Furious....and scared
Posted: Fri Dec 21, 2012 9:37 pm
So, I had trouble getting my script filled the last three times - for methadone, that is. The doctor didn't write it correctly--you have to include the amount both in numbers and words, i.e. 150 (one-hundred and fifty) tablets--so the physician's assistant wrote in the words in a different pen/different handwriting.
But, they finally filled it yesterday, so I thought all was OK.
Then the doctor's office called me a few minutes ago. They said the pharmacist will no longer fill the script because of worries about the DEA. If the DEA came in and did an audit, they are worried that they are filling a script for methadone off-label and that they could get in trouble. They want the doctor's office to send them any research articles about using methadone off-label for WED/RLS. The doctor's office doesn't use this drug for anyone except me, and they prescribe it primarily because of a conversation with Dr Buchfuhrer - meaning they don't know what the research says.
So, they called me and said, hey, do you have any articles? Great. Just how I wanted to spend my day.
Unfortunately, there aren't a lot of articles about using methadone specifically. And not even a lot about using opioids. That's because the pharma companies won't make money by studying it because the drugs are all generic now.
Here's what I've come up with - I think these show a decent overall view of opioids and specifically methadone. I included articles about how the endogenous opioid system may be involved, as these offer an explanation as to why opioids work. I hope this is enough!
Does anyone have any to add?
1. Methadone for refractory restless legs syndrome. Ondo WG - Mov Disord - 01-MAR-2005; 20(3):
Abstract:
Most cases of restless legs syndrome (RLS) initially respond well to dopaminergic agonists. However, an unknown percentage of patients is intolerant of dopaminergic adverse events, initially or subsequently refractory, or develops limiting augmentation. We administered methadone 5 to 40 mg/day (final dose, 15.6 +/- 7.7) to 29 RLS patients who failed dopaminergics. They were currently taking or had previously tried 5.9 +/- 1.7 (range, 3-9) different medications for RLS and 2.9 +/- 0.8 (range, 2-4) different dopaminergics. Of the 27 patients who met inclusion criteria, 17 have remained on methadone for 23 +/- 12 months (range, 4-44 months) at a dose of 15.5 +/- 7.7 mg/day; 2 dialysis RLS patients died while on methadone, and 8 stopped the treatment (5 for adverse events, 2 for lack of efficacy, and 1 for logistical reasons).
All patients who remain on methadone report at least a 75% reduction in symptoms, and none have developed augmentation. Methadone should be considered in RLS patients with an unsatisfactory dopaminergic response.2004 Movement Disorder Society.
2. Dyskinesias while awake and periodic movements in sleep in restless legs syndrome
Treatment with opioids
Wayne A. Hening, Arthur Walters, Neil Kavey, Stephen Gidro-Frank ,Lucien Côté and Stanley Fahn
Abstract
In five unrelated patients with the restless legs syndrome, opioid drugs relieved restlessness, dysesthesias, dyskinesias while awake, periodic movements of sleep, and sleep disturbances. When naloxone was given parenterally to two treated patients, the signs and symptoms of the restless legs syndrome reappeared. Naloxone placebo had no effect. Opioid medications may offer a useful therapy for the restless legs syndrome. The endogenous opiate system may be involved in the pathogenesis of the syndrome.
Citation:
Methadone for refractory restless legs syndrome.
Ondo WG - Mov Disord - 01-MAR-2005;
Full Source Title:
Movement disorders : official journal of the Movement Disorder Society
Long-Term follow-up on restless legs syndrome patients treated with opioids
Arthur S. Walters MD1,6,7,*, Juliane Winkelmann MD2, Claudia Trenkwalder MD2, June M. Fry MD, PhD3, Vandana Kataria PharmD4, Mary Wagner PharmD4, Rakesh Sharma MD5, Wayne Hening MD, PhD6,7, Liren Li MD6
Article first published online: 30 NOV 2001
DOI: 10.1002/mds.1214
The medical records of 493 patients with restless legs syndrome (RLS) from three major centers were studied to determine the number and outcome of patients who had been treated with opioids as a monotherapy. At one time or another 113 patients (51 men, 62 women; age range, 37–88 years) had been on opioid therapy either alone (36 patients) or with opioids added secondarily to other medications used to treat RLS (77 patients). Twenty-three of the 36 opioid monotherapy patients had failed dopaminergic and other therapeutic agents prior to the initiation of opioid monotherapy. Twenty of the 36 opioid monotherapy patients continue on monotherapy for an average of 5 years 11 months (range, 1–23 years), despite their knowledge of the availability of other therapies. Of the 16 patients who discontinued opioids as a sole therapy, the medication was discontinued in only one case because of problems related to addiction and tolerance. Polysomnography on seven patients performed after an average of 7 years 1 month of opioid monotherapy (range, 1–15 years) showed a tendency toward an improvement in all leg parameters and associated arousals (decrease in PLMS index, PLMS arousal index, and PLM while awake index) as well as all sleep parameters (increase in stages 3 and 4 and REM sleep, total sleep time, sleep efficiency, and decrease in sleep latency). Two of these seven patients developed sleep apnea and a third patient had worsening of preexisting apnea. Opioids seem to have long-term effectiveness in the treatment of RLS and PLMS, but patients on long-term opioid therapy should be clinically or polysomnographically monitored periodically for the development of sleep apnea. © 2001 Movement Disorder Society.
4. Dominantly inherited restless legs with myoclonus and periodic movements of sleep: a syndrome related to the endogenous opiates?
Walters A, Hening W, Côté L, Fahn S
Advances in Neurology [1986, 43:309-319]
Type: Journal Article, Case Reports, Research Support, Non-U.S. Gov't
Abstract
The restless legs syndrome is a sensory and motor disorder of evening, repose, and sleep. The cardinal features include (a) restlessness, which is frequently associated with (b) dysesthesias, (c) myoclonic jerks and other dyskinesias while awake, (d) periodic movements of sleep, and (e) sleep disturbances. We have recently had the opportunity to study two patients severely affected by this syndrome whose family histories are consistent with dominant inheritance. Both patients serendipitously discovered that their symptoms responded uniquely well to opiate medication. Both patients were studied extensively with electrophysiological and videotape monitoring, and their movements were characterized. In both patients, all elements of the syndrome responded to opiates, with marked relief of symptoms and without any significant side effects. The specific opiate antagonist naloxone blocked the therapeutic benefit of the opiates. Our findings support the involvement of the endogenous opiate system in the pathogenesis of restless legs and related dyskinesias and suggest that opiate therapy may be a potentially valuable treatment for this sometimes disabling syndrome.
Author Affiliation:
Baylor College of Medicine, Houston Texas
5. The role of opioids in restless legs syndrome: an [11C]diprenorphine PET study
Sarah von Spiczak1,4,
Alan L. Whone1,
Alexander Hammers1,3,
Marie-Claude Asselin2,
Federico Turkheimer1,
Tobias Tings4,
Svenja Happe4,
Walter Paulus4,
Claudia Trenkwalder4 and
David J. Brooks1
+ Author Affiliations
1Division of Neuroscience and MRC Clinical Sciences Centre, Faculty of Medicine, Imperial College and 2Hammersmith Imanet, Hammersmith Hospital, London, 3Department of Clinical and Experimental Epilepsy, Institute of Neurology, UCL, London, UK, 4Department of Clinical Neurophysiology and Georg-August University, Goettingen, Germany
Correspondence to: Sarah von Spiczak, Department of Clinical Neurophysiology, Georg-August University Goettingen, Robert-Koch-Strasse 40, D-37099 Goettingen, Germany. E-mail: sarah.v.s@gmx.de
Received March 17, 2004.
Revision received July 11, 2004.
Accepted January 18, 2005.
Summary
Opioids have been shown to provide symptomatic relief from dysaesthesias and motor symptoms in restless legs syndrome (RLS). However, the mechanisms by which endogenous opioids contribute to the pathophysiology of RLS remain unknown. We have studied opioid receptor availability in 15 patients with primary RLS and 12 age-matched healthy volunteers using PET and [11C]diprenorphine, a non-selective opioid receptor radioligand. Ligand binding was quantified by generating parametric images of volume of distribution (Vd) using a plasma-derived input function. Statistical parametric mapping (SPM) was used to localize mean group differences between patients and controls and to correlate ligand binding with clinical scores of disease severity. There were no mean group differences in opioid receptor binding between patients and controls. However, we found regional negative correlations between ligand binding and RLS severity (international restless legs scale, IRLS) in areas serving the medial pain system (medial thalamus, amygdala, caudate nucleus, anterior cingulate gyrus, insular cortex and orbitofrontal cortex). Pain scores (affective component of the McGill Pain Questionnaire) correlated inversely with opioid receptor binding in orbitofrontal cortex and anterior cingulate gyrus. Our findings suggest that, the more severe the RLS, the greater the release of endogenous opioids within the medial pain system. We therefore discuss a possible role for opioids in the pathophysiology of RLS with respect to sensory and motor symptoms.
But, they finally filled it yesterday, so I thought all was OK.
Then the doctor's office called me a few minutes ago. They said the pharmacist will no longer fill the script because of worries about the DEA. If the DEA came in and did an audit, they are worried that they are filling a script for methadone off-label and that they could get in trouble. They want the doctor's office to send them any research articles about using methadone off-label for WED/RLS. The doctor's office doesn't use this drug for anyone except me, and they prescribe it primarily because of a conversation with Dr Buchfuhrer - meaning they don't know what the research says.
So, they called me and said, hey, do you have any articles? Great. Just how I wanted to spend my day.
Unfortunately, there aren't a lot of articles about using methadone specifically. And not even a lot about using opioids. That's because the pharma companies won't make money by studying it because the drugs are all generic now.
Here's what I've come up with - I think these show a decent overall view of opioids and specifically methadone. I included articles about how the endogenous opioid system may be involved, as these offer an explanation as to why opioids work. I hope this is enough!
Does anyone have any to add?
1. Methadone for refractory restless legs syndrome. Ondo WG - Mov Disord - 01-MAR-2005; 20(3):
Abstract:
Most cases of restless legs syndrome (RLS) initially respond well to dopaminergic agonists. However, an unknown percentage of patients is intolerant of dopaminergic adverse events, initially or subsequently refractory, or develops limiting augmentation. We administered methadone 5 to 40 mg/day (final dose, 15.6 +/- 7.7) to 29 RLS patients who failed dopaminergics. They were currently taking or had previously tried 5.9 +/- 1.7 (range, 3-9) different medications for RLS and 2.9 +/- 0.8 (range, 2-4) different dopaminergics. Of the 27 patients who met inclusion criteria, 17 have remained on methadone for 23 +/- 12 months (range, 4-44 months) at a dose of 15.5 +/- 7.7 mg/day; 2 dialysis RLS patients died while on methadone, and 8 stopped the treatment (5 for adverse events, 2 for lack of efficacy, and 1 for logistical reasons).
All patients who remain on methadone report at least a 75% reduction in symptoms, and none have developed augmentation. Methadone should be considered in RLS patients with an unsatisfactory dopaminergic response.2004 Movement Disorder Society.
2. Dyskinesias while awake and periodic movements in sleep in restless legs syndrome
Treatment with opioids
Wayne A. Hening, Arthur Walters, Neil Kavey, Stephen Gidro-Frank ,Lucien Côté and Stanley Fahn
Abstract
In five unrelated patients with the restless legs syndrome, opioid drugs relieved restlessness, dysesthesias, dyskinesias while awake, periodic movements of sleep, and sleep disturbances. When naloxone was given parenterally to two treated patients, the signs and symptoms of the restless legs syndrome reappeared. Naloxone placebo had no effect. Opioid medications may offer a useful therapy for the restless legs syndrome. The endogenous opiate system may be involved in the pathogenesis of the syndrome.
Citation:
Methadone for refractory restless legs syndrome.
Ondo WG - Mov Disord - 01-MAR-2005;
Full Source Title:
Movement disorders : official journal of the Movement Disorder Society
Long-Term follow-up on restless legs syndrome patients treated with opioids
Arthur S. Walters MD1,6,7,*, Juliane Winkelmann MD2, Claudia Trenkwalder MD2, June M. Fry MD, PhD3, Vandana Kataria PharmD4, Mary Wagner PharmD4, Rakesh Sharma MD5, Wayne Hening MD, PhD6,7, Liren Li MD6
Article first published online: 30 NOV 2001
DOI: 10.1002/mds.1214
The medical records of 493 patients with restless legs syndrome (RLS) from three major centers were studied to determine the number and outcome of patients who had been treated with opioids as a monotherapy. At one time or another 113 patients (51 men, 62 women; age range, 37–88 years) had been on opioid therapy either alone (36 patients) or with opioids added secondarily to other medications used to treat RLS (77 patients). Twenty-three of the 36 opioid monotherapy patients had failed dopaminergic and other therapeutic agents prior to the initiation of opioid monotherapy. Twenty of the 36 opioid monotherapy patients continue on monotherapy for an average of 5 years 11 months (range, 1–23 years), despite their knowledge of the availability of other therapies. Of the 16 patients who discontinued opioids as a sole therapy, the medication was discontinued in only one case because of problems related to addiction and tolerance. Polysomnography on seven patients performed after an average of 7 years 1 month of opioid monotherapy (range, 1–15 years) showed a tendency toward an improvement in all leg parameters and associated arousals (decrease in PLMS index, PLMS arousal index, and PLM while awake index) as well as all sleep parameters (increase in stages 3 and 4 and REM sleep, total sleep time, sleep efficiency, and decrease in sleep latency). Two of these seven patients developed sleep apnea and a third patient had worsening of preexisting apnea. Opioids seem to have long-term effectiveness in the treatment of RLS and PLMS, but patients on long-term opioid therapy should be clinically or polysomnographically monitored periodically for the development of sleep apnea. © 2001 Movement Disorder Society.
4. Dominantly inherited restless legs with myoclonus and periodic movements of sleep: a syndrome related to the endogenous opiates?
Walters A, Hening W, Côté L, Fahn S
Advances in Neurology [1986, 43:309-319]
Type: Journal Article, Case Reports, Research Support, Non-U.S. Gov't
Abstract
The restless legs syndrome is a sensory and motor disorder of evening, repose, and sleep. The cardinal features include (a) restlessness, which is frequently associated with (b) dysesthesias, (c) myoclonic jerks and other dyskinesias while awake, (d) periodic movements of sleep, and (e) sleep disturbances. We have recently had the opportunity to study two patients severely affected by this syndrome whose family histories are consistent with dominant inheritance. Both patients serendipitously discovered that their symptoms responded uniquely well to opiate medication. Both patients were studied extensively with electrophysiological and videotape monitoring, and their movements were characterized. In both patients, all elements of the syndrome responded to opiates, with marked relief of symptoms and without any significant side effects. The specific opiate antagonist naloxone blocked the therapeutic benefit of the opiates. Our findings support the involvement of the endogenous opiate system in the pathogenesis of restless legs and related dyskinesias and suggest that opiate therapy may be a potentially valuable treatment for this sometimes disabling syndrome.
Author Affiliation:
Baylor College of Medicine, Houston Texas
5. The role of opioids in restless legs syndrome: an [11C]diprenorphine PET study
Sarah von Spiczak1,4,
Alan L. Whone1,
Alexander Hammers1,3,
Marie-Claude Asselin2,
Federico Turkheimer1,
Tobias Tings4,
Svenja Happe4,
Walter Paulus4,
Claudia Trenkwalder4 and
David J. Brooks1
+ Author Affiliations
1Division of Neuroscience and MRC Clinical Sciences Centre, Faculty of Medicine, Imperial College and 2Hammersmith Imanet, Hammersmith Hospital, London, 3Department of Clinical and Experimental Epilepsy, Institute of Neurology, UCL, London, UK, 4Department of Clinical Neurophysiology and Georg-August University, Goettingen, Germany
Correspondence to: Sarah von Spiczak, Department of Clinical Neurophysiology, Georg-August University Goettingen, Robert-Koch-Strasse 40, D-37099 Goettingen, Germany. E-mail: sarah.v.s@gmx.de
Received March 17, 2004.
Revision received July 11, 2004.
Accepted January 18, 2005.
Summary
Opioids have been shown to provide symptomatic relief from dysaesthesias and motor symptoms in restless legs syndrome (RLS). However, the mechanisms by which endogenous opioids contribute to the pathophysiology of RLS remain unknown. We have studied opioid receptor availability in 15 patients with primary RLS and 12 age-matched healthy volunteers using PET and [11C]diprenorphine, a non-selective opioid receptor radioligand. Ligand binding was quantified by generating parametric images of volume of distribution (Vd) using a plasma-derived input function. Statistical parametric mapping (SPM) was used to localize mean group differences between patients and controls and to correlate ligand binding with clinical scores of disease severity. There were no mean group differences in opioid receptor binding between patients and controls. However, we found regional negative correlations between ligand binding and RLS severity (international restless legs scale, IRLS) in areas serving the medial pain system (medial thalamus, amygdala, caudate nucleus, anterior cingulate gyrus, insular cortex and orbitofrontal cortex). Pain scores (affective component of the McGill Pain Questionnaire) correlated inversely with opioid receptor binding in orbitofrontal cortex and anterior cingulate gyrus. Our findings suggest that, the more severe the RLS, the greater the release of endogenous opioids within the medial pain system. We therefore discuss a possible role for opioids in the pathophysiology of RLS with respect to sensory and motor symptoms.