AMA opt-out program will keep prescribing data from drug reps

The days of pharmaceutical sales representatives knowing more about a physician's prescribing patterns than the individual doctor does could be over.

Faced with complaints from physicians irked by pushy drug reps questioning their prescribing decisions as well as legislation in five states that would ban the sale of prescriber data for commercial uses, the American Medical Association has implemented a plan that will allow doctors to restrict access to personal information stored in the AMA's Physician Masterfile database.

The Prescribing Data Restriction Program, originally set to take effect July 1, is now in place and allows physicians to opt out of having their prescriber data accessed by drug reps or their direct supervisors. The option is effective for three years, after which doctors would need to sign up again for the opt-out. Drugmakers still will be able to use physician data to evaluate and compensate drug reps, as well as target direct mail to doctors.

Under the new AMA program, drugmakers who buy any Masterfile data will be contractually obligated to train reps to adhere to a toughened set of best-practice guidelines, first adopted in 2001, that call for disciplining drug reps who use prescribing data to pressure doctors. The AMA will set up a system to track physician complaints closely and is threatening to stop giving licensing data to any drugmaker that wantonly breaks the rules.

The opt-out program could empower physicians in their interactions with drug reps, said Robert Musacchio, PhD, AMA senior vice president of business and publishing services.

"Physicians have always had the wherewithal to tell the rep, 'No,' and by and large they haven't done that because it involves too much personal interaction," he said. "This will give them a nice out. They contact their professional society, and we can do the heavy lifting for them."

The AMA licenses Physician Masterfile information such as names, addresses, education credentials and DEA license numbers on about 1 million doctors to data-mining firms such as IMS Health, Verispan and Dendrite International. Those firms also purchase prescribing information from pharmacies, link prescribers to prescriptions and resell the data to drugmakers. Pharmaceutical companies use the data to track how well their estimated force of 115,000 sales representatives is faring in persuading doctors to prescribe their newest and most expensive drugs.

The AMA doesn't publish how much income it makes licensing Masterfile information to data-mining firms, but in 2004 -- the most recent year for which data are publicly available -- the AMA took in $40.4 million from database products, an area that includes the Masterfile. The figure represents nearly 15% of the AMA's consolidated revenues.

Reactions run the gamut

Drugmakers and some physicians reacted positively to the opt-out plan, but others criticized what they viewed as a half-hearted measure.

Paul Antony, MD, chief medical officer of the Pharmaceutical Research and Manufacturers of America, said in a statement that the AMA's plan represents an effort to "balance the public health benefits of using physician-specific prescribing data with the AMA's commitment to providing physicians with the opportunity to choose how their prescribing data are used."

Those public-health benefits, according to a PhRMA spokeswoman, include the ability to alert physicians about safety issues quickly and tailor the distribution of drug samples.

In opposing state legislation that would ban the sale of prescribing data for commercial use, the AMA has said data-mining firms' profits help subsidize the use of data in the development of clinical practice guidelines, prescription monitoring programs, safety studies and disease management programs.

Donna Sweet, MD, immediate past chair of the American College of Physicians' Board of Regents, said the opt-out plan is "a good first step" in protecting physician prescribing data.

"This at least allows those physicians who feel very strongly about this issue to have a say-so about it," she said.

In 2003, the ACP asked the AMA to stop pharmacists, pharmacy benefit management organizations and others from releasing or selling physician-specific prescribing information. Dr. Sweet said she would wait and see whether the AMA's new program alleviates ACP members' concerns before pushing further.

One group that has changed its position thanks to the opt-out plan is the California Medical Assn. In 2004, the CMA favored banning the sale of prescriber data but backed off when the AMA House of Delegates passed a resolution at its Interim Meeting that year calling for implementation of what would become the Prescribing Data Restriction Program.

"The opt-out will change the way pharma reps are trained and how those few among them who are acting inappropriately will be treated by the companies," said Jack Lewin, MD, CEO of the CMA. This summer the CMA will pilot a program to give physicians who do not opt out access to detailed information comparing their own prescribing patterns to other physicians in their area and specialty. The program, scheduled to roll out statewide in January 2007, also will give doctors access to disease- and condition-specific prescribing data.

Dr. Lewin said the CMA does not expect to make money on the program, and that for now the group has no interest in a legislative solution to the prescribing data problem.

Others criticized the AMA's plan.

The AMA makes millions a year "peddling personal information about doctors to pharma without their consent, and now they propose an opt-out procedure that doesn't actually let doctors opt out?" said Carl Elliot, MD, PhD, a professor at the University of Minnesota's Center for Bioethics, who authored an April Atlantic Monthly essay on drug reps' impact on medicine. "If the AMA were serious about fixing this problem, they would ask doctors before they licensed the information to pharma, not after."

Marc Sadowsky, MD, president of the New Hampshire Medical Society, said the new AMA program "puts the drug companies in charge of policing their own behavior. ... Putting the wolf in charge of the henhouse doesn't make a heck of a lot of sense to me."

The NHMS has strongly supported a bill to ban commercial use of prescriber data that was sent to the governor's desk May 4. At press time, Democratic Gov. John Lynch had not announced whether he would sign the bill, and a call to his office requesting comment was not returned.

Arizona, Hawaii, Maine and West Virginia recently have considered similar legislation, with Maine ultimately passing a limited version that addressed only patient privacy. State medical societies in Hawaii and West Virginia expressed support for banning the sale of prescriber data, while the Maine Medical Assn. opposed it. A call to the Arizona Medical Assn. for comment was not returned by press time.