Prior to the development of the LDOI protocol, the authors noted an increased frequency of Addiction Medicine consults for ICU patients with OUD. Patient agitation from opioid withdrawal was prolonging intubation or causing a need for re-intubation in these patients. The LDOI protocol was developed as a quality improvement project to address opioid debts in tolerant individuals and mitigate issues surrounding patient extubation.
Buprenorphine provides a means to manage high opioid requirements without causing significant respiratory depression and can reduce time to extubation by managing patient agitation secondary to opioid withdrawal. Our hospital successfully developed and deployed a LDOI regimen to provide optimal care to our patients suffering from opioid use disorder. The development of this LDOI regimen originated from a collaborative effort among providers and pharmacists. We found that both patient/family education as well as education of medical providers are crucial to successfully utilizing this protocol. Education focuses on the pharmacological reason for using LDOI, highlighting the rationale for administering low doses of buprenorphine on the initial protocol days and emphasizing the goal to minimize withdrawal symptoms.
LDOI regimens that utilize partial sublingual tablets have been described in literature [14,15,16,17,18,19,20,21]. Buprenorphine mono-product is preferred for our regimen because that is the product our pharmacy demonstrated as having the ability to cleanly split, and is readily available on the hospital formulary. Rather than splitting tablets as orders are placed, buprenorphine partial tablets are prepacked and dispensed as unit doses from the hospital pharmacy. Pre-packing split tablets allows for accurate nursing administration of the ordered dose without further manipulation. Additional benefits of pharmacy pre-packing include reduced opioid waste and accurate documentation requirements associated with administering partial doses of controlled substances.
Many current practices for LDOI involve cutting buprenorphine films into smaller pieces, which can be both tedious and imprecise for hospital staff; other practices include buccal or intravenous formulations that are not on this hospital’s formulary. Our current method of splitting buprenorphine tablets resulted in no adverse effects, no observable opioid withdrawal, and most importantly has allowed use of on-hand buprenorphine preparation. With this streamlined method, we hope to reduce hesitancy among providers caring for patients with OUD.
Initiating a buprenorphine LDOI regimen as individual buprenorphine orders can be prone to errors and time consuming. Therefore, we created an order set within our EHR that includes prebuilt buprenorphine titrating orders. The order set allows for simplified order entry and increased prescriber comfort with this new LDOI strategy. Additionally, within the order set, nurses are instructed to notify a provider if withdrawal symptoms occur as evidenced by signs and symptoms. With this being a new protocol at our hospital, the Addiction Medicine consultative service must either be the ordering provider or must make official recommendations as consultants to use the protocol.
Here we review 6 patients who underwent LDOI with buprenorphine as a proof-of-concept. Upon implementation of the protocol, 4/6 patients had a reduced daily MME post-LDOI (Table 2). It is important to note that buprenorphine was not converted to MME. For the purposes of this study, MME calculations serve more to show opioid requirements from sources aside from buprenorphine.
Development and implementation of the LDOI protocol does raise ethical questions regarding the appropriateness of starting a critically ill patient on MOUD, as all patients reviewed were intubated and sedated, and therefore unable to provide consent for treatment. The authors strongly believe that the buprenorphine LDOI protocol will serve as an effective method in harm reduction, particularly in this era of high opioid tolerance related to spikes in synthetic opioid use, as patients had been subject to significant morbidity (discomfort on the ventilator, prolonged intubation, re-intubation, high dose fentanyl drips). Furthermore, all patients were educated on the goals of minimizing withdrawal symptoms using the LDOI protocol on extubation and given the option to stop buprenorphine. Although we cannot prevent all collateral harm from this protocol, we will continue to improve its implementation in vulnerable patient populations.
This study has limitations. Given the retrospective nature of the analysis, this study was only observational and had no patient controls to compare outcomes, therefore no formal analysis was performed. Despite no objective signs of withdrawal in patients initiated on buprenorphine, patient sedation with opioid and non-opioid medications such as benzodiazepines precluded accurate tracking of a complete Clinical Opiate Withdrawal Scale [13] including subjective symptoms (myalgias, anxiety, restlessness) during the LDOI protocol. This study should serve more as proof-of-concept and results cannot be generalized to larger populations given the small patient population observed. Additionally, our institution benefits from having a dedicated Addiction Medicine consultative service to supervise and implement a buprenorphine LDOI regimen, which may be more difficult to implement in smaller hospitals with fewer consulting services.
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