Received May 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | UNK | 645665 | IM / LA |
Date: May 16, 2025 1. Incident Summary On May 16, 2025, at approximately 10:00AM, I administered a Hepatitis B (Heplisav-B) vaccination to patient at Pharmacy. Prior to administration, I conducted a full profile review and a Drug Utilization Review (DUR), confirming no contraindications, no active prescription on file, and no DUR rejections. The prescription record for the first dose was marked ?deactivated,? leading me to believe patient had not yet received her initial vaccination. Even the patient did not say anything and asked my tech so Hep B vaccine. My tech told me she needs Hep B vaccine. 2. Discovery of Prior Dose Hours after administration, the Pharmacy Manager notified me by a phone call to the pharmacy that patient had, in fact, received her first Hep B dose on May 15, 2025. Neither the patient nor my pharmacy technician informed me of that prior administration, likely due to the prescription?s deactivated status in our system. As a result, patient inadvertently received her second dose 29 days after her first, instead of at the manufacturer-recommended interval of 28 days. 3. Actions Taken & Procedural Compliance I performed all standard checks: patient identity, vaccination history, and DUR, with no system alerts or overrides required. I adhered strictly to the ACIP guidelines for Hepatitis B administration based on the information available. I documented the administration of the May 16 dose in patient?s profile immediately after the procedure. 4. Immediate Risks & Regulatory Implications This event constitutes a misfill and deviation from the recommended dosing schedule, which may: Compromise vaccine efficacy and patient safety. Expose the pharmacy to regulatory scrutiny and potential licensure risk under Board of Pharmacy standards. Violate internal quality assurance protocols regarding prescription activation/deactivation procedures. 5. Required Investigation & Corrective Measures To protect patient health and the integrity of our pharmacy operations, I request an immediate, in-depth investigation into: Who administered the first Heplisav-B dose on May 15, 2025, and under what prescription or documentation. Why the original prescription was deactivated in the system without clinical notation or DUR alert. Whether system settings or staff workflows inadvertently allowed the deactivation to override critical vaccination history. I fulfilled my professional duty by relying on the system records available at the time. I expect a prompt response outlining the investigation?s findings and the measures that will be implemented to safeguard both our patients and our license compliance. Thank you for addressing this matter with the urgency it requires.