Opioids are indicated for moderate-to-severe pain caused by trauma, ischemia, surgery, cancer and sickle cell disease, and vaso-occlusive episodes (SCD-VOC). There is only limited evidence regarding the appropriate number of doses to prescribe for specific indications. Therefore, we developed and implemented an opioid prescribing algorithm with dosing guidelines for specific procedures and conditions. We aimed to reach and sustain 90% compliance within 1 year of implementation.
We conducted this quality improvement effort at a pediatric academic quaternary care institution. In 2018, a multidisciplinary team identified the need for a standard approach to opioid prescribing. The algorithm guides prescribers to evaluate the medical history, physical examination, red flags, pain type, and to initiate opioid-sparing interventions before prescribing opioids. Opioid prescriptions written between January 2015 and September 2020 were included. Examples from 2 hospital departments will be highlighted. Control charts for compliance with guidelines and variability in the doses prescribed are presented for selected procedures and conditions.
Over 5 years, 83 037 opioid prescriptions in 53 804 unique patients were entered electronically. The encounters with ≥1 opioid prescription decreased from 48% to 25% between 2015 and 2019. Compliance with the specific guidelines increased to ∼85% for periacetabular osteotomies and SCD-VOC and close to 100% for anterior-cruciate ligament surgery. In all 3 procedures and conditions, variability in the number of doses prescribed decreased significantly.
We developed an algorithm, guidelines, and a process for improvement. The number of opioid prescriptions and variability in opioid prescribing decreased. Future evaluation of specific initiatives within departments is needed.
The opioid crisis in the United States has tragically led to deaths in all age groups, including children, adolescents, and young adults.1 Although the causes are multifactorial, opioid overprescribing has contributed to diversion, misuse, and increasing rates of addiction and overdose.1,2 The Center for Disease Control and Prevention and other federal agencies have established guidelines for opioid prescribing for adults as 1 of several interventions to counteract the effects of this epidemic.3 In the United States, several states have passed legislation encouraging limits on opioid prescribing. In March 2016, Massachusetts was the nation's first state to mandate that whenever more than 7 days of opioids are prescribed, providers must document the reasons for this need.4,5
Opioid overprescribing also affects individuals of all ages. In young children, there is a risk of accidental ingestion6 related to unsafe medication storage practices and delayed disposal of unused opioids.7 In adolescents, the rates of hospitalization, emergency department visits, and deaths secondary to opioid misuse remain high.6,8 Prescriptions from health care providers are a primary source of opioid misuse in adolescents.9,10 Self-reported medical and nonmedical opioid use rates are positively correlated and have begun to decline only recently.11 In adolescents and young adults, there is a strong association between the legitimate use of prescribed opioids and the development of opioid addiction,12 with some data suggesting progression to heroin use.12,13 Despite these concerns, opioids are necessary for managing moderate-to-severe nociceptive and inflammatory pain such as pain caused by cancer, major surgery or trauma, sickle cell disease, and vaso-occlusive episodes (SCD-VOC).14 Therefore, a balanced approach to pain management is essential, using opioid-sparing analgesics when indicated, nonpharmacologic interventions such as cold and heat therapy, and psychological strategies.9 Even when opioids are clearly indicated, there is little evidence to support the necessary number of opioid doses required by patients.9 As a result, the number of opioids prescribed may exceed what is needed.15,16 In addition, patients and parents do not consistently receive instructions regarding the safe disposal of unused opioids, thereby leading to possible misuse.16,17 Furthermore, prescreening for past history of substance use and mental health disorders, which may identify patients at risk, is not consistently completed.18 For these reasons, improvement efforts for opioid prescribing are needed. This manuscript describes the development and implementation of an opioid-prescribing algorithm with guidelines for the number of doses usually required for specific procedures and conditions. We aim to reach and sustain 90% compliance with guidelines within 1 year of implementation. Examples from 2 hospital departments, 1 medical and 1 surgical, will illustrate the process.
Methods
Context
This quality improvement effort was conducted within a 410-bed pediatric academic quaternary care medical institution. As an academic institution, rotating prescribers, including residents and fellows, may not be aware of the appropriate number of opioid doses for each procedure or medical diagnosis in pediatrics.
In 2016, services within the institution started individual initiatives to standardize opioid prescribing with variable levels of engagement and success. In an effort to delineate best practices and create an infrastructure across the institution that supports different departments, in early 2018, the Pain Interdisciplinary Committee (PIC) identified key drivers affecting the high variability in opioid prescription and interventions for change (Fig 1). The PIC recognized the need for a hospital-wide systematic, multifaceted approach to opioid prescribing with written guidelines. This committee in collaboration with the Clinical Pathways Program (CPP), which is part of our institution's quality and patient safety program, led and implemented this effort. The PIC is composed of nurses, nurse practitioners, pharmacists, and physicians (ie, anesthesiologists, pain specialists, and pediatric hospitalists). Stakeholders from the departments that prescribed the greatest percentage of opioids reviewed and edited the algorithm. The below interventions for change were developed based on these drivers (Fig 1).
Hospital-wide opioid prescriptions P-charts. A, Percentage of encounters (inpatient and day-surgery) with at least 1 opioid prescription at discharge. B, Compliance with opioid prescription for ≤7 days in the hospital.
Hospital-wide opioid prescriptions P-charts. A, Percentage of encounters (inpatient and day-surgery) with at least 1 opioid prescription at discharge. B, Compliance with opioid prescription for ≤7 days in the hospital.
Opioid prescriptions status post anterior cruciate ligament (ACL) reconstruction and periacetabular osteotomy (PAO) surgery. A and D, P-chart for ACL (A) and PAO (D) surgery compliance with guidelines. B and E, X-bar chart for average number of opioid doses prescribed for ACL (B) and PAO (E) surgery. C and F, S-Chart for SD of opioid doses prescribed for ACL reconstruction (C) and PAO (F) surgery. Dashed line is the centerline; shadowed area represents 2SD or 3-σ limits; red dots indicate unusual variations.
Opioid prescriptions status post anterior cruciate ligament (ACL) reconstruction and periacetabular osteotomy (PAO) surgery. A and D, P-chart for ACL (A) and PAO (D) surgery compliance with guidelines. B and E, X-bar chart for average number of opioid doses prescribed for ACL (B) and PAO (E) surgery. C and F, S-Chart for SD of opioid doses prescribed for ACL reconstruction (C) and PAO (F) surgery. Dashed line is the centerline; shadowed area represents 2SD or 3-σ limits; red dots indicate unusual variations.
Opioid prescription status post–sickle cell disease, vaso-occlusive episode (SCD-VOC). A, P-chart SCD-VOC compliance with dosing guidelines. B, X-bar chart average number of short-acting and sustained release opioid doses prescribed for SCD-VOC. C, S-Chart for the number of opioid prescription refills per quarter. Dashed line is the centerline; shadowed area represents 2 SD or 3-σ limits; red dots indicate unusual variations.
Opioid prescription status post–sickle cell disease, vaso-occlusive episode (SCD-VOC). A, P-chart SCD-VOC compliance with dosing guidelines. B, X-bar chart average number of short-acting and sustained release opioid doses prescribed for SCD-VOC. C, S-Chart for the number of opioid prescription refills per quarter. Dashed line is the centerline; shadowed area represents 2 SD or 3-σ limits; red dots indicate unusual variations.
Interventions
Opioid-Prescribing Algorithm
On the basis of an extensive literature review and clinician expertise within our institution, the opioid-prescribing algorithm was developed to guide opioid prescribing for ambulatory and hospitalized patients being discharged. The algorithm guides prescribers to consider the medical history, physical exam, and presence of red flags (Supplemental Table 1) such as comorbidities that contribute to respiratory depression, pain that persists longer than expected, or having a voluntary no-opioid-directive (ie, the patient declines in advanced treatment options that include opioids). The algorithm directs prescribers to consider the source of pain. It suggests the use of opioid-sparing interventions before prescribing opioids. Finally, it provides recommendations to consider, including concerns associated with opioid administration, concurrent use of other sedating medications, and history of substance use (Supplemental Fig 5). The algorithm was shared with PIC members and clinical experts within the institution and was iteratively revised.
Identify Stakeholders and the Selection of Best Evidence for Opioid Prescription
We identified departments that prescribe the greatest percentage of opioids within the institution. We discussed the initiative and initial data with these department leaders and prescribers. Stakeholders considered local data, available evidence, and clinical knowledge. Stakeholders then established dosing guidelines by procedures and conditions. They selected specific populations to monitor and identified implementation strategies for their department. Across the institution, some departments had already begun work on similar strategies, and some started the process in collaboration with the PIC and CPP. The Orthopedic and Sports Medicine and Hematology Departments were among the departments with high opioid prescription percentages. These 2 departments were also leaders in establishing and implementing specific dosing guidelines; therefore, we present their experience as clinical examples in this manuscript. Other departments not included in this report have since participated in this effort.
Clinical Examples
Orthopedics and Sports Medicine Department
The Orthopedic and Sports Medicine Department completes over 100 000 outpatient visits and approximately 6000 surgeries per year. This department is committed to improving the safety of their prescribing practices. In 2016, they assessed their prescribing practices and identified improvement areas.19 During 2018, they defined doses recommendations for over 100 different surgeries on the basis of prospective studies20 and expert consensus. They increased onboarding training (Summer 2018) related to safe opioid prescribing for all prescribers. They implemented workflow changes, including delegating opioid prescription writing to a designated group of nurse practitioners (Summer 2019). They selected anterior cruciate ligament (ACL) reconstruction and periacetabular osteotomy (PAO) as 2 procedures to monitor, given the high volume of these procedures performed and the high number of opioid prescriptions written. Guidance for the total number of opioid doses prescribed after an ACL reconstruction or PAO was ≤40 doses.
Hematology Department
The Hematology Department cares for >320 patients per year. They developed and implemented opioid-prescribing guidelines while allowing for individualized patient needs. Some patients require long-acting opioids for a few days after discharge from sickle cell disease and vaso-occlusive episodes (SCD-VOC), whereas others require recurrent courses of short-acting opioids on the basis of weight and pain intensity. They provided education during staff meetings and teaching rounds for providers about the guidelines (Summer 2018). On the basis of expert consensus, they recommended 8 doses of sustained-release opioids or 20 doses of short-acting opioids for patients with SCD-VOC.
Dissemination and Continuous Feedback
Throughout this process, the CPP supported efforts for algorithm and guideline development, implementation, and measurement. The program houses a library of >120 guidelines maintained on a biannual basis and available to hospital clinicians via the EMR and on the Clinical Pathways Web site and mobile applications. The algorithm was included in the education material for nurses and clinicians, and each department was informed of its inclusion in the Clinical Pathways portal. This collaboration allowed us to capitalize on their experience with continuous improvement, in which adjustments to the algorithm and guideline can easily accommodate new evidence or changes in local data. The PIC provided written reports quarterly to stakeholders on guidelines compliance for selected procedures and diagnoses. Additionally, we hold quarterly meetings with the stakeholders to review compliance and evaluate whether adjustments to the current guidelines are needed.
Measures and Analysis
At our institution, prescriptions are entered electronically by hospital mandate. Data on all patients with ≥1 opioid prescriptions were collected between January 2015 and September 2020. By using an informatics platform that allows for querying and reporting of clinical data managed by the Information Services Department, we defined the population on the basis of the procedure or diagnosis and extracted prescription details. For hospital reports, we monitored the total prescription numbers and compliance with state mandates quarterly. For departmental reports, we monitored compliance with dose recommendations in the guideline and average opioid doses prescribed per procedure or diagnosis quarterly. We presented the number of refilled opioid prescriptions as a balancing measure, with the rationale that if the guidelines were lower than what the patient needs, patients would call and receive another opioid prescription. We defined refill as subsequent opioid prescriptions written after discharge but associated with the same hospital encounter. For the overall hospital, we present P-charts for the percentage of encounters receiving at least 1 opioid prescription and the compliance with opioid prescriptions for ≤7 days.
Our primary outcome, percentage compliance with opioid prescription recommendations by procedure or diagnosis, was plotted by using a P-chart. Additionally, an X-bar chart and an S-chart were calculated to evaluate the average number of opioid prescriptions and its SD in each procedure or diagnostic group. Analyses were performed by using R (qicharts2 packages).21
Ethical Considerations
Stakeholders from all departments were invited to participate in this effort. Department-specific data were aggregated by procedure or condition, and no specific clinicians or patients were identified. This effort was designated as quality improvement on the basis of institutional guidelines. Therefore, international review board review was deemed unnecessary.
Results
Total Opioid Prescriptions
At this institution, 83 037 opioid prescriptions in 53 804 unique patients (ambulatory and soon to be discharged hospitalized patients) were entered over 5 years. There was a 31% decrease in the number of opioid prescriptions entered between 2015 and 2019 (18 085 prescriptions for 13 745 patients during 2015; and 12 412 prescriptions for 9311 patients during 2019). Similarly, after 2016, there was a continuous decrease in the percentage of encounters with at least 1 opioid prescription, with an 8-point run below the centerline. Therefore, we changed the centerline in 2018 quarter 4; it went from 35% to 24% (Fig 2A). The decreasing trend in the number of prescriptions over time had a seasonal pattern, in which the number of prescriptions increased during the second and third quarters of each year (summer months). After the state mandate went into effect in the second quarter of 2016, the percentage of opioid prescriptions for ≤ 7 days increased consistently. Therefore, we changed the centerline in 2018 quarter 1, and the percentage has been stable over the 90% goal (Fig 2B). This measure includes all patients, including opioid naïve patients with acute pain and those with chronic and acute recurrent pain.
Orthopedics and Sports Medicine Department
Figure 3A–3D shows P-charts of compliance with guidelines for ACL and PAO surgeries. After 2016, there is a trend toward improvement, with an 8-points run over the centerline. During 2018, there are points of special variation that correlate with departmental prescriber education and initiation of guidelines into practice. Therefore, we adjusted the centerline after 2018 quarter 3. For ACL surgeries, the centerline for compliance before 2018 quarter 3 was 76.7% and increased to 99.7%. For PAO surgeries, compliance increased from 42.9% to 89.5%. The average number of doses prescribed (X-bar chart: Fig 3B–3F) and SD (S-chart: Fig 3C–3F) shows reduced variation and a change in centerline in 2018 quarter 3. The balancing measure, the percentage of refill prescriptions, has been low and stable over time: for ACLs, the average rate is 1.1%, with a maximum of 4.8% during 2020 quarter 2; for PAOs, the average rate is 0.8% with a maximum of 5.8% in 2017 quarter 1.
Hematology Department
Figure 4 shows the P-charts for compliance with the service recommendations for patients discharged after admission for SCD-VOC. After 2017, there is a trend toward improvement, with an 8-points run over the centerline. During summer 2018, they implemented the education strategy. Therefore, we adjusted the centerlines at the beginning of 2019. Compliance increased from 60.7% to 84.2% for short-acting opioids and 72.2% to 89.1% sustained release opioids. The average number of doses prescribed decreased (Fig 4B), and the SD (Fig 4C) showed reduced variation after the intervention. The rate of refill prescriptions is on average 13.2%, with a high of 26% of the prescriptions in 2019 quarter 4.
Discussion
We describe the development and implementation of an opioid-prescribing algorithm with dosage guidelines. The algorithm and guidelines were designed to update new evidence, such as advances that allow for further decreases in the need for opioids. The clinical examples highlight both increased compliance with the guidelines and decreased variability in opioid prescribing. The number of opioid prescriptions decreased significantly over the last 5 years. These results are similar to national trends in which, between 2006 and 2018, the rate of opioid prescriptions decreased by 29%.22 National and local efforts have increased awareness of the risk and unintended consequences of opioid misuse.3,5 Institutions and prescribers have implemented opioid-sparing interventions to decrease opioid use and improve patient safety. By 2017 quarter 3, over 90% of the institution's opioid prescriptions were for ≤7 days. Although we cannot determine causation between these improvements and the intervention, and there has been a constant decrease in the number of prescriptions in our institution, we can appreciate changes occurring with the beginning of this effort to develop and implement an algorithm and guidelines for opioid prescribing.
Although several pediatric initiatives address aspects of opioid prescription and education,23–28 we report on a hospital-wide process for continuous improvement. Most previously written initiatives focus on specific patient groups within a specialty or subspecialty. The opioid-prescribing algorithm provides information on federal and local regulations and links to hospital guidelines for chronic pain management. Notably, the dose guidelines for specific procedures or diagnoses offer a more detailed directive that can evolve over time and can be used to set compliance goals and track improvement.
Common barriers to decreasing opioid prescriptions include providers' education and the fact that rotating residents and fellows are frequent prescribers in academic institutions.21,29 They often lack evidence-based data to prescribe and might have adult standards in mind even when rotating in pediatric hospitals. This algorithm and guideline provide readily available guidance that can ease the burden on attending physicians and trainees when onboarding and may facilitate attending-resident communication about opioid prescribing.29 Similarly, having open guidelines across health care team disciplines, including nurses and pharmacists, allow for a consistent, aligned message. Consistency in communication is important for patient and family education regarding pain management and safe opioid practices.9
Providing feedback to clinical services and prescribers is an essential factor in decreasing opioid overprescribing30 It promotes a culture that openly discusses variability31 in practice and allows for self-improvement. During the revision of the report in the second quarter of 2021, after discussion with the stakeholders of the orthopedic department, given the sustained gains in the decrease of doses prescribed, we are in the process of adjusting the recommended doses for ACLs. The proposed dose recommendation for ACL is 25 doses as opposed to the 40 recommended previously.
Discussions during algorithm and guideline development sparked conversations within the departments that eventually led to different and individualized interventions, making the overall improvement hard to attribute to a single intervention. Every department had a different approach when determining dose recommendations. All departments reviewed the literature. Some performed systematic approaches and prospectively evaluated the needs of opioids after a specific procedure.18,20,32 Some relied more on providers' consensus. Some are still working on developing and/or implementing interventions for their particular patient population.
The decrease in unnecessary variability in the number of opioid doses prescribed without increasing the number of opioid refills is an important finding. This suggests that the decreased numbers of doses prescribed is not merely related to general decreases in opioid prescribing but to the dosing guidelines. In addition, it suggests that the number being prescribed without increased opioid refills is not underprescribing the patient. Of note, in January 2019, the hospital mandated that prescribers submit opioid prescriptions electronically, which made opioid prescribing easier for both prescribers and patients who previously had to pick up a paper copy. The convenience of electronic prescriptions may have contributed to prescribers being more willing to decrease the number of opioids prescribed.
There are several limitations to this quality improvement initiative. First, we cannot attribute the result to this single initiative. During this time period, much has been written about opioid prescribing practices. Second, our experience is specific to this single institution and may not translate to all. However, the information in the algorithm and guidelines may be beneficial as a reference tool in other institutions. Third, we do not have data on patient opioid consumption, pain control, and satisfaction for all patient populations on an ongoing basis. The balancing measure may not accurately measure if the patient received adequate pain management. These are important to consider for future initiatives.
This quality improvement effort describes the development of an opioid prescribing algorithm and guidelines and a process for continuous improvement. The algorithm and guidelines may help reduce the number of opioid prescriptions and the variability in prescribing practices at a pediatric institution. It allows for dosing adjustments as improvements in clinical care occur.
Acknowledgements
We acknowledge the work of clinical and quality improvements teams within BCH that help to evaluate and implement this initiative. A special thanks to Haley Levitt and Jonathan Cho for their work coordinating the development of the algorithm.
FUNDING: No external funding.
Drs Donado and Solodiuk performed the initial analysis and drafted and reviewed the manuscript; all authors participated in the development of the algorithm and different phases during the implementation of the quality improvement initiative; and all authors critically reviewed and revised the manuscript and approved the final manuscript as submitted.
References
Competing Interests
CONFLICT OF INTEREST DISCLOSURE: The authors have indicated they have no conflicts of interest relevant to this article to disclose.
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