HCP Interactions

Connie the Compliance Training Specialist Returns!

PharmaCertify Team , , , , , , ,

Welcome to a new edition of “Dear Connie the Compliance Training Specialist,” where we answer questions about life science compliance training concepts and discuss new ideas for making that training more effective.

This week: create a campaign to make it stick!

Dear Connie,

I am a compliance training manager for a mid-sized life sciences company in Pennsylvania and I am worried about our training on interactions with HCPs. We rolled out a new policy last year, and in January I launched comprehensive training on that policy. But based on our monitoring and data from our hotline, employees are still forgetting the key concepts and principles from their training. Connie, where do I go from here?

Signed,

Perplexed in Perkiomen

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Dear Perplexed,

Your challenge is a common one, but there are steps you can take to make the training more memorable. Just this month, at the 3rd Annual Life Science Compliance Training Conference, a number of your peers talked about how they use a campaign approach to make training more effective and make it stick with their learners.

Create a Brand

Develop a brand for the training campaign. Branding works for your company’s products, and it will work for your compliance training. Every time employees interact with your compliance training “brand” they form associations. The images you select reinforce those associations. Make sure your brand communicates the importance of integrity, clearly and consistently. Carry that branding throughout the training and on all communication.

Less is More

I suggest smaller training delivered throughout the year, rather than a longer more cumbersome course once or twice a year. When you take a “less is more” philosophy and keep seat times to no more than 15 minutes per module, you’re likely to see an uptick in retention. Don’t forget to keep the training flowing continuously, and build in follow up assessments, microlearning and contests to reset the forgetting curve that inevitably occurs after they complete the initial module or workshop.

Build the Messaging

The communication plan is critical too. Clear and concise messaging about the importance of the training, needs to be delivered in all three stages: pre-launch, launch, and post-launch. You should seek help from the stakeholders to deliver the messaging (one presenter at the conference said her company refers to these people as “compliance connectors”). The district managers are important in the process. They are the ones talking to the sales representatives on a regular basis, so you need to get them on board and funnel the messaging through them. Remember, communication is an ongoing process, you should constantly refine, adjust, and expand communications as you monitor the results of the training.

I could talk for hours about the need for a campaign approach to life sciences compliance training. I haven’t even touched on the need to solicit and evaluate learner feedback. Fortunately, my friends at PharmaCertify (that’s the life sciences compliance training division of NXLevel Solutions) have years of experience building training plans, and they’d be happy to share more ideas with you. Email my buddy Dan O’Connor at doconnor@nxlevelsolutions.com to see what they’ve done for other life sciences compliance clients.

Thanks for the great question and good luck!

Signed,

Connie the Compliance Training Specialist

“Dear Connie the Compliance Training Specialist” Debuts on the PharmaCertify Blog!

PharmaCertify Team , , , , , , , , , , , , , , ,

Welcome to the inaugural edition of “Dear Connie the Compliance Training Specialist,” where we answers questions about timely compliance topics and delve into the best training methods to reduce the risks.  

This week: managing the potential perils of speaker programs. 

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Dear Connie,

I am a compliance manager for a small pharmaceutical company in the Northeast. I am concerned that our new sales representatives may assume that they don’t need to worry about the details on speaker programs since an outside vendor manages them for us. We touch on speaker programs in the initial training all representatives take, but I am not sure we emphasized their responsibilities enough. Am I crazy to be concerned?

Signed,

Concerned in Connecticut

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Dear Concerned,

First, you are not crazy and I understand your concern. Speaker programs are a hotbed for potential compliance risks. It has been my experience that if you roll out additional training, like microlearning, assessments, and contests continuously to the reps, you’ll significantly reduce the risk around speaker programs.

Here are just a few topics to keep top-of-mind for the reps, and cover in the continuous training, even when an outside vendor is managing the program for you.

Attending to Attendees Concerns

On-going training needs to emphasize the finer details involving attendance. Representatives need to know that transparency laws require attendance to be documented, and it also helps the company evaluate the program. Whether a meal is offered or not, all attendees must sign-in. Reps need to remember no-shows and those who refuse a meal must be documented.

Speaker programs typically have a minimum required number of attendees. If the RSVPs fall short of that number, the program should be cancelled. Verbal commitments do not count.

Off-label Questions

Off-label questions asked during the presentation are another area of concern. If your company allows speakers to answer off-label questions (not all companies do), the speaker needs to make attendees aware that the question is in reference to an off-label use, and answer only the question that is asked. If that doesn’t happen, the sales representative must interrupt the speaker. Otherwise, the company can be accused of promoting the product for the off-label use. This is a great topic for role-playing during live training.

In addition, physician speakers represent the company. The programs are promotional in nature, so representatives must follow FDA regulations and speakers must follow the approved program. They may not proactively share their experience involving unapproved uses of products.

Speaker Requirements and Issues

I remember one case when a speaker unavoidably arrived late due to traffic and he suggested that he skip several slides to catch up on the time. Make sure the representative knows to stand firm on this. All slides must be delivered.

Another time, the representative realized, after the presentation started, that the speaker added his own slides to the deck. Representatives need to be trained to not panic and cause a disruption, but make note of the incident and notify a manager and the compliance department about the incident. Representatives should remind speakers that in the future, only the approved slides may be used.

Speakers sometimes ask if they can bring additional material about the topic being discussed, to hand out to the attendees. Representatives need to be trained to always let the speaker know that all materials must be approved by their company in advance of the program – whether the request occurs prior to the program or when the speaker arrives. Unapproved handouts are not permitted.

Thank you for a great question!

Connie the Compliance Training Specialist

Kicking Out Kickbacks in the Medical Device Industry

PharmaCertify Team , , , , , , , , ,

The federal Anti-Kickback Statute prohibits the exchange of anything of value to induce or reward the referral of federal health care program business. Business processes that are perfectly legitimate in other industries, like entertaining clients, or providing gifts to prospects, can be tricky in the medical device industry. Identifying the activities hold the potential to implicate the Anti-Kickback Statute is key to reducing risk across a medical device company.

Here are five areas to evaluate for risk:

Device Loaners/Evaluation Units
Device loaners and evaluation units are big risks. Be sure to provide only as many units as needed for evaluation, and for no longer than is necessary for the evaluation. If the loaner is provided to temporarily replace a broken unit, make sure the loan period does not continue past the time necessary to complete the service work.

Pricing Discounts
Pricing discounts require a level of transparency on the part of the seller and the buyer. Purchase agreements must clearly disclose the discount, and purchasers should be advised in writing that they too need to disclose the discount when they submit information to federal healthcare programs for reimbursement.

Gifts, Meals, Travel
Providing meals, gifts, travel and hospitality to an individual who is in a position to purchase, or recommend the use of a product, is risky. Gifts that do not have an educational benefit for the recipient or patients are particularly problematic.

When a gift is provided, the value should be nominal and cash or cash equivalents are never appropriate. Avoid lavish meals, and make sure meals occur in locations that are conducive to holding a business, educational, or scientific discussion. Finally, do not provide lavish travel or hospitality for company training or meetings.

Consulting Agreements
Remember to establish the objectives for consulting engagements with healthcare professionals (HCPs) prior to the start of the business relationship and only use as many consultants as needed to achieve the objectives. Timelines need to be included in the agreement and the consultants must be compensated at fair market value. The consulting relationship needs to be disclosed during the program.

Grants and Donations
Establish processes to objectively evaluate requests for grants and donations. Support should not be awarded to induce or reward the purchase or recommendation of product. Support of educational grants should not be contingent on the ability to select faculty or determine content of the program.

Medical Device Anti-Kickback Training
Our Compliance Foundations medical device eLearning modules cover critical topics such as the Anti-Kickback Statute, interactions with healthcare professionals, transparency, and speaker programs. Course titles include The AdvaMed Code; Global Anticorruption Laws; Medical Device Compliance Overview; and On-label Promotion. To see a demo and learn more, please contact Dan O’Connor at doconnor@nxlevelsolutions.com or 609-483-6875.

Thanks for reading!

Lauren Barnett, Senior Compliance Specialist