Verisys Has the Tools to Tackle Pharma’s Biggest Compliance Challenges
“You can’t do that.”
“That’s against policy.”
“Please revise and resubmit this piece.”
These were the types of phrases I heard on a daily basis in the eight years I spent working in marketing for one of the largest pharmaceutical companies in the world. The organization I was a part of was highly conservative and compliance and optics dominated every decision that was made.
In joining Verisys about ten months ago, I’ve now moved to the other side of the wall – a vendor supporting pharma – and I’ve been amazed to see the varying degrees of risk tolerances across my former competitive set. Things that were never allowed at my former employer are common practice elsewhere in the industry while other “safe spaces” that I used in my marketing materials are taboo for certain companies. It’s obvious that each pharma company I work with now has its own unique view of the regulatory sandbox in which they play.
In this litigious, scrutinized healthcare environment, elements of compliance permeate throughout all pharma organizations. There are common high-risk areas that continue to emerge in my daily interactions with a manufacturer.
3 High-Risk Compliance Areas in Pharma Organizations
Despite being a more “traditional” marketing technique for pharma companies, the concept of having a well-respected physician within a given geography speak on behalf of your branded medication still carries a lot of value. HCPs often look to their peer set for best practices and common challenges, and pharma-sponsored speaker programs can deliver tremendous value for both prescribers as well as the pharma company itself. During my time in marketing at my former employer, we utilized thousands of speakers across the country.
Even though this tactic is seen as a high ROI engagement, it also carries some of the most significant compliance risks for pharma. Anti-kickback statutes loom large over physician payments while off-label promotion is always a challenge during live Q&A sessions. Furthermore, speaker programs present heavy optical and reputational risks since these HCPs are representing the pharmaceutical company.
In 2011, one of the most prominent endocrinologists in my sales region was an active speaker for my previous company. He led multiple programs for us each year. The company was unaware that he was being actively investigated for an illegal drug scheme and the subsequent murder of his wife – crimes to which he was eventually convicted. He was sentenced to life in prison and the story received national attention. Throughout that process, he was still on our payroll and we hadn’t been doing our due diligence to screen him. These types of issues can cause reputational damage to the manufacturer if they aren’t monitoring their faculty.
Research and Development is the lifeblood of any pharmaceutical company regardless of size, profile, portfolio, or therapeutic focus. Whether it’s bringing a new therapy to market or expanding indications on an existing product, clinical trial management is a critical lynchpin for the future success of the company. Some large companies conduct hundreds to thousands of trials in a given year while other companies enter portfolio hinges on the results of just a handful.
Clinical trial compliance can offer unique challenges for pharma clients. First, the stakes are extremely high. Any compliance violation could jeopardize an entire trial leading to possible delays, discontinuation and/or penalties. Second, patient safety is the primary focus of any clinical trial. This extends beyond the potential side effects of a therapy to ensure that clinical investigators have been thoroughly vetted (licensure, sex offender status, etc.) and is being continuously monitored for any relevant change in status. Lastly, most clinical trials are outsourced to a CRO to handle the management of the study. The onus of ensuring these CRO’s have proper controls in place often falls on the shoulders of the pharma client but can be difficult to monitor.
Sampling and Sales
Sampling is common practice in the pharmaceutical industry, especially with launch brands. When a physician onboards a patient onto a new therapy, often a sample is a critical component in ensuring the patient can tolerate the new therapy. While serving as a key marketing tactic, sampling is also rife with potential compliance risks. The practice brings tremendous government oversight being governed by the Food, Drug, and Cosmetic Act, and misuse of samples can lead to penalties, fines, and even imprisonment.
In most instances, either pharmaceutical reps or a central distribution system are responsible for delivering samples to physician offices. Typically, a pharma’s customer master group will verify an HCP’s license and exclusion status and if approved, the rep will then be allowed to sample the HCP within the sales management platform (i.e. Veeva). However, the degree in which these HCPs are monitored varies across companies; it can be monthly, quarterly, yearly, etc. It’s important to remember licensure and exclusion data is dynamic and a client opens themselves up to compliance risk if they are only verifying periodically.
Lastly, HCP verifications are often limited to licensure and exclusions. Many organizations do not screen sex offender status, abuse registry, or civil and criminal backgrounds. Not only does a pharma not want to leave samples with an unlicensed HCP, but they do not want their reps calling on HCPs that are in a state’s sex offender database. Maintaining a tightly controlled, highly compliant call deck for reps not only prevents sampling fraud but also protects a company’s employees.
How Verisys Helps Reduce Your Risk
Verisys is a Credentials Verification Organization (CVO) and is one of six companies nationally that has both URAC and NCQA certifications. Thus, Verisys is in a unique position to address some of pharma’s biggest compliance challenges. We can verify both individuals and entities across a wide range of products – federal/state exclusions or sanctions, licensure, board certifications, employment history, educational history, sex offender status, etc. – and monitor for any changes in status on a daily basis. In that light, there’s no need to worry about an unlicensed physician being sampled or a clinical investigator with false credentials or a speaker with a criminal history. Verisys’ technology works to verify individuals with 99.9% accuracy and can serve as a valuable partner in enhancing compliance controls within your organization.
|Written by Joe Thompson
VP of Pharma & Pharmacy Solutions
Results Driven Problem Solver. Healthcare. Technology. Innovation.
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