Safe Opioid Use Research Articles

An international multidisciplinary consensus statement on the prevention of opioid-related harm in adult surgical patients.

This international multidisciplinary consensus statement was developed to provide balanced guidance on the safe peri-operative use of opioids in adults. An international panel of healthcare professionals evaluated the literature relating to postoperative opioid-related harm, including persistent postoperative opioid use; opioid-induced ventilatory impairment; non-medical opioid use; opioid diversion and dependence; and driving under the influence of prescription opioids. Recommended strategies to reduce harm include pre-operative assessment of the risk of persistent postoperative opioid use; use of an assessment of patient function rather than unidimensional pain scores alone to guide adequacy of analgesia; avoidance of long-acting (modified-release and transdermal patches) opioid formulations and combination analgesics; limiting the number of tablets prescribed at discharge; providing deprescribing advice; avoidance of automatic prescription refills; safe disposal of unused medicines; reducing the risk of opioid diversion; and better education of healthcare professionals, patients and carers. This consensus statement provides a framework for better prescribing practices that could help reduce the risk of postoperative opioid-related harm in adults.

Effect of a brief scenario-tailored educational program on parents' risk knowledge, perceptions, and decisions to administer prescribed opioids: a randomized controlled trial.

This randomized, controlled trial evaluated whether a brief educational program (ie, Scenario-Tailored Opioid Messaging Program [STOMP]) would improve parental opioid risk knowledge, perceptions, and analgesic efficacy; ensure safe opioid use decisions; and impact prescription opioid use after surgery. Parent-child dyads (n = 604) who were prescribed an opioid for short-term use were randomized to routine instruction (Control) or routine plus STOMP administered preoperatively. Baseline and follow-up surveys assessed parents' awareness and perceived seriousness of adverse opioid effects, and their analgesic efficacy. Parents' decisions to give an opioid in hypothetical scenarios and total opioid doses they gave to children at home were assessed at follow-up. Scenario-Tailored Opioid Messaging Program parents gained enhanced perceptions of opioid-related risks over time, whereas Controls did not; however, risk perceptions did not differ between groups except for addiction risk. Scenario-Tailored Opioid Messaging Program parents exhibited marginally greater self-efficacy compared to Controls (mean difference vs controls = 0.58 [95% confidence interval 0.08-1.09], P = 0.023). Scenario-Tailored Opioid Messaging Program parents had a 53% lower odds of giving an opioid in an excessive sedation scenario (odds ratio 0.47 [95% confidence interval 0.28-0.78], P = 0.003), but otherwise made similar scenario-based opioid decisions. Scenario-Tailored Opioid Messaging Program was not associated with total opioid doses administered at home. Instead, parents' analgesic efficacy and pain-relief preferences explained 7%, whereas child and surgical factors explained 22% of the variance in opioid doses. Scenario-tailored education enhanced parents' opioid risk knowledge, perceptions, and scenario-based decision-making. Although this may inform later situation-specific decision-making, our research did not demonstrate an impact on total opioid dosing, which was primarily driven by surgical and child-related factors.

Safe Use of Opioids in Chronic Kidney Disease and Hemodialysis Patients: Tips and Tricks for Non-Pain Specialists.

In patients suffering from moderate-to-severe chronic kidney disease (CKD) or end-stage renal disease (ESRD), subjected to hemodialysis (HD), pain is very common, but often underestimated. Opioids are still the mainstay of severe chronic pain management; however, their prescription in CKD and HD patients is still significantly low and pain is often under-treated. Altered pharmacokinetics and the lack of clinical trials on the use of opioids in patients with renal impairment increase physicians’ concerns in this specific population. This narrative review focused on the correct and safe use of opioids in patients with CKD and HD. Morphine and codeine are not recommended, because the accumulation of their metabolites may cause neurotoxic symptoms. Oxycodone and hydromorphone can be safely used, but adequate dosage adjustments are required in CKD. In dialyzed patients, these opioids should be considered as second-line agents and patients should be carefully monitored. According to different studies, buprenorphine and fentanyl could be considered first-line opioids in the management of pain in CKD; however, fentanyl is not appropriate in patients undergoing HD. Tapentadol does not need dosage adjustment in mild-to-moderate renal impairment conditions; however, no data are available on its use in ESRD. Opioid-related side effects may be exacerbated by common comorbidities in CKD patients. Opioid-induced constipation can be managed with peripherally-acting-μ-opioid-receptor-antagonists (PAMORA). Unlike the other PAMORA, naldemedine does not require any dose adjustment in CKD and HD patients. Accurate pain diagnosis, opioid titration and tailoring are mandatory to minimize the risks and to improve the outcome of the analgesic therapy.

P08 Ten-fold medication errors in a tertiary paediatric hospital

AimTo perform a retrospective analysis of tenfold medication errors between the 1st January 2017 and the 31st December 2018 and identify contributing factors.MethodInformation from all tenfold medication errors reported to the Ulysses system between 1st January 2017 and 31st December 2018 which met the criteria was inputted into a data collection sheet. Information gathered included the age of the patient, the time the error occurred, the location within the hospital, the point in the medication process the error occurred, the drug involved and the NCC-MERP category of harm assigned to the error. Reports were excluded if they were repeated entries or if they did not meet the criteria for a tenfold medication error. The total number of medication errors reported per month and the total number of admissions per month was also identified. Once data collection was complete, these errors were qualitatively analysed and compared with those of a previous audit using errors reported from 1st January 2013 to 31st December 2014.ResultsTenfold errors were most likely to be reported in the Critical Care areas (34.4% of tenfold errors being reported over the two-year period). Prescribing was the most common origin of error accounting for 54.3% of tenfold errors in 2017 and 51.7% in 2018. The most common category of harm assigned was category B (no harm – error did not reach patient) with a total of 40.6% of the errors reported. The age group with the highest number of errors reported was 29–364 days with 39.3% tenfold medication errors reported over the two-year period. Morphine was the most common drug involved accounting for 13.8% of errors reported.ConclusionThe findings from this report mirror the results from the previous audit performed in 2014 in respect to error origin and patient age. Tenfold prescribing errors have more chance of being intercepted before reaching the patient due to there being more steps in the process before administration, therefore it is less likely that errors that originate at prescribing will reach the patient. Tenfold administration errors were more likely to reach the patient and therefore to cause harm. Morphine was the most reported drug in both 2017/18 and the 2013/14 audit suggesting that more work needs to be done on the safe use of opioids. Critical Care was the location with the highest number of errors reported, patients in this area often require complex medication regimes increasing the likelihood of being involved in a medication error.1ReferenceBower R, Coad J, Manning J, et al. A qualitative, exploratory study of nurses’ decision-making when interrupted during medication administration within the paediatric intensive care unit. Intensive Crit Care Nurs 2018;44:11–17.

Role of the nurse in supporting the safe use of opioids.

Opioids are powerful analgesics that are derived from the opium poppy plant. They are recognised as central in the management of acute pain and cancer pain, but concerns about long-term use have resulted in recommendations that they should be used with caution in the management of chronic pain. Opioids have associated side effects and risks, but these may be exaggerated and some healthcare professionals can be unnecessarily cautious and withhold the use of opioids, even in cases where these medicines may be beneficial. It is important that nurses understand the pharmacology, side effects and risks of opioids, so they can ensure these medicines are administered safely.

Patterns of Storage, Use, and Disposal of Prescription Opioids by Young Adults with Cancer

Studies have demonstrated that adults with cancer and parents of children with cancer do not use and store prescription opioids safely. Most YAs (135/146, 92%) unsafely stored opioids. Fifty-two of 146 patients (36%) unsafely used, and 16 of 146 patients (11%) unsafely disposed of opioids. YAs with hematologic malignancies (p < 0.05) were more likely to use opioids safely compared with YAs with other types of malignancies. More research is necessary to understand the scope of this issue. Our data suggest that universal educational interventions regarding the safe storage, use, and disposal of opioids are justified for YAs.

Characterizing the Effect of Opioid Tablet Strength on Post-Operative Opioid Consumption Following ACL Reconstruction

Objectives:Prescription opioid abuse continues to be a national crisis in the United States. Orthopaedic surgeons contribute significantly to this crisis, prescribing nearly a tenth of annual opioid prescriptions. With Anterior Cruciate Ligament (ACL) reconstruction being a common orthopaedic procedure performed at high volumes, understanding how physician opioid prescribing practices affects patient post-operative opioid utilization is of critical importance to curbing the orthopaedic contribution to the opioid epidemic. We aimed to assess how opioid tablet strength affects post-operative opioid consumption following ACL reconstruction. We hypothesized that prescribing a lower strength opioid tablet would not adversely influence post-operative pain or increase opioid consumptionMethods:All data was collected prospectively from patients undergoing ACL reconstruction at a single academic ambulatory surgery center.All patients received the same peri-operative pain management protocol, which consisted of an adductor canal block at the time of surgery, Naprosyn 500 mg to be taken as needed, and pre-operative opioid education that outlined safe opioid use practice. Percocet was prescribed at two dosages in a consecutive fashion. Between March 2018 to October 2018, patients received Percocet at a strength of 7.5 mg (7.5 mg Oxycodone/325 Acetaminophen). From November 2018 to May 2019, patients received prescriptions at a dose of 5 mg. At the first post-operative clinic visit, patients completed a survey describing the quantity of opioid tablets consumed, days of postoperative opioid use, and opioid-related adverse effects. In addition, patients used a smart-phone application to assess post-operative pain on a numeric rating scale from post-operative day (POD) 1 to POD 6.Results:148 patients were prospectively enrolled. 78 (51.3%) received Percocet at a strength of 7.5 mg per tablet and 69 (46.9%)received Percocet at a strength of 5 mg. The median age was 23 years (interquartile range: 18-36) and 49.7% were female. The 7.5 mg cohort took an average of 12.4 tablets (±7.0), while the 5 mg cohort took an average of 8.6 (±7.4) tablets, a 3.7 tablet decrease (p=0.002). Both cohorts consumed opioids for the same amount of post-operative days (5mg cohort: 3.1 days, 7.5mg cohort: 3.5 days; p=0.289). The incidence of opioid related side effect were equivalent between the 5 mg and 7.5 mg cohorts, which included constipation (34.8% and 34.6%, p=0.983), euphoria (5.8% v. 10.3%, p=0.324), nausea/vomiting (13.0% v. 16.7%, p=0.539), fatigue (2.9% v. 6.4%, p0.319), and pruritus (2.9% v. 5.1%, p=0.495). There was no difference in post-operative numeric pain scores in the 5 mg vs. the 7.5 mg cohort (POD 1: 5.7 ±1.9 vs. 5.4 ± 2.0, p=0.633; POD 6: 3.3 ± 2.1 vs. 2.9 ± 1.8, p=0.726).Conclusion:Prescribing a lower strength of oxycodone after ACL reconstruction did not increase pain scores or opioid consumption.This suggests that it is possible to achieve similar pain control while lowering the total opioid prescribed. These finding support future research focusing on optimizing pain control at minimal opioid doses.

PDG50 COMMUNICATION BETWEEN PATIENTS AND HEALTH CARE PROFESSIONALS ABOUT OPIOID MEDICATIONS: A SYSTEMATIC REVIEW

Health care professionals (HCP) are the group primarily responsible for appropriate opioid prescribing, dispensing and promoting safe opioid use. HCP can promote safe opioid use when prescribing or dispensing opioid medications by counseling patients on the safe use of opioids including risks, storage and disposal. Literature lacks empirical evidence about communicating risks of opioids with patients when prescribing or dispensing or following up on opioid therapy nor does it sufficiently address barriers and facilitators to discuss opioid-related information from patient and HCP perspectives.

Pain Management for Pediatric Burns in the Outpatient Setting: A Changing Paradigm?

Childhood burns are common and distressing for children and their parents. Pain is the most common complaint and often thought to be undertreated, which can negatively influence the child's care and increase the risk of posttraumatic stress disorder. There is limited literature on the role of opioids and multimodal therapy in the treatment of pediatric outpatient burns. We sought to evaluate the current use of opioids (including the use of multimodal therapies), storage, and disposal of opioids in this patient population. Parents of burn-injured children 8 months to 18 years old, who were seen in an outpatient setting within 2 weeks of their burn injury, were queried from April to December 2019 regarding their child's pain control, opioid medication use, over-the-counter pain medication use, opioid storage, and disposal. A total of 142 parents of burn-injured children and their parents were surveyed. The median age of the burn-injured children was 2.7 years old and the majority (54.2%; 77/142) were male. The mean total body surface area (TBSA) was 1.8% and half sustained burn injuries to one or both hands. The most frequently used regimens for constant and/or breakthrough pain control were acetaminophen (62.7%) and nonsteroidal anti-inflammatory drugs (NSAIDs; 68.3%). Less than one fifth (26/142;18%) of patients were prescribed opioids and 88% filled their prescription. The median number of doses of opioids prescribed was eight doses, with a median of four doses of opioids unused. Only three patients used all of their prescribed opioids and no patient ≥12 years old used their entire prescription. Burns greater than 3% TBSA, irrespective of burn injury location, were associated with opioid prescription (P = .003). Approximately 40% (10/26) of parents who filled their child's opioid prescription stored the opioid in a locked area. Fewer than one third (7/26) of patients were educated on how to dispose of excess opioid pain medication. Overall, most pediatric outpatient burn injuries can be successfully managed with over-the-counter medications. Providers, who care for burn-injured children ≤ 12 years old with burns that cover ≥3% TBSA in the outpatient setting, should consider no more than four opioid doses for initial pain control. This guideline, coupled with family and provider-centered education on multimodal therapy at the time of initial presentation and safe use of opioids, are important first steps to minimizing the use of opioids in the management of small area burns in children.

Patient-Reported Opioid Pill Consumption After an ED Visit: How Many Pills Are People Using?

Recent guidelines advise limiting opioid prescriptions for acute pain to a three-day supply; however, scant literature quantifies opioid use patterns after an emergency department (ED) visit. We sought to describe opioid consumption patterns after an ED visit for acute pain. Descriptive study with data derived from a larger interventional study promoting safe opioid use after ED discharge. Urban academic emergency department (>88,000 annual visits). Patients were eligible if age >17 years, not chronically using opioids, and newly prescribed hydrocodone-acetaminophen and were included in the analysis if they returned the completed 10-day medication diary. Patient demographics and opioid consumption are reported. Opioid use is described in daily number of pills and daily morphine milligram equivalents (MME) both for the sample overall and by diagnosis. Two hundred sixty patients returned completed medication diaries (45 [17%] back pain, 52 [20%] renal colic, 54 [21%] fracture/dislocation, 40 [15%] musculoskeletal injury [nonfracture], and 69 [27%] "other"). The mean age (SD) was 45 (15) years, and 59% of the sample was female. A median of 12 pills were prescribed. Patients with renal colic used the least opioids (total pills: median [interquartile range {IQR}] = 3 [1-7]; total MME: median [IQR] = 20 [10-50]); patients with back pain used the most (total pills: median [IQR] = 12 [7-16]; total MME: median [IQR] = 65 [47.5-100]); 92.5% of patients had leftover pills. In this sample, pill consumption varied by illness category; however, overall, patients were consuming low quantities of pills, and the majority had unused pills 10 days after their ED visit.

Educating Patients Regarding Pain Management and Safe Opioid Use After Surgery: A Narrative Review.

In recent years, there have been escalating concerns related to the opioid epidemic. With a steadily increasing opioid supply, it is critical to provide proper education to patients who are prescribed these medications. Education should be emphasized as a means of ensuring safe use and potentially as a strategy for curbing the opioid supply. Patients who undergo surgery are frequently prescribed opioids for postoperative pain; however, the content and delivery of information related to usage is inconsistent and often inadequate. Lack of education on postoperative pain management and opioid use places patients at risk for poor compliance and worse pain control. Furthermore, patients are often not properly educated on opioid-related side effects and risks or about safe behaviors when taking medications. The majority of patients are also not informed about how to store and dispose of leftover medications. Patients who are prescribed opioids require education preoperatively to cover the topics of pain management, opioid-related side effects, and risks, storage, and disposal. Evidence from various studies demonstrates that educational interventions improve knowledge and potentially lead to safer behaviors and reduced opioid use. Education can be provided in various formats with each having unique advantages and limitations.

3D printed opioid medicines with alcohol-resistant and abuse-deterrent properties.

In the past decade, prescriptions for opioid medicines have been exponentially increasing, instigating opioid abuse as a global health crisis associated with high morbidity and mortality. In particular, diversion from the intended mode of opioid administration, such as injecting and snorting the opioid, is a major problem that contributes to this epidemic. In light of this, novel formulation strategies are needed to support efforts in reducing the prevalence and risks of opioid abuse. Here, modified release tramadol printlets (3D printed tablets) with alcohol-resistant and abuse-deterrent properties were prepared by direct powder extrusion three-dimensional (3D) printing. The printlets were fabricated using two grades of hydroxypropylcellulose (HPC). Both formulations displayed strong ethanol-resistance and had moderate abuse-deterrent properties. Polyethylene oxide (PEO) was subsequently added into the formulations, which improved the printlets' resistance to physical tampering in nasal inhalation tests and delayed their dissolution in solvent extraction tests. Overall, this article reports for the first time the use of direct powder extrusion 3D printing to prepare drug products with both alcohol-resistant and abuse-deterrent properties. These results offer a novel approach for the safe and effective use of opioids that can contribute to the advantages that 3D printing provides in terms of on-demand dose personalisation.

Patterns of Storage, Use, and Disposal of Prescription Opioids by Parents of Children with Cancer (FR460D)

•Discuss the results of our study.•Recommend strategies for health care providers to provide knowledge about the safe storage, use, and disposal of opioids. Multiple studies have demonstrated that adults do not store prescription opioids safely. Increased prescription opioid rates have led to an increased incidence of opioid poisonings in children and adolescents. We investigated whether parents of children with cancer that were prescribed opioids practiced safe storage, use, and disposal techniques. We conducted a prospective cross-sectional survey of parents whose children were prescribed opioids and asked them about their patterns of storage, use, and disposal of prescription opioids. Virtually all parents (106/109, 97%) completed the survey. Most parents (95/106, 90%) did not store opioids safely. Six of 106 parents (6%) gave their child's opioid pain medication to someone else with pain, and 3 of 106 parents (3%) personally took some of their child's opioid. Parents who personally took their child's opioid (P = .01) or gave it to another person (P < .001) were more likely to use opioids unsafely in their child. A minority of parents (22/106, 21%) did not use opioids safely in their child. A small number of parents (3/22, 14%) did not dispose of opioids safely. Universal education about the safe, use, and disposal of opioids should be adopted when prescribing opioids. Pediatricians need to maintain vigilance about the nonmedical use of prescription opioid use by parents of children.

Adolescents’ Willingness to Commit to Safe Use and Disposal of Prescription Opioids

Introduction and aims: Leftover pills from prescriptions written in emergency departments are a key source of misused opioids among adolescents. Recently, the AMA has proposed emphasizing safe use and disposal of opioids, but patient perceptions on this proposed solution are largely unknown. In this study, we evaluate the willingness of adolescents to commit to pill security and safe opioid use in a clinical setting. Design and methods: In this prospective survey study conducted in an urban emergency department, a consecutive sample of adolescent patients between 15 and 22 years were asked about their exposure to opioids and attitudes toward the potential harm of opioid use/misuse and whether they were willing to consider to committing to pill security and safe opioid use in a clinical setting. We then assessed if willingness to commit varied based on attitude toward opioid misuse or previous experience with prescription opioids. Results: Eighty-one percent (91/113) of eligible patients agreed to participate. Overall 29.7% of adolescents had received a prescription for opioids and 40.7% had leftover pills. 87.9% were willing to commit to take opioids only as prescribed and 83.5% were willing to commit to disposing leftover opioids. Willingness did not vary by previous exposure to prescription opioids or attitudes toward recreational opioid use. Discussion and conclusions: Adolescents are highly willing to commit to safe opioid use and disposal regardless of previous exposure to opioids or attitude toward opioid misuse.

Opioid prescribing and misuse among dental patients in the US: a literature-based review.

Although health care practitioners have become more cognizant of the hazards of opioid use, opioid misuse has emerged as a leading public health problem in the United States, accounting for 20% of all deaths among older adolescents and young adults. Opioid analgesics are an important component of dental pain management following dental procedures. The aim of this study was to assess the status of literature on dental opioid prescriptions, their misuse, and relevant prevention strategies in the US. A keyword search of MEDLINE, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, CINAHL (EBSCO), and Web of Science was conducted in July 2018. The search criteria were carefully selected to include all practitioners treating patients presenting with dental issues and was not restricted to dentists. All peer-reviewed publications in the US written in English about patients with dental problems were included. The initial search led to 267 publications; after removing duplicates, the set consolidated to 196. After an appraisal of the title and abstract for relatedness, 82 publications were selected. Three major themes were identified: epidemiology of dental opioid prescriptions; recognition of the dental providers' contribution to opioid prescription practice; pain management protocols and guidelines in dentistry. There is moderate recognition of the contribution of dental prescriptions to the opioid epidemic. Several tools are available to increase patient education and practitioner knowledge about the safe use of opioids with a focus on patients at greatest risk.

Pragmatic Opioid Use in Painful Diabetic Neuropathy.

The management of painful diabetic neuropathy poses a tough clinical challenge. Although opioid analgesics are considered as second- or third-line agents in the management of moderate-to-severe neuropathic pain, prescription of opioids for this indication is higher than expected. This narrative review is a recommendation on how to ensure pragmatic use of opioids for those with painful diabetic neuropathy while avoiding complications such as opioid overdose, opioid diversion and the development of opioid-use disorder. Risk mitigation strategies at the level of the clinician include periodic assessment and documentation of clinical details, treatment history and psychosocial status. Using a multimodal approach to pain management, medication counselling, adherence monitoring programmes, evidence-based opioid dosing strategies and empowering patients to make treatment decisions are effective strategies in reducing risk associated with prolonged opioid use. At the organisational and policy level, using prescription drug monitoring programmes, carrying out periodic opioid utilisation reviews and providing training to patients and physicians on safe opioid use are useful, implementable strategies.

Towards defining the safer use of opioids in rheumatology.

Use of prescription opioids is prevalent in patients with rheumatic diseases. Studies in 2019 reported the trends and safety of opioids in patients with rheumatoid arthritis or osteoarthritis. Treating underlying disease processes must be the rheumatologists’ priority. Without better long-term safety and effectiveness data, opioid use should be generally limited.

Long-term opioid therapy definitions and predictors: A systematic review.

This review sought to (a) describe definitions of long-term opioid therapy (LTOT) outcome measures, and (b) identify the predictors associated with the transition from short-term opioid use to LTOT for opioid-naïve individuals. We conducted a systematic review of the peer-reviewed literature (January 2007 to July 2018). We included studies examining opioid use for more than 30 days. We classified operationalization of LTOT based on criteria used in the definitions. We extracted LTOT predictors from multivariate models in studies of opioid-naïve individuals. The search retrieved 5,221 studies, and 34 studies were included. We extracted 41 unique variations of LTOT definitions. About 36% of definitions required a cumulative duration of opioid use of 3 months. Only 17% of definitions considered consecutive observation periods, 27% used days' supply, and no definitions considered dose. We extracted 76 unique predictors of LTOT from seven studies of opioid-naïve patients. Common predictors included pre-existing comorbidities (21.1%), non-opioid prescription medication use (13.2%), substance use disorders (10.5%), and mental health disorders (10.5%). Most LTOT definitions aligned with the chronic pain definition (pain more than 3 months), and used cumulative duration of opioid use as a criterion, although most did not account for consistent use. Definitions were varied and rarely accounted for prescription characteristics, such as days' supply. Predictors of LTOT were similar to known risk factors of opioid abuse, misuse, and overdose. As LTOT becomes a central component of quality improvement efforts, researchers should incorporate criteria to identify consistent opioid use to build the evidence for safe and appropriate use of prescription opioids.

Contemporary Approaches to Postoperative Pain Management.

After reading this article, the participant should be able to: 1. Describe the fundamental concepts of multimodal analgesia techniques and how they target pain pathophysiology. 2. Effectively educate patients on postoperative pain and safe opioid use. 3. Develop and implement a multimodal postoperative analgesia regimen. For many years, opioids were the cornerstone of postoperative pain control, contributing to what has become a significant public health concern. This article discusses contemporary approaches to multimodal, opioid-sparing postoperative pain management in the plastic surgical patient.

A Multifaceted Intervention to Improve Patient Knowledge and Safe Use of Opioids: Results of the ED EMC2 Randomized Controlled Trial.

Despite increased focus on opioid prescribing, little is known about the influence of prescription opioid medication information given to patients in the emergency department (ED). The study objective was to evaluate the effect of an Electronic Medication Complete Communication (EMC2 ) Opioid Strategy on patients' safe use of opioids and knowledge about opioids. This was a three-arm prospective, randomized controlled pragmatic trial with randomization occurring at the physician level. Consecutive discharged patients at an urban academic ED (>88,000 visits) with new hydrocodone-acetaminophen prescriptions received one of three care pathways: 1) usual care, 2) EMC2 intervention, or 3) EMC2 +short message service (SMS) text messaging. The ED EMC2 intervention triggered two patient-facing educational tools (MedSheet, literacy-appropriate prescription wording [Take-Wait-Stop]) and three provider-facing reminders to counsel (directed to ED physician, dispensing pharmacist, follow-up physician). Patients in the EMC2 +SMS arm additionally received one text message/day for 1week. Follow-up at 1 to 2weeks assessed "demonstrated safe use" (primary outcome). Secondary outcomes including patient knowledge and actual safe use (via medication diaries) were assessed 2 to 4days and 1month following enrollment. Among the 652 enrolled, 343 completed follow-up (57% women; mean±SD age= 42±14.0years). Demonstrated safe opioid use occurred more often in the EMC2 group (adjusted odds ratio [aOR]= 2.46, 95% confidence interval [CI]= 1.19 to 5.06), but not the EMC2 +SMS group (aOR= 1.87, 95% CI= 0.90 to 3.90) compared with usual care. Neither intervention arm improved medication safe use as measured by medication diary data. Medication knowledge, measured by a 10-point composite knowledge score, was greater in the EMC2 +SMS group (β= 0.57, 95% CI= 0.09 to 1.06) than usual care. The study found that the EMC2 tools improved demonstrated safe dosing, but these benefits did not translate into actual use based on medication dairies. The text-messaging intervention did result in improved patient knowledge.