“Dear Connie the Compliance Training Specialist” is back!

Welcome to this edition of “Dear Connie the Compliance Training Specialist,” where we answer questions about timely compliance topics and delve into the best training for reducing risk.

This week: raising knowledge retention at the next POA.

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Dear Connie,

During the compliance portion of our last Plan of Action meeting, I introduced several scenarios for group discussion with the hope of making the session more engaging. For the most part, I think it was more successful than just reviewing a slide deck (our usual approach), but not everyone was engaged and I’m not sure they’re going to remember the key points. Any suggestions for our next workshop?

Signed,

Bewildered in Bridgewater

Dear Bewildered,

Kudos to you for making the effort to move beyond the “PowerPoint Overload” approach to live compliance training. To engage the entire audience, I suggest you “gamify” the discussion and have everyone team up to solve scenario-based challenges. Research has shown that creating a competitive environment raises the retention of key lessons and makes the content stick with the learners.

Here are a few suggestions that can add a level of interactivity, even if the time allotted to compliance is limited:

Form Teams

Competition is more fun and learning is enhanced when groups of participants work together to solve the scenario. Instead of asking individuals in the audience to give their opinion, create teams of participants based on regions, products, or any number of qualifiers. To save time at the session, create the teams ahead of time, in the planning stage.

Add Activities

Don’t just ask the teams to present their best suggestions for a scenario. Add activities that stimulate cooperation within the team. For instance, you can employ a card-sort exercise with scenario “flashcards” the teams sort into two piles, e.g., “permissible” and “not permissible.”

Teams can also compete against one another to solve a scenario-based “mystery” using their understanding of compliance best practices and company policies. Provide clues (emails, call transcripts, receipts, and text messages) during the workshop or ahead of time via email.

The activities can be developed in analog (paper-based) form or electronically through an online gaming platform or outside vendor.

Keep Score

Enhance the competitive spirit even more with a leaderboard that you update manually or electronically. Display the board continuously during workshop, or only after each activity is completed. If you send out questions in the weeks before the workshop, tell the learners they get points for how quickly they respond and for accuracy. Add those scores to the leaderboard as well.

Remember the Debrief

Don’t forget to leave time to debrief the audience once the activities are completed. You need to make sure the nuances and “gray areas” are understood, and the participants understand which company policies to reference for on-going guidance around the topics that were covered.

These are just a few tactics for raising the retention rate and “making live compliance learning stick.” My friends here at the compliance training division of NXLevel Solutions have experience creating compliance workshops for a range of life sciences clients. Feel free to contact them at 609-483-6875 to hear more ideas.

Thanks for the great question!

Connie the Compliance Training Specialist

The 2017 Compliance Year in Review!

As the year winds to a close, we take a break from the hustle and bustle of holiday preparations to reflect on the 2017 trends, topics, and focal points from the world of life sciences compliance. It’s been a busy year, with some expected updates, along with a few surprises, filling our News in Review missives from month to month. So, grab a cup of egg nog, fire up the Yule Log on YouTube, and enjoy this “year in review” edition of the Compliance News in Review.

Drug pricing transparency was a hot topic at the end of 2016, and the trend carried through 2017. The rules for Chicago’s new sales representative licensure law, which is intended to help combat opioid addiction, went into effect. The law requires representatives to obtain a license to sell products in the city and to document their interactions with healthcare professionals. In California, drug manufacturers must now notify the State and other payers in advance when they intend to raise the wholesale acquisition cost of a drug over a certain percentage, and when new drugs are expected to have a wholesale acquisition cost that exceeds the Medicare Part D specialty drug threshold. Nevada passed similar legislation, but its law focuses on diabetes drugs. Nevada also requires sales representatives to be licensed and provide reports of their interactions with HCPs. Finally, Louisiana also jumped on the pricing transparency train.

In an effort to combat the opioid crisis,  Governor Christie in New Jersey issued rules that cap payments made to healthcare professionals by pharmaceutical companies.  Maine passed a gift ban law similar to the existing Minnesota law and, not surprisingly, we heard from Vermont in 2017. The attorney general there is reportedly investigating whether drug and device companies are adhering to the state’s HCP gift ban law.

Not all state-level action was successful. Missouri’s proposed price transparency law did not pass during the past legislative session, and a bill in California to restrict gifts and payments to HCPs passed the state Senate, but was rejected in the Assembly.

Pharmaceutical support for patient assistance charities was another 2016 hot topic that continued through 2017.  An IRS investigation into one of the charities focused on whether it provided an improper benefit to pharmaceutical donors by using the donations to purchase the drugs manufactured by those same companies. Support of patient assistance charities also figured into one company’s healthcare fraud criminal and civil settlement with the government.

2017 was a quiet year for the Office of Prescription Drug Promotion (OPDP). During December of 2016, the agency dropped a flurry of letters, but 2017 will likely see record low in activity with only three letters being issued so far for the entire year.

This was an interesting year in bribery and corruption enforcement. It began with a bang in January as the Serious Fraud Office entered into its first major Deferred Prosecution Agreement. With a changing of the guard in the U.S., FCPA actions were more subdued, but the diagnostic test company, Alere, settled with the Securities and Exchange Commission over improper payments to foreign officials allegedly made by its Colombian and Indian subsidiaries.

The Department of Justice (DOJ) published its Compliance Program Evaluation Guidance in 2017. The document offers details on what the agency considers to be an effective compliance program. Perhaps most notably, the DOJ made its Foreign Corrupt Practices Act Pilot Program permanent. The pilot program ended in early 2017, but it was effectively made permanent with the announcement of a new FCPA Enforcement Policy. Like the pilot program, the new policy encourages companies to self-report possible FCPA violations and rewards companies for their  cooperation during investigations.

With that, we close out another issue of the Compliance News in Review, and another year in the wonderful world of life sciences compliance. We look forward to keeping you up-to-date on all compliance news fit to blog in 2017 and continuing to provide you with an ever-expanding suite of PharmaCertify compliance training products and services.

Thank you for reading. Have a warm and wonderful holiday season and a happy New Year!

The Do’s and Don’ts of Compliant Product Promotion

In keeping with our mission of helping you reduce risk and strengthen your compliance culture, we present our top do’s and don’ts for promoting products to healthcare professionals:

  1. Do…be balanced and accurate! Present the benefits and the risks of a product equally.
    Don’t…omit or minimize the risks associated with the use of a product, or exaggerate its effectiveness.
  2. Do…stay on-label! All promotional statements about a product must adhere to the product label.
    Don’t…promote any off-label uses of a product.
  3. Do…use approved promotional materials! Use promotional materials provided and approved by the company to promote a product.
    Don’t…Use retired promotional materials or create your own materials to promote a product. Do not add logos, names or other product information to candies, cookies, or other items, without prior approval.
  4. Do…be careful about comparisons! Only share competing product information that has been approved by the company.
    Don’t…Make unsubstantiated comparative claims about a competitor’s product.
  5. Do…spread the knowledge! Share approved scientific publications or journal reprints with healthcare professionals.
    Don’t…alter any approved publications before you share them with the approved audience.

Thanks for reading!

Life Sciences Compliance Congress West: A Preview

CBI’s 8th Annual Life Sciences Compliance Congress West kicks off in San Francisco in two short weeks. During the packed two-day conference, an esteemed lineup of industry professionals and government regulators will address the emerging risks facing life sciences companies. It’s a great opportunity to share notes and best practices with your peers and industry leaders. If you’re considering attending, we can help with a discount on the registration fee.

In the meantime, we’ve perused the agenda to note the sessions that hold the most interest:

Day 1

Session: Industry’s Guide to GDPR

The General Data Protection Regulation of the European Union, or GDPR, applies to companies that control or process the personal data of EU citizens, regardless of geographic location. That’s a wide reach, and your employees need to understand how their role helps ensure compliance with this new and potentially confusing regulation.

Session: Navigate the Complexities of Patient Assistant Programs (PAPs), Reimbursement Support and Patient Services Compliance in an Era of Ambiguity

Industry assistance for patients is an emerging enforcement area in the U.S. and abroad. Several U.S. companies have received subpoenas from the DOJ centered on their relationship with patients assistance organizations. This session covers the compliance issues related to patient support and the strategies for reducing risk.

Session: Small to Mid-Sized Boot Camp

We may be a little biased on this one, since our own Dan O’Connor, Senior Vice President of PharmaCertify, will join Jim Schneider of Seattle Genetics and Jane Wright-Mitchell of AcelRx to cover compliance governance considerations and key elements of compliance program development. It’s a must-attend for anyone building out a curriculum for an emerging company.

Day 2

Keynote Session: A Journey to the Dark Side of International Business and Steps to Protect Your Organization

Presented by a former FCPA Violator turned FBI/UK Cooperator, the session covers a range of international business practices and pitfalls. We expect topics to include privacy; patient interactions; bribery; and compliance risks when conducting business internationally, all critical information whether you’re updating an existing compliance training curriculum, or building one from scratch.

Session: Operations Management — Align Compliance Strategy with Emerging Risks on the Horizon for 2018

As new life sciences compliance risks emerge, training content, and the methods by which those risks are addressed, need to evolve. This session may offer tips for identifying curriculum gaps as well as the overall program adjustments needed to strengthen your curriculum and reduce risk.

Summary

We’re looking forward to catching up with our friends and clients at the 8th Annual Life Sciences Compliance Congress West. If you’re attending, don’t forget to stop by our booth to say hi and see demos of our newest Compliance Foundations™ eLearning modules, QuickTakes™ reinforcement tools, and compliance workshops. While there, don’t forget to enter our drawing to win a JBL Flip 4 Waterproof Portable Bluetooth Speaker.

See you in San Francisco!

Making the Most of Face-to-Face Time with Learners

by Lauren Barnett

Time in front of learners is a valuable commodity. Everyone throughout your organization is busy with his or her designated responsibilities, and the demands on a learner’s time makes scheduling training time challenging. If the learners are field-based,  the opportunities for face-to-face time are limited and everyone is scrambling for their share. So compliance trainers need to make the most of live training time in order for learners to walk away with an understanding of how the policies, rules and regulations affect their jobs day-in and day-out.

Effective and targeted compliance eLearning is one solution. Deploying eLearning before the live session gives trainers the ability to focus their live training time on the application of policies, and any changes in the working environment that might affect the exact interpretation of the rules.  It also allows the trainers more time to delve into learners’ questions about how to handle the situations they face.

Don’t Forget the WIIFM

When learners come to a live session with a baseline knowledge, trainers can utilize role-playing scenarios or interactive games to make the foundational knowledge presented in the eLearning more meaningful. This approach sharpens the WIIFM (What’s in It for Me) in the learner’s mind. When learners understand how the laws and regulations actually affect their daily activities, the information “sticks” even more and the potential for behavior change is stronger.

The Landscape Might Change 

While laws, regulations and policies may not change often, the environment in which learners operate is fluid. Using eLearning courses for foundational training, before the live session, allows trainers to spend that face-to-face time discussing any changes in the company business or the industry. For example, over time, an off-label use of a product may emerge, or a company may enter into a foreign market, creating new risks and/or laws that have to be addressed through training. By deploying eLearning to cover any new laws or policy basics, trainers can use their live time to discuss the more specific details of how those changes are played out in the field.

Leave Time for the Gray Areas

Inevitably, the application of compliance policies and regulations is sometimes left open to interpretation. The nature of those policies can leave those in the field mired in confusion and lost as to how to apply related policies. When you train the foundational knowledge through eLearning, face-to-face training time can be used as an opportunity to answer those questions and educate the learners about how to conduct themselves in a compliant manner. That type of feedback and dialogue represents a major step toward reducing risk and strengthening your compliance culture, as staff learn how to apply the principles, even when there isn’t a ready-made answer in the policy.

Make it Stick

Face-to-face time with learners is a valuable and precious commodity, and as a trainer, you need to seek methods for making that time as rewarding as possible. Deploying a baseline of eLearning courses, such as those found in the PharmaCertify Compliance Foundations™ curriculum, frees the trainer to spend that time detailing how the laws, regulations, and policies affect the learners’ daily activities. When learners understand compliance is not a set of draconian rules, but rather integral facets of what they do daily, the information is more likely to stick with learners and drive more ethical and compliant behavior.

Lauren Barnett is a Compliance Training Content Specialist for the PharmaCertify division of NXLevel Solutions. When she is not identifying subjects for the company’s Compliance Foundations suite of off-the-shelf eLearning modules, or working with clients to create custom training content, she can be found gleefully volunteering for her daughter’s high school band and theater programs.

Compliance News in Review, August 25, 2016

Here’s the tune we’re whistling this week: a California state senator pulls his own proposed transparency bill; an analysis of the FDA user fee programs yields interesting information; former Insys employees in court; FCPA woes at Orthofix International; and a new way for New Jersey residents to learn how much their docs received from the industry.

Summer is coming to a close all too quickly, but you still have a few weeks to cruise the boulevard, roll down the windows and belt out that favorite song at the top of your lungs. Sadly, these anthems tend to disappear at the first hint of cool temperatures, so dance on whilst you can! While you pump up the volume on your music delivery apparatus of choice, we’ll fire up a jam of own, with this edition of the Compliance News in Review.

It’s been a Cruel Summer for a California state legislator. The state senator who proposed a drug pricing transparency bill for the state has pulled the bill from consideration, saying amendments to the bill “made it more difficult for us to accomplish our fundamental goal.”

Could a recent analysis of FDA user fees stir up some Bad Blood? The analysis of FDA user fees showed that the FDA has collected over seven billion dollars in fees since 1992. These fees account for a large percentage, in some cases the majority, of funding for FDA review programs, and there is nearly $300 million dollars in unused user fees being carried by the FDA.

An interactive map shows the Blurred Lines between New Jersey physicians and the pharmaceutical industry. A state news website created an interactive map that provides details of physician and hospital payments from the pharmaceutical industry. Users search by zip code, and see payment details for hospitals and physicians in the area. The site also has an alphabetical listing of physicians and hospitals receiving payments. Data for the site was sourced from the Open Payments website.

Orthofix International allegedly got in the Danger Zone regarding improper payments made by its Brazilian subsidiary. In a recent regulatory filing, Orthofix International registered a charge of $4.6 million to settle potential FCPA charges. The company reported the potential violation to the DOJ and SEC in 2013, and has been cooperating with both agencies to resolve the matter.

If Life is a Highway, a pair of former Insys employees may be about to head down a bumpy road. A former district sales manager and former sales representative recently pleaded not guilty to charges they provided kickbacks to doctors in exchange for prescribing the company’s fentanyl drug. The two are accused of paying speaker fees to doctors for events that were held at upscale Manhattan restaurants and were social, rather than educational, in nature.

With that, it’s time for us to boogie on out of here. We hope to see you back on the dance floor for the next edition of the Compliance News in Review. Until then, stay cool, keep the summertime jams going, and stay compliant.

To Use Employees as Actors for Compliance Training or Not: That is the Question

Shakespeare said, “All the world’s a stage,” but when that stage is your training video, should your colleagues be the players? Before taking the leap and giving employees their “fifteen minutes,” you need to weigh the advantages and disadvantages and determine how each approach could help or hurt the effectiveness of your compliance curriculum. At PharmaCertify™, we have differing opinions based on first-hand experiences developing compliance training and corporate video programs. Here’s where two of us landed.

The Case for Using Employees as Actors
Lauren Barnett, Compliance Content Specialist

One obvious reason to use employees in your compliance training is the cost. Actors, even non-union ones, are expensive. Depending on the level of the skill the actor brings to the table, the cost of talent can be one of the top expenses in your video. A video shoot can last anywhere from a few hours to a few days, depending on the requirements of your project, so using the “free labor” you have at your fingertips can have a significant impact on the overall cost of the project.

Businesses and industries often have their own jargon. Add the medical or product-specific lingo that may need to be included in the training, and understanding the script for your compliance video could be like learning a new language. Your colleagues will be more authentic when delivering jargon-laden lines on camera. Actors won’t have the contextual experience with the language to deliver lines naturally or with confidence. Your learners do have familiarity with the language and they’ll notice when the actors aren’t comfortable and the learning will suffer.

Finally, using employees from the compliance department, or other departments the learners only interact with on a remote level, humanizes those departments and has the potential to build a stronger rapport between compliance and the rest of the company. Too often, the compliance department is seen in a negative light, or as the “police,” who are just waiting for employees to do something wrong. A truly effective compliance training curriculum addresses that concern, and includes components designed to portray those responsible for policy and training as partners who are there to support, encourage and inform. Using team members as actors in the compliance training is one major step toward that goal.

The Case Against Using Employees as Actors
Sean Murphy, Product and Marketing Manager

You may see your coworkers as free talent, but they aren’t professional talent. Acting is an art and a skill, and the fact an employee “was in a play in high school,” doesn’t necessarily mean that colleague is a trained actor. Good actors, even those working in local theater, have typically trained for years in their craft. You might get lucky and have a gem or two in your free talent pool, but when you use someone who is not comfortable or experienced, you run the risk of the key messages being lost behind the bad acting.

You also have to consider the cost to the business in lost productivity when employees are spending their time trying to convincingly read lines. Video shoots are time-consuming (especially when multiple takes are required because the actors are not professionals) and often require the actors to be “on set” for a number of hours. When your colleagues are pulled away from their jobs for that extended period of time, others may have to do their work, or they will at least have to book extra hours to make up the work they missed.

Finally, yes, employees can add an air of authenticity to your video, but it comes with the risk of your learners focusing on the fact they are watching “Bill from Marketing” in a video. Your key training messages may be lost because the learner’s attention is focused on the fact that is “Bill from Marketing,” instead of the subject matter. Additionally, if the audience includes vendors, they won’t know Bill, so he’s just another actor for them, so any authenticity is lost, and if Bill isn’t a good actor, he’s now a distraction as well.

What’s Your Verdict?

Using colleagues as actors can add an element of authenticity and fun to your training videos and can certainly help with the budget department. Before moving ahead in casting colleagues, it is important to consider the training goals of the video and determine if using colleagues will serve those goals or will simply be a distraction.

Now, we want to know what you think. Have you tried using your coworkers as actors in your compliance training? Did it work well? What were the pitfalls? Do you agree with Lauren or Sean? Who gets the bragging rights this time? Contact Sean at smurphy@nxlevelsolutions.com to let us know.