Month: March 2017

Compliance News in Review, March 27, 2017

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Everything’s coming up roses, off-label speech, and corruption, in this edition of the News in Review.

We’ve got the fever…Spring fever! Spring has sprung, and we couldn’t be happier. Warmer weather, more daylight, budding trees and flowers, what’s not to love (besides the severe weather, commuting in the dark, and pollen)? This Spring, the flowers aren’t the only thing blooming, though. A new edition of the Compliance News in Review has appeared in our garden.

Arizona gets to claim the first “bloom” for sharing truthful off-label information with the governor signing the Free Speech in Medicine Act into law. The law protects the free speech rights of those in the medical community to discuss truthful off-label information about FDA approved drugs. It covers speech that is “not misleading, not contrary to fact, and consistent with generally accepted scientific principles,” and only deals with discussions between pharmaceutical companies and healthcare professionals. It does not cover off-label discussions or advertisements targeted to consumers.

The FDA has stemmed the implementation of a new off-label regulation. The agency announced in the Federal Register that it would delay the effective date of a final rule related to “intended use” regulations until March of 2018. It is delaying the effective date to consider public commentary. In February, industry trade groups petitioned the FDA to indefinitely stay and reconsider the rule.

Is a late season chill on the horizon for Novartis? According to a media report, the South Korean government is considering additional penalties against the company in relation to a kickback case. The government’s Ministry of Food and Drug Safety has already imposed a fine against the company and suspended the sale of some of the company’s products. A source at the Ministry of Health and Wellness said the government was considering lowering the price of the drugs involved in the kickback case. Novartis said the court case was on going, and it wasn’t aware of an “imminent” decision from the Health Ministry.

“New life” is being breathed into the FCPA Pilot Program. At the American Bar Association’s National Institute on White Collar Crime , Acting Assistant Attorney General, Kenneth Blanco said the DOJ will evaluate the Pilot Program and determine what, if any, changes should be made. Until the evaluation is complete, the Pilot Program will remain in force. The Pilot Program, the common name for the DOJ Fraud unit’s guidance on FCPA investigations and prosecutions, was due to expire on April 5. The Pilot Program is intended to encourage individuals and companies to voluntarily self-disclose instances of corruption, and establishes requirements for voluntary self-disclosure, cooperation with investigations, and the resolution of FCPA cases.

The growth in global anticorruption settlements and activity is sure to be a hot topic at the Pharmaceutical Compliance Congress, April 26-28 in Washington, DC. The PharmaCertify™ team will be providing demos our new Compliance Foundations™ module, Global Anticorruption Laws, along with all our new and updated compliance training products, at Booth 10 on the Exhibit Floor.

See you in Washington!

The Forgetting Curve and Compliance Training

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What exactly does a 167-year-old German scientist have to do with your compliance training? As a chief compliance officer, or training manager, the answer may keep you up at night – especially if you haven’t integrated micro-learning elements continuously into your company’s compliance learning curriculum.

Hermann Ebbinghaus was a German psychologist who is credited with theorizing fundamentals of human learning, including the learning curve, the spacing effect, and the forgetting curve. The Ebbinghaus Forgetting Curve essentially states that what humans remember after a learning event drops steeply soon after completion of that event. His research shows that memory loss continues to increase until it finally flattens around 30-days post event.

 

Steven Just, Ed.D., Chief Learning Officer at Intela Learning, a developer of continuous learning platforms, writes, “What gets stored in our long-term memories is subject to decay (i.e. forgetting)… deep learning occurs when memories are stored in long-term memory and stabilized. This is called memory consolidation.”

Fortunately for those of us seeking to reduce compliance risks across a company, spacing follow up micro-learning components, in smaller chunks, across a learner’s timeline helps flatten that forgetting curve and increase retention. As Dr. Just writes, “Retrieve the memory from long-term memory, bring it into working memory, process it, and then re-store (re-encode) it in long-term memory.”

Micro-learning Tools

Short “sprints” of learning deployed in follow up to foundational compliance training provides that opportunity for the concepts to be “re-stored” in the learner’s long-term memory. Micro-learning can include brief mini modules focused on one topic that you’ve identified as needing reinforcement. If gifts and meals are a high risk for your HCP-facing employees, a scenario-based mini module built around a common situation they face in the field, deployed soon after the comprehensive training, is one method for alleviating their concerns and reinforcing the appropriate behaviors. Mini modules aren’t the only effective tools for flattening the curve though. Short learning nuggets like quizzes and gaming, strategically deployed over time serve to heighten retention as well. As another option, sprint activities and scenario-based mysteries can be delivered in a competitive workshop format to reinforce participants’ understanding of policies and principles. (We call it the Compliance Reality Challenge).

Code of Conduct

Considering the range of topics covered in a typical code of conduct, from workplace violence; to harassment; and gifts and hospitality, a more creative and engaging approach to reinforcing the initial code training is not only a good idea, it’s crucial to improving the learning. One approach we’ve deployed to successful reviews is what we’ve titled Know the Code. Working with the client, we target specific topics within the broader code of conduct to create a “streaming” series, with each 7-minute “episode” built around those topics. Each animated scene in a scenario lasts approximately one minute. A narrator character tells the story and when necessary, directs the learner to take part in on-screen activities, with individual character voices employed to bring life and realism to the scenarios. The episodes are strategically released across a timeframe designed to once again, “re-store the concepts originally covered in the core module into the learners’ long-term memories.”

Keep it Continuous

The bottom line: to make compliance training as effective as possible in terms of reducing risk across the company, the learning nuggets you continuously rollout after the initial event (eLearning module, instructor-led training, etc.) are as important as the initial event itself. PharmaCertify offers the reinforcement tools, instructional expertise and an exciting new system that uses the most widely-accepted algorithm for creating and delivering post-training learning sprints to accomplish that goal. If you’re attending the 14th Annual Pharmaceutical Compliance Congress April 26-28, stop by Booth 10 to see demos of the products and platform, and ask how we can help reduce risk and strengthen the compliance culture in your company.

Thanks for reading and we’ll see you in Washington!

Sean Murphy, Product and Marketing Manager, PharmaCertify™