Appellate Court Denies State Access to Pharmacy’s Medication Error Data, Citing Federal Privacy Laws: Department of Financial and Professional Regulation v. Walgreen Company

5294_6589.jpgA pharmacy resisted a subpoena from Illinois regulators seeking information on medication errors, citing a federal law that encourages pharmacies to track medication errors, but protects the confidentiality of those records. The trial court agreed with the pharmacy’s position in Department of Financial and Professional Regulation v. Walgreen Company, 970 N.E.2d 552 (Ill. App. 2nd Dist. 2012), and granted its motion to dismiss the subpoenas. The Illinois Court of Appeals affirmed the ruling, finding that federal law privileged the medication error records from disclosure to the state government. Although federal law encourages pharmacies to track medication errors, it limits the uses to which the government may put the resulting records.

The Illinois Department of Financial and Professional Regulation (DFPR) issued three subpoenas to Walgreens in July 2010, seeking reports of medication errors involving three specific pharmacists in Walgreens’ employ. It petitioned the circuit court to enforce the subpoenas in October 2010. Walgreens quickly moved to dismiss the petition, claiming that the records sought by the DFPR were privileged under the Patient Safety and Quality Improvement Act of 2005 (PSQIA).

The PSQIA provides mechanisms for reporting and analyzing a wide array of medication error data. The law provided for the establishment of Patient Safety Organizations (PSOs) under the Agency for Healthcare Research and Quality (AHRQ). PSOs are independent organizations that gather and analyze medication error reports from doctors, pharmacies, hospitals, and other health care facilities within a designated geographic area. They cooperate and collaborate with the AHRQ and other PSOs with the goal of developing improvements in patient safety and reductions in the number of medication errors. The PSQIA provides that all reports made by pharmacies and other organizations to their local PSO are “patient work product,” and therefore are privileged from disclosure.

Walgreens alleged that the only incident reports it generates related to medication errors are created within its “STARS” system, which it uses to create quality control reports. All reports related to medication errors are sent directly to the Patient Safety Research Foundation, a PSO certified by the federal government. As a result, Walgreens argued, all of its medication error incident reports were confidential. Affidavits from a Walgreens executive attested to these claims, and stated that the company does not generate any incident reports other than those bound for the PSO.

The DFPR alleged that Walgreens kept records related to medication errors other than those intended for the PSO, and that those other records were not privileged under the PSQIA. It filed an affidavit from a state prosecutor who, during a 2009 legal proceeding involving Walgreens, reviewed documents that he said referenced medication errors but were not part of the STARS system. The documents included “pharmacy manager performance reviews” and “case inquiry reports.”

The trial court granted Walgreens’ motion to dismiss. The parties brought similar arguments before the appellate court, which affirmed the trial court’s ruling. The appellate court found that the PSQIA covered all of the documents that were relevant to the subpoenas. It held that the documents described by the prosecutor did not relate to medication errors affecting patient safety, but rather to violations of company policies by employees. Even if those records were not privileged under the PQSIA, the court held, they were not relevant to the subpoena.

The Maryland attorneys at Lebowitz & Mzhen can assist victims of medication errors, who have been injured by drugs prescribed, dispensed, or administered incorrectly. Contact us today online or at (800) 654-1949 for a free and confidential consultation to discuss your case.

More Blog Posts:

Court Rejects State Effort to Obtain Patient Data In Pharmacy Error Investigation, Pharmacy Error Injury Lawyer Blog, June 14, 2012
National Patient Safety Board Would Reduce Medication Errors, Say Celebrity Supporters, Pharmacy Error Injury Lawyer Blog, June 7, 2012
Electronic Prescriptions Help Doctors and Pharmacies Avoid Medication Errors, Prevent Fraud and Abuse, Pharmacy Error Injury Lawyer Blog, May 31, 2012
Photo credit: ‘Pills’ by Glory on stock.xchng.

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