Socioeconomic analysis of consumer FAERS reporting rates

Excerpt

US FDA Adverse Event Reporting System (FAERS) reporting rates by consumers vary across US counties and are lower in American Indian and Alaska Native people, according to findings of a study published in Drug Safety. Data from all FAERS reports submitted by consumers directly to the FDA between 2011 and 2015 were used to investigate the 5-year AE reporting rate per 100 000 residents per US county. Negative binomial regression analysis was used to investigate associations between county-level sociodemographic factors obtained from County Health Rankings and AE reporting rates.AE reporting rates across US counties ranged from more than 17.6 reports per 100 000 residents in the highest quartile to no more than 5.5 reports per 100 000 residents in the lowest quartile.After controlling for drug utilization, counties with higher reporting rates had higher proportions of people 65 years of age and older, higher proportions of females, higher proportions of uninsured people, higher household incomes, and more mental health providers per 100 000 residents. Counties with lower reporting rates had higher proportions of people 18 years of age or younger, higher proportions of American Indian or Alaska Native people, higher proportions of people not proficient in English, and more people residing in rural areas."Our study found variations in consumer AE reporting to FAERS that may be related to sociodemographic factors and healthcare access. Because these factors may also correspond to AE susceptibility, complementary data sources are needed for monitoring the safety of medicines among more vulnerable populations," concluded the authors. …