How to Keep Out of Regulatory Quicksand - Pharmaceutical Executive

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How to Keep Out of Regulatory Quicksand
Pharma sales teams may soon need law degrees just to keep up with the changes in federal and state mandates.


Pharmaceutical Executive


HIPAA has limited reps' access to physicians' offices. Today many provider offices require reps to sign HIPAA compliance agreements as a requirement for calling on them. Even after completing those forms, reps are typically denied access to exam rooms and patient files. Instead of discussing details of specific patients with a physician's office staff, doctors and reps talk about anonymous patient "scenarios." These discussions typically occur far from patients, in a secluded office or near the sampling closet. Reps who violate any of the established HIPAA protocols could be banned from the office.

HIPAA training should be embedded in company detailing protocols. To insure that reps understand the field application of the policy, each should undergo a role playing session that outlines different physician office scenarios. The sales management team should also organize ongoing field coaching.

Putting It All Together Like it or not, regulation has become a major factor shaping pharma sales and marketing efforts. Chief compliance officers need to work with the sales department to assure that training includes more than field promotion and product training activities.

Meeting sales goals is still the top priority, but companies cannot sustain profitability unless sales reps and marketing executives meet regulatory requirements. As additional layers are added and compliance becomes more complex, companies will have to invest more resources in comprehensive, legally sound training programs for their field sales reps—and for the people who manage them.

Steven Tarnoff is executive vice president and a managing partner of the Franklin Group, a division of Ventiv Health. He can be reached at
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