How to Tackle Pharma’s 3 Biggest Compliance Risks Head-On with Verisys

How often have you started at a new organization and heard these phrases?

“You can’t do that.” 

“That’s against policy.” 

“We always do it this way, not that way.”

As frustrating as these phrases are to hear, there may be a reason behind them. Some companies make decisions based on compliance standards and optics, while others may be more lax. And what was acceptable at a previous place of employment may be considered taboo at another.  

Pharmaceutical companies are no exception to these dynamic workplace differences. Some employ thousands and offer a diverse medication and vaccine portfolio. On the other hand, start-ups may hire a few hundred employees and have a limited product portfolio. Regardless of the company’s size and portfolio, pharmaceutical companies must adhere to compliance guidelines.

Below, we will discuss three common high-risk compliance areas for pharmaceutical companies and how to address them.

High-Risk Compliance Areas in Pharmaceutical Organizations

Speaker Programs 

Over the course of one’s medical career, most providers have attended at least one pharma-sponsored speaker program. These programs are considered a more “traditional” marketing technique and can deliver tremendous value for providers and the pharmaceutical company. Having a well-respected provider speak on behalf of a branded medication carries a lot of value, as healthcare professionals often look to their peers for best practices and common challenges. 

Despite the potential for a high return on investment, it also carries some of the most significant compliance risks for pharmaceutical companies. Anti-kickback statutes loom large over physician payments, while the off-label promotion of a medication during Q&A sessions is a challenge. Furthermore, speaker programs present serious optical and reputational risks since the speakers represent the pharmaceutical company.

Verisys’ former VP of Pharma and Pharmacy Solutions, Joe Thompson, shared a prime example of how speaker programs introduce risk to 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 issues can cause reputational damage to the manufacturer if they aren’t monitoring their faculty.

Clinical Trials

Research and Development is the lifeblood of any pharmaceutical company regardless of size, profile, portfolio, or therapeutic focus. 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. 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 company’s future success. 

Clinical trial compliance can offer unique challenges for pharmaceutical companies. First, the stakes are incredibly high. Any compliance violation could jeopardize an entire trial leading to possible delays, discontinuation, penalties, or a combination.

Second, patient safety is the primary focus of any clinical trial. This extends beyond the potential side effects of a therapy. Clinical investigators should be thoroughly vetted (e.g., licensure, sex offender status) and continuously monitored for any relevant change in status. 

Lastly, most clinical trials are outsourced to a contract research organization (CRO) to handle the management of the study. The onus of ensuring these CROs have proper controls in place often falls on the shoulders of the pharmaceutical company and can be challenging to monitor.

Medication Samples

Supplying medication samples to prescriber’s offices is common in the pharmaceutical industry, especially with launch brands. When a healthcare provider starts a patient on a new therapy, a medication sample can help ensure the patient tolerates the new treatment or helps bridge the gap until the patient receives their supply from the pharmacy. While serving as a key marketing tactic, sampling is also rife with potential compliance risks.  

This practice brings tremendous government oversight, and misuse of samples can lead to penalties, fines, and even imprisonment. Pharmaceutical reps or a central distribution system usually deliver the samples to the prescriber’s offices. 

Typically, a pharmaceutical customer master group will verify a healthcare provider’s license and exclusion status. If approved, the pharmaceutical rep can provide samples to that healthcare provider. However, the degree to which companies monitor these healthcare providers varies across companies; it can be monthly, quarterly, yearly, or even less frequently. It’s important to remember that licensure and exclusion data is dynamic, and clients open themselves up to compliance risk if they only verify periodically.

Lastly, verification of healthcare providers is often limited to licensure and exclusions. Many organizations do not screen sex offender status, abuse registry, or civil and criminal backgrounds. Not only do pharmaceutical companies not want to leave samples with an unlicensed provider, but they also don’t want their reps calling on providers that are in a state’s sex offender database. Maintaining a tightly controlled, highly compliant call deck for pharmaceutical reps prevents sampling fraud and protects the company’s employees.

How Verisys Helps Reduce Your Risk

Verisys is one of the handful of credentials verification organizations (CVO) with both URAC and NCQA certifications; thus, we are uniquely positioned to address some of the pharmaceutical industry’s biggest compliance challenges.  

With our proprietary database, FACIS, we can verify both individuals and entities across a wide range of datasets, including the following: 

• Federal and state exclusions or sanctions
• Licensure
• Board certifications
• Employment history
• Educational history
• Sex offender status 

Verisys conducts more than just pre-hire screenings. We continue to monitor for any changes in status on a daily basis. Because of this, there’s no need to worry about an unlicensed provider receiving samples, 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. Set up an appointment today to learn more. 

Contact us for a demo of FACIS®, and discuss a staged rollout of screening, verifying, and monitoring for your entire workforce.

The original article was written by Joe Thompson, former Verisys VP of Pharma and Pharmacy Solutions.