- There is a lack of evidence on the comparative clinical effectiveness of the various buprenorphine and buprenorphine-naloxone formulations for treating opioid use disorders (OUDs) during pregnancy.
- There is a lack of evidence on the safety or cost-effectiveness of the various buprenorphine or buprenorphine-naloxone formulations for treating OUD during pregnancy.
- The recommendations from the evidence-based guidelines are mixed — two recommend buprenorphine for treating OUD during pregnancy, citing the lack of evidence on buprenorphine-naloxone; whereas a third guideline, which cites the same evidence, recommends the use of buprenorphine-naloxone as first-line treatment for OUD during pregnancy.
OUD refers to the non-medical use of opioids, a class of compounds that includes not only heroin and opium but also prescribed medications such as morphine, codeine, fentanyl, oxycodone, and hydrocodone. OUD rates in the US are approximately 4.2%, and evidence suggests that the rates are similar in Canada. OUD during pregnancy has escalated in parallel with the epidemic observed in the general population. Treatment goals aim to reduce the maternal and fetal risks associated with OUD.
As an opioid agonist, methadone has long been prescribed to pregnant people to treat OUD. More recently, buprenorphine has been shown to result in similar maternal outcomes and better neonatal outcomes compared with methadone. Buprenorphine is available as a monoproduct in different formulations, or as a combined formulation with naloxone, an opioid antagonist. The buprenorphine-naloxone combination is available as a sublingual formulation taken under the tongue. The naloxone in the combination product is intended to discourage injection use, as it does not get absorbed by the body but causes severe withdrawal if injected. Buprenorphine monoproducts have been recommended to treat OUD during pregnancy to avoid prenatal exposure to naloxone.
Various buprenorphine and buprenorphine-naloxone formulations are used to treat OUD during pregnancy. A review of the comparative clinical effectiveness, the safety, and the evidence-based guidelines will help to inform decisions on the use of buprenorphine and buprenorphine-naloxone formulations for OUD in practice.
A limited literature search was conducted of key resources, and titles and abstracts of the retrieved publications were reviewed. Full-text publications were evaluated for final article selection according to predetermined selection criteria (population, intervention, comparator, outcomes, and study designs).
A total of 204 citations were identified in the literature search, with six additional publications identified from the grey literature. Of these, three guidelines met the criteria for inclusion in this review.