Background

In the first reported appellate decision of its kind in the country, the Illinois Second District Appellate Court (The Department of Financial and Professional Regulation v. Walgreen Company (2012 Ill. App. 2d 110452, filed May 29, 2012) affirmed the dismissal of a lawsuit filed by the Illinois Department of Financial and Professional Regulation (IDFPR) against Walgreens when it refused to turn over subpoenaed “reports of medication error” involving three of its employed pharmacists. Walgreens had previously submitted written objections to the IDFPR which contended that these reports were collected as part of its patient safety evaluation system (PSES) and then reported to the Patient Safety Research Foundation, Inc. (PSRF), a patient safety organization (PSO) created by Walgreens and certified by the Agency for Healthcare Research and Quality (AHRQ) in January of 2009. Walgreens argued that the incident reports qualified as patient safety work product (PSWP) and therefore were not subject to discovery or admissibility into evidence under the federal Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) (42 U.S.C. Sections 299b-21-26 (2006)).

The Patient Safety Act was passed by Congress to encourage voluntary provider-driven initiatives to improve the quality and safety of health care services through the development of PSOs, the establishment of broad federal confidentiality and privilege protections, and to facilitate the aggregation, analysis and dissemination of de-identified quality information at the local, regional and national levels in a protected legal environment.

Walgreens took advantage of these protections when it established its PSES to collect, manage and analyze patient safety activities, including medication error incident reports, which it furnished to PSRF. These incidents were collected as part of Walgreens’ “STARS” system, and were tracked and evaluated in order to improve the quality of its pharmacy services.