Even when reps comply with all federal guidelines, they and their managers may still be violating a state regulation—often
without knowing it. In addition to PDMA compliance training, some manufacturers have added training programs in state regulations.
A few companies have created alliances with state and local governments to assemble the regulatory data the sales managers
need to train reps. Some are automating the reporting process and selecting technology platforms such as Target Sofware's
Target Mobile Field Sales Manager, which monitors sales force activity. Such systems build compliance into the system by,
for example, flagging doctors on call lists who are not authorized to receive samples and electronically alerting reps to
other potential sampling violations.
21 CFR Part 11
In 1997, the federal government passed 21 CFR Part 11, partially in response to requests by manufacturers and vendors to
be able to submit electronic sample records instead of paper. The government has published and recalled these guidelines twice
since then, and a third revision is currently pending. The rapidly changing regulations pose one challenge for companies.
The different electronic platforms favored by physicians create another headache.
Although the burden of responsibility for 21 CFR Part 11 ultimately lies with companies, reps are responsible for producing
valid, reliable data. Policies must be established to hold reps and their managers accountable for accurate reporting; they
should be terminated for non-compliance. Reasonable guidelines might include requiring that reps file data every week, capture
signatures electronically, and store data on a laptop computer provided by the company. If reps were to file data less often,
provide only paper signatures, or use their personal computer to store data, they would be considered non-compliant and could
Training sales reps to comply with 21 CFR Part 11 starts with clearly communicating the company's electronic reporting policy,
including the corporate and individual penalties for non-compliance. Managers must demonstrate the company's sample tracking
system, explain the sample reconciliation process, and test field personnel on the concepts and procedures.
When the OIG was charged with preventing fraud and abuse in the federal healthcare system, its 2003 guidelines effectively
became a new set of regulatory hurdles for pharma manufacturers. Today, in addition to documenting how they promote products,
marketing departments and field reps must, for the first time, demonstrate the "intent" of their marketing activities.
For example, if reps visited five doctors and distributed five hundred samples before the new OIG regulations went into effect,
they only needed to report the total number of samples distributed to each physician to be PDMA compliant. Today, reps must
explain their rationales for distributing 50 samples to one physician and 300 to another.
To support such reasoning, reps must demonstrate, for example, that they did not encourage off-label use by providing samples
to a specialized physician with a patient population unlikely to need the medication. The rep must also prove that he or she
did not offer an excessive number of samples for use with non-insured patients. The government could also ask to see reps'
call notes to determine if telltale language involving agreements, arrangements, deals, understandings or trial use was used
to describe a sales call.
Formal OIG training should be part of the standard sales training model. To foster compliance, managers might coach reps on
how to speak with physicians when they discuss sampling practices. Role-play scenarios can help reps see when a sample might
be regarded as an inducement. Managers should also coach reps on completing call notes using appropriate language.
There was a time not too long ago when physicians took sales calls at the nurse's station. Sales reps hung around while nurses
and patients received instructions, while pharmacy calls were placed, or even when the doctor wrote up patient notes. Physicians
and reps discussed the benefits of a product for specific patients, citing details of the actual patient's case. Reps placed
reminder stickers and educational material directly into patient files. Nurses would even provide lists of expectant mothers
to infant-products reps, so they could send out coupons. Today, all of these practices would be considered HIPAA violations.