Journal of opioid management
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In response to disturbing rises in prescription opioid abuse, the Food and Drug Administration (FDA) has proposed the implementation of aggressive Risk Evaluation and Mitigation Strategies (REMS) that will require prescribers to obtain mandatory education, provide mandatory patient education, register patients into registries, and so forth before prescribing certain opioids. The first opioid to be subject to the new REMS was the recently approved fentanyl buccal soluble film (Onsolis). The FDA plans to extend mandatory REMS to other opioids, including all rapid-onset formulations and eventually all long-acting opioids, whether or not they already have FDA approval. To assess the likely impact of REMS on opioid prescribing, the authors conducted a survey of how REMS implementation might affect opioid prescribing. ⋯ The results suggest that 50 percent of the responding physicians would be willing to comply with the mandatory education component of REMS, including the requirement to provide education to patients. For some REMS components, willingness to continue to prescribe despite the restriction was higher (up to 90 percent). However, this leaves a substantial proportion of physicians who would not be willing to prescribe opioids controlled by the new REMS, which could have the unintended effect of decreasing access to these medications for legitimate medical purposes.
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Clinical laboratories are required to establish reference intervals for all the analytes tested, and these are provided along with the test results. In contrast, laboratories testing for pain medications use cutoffs established by the manufacturers of immunoassay reagents. These cutoffs may be inappropriate for monitoring patients being treated for chronic pain with opioid therapy because the cutoffs are set too high. ⋯ These cutoffs were significantly lower than those suggested by many immunoassay manufacturers and better identify patient compliance in a representative population of pain patients. The limitation of the study is that only values one-half of our lowest calibrator were used. By using population values, laboratories can establish appropriate cutoffs for best monitoring pain patient medication compliance.
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Clinical Trial
Ziconotide: A rapid detoxification protocol for the conversion from intrathecal morphine--the Raffaeli Detoxification Model.
To assess the efficacy and the safety of our rapid detoxificationprotocol in preventing signs and symptoms of withdrawal and pain severity. ⋯ The detoxification protocol was effective in preventing withdrawal signs without increasing pain severity, allowing to rapidly convert IT morphine to ziconotide monotherapy in patients who are refractory to morphine.
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Determination of ethanol use in the pain patient population being treated with chronic opioid therapy is critically important to the treating physician. Urinary ethanol, ethyl glucuronide (EtG), and ethyl sulfate (EtS) have been used to identify alcohol use. Because urine samples are shipped to reference laboratories, the possibility of glucose fermentation during transit producing ethanol complicates interpretation. The purpose of this study was to establish whether ethanol-positive urine samples were due to ingestion or fermentation during shipping. ⋯ Roughly one-third of the time, ethanol-positive urine samples that have been shipped were positive because of fermentation and not because of patient alcohol consumption. This method is a combination of urinary ethanol measurement and liquid chromatography tandem mass spectrometry quantitation of both EtG and EtS. In the absence of these metabolites, the presence of urinary ethanol is attributed to fermentation. The improvement is a better definition of the source of the ethanol. Confirmatory testing showing the presence of the ethanol metabolites EtG and EtS is needed to validate that the ethanol is due to consumption. The presence of glucose, while common in the ethanol-positive samples, is not an absolute indicator that the ethanol was due to fermentation.