While data mining laws are mired in the courts, a number of alternatives are proliferating to help states manage costs and help physicians control encounters with sales reps.

One voluntary, national program making headway is the Physician Data Restriction Program (PDRP), the American Medical Association’s opt-out plan to control physician prescription data. Nearly 12,000 doctors have signed up, at a rate of 120-130 per week, according to Jeremy Lazarus, MD, a member of the AMA Board of Trustees and a speaker of its House of Delegates.

Acceptance hasn’t come cheap. “We’ve spent half a million dollars on advertising in 70 medical journals to raise awareness of the program,” Lazarus told MM&M.

The awareness campaign, aimed at all physicians, appears to be making an impact. About 65% of sign-ups have come from outside of AMA’s roughly 240,000-member base.

PDRP began in July 2006 as a way for doctors—a number of whom were irritated by reps pressuring them to improve their prescribing numbers—to prevent intrusive details. In theory, reps shouldn’t have knowledge of what a PDRP physician is prescribing. It was seen as a chance for pharmaceutical companies to establish appropriate internal policies or face the consequences—state laws prohibiting the sale of prescription records.

Is it working? Lazarus said industry is being true to its agreement with the AMA. Among participants, “so far we’ve had no complaints,” he said. “This gives us a way of gauging whether pharmaceutical companies are taking this seriously, and so far it appears that they are.”

The program isn’t a complete loss for drug companies, which still get access to the data. Moreover, the ability to use information for research purposes is maintained.

“Our data are used widely throughout the healthcare system by government agencies, including the FDA and CDC, by academics and researchers, consumer groups and professional groups,” noted Randy Frankel, VP for external affairs, IMS Health.

He said restrictions on such research were an “unintended consequence” of some of the state laws. New Hampshire passed a complete ban on Rx data mining, but the law was struck down in court on constitutional grounds. Oral arguments were concluded Jan. 9 on the appeal of that law, and if the three judges of the First Circuit Court of Appeals in Boston affirm the decision, it would become the third court to rule that such laws violate First Amendment protection of truthful commercial speech.
In Maine a preliminary injunction was granted to prevent enforcement of its law, which is also on appeal, and Vermont is amending its own data mining law, already passed, in order to avoid a similar fate.

After New Hampshire’s statute was struck down, many states backed off similar efforts, Frankel explained. IMS, which along with Verispan and Wolters Kluwer Health sued to have the three state laws overturned, used the New Hampshire case as an opportunity to articulate the value of the data and how they are used throughout the healthcare system, as well as how restrictions could potentially compromise patient care.

“States went in other directions to manage cost and quality that had more to do with the mechanics of drug selection, such as preferred drug lists,” Frankel said. “Others are experimenting with academic detailing efforts, which by the way are driven by provider-level data.”

Minnesota and others are requiring drug companies to report their expenses at the physician level, while California has codified the voluntary marketing guidelines of industry, specifically the PhRMA code. The District of Columbia is taking yet another tack in licensing sales reps.

The growing trend toward data transparency is important to the dissemination of evidence-based information, Frankel said, as well as informing decision-making by providing useful information about quality and cost that’s relevant, especially considering the amount of treatment variability.

Whether these state-level efforts will work is anyone’s guess, but, like the AMA’s PDRP, they seem to offer real alternatives to indirect or blanket restrictions on data mining without impacting quality and safety.