Results of an Intervention in an Academic Internal Medicine Clinic to Continue, Step-Down, or Discontinue Proton Pump Inhibitor Therapy Related to a Tennessee Medicaid Formulary Change

BACKGROUND: In July 2005, the State of Tennessee Medicaid Program (TennCare) announced formulary changes for proton pump inhibitors (PPIs) to be implemented in August 2005. Prior to these changes, pantoprazole was the only preferred PPI, and there were no restrictions to its use. The revised formulary included 3 preferred PPIs (esomeprazole, lansoprazole, and omeprazole OTC), all of which required prior authorization (PA). In order to obtain an approved PA for a PPI, the patient was required to have either (a) a diagnosis of erosive esophagitis, Barrett's esophagus, Schatzki's ring, a pathological hypersecretory condition (e.g., Zollinger-Ellison syndrome, multiple endocrine adenoma), grade III-IV gastroesophageal reflux disease (GERD), non-steroidal anti-inflammatory drug gastropathy, significant gastrointestinal bleed; or (b) another indication for acid suppression therapy (e.g., GERD, hyperacidity in cystic fibrosis, gastric or duodenal ulcer, gastroparesis) with a history of failure of prior therapy with a histamine-2 receptor antagonist (H2-blocker). The internal medicine clinic of a regional medical center implemented an intervention to address these changes in formulary status of PPIs. OBJECTIVES: To (a) describe the process used by an internal medicine clinic to ensure that patients requiring acid suppression therapy received appropriate treatment according to revised TennCare formulary criteria without unnecessary interruption of therapy, and (b) assess self-reported symptom control 8 months after intervention in the patients who either discontinued therapy or stepped-down to H2-blocker therapy. METHODS: This study involved TennCare patients in an internal medicine clinic who received a new or refill prescription for pantoprazole between April 20 and June 20, 2005, from the medical center's outpatient pharmacy. A clinical pharmacist and an internal medicine physician collaborated to develop a protocol for adjusting acid suppression therapy. A clinical pharmacist reviewed medical records for all patients identified to verify indications for acid suppression therapy and review medication history. Patient telephone interviews were also conducted for patients whose indication or medication history could not be determined by chart review. Patients who met TennCare criteria for PPI therapy were continued on PPI therapy after a PA was obtained (PA group). Patients who had a documented indication for acid suppression therapy but did not meet the PA criteria for PPI therapy were changed to H2-blocker therapy (step-down group). Patients without a documented indication for acid suppression therapy were discontinued from acid suppression therapy (discontinue therapy group). A follow-up chart review and patient telephone interview were conducted 8 months after the intervention for patients in the step-down and discontinue therapy groups. The purpose of this follow-up review was to determine (a) the proportion of patients who were taking acid suppression therapy, (b) the type of acid suppression therapy (PPI or H2-blocker), and (c) self-report of adequate control of symptoms (defined as symptoms once weekly or less). RESULTS: Of 135 TennCare beneficiaries who were active patients of the internal medicine clinic and received a prescription from the outpatient pharmacy for PPI therapy (pantoprazole) between April 20 and June 20, 2005, 6 patients were excluded because they reported stopping PPI therapy on their own. Of the remaining 129 patients, 18 (14.0%) did not have an indication for PPI therapy and acid suppression therapy was discontinued (discontinue therapy group), 40 (31.0%) met the TennCare PA criteria for continuation of PPI therapy (PA group), and 71 (55.0%) did not meet the TennCare PA criteria and were stepped down to a H2-blocker (step-down group). At the 8-month follow-up, acid suppression therapy was assessed in 68 patients (21 patients were lost to follow-up).