Are You Tiptoeing Through Mid-level Sampling, or Plowing Through It?

By Judy Fox, CIS Senior Compliance Manager
judyfox@cis-partners.com

Note: For the purpose of this article, the term “mid-level practitioner” means an individual practitioner other than a physician, such as a nurse practitioner, who is licensed, registered, or otherwise permitted to prescribe and/or dispense prescription drug products.

While the title of this article is a nod to the tulips and daffodils that have started to bloom here in PA, ”tiptoeing” also serves as an accurate description of the delicate maneuvering required to achieve compliance in mid-level sampling.

Navigating numerous state laws isn’t easy, and sampling training is never the most popular subject at sales meetings. But both must be done, and both must be based on state laws. The guidance is specific, so training and procedures should be equally specific. The guidance states:

“One comment stated that, in some States, advanced practical nurses are licensed
to prescribe certain drugs, but are prohibited from obtaining samples of the
same drugs. The comment asserted that, under the proposed definition of
“licensed practitioner,” such non-physician practitioners would be permitted to
obtain samples. In developing the proposed definition of licensed
practitioner, the agency was not aware that some States may permit practitioners
to prescribe certain drugs, but prohibit them from obtaining samples of those
drugs. Because the agency does not wish to interfere with States’
authority to determine who may request and receive drug samples, the agency
clarifies that a practitioner who is prohibited by State law from receiving
samples of certain types of drugs is not permitted to do so under PDMA even
though he or she is licensed or authorized to prescribe those drug.”1

At CIS, we conduct our fair share of Sample Accountability Audits and Assessments, and we review sampling training and documentation. Often, the transactions reviewed during these audits aren’t pretty when it comes to compliance for sampling mid-level practitioners.

CIS has reviewed corporate programs that contain all sorts of caveats to mid-level sampling: training slides that specifically prohibit it, procedures that require signed collaborative agreements, or training and compliance manuals that don’t address the issue at all. During interviews with members of sales forces, we have found, time and time again, that many sales representatives and managers have little, if any knowledge of the existence of state sampling laws. Nevertheless, mid-levels are sampled frequently, creating a potential compliance risk for the manufacturers.

Some procedures and training programs outline a one-time sampling rule, in which a sales representative could sample a new target, and would be notified if he or she had sampled an invalid practitioner. This notification would include instructions to cease any additional sampling to the practitioner in question. The sales force had been trained that “no news was good news” when it came to the practitioner in question, but compliance with the verification and notification procedures were never fully monitored or tested. As a result, no news was not, in fact, good news. No news was just what it sounded like: no news.

Corrective actions in such a situation would require the sales representatives to cease sampling certain targets, making for an uncomfortable conversation for some who had worked hard to build a relationship with the mid-level practitioner.

Sampling is no more secure when it is tracked electronically through a Sales Force Automation (SFA) tool. While most SFA systems can be programmed to “lock-out” a practitioner and prohibit sampling someone without a valid state license, not all systems will lock out a mid-level practitioner based on the corresponding state laws. During the interview process, we at CIS have come to find out that not only are sales forces largely unaware of state laws governing mid-level sampling, but manufacturer and SFA vendors rarely discuss the SFA user requirements for sampling mid-level practitioners.

Where does that leave an already resource-strapped sample compliance department? The issue has been identified, but finding the right solution to the problem and finding the resources to implement it can be difficult. The DEA offers a chart entitled, “Mid-Level Practitioners Authorization by State;”2 however, this chart is limited to the restrictions regarding the sampling of controlled substances. The FDA does not provide such assistance. The compliance risk presented by mid-level practitioner sampling can only be mitigated through research. A company looking to engage in mid-level sampling should conduct a state-by-state search of applicable regulations, in order to develop the appropriate procedures for compliant sampling.

Sources:
1 www.fda.gov
2 http://www.deadiversion.usdoj.gov
3 http://kcsun3.tripod.com/id110.htm