By Judy Fox, CIS Compliance Director
Last month I wrote my first article about my role as an auditor and a common complaint that I hear when interacting with pharmaceutical sales representatives (Common Field Sales Complaint #1- It Always Feels Like Somebody's Watching Me). I don’t know if there is enough space to detail all of the things I have seen and heard from field sales forces, but there are some common complaints that I want to share. A little investigating as the result of complaints from the field can lead to the discovery of compliance concerns.
Most of the pharmaceutical manufacturers I’ve worked with over the past few years have adopted the Pharmaceutical Manufacturers of America Code on Interactions with Healthcare Professionals (PhRMA Code) for all of their promotional activities and a few have only adopted the PhRMA Code in states that require it. From either perspective, everyone I have worked with has chosen to adopt at least a portion of the code and has eliminated all of the ‘reminder items’ for Health Care Practitioners (HCP), such as pens and mugs. All of the companies have conducted training on the PhRMA Code and the representatives have understood that the company would no longer be providing these items.
Before I get started, I have to clarify that I work with all types of sales representatives: those that are in their first job after college and others who have been selling pharmaceuticals for 20+ years. The seasoned and successful sales representatives seem relieved by last year’s change in the PhRMA Code and are grateful that they don’t have a bunch of ‘stuff’ to carry around. The less experienced representatives seem to miss being able to supply an office with pens or post-it notes. This is where Common Field Sales Complaint #2 – “The company took away all of my stuff” rears its ugly head and compliance concerns pop up.
As a compliance consultant who is often called upon to conduct ride-along assessments and audits of field sales forces, I try to engage representatives in a conversation about their work habits. A part of those conversations include questions about company policies and procedures and any Corporate Code of Conduct. Experienced representatives know that no HCP is going to write a script because of a pen. The less experienced representatives sometimes feel like they are missing out on an important business tool to such an extent that they have come up with some pretty interesting interpretations of company policy. Most of the results of these interpretations are creating a compliance risk. The following examples are true stories that may seem far-fetched at first, but some compliance concerns were uncovered. As with any compliance issue, if left alone, they can become serious.
Example #1 – Company XZY has adopted the PhRMA Code across their entire company. I was asked to conduct a sample accountability and general compliance audit of sales representative, John Doe. John was able to rattle off the Corporate Code of Conduct practically verbatim; he had received training on the PhRMA Code and said he knew ‘the company is not allowed to give us stuff like pens or notepads anymore.’ Part of the audit included an inventory of his prescription drug samples as well as an inspection of the sample storage area. We arrived at a commercial storage site and John asked me if I wanted to start with his sample storage unit or his ‘other one’. (His other one? This is the point when an auditor sees a red flag and I will admit, also gets a little rush.) As it turns out, John has two small storage units, one for his samples and the second for his marketing materials. When he opens the door to the second storage unit, it is filled with all kinds of pens, stickers and other ‘reminder items’ as well as the company supplied marketing materials such as detail aids and patient education brochures. When questioned about the items, John proudly tells me that since the company is no longer able to supply the items and they took away all of his stuff, he has used his territory’s budgeted discretionary funds to have the items made on his own. He had been having pens, prescription stampers and coffee mugs made with XYZ’s product logos on them. None of the items had gone through Company XYZ’s legal, medical and regulatory review process, because John didn’t even know there was such a thing. His interpretation was such that the items weren’t prohibited completely, but that the company just couldn’t provide such items and that it was up to each representative to figure out what they needed and to get it themselves. His major complaint was that since the company took all of his stuff away, he had to have the items made on his own. The discovery of the items led to an XYZ review of the compliance training and language in the Code of Conduct and Corporate Policies and all were revised with specific instructions.
Example #2 – Company ABC has adopted the PhRMA Code in a limited capacity. ABC has policies in place that adopt the code in the states where it, or a more restricted code, is required by law. ABC had conducted training on the PhRMA Code and company policies as well as specific training for the representatives who were impacted by state laws. ABC does provide representatives who are not impacted by the state laws with some reminder items, but they have kept them to a limited and monitored quantity to avoid sales representatives sharing the items with other colleagues. ABC’s Corporate Compliance Office contracted with CIS to conduct a corporate compliance assessment and representative ride-alongs were a part of the project. This was Jane Doe’s (no relation to John in example #1) first job as a pharmaceutical representative and she had experienced great success in her first few years with the company. Jane details ABC’s pharmaceutical products in a state requiring adherence to the PhRMA Code. When the subject of the code came up during the ride-along, she acknowledged that she could no longer give her prescribers items such as pens and coffee mugs and that she was given company approved educational items. Jane felt slighted that some of her co-workers did not get their ‘stuff’ taken away and she thought about increasing the frequency of her calls. Jane liked the idea that reminder items helped keep her products in front of the prescriber and the staff. Since Jane is limited to providing modest meals to her prescribers in their offices during ‘lunch and learn’ programs, she came up with her own solution: product stickers. She had printed her own stickers with product logos taken off of the company website. She said she made sure she did not alter the logos at all. Jane then purchased various decorative jars, filled them with candy and put product stickers on them. She then brings a jar with her as part of the meals. She also makes sure the covers for any deli trays or pizza boxes always have a product sticker on them as well. For the holidays, Jane gave the office staff gifts with product stickers on them. She made it clear that she did not give a gift to the prescribers in the office, just the staff. Oh Jane, the concern here is not just with the use of the unapproved stickers, but with Jane assuming that she could provide the office with items as long as she did not give it to the prescriber. State laws vary, but in this case, the state law Jane works in is specific in that the restrictions extend to the employees of the prescriber. The report of the activity led to an evaluation and revision of the training program. In this case, Jane’s manager, Sally was also given refresher training based on the assumption that Sally either knew what Jane was doing or should have known.
As evident in the examples above, sometimes it isn’t enough to just take away everyone’s stuff and provide employees with company policies. It usually takes very specific training that literally spells out: “Do this and don’t do that!”
CIS has the knowledge and experience to create a comprehensive training program that addresses not only Federal and State requirements, but also tackles the interpretive issues that other training programs might overlook.
Feel free to send me some of your own examples where you were left shaking your head and saying, “What were they thinking?” I would love to share them anonymously and as well as some thoughts on compliance.