FDA Officials: ‘Proactive’ Pharmacovigilance Key to Identifying Future Drug Abuse Trends
Learning from experience gathered during the ongoing opioid epidemic, top US Food and Drug Administration (FDA) officials say that proactive pharmacovigilance techniques will be key to heading off future drug abuse trends.In a perspective in the New England Journal of Medicine published Wednesday, FDA Commissioner Scott Gottlieb, Center for Drug Evaluation and Research (CDER) Director Janet Woodcock and Douglas Throckmorton, deputy center director for regulatory programs at CDER, write that FDA hopes to use pharmacovigilance to “identify emerging trends earlier and intervene more quickly.”
To do so, the authors say that FDA will leverage “clinical, epidemiologic, basic science and social science expertise” to interpret data from new and traditional data sources, such as social media sites and adverse event reports.
However, one of the challenges to such an approach will be in deciphering between legitimate changes in drug prescribing and use, and increases of abuse and misuse of prescription and over-the-counter drugs.
For instance, FDA recently flagged gabapentinoid abuse as an emerging concern in part because prescriptions for gabapentinoids tripled between 2002 and 2015.
In an effort to determine whether gabapentinoid abuse was increasing, FDA turned to social media sites such as Facebook, Twitter and Instagram, as well as forums such as Reddit to determine how users were discussing gabapentinoid use.
“A preliminary appraisal of social media topics revealed a shift between 2013 and 2017 from a discussion of legitimate gabapentinoid use for pain and seizures to a focus on misuse and abuse,” the authors write.
The authors also write that FDA can use its existing adverse event database to look for associations between combinations of drugs and adverse events, such as respiratory depression, in reports that cite both an opioid and a gabapentinoid.
“An effective system of pharmacovigilance for drugs such as opioids must include the capacity to determine the reasons behind changing patterns of prescription drug use and to elucidate the dynamics of misuse, abuse, and appropriate changes in prescribing,” they write, noting that FDA has invested “new resources in developing these capabilities.”
NEJM