An appellate court in Illinois has rejected an effort by the state’s Department of Financial and Professional Regulation (DFPR) to obtain quality control reports from a pharmacy. Walgreens Pharmacy refused to comply with a subpoena from DFPR seeking information on several pharmacists under investigation. Walgreens argued that producing the reports would violate patient privacy rules. Under 2005’s federal Patient Safety and Quality Improvement Act (PSQIA), pharmacies are encouraged to report information on prescription misfills and other medication errors to groups known as patient safety organizations (PSO). The law provides that these reports, intended for use in promoting patient safety, are protected from discovery or disclosure. The court ruled that Walgreens’ quality control reports fall under the PSQIA’s protection.
DFPR was conducting an investigation of three pharmacists employed by Walgreens. On July 1, 2010, it served a subpoena on the company, requesting “incident reports of medication error involving” the three pharmacists. Walgreens objected in writing and refused to comply with the subpoena. DFPR filed a petition in circuit court seeking judicial enforcement of its subpoena on October 8, 2010.
Walgreens moved the circuit court to dismiss the case, arguing that any and all “incident reports” were protected by the PSQIA’s “patient safety work product” provisions. Walgreens reportedly has its own internal, confidential reporting system for medication errors, known as the “strategic tracking and analytical reporting system (STARS). According to the pharmacy chain, STARS reports result from any “improperly processed or filled prescription” provided to a patient. Reports to STARS become part of periodic confidential reports sent to the Patient Safety Research Foundation, an approved PSO.
The dispute between the parties ended up being over whether or not Walgreens maintained other records of medication errors outside of STARS. Walgreens insisted that it did not, and DFPR disputed that claim. DFPR pointed to prior litigation involving Walgreens, in which the company referenced “performance reviews,” “inquiry reports,” and “loss prevention statements,” to suggest that the pharmacy had other records reflecting medication errors. The circuit court ruled in Walgreens’ favor, holding that the STARS reports are protected by the PSQIA. DFPR filed an appeal, which led to the recent appellate ruling.
On appeal, DFPR alleged that it has a right to records not directly protected by the PSQIA, based on its earlier arguments that the subpoena was broad enough to cover non-PSQIA reports. It further argued that the record did not prove that Walgreens did not maintain records outside of the PSQIA’s protection. The appellate court found that this claim “lack[ed] merit” and affirmed the circuit court’s ruling.
The ruling, of course, only has legal effect in one part of the state of Illinois. Still, it represents an interesting dilemma for patient safety advocates. The ruling appears to represent an important step in protecting the confidentiality of patient information. Reports of medication errors by necessity contain patients’ personal information, which should be protected. At the same time, state agencies responsible for enforcing pharmacists’ professional responsibilities ought to have access to information on medication errors in order to fulfill their duties.
The Maryland pharmacy error attorneys at Lebowitz & Mzhen can assist you if you have been injured by drugs prescribed, dispensed, or administered incorrectly. Contact us today online or at (800) 654-1949 to see if you may recover damages.
Opinion (PDF), Department of Financial and Professional Regulation v. Walgreen Company, Appellate Court of Illinois, Second District, May 29, 2012
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