How to Handle a Sudden Tenfold Increase in ICSRs-Lessons Learned During the SARS-Cov-2 Pandemic

Introduction: The unprecedented vaccination efforts related to COVID-19 have strained PV systems and resources of stakeholders globally. Objective(s): The Norwegian Medicines Agency (NoMA) wishes to present lessons learned from changes implemented nationally before and during the vaccination campaign. Method(s): Anticipating a large increase in spontaneous reporting, improved tools and procedures simplifying reporting, case processing, and analysis were implemented. Resources for hiring additional temporary staff was made available. The overall aim was that of an agile preparedness with ability to replan and reprioritize activities to fulfil pharmacovigilance obligations of a national competent authority, while continuing NoMAs tradition of transparency towards the public. Result(s): NoMA experienced a tenfold increase in ICSRs from healthcare professionals and consumers during COVID-19 vaccination. Compared to normal vaccine reporting the increase was even higher. Case processing, signal detection and signal management procedures were stretched thin. Still, several international signals were detected and managed early. Despite additional resources supplied, a backlog in handling of non-serious reports accumulated while serious reporting was unaffected. Communication to the public was radically increased. Among measures put in place by NoMA before and during the vaccination campaign, the following were useful: * Electronic reporting forms. * Collection of unique patient identification number. * Daily status meetings, both internally and externally (i.e. Norwegian Institute of Public Health). * Daily triage of incoming ICSRs. * A clear order of priority for case processing. * Simplified processing of non-serious ICSRs. * Automated report generation to monitor special groups, events or outcomes, e.g. children, Adverse Events of Special Interest, fatal cases. * Weekly overviews of suspected adverse reactions associated with COVID-19 vaccination in Norway was made available to the public, both in Norwegian and English. Conclusion(s): By implementing various measures NOMA managed to prioritise processing of the ICSRs that added most value to detecting signals of possible new safety issues.

How to Handle a Sudden Tenfold Increase in ICSRs-Lessons Learned During the SARS-Cov-2 Pandemic: An International Journal of Medical Toxicology and Drug Experience

Introduction: The unprecedented vaccination efforts related to COVID-19 have strained PV systems and resources of stakeholders globally. Objective: The Norwegian Medicines Agency (NoMA) wishes to present lessons learned from changes implemented nationally before and during the vaccination campaign. Methods: Anticipating a large increase in spontaneous reporting, improved tools and procedures simplifying reporting, case processing, and analysis were implemented. Resources for hiring additional temporary staff was made available. The overall aim was that of an agile preparedness with ability to replan and reprioritize activities to fulfil pharmacovigilance obligations of a national competent authority, while continuing NoMAs tradition of transparency towards the public. Results: NoMA experienced a tenfold increase in ICSRs from healthcare professionals and consumers during COVID-19 vaccination. Compared to normal vaccine reporting the increase was even higher. Case processing, signal detection and signal management procedures were stretched thin. Still, several international signals were detected and managed early. Despite additional resources supplied, a backlog in handling of non-serious reports accumulated while serious reporting was unaffected. Communication to the public was radically increased. Among measures put in place by NoMA before and during the vaccination campaign, the following were useful: * Electronic reporting forms. * Collection of unique patient identification number. * Daily status meetings, both internally and externally (i.e. Norwegian Institute of Public Health). * Daily triage of incoming ICSRs. * A clear order of priority for case processing. * Simplified processing of non-serious ICSRs. * Automated report generation to monitor special groups, events or outcomes, e.g. children, Adverse Events of Special Interest, fatal cases. * Weekly overviews of suspected adverse reactions associated with COVID-19 vaccination in Norway was made available to the public, both in Norwegian and English. Conclusion: By implementing various measures NOMA managed to prioritise processing of the ICSRs that added most value to detecting signals of possible new safety issues.

INFLAMMATORY BOWEL DISEASE AND COVID-19: A LARGE INTEGRATED HEALTHCARE EXPERIENCE

Background: Southern California Kaiser cares for 4.7 million patients of which thousands carry a diagnosis of Inflammatory Bowel Disease (IBD). As the SARS-COV2 Virus has rapidly become a worldwide pandemic that causes the deadly COVID-19 respiratory syndrome, particular attention has been paid to patients with chronic IBD, who often take immunosuppressive medications that pose greater infectious risk than those in the general population. Although recent international studies have not shown worsening outcomes among IBD patients with COVID 19, not much is known about the local, regional characteristics of this population. In this study, we aim to describe the characteristics of IBD patients in the Southern California Kaiser healthcare system who have been diagnosed with COVID-19. Methods: We retrospectively gathered data from the electronic medical records of adult IBD patients who carry an ICD-10 diagnosis of Ulcerative colitis (UC) or Crohns disease (CD) and who were also diagnosed with COVID-19 with a positive lab result and ICD 10 code between the dates of January 1, 2020 and October 31, 2020. We then tabulated descriptive data among non-hospitalized, hospitalized, and deceased patients of this population. This data was verified through manual chart review. Results: Among 13,262 patients with IBD, 475 cases with suspected COVID were obtained and 280 patients had a confirmed positive COVID-19 test on manual review (89 CD, 191 UC). Average age was 49 years old with a female predominance of 59%. 14%(n=39) of patients were hospitalized and 2.5% (n=7) died. The population was predominantly White (48%) and Hispanic (37.5%). 36% of patients were not on any IBD medications while 38.9% were on aminosalicylates, 21% were on biologic agents, 9.3% were on thiopurines, and 4.3% were on corticosteroids. Among the hospitalized patients, 67%(n=26) were admitted for COVID-19. Hospitalized patients had an average age of 61 years old, 51% were female, and had an average length of stay of 7.7 days. 56.4% (n=22) were not on any IBD medications, while 7.7% (n=3) were on corticosteroids, and 18% (n=7) were on biologic agents. Among patients that died, 71%(n=5) died of COVID-19 related complications and 14% (n=1) died of renal failure. None were on biologic agents and 71% (n=5) were not on any medications for IBD. Conclusion: This study did not show increased risk of mortality among patients with IBD who are on biologic therapy. Mortality rate is comparable to published data in patients without IBD. Overall, the diagnosis of COVID 19 was associated with patients that were predominantly women, White or Hispanic, and patients not on any medications for IBD. Further research will be conducted to analyze risk factors such as medical co-morbidities in this population. (Table Presented) (Table Presented) (Table Presented)

Otolaryngology consultations for COVID-19: Determining occupational exposure and inpatient interventions

Introduction: The novel coronavirus SARS-CoV-2 has ravaged the United States and transformed the way medical care is delivered. As specialists in upper airway anatomy, otolaryngology (ENT) services may be called upon to manage various head-and-neck complaints for patients with COVID-19. While ear, nose, and throat (ENT) consults may benefit critically ill patients, they also expose physicians to the transmission of COVID-19. We sought to identify the reasons for ENT intervention and examine trends in testing through the pandemic. Method: Records for all ENT consults from May 1 to September 29, 2020, were retrospectively reviewed. Demographic information, admission diagnoses, length of stay, COVID status, and ENT interventions were recorded. Univariate analysis was performed. Results: Of 1343 distinct consults, 965 (72%) were tested for COVID-19, with 62 (4.6%) positive. In May 200 (70%) of 287 consults were tested with 2 (0.7%) positive, while in September, 251 (78.5%) of 320 consults were tested with 22 (6.9%) positive. The most common ENT consultation for COVID-positive patients was nasal and oropharyngeal bleeding (n = 19, 30.6%), followed by facial trauma (n = 15, 24.2%). Other reasons included respiratory distress, tracheostomy, and foreign body (retained COVID swab). Of 96 interventions for patients with COVID-19, 49 (51%) were for management of bleeding, 24 (25%) were for upper airway evaluation (UAE), and 8 (8.3%) were for tracheostomy or trach management. Conclusion: Although patients with COVID-19 necessitated various otolaryngologic interventions, management of bleeding was the most common complaint, which may be associated with therapeutic anticoagulation as well as coagulopathy from the disease process. Bleeding control was followed by UAE and trach management, 2 aerosol-generating procedures that may increase the risk of COVID transmission. The proportion of consults tested and confirmed positive for COVID- 19 at our institution increased from May to September, possibly assisting otolaryngologists to take appropriate preventive precautions.