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.
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.
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 ramifications.
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: