The VA Office of Inspector General (OIG) conducted an inspection to assess the Veterans Health Administration’s (VHA) process in responding to a December 2020 medication recall. The recall included two medications, an antidepressant and erectile dysfunction treatment, which were incorrectly packaged together in the same bottle by the distributor.
The OIG determined that the VHA medication recall process generally met VHA requirements. However, the OIG identified potential vulnerabilities related to the monitoring and reporting of medication recall adverse drug events and variations in the software used to record medication lot numbers in two VHA medical facilities named in the allegations—the VA Oklahoma City Healthcare System and VA North Texas Health Care System.
The OIG found that during the medication recall, the VHA National Center for Patient Safety (NCPS) monitored communications and responded according to VHA policy requirements. NCPS emailed designated VHA leaders and staff providing known details, required actions, and instructions. VHA Pharmacy Benefits Management followed VHA requirements to distribute medication recall safety information throughout VHA medical center facilities and ensured notification of patients affected by the recalled medications. The OIG found that VHA medical facility staff were responsible for notifying all affected patients.
Adverse drug events resulting from recalled medications are not identified specifically as a category nor required to be reported in the VA Adverse Drug Event Reporting System. Therefore, the OIG could not determine if VHA monitored all adverse drug events from recalled medications.
The OIG made two recommendations to the Under Secretary for Health related to the monitoring and reporting of medication recall adverse drug events and vulnerabilities in the medication recall process due to variances in VHA medical facility processes.