P200: Utilization of the AAPCC National Poison Data System (NPDS) in Pharmacovigilance at U.S. Food and Drug Administration
Senior Safety Data Scientist
AbbVie United States
To characterize the utilization of the National Poison Data System (NPDS) data in supporting the safety review of pharmaceutical products and describe the integration of this data source in pharmacovigilance (PV) practices at the U.S. Food and Drug Administration (FDA).
FDA’s Division of Pharmacovigilance completed a descriptive analysis of PV reviews between 2017 and 2022 that incorporated NPDS as a data source. For the reviews that led to regulatory actions and/or public communication, we examined product information, adverse events, and data included from NPDS.
The Division of Pharmacovigilance (DPV) completed 35 PV reviews between 2017 and 2022 that included NPDS as a data source. Sixty three percent (22/35) of the reviews involved an FDA-approved medication; the remaining consisted of unapproved products (37.1%; 13/35). The most common drug classes described in these reviews included: opioids (25.7%; 9/35); hand sanitizers (11.4 %; 4/35); anthelmintics (5.7%; 2/35); antimicrobials (5.7%; 2/35); calcitonin gene-related peptide receptor antagonists (5.7%; 2/35); antihistamines (5.7%; 2/35); loperamide (5.7%; 2/35); melatonin (5.7%; 2/35).
Eight of the 35 (22.9%) PV reviews supported an FDA public communication, safety labeling change, or other compliance action. Three of these reviews evaluated all adverse events for a given product, while the remaining examined specific adverse events, such as systemic adverse events, ocular toxicity, disulfiram-like reactions, hypertension, and hypoglycemia. All 8 reviews included trend analyses and 75% included case narrative evaluation. Four of the 8 PV reviews (50%; 4/8) resulted in FDA public communication, and the remaining PV reviews (50%; 4/8) led to safety labeling changes, and/or other compliance actions.
Five of the 8 PV reviews (62.5%; 5/8) highlighted accidental exposure in the pediatric population and described both routes of administration and clinical effects related to these exposures. Two PV reviews (25%; 2/8) used NPDS as the primary source of safety information. Both reviews led to issuance of FDA public communications to alert the public regarding the appropriate use and the safety of the products reviewed.
The NPDS database serves as an important PV tool for evaluating exposures to prescription and OTC medications and contributes to FDA decisions to take enforcement action and/or communicate safety issues to the public.