For years, the American Medical Association (AMA) has had a thorn in its side: doctors who are concerned about pharmaceutical
sales reps with unrestricted access to their personal prescribing data. It's long been a problem, but finding a solution has
been complicated by the fact that many in the healthcare industry, including pharma companies, make appropriate use of physician-level
prescribing data—in ways that benefit AMA's very members.
Over the years, the AMA House of Delegates has passed resolutions, and calls for government legislation have been sounded.
For example, the California Assembly Bill 262 (AB 262) was designed to regulate the use of physician data for marketing purposes
and to protect doctors' privacy by regulating the activities of pharmacists and data vendors. In November 2004, AB 262 was
defeated by a very narrow margin.
The latest AMA effort—the Prescribing Data Restriction Program (PDRP), a self-regulatory alternative to state regulation—is
said to be its strongest yet. With less than two months left before PDRP goes into effect, the new program looms as one of
the most significant business and compliance challenges for pharma since the introduction of the Prescription Drug Marketing
Act (PDMA). Already, California has decided against reintroducing AB 262 in favor of the PDRP solution. Pharmaceutical manufacturers
need to make the PDRP work, since the alternative, government legislation, is not in anyone's best interest. Without PDRP,
long-term access to physician-level data within the healthcare system is called into question.
Since pharma companies use physician-level prescribing data to determine everything from directing promotional activity to
measuring results and calculating compensation, the impact of PDRP will be widespread. Most of the program's rules were finalized
in August 2005, although it should be expected that changes might occur from time to time. In March 2006, for instance, access
to product quantiles (e.g., quintiles and deciles), which position a physician's prescribing volume in a particular fifth
or tenth of a rep's territory, were removed from the program rules.
Not everyone in the industry is up to speed on PDRP. For those who currently are working on compliance, for instance, a common
strategy is to completely eliminate all individual prescription data from the hands of the first-line manager and sales rep.
But upon reviewing PDRP, it can be seen that this is not the only approach that can be adopted to achieve compliance. In fact,
it will unnecessarily put an organization at a competitive disadvantage.
We suggest seven critical success factors that can help a company build a successful PDRP strategy (see "Compliance Success
Compliance Success Strategies
To address responsible and ethical use of individual prescription data by the pharmaceutical industry, the AMA created the
Best Practices Guidelines for the Use of Physician-Specific Prescribing Data in 2001. Despite these guidelines, physicians
continued to voice concerns over the release of prescribing data, citing their own privacy concerns and condemning some pharmaceutical
sales representatives' behavior. To develop the PDRP rules, the AMA conducted physician surveys and met with the industry
(AMA database licensees and pharmaceutical manufacturers) to convey physician concern and understand the program's potential
Now the AMA is working to allow physicians to enroll in PDRP. Companies who license AMA data will see indicators that identify
physician participation and show whose data cannot be included. These indicators must be observed when processing physician
data in accordance with the PDRP data disclosure rules.
Achieving PDRP compliance requires a complete understanding of the program rules. Applying the complex HIPAA-style data-privacy
rules that describe how to restrict the use of physician prescribing data is the real challenge behind the program. Here are
some key facts about the new program:
- PDRP is effective July 1, 2006.
- PDRP directly affects first-line managers and sales reps, and can indirectly affect other personnel that work with physician-level
prescription data, for example, if a company is buying raw data that must be broken out by PDRP enrollees and non-enrollees.
- Releasing a physician's data to a rep or supervisor is prohibited for three years from the date a physician signs up, but
the participating physician can lift the restriction at any time. PDRP only affects data after the date of physician enrollment.
It does not affect historical data.
- All physician-level prescription data released to sales forces, regardless of update frequency or source, must comply with
PDRP. For example, monthly prescription data must comply within 90 days from receipt of the data; quarterly data must be clean
within 90 days of the end of the quarter during which a physician enrolls. If the rules don't change, companies will get an
enrollment update every quarter.
- Certain products are exempt from PDRP compliance, including those that are dispensed or administered in a physician's office,
or which a physician orders directly from the pharmaceutical manufacturer.