IMPACT OF THE FDA DRUG SAFETY COMMUNICATIONONCODEINE ANDTRAMADOLPRESCRIBING INPEDIATRICDENTALCARE:EVIDENCE FROMNATIONALLY SOURCEDCLAIMSDATA
Author(s)
Yilei Liu, MS1, Bedda L. Rosario, PhD2, Maria M. Brooks, PhD2, Scott Rothenberger, PhD2, Robert Weyant, DMD, DrPH2, Katie Suda, PharmD2;
1University of Pittsburgh, PhD student, Pittsburgh, PA, USA, 2University of Pittsburgh, Pittsburgh, PA, USA
1University of Pittsburgh, PhD student, Pittsburgh, PA, USA, 2University of Pittsburgh, Pittsburgh, PA, USA
OBJECTIVES: Among all opioid prescriptions dispensed to children, approximately one-third are prescribed by dentists. The FDA announced a Drug Safety Communication (DSC) in April 2017 contraindicating codeine and tramadol use in children under 12, but its impact on pediatric dentistry is unknown. We aimed to quantify overall and subgroup-specific changes in pediatric prescribing patterns of codeine and tramadol by US dentists after publication of the 2017 FDA DSC.
METHODS: We conducted a monthly repeated cross-sectional study of dental visits among patients <18 years from 2014-2019 using MarketScan commercial and Medicaid claims data. We identified outpatient prescriptions for codeine or tramadol and compared prescribing before (May 2015-April 2017) and after (May 2017-April 2019) the 2017 FDA DSC (the intervention). We calculated the monthly proportion of visits involving codeine or tramadol among all opioid-related visits. We used interrupted time series analysis with ARIMA regression models, incorporating exogenous variables for time, intervention, and post-intervention trend, to estimate immediate level and slope changes.
RESULTS: From 2014-2019, 85,251 pediatric dental visits involved codeine (93.7%) or tramadol (6.5%) prescriptions. Prescribing declined significantly for codeine (51.4%, p<0.001) but not tramadol (0.1%, p=0.51) in the two years after the DSC compared with before. The largest reductions occurred among children aged 0-3 years (89.3%, p<0.001) and Medicaid beneficiaries (61.7%, p<0.001). Codeine prescribing decreased immediately after the FDA DSC (8.5%, p<0.001) with no additional post-policy trend change (0.14%, p=0.05), whereas tramadol prescribing showed nonsignificant immediate increase (0.11%, p=0.61) or additional increasing trend effects (0.007%, p=0.38).
CONCLUSIONS: Following the 2017 FDA safety communication, pediatric dental codeine prescribing declined substantially, whereas tramadol prescribing did not change. This indicates that an FDA safety communication alone may require complementary implementation strategies to improve pediatric opioid safety.
METHODS: We conducted a monthly repeated cross-sectional study of dental visits among patients <18 years from 2014-2019 using MarketScan commercial and Medicaid claims data. We identified outpatient prescriptions for codeine or tramadol and compared prescribing before (May 2015-April 2017) and after (May 2017-April 2019) the 2017 FDA DSC (the intervention). We calculated the monthly proportion of visits involving codeine or tramadol among all opioid-related visits. We used interrupted time series analysis with ARIMA regression models, incorporating exogenous variables for time, intervention, and post-intervention trend, to estimate immediate level and slope changes.
RESULTS: From 2014-2019, 85,251 pediatric dental visits involved codeine (93.7%) or tramadol (6.5%) prescriptions. Prescribing declined significantly for codeine (51.4%, p<0.001) but not tramadol (0.1%, p=0.51) in the two years after the DSC compared with before. The largest reductions occurred among children aged 0-3 years (89.3%, p<0.001) and Medicaid beneficiaries (61.7%, p<0.001). Codeine prescribing decreased immediately after the FDA DSC (8.5%, p<0.001) with no additional post-policy trend change (0.14%, p=0.05), whereas tramadol prescribing showed nonsignificant immediate increase (0.11%, p=0.61) or additional increasing trend effects (0.007%, p=0.38).
CONCLUSIONS: Following the 2017 FDA safety communication, pediatric dental codeine prescribing declined substantially, whereas tramadol prescribing did not change. This indicates that an FDA safety communication alone may require complementary implementation strategies to improve pediatric opioid safety.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HSD41
Topic
Health Service Delivery & Process of Care
Disease
SDC: Pediatrics, SDC: Sensory System Disorders (Ear, Eye, Dental, Skin)