Type of anesthesia and quality of recovery in male patients undergoing lumbar surgery: a randomized trial comparing propofol-remifentanil total i.v. anesthesia with sevoflurane anesthesia.

BACKGROUND: Previous studies have shown that women achieve a better quality of postoperative recovery from total intravenous anesthesia (TIVA) than from inhalation anesthesia, but the effect of anesthesia type on recovery in male patients is unclear. This study therefore compared patient recovery between males undergoing lumbar surgery who received TIVA and those who received sevoflurane anesthesia. METHODS: Eighty male patients undergoing elective one- or two-level primary transforaminal lumbar interbody fusion (TLIF) were randomly divided into two groups: the TIVA group (maintenance was achieved with propofol and remifentanil) or sevoflurane group (SEVO group: maintenance was achieved with sevoflurane and remifentanil). The quality of recovery-40 questionnaire (QoR-40) was administered before surgery and on postoperative days 1 and 2 (POD1 and POD2). Pain scores, postoperative nausea and vomiting, postoperative hospital stay, anesthesia consumption, and adverse effects were recorded. RESULTS: The QoR-40 scores were similar on the three points (Preoperative, POD1 and POD2). Pain scores were significantly lower in the SEVO group than in the TIVA group on POD1 (30.6 vs 31.4; P = 0.01) and POD2 (32 vs 33; P = 0.002). There was no significant difference in the postoperative hospital stay or complications in the postanesthesia care unit between the TIVA group and the SEVO group. CONCLUSIONS: This study demonstrates that the quality of recovery is not significantly different between male TLIF surgery patients who receive TIVA and those who receive sevoflurane anesthesia. Patients in the TIVA group had better postoperative analgesic effect on POD2. TRIAL REGISTRATION: This was registered at http://www.chictr.org.cn (registration number ChiCTR-IOR-16007987, registration date: 24/02/2016).

Assessment of 2-Year Neurodevelopmental Outcomes in Extremely Preterm Infants Receiving Opioids and Benzodiazepines.

Importance: Extremely preterm (EP) infants frequently receive opioids and/or benzodiazepines, but these drugs' association with neurodevelopmental outcomes is poorly understood. Objectives: To describe the use of opioids and benzodiazepines in EP infants during neonatal intensive care unit (NICU) hospitalization and to explore these drugs' association with neurodevelopmental outcomes at 2 years' corrected age. Design, Setting, and Participants: This cohort study was a secondary analysis of data from the Preterm Erythropoietin Neuroprotection (PENUT) Trial, which was conducted among infants born between gestational ages of 24 weeks, 0 days, and 27 weeks, 6 days. Infants received care at 19 sites in the United States, and data were collected from December 2013 to September 2016. Data analysis for this study was conducted from March to December 2020. Exposures: Short (ie, ≤7 days) and prolonged (ie, >7 days) exposure to opioids and/or benzodiazepines during NICU stay. Main Outcomes and Measures: Cognitive, language, and motor development scores were assessed using the Bayley Scales of Infant Development-Third Edition (BSID-III). Results: There were 936 EP infants (448 [48%] female infants; 611 [65%] White infants; mean [SD] gestational age, 181 [8] days) included in the study, and 692 (74%) had neurodevelopmental outcome data available. Overall, 158 infants (17%) were not exposed to any drugs of interest, 297 (32%) received either opioids or benzodiazepines, and 481 (51%) received both. Infants exposed to both had adjusted odds ratios of 9.7 (95% CI, 2.9 to 32.2) for necrotizing enterocolitis and 1.7 (95% CI, 1.1 to 2.7) for severe bronchopulmonary dysplasia; they also had a longer estimated adjusted mean difference in length of stay of 34.2 (95% CI, 26.2 to 42.2) days compared with those who received neither drug. After adjusting for site and propensity scores derived for each exposure category, infants exposed to opioids and benzodiazepines had lower BSID-III cognitive, motor, and language scores compared with infants with no exposure (eg, estimated difference in mean scores on cognitive scale: -5.72; 95% CI, -8.88 to -2.57). Prolonged exposure to morphine, fentanyl, midazolam, or lorazepam was associated with lower BSID-III scores compared with infants without exposure (median [interquartile range] motor score, 85 [73-97] vs 97 [91-107]). In contrast, BSID-III scores for infants with short exposure to both opioids and benzodiazepines were not different than those of infants without exposure. Conclusions and Relevance: In this study, prolonged combined use of opioids and benzodiazepines was associated with a risk of poorer neurodevelopmental outcomes as measured by BSID-III at 2 years' corrected age.

Government Mandated Consent Dramatically Reduces Pediatric Urologist Opioid Utilization for Outpatient and Minor Emergency Surgeries.

PURPOSE: Postoperative opioids are overprescribed in the United States. In November 2016 the State of Pennsylvania required an opioid consent for minors. Our hypothesis is that this mandate decreased postoperative opioid prescriptions in our division. MATERIALS AND METHODS: All patients who received a urological outpatient or minor emergency procedure from August 2015 to August 2019 were identified. Surgeries performed within 6 months after mandate implementation were excluded to account for the transition period. Perioperative data including case type were extracted by a clinical data warehouse from preexisting fields within the health record. The frequencies of postoperative prescriptions, delayed prescriptions and emergency department encounters were assessed. A multivariable logistic regression to identify predictors of opioid prescription at discharge was performed. RESULTS: A total of 4,349 patients were analyzed. The frequency of postsurgical opioid prescriptions decreased from 45.3% to 2.6% (p <0.001). The median morphine milligram equivalent decreased by 22.5 among children prescribed an opioid (p <0.001). Rates of an emergency department visits (3% vs 2.7%) or delayed nonopioid prescriptions (0.8% vs 1.2%) within 30 days of discharge were unchanged (p >0.05). Fewer patients received a delayed opioid prescription after mandate implementation (0.03% vs 0.5%, p <0.001). Female patients were less likely (OR 0.309, 95% CI 0.195-0.491; p <0.001) to receive opioids prior to but not after the mandate (OR 0.309, 95% CI 0.544-2.035; p=0.122). Increasing age was predictive of receiving an opioid before (OR 1.187, 95% CI 1.157-1.218; p <0.001) and after (OR 1.241, 95% CI 1.186-1.299; p <0.001) the mandate. CONCLUSIONS: A state mandated opioid consent for minors greatly reduced post-urological surgery opioid prescription rates without increasing rates of readmission or delayed prescriptions.

Approaches to Optimize Medication Data Analysis in Clinical Cohort Studies.

OBJECTIVES: Methods for pharmacoepidemiologic studies of large-scale data repositories are established. Although clinical cohorts of older adults often contain critical information to advance our understanding of medication risk and benefit, the methods best suited to manage medication data in these samples are sometimes unclear and their degree of validation unknown. We sought to provide researchers, in the context of a clinical cohort study of delirium in older adults, with guidance on the methodological tools to use data from clinical cohorts to better understand medication risk factors and outcomes. DESIGN: Prospective cohort study. SETTING: The Successful Aging After Elective Surgery (SAGES) prospective cohort. PARTICIPANTS: A total of 560 older adults (aged ≥70 years) without dementia undergoing elective major surgery. MEASUREMENTS: Using the SAGES clinical cohort, methods used to characterize medications were identified, reviewed, analyzed, and distinguished by appropriateness and degree of validation for characterizing pharmacoepidemiologic data in smaller clinical data sets. RESULTS: Medication coding is essential; the American Hospital Formulary System, most often used in the United States, is not preferred over others. Use of equivalent dosing scales (e.g., morphine equivalents) for a single medication class (e.g., opioids) is preferred over multiclass analgesic equivalency scales. Medication aggregation from the same class (e.g., benzodiazepines) is well established; the optimal prevalence breakout for aggregation remains unclear. Validated scale(s) to combine structurally dissimilar medications (e.g., anticholinergics) should be used with caution; a lack of consensus exists regarding the optimal scale. Directed acyclic graph(s) are an accepted method to conceptualize causative frameworks when identifying potential confounders. Modeling-based strategies should be used with evidence-based, a priori variable-selection strategies. CONCLUSION: As highlighted in the SAGES cohort, the methods used to classify and analyze medication data in clinically rich cohort studies vary in the rigor by which they have been developed and validated.

Intrathecal Opioid Dosing During Spinal Anesthesia for Cesarean Section: An Integrative Review.

Approximately one in three women in the United States deliver via Cesarean section (CS), making it one of the most common surgical procedures in the country. Neuraxial (spinal or epidural) anesthesia is the most effective and common anesthetic approach for pain relief during a CS in the United States and often associated with adverse effects such as nausea, vomiting, and pruritus. While recommended dose ranges exist to protect patient safety, there are a lack of guidelines for opioid doses that both optimize postoperative pain management and minimize side effects. This integrative review synthesizes the evidence regarding best practice of opioid dosing in neuraxial anesthesia for planned CS. Evidence supports the use of lower doses of intrathecal (IT) opioids, specifically 0.1 morphine, to achieve optimal pain management with minimal nausea, vomiting, and pruritus. Lower IT doses have potential to achieve pain management and to alleviate preventable side effects in women delivering via CS.

Recommendations for Prescribing Opioids for People With Traumatic Brain Injury.

Our objective was to make recommendations intended to reduce the rate of opioid misuse and overdose for a particularly high-risk group of people with traumatic brain injury (TBI). A consensus process conducted with TBI researchers and expert practitioners developed practical recommendations to inform prescribing of opioids for people with TBI. After determining key general principles for prescribing opioids for people with TBI, 6 TBI-specific recommendations were developed, 1 for acute pain in the agitated patient with TBI, 3 recommendations to be considered before prescribing an opioid, and 2 for follow-up and use by mental health and substance use disorder providers. While there is much needed research to examine the relationship between opioid misuse and TBI, the present recommendations provide at least some clinical considerations that might serve to prevent further deaths among a high-risk group.

Tips and tools for safe opioid prescribing.

This review-with tables summarizing opioid options, dosing considerations, and recommendations for tapering-will help you provide rigorous Tx for noncancer pain while ensuring patient safety.

The effect of dexmedetomidine and remifentanil on the postoperative sore throat after thyroidectomy.

BACKGROUND: Postoperative sore throat (POST) is an important concern in surgical patients undergoing endotracheal intubation. Its prevalence after thyroidectomy is up to 80%. The current study aimed to assess the effect of dexmedetomidine and remifentanil on postoperative sore throat. METHODS: Seventy-four patients who underwent thyroidectomy were randomized to receive either dexmedetomidine (group D) or remifentanil (group R). At anesthesia induction, group D received dexmedetomidine 1 µg/kg over 10 minutes, followed by continuous dexmedetomidine infusion at 0.3 to 0.6 µg/kg/hour during surgery. Group R received remifentanil of 3 to 4 ng/ml during induction, followed by 1.5 to 2.5 ng/ml remifentanil infusion during surgery. POST at rest and swallowing was assessed during the first 24 hours in serial time periods (0-1, 1-6, and 6-24 hours). Hoarseness and postoperative pain score were also assessed. RESULTS: POST incidence at rest (0-1, 1-6, and 6-24 hours) and swallowing (1-6 and 6-24 hours) was lower in group D than in group R. POST severity was significantly lower in group D than in group R during each time period. The incidence of postoperative hoarseness was also lower in group D than in group R at 1 to 6 and 6 to 24 hours. The postoperative pain score was lower in group D than in group R during each time period. CONCLUSION: Intraoperative dexmedetomidine infusion reduced the incidence and severity of POST for 24 hours after thyroidectomy.

Confronting challenges to opioid risk mitigation in the U.S. health system: Recommendations from a panel of national experts.

BACKGROUND: Amid the ongoing U.S. opioid crisis, achieving safe and effective chronic pain management while reducing opioid-related morbidity and mortality is likely to require multi-level efforts across health systems, including the Military Health System (MHS), Department of Veterans Affairs (VA), and civilian sectors. OBJECTIVE: We conducted a series of qualitative panel discussions with national experts to identify core challenges and elicit recommendations toward improving the safety of opioid prescribing in the U.S. DESIGN: We invited national experts to participate in qualitative panel discussions regarding challenges in opioid risk mitigation and how best to support providers in delivery of safe and effective opioid prescribing across MHS, VA, and civilian health systems. PARTICIPANTS: Eighteen experts representing primary care, emergency medicine, psychology, pharmacy, and public health/policy participated. APPROACH: Six qualitative panel discussions were conducted via teleconference with experts. Transcripts were coded using team-based qualitative content analysis to identify key challenges and recommendations in opioid risk mitigation. KEY RESULTS: Panelists provided insight into challenges across multiple levels of the U.S. health system, including the technical complexity of treating chronic pain, the fraught national climate around opioids, the need to integrate surveillance data across a fragmented U.S. health system, a lack of access to non-pharmacological options for chronic pain care, and difficulties in provider and patient communication. Participating experts identified recommendations for multi-level change efforts spanning policy, research, education, and the organization of healthcare delivery. CONCLUSIONS: Reducing opioid risk while ensuring safe and effective pain management, according to participating experts, is likely to require multi-level efforts spanning military, veteran, and civilian health systems. Efforts to implement risk mitigation strategies at the patient level should be accompanied by efforts to increase education for patients and providers, increase access to non-pharmacological pain care, and support use of existing clinical decision support, including state-level prescription drug monitoring programs.

Detecting fentanyl using point-of-care drug checking technologies: A validation study.

OBJECTIVES: Point-of-care drug checking services, wherein individuals can check the content and purity of their drugs, have emerged as a public health intervention to address the fentanyl crisis; however, there have been no rigorous evaluations of the technologies against reference standard laboratory techniques. METHODS: Two point-of-care technologies, fentanyl immunoassay strips and Fourier-Transform Infrared (FTIR) spectroscopy, were implemented at two supervised injection sites in Vancouver, Canada. We calculated sensitivity, specificity, and false negative rate for both testing methods as compared to a laboratory reference standard. RESULTS: Between October 2017 and 2018, 331 samples were sent for confirmatory testing. Immunoassay strips had a sensitivity of 87.5% and specificity of 95.2%, with a false negative rate of 12.5%. FTIR spectroscopy had a sensitivity of 72.1% and specificity of 99.0%, with a false negative rate of 27.9%. CONCLUSION: As expected, while FTIR spectroscopy can quantify concentrations on a wide array of compounds, it can only do so above the detection limit. Using FTIR spectroscopy and immunoassay strips in combination has the potential to offset the limitations of each technology when used alone.

Randomized control trial of ultrasound-guided erector spinae block versus shoulder periarticular anesthetic infiltration for pain control after arthroscopic shoulder surgery: Study protocol clinical trial (SPIRIT compliant).

INTRODUCTION: Moderate to severe postoperative pain and associated opioid use may interfere with patients' well-being and course of recovery. Regional anesthetic techniques provide an opportunity for opioid sparing and improved patient outcomes. A new regional technique called the erector spinae plane (ESP) block has the potential to provide effective analgesia after shoulder arthroscopy with minimal risks and decreased opioid consumption. Our primary objective is to determine whether, in patients who undergo arthroscopic shoulder surgery, a preoperative ESP block reduces pain scores as compared to periarticular infiltration at the end of surgery. Additionally, we will also examine other factors such as opioid consumption, sensory block, adverse events, patient satisfaction, and persistent pain. METHODS: This is a 2-arm, single-center, parallel-design, double-blind randomized controlled trial of 60 patients undergoing arthroscopic shoulder surgery. Eligible patients will be recruited in the preoperative clinic. Using a computer-generated randomization, with a 1:1 allocation ratio, patients will be randomized to either the ESP or periarticular infiltration group. Patients will be followed in hospital in the postanesthesia care unit, at 24 hours, and at 1 month. The study with be analyzed as intention-to-treat. DISCUSSION: This study will inform an evidence-based choice in recommending ESP block for shoulder arthroscopy, as well as providing safety data. The merits of the study include its double dummy blinding to minimize observer bias, and its assessment of patient important outcomes, including pain scores, opioid consumption, and patient satisfaction. This study will also help provide an estimate of the incidence of side effects and complications of the ESP block. TRIAL REGISTRATION NUMBER: NCT03691922; Recruited Date of registration: October 2, 2018.

Opioid stewardship: implementing a proactive, pharmacist-led intervention for patients coprescribed opioids and benzodiazepines at an urban academic primary care centre.

In 2017, almost 4000 Canadians died from opioid-related causes. Coadministration of opioids and benzodiazepines is a risk factor for overdose. Few studies have evaluated leveraging pharmacists to address opioid-benzodiazepine coprescribing. Our aim was to develop and test a role for pharmacists as opioid stewards, to reduce opioid and benzodiazepine doses in coprescribed patients. We conducted Plan-Do-Study-Act cycles between November 2017 and May 2018 across two primary care centre clinics. A third clinic acted as a control. Our intervention included a pharmacist: (1) identifying patients through medical record queries; (2) developing care plans; (3) discussing recommendations with physicians and (4) discussing implementing recommendations. We refined the intervention according to patient and physician feedback. At the intervention clinics, the number of patients with pharmacist developed care plans increased from less than 20% at baseline to over 60% postintervention. There was also a fourfold increase in the number of patients with an active opioid taper. At the control clinic, the number of patients with pharmacist developed care plans remained relatively stable at less than 20%. The number of patients with active opioid tapers remained zero. At the intervention clinics, mean daily opioid dose decreased 11% from 50.5 milligrams morphine equivalent (MME) to 44.7 MME. At the control clinic, it increased 15% from 62.3 MME to 71.4 MME. The number of patients with a benzodiazepine taper remained relatively stable at both the intervention and control clinics at less than 20%. At the intervention clinics, mean daily benzodiazepine dose decreased 8% from 9.9 milligrams diazepam equivalent (MDE) to 9.3 MDE. At the control clinic, it decreased 4% from 10.8 MDE to 10.4 MDE. A proactive, pharmacist-led intervention for coprescribed patients increased opioid tapers and decreased opioid and benzodiazepine doses. Future work will help us understand whether sustaining the intervention ultimately reduces rates of opioid-benzodiazepine coprescribing.

The impact of pain and opioids use on survival in cancer patients: Results from a population-based cohort study and a meta-analysis.

The study aimed to explore whether cancer-related pain and opioids use are associated with the survival of cancer patients, and perform a cohort study and a meta-analysis to quantify the magnitude of any association.A retrospective cohort study was performed to analyze the impact of pain level, and opioids use on cancer-specific survival (CSS) in advanced cancer patients. Patients and relevant medical records were selected from the registry of the Radiation and chemotherapy division of Ningbo First Hospital between June 2013 and October 2017. Hazard ratios (HRs) and 95% confidential intervals (CIs) for CSS by opioids use were calculated by univariate and multivariate Cox regression analyses. The systematic review included relevant studies published before October 2018. The combined HRs and 95% CIs for overall survival (OS) and progression-free survival (PFS) were calculated using random-effect models.A total of consecutive 203 cancer patients were included in the cohort study. Kaplan-Meier curves indicate a negative association between CSS and cancer-related pain or opioids requirement, but less evidence of an association with the dose of opioids use. Multivariate models revealed that the pain level and opioids requirement were associated with shorter CSS, after adjusting for significant covariates. The results of the meta-analysis indicated that postoperative opioids use had a poor effect on PFS, and opioids use for cancer-related pain was associated with poor OS in cancer patients, while intraoperative opioids use was not associated with cancer survival.We concluded that cancer-related pain and opioids requirements are associated with poor survival in advanced cancer patients, and postoperative opioids use and opioids use for cancer-related pain may have an adverse effect on the survival of cancer patients.

Stability study of hydromorphone and bupivacaine mixture by HPLC-UV.

Objectives: The objective of this study was to evaluate the physical and chemical stability of hydromorphone hydrochloride and bupivacaine hydrochloride in concentrations of 15 mg.ml-1 and 10 mg.mL-1 in 0.9% sodium chloride injection. Test samples of hydromorphone/bupivacaine mixtures were stored at 37°C, body temperature encounterd during continuous intrathecal infusion, for 90 days. The solutions were packaged in 20 ml plastic syringes. Evaluations for physical and chemical stability were performed initially and throughout the storage periods. Physical stability was assessed by visual observation. The chemical stability of the drug was evaluated by means of a stability-indicating high-performance liquid chromatographic (HPLC) analytical technique. In addition, pH and osmolarity were measured electronically. Methods: This study determines the stability and compatibility of hydromorphone (15 mg.ml-1) and bupivacaine (10 mg.ml-1) mixture after 3 months at 37°C using a validated method by HPLC-UV. A simple, precise, specific and accurate reversed phase high performance liquid chromatographic (RP-HPLC) method was developed and validated. The different analytical performance parameters such as linearity, accuracy, specificity, precision and sensitivity (limit of detection and limit of quantitation) were determined according to International Conference on Harmonisation ICH Q2 (R1) guidelines. RP-HPLC was conducted on a nucleoshell RP18plus (C18 150×4.6 mm with 2.7 µm particle size) column. The mobile phase consisted of buffer A (phosphate buffer (0.05M) pH 4.5) and acetonitrile B. The gradient used for the elution is the following one: time (min)/% of B: 0 min/20%; 1.9 min/50%; 2.5 min /40%; 4.5 min/40%; 5.5 min/20%; and 8 min /20%, and the flow rate was maintained at 1.0ml.min-1 and performed at 35°C. The molecules were monitored using Dionex ultimate 3000, equipped with photo diode array detector (λ=210 nm). Linearity was observed in concentration range of 9-21 mg.l-1 for hydromorphone and 6-14 mg.l-1 for bupivacaine. All the system suitability parameters were found within the range. Results: The degradation study shows a photolytic degradation compound for hydromorphone and an oxidative degradation compound found for bupivacaine. The stability study shows no visible haze or particulate formation or gas evolution. pH and osmolarity were stable during the 3 months. Colour changed after 2 months, although this colouring is due to hydromorphone, proportional to hydromorphone concentrations and increases with time but it is a well known modification. The quantitative study by HPLC method revealed no significant change in hydromorphone and bupivacaine concentration. There is less than 5% of variability during the 3-month period. Conclusions: Hydromorphone (15 mg.ml-1) and bupivacaine (10 mg.ml-1) were physically and chemically compatible and analysed with HPLC, which revealed no significant change in hydromorphone and bupivacaine concentration in this simulated compatibility study.

Drug Enforcement Agency 2014 Hydrocodone Rescheduling Rule and Opioid Dispensing after Surgery.

BACKGROUND: In 2014, the U.S. Drug Enforcement Agency reclassified hydrocodone from Schedule III to Schedule II of the Controlled Substances Act, resulting in new restrictions on refills. The authors hypothesized that hydrocodone rescheduling led to decreases in total opioid dispensing within 30 days of surgery and reduced new long-term opioid dispensing among surgical patients. METHODS: The authors studied privately insured, opioid-naïve adults undergoing 10 general or orthopedic surgeries between 2011 and 2015. The authors conducted a differences-in-differences analysis that compared overall opioid dispensing before versus after the rescheduling rule for patients treated by surgeons who frequently prescribed hydrocodone before rescheduling (i.e., patients who were functionally exposed to rescheduling's impact) while adjusting for secular trends via a comparison group of patients treated by surgeons who rarely prescribed hydrocodone (i.e., unexposed patients). The primary outcome was any filled opioid prescription between 90 and 180 days after surgery; secondary outcomes included the 30-day refill rate and the amount of opioids dispensed initially and at 30 days postoperatively. RESULTS: The sample included 65,136 patients. The percentage of patients filling a prescription beyond 90 days was similar after versus before rescheduling (absolute risk difference, -1.1%; 95% CI, -2.3% to 0.1%; P = 0.084). The authors estimated the rescheduling rule to be associated with a 45.4-mg oral morphine equivalent increase (difference-in-differences estimate; 95% CI, 34.2-56.7 mg; P < 0.001) in initial opioid dispensing, a 4.1% absolute decrease (95% CI, -5.5% to -2.7%; P < 0.001) in refills within 30 days, and a 37.7-mg oral morphine equivalent increase (95% CI, 20.6-54.8 mg; P = 0.008) in opioids dispensed within 30 days. CONCLUSIONS: Among patients treated by surgeons who frequently prescribed hydrocodone before the Drug Enforcement Agency 2014 hydrocodone rescheduling rule, rescheduling did not impact long-term opioid receipt, although it was associated with an increase in opioid dispensing within 30 days of surgery.

Can We Rely on Results From IQVIA Medical Research Data UK Converted to the Observational Medical Outcome Partnership Common Data Model?: A Validation Study Based on Prescribing Codeine in Children.

Exploring and combining results from more than one real-world data (RWD) source might be necessary in order to explore variability and demonstrate generalizability of the results or for regulatory requirements. However, the heterogeneous nature of RWD poses challenges when working with more than one source, some of which can be solved by analyzing databases converted into a common data model (CDM). The main objective of the study was to evaluate the implementation of the Observational Medical Outcome Partnership (OMOP) CDM on IQVIA Medical Research Data (IMRD)-UK data. A drug utilization study describing the prescribing of codeine for pain in children was used as a case study to be replicated in IMRD-UK and its corresponding OMOP CDM transformation. Differences between IMRD-UK source and OMOP CDM were identified and investigated. In IMRD-UK updated to May 2017, results were similar between source and transformed data with few discrepancies. These were the result of different conventions applied during the transformation regarding the date of birth for children younger than 15 years and the start of the observation period, and of a misclassification of two drug treatments. After the initial analysis and feedback provided, a rerun of the analysis in IMRD-UK updated to September 2018 showed almost identical results for all the measures analyzed. For this study, the conversion to OMOP CDM was adequate. Although some decisions and mapping could be improved, these impacted on the absolute results but not on the study inferences. This validation study supports six recommendations for good practice in transforming to CDMs.

Spillover Effect of Opioid Reduction Interventions From Adult to Pediatric Surgery.

BACKGROUND: Procedure-specific prescribing guidelines and trainee education have reduced opioid overprescribing in adult surgical patients, but tailored interventions do not yet exist for children. It is unknown what effect these adult interventions have had on postoperative opioid prescribing in children at the same institution, where trainees rotate across both adult and pediatric services. MATERIALS AND METHODS: This retrospective study of patients (<18 y) undergoing pediatric surgery (PS), pediatric otolaryngology (ENT), or pediatric urology (URO) procedures at a single tertiary academic center assessed opioid doses per patient before (January 01, 2015 to September 30, 2016) and after (January 01, 2017 to March 31, 2018) opioid prescribing guidelines and trainee education were instituted for adult laparoscopic cholecystectomy. Patient demographics, postoperative opioid prescribing, opioid refills, and emergency department (ED) visits <21 d after surgery were compared using chi-squared analyses and t-tests. Interrupted time-series analyses (ITSA) assessed changes in the rate of opioid prescribing pre- and postintervention for each subspecialty. RESULTS: There were 3371 patients preintervention and 2439 patients postintervention. After the intervention, fewer patients were prescribed opioids (ENT: 97% versus 93%, P < 0.001; URO: 98% versus 94%, P < 0.001; PS: 61% versus 25%, P < 0.001) and fewer opioid doses were prescribed in each prescription (ENT: 63.8 ± 26.1 versus 50.8 ± 22.0 doses, P < 0.001; URO: 33.5 ± 23.4 versus 22.1 ± 11.3, P < 0.001; PS: 20.4 ± 12.8 versus 13.8 ± 11.4 doses, P < 0.001). There were no changes in opioid refill or ED visit rates postintervention. A decreasing rate in ENT prescribing was seen preintervention, with no significant change postintervention (-2.3 ± 1.1 versus -3.3 ± 0.7; P = 0.24). Whereas, the rate of decrease in PS and URO prescribing significantly slowed postintervention (PS: -2.0 ± 0.1 versus -0.9 ± 0.1, P < 0.001; URO: -4.2 ± 0.2 versus -2.3 ± 0.5, P = 0.005). CONCLUSIONS: Opioid prescribing rates are decreasing, but adult interventions did not achieve reductions in pediatric opioid prescribing at the same institution. There was no concomitant rise in postoperative ED visits or opioid refills as prescribing declined, indicating that the risks of reducing opioid prescriptions may be minimal. Development of evidence-based, procedure-specific prescribing guidelines that specifically address pediatric patients are needed to effectively minimize opioid overprescribing in this population.

Conformity in Prescription and Administration of Respiratory Distress Protocols in a Tertiary Care Hospital in the Province of Quebec: RELIEVE Study.

BACKGROUND: Respiratory distress protocols (RDPs) are protocolized prescriptions comprised of 3 medications (a benzodiazepine, an opioid, and an anticholinergic) administered simultaneously as an emergency treatment for respiratory distress in palliative care patients in the province of Quebec, Canada. However, data on appropriate use that justifies the combination of all 3 components is scarce and based on individual pharmacodynamic properties along with expert consensus. OBJECTIVES: Our study aimed to evaluate the conformity and the effectiveness of RDPs prescribed and administered to hospitalized adult patients. METHODS: This was a prospective and descriptive study conducted in a single center. Prescription and administration conformity were assessed based on predefined appropriateness criteria. RESULTS: A total of 467 adult patients were prescribed a RDP, 175 administrations were documented, and 78 patients received at least 1 RDP. Prescription conformity was assessed on 1473 separate occasions over the trial period. Overall prescription conformity was found to be 37% (95% confidence interval [CI]: 33.6-40.4), and administration conformity was 37.7% (95% CI: 26.2-50.7). Low administration conformity was primarily explained by incorrect indications for RDP use. Seemingly important determinants of higher conformity were prescriber's speciality in palliative care, use of preprinted orders, pharmacist involvement, and hospitalization in the palliative care unit. CONCLUSION: This study highlights important gaps in the use of RDPs in our institution. Health-care provider training appears necessary in order to ensure adequate conformity and allow for further evaluation of RDP effectiveness.

The perception of barriers concerning opioid medicines: A survey examining differences between policy makers, healthcare professionals and other stakeholders.

BACKGROUND: In many countries, the consumption of opioid medicines is too low to meet population needs. Discussions within the Access To Opioid Medication in Europe project indicated that there may be significant differences in the perception of barriers for their adequate use, depending on the stakeholders. AIM: The aim of this study was to examine the perception of barriers and their impact concerning opioid medicines, comparing policy makers, healthcare professionals working in the field of pain management, palliative care or harm reduction and other stakeholders. DESIGN: Data were collected using a questionnaire partially constructed from existing surveys, reviewed for content validity by four experts and pilot-tested in Latvia. SETTING/PARTICIPANTS: Participants of the Access to Opioid Medication in Europe national conferences were invited to complete the questionnaire. Stakeholder groups were compared using non-parametric rank-sum tests. RESULTS: In total, 199 participants (54%) in seven countries completed the questionnaire. Most frequently rated major barriers included lack of financial resources and inadequate knowledge, skills and training among policy makers (55%-66%). Overall, policy makers perceived issues less often as major barriers or having major impact (29% barrier, 32% impact) compared to other stakeholders (36%-42% barrier, 39%-51% impact). Significant differences were seen on several aspects. For example, excessive regulation or bureaucracy for prescribing was rated as having major impact by 55%-57% of healthcare professionals in contrast to only 20% of the policy makers (p = 0.002). CONCLUSION: Multiple barriers may play an important role, partly depending on the perspective of the stakeholder involved. Hence, when addressing perceived barriers, it is important to include all relevant stakeholder groups. Only then, effective and widely supported solutions can be implemented.

Expert Consensus on Clinical Use of an Orally Administered Dexketoprofen Plus Tramadol Fixed-Dose Combination in Moderate-To-Severe Acute Pain: A Delphi Study.

INTRODUCTION: In 2016, the orally administered fixed-dose combination of dexketoprofen 25 mg and tramadol 75 mg (DKP/TRAM FDC) was approved in Europe for short-term treatment of moderate-to-severe acute pain, an indication that encompasses a wide range of post-operative and non-surgical painful conditions. This has suggested the necessity to have a clearer indication on its clinical use, with the support of expert pain clinicians, working in different medical specialities, and reinforced by the data present in the literature. METHODS: With the aim of assisting clinicians in the use of DKP/TRAM FDC in daily practice, two rounds of a modified Delphi process were conducted. In the first round, a board of nine experts developed a series of consensus statements based on available evidence, and their clinical experience, with DKP/TRAM FDC. In the second round, 75 clinicians with extensive experience in pain management expressed individually their agreement with the statements, using a dedicated online platform. Consensus was defined as at least 70% agreement. RESULTS: Twenty-eight statements were developed. Of these, 19 reached the defined level of consensus. CONCLUSION: The agreed consensus statements may assist clinicians in applying the results of clinical studies and clinical experience to routine care settings, providing guidance for use of this new analgesic combination in moderate-to-severe post-operative and non-surgical acute pain. FUNDING: Menarini Group.