Characterizing safer supply prescribing of immediate release hydromorphone for individuals with opioid use disorder across Ontario, Canada
Samantha YoungGillian KollaDaniel McCormackTonya CampbellPamela LeeceCarol StrikeAnita SrivastavaTony AntoniouAhmed M. BayoumiTara Gomes
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Hydromorphone
Interquartile range
Discontinuation
Objectives: OROS® hydromorphone (osmotic extended-release oral delivery system [OROS] hydromorphone) is a long-acting opioid analgesic, which is approved in Europe for the management of severe pain. The authors aimed to estimate the economic value of this product relative to other widely used oral opioids, including sustained-release morphine, extended-release (ER) oxycodone, and twice-daily (bid) hydromorphone.Design: An adaptable, decision-analytic cost-utility model was developed. Separate versions of the model were developed for five European countries: Germany, Denmark, Slovakia, Portugal, and Italy.Results: OROS hydromorphone represents a cost-effective alternative to other strong oral opioids in the treatment of both nonmalignant and malignant pain in all five countries. In the treatment of chronic severe nonmalignant pain, OROS hydromorphone was dominant (ie, lower cost and incremental quality-adjusted life years gains) when compared with ER oxycodone in Denmark and bid hydromorphone in Germany. Likewise, OROS hydromorphone was dominant in the treatment of chronic severe malignant pain when compared with ER oxycodone in both Germany and Denmark and when compared with bid hydromorphone in all markets where hydromorphone was marketed.Conclusions: This model demonstrates the cost effectiveness of OROS hydromorphone relative to other strong oral opioids in the treatment of chronic severe malignant and nonmalignant pain.
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The steady-state pharmacokinetics of an extended-release formulation of hydromorphone, OROS® hydromorphone, was investigated in a randomized, openlabel, crossover study in healthy volunteers. Participants were randomly assigned to receive 16 mg of OROS hydromorphone once daily and 4 mg of immediaterelease hydromorphone four times daily for five consecutive days. The two treatments were separated by a washout period of 7-14 days. Naltrexone was given throughout both treatment periods to block the opioid effects of hydromorphone. Steady-state hydromorphone concentrations were statistically analyzed using Helmert contrasts to determine when steady state was reached. A total of 30 participants were enrolled, of whom 29 completed both treatment periods. The two treatments produced comparable steady-state plasma drug concentrations, but peakto-trough fluctuations were smaller with OROS hydromorphone (61 percent vs 172 percent) in comparison with immediate release hydromorphone. Overall systemic exposure to hydromorphone was similar between the two formulations. The ratio of the geometric means between the two formulations for the area under the concentration-time curves at steady state was 105.2 percent with a 90% confidence interval (CI) of 99.8-110.8 (geometric mean: 102.7 percent; 90% CI: 97.6-108.2 after correcting for measured drug content), which was within the bioequivalence range (80-125 percent). The analysis of Helmert contrasts showed that steadystate conditions were attained by day 4. Both treatments were well tolerated. This study shows that OROS hydromorphone maintains steady-state plasma drug concentrations within the same range as immediate-release hydromorphone at the same total daily dose, with less fluctuation.
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Abstract Purpose Opioid conversion calculators (OCCs) are used to convert between opioids. The purpose of this study was to describe the variability in OCC results in critically ill children transitioned from fentanyl to hydromorphone infusions. Methods This was a descriptive, retrospective study. Seventeen OCCs were identified and grouped into 6 groups (groups 1-6) based on the equianalgesic conversions. The OCCs were used to calculate the hydromorphone rate in critically ill children (<18 years) converted from fentanyl to hydromorphone. Information from a previous study on children stabilized on hydromorphone (defined as the first 24-hour period with no change in the hydromorphone rates, <3 hydromorphone boluses administered, and 80% of State Behavior Scale scores between 0 and –1) were utilized. The primary objective was to compare the median hydromorphone rates calculated using the 17 OCCs. The secondary objective was to compare the percent variability of the OCC-calculated hydromorphone rates to the stabilization rate. Results Seventeen OCCs were applied to data on 28 children with a median age and hydromorphone rate of 2.4 years and 0.08 mg/kg/h, respectively. The median hydromorphone rate calculated using the 17 OCCs ranged from 0.06 to 0.12 mg/kg/h. Group 3 and group 6 OCCs resulted in a calculated hydromorphone rate that was higher than the stabilization rate in 96% and 75% of patients, respectively. Use of group 4 and group 5 OCCs resulted in a calculated hydromorphone rate that was lower than the stabilization rate in 64% and 75% of patients, respectively. Conclusion Given the considerable variability of OCCs, caution should be used when applying OCCs to critically ill children.
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Objectives: In 2017, almost 50,000 Americans and over 4000 Canadians died from an opioid overdose. Accordingly, an urgent need exists to improve access to evidence-based treatment for opioid addiction, and also to develop and evaluate alternative treatment options for opioid use disorder (OUD). We present a case of a patient with OUD who was successfully switched and managed on oral hydromorphone after development of a prolonged QTc interval on methadone. Case: A 51-year-old man with longstanding polysubstance use presented to an urban hospital in Vancouver, Canada, for management of alcohol intoxication and hyponatremia. At the time of admission, the patient was stable on 100 mg of methadone daily, but was found to have a persistently elevated QTc (>550 milliseconds), putting him at increased risk for Torsades de Pointes. In an effort to find an alternative opioid agonist therapy for maintenance, a trial of slow-release oral morphine was attempted, but discontinued due to the development of myoclonus. Once-daily sustained-release oral hydromorphone was then started, which was found to manage cravings well without notable side effects. Discussion: The case presented offers promise for the use of once-daily sustained-release oral hydromorphone as a viable treatment option for patients with OUD for whom first-line therapies are not suitable or tolerated. This case report is the first to our knowledge to demonstrate the successful use of oral hydromorphone for treatment of opioid use disorder.
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The vast majority of cancer patients experience pain, and treatment with opioids offers the most effective option for pain management. Long-lasting opioid formulations are usually used as cancer pain management strategies. This review surveys the available literature on the only available once-daily sustained-release formulation of hydromorphone, and its use in cancer pain management. Sustained-release (SR) formulations have a more consistent opioid plasma concentration, thereby minimizing the peaks and troughs associated with immediate-release opioid formulations. OROS hydromorphone (Jurnista, Janssen Pharmaceuticals, NV, Beerse, Belgium) releases hydromorphone over a 24-hour dosing period. Studies comparing its efficacy with other opioids such as morphine and oxycodone found comparable results overall. Recent trials have provided evidence of decreased rescue medication use for breakthrough pain, a good safety profile, and quality of life benefits. It appears to be an efficacious and well-tolerated treatment. The pharmacokinetics of OROS hydromorphone are linear and dose-proportional, and only minimally affected by the presence or absence of food. In addition, the SR properties of OROS hydromorphone are maintained in the presence of alcohol, with no dose dumping of hydromorphone. This formulation shows promise as an addition to cancer pain management strategies, although further randomized, double-blind trials are needed to confirm this.
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Importance to the field: Hydromorphone is a semi-synthetic opioid approved in the USA for the treatment and relief of moderate to severe pain and postoperative pain. However, the compound is short-acting, and there is no extended-release formulation clinically available. A previous hydromorphone extended-release formulation that successfully came to market was subsequently withdrawn on account of safety concerns. Clinical need supports the presence of an extended-release formulation of hydromorphone.Areas covered in this review: Medline articles showing from a search of ‘hydromorphone and OROS’ were included in the review. In addition, searches were done relating to published data regarding regulatory affairs dealing with this specific topic. Physicians prescribing information for hydromorphone was also reviewed.What the reader will gain: The reader will gain an increased understanding of the use of an extended-release formulation of hydromorphone using the OROS technology and will appreciate that this technology has safety advantages compared with previous extended-release formulations of hydromorphone.Take home message: Hydromorphone-OROS is an effective agent for the long-acting control of pain and a welcome addition to other available opioid formulations.
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BACKGROUND When a change of opioid is considered, equianalgesic dose tables are used. These tables generally propose a dose ratio of 5:1 between morphine and hydromorphone. In the case of a change from subcutaneous hydromorphone to methadone, dose ratios ranging from 1:6 to 1:10 are proposed. The purpose of this study was to review the analgesic dose ratios for methadone compared with hydromorphone. METHODS In a retrospective study, 48 cases of medication changes from morphine to hydromorphone, and 65 changes between hydromorphone and methadone were identified. The reason for the change, the analgesic dose, and pain intensity were obtained. RESULTS The dose ratios between morphine and hydromorphone and vice versa were found to be 5.33 and 0.28, respectively (similar to expected results). However, the hydromorphone/methadone ratio was found to be 1.14:1 (5 to 10 times higher than expected). Although the dose ratios of hydromorphone/morphine and vice versa did not change according to a previous opioid dose, the hydromorphone/methadone ratio correlated with total opioid dose (correlation coefficient = 0.41 P < 0.001) and was 1.6 (range, 0.3-14.4) in patients receiving more than 330 mg of hydromorphone per day prior to the change, versus 0.95 (range, 0.2-12.3) in patients receiving æ330 mg of hydromorphone per day (P = 0.023). CONCLUSIONS These results suggest that only partial tolerance develops between methadone and hydromorphone. Methadone is much more potent than previously described and any change should start at a lower equivalent dose. Cancer 1996;78:852-7.
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