The most important aspect of the PDRP cannot be read in the text of the regulations. Taken as a whole, the PDRP is a call
for pharma to refine the approach companies currently take in their interactions with physicians. While few within the pharmaceutical
industry will applaud the PDRP as a welcome turn of events, it is important to consider the program in context. First, it
satisfies a long-expressed desire on the part of the industry's customers. Second, it serves as a workable alternative to
more restrictive legislation and should deter professional organizations from seeking such measures. Third, even though it
limits reps and their supervisors from accessing data on some physicians, it nonetheless enables companies to continue to
run essential business applications that rely on prescriber data.
It is now up to the industry to see that the AMA PDRP satisfies physicians' desire for privacy. Successfully implementing
the program will stem the call for further restrictions. Physicians, public health agencies, academia, and patients are all
depending on manufacturers to regulate themselves.
AMA PDRP IN CAPSULE
Full details of the program will be available via AMA Database Licensees (DBL). Here are the highlights:
- PDRP enrollment will begin on the AMA's Web site so that the program can take effect on July 1, 2006. Enrolling in the program
is sometimes known as "election."
- Enrollment will remain in effect for three years from the date on which the AMA receives the physician's election.
- Pharmaceutical companies will have ample time (approximately 90 days from receiving a notice that a physician has enrolled)
to make the internal system changes needed to suppress data from being released to restricted employees.
- Physicians may revoke the election at any time by notifying the AMA.
- Pharmaceutical employees having direct contact with physicians will be blocked from accessing restricted data on PDRP physicians.
The block-outs apply to part-time and temporary sales employees and contractors, as well as full-time sales reps and first-line
sales managers.
- Restricted data are defined as any product-level data regarding the prescribing practices of an identifiable physician who
has made the PRDP election. This includes measures of prescription volume in absolute and percentage terms, the associated
dollar value of a physician's prescribing, any indicators of change in these measures, as well as any means of ranking, benchmarking,
or grouping physicians that may reveal prescribing habits for a particular product. Furthermore, sales representatives must
not "reverse engineer" or re-identify any prescribing information of a PDRP physician.
- The restrictions do not apply to (a) deciles at the market or therapeutic class level, (b) segmented data that are not likely
to reveal the actual or estimated activity of an individual physician, or (c) data on products ordered by physicians from
pharmaceutical companies.
- A physician's participation in the PDRP has no bearing whatsoever on the AMA's "No Contact List," which has been in place
for more than 20 years to prevent listed physicians' names from being licensed for marketing purposes.
- Compliance will be gauged by physician complaints to the AMA.
- Isolated and minor infractions will likely result in an investigation, followed by a warning. Those manufacturers who show
a disregard for the program's requirements by maintaining a pattern of abuse may lose access to AMA data, and, if infractions
continue, may subsequently lose access to HIO data.
- The information available to the "home office" will not change, regardless of physician enrollment in PDRP. This program will
not affect headquarter business systems. As long as the industry complies with PDRP, the program will not restrict access
to information used in efficient marketing and compensation practices.
Robert A. Musacchio is senior vice president of publishing and business services at the American Medical Association. He can be reached at robert.musacchio@ama-assn.org
Robert J. Hunkler is director of professional relations at IMS Health. He can be reached at rhunkler@us.imshealth.com
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