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In the setting of an opioid epidemic, this study aims to provide evidence on opioid use trends, risk factors for prolonged use, and complications from perioperative opioid consumption in hallux valgus surgery. A national database was queried for patients who underwent hallux valgus correction. Regression analysis identified: (1) risk factors for prolonged postoperative narcotic use; and (2) association between preoperative/prolonged postoperative narcotic use and postoperative complications. A linear regression analysis was used to determine trends. About 20,749 patients were included, of which 3464 patients were prescribed narcotics preoperatively and 4339 were identified as prolonged postoperative narcotic prescription users. Preoperative prescriptions were identified as risk factors for prolonged use. Perioperative narcotic use was observed to be a risk factor for poor outcomes. About 21% of patients were identified as prolonged postoperative narcotic prescription users. Patients undergoing hallux valgus corrective surgery should be counseled regarding their increased risk of complications when using narcotics.

Background The Choosing Wisely Campaign was launched in 2012 and has been applied to a broad spectrum of disciplines in almost thirty countries, with the objective of reducing unnecessary or potentially harmful investigations and procedures, thus limiting costs and improving outcomes. In Canada, patients with burn injuries are usually initially assessed by primary care and emergency providers, while plastic or general surgeons provide ongoing management. We sought to develop a series of Choosing Wisely statements for burn care to guide these practitioners and inform suitable, cost-effective investigations and treatment choices. Methods The Choosing Wisely Canada list for Burns was developed by members of the Canadian Special Interest Group of the American Burn Association. Eleven recommendations were generated from an initial list of 29 statements using a modified Delphi process and SurveyMonkey™. Results Recommendations included statements on avoidance of prophylactic antibiotics, restriction of blood products, use of adjunctive analgesic medications, monitoring and titration of opioid analgesics, and minimizing ‘routine’ bloodwork, microbiology or radiological investigations. Conclusions The Choosing Wisely recommendations aim to encourage greater discussion between those involved in burn care, other health care professionals, and their patients, with a view to reduce the cost and adverse effects associated with unnecessary therapeutic and diagnostic procedures, while still maintaining high standards of evidence-based burn care.

Болевой синдром после обширных оперативных вмешательств, в частности после тотального эндопротезирования тазобедренного сустава, лежит в основе синдромокомплекса, приводящего к развитию различных послеоперационных осложнений — легочных, кардиальных и тромботических. Новый неопиоидный анальгетик — парацетамол для внутривенного введения Инфулган («Юрия Фарм») расширяет возможности обеспечения эффективного и безопасного послеоперационного обезболивания как самостоятельно, так и в комплексной мультимодальной аналгезии в травматологии и ортопедии при значительном сокращении потребности в опиоидных анальгетиках и снижении связанных с ними побочных эффектов, способных осложнить состояние оперированного пациента.

Background Oral mucositis (OM) associated with cancer treatment not only impairs patients’ quality of life but also causes treatment delays or changes. This prospective exploratory study was conducted to evaluate the efficacy of Episil® oral liquid, which is an approved protective formulation for the oral mucosa in patients with OM. The extent of the pain-relieving effect, feeling during use, and adverse events or problems were evaluated. Methods In total, 10 Japanese cancer patients with OM receiving chemotherapy, pretreatment therapy for hematopoietic stem cell transplantation, or radiation therapy for head and neck cancer were enrolled. Results A numerical rating scale (NRS) was used to assess oral pain intensity due to OM. Compared to baseline, the mean NRS began to decrease at 5 min after using Episil® (7.1 ± 1.4 to 4.6 ± 2.87; p = 0.264). A significant decrease was observed in the pain score after using Episil® compared with that before using Episil®, and this effect lasted up to 120 min. The protective effects of Episil® were observed 3–5 min after application. Some patients felt slight soreness or discomfort when applying Episil®. However, this discomfort due to Episil®’s stimulation was within the allowable range and transient. No adverse events were observed in any of the cases. Conclusions The results of this prospective study showed that Episil® could be an effective treatment to relieve oral pain in Japanese patients with moderate to severe OM, and this newly approved product might adequately support patients’ oral intake. Trial registration University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) (UMIN000031921).

To evaluate "high-risk" opioid dispensing to adolescents, including daily morphine milligram equivalents (MME) above recommended amounts, the percentage of extended-release opioid prescriptions dispensed to opioid-naïve adolescents, and concurrent use of opioids and benzodiazepines, and to evaluate changes in those rates over time.Retrospective cohort study of one state's prescription drug monitoring program data (2010-2017), evaluating adolescents 12-18 years old dispensed opioid analgesic prescriptions. Outcomes of interest were the quarterly frequencies of the high-risk measures. We utilized generalized linear regression to determine whether the rate of the outcomes changed over time.The quarterly percentage of adolescents ages 12-18 years old dispensed an opioid who received ≥90 daily MME declined from 4.1% in the first quarter (Q1) of 2010 to 3.4% in the final quarter (Q4) of 2017 (p 0.0001). The frequency of adolescents dispensed ≥50 daily MME changed little over time. In 2010, the percentage of adolescents receiving an extended-release opioid who were opioid naïve was 60.7%, declining to 50.6% by Q4 of 2017 (p 0.10 overall change 2010-2017). The percentage of adolescent opioid days overlapping with benzodiazepine days was 1.6% in Q1 of 2010, declining to 1.1% by Q4 of 2017 (p 0.001).Among persons 12-18 years old dispensed an opioid analgesic, receipt of ≥90 daily MME declined during the years 2010-2017, as did the percentage of adolescent opioid days that overlapped with benzodiazepines. More than half of the individuals who received extended-release opioid analgesics were identified as opioid naïve and, counter to guidelines, received products intended for opioid-tolerant individuals.

Mayank Gupta, Mahoua Ray, Nicole Ladesich, Akshat Gupta Neuroscience Research Center, LLC, Overland Park, KS, USACorrespondence: Mayank Gupta 10995 Quivira, Overland Park, KS, 66201, USATel +913 339-9437Fax +913 339-9538Email kansaspaindoctor@gmail.comBackground: Chronic pain is a common condition associated with decreased quality of life and increased health-care costs. Opioid analgesics are routinely used to treat chronic pain despite limited evidence of long-term efficacy. Spinal cord stimulation at a frequency of 10 kilohertz (10kHz-SCS) has been shown to be effective for treating chronic pain.Objective: This study was conducted to evaluate the effects of 10kHz-SCS on patients’ pain intensity, volume of pain interventions, and opioid intake in a real-world setting.Study Design: This study was a retrospective review of patient data.Setting: The study was conducted at a single, community-based clinic.Methods: Outcomes including pain relief, quality of life, opioid intake, and rate of health-care usage were evaluated using data from patients who were implanted with a 10kHz-SCS device to treat chronic pain. These outcomes were then compared for the pre- and post-implant periods.Results: A total of 47 patients with a mean follow-up duration of 15.6 ± 6.2 months were included in this analysis. Mean pain relief was 73 ± 22% and 89% were responders at the final follow-up visit. The rate of medical interventions fell from 3.48± 3.05 per year before starting 10kHz-SCS to 0.49± 1.16 per year afterward (P < 0.001). Of 30 patients with available opioid consumption data, 89% maintained or decreased their intake after implant.Conclusion: Retrospective data from a single center, with minimal exclusion criteria shows clinically significant pain relief with 10kHz-SCS, accompanied by significant indirect benefits including stable or reduced opioid use and reduced interventional procedures.Keywords: chronic pain, pain management, spinal cord stimulation, health care costs, opioid analgesics

OBJECTIVE To prospectively analyze pain and pain medication use following otologic surgery. STUDY DESIGN Prospective cohort study with patient reported pain logs and medication use logs. SETTING Tertiary academic hospital.Patients: Sixty adults who underwent outpatient otologic surgeries. INTERVENTIONS Surveys detailing postoperative pain levels, nonopioid analgesic (NOA) use, and opioid analgesic use. MAIN OUTCOME MEASURES Self-reported pain scores, use of NOA, and use of opioid medications normalized as milligrams morphine equivalents (MME). RESULTS Thirty-two patients had surgery via a transcanal (TC) approach, and 28 patients had surgery via a postauricular (PA) approach. TC surgery had significantly lower reported pain scores than PA surgery on both postoperative day (POD) 1 (median pain score 2.2, IQR 0-5 vs. median pain score 4.8, IQR 3.4-6.3, respectively; p = 0.0013) and at POD5 (median pain score 0, IQR 0-0 vs. median pain score 2.0, IQR 0-3, respectively; p = 0.0002). Patients also used significantly fewer opioid medications with TC approach than patients who underwent PA approach at POD1 (median total MME 0, IQR 0-5 vs. median total MME 5.0, IQR 0-15, respectively; p = 0.03) and at POD5 (median total MME 0, IQR 0-0 vs. median total MME 0, IQR 0-5, respectively; p = 0.0012). CONCLUSIONS Surgery with a postauricular approach is associated with higher pain and opioid use following otologic surgery. Patient- and approach-specific opioid prescribing is feasible following otologic surgery.

Opioids have been shown to temporarily reduce the severity of pain when prescribed for medical purposes. However, opioid analgesics can also lead to severe adverse physical and psychological effects or even death through misuse, abuse, short- or long-term addiction, and one-time or recurrent overdose. Dynamic computational models and simulations can offer great potential to interpret the complex interaction of the drivers of the opioid crisis and assess intervention strategies. This study surveys existing studies of dynamic computational models and simulations addressing the opioid crisis and provides an overview of the state-of-the-art of dynamic computational models and simulations of the opioid crisis. This review gives a detailed analysis of existing modeling techniques, model conceptualization and formulation, and the policy interventions they suggest. It also explores the data sources they used and the study population they represented. Based on this analysis, direction and opportunities for future dynamic computational models for addressing the opioid crisis are suggested.

GOALS/BACKGROUND Pain is common among cirrhosis patients, particularly those hospitalized with acute illness. Managing pain in this population is challenging due to concern for adverse events and lack of guidelines for analgesic use. We sought to characterize analgesic use among inpatients with cirrhosis compared with matched noncirrhosis controls, as well as hospital-level variation in prescribing patterns. METHODS We utilized the Vizient Clinical Database, which includes clinical and billing data from hospitalizations at >500 US academic medical centers. We identified cirrhosis patients hospitalized in 2017-2018, and a matched cohort of noncirrhosis patients. Types of analgesic given-acetaminophen (APAP), nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and adjuvants (eg, gabapentinoids, antidepressants) were defined from inpatient prescription records. Conditional logistic regression was used to associate cirrhosis diagnosis with analgesic use. RESULTS Of 116,363 cirrhosis inpatients, 83% received at least 1 dose of an analgesic and 58% had regular inpatient analgesic use, rates that were clinically similar to noncirrhosis controls. Cirrhosis inpatients were half as likely to receive APAP (26% vs. 42%, P

PURPOSE: To examine the prevalence of rapid discontinuation of chronic, high-dose opioid analgesic treatment, and identify associated patient, clinician, and community factors. METHODS: Using 2017–2018 retail pharmacy claims data from IQVIA, we identified chronic, high-dose opioid analgesic treatment episodes discontinued during these years and determined the percent of episodes meeting criteria for rapid discontinuation. We used multivariable logistic regression to estimate the probability of rapid discontinuation, conditional on having a discontinued chronic, high-dose opioid treatment episode, as a function of patient, provider, and county characteristics. RESULTS: We identified 810,120 new, chronic, high-dose opioid treatment episodes discontinued in 2017 or 2018, of which 72.0% (n=583,415) were rapidly discontinued. Rapid discontinuation was significantly more likely among Medicare (aOR 1.14, 95% CI 1.12 to 1.15) and Medicaid enrollees (aOR 1.03, 95% CI 1.02 to 1.05) compared to the commercially insured; in counties with higher fatal overdose rates (aOR 1.03, 95% CI 1.01 to 1.04) compared to counties with the lowest fatal overdose rates; and in counties with a higher percentage of non-white residents (aOR 1.21 for counties in the highest quartile relative to the lowest, 95% CI 1.19 to 1.24). Likelihood of rapid discontinuation also varied by prescriber specialty. CONCLUSIONS: Most chronic, high-dose opioid treatment episodes that ended in 2017 or 2018 were discontinued more rapidly than recommended by clinical guidelines, raising concerns about adverse patient outcomes. Our findings highlight the need to understand what drives discontinuation and to inform safer opioid tapering and discontinuation practices.

Dependency on benzodiazepine and opiates is an increasing problem. Jeff Fernandez uses case studies to show how a nurse-led addiction service based in primary care can improve patient outcomes This article looks at the development of the benzodiazepine and opiate withdrawal service (BOWS) based in addiction services in London. The service was created to implement a manageable and sustainable model that would treat patients with benzodiazepine and codeine-based dependencies. It was envisaged the service would effectively treat patients in GP practices in two boroughs in London. The article outlines what is possible in terms of treatment for patients with issues of opioid dependency, by examining two in-depth case studies. It also illustrates what is possible for nurses in the modern NHS and can be used as a resource to shape and deliver services with positive patient outcomes. Nurses should be seen as shaping and delivering care in the NHS. This is a role that should be promoted to a greater degree, wherever possible.

Cólico renal es una de las patologías consultadas por emergencia, afectando a uno de cada once individuos, se estima que al menos el 50% de estos pacientes presentaran un nuevo episodio de dolor en los próximos 5 años y del 80 al 90 % repetirá un episodio en 10 años, es importante conocer el manejo adecuado para casa caso sobre todo en fase de dolor agudo en la sala de emergencia por lo que se presenta un caso clínico resuelto adecuadamente. Objetivo: actualización bibliográfica sobre el manejo del cólico renal en sala de emergencia. Materiales y métodos: se realizó búsqueda bibliográfica en las principales bases de datos disponibles en la actualidad, encontrando 3 revisiones sistemáticas, 2 guías prácticas de instituciones internacionales de urología, múltiples revisiones bibliográficas y reportes de caso, se seleccionó y cito las fuentes bibliográficas más relevantes y actualizadas. Conclusiones y recomendaciones: Los analgésicos no esteroidales son los medicamentos de elección para manejo del dolor agudo del cólico renal, los analgésicos opioides son de segunda línea. Terapia expulsiva ha demostrado ser útil en cálculos mayores de 5mm localizados en uréter distal. Anuria, infección urinaria y/o dolor refractario son criterios de internación y descompresión de urgencia mediante drenaje percutáneo o colocación de catéter ureteral.

Objective: to evaluate the clinical and economic feasibility of opioid therapy based on the analysis of its cost and effectiveness in patients with chronic pain syndrome in pancreatic cancer.Material and methods. An observational prospective study in parallel groups of patients with chronic pain syndrome associated with pancreatic cancer was carried out. The analysis of cost minimization and cost-effectiveness was applied, as well as pharmacoeconomic modeling, which included the construction of a decision tree in patients receiving morphine sulfate (n=45) and fentanyl TTS (n=45) for pain relief. The sensitivity of the obtained data was assessed using one-way analysis.Results. It was shown that the treatment of chronic pain syndrome in patients with pancreatic cancer with opioid analgesics as part of combined treatment is the least expensive in the morphine sulfate group (incremental cost-effectiveness ratio 144.93). Based on the results of modeling, the prognostic factors of influence on the cost of analgesic therapy were determined: the cost of combined analgesic therapy, the cost of treatment of adverse reactions, and the cost-effectiveness ratio.Conclusion. Analgesic therapy of chronic pain syndrome with morphine sulfate in patients with pancreatic cancer is pharmacoeconomically feasible.

DISCLAIMER: In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE: To identify the proportion of patients with continued opioid use after total hip or knee arthroplasty. METHODS: This systematic review and meta-analysis searched Embase, MEDLINE, the Cochrane Central Register of Controlled Trials, and International Pharmaceutical Abstracts for articles published from January 1, 2009, to May 26, 2021. The search terms (opioid, postoperative, hospital discharge, total hip or knee arthroplasty, and treatment duration) were based on 5 key concepts. We included studies of adults who underwent total hip or knee arthroplasty, with at least 3 months postoperative follow-up. RESULTS: There were 30 studies included. Of these, 17 reported on outcomes of total hip arthroplasty and 19 reported on outcomes of total knee arthroplasty, with some reporting on outcomes of both procedures. In patients having total hip arthroplasty, rates of postoperative opioid use at various time points were as follows: at 3 months, 20% (95% CI, 13%-26%); at 6 months, 17% (95% CI, 12%-21%); at 9 months, 19% (95% CI, 13%-24%); and at 12 months, 16% (95% CI, 15%-16%). In patients who underwent total knee arthroplasty, rates of postoperative opioid use were as follows: at 3 months, 26% (95% CI, 19%-33%); at 6 months, 20% (95% CI, 17%-24%); at 9 months, 23% (95% CI, 17%-28%); and at 12 months, 21% (95% CI, 12%-29%). Opioid naive patients were less likely to have continued postoperative opioid use than those who were opioid tolerant preoperatively. CONCLUSION: Over 1 in 5 patients continued opioid use for longer than 3 months after total hip or knee arthroplasty. Clinicians should be aware of this trajectory of opioid consumption after surgery.

Pain is a symptom of ninety percent of human diseases, and pain management is a very important medicinal problem. Various modulators of the pain response have been detected, and analgesic effects are obtained by increasing inhibition or decreasing excitation in the nervous system. Various known analgesic drugs are commonly used to relieve the pain; however, this problem is still not fully resolved by currently available treatments. Available analgesic drugs (non-steroidal anti-inflammatory drugs, opioids and analgesic adjuvants) are not too effective and are severely limited by adverse effects, for example, opioid addiction. Therefore, developing effective pain management is a difficult but necessary task. Thus, there is an urgent need for further development of the design and synthesis of new analgesic agents. The aim of this review is to present recent progress in search of new small molecule analgesics. The structures and effects of new perspective analgesic agents (anti-inflammatory agents, opioid analgesics, adjuvant agents for pain management, and natural compounds) are presented and discussed. The review covers the literature published in 2015-2020 years and includes 173 references.

Objective To compare the effectiveness, safety, and tolerability of add-on nabiximols (NBX) oromucosal spray vs typical oral long-acting opioid (LAO) analgesics in patients with severe (± chronic) peripheral neuropathic back pain poorly responsive to other treatments. Methods Retrospective analysis of anonymized, propensity score–matched data from the German Pain e-Registry of adult outpatients who initiated NBX or LAO between March 2017 and March 2020. Results Data were analyzed from propensity score–matched patients treated with NBX (n = 655) or LAO (n = 655): mean age ≈51 years; 57% female; mean pain duration ≈2.6 years; chronic pain 61%; severe dysfunctional pain 93%. At 6 months, NBX was noninferior to LAO for overall symptom relief, based on the least-squares mean difference between cohorts in change from baseline in patient-reported, pain-related aggregated nine-item scale scores (−27.84%; 95% confidence interval [CI] −29.71 to −25.96; P Conclusion Within study limitations (e.g., observational design, all potential biases), add-on NBX was superior to and better tolerated than add-on treatment with typical oral LAO analgesics in patients with neuropathic back pain inadequately controlled by recommended/established systemic therapies.

Evidence shows that chronic opioid therapy is usually not beneficial; weaning patients off opioids many times results in less pain and better function, and opioid-induced hyperalgesia is real and frequent. Further evidence suggests that surgical outcomes are better if patients are weaned off opioids before surgery, and that the chronic use of opioids may adversely alter the assessment of maximum medical improvement (MMI).

Compound opioid analgesics (COA) are widely used for cancer pain relief, but few studies investigated the use of that. We aimed to report the characteristics and trend of COA consumption in different regions and health facilities in China. The procurement data of two types of COA, compound codeine phosphate (CCP) and oxycodone and acetaminophen (OAA), in all medical institutions of 20 provinces from 2015 to 2018 were used. Data were presented as Defined Daily Dose for Statistical purpose (SDDD) and expenditures per million inhabitants per day. The annual consumption of COA and ratio of two combinations were compared among regions and institutions. We found, during 2015 - 2018, COA consumption increased at an average rate of 7.32% in SDDD and 19.19% in expenditures, while OAA accounted for most of the consumption. Highest COA consumption appeared in Northern China, with 121.72 SDDD and 1689.87 RMB (2015), whereas the lowest COA consumption was only 11.28 SDDD appearing in Southern China. The ratio of OAA and CCP (in SDDD) was highest in Southern China (53.14 in 2018), whereas lowest in West North (0.37 in 2018). In terms of institutions, tertiary had the highest COA consumption, with 16.74 SDDD and 292.73 RMB (2018). The SDDD of OAA was 27.44 times of that of CCP in tertiary, while it was only 0.11 in primary. Overall, COA consumption is on an upward trend and different among regions and health institutions in either amount or types of COA. These findings call for establishment of COA management regulations.

Although buprenorphine is the most frequently used opioid analgesic in common marmosets (Callithrix jacchus), there is limited information in the literature supporting current dosing regimens used for this species. The purpose of this study was to determine the pharmacokinetic profiles of single-dose buprenorphine HCl administered intramuscularly (IM) at 0.01 mg/kg in 6 adult marmosets (1.8 to 12.8 y old; 2 males, 4 females) and subcutaneously (SQ) at 0.01 mg/kg in 6 adult marmo- sets (2.3-4.4 y old; 3 males, 3 females) by mass spectrometry. Blood was collected at multiple time points from 0.25 to 24 h from unsedated animals following a hybrid sparse-serial sampling design. The maximal observed plasma concentration of buprenorphine (Cmax) administered IM (2.57 ± 0.95 ng/mL) was significantly higher than administered SQ (1.47 ± 0.61 ng/mL). However, the time to Cmax(Tmax) was not statistically different between routes (17.4 ± 6 min for IM and 19.8 ± 7.8 min for SQ). The time of the last quantifiable concentration of buprenorphine was 5 ± 1.67 h for IM compared with 6.33 ± 1.51 h for SQ, which was not statistically different. The mean buprenorphine plasma concentration-time curves were used to propose a dosing frequency of 4 to 6 h for buprenorphine at 0.01 mg/kg IM or SQ based on a theoretical therapeutic plasma concentration threshold of 0.1 ng/mL. Based on the mean pharmacokinetic parameters and plasma-concentration time curves, both IM and SQ routes of buprenorphine at this dose provide a rapid increase in the plasma concentration of buprenorphine above the therapeutic threshold, and may be more effective for acute rather than long-lasting analgesia. Further studies are needed to examine repeated dosing regimens and the efficacy of buprenorphine in common marmosets.

Objective We sought to determine whether author conflict of interest (disclosed or undisclosed) or industry sponsorship influenced the favorability of reporting of systematic reviews and meta-analyses investigating the use of opioid analgesics for the management of chronic non-cancer pain. Methods Our search included the MEDLINE (Ovid) and Embase (Ovid) databases. Study sponsorship was determined using the funding statement provided in each systematic review. Author COI information was extracted from the COI disclosure statement. This information was cross-referenced with information available on the CMS Open Payments Database, Dollars for Profs, Google Patents, the United States Patent and Trademark Office (USPTO), and previously published COI disclosures. Results Eight systematic reviews authored by 83 authors were included. Of these authors, 19 (23.0%) were found to have a COI, of which the majority (17/19; 89.5%) had at least one undisclosed COI. Despite nearly one-quarter of authors having a COI, we found no association between the presence of a COI and the favorability of results (P = 0.64) or conclusions (P = 0.07). Conclusions COI are common and frequently undisclosed among systematic review authors investigating opioid analgesics for the management of chronic non-cancer pain. Despite a high prevalence of COI, we did not find that these author-industry relationships had a significant influence on the favorability of results and conclusions; however, our findings should be considered a lower bound estimate of the true influence author COI have on outcomes of pain medicine systematic reviews secondary to the low sample size included in the present study.

Background The ways in which prescription drug monitoring programs (PDMPs) have been integrated into primary care practice remain understudied, and research into physician utilization of PDMPs in states where PDMP use is mandated remains scant. Objectives To characterize primary care physician perspectives on and utilization of a mandatory PDMP in New York City. Methods We conducted face-to-face, in-depth interviews with primary care physicians who reported that they currently prescribed opioid analgesic medication. We used a thematic analytic approach to characterize physician perspectives on the PDMP mandate and physician integration of mandatory PDMP use into primary care practice. Results Primary care providers demonstrated a continuum of PDMP utilization, ranging from consistent use to the specifications of the mandate to inconsistent use to no use. Providers reported a range of perspectives on the purpose and function of the PDMP mandate, as well as a lack of clarity about the mandate and its enforcement. Conclusion Findings suggest a need for increased clinical and public health education about the use of PDMPs as clinical tools to identify and treat patients with potential substance use disorders in primary care.

Background Increasing naloxone awareness and carrying among individuals who misuse opioid analgesic medications (OAs) could reduce opioid overdose mortality. Methods Self-report surveys were completed by 322 adults receiving residential addiction treatment who misused OAs in the past year. Descriptive analyses and prevalence ratios (using Poisson generalized estimating equations) examined whether illegal opioid (e.g., heroin) initiation was associated with naloxone awareness. Results Among this sample of participants who misused OAs, naloxone awareness was lowest among those who never used illegal opioids (26%) and highest among those who transitioned from OAs to illegal opioid use over time (83%). Naloxone awareness remained higher among participants who had used illegal opioids after adjustment for sociodemographic and substance use characteristics. Those who used OAs before initiating illegal opioids were 2.3-fold (95% CI: 1.5–3.3) more likely to have naloxone awareness than those who had only misused OAs after adjustment. Half of participants who had only used OAs had experienced an overdose, 75% had witnessed an overdose, and 61% were prescribed OAs to treat pain in the past 6 months. Conclusions Implementing overdose education and naloxone distribution programs during addiction treatment could bolster naloxone awareness among people who misuse OAs but who have not used illegal opioids.

Objective To curb opioid overprescription and diversion, 49 states have implemented mandatory prescription drug monitoring programs (PDMPs). This study aims to examine the changes in analgesic prescription patterns associated with mandatory PDMP usage by oral and maxillofacial surgeons. Design This retrospective observational cohort study analyzed analgesic prescriptions after third molar surgeries from the University of Pennsylvania from July 2016 to December 2019. Because Pennsylvania mandated PDMP usage on January 1, 2017, we analyzed prescriptions 6 months prior to and for each 6-month interval after implementation. Results Prescriptions after 13,430 procedures on 6437 patients across 7 6-month periods were analyzed. Patients in all study periods had an average age of 40 years and there was a slight majority of females. After PDMP implementation, patients who received analgesics had an 80% lower odds of receiving an opioid option after adjusting for age, sex, and procedural severity. When an opioid was prescribed, the mean pills per script decreased from 20.18 to 10.96 1 year after PDMP implementation. Conclusions Mandatory PDMP usage was associated with decreased odds of a patient receiving an opioid analgesic and with a decrease in mean opioid pills per script. PDMPs may be helpful in reducing opioid prescriptions by oral and maxillofacial surgeons after third molar surgery.

In this article we performed publication analysis devoted to pain medicine in oncology during anticancer therapy and in palliative setting. Until recently, the main WHO guidelines for pain management in oncology were the recommendations of 1996, which included only pain relievers, as well as adjuvant and symptomatic drugs, which were applied according to the WHO analgesic ladder. These recommendations were based on the collective expert opinion of leading clinicians and scientists. The new WHO clinical guidelines were published in 2019. They are based on the principles of evidence-based medicine, including modern concepts of the etiology and pathogenesis of tumor pain syndrome. This recommendations contain sections on the analgesic efficacy of radiation therapy and antitumor drug therapy. The new WHO recommendations have not yet been published in Russian and are not sufficiently available for a wide range of oncologists and palliative specialists in our country. The purpose of this publication is to present within one volume a concise but complete and comprehensible discussion of the latest trends in pain therapy in oncology, published by WHO experts.

Opioids are a mainstay of treatment for pain worldwide. Pruritus, a common side effect of opioids, is a patient dissatisfier that limits their use in many clinical settings. Both parenteral and neuraxial administration of opioids frequently evoke pruritus. The ability of opioids to suppress pain while causing itch continues to perplex clinicians and researchers alike. Several mechanisms have been proposed to explain how opioids can give rise to pruritus, but specific knowledge gaps perpetuate debate. This review summarizes the clinical burden of opioid-induced pruritus and emphasizes recent discoveries of peripheral and central mechanisms for opioid-induced pruritus, particularly with respect to scientific and conceptual advances in spinal cord circuitry and mast cell biology. The mechanisms and effectiveness of existing medications used for clinical management of pruritus will be evaluated, and we will highlight the emerging preclinical utility of selective κ-opioid receptor agonists, such as nalfurafine, for the management of opioid-induced pruritus.

Objective To evaluate trends in the use of epidural analgesia and nonopioid and opioid analgesics for patients undergoing lobectomy from 2009 to 2018. Methods We queried the Premier database for adult patients undergoing open, video-assisted, and robotic-assisted lobectomy from 2009 to 2018. The outcome of interest was changes in the receipt of epidural analgesia and nonopioid and opioid analgesics as measured by charges on the day of surgery. We also evaluated postoperative daily opioid use. We used multivariable logistic and linear regression models to examine the association between the utilization of each analgesic modality and year. Results We identified 86,308 patients undergoing lobectomy from 2009 to 2018 within the Premier database: 35,818 (41.5%) patients had open lobectomy, 35,951 (41.7%) patients had video-assisted lobectomy, and 14,539 (16.8%) patients had robotic-assisted lobectomy. For all 3 surgical cohorts, epidural analgesia use decreased, and nonopioid analgesics use increased over time, except for intravenous nonsteroidal anti-inflammatory drugs. Use of patient-controlled analgesia decreased, while opioid consumption on the day of surgery increased and postoperative opioid consumption did not decrease over time. Conclusions In this large sample of patients undergoing lobectomy, utilization of epidural analgesia declined and use of nonopioid analgesics increased. Despite these changes, opioid consumption on day of surgery increased, and there was no significant reduction in postoperative opioid consumption. Further research is warranted to examine the association of these changes with patient outcomes.

Introduction Laparoscopic splenectomy (LS) is the standard of care for hematologic disorders requiring splenectomy. Less is known about the outcomes following robotic-assisted splenectomy (RS) for this indication. Our aim was to describe outcomes of RS to LS in pediatric patients with hematologic disorders in our institution. Methods A single institution retrospective review was performed of pediatric patients undergoing LS vs. RS from 2014 to 2019. Patient demographics, diagnosis, spleen size, hospital length of stay (LOS), operative time, post-operative opioid use, and hospital charges were evaluated. Standard univariate analyses were performed. Results Twenty-four patients were included in the study (14 LS, 10 RS). The mean spleen size at the time of surgery was larger in the RS group compared to LS (14.5 cm vs. 12.2 cm, p = 0.03). Operative time between the two cohorts was comparable (RS 140.5 vs LS 154.9 min). Median LOS for RS was shorter than LS (2.1 vs. 3.2 days, p = 0.02). Cumulative postoperative opioid analgesic requirements were not significantly different between the groups (17.4 mg vs. 30.5 mg). The median hospital charges, including the surgical procedure and hospital stay were higher in the RS group ($44,724 RS vs $30,255 LS, p = 0.01). Conclusion Robotic splenectomy is a safe and feasible option for pediatric patients with hematologic disorders, and was associated with decreased LOS but higher charges compared to laparoscopic splenectomy. Further studies are required to delineate the optimal use and potential benefits of robot-assisted surgical techniques in children. Level of Evidence II.

BACKGROUND: Limiting the incidence of opioid-naïve patients who transition to long-term opioid use (i.e., continual use for > 90 days) is a key strategy for reducing opioid-related harms. OBJECTIVE: To identify variables constructed from data routinely collected by prescription drug monitoring programs that are associated with opioid-naïve patients’ likelihood of transitioning to long-term use after an initial opioid prescription. DESIGN: Statewide cohort study using prescription drug monitoring program data PARTICIPANTS: All opioid-naïve patients in California (no opioid prescriptions within the prior 2 years) age ≥ 12 years prescribed an initial oral opioid analgesic from 2010 to 2017. METHODS AND MAIN MEASURES: Multiple logistic regression models using variables constructed from prescription drug monitoring program data through the day of each patient’s initial opioid prescription, and, alternatively, data available up to 30 and 60 days after the initial prescription were constructed to identify probability of transition to long-term use. Model fit was determined by the area under the receiver operating characteristic curve (C-statistic). KEY RESULTS: Among 30,569,125 episodes of patients receiving new opioid prescriptions, 1,809,750 (5.9%) resulted in long-term use. Variables with the highest adjusted odds ratios included concurrent benzodiazepine use, ≥ 2 unique prescribers, and receipt of non-pill, non-liquid formulations. C-statistics for the day 0, day 30, and day 60 models were 0.81, 0.88, and 0.94, respectively. Models assessing opioid dose using the number of pills prescribed had greater discriminative capacity than those using milligram morphine equivalents. CONCLUSIONS: Data routinely collected by prescription drug monitoring programs can be used to identify patients who are likely to develop long-term use. Guidelines for new opioid prescriptions based on pill counts may be simpler and more clinically useful than guidelines based on days’ supply or milligram morphine equivalents. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11606-020-06555-x.

Opioid overdoses and deaths continue to be a problem in the USA with a significant portion related to prescribed opioid analgesic agents. The role of pharmacogentic factors in opioid addiction is an active area of research. While all opioid analgesic agents have some addictive potential, it is clear that there are some with greater addictive potential. Oxycodone is the most widely abused opioid analgesic and it appears to predispose to chronic use with high likability by users. Fentanyl and hydromorphone are both very lipophilic allowing rapid penetration into the CNS, but are not rated as highly as other agents. Providers should consider the risk of addiction with the opioids they prescribe and give those with a lower addictive potential.

Risk of postpartum opioid use disorder or overdose is low among women with prenatal opioid analgesic use.

Supplemental Digital Content is available in the text., Background: It is unclear whether confounding accounts for the increased risk of preterm birth and small for gestational age (SGA) birth in opioid analgesic exposed pregnancies. Methods: Using universal coverage health data for Ontario, we assembled a cohort of mother–infant pairs without opioid use disorder (627,172 pregnancies and 509,522 women). We estimated risk ratios (RRs) between opioid analgesics and preterm birth, SGA birth, and stillbirth; neonatal abstinence syndrome was a secondary outcome. We used high-dimensional propensity scores and sensitivity analyses for confounding adjustment. Results: 4% of pairs were exposed, mainly to codeine (2%), morphine (1%), and oxycodone (1%). Compared with unexposed, the adjusted risk of preterm birth was higher with any (1.3, 95% confidence interval [CI] = 1.2, 1.3), first- (RR: 1.2, 95% CI = 1.2, 1.3), and second-trimester (RR: 1.3, 95% CI = 1.2, 1.4) opioid analgesic exposure. Preterm birth risk was higher for first- and second-trimester codeine, morphine, and oxycodone exposure, and for third-trimester morphine. There was a small increase in SGA with first-trimester exposure to any opioid analgesic or to codeine. Exposed pregnancies had an elevated stillbirth risk with any (RR: 1.6, 95% CI = 1.4, 1.8), first- and second-trimester exposure. Few infants had neonatal abstinence syndrome (N = 143); the risk was higher in exposed (RR: 3.6, 95% CI = 2.1, 6.0). In sensitivity analyses of unmeasured confounding, an elevated risk in exposed pregnancies persisted for preterm birth but not SGA. Conclusions: Opioid analgesic-exposed pregnancies had a small increased risk of preterm birth and possibly stillbirth after accounting for confounding by indication and sociodemographic factors.

Daina B Esposito,1 Vibha CA Desai,1 Judith J Stephenson,1 M Soledad Cepeda,2 Jennifer G Lyons,1 Crystal N Holick,1 Gregory P Wedin,3 Stephan Lanes1 On behalf of members of the REMS Program Companies Metrics Subteam1HealthCore, Inc., Wilmington, DE, USA; 2Janssen Research and Development, Titusville, NJ, USA; 3Upsher-Smith Laboratories, LLC, Maple Grove, MN, USACorrespondence: Judith J StephensonHealthCore Inc, 123 Justison Street, Suite 200, Wilmington, DE, 19801, USATel +1 302-547-5770Email jstephenson@healthcore.comBackground/Rationale: The US Food and Drug Administration (FDA) approved a Risk Evaluation and Mitigation Strategy (REMS) for extended release/long-acting (ER/LA) opioids in 2012. The purpose of this study was to assess patient knowledge of the safe use of these products following implementation of the REMS and to determine possible effects of the REMS, including impact on medication access.Objective: To assess patient knowledge of safe use of ER/LA opioids and use of REMS patient education tools such as the Medication Guide (MG) and Patient Counseling Document (PCD).Methods: This was a cross-sectional survey of commercially insured (Commercial) and Medicare Advantage-insured (Medicare) adults with ≥ 1 pharmacy claim for an ER/LA opioid (10/01/2015 – 02/28/2017) in the HealthCore Integrated Research Database and Medicaid-insured (Medicaid) adult members of a research panel, about their knowledge of safe use of ER/LA opioids and receipt/comprehension of the MG and PCD.Results: Survey respondents consisted of 382 Commercial, 43 Medicare and 40 Medicaid adults. While ≥ 95% of respondents received and read the MG, fewer were aware of the PCD (Commercial: 47%, Medicare: 65%, Medicaid: 53%). Almost 75% of the knowledge questions were answered correctly by ≥ 80% of all respondents; fewer respondents recognized that use of opioids as directed can lead to death (Commercial: 73%, Medicare: 56%, Medicaid: 63%), the MG should be read at each dispensing (Commercial: 78%, Medicare: 53%, Medicaid: 75%), opioids should not be stored in the medicine cabinet (Commercial: 77%, Medicare: 79%, Medicaid: 58%), missed doses should not be taken as soon as possible (Commercial: 56%, Medicare: 51%, Medicaid: 50%), and pills should not be crushed (Commercial: 85%, Medicare: 67%, Medicaid: 52%).Conclusion: Although most respondents reported reading and understanding the MG and exhibited knowledge of safe use of ER/LA opioids, providers’ use of the PCD and increased understanding of safe use core messages need reinforcement.Keywords: Risk Evaluation and Mitigation Strategy, opioids, patient knowledge

In the U.S., an opioid overdose crisis has emerged, attributable to over-prescription of opioid analgesics, driven by aggressive marketing by pharmaceutical companies, followed by surging heroin overdose deaths, and more recently, by the high mortality rates predominately because of illicitly manufactured fentanyl and analogs of fentanyl. In Europe, the use of prescription opioids for pain management has also increased in the last 2 decades, although it is debatable as to whether this could lead to a similar opioid overdose crisis. To address this issue, recent trends in opioid prescription rates, prevalence rates of fatal and nonfatal incidents, and addiction care treatment were used as proxies of opioid-related harm. The current overview, comparing opioid use and its negative consequences in Germany, France, the U.K., and the Netherlands, using the same indicators as in the U.S., demonstrates that there is no evidence of a current or emerging opioid crisis in these European countries. Scotland, however, is an alarming exception, with high rates of opioid-related harms. Considering that the use of prescription opioids has been declining rather than increasing in Europe, an opioid crisis is not anticipated there yet. Authorities should, however, remain vigilant.

Introduction: The coronavirus disease 2019 (COVID-19) pandemic and subsequent restrictions on dental services have had a significant impact on the provision of dental care in Australia and around the world. Objectives: To investigate the impact of COVID-19 on medications prescribed by dentists under the Australian Pharmaceutical Benefits Scheme (PBS). Methods: Data on the number of dental prescriptions dispensed for all medications listed on the PBS Dental Schedule, from January 2019 to June 2020, were extracted from publicly available data sets. Analysis of prescription trends was performed for 1) total medications, 2) each major medication class, and 3) individual medications. The number of prescriptions dispensed in each month from January 2020 to June 2020 was compared to the same month in 2019 to determine the relative (percentage) change, and z statistics were used to determine whether changes were statistically significant. Results: There was a significant decrease in dental prescriptions in April 2020 compared to April 2019 (14,785, 18%; P < 0.05). Decreases in prescriptions for antibiotics (10,512, 16%; P < 0.05) and opioid analgesics (3,129, 18%; P < 0.05) were smaller compared to other major medication classes. There was a significant increase in June 2020, compared with June 2019, for prescriptions of amoxicillin with clavulanic acid (4,903, 20%; P < 0.05), tramadol (89, 46%; P < 0.05), and oxycodone (381, 73%; P < 0.05). Conclusion: Dental service restrictions during COVID-19 likely drove an unmet need for routine dental treatment, which had significant implications for public oral health following easing of restrictions. During the initial surge and subsequent lockdown, antibiotics and opioid analgesics may have been used an as alternative to routine operative treatment. Continued professional guidance is required to ensure dental prescribing remains evidence based during the pandemic period. Knowledge Transfer Statement: The COVID-19 pandemic and subsequent restrictions on dental practice have had a profound impact on the provision of dental care in Australia and elsewhere in the world. In this context, population-level medication surveillance is important to identify and respond to changes in prescribing patterns that have arisen due to COVID-19 and restrictions on the provision of dental care. This research is particularly important for governments, regulators, and professional associations to ensure therapeutic guidelines and recommendations during the pandemic period remain relevant and evidence based.

Background: Surveillance data suggest that women are prescribed more opioid analgesics than men. It remains unclear whether these sex-related differences solely reflect the associations with other ...

Objectives: This study aimed to assess the completeness and quality of adverse drug reaction (ADR) reports that were submitted to the Pharmacovigilance Unit (PVU) in clinical training center (CTC), Faculty of Medicine, UiTM Sungai Buloh Campus. Materials and Methods: A retrospective study was conducted using all ADR reports that were submitted to the PVU in CTC from December 31, 2000, to December 31, 2018. The completeness was assessed by reviewing all the required elements to be filled in the ADR reports. The quality was assessed by investigating the required information in the ADR reporting form. Descriptive statistics have been used to present the findings. Key Findings: In a total of 31 reports that were submitted to the PVU in CTC, 98.9% of patient's information and 100% of ADR descriptions were completed. Suspected drug information and the reporter's details were completed by 52.2% and 79.6%, respectively. Of 58.0% of the information about seriousness recorded, 38.9% (n = 7) is mild, 44.4% (n = 8) is moderate, and 16.7% (n = 3) is severe. Among all the suspected medicines, drug class of antibiotics (32.4%, n = 12) is the most reported suspected drugs that caused ADR, followed by opioid analgesic (8.1%, n = 3) and nonsteroidal anti-inflammatory drugs (8.1%, n = 3). Conclusion: Further efforts and relevant interventions should be considered to increase the reporting frequency and to enhance the completeness and the quality of the ADR reports in the study setting.

Background The guidelines on pharmacotherapy for cancer-related pain advocate active measures against the adverse effects of opioids to increase adherence to medication. However, preventative therapy for the management of nausea and vomiting has not been specified. This study aimed to verify the effects of prophylactic anti-emetics in preventing opioid-induced nausea and vomiting. Patients and methods We conducted a retrospective analysis of cases at our hospital in which oral opioids or patches were initiated for the management of pain due to malignant tumours from January 2017 to September 2019. Results Strong opioids were initiated for 349 patients; of these, data for 298 patients were analysed. A total of 193 patients were on anti-emetic prophylaxis. We found that the group that did not receive anti-emetic prophylaxis was significantly more likely to be prescribed an additional anti-emetic. Conclusion Prophylactic administration of anti-emetics at the time of initiating opioid analgesics may reduce gastrointestinal toxicity.

The opioid analgesic tapentadol was the first pain medication to be developed for the treatment of pain in children under a formal process established by the regulatory authorities. This article summarizes the outcomes of the pediatric development program for tapentadol across the entire age range from birth (including neonates) to adolescents

Introduction. Pre- and post-graduate education, provided for many years, has quite significantly changed the perception of the role of opioids in the treatment of patients with pain, mainly chronic pain. However, research on the knowledge of students on opioids has not been conducted, which makes it difficult to implement desired changes in educational programmes. The aim of the paper was to evaluate the knowledge of medical students on selected opioid drugs: tramadol, buprenorphine and oxycodone, based on a survey filled in after one-week classes in palliative medicine and pain management. Respondents and methods. The study included 140 fourth-year students of medicine at the University of Medical Sciences in Poznan who completed one-week classes in palliative medicine and pain management. Their knowledge on opioid analgesics was checked using an anonymous survey that included 7 statements. Results. Students demonstrated better knowledge in statements regarding theoretical aspects of the use of specific opioids and their mechanisms of action. The percentage of correct answers in the group of statements concerning the availability of specific opioid analgesics was much lower, which confirms that they have less knowledge in this area. Conclusions. Paying attention to the characteristics of specific opioids should improve the individual selection, effectiveness and safety of treatment. Better knowledge on pain management among students, doctors and the general public may dispel their concerns about using opioid analgesics as well as increase the effectiveness of pain management and improve the quality of life of patients with cancer and chronic pain in palliative care.

Approximately 30% of patients experience nausea after initiation of opioid therapy, which can lead to poor quality of life. We aimed to identify risk factors for opioid-induced nausea at the initiation of opioid therapy by conducting a retrospective review of medical records of patients diagnosed by palliative care specialists with solid cancer and pain at the lesion site at Showa University Hospital between June 2005 and June 2011. The primary endpoint was the development of nausea grade ≥1 according to the Common Terminology Criteria for Adverse Events version 4.0 within 48 hours of initiation of opioid therapy. The median age of the 134 enrolled patients was 67.7 (range 28-95) years. Fifty-three percent were male and 44% had gastrointestinal cancer. Furthermore, 22.4% had opioid-induced nausea. Age (odds ratio (OR) 1.74; 95% confidence interval (CI), 1.13-2.69), edema (OR 5.83; 95% CI, 1.22-28.19), and gastrointestinal cancer (OR 2.61, 95% CI 1.07-6.36) were significantly associated with opioid-induced nausea. Prophylactic antiemetics were found to be ineffective.

Objectives Although trends in opioid-related death rates in the United States have been described, the association between state-level opioid overdose death rates in early waves and substance-related overdose death rates in later waves has not been characterized. We examined the relationship between state-level opioid overdose death rates at the beginning of the crisis (1999-2004) and overdose death rates for opioids and other substances in later years. Methods Using 1999-2018 multiple cause of death data from the Centers for Disease Control and Prevention, we first categorized each state by quartile of baseline (1999-2004) opioid overdose death rates. By baseline opioid overdose death rates, we then compared states’ annual overdose death rates from any opioid, heroin, synthetic opioids, sedatives, stimulants/methamphetamine, and cocaine from 2005 through 2018. To test the association between baseline opioid overdose death rates and subsequent substance-related overdose death rates for all 6 substances, we estimated unadjusted and adjusted linear models controlling for annual state-level unemployment, median household income, age, sex, and race/ethnicity. Results Our results suggest 2 characteristics of the opioid crisis: persistence and pervasiveness. In adjusted analyses, we found that for each additional opioid overdose death per 100 000 population at baseline, states had 23.5 more opioid deaths, 4.4 more heroin deaths, 8.0 more synthetic opioid deaths, 9.2 more sedative deaths, 3.3 more stimulant deaths, and 4.6 more cocaine deaths per 100 000 population from 2005 to 2018. Conclusion These findings have important implications for continued surveillance to assist policy makers in deciding how to deploy resources to combat not just opioid use disorder but also polysubstance use disorder and broader problems of substance use disorder.

The efficiency and quality of postoperative pain management may be considered unsatisfactory in Europe, as well as in the United States. Notwithstanding our better understanding of the physiology of pain and the development of new analgesia procedures, the improvement in satisfaction of patients has not be enhanced to the same degree. Obstetrics and gynecology are no exception to this statement. In fact, obstetrics and gynecology are surgical departments in which patients experience the greatest severity of postoperative pain. Current concepts of postoperative pain management are largely based on the administration of systemic non-opioid and opioid analgesics, supplemented with regional analgesia procedures and/or peripheral nerve blockades and, in some cases, the administration of other pain-relieving pharmaceutical agents. Based on the existing body of evidence, it would be appropriate to develop procedure-related concepts of analgesia. The concepts are based on the special circumstances of the respective department, and the scheme of analgesia is aligned to the respective interventions. Generally, however, a surgeon’s individual experience in dealing with the procedures and substances could be more significant than the theoretical advantages demonstrated in preceding investigations.