Does It Means for Your Compliance Training?

Whether you work in the pharmaceutical or medical device industry, the world of compliance is evolving, and the design and delivery of training must evolve as well. Based on the information shared in the OIG, DOJ, and AUSA sessions, the guidelines for who receives what training, at what frequency, needs to be enhanced.

As an example, during the session on reducing risk using a portfolio approach to compliance training, panelists discussed the need to integrate contextual reminders like vis aids, static prompts like intranet banners and poster, and active prompts like emails and desk drops to more effectively change behavior and facilitate a shift to that “culture of integrity.” The need to “make compliance training stick” is growing and now is the time to reevaluate your training curriculum and delivery methods.

Thanks for reading, I hope to see you at the “21” Annual Pharmaceutical and Medical Device Compliance Congress in 2020!

Sean Murphy
Product and Marketing Manager
PharmaCertify by NXLevel Solutions

Off-the-Shelf Compliance Training Myths

Myth #3: It won’t run properly on my learning management system.

In this third installment of our series on the myths associated with off-the-shelf compliance training, I discuss the concern that only training sold in conjunction with an LMS, or other type of online content delivery system, will run properly and accurately record data with that LMS. This theory is based on the idea that training modules from other vendors are not developed with the specifications of that system and therefore hold the potential for technical difficulties and “clunky” performance.

So, if you’ve already committed to an online compliance training content management system, the only way to ensure eLearning modules function correctly is to utilize the training that is packaged with the system, right? In a word…no.

The Myth 

Companies selling whole compliance training systems are understandably interested in fostering the notion that customers have no need to search elsewhere for training after they have made the commitment to purchase an enterprise-wide system to manage and deliver compliance training. The modules are a natural extension of the core product and offer myriad opportunities to garner additional revenue throughout the life of the system contract.

Adding fuel to the “it won’t run properly” fire is the idea that since there are so many varieties and brands of systems available to life sciences companies, including the large, well-known names; small systems targeted to compliance; industry upstarts; and systems intended more for GMP training where 21 CFR Part 11 compliance is a requirement, consistent performance across all platforms must inherently be a difficult, if not impossible, challenge. It’s a logical conclusion, even when SCORM compliance is factored into the compatibility equation as indicated by the fact that LMS compatibility continues to be one of the first questions our clients ask when we map out a strategy for deploying our Compliance Foundations™ off-the-shelf eLearning modules.

The Reality

If an LMS is built to modern specifications by a technical team that understands the need for it to house a range of training types, and the training is built with an eye toward flexibility and SCORM compliance, compatibility and performance of the individual components should never pose a problem. An effective compliance training curriculum requires a thoughtful and well-planned mix of training modalities delivered continuously across a learner’s timeline. That formula sometimes consists of elements from a variety of development vendors and the ultimate success of that curriculum must never be threatened by the limitations or lack of flexibility on which the training is housed.

So not only is the suggestion that off-the-shelf training won’t run properly on a wide range of systems a misleading and counterproductive myth, it is anathema to the very notion of what is at the foundation of successful compliance training.

The Bottom Line

In 15 years of delivering online life sciences compliance training, the technical team behind PharmaCertify has never faced an LMS communication and compatibility issue we could not overcome quickly and efficiently. The training we build for our pharmaceutical and medical clients is launched on systems large, small, and everything in between. Communication with the LMS team on the client side is key and early in the project, we learn the specifications of the system and provide a test module to that team to ensure seamless integration into the LMS.

Since we work with companies in various stages of training preparedness, including some that do not have an LMS in place, we also offer our Access LMS as a cost-efficient solution for deploying training to employees and third-party vendors alike. But, no matter the LMS, our first goal is to ensure your training reaches your learners according to your planned schedule and without technical concerns, and the critical completion and reporting data you need to verify learner compliance with your training curriculum is accurate, accessible, and reliable.

To see a demo of the PharmaCertify compliance training solutions, including the Access LMS, contact Dan O’Connor at doconnor@nxlevelsolutions.com.

Thanks for reading!

A Preview of the 4th Annual Life Science Ethics & Compliance Training Conference

PharmaCertify is a proud sponsor of the 4th Annual Life Science Ethics & Compliance Training Conference scheduled for June 5th and 6th in Chicago. As someone who has spent the last 12 years in the field of life sciences compliance training, I find the focus of this annual conference especially compelling as industry leaders and consultants share ideas, tips, and experiences for reducing risk through innovative training. It’s an exciting and energized group of presenters every year. Below are some of the presentations I find to be of note this year. You can learn more about the conference and download a full agenda at https://www.q1productions.com/compliancetraining/. Contact us about our sponsor discount if you are interested in registering.

Day 1: Wednesday, June 5

Day 1 will be chaired by PharmaCertify’s own Dan O’Connor, and after the opening ice-breaker, the conference begins in earnest with a keynote panel titled, Assessing Risk Tolerance & Company Culture as a Driver for Ethics and Compliance Education. Kudos to the conference organizers for scheduling a great kickoff session. Building an effective compliance training curriculum begins with a thorough risk assessment and I am looking forward to hearing the details of each presenter’s process for “shaping training based on tolerance, and conveying liabilities to ultimately create a culture of compliant and ethical behavior…”

Following the keynote panel, a multi-part session from 10:00 AM to Noon begins with the Legal Interpretation of Enforcement Trends & Areas of Inspection presentation. The talking points on the agenda include the first official reference to the new and trending topic of patient assistance programs. That theme continues later in the day with a case study from Catherine Starks of Sidley Austin, Risk Evaluation & Training Approaches for Compliant Patient Assistance Programs.  With PAPs and PSPs programs being the focus of recent corporate integrity agreements, any discussion of the associated risks and the best practices for conducting compliant programs is worthwhile.

The first session after the lunch break, Developing a Compliance Training Cadence Based on Risk & Needs of Business caught my if for only one word: cadence. The rhythm and pace at which compliance training is launched across a life sciences company is critical to the success of that training. Microlearning is all the rage lately and effective microlearning is more about the frequency and schedule at which training is delivered than it is about the length of the individual learning components. In this session, the presenter will discuss the factors affecting that cadence, including establishing a “cadence to coincide with business agendas and timetables to inform stakeholders at optimal moments.”

Two case studies on the topic of “measuring training effectiveness and risk reduction” are scheduled for the afternoon and I am excited to hear the speakers from Exsurco and Gilead detail their strategies for tracking retention and engagement, and as described in the agenda, “translating the data into actionable strategy.”

Day 2: Thursday, June 6

Day 2 kicks off with one of the more intriguingly-titled sessions from this or any conference: Masterclass: Effectively Maintaining Training Priorities Upon Exiting a Corporate Integrity Agreement. The end of a CIA presents a great opportunity for companies to incorporate the lessons learned during the term of the CIA, when training schedules and the modules were under the demands of the agreement and create a curriculum even more dynamic in terms of scope and levels of engagement. I look forward to hearing Maureen Mason of AstraZeneca discuss her philosophy and suggestions for maintaining the diligence of a strict curriculum while expanding and enhancing the company’s compliance curriculum.

“Cadence” isn’t the only word that jumped off the screen when I initially reviewed the conference agenda. The sessions scheduled after the 10:00 AM coffee and networking break (don’t forget to visit us at the PharmaCertify booth to see demos of our newest training products), Multi-Part Case Study: Contextual Compliance Risk Evaluation in Prioritizing Training caught my eye for the use of one word: contextual. In our 15th year developing compliance training for life sciences, the team at PharmaCertify has worked with compliance departments ranging from an “n of 1”, to those that have a full team of internal resources. And while context does matter, ultimately results are what count no matter the number of resources. In this case, the large corporation perspective will be provided by Abbvie, the mid-sized by a speaker from Convatec, and the “limited resources” perspective by Otsuka.

After the lunch break, two breakout groups are divided by industry, in sessions titled, Compliance Considerations Specific to Pharmaceutical & Medical Device Organizations. I am glad to see the focus on the medical device industry, which too often is not as well represented at conferences. Two speakers from Teleflex will provide the me device experience and their talking points include updates to the AdvaMed Code of Conduct; compliant interactions & “no touch;” and the EU General Data Protection Regulation.

The afternoon of Day 2 includes a session on third-party vendors: Managing Distributor Partner Compliance Training. The intricacies of doing business through third-party vendors hold the potential for increased risks compliance violations. It’s a critical topic and any opportunity to hear tips and suggestions related to training, tracking and managing global vendors is worthwhile and valuable.

Discounted Conference Registration

The 4th Annual Life Science Ethics & Compliance Training Conference is scheduled for June 5-6, in Chicago, Illinois and if you’re interested in hearing industry leaders share their experiences and best practices, there is still time to register. Contact me at smurphy@nxlevelsolutions.com to take advantage of our discount registration rate. I can’t recommend this conference more highly!

Thanks for reading!

Sean Murphy
Product and Marketing Manager
PharmaCertify by NXLevel Solutions

Off-the-Shelf Compliance Training: Myth vs. Reality

Myth #1: Off-the-Shelf Training Doesn’t Align with My Content Requirements

Welcome to the first installment of our series on the myths and realities associated with off-the-shelf compliance training. In each post, we will dive into one commonly heard myth concerning the pros and cons of using off-the-shelf eLearning to reduce compliance risk in the life sciences industry. We begin this week with the frequent lament, “off-the-shelf training doesn’t align with my content requirements.”

The Myth 

Multiple presenters at the 2019 Pharmaceutical Compliance Congress emphasized the importance of targeting training to the audience. As one speaker said, “scientists are not going find value in training that features scenarios with sales representatives.” He ended his comments by saying that is why he only uses custom-developed training.

In addition, in its recently updated guidance on the evaluation of corporate compliance programs, the Department of Justice emphasizes the need for “appropriately tailored training and communications.” When describing what prosecutors should take into consideration when evaluating a company’s program, the DOJ asks, “has the company provided tailored training for high-risk and control employees, including training that addresses risk in the area where the misconduct occurred?”

Clearly, government regulators and industry leaders recognize the importance of targeting training to the roles and risks associated with individual learner groups. And the belief that only fully-custom training can meet those requirements is predictable and understandable.

But is it reality?

The Case for Off-the-Shelf

Knowledge Check from the Compliance Foundations eLearning module: Healthcare Compliance Overview

While I agree wholeheartedly about the need to target the audience and use role-appropriate content, well-designed off-the-shelf training allows for extensive customization, in a streamlined, cost-efficient manner.

Consider Healthcare Compliance Overview, a module from our library of Compliance Foundations eLearning courses. The module covers a broad range of commercial compliance topics, including the False Claims Act, off-label promotion, HIPAA, good product promotion, and the Anti-Kickback Statute so our clients typically launch it to their full staffs. Most of our clients customize the content to reflect the needs of specific learner groups, e.g. sales, medical, clinical, and corporate. Since the modules are built in a “templated” format, the process is simplified and the cost is less than custom-developed training.

Healthcare Compliance Overview features knowledge checks instructionally designed to reinforce key objectives throughout the module. The knowledge checks are often written in the form of scenarios that reflect “real-life” experiences some learner groups are likely to face in their daily activities. Since the modules are so easy to customize, our clients roll out multiple “versions” of the module, each one tailored to the appropriate audience. The result: highly professional and engaging customized compliance training at less cost than custom training.

The Bottom Line

Custom development certainly offers the opportunity to tailor compliance training to various learner groups within a life sciences company, but it comes with a steep price and lengthy development timeline. Delivering appropriately targeted off-the-shelf compliance training throughout the company is not only possible, but it is often the optimal solution based on budget and time frame. Just be sure the off-the-shelf training offers the right level of flexibility.

Launching off-the-shelf compliance training, customized for your learners, is a simple four-step process with PharmaCertify:

  1. Review your risks and goals with our team.
  2. Select from our Compliance Foundations curriculum.
  3. Make our content your content through the customization process.
  4. Launch your training!

Contact me at smurphy@nxlevelsolutions.com to learn more about our customization process.

Thanks for reading!