Furious....and scared

[ViewsAskew]

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.

[Polar Bear]

Never, ever, would I have thought that a pharmacy would question a prescription written by a doctor.
The doctor decides, he writes the script... the pharmacy fills the script.
Yes, so , maybe there is a point where they check that the script is valid because of two different pens etc. but not to question the reasoning behind why a doctor is prescribing a particular medication !

I wouldn't have anything to add with regard to research articles, you are much more versed in this regard.
Just a thought... Could Dr B have anything to advise?

I am appalled that a patient is in the position of having to prove what a doctor has already decided.
I wish you well.

[Polar Bear]

And just to add, of course the fear that the medication could be withdrawn.
This is a dreadful scary situation. (( hugs ))

[ViewsAskew]

You said it very well, PB. I can't fathom that the pharmacy would do this. I don't know if it's one pharmacist there, or that particular pharmacy, or the whole chain.

The thought that the ONLY medication that I've been able to count on - and I've tried many - might be unavailable to me absolutely terrifies me.

Of course, the doctor's office staff probably isn't thinking about it that way. I sent the list to them hours ago and they still haven't responded to my email saying it's good, not good, they got it, etc.

Hubby and I have been contemplating moving to California. There is more work there for me (still deluding myself I can potentially work full-time) and hopefully a decent amount of contract work. I'd be close to Dr B, and I have friends in So Cal along with family. If I can't get the script here, that might be the tipping point. I guess I could go out and stay with friend or family for a month or two, see Dr B, job hunt, etc. I just didn't think it might happen in the next 29 days (when the script runs out).

[Polar Bear]

You say that you have been contemplating a move to California - all for positive reasons.
This has to have been a shock of a day for you, enough that you feel it could be the tipping point for your move.
OMG - non sufferers have just no idea, have they. The effects of this disease !!

You are very patient with regard to your doctors office, think I might have been ringing them to ask if all was sufficient.
I have very little patience (in some matters). It is very hard to be in limbo.

[ViewsAskew]

I agree, PB - people really have no idea. Just no idea. Even I'm shocked by it now and again.

[majoraward]

Can't you just got to a different pharmacy? I have had similar problems. You go up to them and demand the prescription back and take it to another place. I have had 4 pharmacies in the last year. Finally the one I am at now gets it. Have the doctor put on the prescription "For Restless Leg Syndrome" so it appears on bottle.

Also you pull all the prescriptions out of there and don't go back.

[ViewsAskew]

To me, it's not so much about needing to find another pharmacy, as what we have to go through in general - the lack of respect and the lack of knowledge by the medical community. I have to PROVE that I am deserving of this drug and that this drug works. When was the last time a diabetic had to prove he or she was deserving of Metformin or insulin? As Polar Bear said, the doc wrote it, you expect the pharmacy to fill it - and they have for two years.

It also sux that I don't have a doctor who "has my back" and will go to bat for me. To call the patient and tell them to find proof that the treatment is acceptable? That's pretty funny and a very dark way.

The DEA involvement terrifies me. That a pharmacy would feel so scared about audits that they would stop filling scripts that doctors write (I mean, as Polar Bear notes- a doctor wrote it!) unless the doctor can prove that he/she has evidence? Why would a doctor write a script if he/she didn't think it would work? And, don't forget the recent push by a group of doctors to get the DEA to stop allowing opioid scripts for anything except pain - not for cancer, RLS/WED, etc. If they get their way, none of us will be taking these drugs unless we move to another country.

But, if you only look at it from the perspective of simply getting it filled, I've already had to change pharmacies and many of the pharmacies do not stock methadone where I am. I don't own a car, so switching and finding one that has it and that I can get to isn't necessarily easy. This one is part of a large chain - if this is a chain-wide initiative, I won't be able to use them at all unless I can prove it - so the other bazillion of their stores are out of bounds, too. Of course, that remains to be seen. Chain 2 tell me they never have methadone and of the four or five locations of Chain 3 I've gone to, they've yet to carry it.

[majoraward]

All I can say is I am shocked. I would have thought Chicago was a more open minded city like Seattle. I mean even Boeing moved its corporate offices to Chicago. Now if it were my home town of 2,200 with many narrow minded inhabitants, then I could understand - sort of.

[majoraward]

Okay so my wife just called from the pharmacy and they said the insurance wouldn't pay for my prescription until the 27th. A new prescription for a blood pressure med used for RLS that I have never had I spoke too soon My wife asked how much it was, it was $11, she told her to just fill it and she would pay. OMG such morons!

[ViewsAskew]

Just got a response from Dr B. He added two articles to the list above. One written by him and one by Silver. The one by Silver is a ten year longitudinal assessment of DA and methadone.

He said it's very unusual for a pharmacist to question a doctor when it's a low dose of opioids. [A heroin addict takes from 80 to 325 mg per day - at the most, we take 30 and it averages about 15 mg.] He also said a few area pharmacies have asked him to write "for RLS Pain" on the script instead of "for RLS." That seems a GREAT idea. He said then it fulfills the criteria of writing opioids for pain. I'm going to suggest that.

If anyone else runs into their pharmacy or pharmacist refusing to fill a methadone or opioid script, feel free to use anything learned in this post. I hope that this is a one-time thing and that no one else has this happen.

Oh, Majoraward, when I first started taking methadone, I went to see my old doctor in a rural town of 5000 people. I used to live there and then moved into Chicago. He was fine writing it after talking to Dr B. One day he was busy and they had me see a new partner in his practice. The guy used to live and practice in Chicago. He got angry with me when I told him why I was there, refused to treat me, and walked out. I was shocked! The nurse scuttled me over to the other part of the office where my regular doctor was seeing patients. He came in as soon as he could and apologized. He said that the other doctor saw a lot of drug-seeking people and addicts, and had seen people die from using said drugs. Because he'd seen so much of the "bad" side of such things, he was completely against using methadone for anything.

I spent a couple years trying to find a doctor here while driving 60 miles each way to see my old doc - every month (still had a car in those days). I tried 15 doctors and not one would prescribe methadone. So, maybe those small towns are better for these things.

[majoraward]

My doctor actually writes me 3 months of scripts at a time. I put them on the fridge with a magnet hanger. They show that they are all written at same time but "postmarked" like 11/15/12, 12/15/12, 01/15/13. It is a wonderful way to get them and the pharmacy isn't going to let me have them if they are not the take home date (or whatever it is called). A certain comfort factor for me for sure. I think mine are only 5mg tabs, but 3 times a day.

[Polar Bear]

Ann, I'm glad that Dr B was able to come up with some further research, also a good idea about writing 'for rls pain' on the script.

With regard to everyone else involved there is some very strong language trying to squeeze out between my tightly pursed lips. !!

[debbluebird]

While I was still working, I heard of pharmacies doing this. They seem to think they know more than doctors.
Good luck

DEB

[ViewsAskew]

My doctor actually writes me 3 months of scripts at a time. I put them on the fridge with a magnet hanger. They show that they are all written at same time but "postmarked" like 11/15/12, 12/15/12, 01/15/13. It is a wonderful way to get them and the pharmacy isn't going to let me have them if they are not the take home date (or whatever it is called). A certain comfort factor for me for sure. I think mine are only 5mg tabs, but 3 times a day.

That didn't used to be legal. A law changed a few years ago. Before that, you had to see your doctor EVERY month AND the script had to be filled in 24 or 72 hours (can't remember - just remember going to the doctor and the pharmacy a LOT). The FDA made the new ruling, but states do not have to adopt these rulings as they may adopt stricter rules. In some states, for example, only methadone clinics can write scripts for methadone. I don't know what your state allows. Illinois adopted the new rule a few years ago, so a 90 day supply is allowed.

Doctors aren't allowed to write a date in the future, legally, by the way, as I understand the FDA rule. The rules require them to write today's date on them and then, on the bottom, write, "Not to be filled before xx/xx/xxxx." They aren't going to know if the doctor post dated it, but if they found out, they would not fill it. See the listing at this site for the Class Ii Narcotics: http://www.fpnotebook.com/pharm/Manage/ ... Sbstnc.htm