Oxycodone Ingestion Patterns in Acute Fracture Pain With Digital Pills

Chai, Peter R. MD, MMS; Carreiro, Stephanie MD; Innes, Brendan J. BS; Chapman, Brittany BS; Schreiber, Kristin L. MD, PhD; Edwards, Robert R. PhD; Carrico, Adam W. PhD; Boyer, Edward W. MD, PhD

Disclosures

Anesth Analg. 2017;125(6):2105-2112. 

In This Article

Discussion

The findings of this pilot study indicate that most opioid-naive patients self-administer opioids to manage the pain from acute fracture for only a brief period, even among patients with fractures requiring surgical management. Furthermore, most patients stopped self-administering opioids in advance of exhausting their opioid supply. The point at which most of our patients completely stopped taking opioid analgesics after fracture, 96 hours, is far shorter than the week-long duration of opioid analgesia for the management of acute pain often prescribed by physicians.[5,6] In addition, we observed that the majority of participants, whether they had operative and nonoperative fractures, tapered (increasing the length of intervals in their dosing schedule) the dose of opioid analgesic. These findings therefore may be used to improve the precision with which physicians prescribe opioids. Rather than prescribing medications on a PRN basis, we propose that clinicians consider instructing patients to begin tapering the dose of opioid analgesics beginning at 24 hours after injury, which would also reduce the number of pills dispensed, and ultimately wasted or made available for diversion.

Interestingly, patients only ingested a median of 6 pills, despite being given 21 pills to each participant, suggesting that even a week-long duration of therapy after fracture may represent overprescribing opioids. Overprescribing may lead to several important problems. First, it may encourage increased opioid use by that patient. A recent study of postoperative patients showed an association between a larger number of tablets dispensed and the number consumed, independent of patient characteristics or pain, suggesting that patients may take more pills just because they are given more, and that this does not lead to improved pain control or satisfaction.[21,22] Our results showing that most patients stopped use within 3 days are especially significant in light of data from the Centers for Disease Control and Prevention that correlate opioid therapy of >3 days duration with long-term nonmedical opioid use.[23,24] Limiting the availability of unused opioids through evidence-based prescribing is an effective strategy in preventing downstream opioid abuse.[25]

Investigators have proposed limiting the number of opioid dosage units to the amount truly needed for a specific clinical indication.[26,27] Unfortunately, previous methods of assessing medication-taking behavior (which only infer but do not measure ingestion) are easily manipulated, suffer from user bias, provide aggregated information regarding opioid ingestion, and thus cannot provide information on patterns of opioid ingestion. Consequently, the precise number of dosage units and duration of therapy have remained undefined. Our data suggest that approximately six 5-mg oxycodone tablets, when properly tapered, may be sufficient to control pain from acute fractures in the majority of patients, and may serve to support governmental policies directed toward limiting the number of prescribed dosage units of opioid analgesics. Additionally, the mismatch between what was prescribed and what was self-administered underscores the importance of directed teaching to promote nonopioid analgesia (nonsteroidal antiinflammatory drugs and acetaminophen) among providers, despite it being potentially time consuming in a busy ED setting. Physicians should consider providing patients with anticipatory guidance regarding the expected duration of opioid use and the amount of opioids required. Understanding that patients likely need considerably fewer opioid dosage units that are commonly dispensed is important in preventing both downstream long-term opioid use and opioid diversion.[23] Our data regarding actual opioid utilization are consistent with other studies demonstrating that physicians significantly overprescribe opioids in response to acute pain.[1,5,28]

Participants' practice of ingesting opioid analgesics before sleep is concerning. Patients reported the concern of waking up at night with pain as the rationale for ingesting opioids before sleep, and indeed, this is a common informal instruction that patients receive from providers in recovery. This approach carries considerable risk, however, because of the respiratory depressant effect of opioids, which may exacerbate preexisting obstructive sleep apnea. Discharge instructions given to patients receiving opioid prescriptions should therefore include explicit warnings regarding the risk of new or worsening sleep apnea that may culminate in death.

Our ultimate goal is not to prevent physicians from prescribing opioids. Instead, our intent is to provide guidelines, based on direct observation, on how to best manage acute pain while preventing overdose and long-term misuse. Pain is not merely distressing; it is also therapeutic. Acute pain promotes healing by limiting an individual's activity after injury. A careful balance must be struck between functional analgesia and opioid prescribing to avoid long-term nonmedical opioid use. Our data from digital pills that can detect patterns of opioid use are a novel and important step toward responsible and evidence-based opioid prescribing.

Limitations

This study has several limitations. First, it was conducted at a single academic tertiary ED. The demographics of individuals presenting to our ED and their preferences for opioid analgesics may not be generalizable to other EDs in different settings. Second, the small number of participants enrolled in the study limits the ability to draw conclusions regarding the median number of opioid analgesics required to control acute pain. Despite this, our data suggest that individuals ingesting opioids for acute pain may use less opioids than previously thought. Future investigations will investigate opioid ingestion patterns after more homogenous painful conditions (eg, acute pain after a specific surgical procedure). Third, this study focused on opioid-naive individuals with acute fractures. Individuals with a history of opioid use may respond differently to acute exacerbations of pain producing different ingestion patterns. Fourth, we selected a single painful condition—acute fractures. Our results, while important, may be different in individuals with other painful conditions.

Implications for Further Research

With increasing restrictions on opioid prescribing, detecting opioid ingestion patterns in individuals provide greater precision in determining the numbers of opioid dosage units needed to treat pain while minimizing the threat of misuse. As an investigational tool, the digital pill provides not only a direct measure of opioid ingestion but also evidence of more dynamic changes in medication-taking behavior. Additionally, use of a digital pill technology, when linked to ecologic momentary assessments, can define affective and environmental contexts that surround opioid-taking behavior, such as whether opioid ingestion is linked to subjective notions of increasing pain or periods of stress.

We recognize that the technology associated with the digital pill described here may appear cumbersome and difficult to use. Despite this, we demonstrated that individuals, with short instruction in the ED, can operate digital pills in the real world. Iterative improvements in the technology will make digital pills more seamless; we project that there will be 2 major advances. First, we have witnessed, even during our study period, iterative improvement in energy harvesting in the digital pill. This is significant because improved energy harvesting allows the digital pill to transmit ingestion data across a larger distance. Second, because of improved detection capabilities of the digital pill, the most cumbersome components of the digital pill (eg, the reader and associated patch) will miniaturize and integrate into other on-body technology like a smartwatch or the patient's smartphone. We believe that these advances will improve the overall acceptability of digital pills and allow expansion of this technology to observe opioid ingestion in disparate populations. The improved technology can also be used in future trials to observe differences in opioid use between different age groups, individuals with disparate risk factors and among various types of surgical procedures.

Clinically, the wireless delivery of opioid ingestion information allows interventions to be delivered to patients at the precise moment they are needed. The discovery of behaviors consistent with the development of tolerance—either an escalation of opioid dose or an increase in dosing frequency—can trigger interventions by clinicians in real time. The development of real-time interventions that are linked to specific patterns of opioid ingestion is an area of urgent need.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....