Pharmaceutical firms will face challenges related to the mandate -- which will require changes to sales force automation systems -- and may be denied access to detailed data about the drugs physicians prescribe and how often they prescribe them, according to a March research report from Gartner.
The AMA mandate provides an 'opt-out' provision for physicians who do not want pharmaceutical sales representatives to have access to their prescribing information, said Dale Hagemeyer, a Gartner analyst. 'There is a feeling from physicians that pharmaceutical representatives have all sorts of data about them and they are browbeating them,' Hagemeyer said.
Most pharmaceutical companies buy detailed data about the drug prescribing behavior of individual physicians -- stripped of any information that would identify a patient -- from companies that obtain it from pharmacies. The pharmaceutical companies can obtain more than 10 different 'sliced and diced' views of the data. Routinely, they use it in their internal marketing departments and for their field sales representatives.
Under the coming mandate, marketing departments can still have full access to the information -- even after a physician opts out -- but the data cannot be shared with field sales representatives or their sales managers.
A 2004 AMA poll indicated that about 27 percent of physicians would opt out, if given the chance, according to Hagemeyer. However, an informal Gartner poll last month of 10 pharmaceutical companies found that only 20 percent will be compliant by the July 1 deadline, he said. 'The implication is that these marketing departments are going to have to do the analysis and tell the representatives where to go, who to see and what to say,' he said.
When a doctor opts out, pharmaceutical companies need a way to automatically delete the various metrics about that physician in the sales force automation system before the representative synchronizes with the system the next time. 'You have to have really robust synchronization to flip those switches and to test it to know that there is no way the data can get out,' he said. 'The synchronization has to push it out to the right sales representatives and only the representatives. The home office has to push additional information out to help when they are blind.'
The AMA has vowed to aggressively monitor compliance, Hagemeyer said, noting that state legislatures are likely to impose harsher restrictions to prescribing data if the mandate doesn't bring the companies into compliance.
Gartner advises sales and compliance managers in pharmaceutical companies to move quickly to meet the deadline by taking these steps:
-- Contact the sales force automation vendor immediately to find out when compliant solutions will be available and for which software versions. The crux of being compliant lies in rules-based data synchronization that limits physician-specific prescribing data sent to sales personnel calling on doctors.
-- Map out an upgrade path if the compliance enhancements to the sales force automation system don't include the current version.
-- Perform a conference room pilot to ensure that the synchronization rules are foolproof for physicians who have opted out.
-- Train sales representatives on the rationale for the restriction. Ensure that they understand that opting out means 'no prescribing data' for those physicians. They cannot reverse-engineer the data or obtain it from another source.