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Route of Administration and Other Clinical Outcomes Among Exposures to Buprenorphine Pain Medications and Schedule II Opioids

P-021 - (Poster #21) Route of Administration and Other Clinical Outcomes Among Exposures to Buprenorphine Pain Medications and Schedule II Opioids

Thursday, September 4, 2025
4:00 PM - 5:30 PM PST
Location:  Exhibit Hall (Level 4)
Background: Opioid medications are important pain management tools but are not without risk of misuse/abuse (Dowell et al., 2022). The Controlled Substances Act (CSA) places substances into one of five classifications or “schedules” based upon acceptable medical use, potential for abuse, and dependence. As the schedule increases, the risk for abuse and dependence decreases.  Most prescription opioid medications (e.g., oxycodone, hydrocodone) are designated as Schedule II (CII) (Dalal et a., 2021; Adler et al., 2024). Buprenorphine is designated as CIII and is available as an analgesic in buccal film and transdermal patch formulations. Few studies have evaluated real-world evidence to compare buprenorphine indicated for pain to CII opioid therapies. The National Poison Data System is the data warehouse for the nation’s 53 Poison Centers and often used to evaluate drug safety. Each poison center submits de-identified case data to NPDS after providing necessary poison exposure management and information services to callers. This case information is uploaded to NPDS in near real time, including routes of administration (ROAs) and clinical outcomes, making NPDS one of the few operational systems of its kind (https://poisoncenters.org/national-poison-data-system).

Purpose/Objectives: The purpose of this study was to evaluate the relative risk of intentional abuse/misuse via unintended ROAs and associated clinical outcomes between buprenorphine analgesics and CII opioid medications.

Methods: This observational cross-sectional study evaluated NPDS exposures among individuals age >=12 years of age reported during the study period from 01 January 2020 to 31 December 2023. Four study groups were studied: buprenorphine buccal film (BBF), buprenorphine transdermal patch (BTP), CII immediate-release (CII-IR) opioids, and CII extended-release (CII-ER) opioids. CII opioid compounds included solid oral dosage forms of hydrocodone, oxycodone, hydromorphone, oxymorphone, and tapentadol. The relative risk of exposure 1) resulting in major effect or death, 2) resulting in hospital admission, and 3) via clinically unintended route (any route other than indicated in the FDA approved label), was calculated using BBF as the reference group. Statistical significance was achieved if the relative risk 95% confidence interval did not cross 1.0. Relative risks were calculated using SAS Proc Genmod.

Results: From 1 January 2020 to 31 December 2023, there were 276 exposures to BBF (9 resulted in a major effect or death); 134 exposures to BTP (13 resulted in a major effect or death); 43,322 exposures to CII-IR opioids (5,519 resulted in a major effect or death); and 2,453 exposures to CII-ER opioids (435 resulted in a major effect or death) reported to NPDS. The risk of exposure resulting in major effect or death was greatest for CII-ER opioids (0.18), followed by CII-IR opioids (0.13), BTP (0.10) and lowest for BBF (0.03). Exposure resulting in major effect or death was 3.91 times (95% CI: 2.05,7.43) greater for CII-IR opioids, 5.44 times (95% CI: 2.84,10.40) greater for CII-ER opioids, and 2.98 times (95% CI: 1.30,6.79) greater for BTP compared to BBF.  Exposure resulting in hospital admission was 2.27 times (95%CI: 1.76,2.93) greater for CII-IR opioids and 1.94 times (95%CI: 1.50,2.52) greater for CII-ER opioids compared to BBF. Exposure via clinically unintended route was significantly greater for all groups compared to BBF, though only statistically significantly greater for BTP (RR=7.27; 95%CI: 4.42,11.95). Risk of hospitalization based on exposure was 0.40 (CII-IR opioids), 0.35 (CII-ER opioids), 0.22 (BTP) and 0.18 (BBF). Exposures resulting in hospital admission were 2.27 (95% CI: 1.76,2.93) times greater for CII-IR opioids and 1.94 (95% CI: 1.50,2.52) times greater for CII-ER opioids. The relative risk for BTP was not statistically significantly different from BBF (RR=1.22; 95% CI: 0.81,1.84).  Risk of exposure via a clinically unintended ROA was greatest for BTP (0.45), followed by CII-ER opioids (0.08) and lowest for CII-IR opioids and BBF (0.06, each). Relative Risk of exposure via a clinically unintended ROA was 7.27 (95% CI: 4.42,11.95) times greater for BTP than BBF and did not statistically significantly differ between CII-ER opioids (RR=1.27; 95% CI: 0.79,2.05) or CII-IR Opioids (RR=0.94; 95% CI: 0.59,1.49) and BBF.

Conclusions/Implications for future research and/or clinical care:

NPDS exposures to BBF were associated with a significantly lower risk of major effect or death than all 3 comparator groups: CII-IR opioids, CII-ER opioids and BTP. Exposure to BBF was also associated with a significantly lower risk of hospital admission than CII-IR and CII-ER opioids. Further, a significantly lower risk of exposure via clinically unintended ROA was observed for BBF when compared to BTP.  Limitations of this study include that the NPDS data are self-reported although recorded and vetted by a healthcare professional. NPDS data include only what is reported to poison centers and does not capture all exposures (Mowry et al., 2023). These relative risks should be considered when selecting opioid medications for patients with pain.