Showing papers in "Journal of opioid management in 2016"
TL;DR: There is low to moderate quality evidence suggesting that the presence of opioid prescribing policy will reduce the amount and strength of opioid prescribed, but there is no clear evidence to suggest that it reduces opioid misuse.
Abstract: Objective: In response to persistent public health concerns regarding prescription opioids, many states and healthcare systems have implemented legislation and policies intended to regulate or guide opioid prescribing. The overall impact of these policies is still uncertain. The aim of this systematic review was to examine the existing evidence of provider-level and patient-level outcomes preimplementation and postimplementation of policies and legislation constructed to impact provider prescribing practices around opioid analgesics. Design: A systematic search of MEDLINE, EMBASE, the Web of Science, and the Cochrane Database of Systematic Reviews was conducted to identify studies evaluating the impact of opioid prescribing policies on provider-level and patient-level outcomes. The systematic review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Results: Eleven studies were included in the review. A meta-analysis was not possible due to between-study heterogeneity. Six of the studies assessed state-level policies, and five were at the level of the healthcare system or hospital. Studies showed temporal associations between policy implementation and reductions in opioid prescribing, as well as opioid-related overdoses. Results were mixed regarding the impact of policies on misuse. The majority of the studies were judged to be of low quality based on the GRADE criteria. Conclusions: There is low to moderate quality evidence suggesting that the presence of opioid prescribing policy will reduce the amount and strength of opioid prescribed. The presence of these policies may impact the number of overdoses, but there is no clear evidence to suggest that it reduces opioid misuse.
34 citations
TL;DR: At a clinically effective analgesic dose, methamphetamineadone dosage and duration were not correlated with QTc prolongation, even in the presence of other risk factors, suggesting that methadone use may be safe in pediatric populations.
Abstract: Objective: Methadone prolongs cardiac conduction, from mild corrected QT (QTc) prolongation to torsades de pointes and ventricular fibrillation, in adults. However, methadone use for pain and its effects on cardiac conduction have not been investigated in pediatric populations. Methods: A retrospective review of QTc intervals in patients receiving methadone analgesia was conducted. Medical records from a 4-year period (September 2006 to October 2010) at a pediatric oncology institution were reviewed, and correlations were tested between cardiac conduction and methadone dosage and duration of therapy, electrolyte levels, renal and hepatic dysfunction, and concurrent medications. Results: Of the 61 patients who received methadone, 37 met our inclusion criteria and underwent 137 electrocardiograms (ECGs). During methadone treatment, the mean QTc was longer than that at baseline (446.5 vs 437.55 ms). The mean methadone dose was 27.0 ± 24.3 mg/d (range, 5-125 mg/d; median, 20 mg/d) or 0.47 ± 0.45 mg/kg per day (range, 0.05-2.25 mg/kg per day; median, 0.37 mg/kg per day), and the mean duration of therapy was 49 days. The authors identified a correlation between automated and manual ECG readings by two cardiologists (Pearson r = 0.649; p < 0.0001), but the authors found no correlations between methadone dose or duration and concurrent QTc-prolonging medications, sex, age, electrolyte abnormalities, or renal or hepatic dysfunction. Conclusion: At a clinically effective analgesic dose, methadone dosage and duration were not correlated with QTc prolongation, even in the presence of other risk factors, suggesting that methadone use may be safe in pediatric populations. The correlation between automated and manual ECG readings suggests that automated ECG readings are reliable for monitoring cardiac conductivity during the reported methadone-dosage regimens.
32 citations
TL;DR: The attitudes toward, and use of, the Canadian Opioids Guideline among pain physicians are investigated and it is found that the guideline is excessively long and the format suboptimal, and improved dissemination and education are needed to enhance guideline uptake.
Abstract: Background: Chronic noncancer pain (CNCP) refers to all pain disorders, not due to cancer, that persist for ≥ 3 months. The point prevalence of CNCP in the general population of Western countries is between 19 and 33 percent. Opioids are commonly prescribed for CNCP and are associated with both benefits and harms. The Canadian Guideline for Safe and Effective Use of Opioids for CNCP was published in 2010 to provide guidance for optimal opioid prescribing in patients with CNCP. Objectives: To investigate the attitudes toward, and use of, the Canadian Opioids Guideline among pain physicians. Design: A qualitative study using one-on-one, semistructured interviews with 12 pain physicians in Ontario, Canada, and thematic analysis of verbatim transcripts. Results: Major themes that emerged from interviews included: (1) generally positive attitudes toward the 2010 Canadian Opioids Guideline, but limited use—half (six of 12) reported they did not use the guideline in practice; (2) strongly contrasting views regarding the 200 mg/d morphine equivalent watchful dose; (3) recognition of gaps in the guideline, especially recommendations for urine drug screening and pain severity-specific therapy; (4) the guideline is excessively long and the format suboptimal; and (5) improved dissemination and education are needed to enhance guideline uptake. Conclusions: Despite its merits, the Canadian Opioids Guideline suffers from information gaps and from limited uptake, at least in part due to suboptimal format and suboptimal dissemination.
29 citations
TL;DR: A retrospective analysis of medication use evaluation at an academic level 1 trauma hospital system shows a very substantial decrease in utilization of hydrocodone-containing products and concomitant increase in the utilization of tramadol and codeine products at the authors' hospital after the DEA schedule change.
Abstract: Background: Hydrocodone-containing products were recently rescheduled from Drug Enforcement Agency (DEA) schedule III to schedule II due to concerns of abuse and misuse. These changes went into effect on October 6, 2014. Objective: This quality improvement project involved a retrospective analysis to determine the effect of the DEA schedule change on prescribing habits of hydrocodone-containing products as well as the remaining schedule III and IV opioids, codeine (schedule III) and tramadol (schedule IV). Methods: The authors performed a medication use evaluation at our academic level 1 trauma hospital system on outpatient use of hydrocodone-containing products, tramadol, and codeine-containing products for 6 months before and 6 months after the change to schedule II using our electronic record and pharmacy system. Results: A total of 88,428 prescription orders were analyzed. Comparison of prescriptions before and after the DEA schedule changes showed hydrocodone prescriptions reduced from an average of 225.97 per day to 1.20 per day. In addition, tramadol increased from 60.04 per day to 91.85 per day and codeine from 6.81 per day to 98.94 per day. Conclusions: Our data show a very substantial decrease in utilization of hydrocodone- containing products and concomitant increase in the utilization of tramadol and codeine products at our hospital after the DEA schedule change.
23 citations
TL;DR: A short form developed from the MNS shows promise as a possible screening measure for neonatal abstinence syndrome and discriminated between the treated and untreated NAS groups.
Abstract: Objectives: 1) How well do the short forms previously developed from the Maternal Opioid Treatment: Human Experimental Research (MOTHER) neonatal abstinence syndrome (NAS) scale (MNS) discriminate between neonates untreated and treated for NAS? (2) Can a short form be developed that is superior to other short forms in discriminating between the two groups? Design / participants: This secondary analysis study used data from 131 delivered neonates in the MOTHER study, a randomized controlled trial comparing neonatal and maternal outcomes in opioid-dependent pregnant women administered buprenorphine or methadone. Setting: Comprehensive care was provided at seven university hospitals . Outcome measures: A 19-item instrument measuring neonatal abstinence signs. Results: A five-item index proved superior to the previous indices (ps < 0.01) and discriminated between the treated and untreated NAS groups as well as did the MNS total score (p=0.09). Conclusions: A short form developed from the MNS shows promise as a possible screening measure .
17 citations
TL;DR: Naloxegol was generally safe and well tolerated in this 12-week extension study in patients with noncancer pain and OIC and improvements in symptoms and quality-of-life observed in KODIAC-04 were maintained throughout the extension study.
Abstract: Objective: To compare the long-term safety and tolerability of naloxegol with placebo in patients with opioid-induced constipation (OIC) and noncancer pain. Design: Twelve-week, multicenter, randomized, double-blind, parallel-group phase 3 extension study (KODIAC-07, NCT01395524). Setting: Clinical investigation centers in the United States. Patients: Adult outpatients (N = 302) with confirmed OIC who had completed a 12-week pivotal phase 3 study (KODIAC-04, NCT01309841). Interventions: Daily oral administration of naloxegol (12.5 and 25 mg) or placebo. Main Outcome Measures: Adverse events (AEs), including treatment-related AEs, serious AEs, and AEs of special interest; changes from baseline to week 12 in pain scores, daily opioid dose, and symptoms and quality-of-life measurements. Results: No important new AEs occurred during this extension study compared with KODIAC-04. AEs occurred more frequently with naloxegol 25 mg (41.2 percent) versus naloxegol 12.5 mg (34.0 percent) and placebo (33.0 percent). Treatment-emergent AEs occurring in >5 percent of patients in either naloxegol group during the treatment period were arthralgia (25 mg; 5.2 percent) and diarrhea (12.5 mg; 5.3 percent); two reported AEs attributable to opioid withdrawal syndrome in naloxegol groups were deemed unrelated to study medication. None of the gastrointestinal serious AEs was adjudicated as bowel perforation; one patient (naloxegol 12.5 mg) had an event adjudicated as a major cardiovascular event and was unrelated to study medication. Pain scores and daily opioid dose were unchanged, and improvements in symptoms and quality-of-life observed in KODIAC-04 were maintained throughout the extension study. Conclusion: Naloxegol was generally safe and well tolerated in this 12-week extension study in patients with noncancer pain and OIC.
16 citations
TL;DR: This article examines the risk factors described in the general adult and adolescent medication abuse literature and aims to provide recommendations for practice in the AYA oncology population.
Abstract: Prescription opioid use has increased in recent decades. Although opioids provide effective pain control, their use may be associated with the risk of misuse. Opioid misuse (OM) is prevalent among adolescents and young adults (AYAs). Opioids are necessary to treat cancer-related pain; however, oncology patients are not immune to medication misuse. Research examining OM among AYAs with cancer is scarce. This article examines the risk factors described in the general adult and adolescent medication abuse literature and aims to provide recommendations for practice in the AYA oncology population. The following risk factors should be examined in AYA oncology patients to determine their relevance: age, sex, behavioral and academic problems, psychological conditions, and a history of illicit drug use/abuse. To maintain the delicate balance of providing adequate pain relief while protecting patients from the risk of OM, clinicians must consider potential risk factors, motivating factors, and individual behaviors. Placing these challenges in perspective, this review provides clinical considerations, recommendations, and intervention strategies for OM prevention in AYA oncology patients.
16 citations
TL;DR: Opioid conversion to methadone is commonly practiced at this institution; however, dosing was significantly lower compared to adult conversion ratios, and more than 40 percent of children were undermedicated.
Abstract: Objective: Methadone administration has increased in pediatric clinical settings. This review is an attempt to ascertain an equianalgesic dose ratio for methadone in the pediatric population using standard adult dose conversion guidelines. Setting: US tertiary children's hospital. Patients: Hospitalized pediatric patients, 0-18 years of age. Main outcome measures: A retrospective chart review was conducted for patients who were converted from their initial opioid therapy regimen (morphine, hydromorphone, and/or fentanyl) to methadone. The primary endpoint was whether or not a dose correction was needed for methadone in the 6 days following conversion using standard dose conversion charts for adults. Documented clinical signs of withdrawal, unrelieved pain, or oversedation were examined. Results: The majority (53.7 percent) of the 199 children were converted to methadone on intensive care units prior extubation or postextubation. The mean conversion ratio was 23.7 mg of oral morphine to 1 mg of oral methadone (median, 18.8 mg:1 mg, SD = 25.7). Most patients experienced an adequate conversion (n = 115, 57.8 percent), while 83 (41.7 percent) appeared undermedicated, and one child was oversedated. There were no associations found with conversion ratios for initial morphine dose, days to conversion, or effect of withdrawal of concomitant agents with potential for withdrawal. Conclusions: Opioid conversion to methadone is commonly practiced at our institution; however, dosing was significantly lower compared to adult conversion ratios, and more than 40 percent of children were undermedicated. The majority of children in this study received opioids for sedation while intubated and ventilated; therefore, safe and efficacious pediatric methadone conversion rates remain unclear. Prospective studies are needed.
15 citations
TL;DR: Continued refinements of established μ-opioid agonist formulations have virtually eliminated the centrally mediated side effects of dysphoria and sedation that limited the applicability of previous KOP agonists.
Abstract: The current practice of μ-opioid receptor agonists such as morphine as the primary means of acute and chronic pain relief has several dangerous consequences that limit their effectiveness, including respiratory depression, gastrointestinal motility inhibition, addiction, tolerance, and abuse. Several other opioid receptors, notably the μ-opioid (KOP) receptor, have long been known to play a role in pain relief. Recent discoveries and advancements in laboratory techniques have allowed significant developments of KOP agonists as potential novel therapies for pain relief and other pathological processes. These drugs exhibit none of the classic opioid adverse effects and have displayed pronounced analgesia in several different scenarios. New formulations since 2014 have unveiled increased oral bioavailability, exceptional peripheral versus central selectivity, and a positive safety profile. Continued refinements of established μ-opioid agonist formulations have virtually eliminated the centrally mediated side effects of dysphoria and sedation that limited the applicability of previous KOP agonists. Further research is required to better elucidate the potential of these compounds in pain management, as well as in the mediation or modulation of other complex pathophysiological processes as therapeutic agents.
14 citations
TL;DR: The chemical and physical properties of oxycodone DETERx provide barriers to manipulating the microspheres for the purpose of IV injection, and are shown to be effective in deterring abuse.
Abstract: Objective: Abuse of prescription analgesics is a well-recognized problem, with nearly 2 million people aged 12 years or older initiating nonmedical use of pain relievers in 2012. The prevalence of opioid abuse via intravenous (IV) injection has led to the development of dosage forms designed to deter abuse using different inactive ingredients and formulation strategies. This study evaluated the IV abuse potential for a novel, microsphere-encapsulated abuse-deterrent formulation of oxycodone, Xtampza™ ER (referred to as “oxycodone DETERx”). Methods: The extraction of oxycodone DETERx and two comparators, extendedrelease oxycodone (oxycodone ER) and immediate-release oxycodone (oxycodone IR), was evaluated in small volumes (5 and 10 mL) of water after manipulation of the dosage forms. The syringeability and injectability of these products were evaluated to determine the feasibility of using these products via IV injection. Results: The extraction of oxycodone from oxycodone DETERx was nominal, with <12 percent extracted under any test condition. Oxycodone ER and oxycodone IR had as much as 83 and 98 percent oxycodone extracted, respectively. Injectability and syringeability analyses showed that injection of oxycodone DETERx microspheres in suspension is not feasible. In contrast, oxycodone ER and oxycodone IR suspensions were more easily drawn into and expelled from a syringe. Furthermore, injection of molten oxycodone DETERx microspheres was also shown to be ineffective. Conclusion: The chemical and physical properties of oxycodone DETERx provide barriers to manipulating the microspheres for the purpose of IV injection.
12 citations
TL;DR: If D-methadone is well tolerated, it is likely to become a useful adjuvant to the treatment of a wide spectrum of pain syndromes.
Abstract: D-Methadone is the d optical isomer of racemic mixture (DL-methadone) used clinically to treat pain and addiction in the United States. D-Methadone is practically devoid of opioid activity but maintains N-methyl-D-aspartate (NMDA) receptor antagonism. Evidence from extensive preclinical studies suggests that NMDA receptor antagonists attenuate neuronal plasticity, reverse opioid analgesic tolerance, and alleviate chronic pain states. The authors conducted a phase I open label study of D-methadone administered for the first time to patients with chronic pain to determine the safety and tolerability of D-methadone. In addition to their long-term regimen of opioids, the patients received 40 mg of D-methadone twice daily for 12 days. Analgesia and toxicity were recorded by the patients in a daily diary and assessed in clinic on days 1, 8, and 12. Eight patients of the 10 enrolled completed the study. Pain scores on Edmonton Symptom Assessment System (ESAS) did not change between days 1 and 12, but five of eight patients (62.5 percent) characterized D-methadone as moderately or very effective in relieving pain on the Global Assessment for pain. Five of the eight patients (62.5 percent) who completed the study requested to start treatment with commercially available methadone (DL-racemic methadone) after completing the study. D-Methadone at the dose of 40 mg PO Q 12 hours was well tolerated. Perspective: This is the first clinical study of D-methadone in patients suffering from chronic pain. Additional phase I and phase II studies are needed to confirm its safety and analgesic effects. If D-methadone is well tolerated, it is likely to become a useful adjuvant to the treatment of a wide spectrum of pain syndromes.
TL;DR: Tramadol has abuse potential (even in therapeutic doses) more than Placebo but less than or comparable to Buprenorphine.
Abstract: Background: Tramadol is a widely used opioid analgesic. Different preclinical, clinical, and postmarketing surveillance studies show conflicting results regarding abuse potential of this drug. Methods: A randomized double-blind complete crossover study was conducted at National Drug Dependence Treatment Centre, All India Institute of Medical Sciences, New Delhi. Total subjects were 10, comprising total 120 observations (each subject assessed at baseline, 5, 45, and 240 minutes). Subjects with history of substance abuse were included after detoxification and informed consent. Assessment was done using modified single dose opiate questionnaire, morphine benzedrine group (MBG), pentobarbital chlorpromazine alcohol group (PCAG), and two bipolar visual analogue scales (VAS) after administration of three drugs—Tramadol (100 mg), Buprenorphine (0.6 mg), and Placebo (Normal Saline) intramuscularly, at 5-day interval. Results: In intra-group analysis, there was statistically significant increase in scores of all four scales from baseline to all three time points after Tramadol and Buprenorphine administration. In inter-group analysis, statistically higher scores were seen for Buprenorphine in comparison to Tramadol at 5, 45, and 240 minutes for MBG scale; the score was significantly higher for Buprenorphine in VAS for pleasurable effect at 45 and 240 minutes, but not at baseline and 5 minutes. There was no significant difference in score at any point of time between Tramadol and Buprenorphine in PCAG scale and VAS for sedative/alertness effect. The scores were statistically insignificant in case of Placebo. All the subjects liked Buprenorphine most and then Tramadol followed by Placebo. Conclusion: Tramadol has abuse potential (even in therapeutic doses) more than Placebo but less than or comparable to Buprenorphine.
TL;DR: Abuse-deterrent hydrocodone ER was generally well tolerated in patients with chronic low back pain, maintained efficacy, and was associated with low rates of loss and diversion.
Abstract: Objective: To evaluate long-term safety, maintenance of analgesia, and aberrant drug-related behaviors of hydrocodone extended release (ER) formulated with CIMA ® Abuse-Deterrence Technology. Design: Phase 3, multicenter, open-label extension. Setting: Fifty-six US centers. Patients: Adults with chronic low back pain completing a 12-week placebo-controlled study of abuse-deterrent hydrocodone ER were eligible. One hundred eighty-two patients enrolled and received ≥ 1 dose of study drug, 170 entered open-label treatment, and 136 completed the study. Interventions: Patients receiving hydrocodone ER in the 12-week, placebo-controlled study continued their previous dose unless adjustment was needed; those previously receiving placebo (n = 78) underwent dose titration/adjustment to an analgesic dose (15-90 mg every 12 hours). Patients received 22 weeks of open-label treatment. Main outcome measures: Safety: adverse events (AEs). Maintenance of analgesia: worst pain intensity (WPI) and average pain intensity (API) at each study visit. Aberrant drug behavior: study drug loss and diversion. Results: AEs were reported for 65/182 (36 percent) patients during dose titration/adjustment and 88/170 (52 percent) during open-label treatment. No treatment-related serious AEs were reported. There were no clinically meaningful trends in other safety assessments, including physical examinations and pure tone audiometry. One patient receiving hydrocodone ER 30 mg twice daily experienced a severe AE of neurosensory deafness that was considered treatment related. Mean WPI and API remained steady throughout open-label treatment. Six (3 percent) patients reported medication loss, and 5 (3 percent) reported diversion. Conclusions: Abuse-deterrent hydrocodone ER was generally well tolerated in patients with chronic low back pain, maintained efficacy, and was associated with low rates of loss and diversion.
TL;DR: Benefits appear to be better for those with chronic noncancer pain compared with individuals with cancer when constipation was the primary outcome and safety monitoring during randomized trials was not been well described in published manuscripts.
Abstract: The rationale for putting opioid antagonists with an agonist is to improve pain control, to reduce side effects, and/or to reduce abuse. The combination of prolonged release (PR) oxycodone and naloxone reduces constipation as demonstrated in multiple studies and has been designated a tamper-resistant opioid by the Food and Drug Administration. Bioequivalence of the combination product compared with PR oxycodone has not been established. Several of the pivotal studies provided suboptimal laxative support in the control arm of the randomized trials. Two noninferiority trials have demonstrated equivalent analgesia between PR oxycodone and the combination product at doses of less than 120 mg of oxycodone per day. There appears to be an analgesic ceiling above 80-120 mg of oxycodone per day. Safety monitoring during randomized trials was not been well described in published manuscripts. Benefits appear to be better for those with chronic noncancer pain compared with individuals with cancer when constipation was the primary outcome.
TL;DR: Concentrations of opioids used in vitro should include those that are present in the relevant clinical setting if the effects of opioids detected in vitro are to be of potential relevance to the clinical setting.
Abstract: Objectives: Numerous in vitro studies have evaluated the influence of opioids on many biological and immunological processes. The concentrations that have been used in these studies span a large range and often do not reflect levels that are present in the relevant patient groups. This article reviews the literature concerning the concentrations of opioids that are detected in patients so that the concentrations of opioids that are used for in vitro studies can better reflect those that are present clinically. This will enable scientists and clinicians to more effectively model and interpret potentially relevant clinical effects from in vitro studies. Methods: Data on the concentrations of six commonly used opioids from clinical studies in adults were collected by searching PubMed (Medline). Results: A total of 42 relevant studies were included in the review. Concentrations of the opioids from previous clinical studies were mostly between 1 and 10 ng/mL for buprenorphine, 1 and 10 ng/mL for fentanyl, 50 and 500 ng/mL for methadone, 25 and 250 ng/mL for morphine, 10 and 100 ng/mL for oxycodone, and 100 and 1,000 ng/mL for Tramadol and were dependent on the patient group and indication under investigation. Conclusions: Concentrations of opioids used in vitro should include those that are present in the relevant clinical setting if the effects of opioids detected in vitro are to be of potential relevance to the clinical setting. Therefore, it is essential that these concentrations in the relevant clinical context(s) are known.
TL;DR: Multimodal options include pharmacological and nonpharmacological approaches, psychological support, and interventional pain procedures, all focused toward providing optimal pain control while preventing undertreatment, withdrawal symptoms, and other complications.
Abstract: Opioid dependence can occur due to prescription opioid use, recreational opioid use, or as a result of opioid use for the treatment of drug addiction. Pain control in these patients is truly a challenge. It is important to understand the patient's condition such as the phenomenon of drug dependence, drug addiction, and pseudoaddiction to provide effective analgesia. This may be accomplished using appropriate multimodal therapies and by treatment of coexisting diseases such as anxiety. The goal is to provide effective analgesia, prevent cognitive and emotional problems, and produce a positive postoperative rehabilitation process. Multimodal options include pharmacological and nonpharmacological approaches, psychological support, and interventional pain procedures, all focused toward providing optimal pain control while preventing undertreatment, withdrawal symptoms, and other complications.
TL;DR: Further scrutiny is warranted to more closely analyze provider opioid prescribing habits and ensure that the providers at the Institution are prescribing Schedule II controlled substances in compliance with HB1.
Abstract: Objective: Prescription opioid abuse poses a significant public health concern. House Bill 1 (HB1) was enacted in 2012 to address prescription drug abuse in Kentucky. The authors investigated the impact of HB1 on primary care providers’ (PCPs) prescribing practices of Schedule II controlled substances. Design: Retrospective evaluation of PCPs’ prescribing practices in an adult outpatient setting. Methods: A review of the prescribing practices for Schedule II controlled substances written by 149 PCPs. The number of prescriptions for Schedule II controlled substances written by 149 PCPs was compared to the top 10 PCP prescribers. Attention was focused on providers who wrote for oxycontin and/or opana and prescriptions with > 90 pills dispensed. Results: The top 10 PCP prescribers accounted for 38.4 percent of the Schedule II controlled substances and 47.8 percent of the Schedule II controlled substances with > 90 pills dispensed. Of the 60 PCPs who prescribed opana and/or oxycontin, the average number of prescriptions was 14.7 compared to 51.0 for the top 10 PCP prescribers. The average percentage of Schedule II controlled substance prescriptions compared to the total number of prescriptions was 27.9 percent for the top 10 PCP prescribers and 7.05 percent of all PCPs. The average percentage of office visits with Schedule II controlled substance prescriptions compared to total office visits was 24.8 percent for the top 10 PCP prescribers versus 7.7 percent for all PCPs. Conclusions: Further scrutiny is warranted to more closely analyze provider opioid prescribing habits and ensure that the providers at our Institution are prescribing Schedule II controlled substances in compliance with HB1.
TL;DR: Severe pain was correlated to male gender, respiratory intervention, opioid administration, and the diagnosis unspecified multiple injuries as well as the application of the pain scale Numeric Rating Scale (NRS).
Abstract: Objective: To elucidate pain treatment with analgesics in a prehospital trauma population. Design: Retrospective database study. Setting: Prehospital data from the anesthesiologist-manned Mobile Emergency Care Unit (MECU) in Odense, Denmark, were extracted and subjected to analysis. Patients: During the period of January 1, 2013 to December 31, 2014, patients with the diagnoses “unspecified multiple injuries,” “examination and observation following traffic accident,” “examination and observation following other accident,” and “commotio cerebri” were included in the analysis. Main Outcome Measures: Evaluation of the application of the pain scale Numeric Rating Scale (NRS). Furthermore, the authors performed a characterization of the patients with mild pain and severe pain according to specific parameters such as pharmacological interventions, opioid consumption, intubation, and others. Results: Nine hundred eighty-five cases were analyzed. NRS was documented only in one case. In all, 787 patients experienced no pain or mild pain (no pain, n = 242; mild pain, n = 545) and 168 patients severe pain or worse (severe pain, n = 155; intolerable pain, n = 13). In the severe pain group, 138 were treated with opioid analgesics or S-ketamine, while no pharmacological intervention was documented in 30 cases. Eight of the 138 cases with severe pain needed endotracheal intubation, whereas nine cases in the patients with mild or no pain needed endotracheal intubation; odds ratio (OR) 4.3 (p = 0.003). Conclusions: Effect was only documented in one patient after administering opioids in a patient with trauma population, where approximately 17 percent of patients experienced severe pain. Severe pain was correlated to male gender, respiratory intervention, opioid administration, and the diagnosis unspecified multiple injuries.
TL;DR: VHA patients with metastatic cancer and extensive prescription opioid use who are prescribed anxiolytics are likely to have a Food and Drug Administration-approved indication for psychotropics, and anxIOlytics in particular, but represent a clinically vulnerable group which merits careful monitoring.
Abstract: Objective: To examine the prevalence and correlates of concomitant anxiolytic prescription fills in Veterans Health Administration (VHA) patients with metastatic cancer who have extensive prescription opioid use. Design, Setting, and Participants: National VHA data for fiscal year 2012 were used to identify veterans diagnosed with metastatic cancer (ICD-9 codes 196-199) who also had extensive prescription opioid use (at least 10 opioid prescriptions during the year, comprising the highest 29 percent of opioid users). Bivariate and multivariate analyses were used to examine correlates of receiving anxiolytic medication among veterans with metastatic cancer and extensive prescription opioid use. Results: Of the 5,950 veterans with metastatic cancer and extensive prescription opioid use, 51 percent also received anxiolytic medication, of whom 64 percent had a medical indication and 85 percent had a psychiatric or medical indication for psychotropics. Of those with extensive prescription opioid use who filled an anxiolytic, 64 percent also received antidepressants and 38 percent received three or more classes of psychotropic medication (ie, polypharmacy). In multivariate analyses, factors associated with receipt of an anxiolytic included any anxiety disorder, insomnia, the prescription of antidepressants or antipsychotics, bipolar disorder, younger age, more emergency department visits, and greater number of opioid prescriptions. Conclusions: VHA patients with metastatic cancer and extensive prescription opioid use who are prescribed anxiolytics are likely to have a Food and Drug Administration-approved indication for psychotropics, and anxiolytics in particular, but represent a clinically vulnerable group which merits careful monitoring.
TL;DR: The PP of opioids increased toward death with higher PP during the last 3 months of life compared to previous 3-month periods, and older patients (>60) were less likely to receive opioids, while prostate or pancreatic cancer increased the odds for opioid prescriptions.
Abstract: Objective: Opioids are the main pharmacological treatment for moderate-to-severe cancer pain. Few longitudinal studies have examined the prescription prevalence (PP) of opioids to patients with cancer. The aims of the study were to examine 1) changes in the PP of opioids from 2005 to 2009 among outpatients with cancer who were in their last year of life and 2) associations between the PP of opioids and medical and sociodemographic factors. Design: Retrospective, registry-based, national study. Patients: This study used data on all patients with cancer who died 2005-2009, combining the following three complete nationwide registries; prescription data from the Norwegian Prescription Database, data on cancer diseases from the Cancer Registry of Norway, and sociodemographic data from Statistics Norway. Results: The study population consisted of 44,579 adults (mean age 72 years at death, 54 percent males). The opioid PP increased from 74 to 82 percent during the study period. Oxycodone had the highest PP, and increased from 39.8 to 48.5 percent during the period, whereas the PP of morphine declined from 29.0 to 27.3 percent. The PP for fentanyl remained stable at 17 percent. The PP of opioids increased toward death with higher PP during the last 3 months of life compared to previous 3-month periods. Older patients (>60) were less likely to receive opioids, while prostate or pancreatic cancer increased the odds for opioid prescriptions (p < 0.001, Odds ratio [OR] 2.60 and OR 1.98, respectively). Conclusion: The PP increased yearly during the study period. Use of oxycodone increased while that of morphine decreased.
TL;DR: Add benefit of tapentadol in all endpoint categories suggests that it may be beneficial to initiate treatment of chronic severe nonmalignant pain with tapentADol rather than oxycodone.
Abstract: Objective: To perform a systematic comparison of tapentadol prolonged release (PR) and oxycodone controlled release (CR) using patient-relevant endpoints of efficacy, safety, and health-related quality of life (HRQoL) according to criteria used in health technology assessment. To derive a minimal important difference (MID) for the EQ-5D from three pivotal trials to measure patient-relevant changes in HRQoL. Design: Randomized, double-blind, placebo and active controlled. Setting: Outpatient primary care. Participants: Patients with severe chronic osteoarthritis pain (two pivotal studies) and severe lower-back pain (one pivotal study) were enrolled. The intent-to-treat population of the three studies comprised a total of 2,968 patients (tapentadol PR arms: 978, oxycodone CR arms: 999, and in the placebo arms: 991). Interventions: Tapentadol PR (100-250 mg bid), oxydodone CR (20-50 mg bid), or placebo over a period of 15 weeks (3 weeks titration plus 12 weeks maintenance). Outcome Measures: Patient-relevant endpoints of efficacy, safety, tolerability, and HRQoL. Results: Tapentadol PR demonstrated significant added benefits as compared to oxycodone CR in meta-analyses of the patient-relevant outcomes 30 percent pain relief (Realtive risk [RR]: 0.80 [0.75, 0.87]), treatment discontinuations (RR: 0.55 [0.363, 0.825]), safety (RR: 0.652 [0.599, 0.710]), and HRQoL (RR: 0.78 [0.64, 0.96]) based on a MID derived for the EQ-5D summary index. Conclusions: Added benefit of tapentadol in all endpoint categories suggests that it may be beneficial to initiate treatment of chronic severe nonmalignant pain with tapentadol rather than oxycodone.
TL;DR: Continued efforts toward an improved understanding of UDT utility by providers, along with expedited placement of e-consult following urine collection, may allow for increased implementation of pharmacist interventions and lead to more optimal use of this clinical tool.
Abstract: In 2013, the North Florida/South Georgia Veterans Healthcare System established a pharmacist-run urine drug testing (UDT) electronic consultation (e-consult) service to assist providers with interpretation of this useful yet complex clinical tool. This pilot study aimed to classify clinical treatment changes implemented following e-consult to a pharmacist-run UDT service and analyze factors limiting pharmacist intervention postconsultation. One hundred forty-three e-consults were completed in the 2-year study period including interpretation of 190 UDT results classified as expected, unexpected, or not necessarily inappropriate based on prescription profile at time of urine immunoassay test. Preconsult evaluation revealed that in more than 70 percent of cases, no confirmatory testing was ordered on the sample in question by the requesting provider. Of the 28 percent of UDT results classified as unexpected, 32 percent identified the presence of an illicit substance. Completed e-consults provided either education-based (informative) or actionbased (decisive) recommendations. In 50 percent of the cases where unexpected substances were identified, pharmacy specialists recommended immediate action to be taken by the provider. Subsequent review indicates that timely documentation of postconsultation action by requesting provider was only present in 32 percent of this group. Continued efforts toward an improved understanding of UDT utility by providers, along with expedited placement of e-consult following urine collection, may allow for increased implementation of pharmacist interventions and lead to more optimal use of this clinical tool.
TL;DR: It is demonstrated that online drug-information compendia may contain inaccurate information, and healthcare professionals and consumers must be informed of potential misinformation so they may consider using multiple resources to obtain accurate and current drug information, thereby helping to ensure safer use of prescription medications, such as opioids.
Abstract: Background: Healthcare professionals and consumers refer to online drug-information compendia (eg, Epocrates and WebMD) to learn about prescription medications, including opioid analgesics. With the significant risks associated with opioids, including abuse, misuse, and addiction, any of which can result in life-threatening overdose, it is important for those seeking information from online compendia to have access to current, accurate, and complete drug information to help support clinical treatment decisions. Although compendia are informative, readily available, and user friendly, studies have shown that they may contain errors. Objective: To review and identify misinformation in drug summaries of online drug-information compendia for selected opioid analgesic products and submit content corrections to the respective editors. Methods: Between 2011 and 2013, drug summaries for Purdue's prescription opioid analgesic products from seven leading online drug-information compendia were systematically reviewed, and the requests for corrections were retrospectively categorized and classified. At least 2 months following requests, the same compendia were then reexamined to assess the degree of error resolution. Results: A total of 859 errors were identified, with the greatest percentage in Safety and Patient Education categories. Across the seven compendia, the complete or partial resolution of errors was 34 percent; therefore, nearly two thirds of the identified errors remain. Conclusion: The results of this analysis, consistent with past studies, demonstrate that online drug-information compendia may contain inaccurate information. Healthcare professionals and consumers must be informed of potential misinformation so they may consider using multiple resources to obtain accurate and current drug information, thereby helping to ensure safer use of prescription medications, such as opioids.
TL;DR: Aside from race, most patient characteristics were not predictive of pain agreement implementation, however, controlled medication of higher schedules and the use of certain guideline-recommended practices were associated with an agreement.
Abstract: Objective: Characterize primary care patients prescribed opioids for chronic noncancer pain (CNCP), explore guideline-recommended opioid-monitoring practices, and investigate predictors of pain agreements. Design: Retrospective chart review. Setting: Primary care clinic at a tertiary academic medical center. Patients: Adults prescribed chronic opioids (three or more monthly prescriptions within a year) for CNCP between April 1, 2014 and April 1, 2015. Patients without CNCP served as controls. Main Outcome Measure: Patient demographics, medical diagnoses, tobacco status, provider status, documentation of guideline-recommended opioid-monitoring practices, pain agreement status, and opioid prescription. Univariate statistics were used to explore differences in patient demographics, comorbidities, and guideline-recommended opioid-monitoring practices by chronic pain and pain agreement status. Logistic regression was used to investigate predictors of agreement status. Results: The clinic had 834 (9 percent) patients on chronic opioids, with 335 on a pain agreement. Documentation of opioid-monitoring practices was lacking. Logistic regression indicated that patients were significantly more likely to be on an agreement if they were Caucasian (adjusted odds ratio [OR] 2.17 [95% CI 1.41, 3.39]), had a baseline urine drug screen (adjusted OR 10.72 [95% CI 6.16, 19.41]), were prescribed a schedule II controlled medication (adjusted OR 11.92 [95% CI 6.93, 21.62]), and had risk assessed to some degree (adjusted OR 3.06 [95% CI 1.90, 4.96]). Conclusions: Aside from race, most patient characteristics were not predictive of pain agreement implementation. However, controlled medication of higher schedules and the use of certain guideline-recommended practices were associated with an agreement. Studies are needed to examine whether pain agreement or guideline-adherence influence clinical outcomes.
TL;DR: Following orthopedic surgery, patients and investigators more frequently reported global assessment of pain control as "excellent" on the PGA and IGA assessments with fentanyl ITS than with morphine i.v. PCA.
Abstract: Objective: To compare the efficacy and safety of patient-controlled pain management following orthopedic surgery using either fentanyl iontophoretic transdermal system (ITS) or morphine intravenous (IV) patient-controlled analgesia (PCA) Setting: Acute Care Hospital Patients: Three-open-label, multicenter, randomized, active-controlled, parallel-group phase 3B studies (N = 2095) were conducted that compared fentanyl ITS with morphine IV PCA for postoperative pain in hospitalized postoperative patients A subgroup of orthopedic surgery patients (N = 1,216) was pooled for this analysis; of which 819 completed treatment Interventions: A total of 590 patients received fentanyl ITS (40 μg/dose) and 626 patients received morphine IV PCA (1 mg/dose) for up to 72 hours Main outcome measures: Efficacy measures included the patient global assessment (PGA) and the investigator global assessment (IGA) of the method of pain control Results: Patients had a mean age of about 60 years, were predominantly Caucasian (905 percent), and the majority underwent hip replacement (803 percent) There were more patients treated with fentanyl ITS who rated their pain control method as “excellent” compared to morphine IV PCA at 24 hours postsurgery (448 percent vs 330 percent, respectively; p < 0001), 48 hours (375 percent vs 253 percent, respectively; p < 0001), and at the last assessment (543 percent vs 396 percent, respectively; p < 0001) There were more investigators who rated treatment with fentanyl ITS as “excellent” compared to morphine IV PCA at the last assessment (574 percent vs 369 percent, respectively; p < 0001) Conclusions: Following orthopedic surgery, patients and investigators more frequently reported global assessment of pain control as “excellent” on the PGA and IGA assessments with fentanyl ITS than with morphine IV PCA
TL;DR: The introduction of OxyNEO was associated with a statistically significant reduction in oxycodone exposure in a population of methadone-maintained patients.
Abstract: Objective: Emerging data are demonstrating that tamper-resistant opioids may play an important role in changing prescription opioid abuse behaviors. This study was a chart review to examine if the reformulation of OxyContin ® into a version with tamper-resistant properties (OxyNEO ® ) had an impact on oxycodone-positive urine drug screens (UDSs) in opioid-dependent patients receiving methadone maintenance therapy (MMT). Design: The historical element of this study examined 250 eligible charts from patients on MMT who had data during the time periods when only OxyContin was available (baseline period), during the transition to OxyNEO, and when only OxyNEO was available. The prospective element included an exploratory questionnaire regarding retrospective opioid use. Setting: The study was conducted at three methadone clinics, in Oshawa, Peterborough, and Scarborough in Ontario, Canada. Participants: Male and female patients were eligible if they had a diagnosis of opioid dependency, received MMT, and had at least one oxycodone-positive UDS during the baseline period. Intervention: This was a noninterventional study. Main outcome measure: The main outcome was the number of oxycodone-positive UDSs. Results: The results demonstrated a marked reduction in oxycodone-positive UDSs that showed stepwise, statistically significant decreases during the transition and post-OxyContin periods relative to baseline. While the oxycodone-positive UDS results were decreasing, morphine-related-positive UDSs remained relatively stable during the same periods. There were no significant gender differences noted. Conclusions: The introduction of OxyNEO was associated with a statistically significant reduction in oxycodone exposure in a population of methadone-maintained patients.
TL;DR: Primary care practices, particularly primary care training sites, looking to implement a coprescription initiative should take several important factors into consideration during the planning stages, including naloxone availability and availability of the patient for nalOXone education.
Abstract: Objective: To describe the development and implementation of a resident-led effort to increase coprescription of naloxone in a primary care setting. Design: An exploratory, prospective pilot project to increase coprescription rates of naloxone. Setting: Four primary care offices in western Connecticut serving as medical home training sites for primary care residents. Patients, Participants: All patients on chronic opioid therapy. Interventions: Over a 2-month period, eligible patients were identified and approached to receive a naloxone coprescription. Main Outcome Measure: Rate of coprescriptions written. Results: Three out of four training sites were able to increase coprescription rates, and 26 percent of eligible patients were able to have a prescription written. Conclusions: Primary care practices, particularly primary care training sites, looking to implement a coprescription initiative should take several important factors into consideration during the planning stages, including naloxone availability and availability of the patient for naloxone education. More extensive research on best practices is needed.
TL;DR: Serial testosterone levels are reported at 2-hour intervals once weekly for 22 weeks in a man after his ingestion of 0, 5, or 10 mg of hydrocodone.
Abstract: Context: Multiple morning testosterone levels are needed to establish the presence of male hypogonadism and to justify its replacement therapy. Any influence on these levels by short-term opioid ingestion has not, however, been reported. Case Description: Serial testosterone levels are reported at 2-hour intervals once weekly for 22 weeks in a man after his ingestion of 0, 5, or 10 mg of hydrocodone. Conclusions: Five milligrams of hydrocodone did not significantly alter postingestion testosterone levels, but 10 mg ingestion lowered them at 2, 4, and 6 hours postingestion.
TL;DR: This study evaluated acceptability of the use of cellular phone and computer pictures/video for "pill counts" by patients in buprenorphine maintenance treatment and found it could be used in settings where a larger proportion of controlled substances are prescribed.
Abstract: Objective: As part of a comprehensive plan to attempt to minimize the diversion of prescribed controlled substances, many professional organization and licensing boards are recommending the use of “pill counts.” This study sought to evaluate acceptability of the use of cellular phone and computer pictures/video for “pill counts” by patients in buprenorphine maintenance treatment. Setting and intervention: Patients prescribed buprenorphine/naloxone were asked a series of questions related to the type(s) of electronic communication to which they had access as well as their willingness to use these for the purpose of performing a “pill/film count.” Results: Of the 80 patients, 4 (5 percent) did not have a phone at all. Only 28 (35 percent) had a “smart phone” with some sort of data plan and Internet access. Forty (50 percent) of the patients had a phone with no camera and 10 (12.5 percent) had a phone with a camera but no video capability. All patients said that they would be willing to periodically use the video or camera on their phone or computer to have buprenorphine/naloxone pills or film counted as long as the communication was protected from electronic tampering. Conclusions: With the advent of applications for smart phones that allow for Health Insurance Portability and Accountability Act of 1996-compliant picture/video communication, a number of things can now be done that can enhance patient care as well as reduce the chances of misuse/diversion of prescribed medications. This could be used in settings where a larger proportion of controlled substances are prescribed including medication assisted therapy for opioid use disorders and pain management programs.