On-The-Job Off-Label Compliance - Pharmaceutical Executive


On-The-Job Off-Label Compliance

Pharmaceutical Executive

Document review of formulary presentations Presentations to the Pharmaceutical and Therapeutic (P&T) Committee at a managed care organization (MCO) or prescription benefit manager (PBM) provide companies an opportunity to get their product included on the formulary. They also provide an opportunity for off-label communication. The key here is whether the information is provided as a marketing disclosure or as a response to a legitimate inquiry. This is particularly important for P&T meetings in which pricing is discussed or when a change in a product's tier within the formulary is under consideration. Reviewing a representative sample of formulary presentations for comparisons of material presented to material requested can identify any inappropriate disclosures. The results of the presentations can be equally instructive. For example, check if the MCO or PBM included the product on the formulary under a therapeutic category for which it is not approved.

Analysis of information requests Data records maintained by the medical information department provide another valuable test. Analysis can reveal unusual request patterns that might indicate improper off-label marketing prompting physicians to request the data. Effective interpretation, however, requires the ability to track requests by sales region and territory. While it is likely that this analysis is done by the medical information department, compliance managers must ensure that the analysis is timely and that corrective action is taken when issues are identified.

Ride-alongs Many compliance departments monitor field performance by accompanying randomly selected staff as they conduct their HCP visits. While it is unlikely that individuals will knowingly violate policy during a ride-along, compliance managers should shadow sales staff and MSLs for half-day periods. This provides insight into their actual practices and operating environment. In addition, the ride-along will highlight training lapses and provide a more informal forum for an extended discussion.

Call-note review Finally, compliance departments may also review the call-note systems for both sales and MSL functions. While the value of this technique depends largely on the quality of the data, there are opportunities to correlate call-note records with patterns of information requests made to the medical information group.

These solutions are not easy to implement. The daily grind of conducting business does not stop while the compliance managers are testing and taking action on the company's off-label compliance practices. Therefore, it may be tempting to address perceived risks by simply updating company policies and procedures. But only by taking certain control and monitoring steps to ensure that what is actually occurring is in line with what is supposed to be occurring can a true culture of compliance be built.

Mark Scallon is a senior manager at Polaris Management Partners; he can be reached at
Fred Eaton is a partner at Polaris Management Partners; he can be reached at


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