OSE's annual report details Sentinel efforts during COVID pandemic

The US Food and Drug Organization’s (FDA’s) Office of Surveillance and Epidemiology issued its first-ever annual report summing up the office’s work.
 
The scope of the office’s charge meant that during the pandemic, staff effort was largely directed toward addressing the global public health emergency of the COVID-19 pandemic, noted Gerald Dal Pan, director of FDA’s Office of Surveillance and Epidemiology (OSE).
 
However, OSE also continued its efforts in other arenas. These are divided across four core functions: pharmacovigilance, pharmacoepidemiology, medication error prevention and analysis, and risk management. “Everything in OSE is tied to these four core functions,” wrote Dal Pan in his forward to the report.
 
Pandemic responses at OSE included keeping track of safety and supply issues for both novel COVID-19 therapeutics and repurposed drugs. The office advised other units within FDA about how risk evaluation and mitigation strategies (REMS) could be adapted to continue to provide safeguards during the pandemic.
 
The office also consulted with agencies outside of FDA, including the National institutes of Health and the Centers for Disease Control and Prevention (CDC); OSE also provided safety and epidemiological findings with the COVID-19 Evidence Accelerator. Working internationally, OSE collaborated in developing common protocols to monitor the safety of COVID-19 therapeutics.
 
Pandemic-related pharmacovigilance efforts at OSE included daily literature searches and monitoring of the FDA Adverse Event Reporting System (FAERS). The office also tracked poison control reports for calls related to hydroxychloroquine or chloroquine ingestion, since the two drugs were touted early in the pandemic as prophylaxis or treatment for COVID-19. Later studies proved they were ineffective.
 
More pharmacovigilance activities during the pandemic focused on authorized treatments and adjuvant therapies for COVID-19 and attending to adverse event and poison control reports related to hand sanitizers. “These activities have contributed to the Agency’s oversight of, and public communications concerning, Emergency Use Authorizations (EUAs) and the recall of methanol-containing hand sanitizers,” wrote OSE in the report.
 
OSE also has oversight of FDA’s Sentinel System, which allowed closer monitoring of the amount and geography of utilization of critical drugs; tracking of the illness course of hospitalized COVID-19 patients; querying electronic health records (EHRs) “to identify covid-19-positive patients in real world data;” building a framework to study COVID-19 in special populations, such as pregnant women and children; looking at coagulopathy trends; and continuing work with the COVID-19 Evidence Accelerator.
 
Gaps and excessive lag time in access to EHR data became apparent during the pandemic, resulting in a refresh of the Sentinel System. “These lessons will be carried forward in furthering the Sentinel System’s capabilities and preparedness for future public health emergencies,” according to the report.
 
The report provides detailed explanations of OSE’s work with FAERS and Sentinel both within and outside of pandemic-related efforts. Sentinel now includes 14 data partners and 14.8 billion prescription records that pertain to a total 70 million patients whose data is being actively gathered by Sentinel. “Sentinel remains one of the world’s largest multi-site, privacy-preserving, medical product safety surveillance systems available,” noted OSE.
 
As an example of ongoing Sentinel work, the report relates that machine learning and artificial intelligence techniques are being applied to the database to identify health outcomes of interest. The office recently refined an algorithm that identifies anaphylaxis incidents from EHR data.
 
OSE work touched on container and carton labeling practices to reduce the risk of medication errors; the office also leads human factor analysis work for FDA’s Center for Drug Evaluation and Research (CDER).
 
CDER also turns to OSE to review proposed proprietary names when drugs are being developed and during the pre-market review process, which it accomplished with the use of the Phonetic and Orthographic Computer Analysis Program (POCA). OSE was able to move 499 proprietary name reviews to completion during FY20, meeting its user fee goals.
 
The report goes through drug safety modernization and innovation efforts, including work to develop a computerized labeling assessment tool, instituting a new review process for public health surveillance studies and beginning use of a new informatics tool to track contractor performance.
 
OSE continues research activities; the report breaks down the 61 OSE-authored publications by discipline in its annual report. Public initiatives and outreach events, which have international reach, are also enumerated in the report.
 
Future priorities include continuing implementation of Drug Safety Teams, “a major modernization initiative.” These teams allow CDER to effect “collaborative, interdisciplinary centralized scientific safety expertise and ownership for an assigned portfolio of drugs,” according to the report.
 
OSE report